Background Info

Gardasil Girls’ Families Issue a Warning to Families with Sons to be Wary of HPV Vaccineshttp://www.seopressreleases.com/gardasil-girls-families-issue-warning-families-sons-wary-hpv-vaccines/9385

NORTH HOLLYWOOD, CALIFORNIA, June 7, 2010 — In the four years since the approval of Gardasil there has been 18,229 adverse reactions and 70 deaths reported to the Vaccine Adverse Reporting System (VAERS) with an estimated 1 to 10% of the victims reporting.  On September 8, 2009 the FDA approved the use of Gardasil for boys ages 9 to 26.  How is it that with increasing numbers of adverse reactions amongst girls that the same vaccine can in good faith be marketed to boys?

On September 11, 2009, ABC News Men’s Health Coverage posted an article titled Doctors Say ‘Wait And See’ Before Prescribing Gardasil In Boys – Experts Advise Caution After FDA Panel Approves HPV Vaccine for Maleshttp://abcnews.go.com/Health/MensHealthNews/gardasil-boys/story?id=8541892 stating that “some say a conservative approach should be taken in vaccinating boys until more evidence is in.”

TruthAboutGardasil.org (TAG) is demanding to know what evidence has come in between September of 2009 and May of 2010 to warrant marketing the vaccine to boys.  Other than the fact that Merck has saturated the adolescent girl’s market, and is moving on to another market. This is a tactic historically used by pharmaceutical and tobacco companies when targeted markets realize risks outweigh benefits. They strategically shift into “virgin” demographics.

TAG is already receiving queries from young men adversely affected by the vaccine:

“I am a 25 year old male who has received two doses of the Gardasil Vaccine.  First dose was

Dec 1, 2009 and the second one on February 1, 2010.  In recent weeks I have been experiencing severe abdominal pain.  I thought it was a hernia at first but it was not.  I have been told to observe and that is very frustrating.  I was just wondering if you have heard any stories from males experiencing abdominal pain after getting the vaccine.  Also what should I do?  How can I get rid of this pain?”

On May 28, an angered parent from Florida posted this comment to the National Vaccine Information Center’s Investigate Gardasil Vaccine Risks NOW petition site:

“My daughter and my son both had the shot on the same day. My daughter had a seizure less than a month after the shot, and my son had a seizure three months after the shot. My children are healthy kids; 17 and 14, who have no history of seizures in their family. Please realize that this vaccine is a killer and should be taken off the market. I am just worried sick that my children will have more adverse reactions in the future.”

Do we need to wait another four years and watch the statistics rise in the VAERS reports for adolescent boys before these vaccines are taken off the market?

With crucial information lacking about the vaccine’s duration and potential to protect against cancer in males, vaccinating young boys is discouraged until such time as additional safety and efficacy studies have been completed.

What is Wrong with the Gardasil Girls? HPV Vaccines Causing Injuries Globally & No One Has Answers

<http://www.seopressreleases.com/wrong-gardasil-girls-hpv-vaccines-causing-injuries-globally-answers/9216>

North Hollywood, California, June 2, 2010 — If the FDA, the AMA, and the CDC are not to going to ask this question – then TruthAboutGardasil.org (TAG) will keep asking until the families of the injured girls have the answers, the medical attention and vaccine injury compensation they deserve.

On May 11, 2010, an interview with TruthAboutGardasil.org co-founder Rosemary Mathis was aired on NBC affiliate WXII12 in Winston-Salem, North Carolina. The expose titled: Mom Blames Teen’s Illness on HPV Vaccine, http://www.wxii12.com/news/23519907/detail.html has been read and the video viewed by thousands of people globally.  What was unexpected was the high number of comments from mothers whose daughters have been injured by the vaccines.

My daughter had all 3 injections, and after each one she got sicker and sicker. At the time, we had no idea that it was the shots doing it to her. After the first shot, she had flu like symptoms, would pass out, and had seizures. The second shot, left her with vision problems and a lot of pain. She was so sick they hospitalized her, but couldn’t find what was wrong. The doctor declared: “You have one sick daughter, but we don’t know why.”

Late June 2007, our daughter’s life changed after Gardasil. She went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals, and the list just keeps growing.

Internet searches reveal thousands of posts from mothers desperate to connect with other mothers of injured daughters. Social media networks host hundreds of groups with thousands of disturbing stories about adverse reactions. One common denominator for all of the girls afflicted – with varying degrees of severity – is autoimmune diseases. A medical source close to TAG has stated:  “I find it disturbing that Merck’s agreement with the FDA is based on an agreement that no adverse events will be labeled as such unless there is a TWO fold increase seen of diseases that occur at least as frequently as 1/10,000.  This takes away all of the rare autoimmune demyelinating syndromes that cause blindness, paralysis and death.”

A February 2010 study was published on the PubMed.gov web site titled Vaccines and autoimmune diseases of the adult. The abstract states: “Infectious agents contribute to environmental factors involved in the development of autoimmune diseases possibly through molecular mimicry mechanisms. Hence, it is feasible that vaccinations may also contribute to the mosaic of autoimmunity. Evidence for the association of vaccinations and the development of these diseases is presented in this review. Infrequently reported post-vaccination autoimmune diseases include systemic lupus erythematosus, rheumatoid arthritis, inflammatory myopathies, multiple sclerosis, Guillain-Barré syndrome, and vasculitis. In addition, we will discuss macrophagic myofasciitis, aluminum containing vaccines, and the recent evidence for autoimmunity following the use of human papillomavirus vaccine.”

Evidence of absence does not mean absence of evidence.

Download as PDF  <http://www.seopressreleases.com/wp-content/plugins/as-pdf/generate.php?post=9216>

Other press releases from Truth About Gardasil

• Truths about Gardasil®, Cervarix® and Cervical Cancer Suppressed – Part III <http://www.seopressreleases.com/truths-gardasil-cervarix-cervical-cancer-suppressed-part-iii/9103>  - May 27th, 2010
• End of Cervical Cancer Possible – But At Whose Cost? <http://www.seopressreleases.com/cervical-cancer-cost/8921>  - May 24th, 2010
• Truth About Gardasil Founder Voices Concerns About HPV Vaccine <http://www.seopressreleases.com/truth-gardasil-founder-voices-concerns-hpv-vaccine/8728>  - May 17th, 2010
• Truths about Gardasil®, Cervarix® and Cervical Cancer Suppressed – Part II <http://www.seopressreleases.com/truths-gardasil-cervarix-cervical-cancer-suppressed-part-ii/8655>  - May 13th, 2010
• Truths about Gardasil®, Cervarix® and Cervical Cancer Suppressed – Part I <http://www.seopressreleases.com/truths-gardasil-cervarix-cervical-cancer-suppressed-part/8513>  - May 10th, 2010
  

VOL. 114, NO. 6, DECEMBER 2009 OBSTETRICS & GYNECOLOGY

Pp 1168-1169

Update on Quadrivalent Human Papillomavirus

Vaccination and Pregnancy Outcomes

Is Contraception Advisable?

Karen Smith-McCune, MD, PhD

George F. Sawaya, MD

Current guidelines from the Centers for Disease Control and Preven-

tion recommend prophylactic quadrivalent human papillomavirus

(HPV) types 6/11/16/18 vaccination of women up to the age of 26 years,

a population with childbearing potential. While the vaccine is not

recommended for use in pregnant women, inadvertent exposures during

pregnancy do occur. Therefore, clinicians and patients will be interested

in two articles in this issue of Obstetrics & Gynecology that report pregnancy

outcomes among women who received HPV vaccination within 30 days

of conception, at any time during pregnancy, or at any time during phase

III vaccine trials.

The article by Dana et al1 (see p. 1170) presents data from the first 2

years of the Pregnancy Registry established by Merck and Co., Inc.

tion recommend prophylactic quadrivalent human papillomavirus

(HPV) types 6/11/16/18 vaccination of women up to the age of 26 years,

a population with childbearing potential. While the vaccine is not

recommended for use in pregnant women, inadvertent exposures during

pregnancy do occur. Therefore, clinicians and patients will be interested

in two articles in this issue of Obstetrics & Gynecology that report pregnancy

outcomes among women who received HPV vaccination within 30 days

of conception, at any time during pregnancy, or at any time during phase

III vaccine trials.

The article by Dana et al1 (see p. 1170) presents data from the first 2

years of the Pregnancy Registry established by Merck and Co., Inc.

(Whitehouse Station, NJ) at the time of vaccine licensure to monitor

postmarketing vaccine exposures during pregnancy. There were 517

evaluable prospective reports with known pregnancy outcomes after

exposures occurring within 1 month before the last menstrual period or at

any time during pregnancy. In these women, the rate of spontaneous

abortion was comparable to published data. The rate of fetal death was

slightly higher than that in the general population, but the total number of

fetal deaths in the registry was small. The rate of major birth defects was

similar to that in the general population. Regarding congenital anomalies,

there were two cases of schizencephaly, a rare central nervous system

malformation with an estimated population prevalence of 1.5 in 100,000

births; one case was reported prospectively (before the pregnancy out-

come was known) and one retrospectively (after the pregnancy outcome

was known). Two cases of anencephaly were reported, one prospectively

and one retrospectively. Anencephaly is a rare neural tube defect with an

estimated population prevalence of 1.1 cases in 10,000 births. The

significance of the findings is severely limited due to the potential

reporting bias for retrospective cases and absence of an optimal unex-

posed comparison group. The ongoing registry will continue to monitor

the occurrence of these and other defects.

Garland et al2 (see p. 1179) report pregnancy outcomes from phase

III randomized trials. These analyses have the important advantage of a

concurrent unexposed comparison group (the placebo groups of the

trials). The report contains pregnancy outcomes from 3,620 women who

became pregnant during four completed and one ongoing phase III

quadrivalent vaccine trials. The authors report that the vaccine was well-

tolerated by pregnant women. Slightly higher rates of congenital anom-

alies were noted among infants in the vaccine group, but these differences

were not statistically significant. Experts in teratology reviewed reports of

1168 VOL. 114, NO. 6, DECEMBER 2009 OBSTETRICS & GYNECOLOGY

the anomalies and concluded that they were unlikely

to be related to vaccination, but the authors conclude

that their findings should be considered preliminary

due to limited power to detect differences.

The most uncertainty, perhaps, surrounds the

effect of vaccination on pregnancies that occur among

women becoming pregnant within 30 days of vacci-

nation. Of note, this is a separate issue from vaccine

exposure in women known to be pregnant. A previ-

ously published interim analysis of pregnancy out-

comes among women becoming pregnant within 30

days of vaccination (in combined results from four

phase III trials) showed a statistically significant in-

creased risk of congenital anomalies in the vaccine

group.3 Garland et al report that no further pregnan-

cies occurred within 30 days of vaccination in these

four trials,2 but they update the analysis to include

outcomes from an ongoing trial (protocol 019). In this

trial, one additional congenital anomaly has occurred

in the placebo group among women becoming preg-

nant within 30 days of vaccination. The difference

noted in risk of anomalies between groups is now no

longer statistically significant (5 anomalies compared

with 1, absolute risk difference 3.2%, 95% confidence

interval 􏰀0.5% to 6.9%). More information is forth-

coming; the authors report that approximately 30% of

unknown pregnancy outcomes are due to ongoing

pregnancies in protocol 019. In the Pregnancy Regis-

try, vaccine exposure apparently occurred before or

close to the time of conception, based on the reported

last menstrual period, for the two cases of schizen-

cephaly and the two cases of anencephaly. Ongoing

monitoring of registry data from pregnancies con-

ceived within 30 days of vaccination will determine

the significance of these findings.

How can the results from these two reports be

interpreted in a clinical context? Human papilloma-

virus vaccination during pregnancy is still not recom-

mended, and women should be assessed for possible

pregnancy before receiving vaccination. Clinicians

should continue to report to the Pregnancy Registry

any HPV vaccine exposures during pregnancy as well

as exposures within 30 days before conception. While

differences in the numbers of congenital anomalies

among women receiving HPV vaccination were not

significant, these results are considered preliminary

by the authors. The most challenging results to inter-

pret pertain to the potential adverse outcomes ob-

served among women conceiving within 30 days of

vaccination. The current findings are fragile: analyses

are interim, the total number of outcomes is small

(especially in the placebo group), and the association

lacks clear biologic plausibility. Nevertheless, results

from randomized trials suggesting harm warrant fo-

cused attention, especially when stakes are high (po-

tential fetal and infant harms). Participants in the trials

were advised to use effective contraception until 1

month after the third dose. At the current state of

evidence, a cogent argument can be made to also

recommend that women at risk of pregnancy seeking

HPV vaccination be similarly advised. Guidance re-

garding this issue from groups recommending vacci-

nation of sexually active women, such as the Centers

for Disease Control and Prevention, would certainly

be useful to clinicians and patients.

REFERENCES

1. Dana A, Buchanan KM, Gos MA, Seminack MM, Shields KE,

Korn S, et al. Pregnancy outcomes from the Pregnancy Reg-

istry of the quadrivalent human papillomavirus types 6/11/

16/18 vaccine. Obstet Gynecol 2009;114:1170– 8.

2. Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero

KL, et al. Pregnancy outcomes in the clinical trials of the

human papillomavirus type 6/11/16/18 vaccine. Obstet

Gynecol 2009;114:1179– 88.

3. The FUTURE II Study Group. Quadrivalent vaccine against

human papillomavirus to prevent high-grade cervical lesions.

N Engl J Med 2007;356:1915–27.

Karen Smith-McCune, MD, PhD, is from the De-

partment of Obstetrics, Gynecology and Reproductive

Sciences and the Helen Diller Family Comprehensive

Cancer Center at the University of California San

Francisco (UCSF); e-mail: kmccune@cc.ucsf.edu.

George F. Sawaya, MD, is from the Department of

Obstetrics, Gynecology and Reproductive Sciences, the

Department of Epidemiology and Biostatistics, and the

Helen Diller Family Comprehensive Cancer Center at

UCSF; e-mail:sawayg@obgyn.ucsf.edu.

Financial Disclosure

The authors did not report any potential conflicts of

interest.

© 2009 by The American College of Obstetricians

and Gynecologists. Published by Lippincott Williams

& Wilkins.

ISSN: 0029-7844/09

Judy Wilyman

A Critique of the Promotional Campaign for Gardasil®

Dr. Diane Harper is a researcher who was involved in the safety and efficacy trials for the Human Papillomavirus (HPV) vaccine – Gardasil®. This drug is observed to prevent infection from 2 strains of HPV virus (16 and 18) and it has been promoted to the public as being preventative against cervical cancer. The clinical trials for this drug were funded by the pharmaceutical company Merck and many of the researchers were employed by Merck (1). On the 19^th August Dr. Harper spoke out about the concerns she has regarding the safety of this drug and its ability to prevent cervical cancer. She is to be commended for doing this and her comments have been presented in a CBS media release titled Gardasil® Vaccine causes More Deaths and Damage than the Vaccine itself (2). As a parent and a researcher, I have been compelled to write the following article about Dr. Harper’s comments because it is apparent that the public has been misinformed about this drug.

In the interview Dr. Harper gave to CBS she stated that she believes “the public should receive more complete warnings before receiving the vaccine”. This is incorrectly stating the problem. Instead of ‘more complete warnings’ I believe it is extremely important that parents are given accurate information on Gardasil®. This drug has been promoted as a cervical cancer drug when in fact it has only been observed to prevent HPV infection (1).

Health authorities have claimed that this vaccine will be effective for 5 years. Considering this vaccine was tested for only 4 years in women 16 – 26 years of age, I think it is important that parents are informed how this information was generated. Parents would also like to know what ‘protection’ for 5 years actually means. Given that we have evidence it will protect against infection from HPV strains 16 and 18 but we have no evidence that it is the determining factor needed for carcinomas to form (3) (4). So it may prevent some cervical cancer (remembering that HPV does not cause cervical cancer on its own – another co-factor is required) assuming these 2 strains (16 and 18) are a determining factor in cancer development and assuming there is no infection from one of the other 12 HPV viruses known to be associated with cervical cancer development in humans (3) (4).

The US CDC claims the vaccine is ‘safe and effective’ but where is the supportive data for this statement? Vaccine safety and efficacy studies for Gardasil® were funded by Merck and other pharmaceutical companies. As producers of the vaccine they have a serious conflict of interest. Consequently the public is entitled to demand accountability and rigour in the presentation of immunisation policies. Particularly since Merck’s chief executive officer was quoted in 2006 claiming ‘Gardasil® was the pharmaceutical brand of the year for building a market out of thin air’ (5).

This media hype is also supported by the fact that cervical cancer is not a significant problem in all countries. Yet it was portrayed to women as the “second most life-threatening cancer among women worldwide (3).  In developed nations where Pap Smear Screening Programs have been implemented cervical cancer is a very low risk to women (3). It is almost 100% curable when it is detected early (6) and in Australia it is listed as the 18^th most common cancer in women (5).

In addition, it remains unproven that HPV infection is the determining factor in carcinoma development given that the majority of women are infected with HPV but the majority of women do not get cervical cancer (3) (4). Pfister (1990) confirms this by stating “vaccination is not yet justified as there is no formal proof for HPV causing cancer” (8) He continues by saying that “although the latter is certainly true, the best way to prove a necessary role of HPV in genital cancer development would be prevention by vaccination”. This is particularly interesting as he finishes by saying “extensive research is needed before a vaccine will be available”. Yet Haverkos is still stating in 2005 that many scientists admit they still do not know what the co-factor is that is necessary to turn HPV infection into a carcinoma (3).

Until a truly independent body is allowed to assess the data that pharmaceutical companies are presenting to general practitioners, governments and the public, the health of the community will continue to be at risk. We will continue to see chronic illness increase in the population as the government spends greater amounts of money on health. Is anybody going to argue that the primary interest of pharmaceutical companies is women’s health or that their primary interest is the health of the population? Pharmaceutical companies have a serious conflict of interest and nobody is making them accountable. The public is sitting back as Merck informs us that the 32 deaths after Gardasil® vaccination were a coincidence. What sort of science is this? Are our children’s lives not important enough to apply the Precautionary Principle to this vaccine – a vaccine which is of dubious benefit?

Not only are we told that the benefits of this vaccine are not fully determined but the public is informed that the onus is on us to prove that the vaccine has caused these deaths. In other words, manufacturers do not have to prove the vaccine cannot cause deaths before they use it on our daughters. Why have we allowed the Precautionary Principle to be turned upside-down? This principle states the ‘burden of proof of harmlessness is on the manufacturer not the general public’. How is it that this unethical situation is allowed to persist? We can no longer trust the government or medical practitioners to look after public health because their decisions are influenced by financial ties to pharmaceutical companies.

Dr. Harper’s article states that ‘Merck has confidence in the safety of Gardasil®’. Did anyone expect Merck to say they didn’t have confidence in a product they have spent millions of dollars investing in? Why should this statement give us confidence in the vaccine? How confident would we feel if we re-state it correctly as ‘Merck continues to have confidence in Gardasil’s® safety profile as evidenced from the studies Merck has carried out and funded’. How confident does this make us feel?

Dr. Harper reports that Lou Gehrig’s disease (Amyotrophic Lateral Sclerosis -ALS), a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord has been reported after Gardasil® vaccination. It is also reported that 32 deaths have occurred plus many serious adverse reactions. There is a statement by Dr. Slade later in the article from the Centers for Disease Control and Prevention (CDC), saying that a third of the possible deaths were left out of the statistic. But instead of taking a precautionary approach for this non-essential vaccine Merck tells us “just because patients died just after the shots doesn’t mean the shots were necessarily to blame”. Is this for real? Parents would like to know – and are legally entitled to know – whether the vaccine can cause these types of reactions before the vaccines are used on our children – not after they have been used on our children. To date Merck has made 1.4 billion dollars from this experiment (9).

Dr. Slade reports that the risk of serious events including death after gardasil was 3.4/100,000 doses distributed. Dr. Harper then states that ‘the rate of serious adverse events is on par with the death rate of cervical cancer’. This figure is then corrected because the figure was determined by using the total number of doses that were produced by the manufacturer and many of these (one-third) are still sitting in the refrigerator waiting to be distributed. Therefore using a smaller denominator the incidence of serious adverse events is now 5 fold greater than the incidence of cervical cancer – which in fact varies between countries. This measure of harm is based on the assumption that the vaccine will prevent some cervical cancer.

In other words, we have seriously increased the amount of chronic illness and deaths in young women without a guarantee that cervical cancer will be reduced. Dr. Harper asks ‘how parents value this information?’ Parents are very angry that our trust in the medical profession has been betrayed by the governments who have not put the public interest first. Governments have allowed the pharmaceutical companies to fund Professional Medical Associations in order to influence the promotion of this vaccine to the public (9).

Dr. Harper goes on to say that she agrees with Merck and the CDC that this vaccine ‘is safe for most girls’. What is this statement being based upon when chronic illness has not been factored into the safety trials that were carried out by Merck?  The chemicals in vaccines can affect biological systems hours, months or years after exposure (10). This vaccine contains 225 micrograms of aluminium adjuvant which is several times more than other vaccines (1). It has been known since 1966 that this adjuvant is linked to hypersensitivity reactions in humans (11). The results of the trials showed numerous adverse reactions from Gardasil® and the placebo that contained aluminium adjuvant (1). The vaccine was also linked to autoimmune diseases in the trials, in particular an increase in arthritis and rheumatoid arthritis (1).

A further point is made regarding the fact that the vaccine won’t protect against 30 percent of cervical cancer. This is because there are at least 14 HPV strains that cause 90% of cancers (12). HPV strains 16 and 18 are only associated with 70 percent of cervical cancers in women. The following statement by Dr. Harper about gardasil vaccination needs clarification ‘should women believe this is preventative for all cancers – something never stated but often implied in the population…”. The reason the public believes that Gardasil® vaccination will protect against all cervical cancer is because that is what they have been told in education programs in schools and through the media, which are funded by governments and pharmaceutical companies.

The information presented to young girls did not emphasis that 30 percent of cervical cancer was not protected by the vaccine. It was implied to women that the vaccine would protect against all cervical cancers. This problem has arisen because of the misinformation presented to women about this vaccine. This information has been supported by the health departments and the medical profession of all countries.

Dr. Harper is to be commended for speaking out. However, claiming that Gardasil® vaccine could be a ‘miserable failure’ is understating the problem. There’s great urgency to determine whether Gardasil® has precipitated chronic illness and death. That determination would make it a huge public health disaster if it is established that HPV 16 and 18 are not the determining factor in the progression of dysplasia to cervical cancer. Public health authorities should have required these answers before Gardasil® was promoted to women not after the event.

Judy Wilyman

PhD Candidate Murdoch University

December 2009

Acknowledgements:

I would like to acknowledge Catherine Frompovich for her comments on the structure of this paper and for the support of Associate Professor Peter Dingle.

19 August 2009

http://jama.ama-assn.org/cgi/content/full/302/7/795

The Risks and Benefits of HPV Vaccination

Charlotte Haug, MD, PhD, MSc

JAMA. 2009;302(7):795-796.

When do physicians know enough about the beneficial effects of a new medical intervention to start recommending or using it? When is the available

information about harmful adverse effects sufficient to conclude that the

risks outweigh the potential benefits? If in doubt, should physicians err on

the side of caution or on the side of hope? These questions are at the core

of all medical decision making. It is a complicated process because medical

knowledge is typically incomplete and ambiguous. It is especially complex to

make decisions about whether to use drugs that may prevent disease in the

future, particularly when these drugs are given to otherwise healthy

individuals. Vaccines are examples of such drugs, and the human

papillomavirus (HPV) vaccine is a case in point.

zur Hausen, winner of the Nobel Prize in Physiology or Medicine in 2008,

discovered that oncogenic HPV causes cervical cancer.1  His discovery led to

characterization of the natural history of HPV infection, an understanding

of mechanisms of HPV-induced carcinogenesis, and eventually to the

development of prophylactic vaccines against HPV infection.

The theory behind the vaccine is sound: If HPV infection can be prevented,

cancer will not occur. But in practice the issue is more complex. First,

there are more than 100 different types of HPV and at least 15 of them are

oncogenic. The current vaccines target only 2 oncogenic strains: HPV-16 and

HPV-18. Second, the relationship between infection at a young age and

development of cancer 20 to 40 years later is not known. HPV is the most

prevalent sexually transmitted infection, with an estimated 79% infection

rate over a lifetime5   The virus does not appear to be very harmful because

almost all HPV infections are cleared by the immune system.7  In a few

women, infection persists and some women may develop precancerous cervical

lesions and eventually cervical cancer. It is currently impossible to

predict in which women this will occur and why. Likewise, it is impossible

to predict exactly what effect vaccination of young girls and women will

have on the incidence of cervical cancer 20 to 40 years from now. The true

effect of the vaccine can be determined only through clinical trials and

long-term follow-up.

The first HPV vaccine was licensed for use in the United States in June

2006,9  and the Advisory Committee on Immunization Practices recommended

routine vaccination of girls aged 11 to 12 years later that same month.10

However, the first phase 3 trials of the HPV vaccine with clinically

relevant end points—cervical intraepithelial neoplasias grades 2 and 3 (CIN

2/3)—were not reported until May 2007.11  Previously only reduction in the prevalence ofpersistent infection and CIN from the 2 virus strains included in the vaccine had been reported. The results were promising, but serious questions regarding the overall effectiveness of the vaccine for protection against cervical cancer remained to be answered, and more long-term studies were called for.12 However, no longer-term results from such studies have been published since then.

So how should a parent, physician, politician, or anyone else decide whether

it is a good thing to give young girls a vaccine that partly prevents

infection caused by a sexually transmitted disease (HPV infection), an

infection that in a few cases will cause cancer 20 to 40 years from now? Two

articles in this issue of JAMA13   present important data that may

influence, and probably already have influenced, such decisions about HPV

vaccination.

The report by Rothman and Rothman13 demonstrates how the vaccine

manufacturer funded educational programs sponsored by professional medical

associations in the United States. The article illustrates how the Society

of Gynecologic Oncology, the American Society for Colposcopy and Cervical

Pathology, and American College Health Association helped market the vaccine

and influenced decisions about vaccine policy with the help of ready-made

presentations, slide sets, e-mails, and letters. It is of course reasonable

for professional medical associations to promote medical interventions they

believe in. But did these associations provide members with unbiased

educational material and balanced recommendations? Did they ensure that

marketing strategies did not compromise clinical recommendations? These

educational programs strongly promoting HPV vaccination began in 2006, more

than a year before the trials with clinically important end points were

published. How could anyone be so certain about the effect of the vaccine?

This matters because the voices of experts such as the professional medical

associations are especially important with a complex issue such as this.

In another article, Slade and colleagues14 from the US Centers for Disease

Control and Prevention and the US Food and Drug Administration describe the

adverse events that occurred 2.5 years following the receipt of quadrivalent

HPV vaccine that were reported through the US Vaccine Adverse Events

Reporting System (VAERS). Even though most of the reported adverse events

were not serious, there were some reports of hypersensitivity reactions

including anaphylaxis, Guillain-Barré syndrome, transverse myelitis,

pancreatitis, and venous thromboembolic events. VAERS is a passive,

voluntary reporting system, and the authors call attention to its

limitations. They point out that only systematic, prospective, controlled

studies will be able to distinguish the true harmful effects of the HPV

vaccine. These limitations work both ways: it is also difficult to conclude

that a serious event is not caused by the vaccine.

Whether a risk is worth taking depends not only on the absolute risk, but on

the relationship between the potential risk and the potential benefit. If

the potential benefits are substantial, most individuals would be willing to

accept the risks. But the net benefit of the HPV vaccine to a woman is

uncertain. Even if persistently infected with HPV, a woman most likely will

not develop cancer if she is regularly screened.15  So rationally she should

be willing to accept only a small risk of harmful effects from the vaccine.

When weighing evidence about risks and benefits, it is also appropriate to

ask who takes the risk, and who gets the benefit. Patients and the public

logically expect that only medical and scientific evidence is put on the

balance. If other matters weigh in, such as profit for a company or

financial or professional gains for physicians or groups of physicians, the

balance is easily skewed. The balance will also tilt if the adverse events

are not calculated correctly.

Gardasil: All cost and no benefit

Marian Vickers, Convenor, DES Action Australia.

July 6 2009

http://www.desaction.org.au

There is an urgent need for questions about the safety and efficacy of Gardasil to be fully and objectively debated.

The TGA’s current stance/dismissal that “the benefits of Gardasil far outweigh any potential risk” is laughable and shows a strange interpretation of evidence from the government’s own screening programs.

It’s time to take a closer look at this risk/benefit equation. The first consideration is that Gardasil is not a “cervical cancer” vaccine. It is a HPV vaccine, and there is no evidence of a causal link between HPV and cervical cancer. There is an association, but no causal link has ever been established.

Further, Gardasil is really a “part HPV vaccine” as it targets only 4 of the 40 strains of genital HPV. According to the government’s online information HPV is a very common and benign virus. To quote: “Genital HPV is so common that it could be considered a normal part of being a sexually active person. Most people will have HPV at some time in their lives and never know it… in most people it clears up naturally in about 8-14 months.” [http://www.health.gov.au/internet/screening/publishing.nsf/Content/hpv

] According to figures from the National Cervical Screening Program (NCSP) reported in 2005, over 98% of low-grade abnormalities associated with HPV resolved naturally within 5 years. Of the small % of cases where the infection persists, treatment is straightforward and successful at this early stage.

Now to me this seems pretty good odds. There is minimal “risk” from a virus which your immune system clears naturally in the vast majority of cases. The key is to have regular Pap smears.

So the real question is: why bother having a vaccine? Why have a “part vaccine” for a virus which your immune system will almost certainly clear naturally?

The answer of course is the pharmaceutical companies’ greed for profits. The only way to “sell” such a vaccine was through scare-mongering: by erroneously implying that HPV was causally linked to cervical cancer and cervical cancer deaths.

As is often stated in the push for Gardasil “Over 700 women are diagnosed every year with cervical cancer. Over 200 women die of cervical cancer each year.” However, there are other important statistics to consider. Cervical cancer is one of the most preventable and curable of all cancers. The incidence, prevalence and mortality rate from cervical cancer has fallen markedly in Australia since 1991 due to the great success of the NCSP. When the program was introduced in 1991, the number of women newly diagnosed with cervical cancer was over 1000 per year, now it’s down to around 700. The age-standardised mortality rate for cervical cancer has more than halved from 4.0 deaths per 100,000 women in 1991 to 1.9 deaths per 100,000 women in 2006. Further, of the approximately 200 women who die each year, most are aged over 50 years and have never had a Pap smear at time of diagnosis. As stated on the NCSP website, cervical cancer is a disease of the never screened or under-screened.

As the government’s own literature states: “The most important preventative strategy against cervical cancer for women who are sexually active is two yearly Pap screening. Women who have received Gardasil still require two yearly Pap screening because the vaccine does not provide protection against all HPV types”

Quite apart from any harm it is causing individual girls and young women, Gardasil is a scandalous waste of public health money. The money should have been spent on education and expanding Pap smear services. Or spent on researching ovarian cancer which has a high mortality rate and no screening test.

I guess another question that should be asked is: How many doctors, health bureaucrats and politicians have shares in CSL?

(See also my letter to the British Medical Journal (BMJ) ‘A wonder vaccine we should all wonder about’ (7 December 2008)

http://www.bmj.com/cgi/eletters/337/dec02_2/a2642#205643)

http://www.onlineopinion.com.au/view.asp?article=9112

Gardasil: The Denial Continues

Jne 30 2009

Dr Renate Klein

Two weeks after receiving the ‘cervical cancer’ vaccination Gardasil, 26-year old Shannon from Melbourne remembers, ‘it became so difficult to breathe that I went straight to the emergency room. I was very frightened at this point. Two weeks before I had been fit and healthy, and by this stage I was limping around the house like a stroke victim, wheezing and worried I was suffocating.’ At the hospital Shannon had x-rays, blood tests and an MRI. She was told that the lining of her left lung had become so inflamed that it was rubbing against her chest wall each time she breathed. The Head Consultant looking after her said that she must have gotten some mysterious virus and that Gardasil had been tested and was safe. She was released with no diagnosis other than ‘pleurisy’ and given painkillers.

Five months after receiving the vaccine she saw a neurologist who confirmed that she had damage to her left side and that it was ‘an auto-immune reaction, resulting in inflamed lining of the left lung and nerves on the left side, with a temporal connection to Gardasil injection.’

Shannon says she’s never been so sick all her life. Fourteen months later she had to quit her job and is now desperately trying to regain her health.

Jade, a healthy 15-year-old girl from Adelaide spent 6 weeks in hospital after the first Gardasil injection because of severe lower back pain and paralysis of the legs. She was advised to get the second Gardasil injection and ‘within 2 hours she had paralysis of the legs again. They just gave out on her while she was walking along.’ 12 months later, Jade almost drowned, her leg paralysis recurs regularly and she was re-admitted to hospital. She is in excruciating pain and the daily physiotherapy makes it worse. Morphine helps her sleep for a few hours but then the pain starts again. Her relatives are beside themselves with worry. And as they say ‘not one medical person would say that Gardasil was responsible for her condition. The moment you mention it, they all clam up.’ Despite an MRI no one has a diagnosis.

Shannon and Jade are just two of the Australian girls and women who have become seriously sick after receiving one or all three shots of the ‘cervical cancer’ vaccine Gardasil free of charge, care of the Australian Government. Their upsetting stories and many others can be read on http://womenhurtbymedicine.wordpress.com/

The free vaccinations for girls aged 12-13 and women up to 26 were started in April 2007. Gardasil is a vaccine against 4 strains of the sexually transmitted infection with human papillomavirus (HPV), two of which are associated with the development of cervical cancer. There are over 100 strains of HPV and we are told that up to 80 per cent of people acquire the virus at some point in their lives. The good news is that in 90 per cent of these, a healthy immune system disappears the virus infection in one to two years and no abnormal cells, let alone cancer, will ever develop (Lippman et al., 2007; http://www.cmaj.ca/content/vol177/issue5/). Moreover, as Merck-and GlaxoSmithKline-funded Rachel Skinner and colleagues write, ‘Estimates of the prevalence of HPV infection among women range from 2 % to 44 %, depending on age’ (Skinner et al., Medical Journal of Australia, Vol. 188, number 4, 18 February 2008, www.mja.com.au/public/issues/188_04…/ski10485_fm.html). Such figures are much less scary than the widely quoted ‘80 percent infected’ (both women and men). Even more confusing is the fact that HPV infection, usually classified as a sexually transmitted infection (STI), can already be found in new born babies even if their mothers do not carry the HPV virus (Xavier Castellsague and colleagues, 2009, ‘Human Papillomavirus (HPV) infection in pregnant women and mother-to-child transmission of genital HPV genotypes: a prospective study in Spain’ BMC Infectious Diseases, 9:74; http://www.biomedcentral.com/1471-2334/9/74/abstract). There is a lot more to learn about the HPV virus than the simple story of a ‘cancer virus’ annihilated by a miracle vaccine that the proponents of Gardasil want us to believe.

Furthermore, deaths from cervical cancer in Australia are continuing to decline probably due to a mixture of regular screening, improved general health and sexual hygiene. According to a report by the World Health Organisation, in 2006, 249 women died in Australia, and cervical cancer mortality ranks 17 out of all 23 listed cancers (WHO/ICO, 2007, p. 8 http://apps.who.int/hpvcentre/statistics/dynamic/ico/SummaryReportsSelect.cfm). While every death is a tragedy, pre-cancerous cells are being detected through systematic Pap screening programs. Indeed, Gardasil advocates caution that women must continue with the Pap Smears as the vaccine will not be 100% protective. For all these reasons, the question really must be asked how the need for this costly vaccine can be justified?

Australia was the first country to rush into administering this new and experimental vaccine on a grand scale. Straight after the first vaccinations reports about serious adverse effects began to surface (‘Gardasil: we must not ignore the risks’ Renate Klein and Melinda Tankard Reist, June 1, 2007 http://www.onlineopinion.com.au/view.asp?article=5917 and ‘The Gardasil ‘miracle’ coming undone?’ Renate Klein, August 21, 2008 http://www.onlineopinion.com.au/view.asp?article=7786

Commonwealth Serum Laboratories (CSL) and Merck – the manufacturers of Gardasil – deny that there are any problems. So does the Therapeutic Goods Administration (TGA). They continue their assessment of ‘Gardasil as safe and effective.’ Their latest communiqué of May 5, 2009 states that ‘As of April 2009 a total of 1,304 suspected adverse reactions have been reported…’ but that ‘The great majority have been mild and common problems such as soreness, swelling, or redness of the injection site’ (see http://www.tga.gov.au/alerts/medicines/gardasil.htm).

These ‘mild problems’ are a far cry from Shannon’s and Jade’s serious illnesses or from Julie’s experience of grand mal seizures and the woes of Philippa who continues to suffer from pancreatitis – all developed after the Gardasil injections.

In the USA by May 2009 over 16,000 adverse reactions were reported (these figures represent only between 1 and 10 per cent of all adverse reactions) and 47 deaths have been associated with Gardasil: four times the number of deaths associated with Menactra (a vaccine against meningococcal) (see www.nvic.org/Downloads/NVICGardasilvsMenactraVAERSReportFeb-2009u.aspx).

The Gardasil manufacturers maintain that these deaths are not directly linked to the vaccines. With respect to the deaths of healthy US teenagers from cardiac problems the suggestion has been made that these girls might have suffered from a pre-existing undiagnosed weakness (eg a heart murmur). For the tragic testimonial of a heartbroken mother who lost her child, see http://www.youtube.com/watch?v=Kcpoqo_MNis&feature=email. Gardasil is not recommended for pregnant women but there have been reports of spontaneous abortions and foetal abnormalities when pregnant women were inadvertently injected with Gardasil during the Merck trials. Merck is sufficiently concerned that it has set up a registry to follow pregnant women who have received Gardasil (http://www.merckpregnancyregistries.com/gardasil.html)

It is unknown if Gardasil will affect fertility.

While the promoters of Gardasil continue to assert that these health concerns are unwarranted and that their vaccine will greatly reduce the incidence of cervical cancer, such claims are far from uncontested. In November 2008, 13 scientists from Germany’s Bielefeld University challenged the STIKO (the equivalent of the TGA) to reconsider their endorsement of Gardasil for health insurance reimbursement (http://bis.unibielefeld.de/infomanager/SilverStream/Pages/Aktuelles_Blog_Detail.html?query=BUZ.ID+=+51446). Their main point is that results from the manufacturer-sponsored research trials resulted in only 17 per cent reduction of cervical lesions – nothing like the 98 per cent of reductions Merck is claiming. In April and May 2009 in the UK and Scotland, groups of parents have started to sue GlaxoSmithKline, the manufacturer of the ‘sibling’ vaccine Cervarix (from which CSL also gains royalties) for seriously injuring their children (www.express.co.uk/posts/…/Teenage-girls-sue-over-cancer-jab -; news.scotsman.com/…/Fears-over-reactions-to-cervical.5319871.jp). In New Zealand, up to 80 schools are refusing to implement the HPV vaccinations (http://article.wn.com/view/2009/05/04/New_Zealand_schools_refuse_Gardasil_vaccination/). Even one of the scientists involved in the Merck research of Gardasil, Diane Harper, has since 2007 called it a ‘great public health experiment’ and voices long-term concerns about safety and effectiveness, especially when girls as young as 11 are vaccinated. As she put it, ‘We don’t know the vaccine will continue to be effective. To be honest, we don’t have efficacy data in these young girls right now’ (‘Vaccination campaign funded by drug firm,’ Sarah Boseley, 26 March 2007, http://www.guardian.co.uk/society/2007/mar/26/cancercare.health1). Two years later, the situation hasn’t changed: fewer than 1200 girls under 15 have ever been in Gardasil trials. And yet millions of 12-13 year old girls have already received the three shots.

On June 9, 2009, the US Food and Drug Administration (FDA) approved a new label for Gardasil which now includes fainting (syncope) and seizures in its Warnings and Precautions (www.fda.gov/BiologicsBloodVaccines/…/ucm165145.htm). And, crucially, in Australia ordinary citizens are beginning to be critical of the HPV vaccination – quite simply because more and more personally know injured girls and young women or hear about them from friends or teachers.

But the Australian government remains silent and thereby continues its denial about problems with Gardasil. The TGA hasn’t even issued a new Communiqué that details the June FDA warnings. It is high time that the Federal Health Minister, Nicola Roxon, showed leadership. June 30, 2009 brings the end of free vaccinations for women up to age 26: a good time to suspend all Gardasil vaccinations (those for schoolgirls included) and check the health status of every single woman and girl who was vaccinated with Gardasil since April 2007. This should be done with the help of the belatedly implemented HPV Register (http://www.hpvregister.org.au/). Such a serious investigation will show the world that Australia cares about the health of its young female population and will hopefully give the victims of Gardasil the rightful acknowledgment and care that so far has been sorely lacking.

The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection

Written by Crunchymomma, published here, 20/12/08
Effect of Male Circumcision on the Prevalence of High-Risk Human Papillomavirus in Young Men: Results of a Randomized Controlled Trial Conducted in Orange Farm, South Africa (The Journal of Infectious Diseases 2009;199:14-19)

Background
A causal association links high-risk human papillomavirus (HR-HPV) and cervical cancer, which is a major public health problem. The objective of the present study was to investigate the association between male circumcision (MC) and the prevalence of HR-HPV among young men.

Methods
We used data from a MC trial conducted in Orange Farm, South Africa, among men aged 18-24 years. Urethral swab samples were collected during a period of 262 consecutive days from participants in the intervention (circumcised) and control (uncircumcised) groups who were reporting for a scheduled follow-up visit. Swab samples were analyzed using polymerase chain reaction. HR-HPV prevalence rate ratios (PRRs) were assessed using univariate and multivariate log Poisson regression.

Results
In an intention-to-treat analysis, the prevalences of HR-HPV among the intervention and control groups were 14.8% (94/637) and 22.3% (140/627), respectively, with a PRR of 0.66 (0.51-0.86) ( ). Controlling for propensity score and confounders (ethnic group, age, education, sexual behavior [including condom use], marital status, and human immunodeficiency virus status) had no effect on the results.

Conclusions
This is the first randomized controlled trial to show a reduction in the prevalence of urethral HR-HPV infection after MC. This finding explains why women with circumcised partners are at a lower risk of cervical cancer than other women.

Gardasil Deaths, Injuries & Money

Written by Barbara Loe Fisher, published here, 12/12/08

At the same time that more Gardasil injuries and deaths are being reported every day, those promoting mass use of Gardasil are busy denying the significance of vaccine reactions while Merck is making plans to increase its market share by asking young boys to roll up their sleeves as well.

The discussion in states about whether or not Gardasil should be mandated is still taking place even though all but two state legislatures (Virginia and D.C.) rejected mandates in 2007. It makes it easier for pro- forced vaccination proponents to keep proposed Gardasil mandates on the table when the CDC insists all of the health problems, hospitalizations, injuries and deaths that have been reported to the government’s Vaccine Adverse Events Reporting System (VAERS) after Gardasil vaccination are just a “coincidence.”

Through the end of October 2008, the government has published a list of 9,762 Gardasil- related adverse events, including 30 deaths, that have been reported to VAERS. This number does not include the Gardasil vaccine-related health problems which have been reported to the VAERS but not yet published. It is estimated that only between one and ten percent of all serious health problems following administration of pharmaceutical products are ever reported to the government. This gross underreporting of vaccine- related hospitalizations, injuries and deaths means that there potentially could be nearly one million health problems following Gardasil vaccination that have actually occurred since the vaccine was licensed in 2006.

But who needs to count if it is all just a “coincidence?” It is good for business to downplay the significance of vaccine reactions and so researchers associated with Glaxo Smith Kline (GSK), who are perhaps looking toward the lucrative U.S. market for GSK’s new HPV vaccine (Cervarix), are doing just that.

Waiting for approval at the FDA, Cervarix contains a powerful adjuvant (ASO4) that has not been licensed for use in the U.S. That adjuvant is designed to send the immune system into overdrive. Will it also swell the numbers of VAERS Gardasil adverse events reports that can be conveniently written off as a coincidence by doctors, government and drug company officials?

When perfectly healthy, bright teenage girls and young women get an HPV vaccination and collapse, have seizures, become paralyzed, are left with crippling fatigue and joint pain or suddenly die, their mothers and fathers deserve more than a “coincidence” explanation from doctors, government health officials and vaccine manufacturers. Until the public stands up to the Big Lie and calls it for what it is, those in charge of the U.S. vaccination system will continue to get away with putting policy and profits before good science every time a new vaccine is licensed and recommended for use by millions of Americans.

The Gardasil ‘Miracle’ Coming Undone?

Written by Renate Klein, published on Online Opinion, 21/8/2008

The Therapeutic Goods Administration (TGA) has announced that it is investigating whether there is a link between Gardasil, the vaccine against the human papilloma virus (HPV) and the development of pancreatitis in three young women as reported in a letter to the Medical Journal of Australia (Louise Hall in Sydney Morning Herald, August 17, 2008 referring to Das et al., MJA 189(3), August 4).

This investigation is good news – but not one minute too early. While the TGA are doing this work, they should also look in detail at the other adverse effects that have been reported in Australia and around the world. And it’s not just “headaches, redness at the injection site, nausea and vomiting” as the TGA claims (ABC News, August 17, 2008).

There are many serious reports including seizures, debilitating tiredness, body rashes, serious walking problems, severe menstrual pain and irregularities, chest pain, anaphylactic reactions. And these symptoms can persist for weeks, sometimes months. (See our blog which we started so that girls and women would have a space to tell their stories, as well as to make available critical background reading.)

Then there is Guillain Barré Syndrome (paralysis), Acute Demyelinating Encephalomyelitis (ADEM, a neurological disorder characterised by inflammation of the brain), miscarriages and fetal abnormalities in women who were mistakenly administered the vaccine while pregnant.

Not to mention the 17-20 deaths that have been associated with the vaccine in the USA (reported to the federal Vaccine Adverse Events Reporting System, VAERS) as well as one death in Germany and one in Austria. Like Jessica Ericzon, a 17-year-old student who was a softball player but collapsed and died two days after receiving the second Gardasil shot (Susan Edelmann, The New York Post, July 20, 2008).

Or 14-year-old Jenny and her sad story of rapidly deteriorating motor neurone disease following the Gardasil injection. Her family is desperately seeking “comparables”, other girls with similar conditions, whose treatment might help save their severely ill daughter.

Australia may just be lucky that no deaths associated with Gardasil injections have occurred (or been reported?). But the luck might run out any moment, so the vaccination program needs to be suspended now. The precautionary principle should be used whenever the health and lives of young girls and women are at stake.

So far the TGA as well as the FDA (US Food and Drug Administration) have denied any association between the deaths or serious health problems and Gardasil. And already insinuations abound, “… might have been a genetic disposition”; “might have been an pre-existing heart murmur”. So it was all the girls’ “fault”, nothing to do with the vaccine!

In January 2008, Channel 7 analysed TGA data from a FOI request which showed 681 adverse reactions with 162 girls and women not recovered. Girls between 14 and 17 had not recovered for an average of 165 days. On July 4, 2008, the TGA published new figures of just over 1,000 adverse reactions to-date that had been reported. But they did not release in depth details of what these reactions were and, importantly, whether or not the girls and women had recovered.

Reporting is not mandatory in Australia (or the USA) and it is well known that only between 1 per cent and 10 per cent of adverse reactions are ever reported. So we are looking at much higher figures – especially as many doctors dismiss girls and women’s health complaints after the injections as unrelated to the vaccine. In the USA, by June 30, 2008, the reported figure had grown to 9,749 adverse effects.

We have been told that more than 3 million doses of Gardasil have been distributed in Australia. That’s about a million girls and young women who received the three Gardasil injections since the free vaccination began to be rolled out on April 2, 2007 for 12- to 18-year-olds in schools and at GP surgeries for 16- to 26-year-old girls and women. Now every single one of them needs to be contacted and asked about the state of their health since the three injections. General lethargy and tiredness as well as menstrual problems have to be included in the questions as they might be indications of auto immune problems. And if the girls and women are still unwell, free treatment should be offered.

To find them all will be a tedious job but this is the government’s own fault. It was only on February 23-24, 2008 that the Victorian Cytology Service ran a job advertisement for a “newly created position” to “help establish and operate the new National HPV Vaccination Program” (The Australian, 23-24 February 2008). That’s 11 months after thousands of school girls had already received the jab.

It is quite scandalous that Australia rushed so breathlessly into the world’s first free vaccination program without also simultaneously establishing a Vaccine Registry in which every vaccination recipient would be included and could easily be tracked if any problems emerged or to establish the remaining level of antibodies. Now they have to do it the hard way and shortcuts must not be allowed to occur.

But why this rush to use Australian girls and young women as guinea pigs for this new vaccine? What is the appeal of Gardasil? There is no epidemic of cervical cancer in developed countries. In Australia, about 200 women a year die from it – approximately two per 100,000 – and while every death is one death too many, the numbers have been going down from year to year due to Australia’s screening program.

At least three main reasons account for the vaccine hype.

One, the word “cancer” triggers an incredible fear reaction in most people.

Two, great marketing of the vaccine which, in Australia, is mixed with a good dose of patriotism. We are told that Queensland scientist, Professor Ian Frazer, with his Chinese colleague was the “inventor” of the HPV vaccine. This has made him into a national hero and the Australian of the Year 2006. Frazer: “God’s Gift to Women” proclaimed the cover of The Weekend Australian’s magazine on March 4-5, 2006. In actuality, like Ian Frazer at Queensland University, US Universities of Georgetown and Rochester and the US National Cancer Institute (NCI) all claim “… to be responsible, for original work leading to a cervical cancer vaccine” (see Ruth Beran, July 21, 2006). Is acknowledging others that hard?

In Australia, critics are almost perceived as national traitors and unlike in Germany, Canada and Spain, very few critical voices have been heard in the public debate (www.harald-terpe.de/2637.98.htm June 17, 2008; Lippman et al. CMAJ, August 2007; Juan Gérvas, Rev Port Clin Geral 2007 23, 647-55, accessed here).

In the USA, one of the scientists who worked on the Gardasil trials sponsored by Merck, Professor Diane Harper of Dartmouth Medical School, has been urging caution for some time. “It’s not a cure-all for cervical cancers and it’s not meant to be a replacement for Pap tests’ she said (Danielle Egan, May 31, 2007 The Tyee, Vancouver, Canada).

The third reason can be found in media reports which too often unquestioningly repeat what is fed to them by vaccine advocates. The fact is that HPV as well as cervical cancer are complicated and messy scientific phenomena with lots of question marks remaining. This complexity is difficult to explain. So the over enthusiastic media message gets simplified to “Gardasil Prevents 70 per cent of Cervical Cancer”. And parents who want to do the responsible thing sign their daughters up for vaccination.

But no one knows if Gardasil will ever prevent a single case of cervical cancer. There is certainly no proof to date because cervical cancer can take 20 to 30 years to develop and research into the HPV vaccine has only taken place for the past five years. What manufacturer-sponsored researchers have claimed as success was seeing fewer benign lesions develop in research participants.

Of course it would be highly unethical not to treat women who develop such abnormal cells in either the vaccine or the control group. And therefore we might never know whether the vaccine really worked or whether perhaps the new “Thin Prep” (PDF 96KB) adjunctive to Pap Smears might be the reason for a higher and more reliable detection rate that further reduces deaths from cervical cancer.

HPV strains appear to be present in 80 to 90 per cent of both women and men (another estimate as no one really knows), but clear up within one to two years. Co-factors that stop the body from naturally clearing abnormal cells are smoking, poverty, a poorly functioning immune system, bad nutrition, use of the oral contraceptive, unsafe sex, multiple sexual partners and a lack of male sexual hygiene (circumcised men have fewer HPV infections; see Zukerman in The Weekend Australian, August 16-17).

On top of all of this, if the vaccination program had indeed been aimed at reducing HPV infection in the general population (i.e. create “herd” immunity), boys should have been included from the very beginning. That they were not, shows once more that it is always women – and now even girls – who bear the burden of dangerous drugs for prevention whether it’s an unplanned pregnancy or an HPV infection. No shared responsibilities here!

In fact there is even still disagreement if HPV, a sexually transmitted virus, is at all implicated in cervical cancer. In at least 30 per cent of such cancers this virus is not found. So screening must never be stopped; no HPV vaccine will protect these women. A “quick fix” technology won’t work.

It’s also unclear if HPV “causes” the cancer or, rather, is “associated” with it (e.g. already existing cancer cells might spread more rapidly if HPV is present). Most importantly, there are an estimated 20-40 HPV strains that infect the female genital tract and of those Gardasil covers only two “high” risk strains (16 and 18) and also 6 and 11 which can lead to genital warts. The great worry is that even if strains 16 and 18 were neutralised by the vaccine, other virus strains might become more active.

This is a very important point because it appears that most infections are “mixed”, that is they consist of a number of HPV strains (see “HPV Vaccination – More Answers, More Questions” by George F. Sawaya, M.D., and Karen Smith-McCune, M.D., Ph.D. in the New England Journal of Medicine 356:1991-1993).

We also don’t know if the vaccine-produced immunity will last, nor if and when booster shots might be needed. Further, there are fears that an immunity created early in life might allow for more virulent reactions in later years. And Gardasil is a genetically engineered vaccine; it also contains a high amount of aluminium adjuvant which is known to be responsible for very serious reactions in other vaccinations.

With all these unanswered questions, the worrying rise of serious adverse effects, the lack of independent research, parents of girls and young women themselves should seriously consider if the vaccine is worth the risk.

Let’s not forget that Gardasil was fast tracked through the FDA, a process normally reserved for life saving drugs. And that, amazingly, it received the green light in 2006 for girls as young as nine despite the fact that fewer than 1,200 girls under 16 had taken part in the manufacturer-sponsored research. And that some trials weren’t even finished.

Since then Gardasil has become the fastest selling drug to reach US$1 billion sales – cash much needed by Merck who has started this year to pay compensation to the Vioxx victims (a Cox2 anti-inflammation drug for arthritis that had resulted in thousands of heart attacks and deaths). And great for the Australian manufacturer, Commonwealth Serum Laboratories (CSL) which receives royalties from Merck from its overseas license of Gardasil. CSL reported a 30 per cent rise in full year profit (to June 30, 2008), and is so cashed up that it has recently entered a sales agreement for $3.48 billion for a plasma manufacturing company (AAP, August 13, 2008).

But surely girls’ and women’s health must never be compromised by monetary gains for shareholders. The Gardasil saga reminds me of Hormone Replacement Therapy (HRT) where for 40 years millions of women were told that this “miracle drug” would save them from a life of misery after menopause when, in fact, it increased the risk of breast cancer and heart attacks. Since 2002, when medical consensus finally dealt a blow to HRT, breast cancer rates have been falling both in Australia (in NSW by 6.7 per cent) and the USA (by 12 per cent) (Cathy O’Leary, The West Australian, June 2, 2008).

I hope we won’t have to wait 40 years for the Gardasil “miracle” to become undone.

It is time for Nicola Roxon, the Federal Health Minister, to step into this fray and listen to the girls and women for whom the vaccine has meant pain and debilitating illness. She must suspend the Gardasil vaccination program before it claims more victims and launch an thorough investigation into the health of vaccine recipients.

We need her strong leadership now.

Study Questions Cost-Effectiveness Of Gardasil Cervical-Cancer Vaccine

Written by Peter Loftus, published on Wall Street Journal, 21/8/2008

A new study suggests that giving Merck & Co.’s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot.

The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen. This has contributed to a slowdown in Gardasil sales, casting a cloud on Merck’s financial outlook.

Questions surrounding Gardasil’s cost- effectiveness also could make for tougher market conditions for GlaxoSmithKline PLC’s Cervarix, a cervical-cancer vaccine that is available outside the U.S. and is under review by the U.S. Food and Drug Administration.

Gardasil is designed to prevent infection by four strains of the human papillomavirus, or HPV, which is transmitted through sexual activity. Two of the targeted HPV strains are believed to cause about 70% of all cervical-cancer cases, while the other targeted strains cause most cases of genital warts. HPV also can cause other, rare tumor types such as vaginal and anal cancers. Gardasil isn’t guaranteed to prevent cervical cancer because it doesn’t protect against certain cancer-causing HPV strains.

The FDA approved Gardasil for use in females ages 9 to 26. The Centers for Disease Control and Prevention recommends routine HPV vaccination for girls 11 and 12 years old, as well as a temporary “catchup” vaccination for girls and women ages 13 through 26 who were never immunized. The CDC says it’s ideal to get vaccinated before becoming sexually active, but vaccination after becoming sexually active can still offer protection because girls and women may not become exposed to all four HPV strains for many years. The vaccine doesn’t treat existing infections, however.

The study published by researchers from the Harvard School of Public Health suggests Gardasil’s cost is justified in pre-adolescent girls, partly because they are less likely to have already been exposed to HPV. But among older females, the cost-effectiveness of Gardasil becomes less and less favorable, researchers concluded. “Under most scenarios, extending the catchup to 26 wasn’t cost-effective,” Jane Kim, an assistant Harvard professor, said in an interview.

Merck, Whitehouse Station, N.J., disputed the conclusions, saying its own health-economic models suggest the vaccine is worth the cost. “We believe there’s important value in vaccinating all women who are in the indicated age groups,” said Rick Haupt, Merck’s head of clinical research for Gardasil. Ms. Kim and Harvard colleague Sue Goldie concluded that it cost about $43,600 per “quality-adjusted life year” gained, when HPV vaccine is administered to 12- year-old girls. This falls below the $50,000 per quality- adjusted life year threshold that some researchers use as a maximum for cost-effectiveness. Other researchers use a higher maximum benchmark of $100,000 per QALY to gauge cost-effectiveness. It would cost $97,300 per QALY, however, to vaccinate girls and women through age 18, $120,400 per QALY for girls and women up to age 21, and $152,700 for girls and women up to age 26. The cost-effectiveness becomes more attractive when protection against genital warts is factored in.

The researchers arrived at these numbers by projecting HPV infection rates in various age groups, gauging the effectiveness of the vaccine and estimating cervical-cancer screening rates. Screening via Pap smear is recommended for women who are sexually active, even with the availability of Gardasil.

The screenings can detect pre-cancerous lesions that can be removed; the availability of these tests has helped reduce the cervical-cancer death rate in the U.S. dramatically since the 1950s.

Merck’s Dr. Haupt said the company’s own models show that the cost per QALY is “well under $50,000″ for women up to age 26. Among the differences between the models were that the Harvard researchers included patient time and travel costs, while Merck didn’t, and the Harvard researchers didn’t include genital warts in males, while Merck did, according to the CDC.

At least one of the factors in the primary Harvard calculations may be a relatively optimistic assumption — that vaccination would produce lifelong immunity. Because the vaccine was only studied for five years and has been on the market for two years, no one knows for certain if its protection is lifelong, or if it wanes over time.

The Harvard researchers concluded that the cost per QALY would rise if the vaccine’s effect wanes after 10 years.

Merck says the vaccine will offer protection well beyond five years, Dr. Haupt said. The Merck economic model that arrived at the cost per QALY below $50,000 assumed lifelong immunity, he said. Still, the study is likely to fuel skepticism about Gardasil, which has already faced questions surrounding its safety and effectiveness (Merck and the CDC maintain it is safe and effective, with the most common side effect being soreness at site of injection.)

Now Hold On One Hormonal Minute….

Written by Leslie Carol Botha and H. Sandra Chevalier-Batik, published on Holy Hormones, Honey, 21/8/2008

Why has there not been any mention of the potentially adverse effects of Merck’s cervical cancer vaccination, Gardasil® in relationship to the timing of the vaccination and where a young woman is in her menstrual cycle? This information is especially critical considering the vaccination is recommended for adolescent girls from the age of nine to young women up to 26-years.

Why is it that women are constantly forced into a male medical model which blatantly ignores their menstrual health and administers drugs, surgeries, and vaccinations without any regard to where women are in their hormone cycle?

This is outrageous. Even though women are asked to fill out the date of their last menstrual period (LMP) that information is used primarily to note that a woman is not pregnant. But it is much more valuable than that; the date of the LMP could actually be indicative of why that woman is in the doctor’s office to begin with.

Every cycling woman, who is aware of the changes that her body goes through prior to menstruation, knows that she is more prone to infections, colds, fatigue, irritability and a general feeling of malaise at this time. All of these issues are a direct result of hormonal changes that are cycling through her entire body, from the brain right on down to the uterus. Why haven’t the clinical researchers, FDA/CDC oversight committees, gynecologists, pediatricians or family practice physicians who have approved and administered Gardasil®, considered how the injection of this chemical cocktail might affect a still maturing female body that is least able to defend itself during the paramenstrum?*

As the female hormone levels of estrogen and progesterone decrease during the premenstrual phase, the female body begins the process of releasing the uterine lining in the act of menstruation. The decrease in hormones actually affects a woman’s energy levels and her emotions. The immune system becomes more compromised, and that translates to a lowered defense system to fight off invading, foreign toxins.

Due to limited access to women’s menstrual health education, many women are totally unaware of the systemic aspects of their feminine hormone cycle. The medical, pharmaceutical industrial complex continues to ignore the premenstrual phase of menstrual cycle as a factor in testing and administration of drugs and vaccines. The only question women have to ask themselves is, “Is that policy based in ignorance, arrogance or methodical design?”

In her 1977 groundbreaking book, “The Premenstrual Syndrome”, Katharina Dalton noted that drug reactions “….are common during the premenstruum and may follow administration of antibiotics and inoculations. Confusion may occur as to the real origin of such reactions. In double-blind, clinical trials the placebo drugs are often reported to have side effects such as increased drowsiness, headache, nausea, or increased pain; which may be no more than the usual premenstrual symptoms which have not been meticulously observed and reported.” 1.

Dalton’s work is intriguing and her studies compelling. However, feminists dismissed the book and the author in the 1980′s, because the premise was considered damning to women suffering from premenstrual syndrome. Dalton stated in the preface to her book, “….In those days we believed that the premenstrual syndrome was a rare condition, but we know now that it is the world’s commonest, and probably oldest, disease.” 2.

Classifying PMS as a disease provided the pharmaceutical and medical industry the leveraged justification that they skillfully exploited to extort billions of dollars from the systematic the medicalization of women’s bodies.

Fortunately, there is a growing body of clinical researchers, health practitioners, university professors, media professionals, feminists, and lay people who are beginning to realize that the menstrual cycle is not an illness or disease. Menstruation is becoming recognized as a natural cycle, that when understood and experienced holistically, could add healthy years to women’s lives.

Regrettably, Dalton’s work concerning premenstrual syndrome as it related to common drug reactions during the premenstruum was ignored – the issue denied; and many women have suffered in the past 40-years. The pharmaceutical, medical industrial complex filled the void of our self-knowledge and lack of understanding with calculated marketing campaigns that methodically exploited every aspect of a woman’s natural cycle.

Gardasil®, as well as other immunizations administered to adolescent women, are dispensed without regard to where a woman is within her menstrual cycle. During Gardasil®’s, clinical trial period, FDA approval, and during the two years it has been on the market, not one article has been written about how a young woman might tolerate the injection during premenstruum; nor is there any information in the Patient Product Information or the Prescribing Information on the Gardasil® web site, that cites any corollary to adverse reactions to the injection in relationship to the menstrual cycle.

Withholding this information is nothing less than a crime against women.

Cancer Jab Linked to Pancreas Disease

Written by Louise Hall, published by the Sydney Morning Herald, 17/8/2008

The cervical cancer vaccine is under fresh scrutiny after three women were struck down with pancreatitis soon after receiving the injection.

The Therapeutic Goods Administration (TGA) is investigating whether the shot of Gardasil caused the sudden inflammation of the pancreas in the three patients, or whether it was just a coincidence.

A 26-year-old woman went to Bankstown Hospital four days after receiving her first dose of the quadrivalent vaccine, which protects young women from the strains of human papillomavirus (HPV) that cause 70percent of cervical cancers.

Writing in the Medical Journal Of Australia, surgery fellow Amitabha Das said the woman developed a fever, rash, severe pain and vomiting and was diagnosed with pancreatitis. After 10 days the symptoms settled and she was discharged from hospital and remains well.

Dr Das and his colleagues said an extensive investigation could find no other cause for the pancreatitis and while a coincidental illness could not be ruled out, “neither can HPV vaccination be excluded as a potential cause”.

“We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination,” they wrote.

A spokeswoman for the TGA said in the second case, the patient’s level of pancreatic enzymes normalised within 24 hours. A third woman is still under the care of a gastroenterologist.

Acute pancreatitis is a sudden, debilitating attack of severe upper abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. Complications include respiratory, kidney or heart failure, all of which can be fatal.

Rachel David, spokeswoman for Gardasil manufacturer CSL, said the firm remained confident the drug was safe and effective, but the reports of pancreatitis would be immediately investigated.

“No causative relationship with the vaccine has been established but obviously we do take reports of associations like this very seriously,” Dr David said.

The TGA has received 1013 reports of suspected adverse reactions to Gardasil, including soreness, swelling, redness or other reaction at the injection site (20percent), headaches (20percent), dizziness (15percent), nausea (16percent) and vomiting (6.9percent).

It said the overall level of reporting for Gardasil, following the distribution of 3.7million doses in Australia, was very low and consistent with other new vaccines and rates reported from other countries.

Meanwhile the federal program to cover the cost of three doses of the vaccine expires in June. The two-year program provided free Gardasil immunisation delivered by GPs for women aged 18-26 and girls 12-18 who missed out on the injections at school.

Once the program ends, Gardasil will cost $150 a dose, or $450 overall, on a private script.

The school-based program for girls aged 12-13 will continue but funding for older students will finish at the end of the year.

GARDASIL Vaccine: The Damage Continues

Written by Barbara Loe Fisher, published on NVIC Vaccine E-Newsletter, 13/8/2008

The vaccine reaction reports keep coming into the National Vaccine Information Center (NVIC) from mothers describing how they took their healthy teenage girls into a pediatrician or gynecologist’s office where they were given a GARDASIL shot and, then, nothing was ever the same again. The reports of HPV vaccine reactions, injuries and deaths continue to roll in, not only to NVIC but also to the federal Vaccine Adverse Events Reporting System (Search HPV4 at http://www.medalerts.org/vaersdb/index.html) newspapers, and television stations. And the only response that comes from officials at the CDC, FDA and drug companies when perfectly healthy teenage girls collapse into unconsciousness, suffer a massive seizure, get paralyzed or die suddenly after being injected with GARDASIL is the zombie mantra: “It is a coincidence.”

Last week a nurse who is an administrator in the outpatient department for a group of hospitals in California called and asked if NVIC had been getting reports of unusual collapse after GARDASIL vaccination. I said, yes, we are getting those reports and she said “A lot of our patients are collapsing after the shot is given. It happens with GARDASIL more frequently than with any other vaccine we give.” That same week, NVIC received a report from the mother of a 15 year old daughter who got her first GARDASIIL shot last month. Within 10 minutes of being injected, she collapsed and had her first grand mal seizure, became incontinent, temporarily lost vision in her right eye, suffered uncontrolled vomiting and had to be taken by ambulance to the hospital. Another report to NVIC that week also involved first-time seizures in a 15 year old girl after she got a GARDASIL shot.

Through June 30, 2008, there have been reports that at least 17 to 20 deaths have occurred following GARDASIL and were filed with the federal Vaccine Adverse Events Reporting System (VAERS), although the FDA has yet to admit even one death is causally related to the vaccine, suggesting that the girls would have died that day even if no vaccine had been given. Many of the teenage girls ,who die suddenly after vaccination without explanation, were among the brightest and the best and in top physician condition. This was true for 17 year old Jessica Ericzon, a New York softball player, snowboarder and honor roll student who dropped dead within 48 hours of getting a GARDASIL shot. A coroner could find no cause for her death after an autopsy.

There have been so many reports of reactions, injuries and deaths following GARDASIL vaccination (20-25 percent of all vaccine adverse event reports being filed with VAERS are for GARDASIL vaccine reactions) that the FDA and CDC issued a statement defending the vaccine’s safety on July 22.

But one of the vaccine’s developers has urged caution and offers practical advice about the need for continued use of Pap screening to prevent cervical cancer rather than relying on the vaccine to do the job. ” If you are at all concerned, then don’t have the vaccine – have regular Pap smears and you will be equally protected from cervical cancer….Pap screening is still the only proven method we have for cervical cancer prevention,” said Professor Diane Harper, Ph.D. “We don’t know how long the vaccine will protect a woman from HPV infection, and the vaccine does not protect against all types of HPV infection that cause cervical cancer.”

The “coincidence” defense mounted by doctors and drug company officials every time a vaccination is followed by injury and death is as old as it is unscientific. It is amazing that they have been able to get away with it for so long. Babies can’t talk and babies can’t walk so who they will become is still a dream. But young girls and women have already become much of who they will be and, on the cusp of fulfilling the dream, their vaccine deaths and injuries are much more difficult to sweep under the carpet.

It is immoral for doctors in government and industry to continue to look away from the damage done when vaccines cut down the brightest and most physically fit among us. The suggestion that these healthy, high functioning girls were biologically compromised and would have died or been injured that day even if no vaccine had been given is ludicrous. If those in government responsible for protecting the public health and safety look the other way when healthy individuals die and are injured by pharmaceutical products pronounced by government as “safe” for public use, then we cannot be assured that any licensed drug or vaccine is safe.
__________________________________________

“I just kept thinking about the good outcomes rather than what could actually happen.” What happened to Crystal Olivera was arm pain so severe that it left her unconscious immediately after a Gardasil shot, something she had never experienced with her hepatitis and meningitis vaccines. “The next thing I know I am on the floor in the fetal position.” Had she known more about Gardasil – “I wish I’d waited a little until it was out in the public more and also that they did more research about the negative side effects.” – Jamie Colby, Fox News (July 11, 2008 ) SEE VIDEO.

“Jessica Ericzon, 17, was “an all- American teenager,” as described by one of her upstate LaFargeville teachers. Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother. Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom. It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer. Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa. On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine. The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep. Jessie never showed up for the class she was taking at Jefferson Community College. When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot. Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause.” – Susan Edelman, New York Post (July 20, 2008).

“Katherine Kimzey got her first injection of Gardasil along with a Hepatitis-A vaccine and a chicken pox booster. She got the second injection two months later, along with the D-TaP vaccination. Six weeks after the second injection of Gardasil, Katherine passed out. “I tried to get up and my neck was stiff, and I couldn’t move it,” the teenager explained. “I couldn’t move at all.” Katherine spent five days in the hospital……Shannon Nelson, 18, from the Chicago area, got the Gardasil shot and two other vaccines– at the same time. Within a week the soccer star could barely move. “When I went into the hospital I couldn’t walk at all. I had to have a wheelchair. It just got worse each day,” she explained. Nelson spent 23 days in the hospital and while she’s better now the teenager believes one of the vaccines she received is responsible for her illness and her neurologist says it’s certainly possible. Katherine Kimzey is back on the soccer field in North Texas. But she still has occasional pain and doesn’t know what the future will hold. Thinking about her past experience she says she still worries and so does her mom. Michelle Kimzey says next time; she won’t be so quick to jump on the new vaccine bandwagon. “I think the connection is huge,” she said…..In a statement to CBS 11 News, Merck — the maker of Gardasil — said it has analyzed the reports of paralysis and death, and believes: no safety issue related to the vaccine has been identified.” – Ginger Allen, CBS News 11 – Dallas (July 21, 2008).

My Girl Died As ‘Guinea Pig’ For Gardasil

Written by Susan Edelman, published by New York Post, 20/7/2008

She loved SpaghettiO’s, pepperoni, lilies, listening to her iPod and making her pals laugh.

In her senior yearbook, she wrote, “The best things in life aren’t things, they’re friends.”

Now that’s the quote chiseled into her gravestone.

Jessica Ericzon, 17, was “an all-American teenager,” as described by one of her upstate LaFargeville teachers.

Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.

Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.

It started with a pain in the back of her head.

On the advice of her family doctor, Jessie had taken a series of three Gardasil shots.

The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.

Jessie got the first injection in July 2007.

After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.

On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.

The next night, “she told me the spot on the back of her head was bothering her again,” her mom said.

The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.

Jessie never showed up for the class she was taking at Jefferson Community College.

When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.

Jefferson County Medical Examiner Samuel Livingstone is stumped.

“She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause.

He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.

Jessie had been on birth-control pills for a year to treat acne, records show.

Livingstone reported Jessie’s death to the federal Vaccine Adverse Events Reporting System.

Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.

Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.

Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.

They have found “no pattern or connection” to Gardasil in eight deaths and are still reviewing three, he said.

Lisa Ericzon now feels her daughter was “a guinea pig” for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.

“I want other mothers to know,” said Lisa, the first parent of a girl who died after Gardasil to speak publicly.

“I don’t want them to go through what I went through.”

Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition – to become a New York state trooper.

Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.

Her family started the Jessica Ericzon Memorial Fund to award scholarships to her classmates.

HPV Vaccine Adverse Events Worrisome Says Key Investigator

Written by Allison Gandey, published in Medscape Medical News, 26/7/2008

Serious neurologic, thromboembolic, and autoimmune complications have been reported in patients who received human papillomavirus (HPV) vaccines. Although not the norm, experts suggest that the events are grave enough to encourage caution. “The side effects that have been reported are real and they cannot be brushed aside,” Diane Harper, MD, from the Dartmouth Medical School, in Hanover, New Hampshire, told Medscape Oncology. Dr. Harper was a principal investigator of clinical HPV vaccine trials for both Merck and GlaxoSmithKline.

News reports of adverse events, teen paralysis, and death have fueled public concern. Back-to-school immunization clinics are stocking up on Merck’s Gardasil and more than 16 million doses have reportedly already been distributed in the United States alone. But many parents are questioning whether their children should be vaccinated. And many women are wondering whether they should be vaccinated too.

According to the US Food and Drug Administration (FDA), as of June 30, 2008, more than 9700 adverse events have been reported since the vaccine was approved 2 years ago. Of these, 94% were classified as nonserious events and 6% as severe.

Serious Adverse Events

• Nervous system disorders, such as Guillain-Barré syndrome and headache
• Thromboembolic events
• Musculoskeletal and connective tissue problems
• Lymphatic system disorders
• Gastrointestinal problems
• General disorders and administration site conditions
• Immune system problems, including hypersensitivity reactions, bronchospasm, and urticaria

Most Commonly Reported Events

• Fainting
• Pain at the injection site
• Headache
• Nausea
• Fever

To prevent fainting, which can sometimes cause serious harm and lead to head injuries, Dr. Harper recommends that patients receive vaccines on a full stomach and be seated when the shots are administered. The FDA recommends that patients remain seated for up to 15 minutes after vaccination.

Dr. Harper also suggests that physicians not vaccinate patients with personal or family histories of the more serious conditions outlined in recent adverse-event reports. “Physicians have a responsibility to communicate risks to patients and if patients and families are concerned, it is reasonable to hold off on vaccinating,” Dr. Harper said.

It is a sentiment that is echoed by others, such as Abby Lippman, PhD, from McGill University, in Montreal, Quebec, who is chair of the policy committee at the Canadian Women’s Health Network. In this month’s issue of the Journal of Epidemiology and Community Health, she expresses concern about public policies that have seemingly rushed to embrace HPV vaccination. “Why the hurry,” Dr. Lippman asks. Especially in developed countries where there is no epidemic of infection and mortality rates from cervical cancer have been in decline.

What is Causing Adverse Events?

The cause of recent complications remains a mystery and it is difficult to know whether they are linked to vaccines. “Nobody knows why we are seeing adverse events,” Dr. Harper said.

Members of the antivaccine movement point to a number of potential perils, including the presence of aluminum in injections. Like many vaccines, Gardasil contains aluminum salts. Each 0.5-mL dose contains approximately 225 μg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 μcg of polysorbate 80, 35 μg of sodium borate, and water.

“The scientific work to date seems to suggest that aluminum salts in vaccines are safe,” Dr. Harper said. But she told Medscape Oncology that she heard that 1 lot of Gardasil might have had an accidentally high yeast concentration, and this might be why there are problems. “No one knows for sure,” Dr. Harper said.

The manufacturer was not available to comment about product yeast concentrations, but directed Medscape Oncology to an online statement responding to questions about recent adverse effects. “Merck has analyzed the adverse events reported for Gardasil relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population.”

Richard Haupt, MD, executive director of clinical research at Merck’s research laboratories added: “We remain confident in the safety profile of Gardasil.”

FDA and CDC Issue Joint Statement Reassuring Clinicians and Patients

Responding to public concern, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint statement on Tuesday reassuring clinicians and patients about the safety of Gardasil. A second vaccine, GlaxoSmithKline’s Cervarix, is already available in some countries, but is still being assessed by the FDA.

Despite company and regulatory assurances, some clinicians, who are also parents, say they are less confident about the safety of the vaccines. After reviewing the information, Scott Ratner, MD, a cardiologist with a practice in Franklin Square, New York, and his wife, a rheumatologist, opted to have their 17-year-old daughter vaccinated. It is a decision they say they now regret.

Following vaccination, their teenage daughter began showing signs and symptoms of autoimmune disease. “She went from being a healthy, active teen running, playing lacrosse, and participating on swim team to becoming a chronically ill patient,” Dr. Ratner said.

“I worry about the kids who may be having problems, are perhaps struggling with immune damage, and are feeling generally achy and unwell, but are probably going unreported and undiagnosed,” he said. Dr. Ratner has 2 younger daughters and he says he definitely won’t be encouraging either of them to be vaccinated.

Gynecologist Christiane Northrup, MD, told Medscape Oncology that she won’t be advocating that her daughters be vaccinated either. Dr. Northrup appeared on a recent episode of the Oprah Winfrey Show, which has an estimated 20 million viewers per week, most of them women. She told viewers that healthcare dollars would be better invested elsewhere.

Questioning the Safety

Dr. Northrup recommended that the money going toward vaccines and related programs be allocated to general health and wellness initiatives and proper nutrition. This harkens back to the age-old debate between Louis Pasteur and Antoine Beauchamp, Dr. Northrup suggests.

For most of his career, Pasteur subscribed to germ theory, while Beauchamp backed the more unpopular theory of biological terrain. The question: Is it the germs themselves that make people sick or a weakened state of immunity that allows germs to take root? “Pasteur was widely supported, but on his death bed conceded that Beauchamp was right,” Dr. Northrup said during an interview. She suggests that this is what experts should be concentrating on now.

Instead of focusing on germ theory by pouring efforts into HPV vaccines, she says more resources should be dedicated to fostering the overall health of the host.

Dr. Lippman makes a similar argument and points to the capacity of healthy, immunocompetent women to spontaneously clear up to 90% of HPV infections – infections, she says, almost everyone will one day acquire – within 1 to 2 years.

When Gardasil was approved in the United States in June 2006, it was hailed as an important day for public health and for women’s health. Dr. Harper was quoted as saying that the vaccine is the biggest advance since the Pap smear. Dr. Harper told Medscape Oncology that she still thinks this is the case, but enthusiasm must be tempered with caution.

Dr. Harper noted that we shouldn’t be calling the new immunizations cervical cancer vaccines. “Even if everyone was vaccinated, we would still have cervical cancer,” she said. “I don’t want people to be lulled into thinking this will prevent cancer. If Pap screening rates decline, cervical cancer rates will rise,” she emphasized.

If Pap Screening Rates Decline, Cervical Cancer Rates Will Rise

The decline in cervical cancer in developed countries has been largely attributed to regular Pap screening – something Dr. Harper believes has done a superb job. Women who haven’t received an HPV vaccine, and even those who have, are still encouraged to undergo regular screening.

At the 2006 American Society of Clinical Oncology annual meeting, delegates were enthusiastic. One presenter showed a series of cervical cancer photos and told observers that “these types of pictures will soon disappear in clinical oncology.”

Unfortunately, that utopian prediction is unlikely. “Cervical cancer is not a vaccine-preventable disease,” Dr. Lippman said during an interview. And in her recent editorial, she points out that surrogate end points – not cervical cancer – were used to measure the efficacy in the clinical trials.

“No one would want to wait to see cervical cancer develop in participants,” she writes. “But the general failure to mention that the precancerous lesions chosen for study are not only potentially removable, most (those that are CIN 2) would probably have resolved on their own without any intervention, is arguable.”

Many Questions Remain

As previously reported by Medscape Oncology, Sharmila Makhija, MD, from the University of Alabama School of Medicine, in Birmingham, pointed to other limitations of HPV vaccines. Dr. Makhija is the principal investigator on Merck’s FUTURE III trial, looking at the vaccine’s efficacy in women 24 to 45 years old, and is a coinvestigator on GlaxoSmithKline’s vaccine trials.

Dr. Makhija noted that the bulk of the work to date has focused on just 2 types of HPV – 16 and 18. She added that, going forward, more virulent cancer-causing strains could emerge, making it difficult to eliminate disease. And other important questions remain:

• How long does the vaccine last?
• Will it require a booster?
• Who should be vaccinated and at what age?

“While vaccine proponents emphasize the many thousands of women who participated in clinical trials of the product, they gloss over how few young girls in the 9 to 13 year age range, targeted specifically for school-based immunizations, were included,” Dr. Lippman argues. She said that only the very short-term immunogenicity and safety, and not the efficacy, of Gardasil was studied.

“It is a good vaccine,” Dr. Harper said. “We are simply still in the early stages of investigation.”

The World Health Organization (WHO) has weighed in on the vaccines and is recommending that they be considered only 1 component of any successful strategy. Immunization will have to be added to the other aspects of cervical cancer control, Andreas Ullrich, MD, medical officer at WHO’s department of chronic diseases and health promotion, said in a news release. “There is no question that early detection will continue to be a key element.”

Merck is encouraging healthcare providers and consumers to report any adverse events associated with Gardasil to the company and to the US Vaccine Adverse Event Reporting System at 1-800-822-7967.

J Epidemiol Community Health. 2008;62:570-571. Abstract

Judicial Watch Uncovers New FDA Records Detailing 10 New Deaths & 140 “Serious” Adverse Events Related to Gardasil

Watchdog Publishes New Special Report Examining 8,864 Adverse Event Reports Detailing Safety Concerns

Written by Judicial Watch, published on Marketwire, 30/6/2008

Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 10 deaths since September, 2007. (The total number of death reports is at least 18 and as many as 20.) The FDA also produced 140 “serious” reports (27 of which were categorized as “life threatening”), 10 spontaneous abortions and six cases of Guillain-Barre Syndrome — all since January 2008. Adverse reports excerpts include:

– Information has been received… concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil… The patient died four days after… patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID: 310262-1 (D)

– Information has been received… concerning a 23-year-old female… who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil… the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness… respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone… Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)

– Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction… Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)

– Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient’s outcome was unknown. VAERS ID: 303188-1

“Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” stated Judicial Watch President Tom Fitton.

Judicial Watch had previously obtained 3,461 reports relating to Gardasil. On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records. These documents and the new Judicial Watch report, titled “Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment,” are available at www.judicialwatch.org.

HPV Vaccine’s Suspected Side Effects Cause Concern; CDC Says Drug is Safe

Written by Jessica Meyers, published on the Dallas Morning News, 6/6/2008

Katherine Kimzey started suffering debilitating headaches, fainting spells and arthritis-like stiffness last November.

Six weeks later, the 14-year-old Dallas resident became so dizzy she could barely walk. She was hospitalized and missed three weeks of school. Then, she had a seizure. For weeks, she bounced back and forth between specialists and was eventually diagnosed with epilepsy.

Katherine’s mother, Michelle Kimzey, now believes her daughter’s symptoms were caused by a new vaccine that was supposed to protect her against cervical cancer.

The symptoms started not long after Katherine had her second shot late last year, she said. And they mirrored many of the 5,000 reports filed by the public through a national database that monitors the safety of vaccines after they are licensed.

“When you read everybody’s stories, they’re too similar not to be related,” Mrs. Kimzey said.

But officials with the Centers for Disease Control and Prevention and doctors nationwide said such concerns about the drug are unfounded and most significant side effects reported are unrelated to the vaccine.

“The safety of the vaccine is being very closely monitored,” said John Iskander, acting director for immunization safety at the CDC, which runs the database along with the Food and Drug Administration.

Fainting, he said, has been the strongest negative response to the vaccine. “There certainly have been high-profile suspected side effects, some reports of deaths,” he said, “but those have been investigated and they don’t appear to have been causally related.”

The recommendations have not changed and the vaccine will remain available, he said.

Jennifer Allen, a spokeswoman for New Jersey-based Merck & Co.’s vaccine division, which makes Gardasil, said on Thursday that the company conducted clinical trials for 10 years and that it remains confident in its product.

But this hasn’t assuaged Mrs. Kimzey, 41. And Katherine has refused to get her third and final dose of the vaccine.

Approved 2 years ago

Gardasil was approved by the Food and Drug Administration two years ago for females between ages 9 and 26. It protects against sexually transmitted diseases caused by the human papillomavirus, or HPV, responsible for 70 percent of cervical cancers and 90 percent of genital warts. Females are encouraged to get the vaccine before they become sexually active.

Three shots are given over a six-month period. The company said 16 million doses have been administered since its approval. And it lists nausea, vomiting and pain following the shot among the side effects.

The HPV vaccine has generated debate across the country and in Texas. Gov. Rick Perry issued an executive order in February 2007 requiring that all sixth-grade girls get the HPV shot. But angry parents and conservative groups fought the mandate, fearing it condoned premarital sex and took away parental rights. The Legislature defeated the order last April.

The National Vaccine Information Center heralded the decision, saying that testing of the vaccine was not extensive enough in girls under 12. The nonprofit center had already started warning about the possibility of adverse reactions such as extreme fatigue, arthritis and loss of consciousness.

Barbara Loe Fisher, co-founder and president of the center, said she’s frustrated that the CDC has “assumed safety” for Gardasil, which has been tested only in conjunction with the vaccine for Hepatitis B.

Today, girls often receive the Gardasil shot at the same time as a meningitis vaccine and another new booster that immunizes against tetanus, diphtheria and pertussis.

The FDA has approved all the vaccines separately, but studies on administering them together are still ongoing.

“Not only was Gardasil put on the fast track and licensed quickly,” said Ms. Fisher, “but to say safety is assumed and you can give any vaccine with it is even more shocking.”

Enough evidence

Joseph Bocchini, chairman of the Committee on Infectious Diseases for the American Academy of Pediatrics, says there’s enough evidence to support mixing the drugs and not enough adverse reactions to stop it.

“From the data, we already know [the vaccines] would not be expected to interfere with each other in terms of antibody or safety,” said Dr. Bocchini. “If we look at the number of doses given vs. the reports, it’s very clear that there are significant benefits that far outweigh potential risks at this time.”

Dr. Bocchini cautioned that reactions that do not occur immediately, like seizures, may actually be caused by something else. So far, he said, there have not been enough verifiable reports of extreme side effects through the Vaccine Adverse Event Reporting System, or VAERS, to generate a study.

Dallas County’s Health and Human Services officials said they have received no reports of severe reactions to the vaccine.

The Texas Department of Health and Human Services said it had 210 reports of reactions to Gardasil last year, eight of which required hospitalization.

But officials said this is not an uncommon number for a vaccine. Dr. Jennifer Walsh said she will continue to encourage use of the vaccine where she works, the Adolescent Medical Clinic at Children’s Medical Center Dallas.

“I’m still following the standard guidelines,” Dr. Walsh said. “I don’t have any worries at this point.

HPV Scientist Speaks Out

Written by Michele Gillen, published on CBS4, 7/5/2008

Gardasil. It is a first of its kind vaccine designed to prevent cervical cancer and approved by the Food and Drug Administration on June 8, 2006 for use in females aged 9 to 26. Within weeks the vaccine was unanimously approved by the CDC’s Advisory Committee on Immunization Practices for 11 and 12- year old girls. What followed was a cascade of calls by legislators around the country, including in Florida, pushing for this new to the market vaccine to be mandated for scores of young girls.

“This is a real danger zone, ” says Dr. Diane Harper.

Why might you care about what she says? Dr. Harper is one of the world’s top experts on the Human Papilloma virus, HPV, which can lead to cervical cancer. In fact, she’s one of the leading scientists the pharmaceutical industries turned to for help to conduct clinical trials – including those that led to approval by the US Food and Drug Administration of Gardasil – and the recommendations that followed.

Speaking out in her first such television interview with WFOR-TV Chief Investigative Reporter Michele Gillen, Dr. Harper expresses concerns over what she considers a rush to recommend and mandate the vaccination of very young girls with the vaccine. “It went too fast, it went too fast without any breaks,” says Harper, who devoted nearly two decades of her career to research on HPV.

Dr. Harper says she believes the vaccine is safe but cautions that time is needed to study potential side effects in larger numbers of young girls before any consideration should be given to mandating such a vaccine.

According to Dr. Harper, “the vaccine has not been out long enough for us to have post marketing surveillance to really understand what all the potential side effects are going to be. We feel it is very safe.” However, she adds, “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.”

Barbara Low Fisher agrees. She took to the streets a grass roots fight credited with derailing many efforts around the country to mandate the vaccine. “It was the quickest effort I have ever seen in 25 years for a vaccine to be mandated,” says Fisher. A mother of a son who she say was left with learning disabilities following a routine vaccination in the 1980′s, Fisher is President and Co Founder of the National Vaccine Information Center. It is a non-profit independent clearinghouse for information on vaccines and disease.

Fisher says her organization has been contacted by nearly 100 parents claiming their daughters have suffered some type of adverse reaction following a Gardasil shot – at times given in combination with other vaccines. She says many parents are frustrated in their search for answers and that they don’t know where to turn. She tells Gillen “the National Vaccine Information Center is getting reports every week, mostly mothers, of what is happening to their 11-year old girls after receiving Gardasil.”

Fisher says she has heard from parents upset that their doctors are refusing to report reactions potentially tied to this vaccine they recommended, if not aggressively pushed.

“I think that this has caused a real crisis of trust in the hearts and minds of parents who are being more educated about vaccines and all types of products they give their children,” says Fisher.

Harper says parents need to be armed with as much information as possible. She believes the vaccine should be an educated choice. She explained that many parents do not realize or are not being told by physicians, that their daughters might end up needing a booster shot. She says what can be considered key study trials lasted at most 5 years and that there is no way to know exactly how long the vaccine will be effective.

“I think the thought is that there probably will be efficacy for longer than 5 years but its probably not going to be lifetime efficacy. There probably will be some need for a booster. There will be some need for understanding when we going to need to be able to revaccinate those women. Those are all open questions,” says Dr.Harper.

Given that it is unknown for how long the vaccine will be effective, Dr. Harper says she can’t stress enough the need for pap tests throughout a woman’s lifetime, even if she has received an HPV vaccine.

Dr. Harper understands why some parents are left wondering how young might be too young?

Gillen asked Dr. Harper what she thought the optimum age of a girl should be to receive the shot.

“I would have started at 15, and not at 12,” explained the physican.

Fisher says she applauds Dr. Harper for being willing to address controversial questions regarding HPV vaccines and concerns by parents who say they want more information before deciding if the shot is right for their daughters.

“I think that Dr. Harper has done a tremendous public service to stand up,” says Fisher.

Dr. Harper says she is convinced HPV vaccines can help prevent cancers in the long run. But that parents and women should have a choice. Dr. Harper has also served as a consulting researcher for study trials for another HPV vaccine named Cervarix, being developed by GlacoSmith Kline, GSK. “I am the first author on two of the GSK papers,” she noted.

But again she expressed her disapproval for any potential effort to mandate a Cervex vaccine for young girls. As Dr. Harper explains ” It’s still like-wise with Gardasil. They haven’t been out long enough , there isn’t enough information to have a mandate that you can’t go to school until you have this vaccine. It does not make any sense.”

Dr. Harper served as a researcher on study trials for Gardasil and Cervarix while employed as a professor at Dartmouth College. The University was contracted by both Merck and Co.. and Glaxo Smith Kline for the HPV studies who paid for the studies. Dr. Harper has disclosed receiving speaking fees from both Merck and from GSK for speaking about the HPV vaccines, and has received consultation fees from both Merck and GSK for consulting about trial development and data interpretation, in addition to the monies paid to Dartmouth to conduct the trials.

In asking a representative from Merck. for a response to the WFOR-TV interview with Dr. Harper and the types of concerns she raised a Merck representative provided WFOR-TV with the following statement:

Merck’s research program for GARDASIL® [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18 ) Vaccine, Recombinant] spans more than 10 years of rigorous study of more than 25,000 individuals around the world and the labeling for GARDASIL reflects the extensive data available from our clinical trials.

In addition, the data from our clinical trials have been discussed in public settings by leading medical and policy experts, including an FDA Advisory Committee meeting in May 2006, publications in The New England Journal of Medicine and The Lancet and meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In February of 2006 the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for GARDASIL and designated the file for priority review. A priority designation is intended for products that address unmet medical needs and under the prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review and act on BLAs designated as priority review within six months of receipt.

GARDASIL received its U.S. FDA approval on June 8, 2006 and on June 29, 2006 received a universal ACIP recommendation for use in 9-26 year old girls and young women.

We began discussions of data from the clinical trials with the ACIP’s HPV Working Group as early as 2004. It is important to note that the three week time period between FDA licensure and the ACIP recommendation in June of 2006 does not represent the total amount of time the ACIP Working Group and full ACIP membership actually discussed the data and potential recommendation for GARDASIL – this time period was more than two years.

Since FDA licensure in June 2006 GARDASIL has been approved in 101 countries around the world and through March 31, 2008 more than 26 million doses have been distributed globally.

We are very confident in GARDASIL, and look forward to continuing to lead in the fight against cervical cancer. Here are some additional milestones you may be interested in as you complete your story.

• By 1996, Merck started production of the HPV-16 targeted prototype of GARDASIL.
  Merck filed an Investigational New Drug Application and started Phase I clinical trials of the HPV-16 prototype in 1997.
  Phase II trials of the prototype began in 1998.
  In 2000, Merck conducted the first dose-ranging trial of a vaccine to protect against HPV types 6, 11, 16 and 18.
  The first pivotal Phase III trial of GARDASIL, FUTURE 1, started in 2001.
  November 2001: An FDA Advisory Committee agreed on clinical trial design.
  The results from the first phase II trials of the HPV-16 prototype were published in NEJM in 2002.
  Merck presented results from the pivotal Phase III trials of GARDASIL at the Infectious Diseases Society of America (IDSA) meeting in October 2005.
  In December, 2005, Merck submitted its first license application for GARDASIL to the FDA. FDA later grants priority review. Merck also begins to file regulatory applications worldwide.
  May 2006: An U.S. FDA Advisory Committee unanimously agrees that the clinical data support the efficacy and safety of GARDASIL.
  June 8: U.S. FDA approves GARDASIL.
  June 29, 2006: In the U.S., the Center’s for Disease Control (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously recommended broad vaccination with GARDASIL – routine for girls and women ages 11-26, with 9- and 10-year-old girls vaccinated at their physicians’ discretion.
  Since July 2006: GARDASIL receives approval in more than 70 countries worldwide, including Canada, those in the European Union, Australia, New Zealand, Brazil, Peru, Taiwan and two countries in Africa.
  Nov. 1, 2006 – GARDASIL is added to the CDC’s Vaccines for Children (VFC) Program
  In January 2007, GARDASIL was added to 2007 U.S. Childhood and Adolescent Immunization Schedules released jointly by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).
  Recommendations have since been made by health agencies in other countries (i.e. Canada’s National Advisory Committee on Immunization (NACI) on Jan. 30, 2007 and by the Australian Government in November 2006) and funding and reimbursement for GARDASIL is also becoming available in additional countries as well (i.e. Austria, Germany).
  In March 2007 the CDC finalized the provisional recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL. These vaccination guidelines were published in the March 23, 2007, issue of the CDC’s Morbidity and Mortality Weekly Report (MMWR)

Merck Gardasil Vaccine Plant Cited In FDA Warning Letter

Published by News Inferno, 1/5/2008

Merck & Co. has received a warning letter from the Food & Drug Administration (FDA) regarding conditions at the plant where the company makes the cervical cancer vaccine Gardasil, along with several children’s vaccines. Late last year, Merck issued a recall for 1.2 million doses of some pediatric vaccines made at the West Point, Pennsylvania plant cited in the warning letter.

Last week, The Philadelphia Inquirer reported that an FDA inspection of the Merck vaccine plant had uncovered 45 areas of concern, including contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots. An FDA spokesperson told The Philadelphia Inquirer that the agency sent the letter, dated April 28, because it did not believe the company was moving fast enough to correct past problems.

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The warning letter said the company had failed to ensure that equipment for manufacturing and processing was “calibrated, inspected or checked according to a written program designed to assure proper performance.” The letter also said that in the course of making vaccines, “failures are not fully investigated and documented”.

The FDA specifically cited unwanted fibers that were showing up on vial stoppers for such vaccines as MMR, or measles, mumps and rubella. These stoppers are placed in special bags for sterilization. The FDA said the company was using “lesser quality” bags that were breaking down slightly and producing the fibers. The FDA cited Merck for only discarding vaccines where the fibers were found. The company should have assessed all potentially affected products, the FDA said.

In December, Merck recalled over 1.2 million doses of defective vaccines-11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine-when quality control checks revealed production equipment might not have been properly sterilized. Merck also quarantined a nearly one-year supply of other potentially suspect doses. Vaccines involved protect against Hib-or Haemophilus influenzae type b-disease and other conditions; Comvax also prevents against hepatitis B. The vaccines were distributed beginning April 2007 and all but one lot was distributed in the United States. Merck supplies about half the 14 million doses of Hib vaccine used in the U.S. annually. FDA inspectors visited the Montgomery County plant on 30 separate occasions from November through January.

The Merck plant also makes Gardasil, the controversial cervical cancer vaccine. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Despite such reports, Merck has made aggressive efforts to convince state legislatures to make Gardasil mandatory for young girls.

In a posting on its website, the FDA said it “does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck.” The FDA also said it did not expect the deficiencies to affect availability of the firm’s vaccines, except for the recalled PedvaxHIB and COMVAX vaccines. The FDA has given Merck 15 working days to correct the violations cited in the warning letter.

Vaccine Concern Part 1

Written by Michele Gillen, published on CBS4, 24/4/2008

MIAMI (CBS4) – If you are the parent of a young girl you most likely have heard of a first of its kind vaccine named GARDASIL, developed to protect against the viruses which can cause cervical cancer.

The FDA’s approval of the vaccine triggered efforts in Florida and across the nation to mandate its use for 11 and 12 year old girls. CBS4 Chief Investigative Reporter Michele Gillen has learned there is an increasing concern over the use of the vaccine.

Christina Bell’s daughter, Brittney, was one of the young girls who received the vaccine. Just weeks later, her life took a radical turn for the worse.

Seemingly, in a moment’s time, Brittney’s left leg became paralyzed, her ankle swinging like a rag doll’s. Even with a shoe brace, she walks with a limp.

“It’s hard for me to lift it up,” Brittney told Gillen.

Brittney’s limb paralysis occurred shortly after the 12 year old went to the doctor for a routine tetanus shot for school. That is when Bell says the doctor suggested Brittney also have the GARDASIL vaccine on the same day. And she did.

GARDASIL is a first-of-its-kind vaccine approved by the U.S. Food and Drug Administration (FDA) for girls as young as nine. The vaccine is profiled on the FDA website with the headline, “New vaccine prevents cervical cancer.”

In trials, the vaccine was shown to prevent pre-cancerous lesions due to certain types of Human Papillomavirus (HPV).

In searching for answers as to why her daughter now suffers from a limb paralysis, Christina Bell says she couldn’t shake the idea that it might somehow be tied to the HPV vaccine. She hasn’t found a doctor to agree with her, including the paediatrician who recommended the shot.

“He doesn’t believe it has anything to do with the shot at all,” said Bell.

She says he stopped returning her calls. When the CBS4 I-Team tried calling him, he didn’t return the calls.

Bell began to research the vaccine herself and what she found startled her – government-compiled reports, filed from around the country, of adverse events that occurred sometimes within hours, other times within weeks, of a GARDASIL vaccination.

While they don’t prove a link, they do document that in some cases an adverse event occurred following an injection. These types of events have been reported to VAERS, a federal vaccine reporting system.

“We’ve seen reports of] paralysis, convulsions, seizures in young girls. It’s very, very, scary and very unfortunate,” said Irene Garcia, spokesperson for Judicial Watch, a government watchdog group that obtained the VAERS records from the FDA through the Freedom of Information Act and posted them on the Internet.

When the data was finally released, Garcia said she felt outraged.

“It was outrage because all that I had seen publicly in the media and on television and from pediatricians was positive,” said Garcia.

Last February, the FDA told CBS4 that it was investigating reports of 13 deaths following an HPV vaccination. At the time, the agency said it was confident that none were tied to the vaccine and that reports of adverse events were under review but not considered anything out of the ordinary.

An FDA spokeswoman told CBS4 this week that she could not provide an update on the number of reported events, including deaths.

“I haven’t seen updated numbers for several months. We monitor on a daily basis but we don’t total it up. We are not seeing a problem,” said Susan Cruzan, spokesperson for the FDA.

In some states across the U.S., it is mandatory to report a suspected reaction to VAERS. But in others, it isn’t.

“It varies by state and there is no blanket federal law, unfortunately,” said Garcia.

Brittney’s mom said she can’t find a doctor willing to report an adverse reaction following the administration of her daughter’s vaccines. CBS4 informed her that parents, just like doctors, can report an adverse event and the Bell family has done just that.

“It might always be that people will say you can’t prove that this is linked,” Gillen told Bell.

“I am still going to speak and tell everybody what I think. I tell everybody,” replied Bell. “What do I want today? I want my daughter back to normal,” said Bell.

In a response to this report Merck, which makes the GARDASIL vaccine, issued the following statement:

Merck actively monitors adverse event databases throughout the world, including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event report does not mean that a causal relationship between an event and vaccination has been established – just that the event occurred after vaccination.

The labelling for GARDASIL reflects the extensive data available from our clinical trials. The data, including safety information, have been thoroughly reviewed and discussed by medical experts.

Since its FDA approval in June 2006 through March 31, 2008, Merck has distributed more than 26 million doses of GARDASIL worldwide.

Merck will continue to evaluate all reports in the context of our own post-marketing adverse experience database and our clinical trial database. Post-marketing adverse event reports received by the Company are sent to regulatory authorities worldwide in accordance with regulatory requirements, and Merck updates its product labels with new safety information as appropriate.

Merck encourages healthcare providers and consumers to report any potential adverse experiences following vaccination with GARDASIL to the Company and to adverse event reporting systems.

The HPV Vaccine: Herd Immunity or Human Sacrifice?

Written by Joanne Waldron, published on Natural News, 22/4/200

Reports of adverse reactions to the new HPV vaccine are escalating. One particularly heart-wrenching example is the story of an active 12-year-old little girl named Brittany who recently lost all feeling in her leg and collapsed two weeks after receiving the Gardasil vaccine. Although she once had dreams of earning an athletic scholarship, she now struggles to hobble around each day with the aid of braces and a walker, First Coast News reports. According to the article, she has been diagnosed with Acute Demyelinating Encephalomyelitis (ADEM), a condition characterized by inflammation of the brain and associated with the vaccination.

Like many other parents, this girl’s mother had no idea that this kind of reaction to the vaccine was possible and never would’ve allowed her daughter to receive it had she been made aware of this. To add insult to injury, people who are injured by the vaccine cannot even sue Merck, the maker of the Gardasil vaccine, because the vaccine is part of the National Vaccine Injury Compensation Fund. Unfortunately, the only recourse for those injured by this vaccine is to file a claim with the government. Translation: compensation of the victims becomes the responsibility of taxpayers.

While the FDA may claim that adverse reactions to this vaccine are rare, a review of the U.S.’s Vaccine Adverse Events Reporting System (VAERS) data shows that thousands and thousands of adverse reactions have been reported in the United States alone. Girls from other countries have been injured by this vaccine, as well. Hundreds of Australian girls have experienced side effects like paralysis, dizzy spells and seizures, but Australia’s Department of Health and Ageing won’t release any of the details . According to LifeSiteNews, The European Medicines Agency reports that there were two more women who died not long after they received the vaccine, one in Austria and one in Germany. The Financial Times reports that there have been eleven deaths and a wide array of other adverse reactions, including Bells Palsy, Guillan-Barre syndrome, seizures, blood clotting, heart problems, and even miscarriages and fetal abnormalities amongst pregnant women who received the vaccine.

Many doctors are not recommending this vaccine, because in addition to the serious adverse reactions and deaths that have been reported, they have concerns about the vaccine’s long-term safety and efficacy. In her well-written book called The Parents’ Concise Guide to Childhood Vaccinations, Dr. Lauren Feder notes that the pain that many girls experience after the shot is probably due to the aluminum adjuvants in the vaccine. She also cautions that the vaccine contains polysorbate 80, a substance linked to infertility in mice. After some deliberation, it was her opinion that the vaccine had more risks than benefits.

One vaccine researcher, Diane M. Harper, a physician and someone who has spent twenty years on the development of the HPV vaccine, has publicly stated through a KPC News report that giving this vaccine to young girls is a “great big public health experiment,” as this vaccine’s safety and efficacy for young girls is unknown. She notes that HPV is a skin infection and can be spread in ways other than sex, and it’s quite possible that tiny girls have already been exposed to the strains of HPV covered by the vaccine which would render the vaccine ineffective. She thinks the vaccine should only be offered to women 18 and older, and only if they have first tested negative for the strains of HPV covered by the vaccine. Of course, testing tiny girls with a vaginal swab to see if they’ve already been exposed would be wholly inappropriate. Harper has many other concerns, as outlined in the news report, but she is having trouble getting her views heard through mainstream media. Another concern voiced by Harper and many other doctors is that even if someone gets the HPV vaccine, regular pap smears are still needed, as the vaccine doesn’t protect against all strains of HPV.

The reason many doctors like this vaccine is because HPV can cause cervical cancer. According to the CDC, certain types of HPV can cause genital warts, and certain types of HPV can cause cervical and other cancers. The types of HPV that can cause genital warts are considered low-risk and are not the same as the types that cause cancer. Again, genital warts will not turn into cancer. However, the CDC reports that in 90% of all cases of HPV, including both the wart-causing and the cancer-causing varieties, the body’s immune system will clear the infection naturally within two years. In fact, the CDC maintains that most people who contract HPV will not have any symptoms at all.

But just how common is cervical cancer in the United States? To answer this question, it is useful to look at some statistics that Kaiser has posted on its website concerning the incidence of cervical cancer in the United States. The statistics are available by state and by ethnicity. For example, in the state of Maryland, 9.3 out of every 100,000 women contracted cervical cancer in 2003. Without considering any of the personal risk factors (like cervical cancer in the family), the general risk for someone living in Maryland would be 9.3/100000 or .0093% chance of contracting this disease. It is important to note that many people have pre-cancerous lesions that are treated by their doctors and that data is not reflected here. However, generally speaking, assuming that a woman gets regular pap smears, the risk for developing cervical cancer seems relatively small. Using the state of Maryland as an example again, according to the statistics provided by Kaiser, only 2.5 out of every 100,000 women or .0025% actually died from cervical cancer in the state of Maryland in 2004.

The World Health Organization (WHO) reports that 80% of all cervical cancer deaths happen in developing countries. The remaining deaths from cervical cancer are divided amongst all of the other developed nations. However, there is currently a big push in the United States for girls to have this vaccine. According to CorpWatch.org, Merck even lobbied to make the vaccine mandatory. Given that each course of the vaccine would cost hundreds of dollars, Merck would stand to make billions if this vaccine were required for all young girls. After all of Merck’s problems with its Vioxx drug that was taken off the market, this vaccine would certainly allow Merck to recoup its losses.

For all of these reasons and many more, parents naturally have grave concerns about this vaccine. Even girls who receive the HPV vaccine still need regular pap smears, because 30% of cervical cancers won’t be prevented by this vaccine (and that’s assuming the vaccine works all the time for the other types). Numerous doctors have also pointed out that just because a vaccine may seem to prevent precursor lesions from developing doesn’t mean it will prevent cervical cancer — this, along with many other long-term variables concerning the vaccine, won’t be known for many years.

Given all of the adverse reactions associated with this vaccine and even the possibility of death, one has to question if young girls should be given a vaccine whose long-term effects are unknown in a country where women have good access to medical care and are able to get regular pap smears. This whole vaccine mentality is eerily reminiscent of the story told in Stravinsky’s “Rite of Spring,” which recounts the tale of a young maiden being sacrificed in pagan Russia as an offering to the gods in order to have abundant crops. Is the suffering and possible death of some girls for the purpose of “herd immunity” really worth it? Go ask Brittany.

The State Wants my Daughter to be Vaccinated, but I Want to Know More

Written by Anne Karpf, published in the Guardian, 1/3/08

I like to start worrying early. You may be anxious about next week, but I did that ages ago and am already on September. Yet reading the parent message-boards over the past few weeks, I’ve realised that I’m not the only one worried about the HPV vaccination programme to be introduced into schools by the Department of Health in September. It’s targeted at 12- to 13-year-old girls, and I have one. The vaccine, made by Merck, is called Gardasil. If it’s administered before a girl becomes sexually active, it’s effective against four strains of human papillomavirus (HPV) that can cause cervical cancer. Put like that, unless you’re a Christian Scientist, an abstinence campaigner or an activist against “Big Pharma”, why wouldn’t you be happy?

Even many medics, it turns out, aren’t. On the Financial Times website last week, a news service devoted to the global pharmaceutical market reported widespread scepticism among US doctors about Gardasil’s long-term safety and efficacy. As for me, well I’m more angry than sceptical, both about Gardasil itself, and the way it’s being sold.

This is what concerns me. Not just that Gardasil works on only four strands of HPV when there are between 15 and 40 that can cause cancer. Or that some serious adverse reactions include convulsions and numbness. (Most medicines, even alternative, produce some adverse reactions.) No, what’s really disquieting about this public health campaign is that most cases of HPV clear up of their own accord – a healthy immune system knocks it on its head. It’s pretty bad reasoning not to understand that, although 99% of invasive cervical cancer is caused by HPV, this doesn’t mean that 99% of HPV causes invasive cervical cancer. Only a small percentage of women infected with HPV go on to develop cervical cancer, and other factors, such as smoking, seem to be partly responsible.

How long will Gardasil be effective? No one knows if the immunity it confers will last longer than four or five years without a booster, so it could run out just as a girl is becoming sexually active, providing her with a false sense of security. Could it cause fertility problems or birth defects? No one knows this either. Perhaps this is why some doctors claim that the mass vaccination programme is using young girls as guineapigs. The New England Journal of Medicine last year urged caution because of “unanswered questions, duration of protection, and adverse effects that may emerge over time”.

Another reason I object to the policy is because it pretty much requires me to talk to my pre-teen not just about sex (fine, although who’s Alan Johnson, the health secretary, to command me to?) but also about cervical cancer – a fairly rare disease, especially if you use a condom, and easily treated if caught early through regular smears. Of course we need to tell our kids about sexually transmitted disease, but I’m not sure I want them, at a tender and impressionable age, to equate sex with disease. Rather than reassuring my child, I think I’d be flooding her with anxiety.

We’re constantly told we should be responsible parents, but I’m coming to think that this is a euphemism for compliant. Why else would the Department of Health fail to give parents any information that might encourage them to ask critical questions about the vaccination programme, or to discuss the alternatives – such as improving the smear programme, running a campaign about how condoms, stopping smoking etc can reduce the risks of catching cervical cancer, and introducing the new and more effective HPV detection test?

Though you might not know it (and unlike some states in the US), HPV vaccination won’t be obligatory. The messageboards are already buzzing about how to ensure that your daughter’s school knows that you haven’t given consent. Keep her away from school on the day the vaccination is due to be given, just to be sure? Or write “NO CONSENT” in large felt-tipped letters on her arms? I’m wondering – purple, or red?

RESPONSE TO ABOVE ARTICLE

‘Informed Choices on HPV Vaccine and Birth Control’, written by Professor David Salisbury, Director of Immunisation, Department of Health, 10/3/08

Anne Karpf’s views on the new HPV vaccine were factually incorrect and misguided. Cervical cancer kills women – about 1,000 every year in the UK. We are not suggesting girls be vaccinated against all strains of HPV, but the strains that cause 70% of cervical cancer cases. While cervical screening has been very effective, it has to be better to prevent cancer rather than rely on picking up the early signs of cervical abnormalities.

The brand of vaccine has not yet been chosen. There are two candidates, Gardasil (manufactured by Sanofi Pasteur) and Cervarix (manufactured by GlaxoSmithKline). These HPV vaccines have been studied carefully for more than six years, and all indications are that they will continue to protect against cervical cancer for very much longer. Hundreds of thousands of young women have had HPV vaccines in the US, Canada and Australia. No adverse reactions specific to these vaccines have been identified and long-term follow-up for safety continues.

The Department of Health is rolling out a public information campaign this year, so parents and young women have all the information they need to consent to this important vaccine.

Gardasil Side-Effects Controversy

Reported by Laura Sparkes, published on Today Tonight, broadcast date: 7/12/07

When the vaccine for cervical cancer was found, it was an Australian first. Gardasil was designed to protect against the second biggest cause of female deaths from cancer.

Now available free to any woman under 26, it has been given to millions.

But there have been side effects for a few hundred: nausea, dizziness, hallucinations, paralysis.

Allie Harvey lined up along with 2.2 million other Australian women to be administered with Gardasil, the cervical cancer vaccine developed by former Australian of the Year Professor Ian Frazer.

“I had a headache, I was dizzy, I was nauseous, my right side was weak, my right fist was clenched and I was hallucinating,” Allie said.

“It was absolutely terrifying because I didn’t know why it was happening. I felt absolutely terrified.”

Gardasil has been hailed as a medical breakthrough, the first ever immunisation against cancer; but no-one was warned about this.

Far more frightening for the year 12 student – who received the first of three injections for the vaccine at school courtesy of a government sponsored initiative – was the response she received from the health professionals around her.

“The nurses that had come in from the government told me that I didn’t have a rash, that it wasn’t a reaction to the immunisation, that I was pretty much making things up,” Allie said.

But Allie wasn’t alone. Jade Foreman, 15, is another of the 496 young women who have reported having adverse reactions to the vaccine.

“I woke up one morning and tried to stand up and I couldn’t put pressure on my legs, I had funny feelings in my legs,” Jade said.

Since receiving the life saving injection at her school in June this year, Jade has been under intense physio to enable her to walk again. She is only able to cope with two hours of school per day.

“I now have no social life,” Jade said. “The pain is ruling my life.”

“Apart from the lower back pain and the neck and the middle back pain, I’m having trouble with my arms dropping things and funny sensations in my arms. It’s just ruining my life.”

Scientist and health researcher Bronwyn Hancock believes the
mass-distribution of Gardasil is simply unsafe.

“The Gardasil vaccine has never been shown to be safe or effective in preventing cervical cancer,” Bronwyn said. “There are so many limitations with the testing that they’ve done.”

As a member of the Vaccination Information Service, an anti-immunisation group, Bronwyn says the research behind Gardasil is too flimsy and that the 18 million women worldwide who’ve already had the vaccine could be setting themselves up for broader health and fertility issues.

“They themselves admit they haven’t tested it to show that it doesn’t cause infertility or cancer,” she said.

“They make a lot of money out of making vaccines and selling them and the government is very heavily influenced by big business, including the pharmaceutical industry.”

But the vaccine’s inventor appears to have one clear motive.

“We really want to see cervical cancer become something that’s a disease of the past,” Professor Frazer said.

And Professor Frazer refutes any suggestion further trials are needed before the drug is supplied to young women.

“If we had to wait to see if the vaccine could be proved its safe lifelong, we would be having epidemics of polio each summer, because the polio vaccine was only introduced 50 years ago.”

He stands by the safety and effectiveness of his vaccine: “If 17 girls a week have been reported as having adverse reactions amongst 2.2 million women immunised in Australia to date, that sounds like a pretty small rate to me.”

That’s one in every 4,400 women.

Roberta Nicholls is one of the vast majority who reported no side effects from her Gardasil injections and has faith in the drug’s ability to protect her from human papiloma virus (HPV), which is thought to cause cervical cancer.

“I think that cancer is something that everybody fears,” Roberta said. “And if something’s out there and it’s a really easy simple way to prevent yourself from getting it, then why wouldn’t you.”

Information on Gardasil is available from the federal government: Gardasil and HPV.

The anti-immunisation group Vaccination Information Service is at www.vaccination.inoz.com or phone (02)
9144 6625

Gardasil: Too Many Questions Unanswered

First published in The Daily Telegraph on the 5/12/2007
By Melinda Tankard Reist and Dr Renate Klein

WHEN reports first emerged a few months ago of Melbourne school girls fainting, suffering dizzy spells and paralysis after their Gardasil injections, the anti-cancer drug’s inventor Ian Frazer put it down to auto-suggestion.

Dr Stephen Downes said it was mass sociogenic illness – hysteria.

Now it has been revealed that, as of November 30, 496 adverse reactions have been lodged with the Therapeutic Goods Administration (TGA). In the US it’s fast approaching 3500 reported cases.

There are too many unanswered questions about the drug, which has also been linked with other symptoms such as temporary blindness, convulsions, disorientation, hyperventilation and tinnitus.

Why are we pushing ahead with a $450 million dollar program when there is so little information about safety and whether the drug actually works?

Only a small number of randomised trials have been reported – all with funding from the vaccine’s manufacturer.

Gardasil was tested on fewer than 1200 girls under 16. It is essentially an untested product in this age group.

There is little evidence that the drug, when administered to very young girls, will still be active later in life – when most cervical cancers develop.

There are more than 100 strains of the human papilloma virus (HPV). At least 13 of these can cause cancer. Gardasil covers only two. Yet all the advertising for the drug leads you to think that if you get the jab, you won’t get cancer.

Are girls being given the opportunity to understand and avoid risks factors for cervical cancer such as smoking, a weak immune system, the pill, multiple sex partners and unprotected sex?

Are girls told pap smears are still necessary – or do they not bother because they think they are now safe?

An editorial in the Journal of the American Medical Association this year stated: “It is important to emphasise that the vaccine is supported by limited efficacy and safety data.”

Why doesn’t the health department want to give us details of the 17 girls a week experiencing adverse reactions?

No one’s asking for their names and addresses. But those of us concerned about women’s health want to know what happened to them and give other young women the opportunity to make an informed decision about Gardasil.

* Melinda Tankard Reist is an author and director of the think tank Women’s Forum Australia. Dr Renate Klein is a long-term health researcher

Uninformed Consent: Women, Girls and the Gardasil Marketing Campaign

Written by Gertrude Green, 1/11/07

Behind new cervical cancer vaccine Gardasil is one of the biggest medical marketing campaigns in history. Even before the federally funded vaccination program began, ads appeared on TV and in print to raise awareness about cervical cancer, HPV and Gardasil.

Merck and CSL are the companies marketing Gardasil. Regarding the pre-vaccination program campaign, a Merck spokesperson told a Canadian newspaper, “Over the last few weeks, there has been heightened media attention around Gardasil. We hope our new advertising campaign will contribute to this dialogue and encourage women to talk to their doctors.”

In spite of this marketing campaign, critics claim that women are not fully informed of the issues surrounding Gardasil. Doctors and advertisers claim that women don’t want to be fully informed. What is the real information underneath the publicity? What is the effect of marketing campaigns for drugs on the public?

I meet Claire in a flashy café near her home, where the cappuccinos come with chocolate cows on the top. A recent university graduate, Claire Scully saw the government ads in the lead up to the vaccination program. “I just heard about it, and thought, well if it is free, then I may as well do it.”

Even after having two out of the three necessary doses, Claire only knows as much about Gardasil as the ads have told her. “By not getting the injection, I’m kind of asking for cervical cancer,” she says. “It’s the right thing to do.” I’m reminded of the ‘I did’ campaign, where women who have been vaccinated proudly display their ‘I did’ Band-Aid.

“It’s about peace of mind, to make you feel like you have done everything you can to protect yourself,” she continues. Her heart pendant clangs against the cow cup.

“Health is something that you can’t fool people with. There is a responsibility. It’s all very well to lie about something that doesn’t affect someone personally, but something like health, then why would there be an ulterior motive?”

She pauses. “I didn’t know much about it before I got it, and I just hope that something doesn’t bite me in the bum in 10 years or so.”

Gardasil has been called by some the “Help pay for Vioxx medical cure”. In 2005 Merck’s drug Vioxx was pulled off the market because of strong evidence linking it to heart attacks and stroke.

The Vioxx recall is estimated to have cost Merck US $2.5 billion in annual revenue. According to Merck, as of the end of March this year, it is being sued in more than 27,000 lawsuits.

The people suing the company claim that Merck intentionally suppressed findings of the risks associated with Vioxx, producing damaging internal emails to back their assertions. They allege that Merck was executing an aggressive direct-to-consumer advertising campaign to increase demand for the drug at the same time.

Thanks to the successful marketing of Gardasil, the company has had a turnaround on both their share price and yearly profits. Yearly profits are expected to top $100 million. CSL share prices have risen from $2 in 1994 to $93 today. Head of CSL, Brian McNamee said in the Australian Associated Press, “The very successful rollout of Gardasil is an indication of the importance of this very significant unmet medical need.”

Australia currently has the second-lowest incidence of cervical cancer and the lowest mortality rate from cervical cancer in the world. Cervical cancer is among the most preventable and curable cancers. If cervical cancer is caught when it is pre-cancer, then it is 100% curable.

So how do HPV and Gardasil actually work? Almost all cases of cervical cancer are associated with HPV infection, a sexually transmitted disease. In very rare cases, the virus may lead to cervical cancer if it is not detected on pap smears. It usually takes about ten years for HPV to develop into cervical cancer.

There are about 15 strains of HPV that are associated with cervical cancer. Gardasil protects against two of these viruses that may lead to 70% of cervical cancers.

This is information that Caitlin doesn’t know. Caitlin Philips-Peddlesden is a first year arts student. We meet at one of those hippy cafes in Brunswick, where the music is loud and the tables are sticky. Caitlin got an email from her university health service, and decided to get Gardasil.

Caitlin doesn’t know much about Gardasil. “It’s not something I have ever really thought about”, she says. “I s’pose I just thought about this as another preventative, that might make the chance of getting cervical cancer less, that’s all.”

I ask Caitlin if she usually researches drugs she takes. She says, “If I hadn’t heard any negative things about a drug then I s’pose I would trust my doctor’s advice and not research it before having it.”

She sips her hot chocolate. “I trusted Gardasil for being safe because of the emails through the university, and because I thought my doctor has my interests in mind, and ‘cos it seems like a perfectly normal respectable thing”, she says.

“It’s not like I was doing it in a dirty lane or anything.”

Overseas, Merck is fighting allegations that its marketing campaign is corrupt. Three public relations people Merck employed to push the Gardasil vaccination program in Canada were formerly government advisors. One Merck lobbyist who has played a vital role in the push for a mandatory vaccination program in Texas is the former chief of staff to the Texas Governor.

The marketing campaign for Gardasil has even convinced those who are more sceptical about the drug industry and doubtful about how useful the vaccine is.

Anne is a third year medical student. We meet at a university cafe where she works, where the soy doesn’t cost extra and everything is organic. “Biomedicine finds what it wants to”, she says. “If pharmaceutical companies are paying huge amounts to get a drug out, and they know they will make a packet out of it, then other things will not be researched, and data can be interpreted to say what you want it to say.”

Even though she is sceptical of the medical industry, she still got vaccinated with Gardasil earlier this year. “I did just accept that biomedicine is right, and that if Western medicine says this is a really good thing, then this is a really good thing, and I should have it”, she says.

It is important to Anne to be informed about what drugs she takes. “I think that doctors have an obligation to tell people what the side effects can be, and even more, to tell them exactly what the mechanism of the vaccine is, in language that is understood”, she says.

Anne goes on to say, “Public health loves vaccination, because it is like they are doing something concrete, and the government thinks they have to get it out right now.” She tidies her blonde hair into its bun. She will still recommend the vaccine to other women. “I would rather not worry about HPV, and I won’t worry about HPV now. I think it is worth it just for the peace of mind”, she says.

Why would Anne be worried when Australia has one of the best national cervical screening programs in the world? Since its introduction in 1991, the screening program has more than halved deaths from cervical cancer. A pap smear every two years can prevent the most common form of cervical cancer in up to 90% of cases. As more women are included in the screening program, cervical cancer cases continue to decline.

Stephen Downes, an expert in advertising and medical and pharmaceutical marketing, describes the advertising tactic that Gardasil used in their marketing campaign as first raising awareness or doubt, and in some cases worry.

Unlike Anne, Dr Downes doesn’t think people want to be fully informed about the drugs or vaccines they take. “I think as consumers we often make decisions on incomplete information. In a lot of other fields people spend money on things they don’t know much about…” He goes on to talk about how termite companies often mislead their customers. I ask Dr Downes, who worked on the advertising campaign for Cervarix, another vaccine for cervical cancer, whether he thinks health should be different from termites.

“I struggle to find where the dividing line is”, he says. “I tend to reject the idea that health is so completely different from other aspects of life that it should be treated entirely differently.”

Others are more concerned about Gardasil’s advertising campaign.

Dr Paul Mitchell, director of cancer services at Austin Hospital, is worried about drug advertising. “It is something that makes the medical profession really quite uncomfortable”, he says.

Although Dr Mitchell thinks that the Australian drug regulatory authority, the PBAC, is immune from corporate lobbying, he recognises the influence that drug companies have on doctors. “You have to infer that the companies are not so silly that they would spend a lot of money if it wasn’t going to bring some kind of return”, he says.

Like Dr Downes, Dr Mitchell remains unsure as to how informed people want to be. “I think as a medical practitioner we have a duty to try and provide information when it is offered, but I wouldn’t be as naïve to think that it is what people want.”

It is not only advertising that influences people to get a drug or vaccine. The media also plays an important role. Compared to the both positive and negative media coverage of Gardasil in Canada and America, the Australian media has been overwhelmingly positive about the vaccine.

A long-term researcher on reproductive technologies, Dr Renate Klein says, “The uncritical coverage of Gardasil in Australia is scandalous. The public needs to know about the controversy surrounding the safety and appropriateness of Gardasil.”

“We need unbiased coverage of this issue so that we can question the exposure of young women to another drug which may have detrimental long-term effects.”

Maurice Punch, author of the 1996 book Dirty Business: Exploring Corporate Misconduct, describes how the influence of the media is often vital in keeping controversial issues and specific cases in the public arena. However, “In practice, the media itself are responsive to commercial pressure in terms of sponsorship and advertising revenue, to political influence, and to inter-connections between the media and the business world.”

Stephen Downes believes that the mainstream media played an important role in advertising for Gardasil. “It is only 18 months ago that Ian Frazer was profiled on the front cover of Good Weekend magazine as God’s gift to women”, he says. “From that moment onwards it has been a bit of a darling topic for the media.

“In the tabloid media and commercial news coverage everything is a breakthrough, and everything is so poorly evaluated”, he continues.

He says that sometimes the government or drug companies even use the media to bypass the PBAC. “When the last great new hope in effective breast cancer came out, the PBAC was effectively bypassed because of effective lobbying by parliamentarians. The breast cancer lobby got behind it, and Janette Howard got personally involved to set up a separate funding stream just for that drug”, he says.

“The marketing campaign for Gardasil has some of the same ingredients as the last breast cancer drug had for bypassing the PBAC through effective lobbying in Australia.”

Some worry that the authorities were compromised in the US. Non-profit organisations such as Women in Government and the National Foundation for Women Legislators pushed legislation for Gardasil through the US parliament. Both of these organisations received payments from Merck.

The marketing campaign has scored some big victories. Gardasil is now widely used on girls as young as 9 and women up to the age of 29 in many countries, including the US, Britain, Germany, Spain, Italy, South Korea and Canada.

Dr Diane Harper, who has studied HPV for 20 years, told an online reporter, “I’ll give Merck credit – there is absolutely nothing factually incorrect in Merck’s advertisements. But the interpretation of the rock stars, and the media, and of everyone else is that this vaccine will completely eliminate cervical cancer. I’ve worked with ABC, with NBC, and on their nightly news, their headline is ‘HPV vaccine prevents cervical cancer.’ It’s true, but it is not accurate.”

John Carreyrou from the Wall Street Journal argues that Merck has crafted its advertising and public relations to avoid some of the less favourable numbers surrounding Gardasil, such as the lower efficacy against precancerous lesions or use in populations where some women are already infected.

Behind the scenes, Gardasil has been dogged by uncertainty about how effective it really is. Trials for the vaccine focused on how effective it was for protecting against the two HPV types rather than cervical cancer itself. In the clinical trials, women who received Gardasil were only 14% less likely to develop precancerous lesions on their cervixes within 3 years of vaccination than were the group given placebos.

There has also been concern about the safety of Gardasil. While authorities claim that there is not enough data to measure negative side effects in Australia, negative side effects to Gardasil reported to the Food and Drug Administration in America are growing. The known total of adverse reactions has now grown to three and a half thousand. This includes about 350 serious reactions, such as paralysis, Bells Palsy, and seizures.

There have been eleven deaths linked to the vaccine in America alone. One 17-year-old girl was vaccinated with her first dose of Gardasil, and later that same day was found dead by her mother.

Tom Fitton is the president of Judicial Watch, an American public interest group that investigates and prosecutes government corruption. He says, “These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal. In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls.”

This information from overseas continues to be ignored, as the only information on the Australian government website about side effects from Gardasil is, “Your daughter may experience minor side effects such as redness, pain, and swelling at the injection site and mild fever.”

The PBAC rushed funding approval for Gardasil through its processes. According to a Government fact sheet, the reason for this was, “To avoid as many cases of cervical cancer as possible, it is important that a vaccine program starts as soon as possible.”

If the government was dedicated to avoiding as many cases of cervical cancer as possible, then we could assume that the latest screening technology is available and free for women to use. A new method of screening, such as the ThinPrep, has been developed using liquid-based technology. New research has proven this test to be 17% more effective than the Pap in detecting high grade precancerous lesions, and 36% more accurate in detecting true low-grade disease. The ThinPrep uses this new technology, but most women don’t even know it exists, and it costs an extra $40 on top of their pap smear.

Medical researcher and epidemiologist, Abby Lippman told a Canadian newspaper, “Advertising and savvy marketing shouldn’t set the public health agenda.”

“This is not a public health crisis,” she said. “I want that data out there for discussion before we go and spend money when we don’t have a lot of money in the health-care system already.”

Stephen Downes predicts that the issues of drug advertising and press releases from drug companies being reproduced in the media will continue to be a problem in the future. He says that while regulations on doctors are becoming tougher, “There certainly isn’t the same level of scrutiny on the PR that goes on in the consumer media”.

“The ill-informed PR piece does tend to create the situation where people run into the GP on Monday morning and say, ‘I want the new tablets, I want the new treatment.’”

HPV, Vaccines, and Gender: Policy Considerations

Written by and published on the Canadian Women’s Health Network, 25/6/07

This paper reflects data available to us as of June 2007. Studies about HPV vaccines – their efficacy, safety, place in women’s health care – and research on the implications of initiating vaccination programs continue to evolve. We will be adding new references and links to some of this work as best we can in the future.

A summary of this paper is to appear in the 28 August 2007 Canadian Medical Association Journal; a pre-released version can be found online now at: http://www.cmaj.ca/cgi/content/full/177/5/484.

Read the full paper: HPV, Vaccines, and Gender: Policy Considerations (PDF 238k/19p)

Executive Summary

Cancer prevention remains a high priority for women and men in Canada, and critical steps for cancer prevention are identifying and eliminating the causes of such diseases. The federal government’s recently-announced $300 million investment toward a program for vaccinating girls and women with the currently available human papillomavirus (HPV) vaccine, Gardasil (manufactured by Merck Frosst) framed by some as a way to prevent cervical cancer in Canada, has generally been welcomed by a wide range of commentators. The policy commitment to improve the health of women and girls is laudable and emerging research about the effectiveness of immunization in reducing HPV prevalence is promising.

However, although HPV infection is necessary for the development of cervical cancer, and while evidence suggests that Gardasil may prevent primary infection with HPV types 16 and 18 (currently thought to be a necessary cause of about 70 per cent of cervical cancer cases), we propose that these facts be assessed within a broad context, which at this moment contains many unknowns, before immunization policies are developed and implemented.

A careful review of the literature, including that which was submitted by the manufacturer with its application for approval of Gardasil, reveals a sufficient number of unanswered questions to lead us to conclude that a universal immunization program aimed at girls and women in Canada is, at this time, premature and could possibly have unintended negative consequences for individuals and for society as a whole. We suggest that rather than giving widespread administration of this vaccine a “green light,” a more appropriate policy at this time would be a “yellow light” of caution. We recommend that the funding announced by the federal government be used to support the research needed to answer the many questions outlined below; to fund a public education campaign to quell the unfounded anxiety that has been instilled by marketers of the vaccine that HPV represents a “new” or “imminent” threat; and to ensure equal access to Pap testing, including timely follow-up and application of improvements in testing. Only when there is a solid evidence base and an appropriately-provisioned cervical screening program accessible to all can we determine the most appropriate holistic strategy – and the place of vaccination in it – to address cervical cancer and the transmission of HPV between and among Canadian girls, boys, women, and men. We have been given an exciting opportunity to establish effective guidelines and to create a model of how to approach future vaccines. We must take full advantage of it.

In this paper, we summarize some of the major questions and concerns that need to be addressed before there is a full-scale roll-out of an HPV vaccination program. These closely reflect issues raised in the analytical framework created by Erickson et al. in the context of the development of the National Immunization Strategy (NIS), and support efforts to ensure a comprehensive and systematic evaluation of all relevant factors before decisions regarding the importance of a new immunization program are made. As well, they echo some of the research questions identified as important in the Final Report from the Canadian Human Papillomavirus Vaccine Research Priorities Workshop held in Quebec City in 2005.We hope raising these questions now will contribute to the deliberations necessary to ensure a responsible and transparent evidence-based decision-making process.

Our major points, summarized here, are discussed in detail in the text that follows. They are also summarized in a Commentary appearing in the 28 August 2007 issue of the Canadian Medical Association Journal (CMAJ), online as of 1 August 2007.

1. There is no epidemic of cervical cancer in Canada . According to Canadian Cancer Statistics 2006, approximately 400 women were anticipated to die of this disease in 2006.
2. Invasive cervical cancer typically follows a slowly progressive course that can be halted at one of various stages. Consequently, deaths associated with cervical cancer, relatively rare in Canada, but always unfortunate and not distributed evenly among women, must be considered as a failure in the adequate support of both the primary care and reproductive health services that would guarantee healthy living conditions for all women as well as ensure all women get appropriate Pap testing and follow-up.
3. Most HPV infections are cleared spontaneously. Recent research using available molecular detection technologies suggests that clearance occurs within one year for about 70 per cent of those infected, and within two years for 90 per cent. Thus, HPV infection and cervical cancer must not be conflated: most women who are infected with even a “high-risk” strain of HPV will not develop cervical cancer.
4. The nature of an immunization program is necessarily dependent upon the definition of clear and tangible goals. To date, such goals have not been made explicit with regard to a Canadian initiative. Is the aim of the vaccination program the eradication of high-risk HPV types from the population? Or is the aim to reduce the number of cervical cancer deaths? These different goals require different strategies.
5. Information about the efficacy of Gardasil appears promising, but remains uncertain. Recent reports seem to suggest that Gardasil ‘s efficacy may be significant only for grade 2 cervical intraepithelial neoplasia (potentially removable pre-cancerous lesions 40 per cent of which regress spontaneously and which may not even be recommended for treatment), while the data are “insufficient to support a conclusion of efficacy for grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ.”Related to this are other unknowns about the vaccine’s effectiveness in the “real world” including the possible need for booster shots, concerns about altering the natural history of viral infection, and the impact of vaccination programs on safer sex practices and Pap screening rates, all of which highlight the essential need for careful health services research for the development of appropriate vaccination policies.
6. Relatively few young girls (about 1200 aged 9 – 15 years) were enrolled in the clinical trials of Gardasil. Of these, a mere 100 were nine years of age, with the youngest being followed for only 18 months. Yet, based on the assumption that they will not yet have been exposed to HPV viruses, girls in this age group represent the priority “target” population for mass vaccination. Clearly, this is a very weak information base on which to construct a policy of mass vaccinations for all girls aged 9 to 13, as per the National Advisory Committee on Immunization’s (NACI) recommendations.
7. Rigorous collection and analysis of reports on adverse effects are needed for risk-benefit assessments that would allow for truly informed consent by individuals offered the vaccine. A list of adverse events is being compiled in the USA Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS) database, but because these reports are both incomplete and hard to interpret, there remains a need for careful and unbiased analyses of harm.
8. Media and marketing claims about the impact of HPV prevalence are very misleading and the naming of Gardasil as the “cervical cancer vaccine,” implying the vaccine eliminates all cervical cancer, is incorrect. The marketing of Gardasil , which began in the United States even before it had been approved by the FDA, has made it difficult for there to be reflective discussions between parents and children, health care providers and their clients, as well as among the public and policy makers, about the nature and meaning of HPV and of vaccination.
9. There is a great need for cost/effectiveness analyses of proposed vaccination programs, since the “added value” of the vaccine is far from clear: girls and women, even if vaccinated, will still need to practice safe(r) sex and have access to existing reproductive and primary care programs – not only for Pap testing, but for other aspects of reproductive care as well. Such analyses are usually done prior to the initiation of a mass vaccination program to ensure that the most efficient and appropriate approaches are taken.

Notes:

Erickson LJ, De Wals P, and Farand L. An analytical framework for immunization programs in Canada . Vaccine . 2005; 23: 2468-2474.

Public Health Agency of Canada . Canadian Human Papillomavirus Vaccine Research Priorities Workshop: Final Report. November 17 th -18 th , 2005 ; Quebec City . CCDR 2006;32S1:66. http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/06vol32/32s1/index.html.

Canadian Cancer Society and National Cancer Institute of Canada . Canadian Cancer Statistics 2006. Toronto , Canada , 2006.

Public Health Agency of Canada . What everyone should know about Human Papillomavirus (HPV): Questions and Answers. http://www.phac-aspc.gc.ca/std-mts/hpv-vph/hpv-vph-qaqr_e.html (Accessed February 20, 2007 ).

Sawaya G, and Smith-McCune K. HPV Vaccination- More Answers, More Questions. The New England Journal of Medicine . 2007; 356: 1991-1993.

Rabin, R. “A new vaccine for girls: but should it be compulsory?” New York Times , July 18 th , 2007.

National Advisory Committee on Immunization (NACI), Statement on human papillomavirus vaccine . Canada Communicable Disease Report . Februrary 2007; 33, ACS-2 15.

U.S. Food and Drug Administration. Vaccine Adverse Event Report System (VAERS) http://www.fda.gov/cber/vaers/vaers.htm . Accessed 24 May 2007.

Dangerous Government Spin Finds a New Target: Children

Written by Pam Martens, published in the Wall Street Journal Health Blog on 1/5/2007

Does this sound familiar: a massive disinformation campaign is launched. Leading U.S. experts speak out against the contrived “facts.” Their voices are either ignored or ridiculed. The manipulated game plan plays out. The U.S. loses credibility around the world.

Today, the United States has on its hands a dangerous debacle that could finish off what little credibility we have left on the world stage. It follows an almost identical play script to the Iraq occupation and involves Merck’s vaccine, Gardasil, for treating human papillomavirus (HPV), a sexually transmitted disease and, ostensibly, preventing cervical cancer.

The disinformation campaign is rolled out as follows: A U.S. government agency, the Food and Drug Administration (FDA), issues a press release heralding the launch of a “New Vaccine for Prevention of Cervical Cancer.” Except there is no evidence this vaccine prevents cervical cancer as illuminated April 16 in a front page story in the Wall Street Journal, “Questions on Efficacy Cloud a Cancer Vaccine.” According to the article, “In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years of vaccination, just 14% fewer than in a placebo control group.”

Another government agency, the Centers for Disease Control and Prevention (CDC), approves the vaccine for the national Vaccine for Children’s Program and over 20 U.S. states, under heavy lobbying by Merck, have legislation quickly introduced to make the vaccine mandatory for 11 and 12 year old girls. (The stated premise is that the vaccine should be given before the onset of sexual activity.) Except there are no studies to show the vaccine works in this age group and there are insufficient studies on its safety in this population, according to FDA’s own documents.
Using the same heavy-handed and ethically questionable marketing tactics it used in the U.S., Merck has licensed the vaccine in 52 countries with Australia this month initiating nationally funded mass inoculations of school girls aged 12 to 18. The vaccine is under review for licensing in an additional 50 countries, according to Merck’s web site.

In what strikingly resembles the Judith Miller affair in the lead up to the Iraq war, where Ms. Miller’s writings in The New York Times effectively became the credible public voice of dubious government claims, The Times has, inexplicably, written two editorials advocating making this new, unproven, inadequately tested drug mandatory as a condition for entering public school for 11 and 12 year old girls. The Times went so far as to applaud the Governor of Texas, Rick Perry, for making the vaccine mandatory for school girls in his state while not mentioning that he had illegally bypassed the state legislature and issued an executive order. They suggested that “Other states would be wise to follow the same path.” (A Vaccine to Save Women’s Lives, February 6, 2007.) The Texas state legislature is in the process of overturning that order.

In the same editorial, The Times stated: “There is no doubt that Merck’s vaccine against the human papillomavirus, given in three shots over eight months, is highly effective.”

But far from “no doubt” there was massive doubt and it was coming from leading health experts with a chorus calling it an “experiment” on the public because of inadequate testing.

One of the very researchers who had been involved in the clinical trails for the vaccine, Dr. Diane Harper, a top level scientist and professor at Dartmouth Medical School in New Hampshire, stated the following in the Fort Wayne Daily News: “Giving it to 11-year-olds is a great big public health experiment…There also is not enough evidence gathered on side effects to know that safety is not an issue…It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.”

Even the FDA had doubt. Buried at the bottom of its June 8, 2006 letter to Merck licensing Gardasil, it indicated that it did not believe sufficient studies had been done to prove the safety of the vaccine on 11 and 12 year old girls: “…a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008.”

Another health expert at a sister agency of the FDA, Joseph DeSoto, physician and scientist at the National Institutes of Health wrote an OpEd for the Charleston, West Virginia Daily Mail on January 23, 2007, urging the state not to mandate the vaccine for young girls: “… according to the data presented to the FDA, which I have reviewed…the risk for pelvic inflammatory disease, appendicitis and gastroenteritis is doubled… Here we are talking about forcing a person to undergo mandatory drug therapy (vaccination), when they have no disease…”

On April 4, the oldest newspaper in New Hampshire, the Keene Sentinel, ran a feature story on Gardasil in its Health section. Quoting Dr. Laura Scheinblum, an area pediatrician, the article stated: “…the HPV vaccine has shown few side effects except for some soreness at the site of the injection….” In reality, the Federal government’s own Vaccine Adverse Events Reporting System (VAERS) is publishing reports of seizures, convulsions, internal bleeding, loss of consciousness, life threatening swelling in the throat, loss of hair in children and hundreds of other adverse events.

The concentration of wealth, and its appendages of power and control of message, have reached unprecedented levels in America with tentacles now extending into the editorial pages of The New York Times and news pages of New England dailies. Children in Iraq have been dying for four years because of this unbridled disinformation and now children in America and around the world are threatened by it. What will it take to say, “Enough!”

Warning: Merck’s Vaccine Is Hazardous to the Truth

Written by Pam Martens, published at Alliance for Human Research Protection on 23/2/2007

Merck, one of the largest pharmaceutical companies in the world, is heavily marketing a vaccine, Gardasil, that it touts as 100% effective in stopping strains of the human papillomavirus (HPV) from developing into cervical cancer. The Food and Drug Administration (FDA) went even further, headlining its press release “FDA Licenses New Vaccine for Prevention of Cervical Cancer.” What has gone largely unnoticed, except for a few sharp eyed doctors and researchers, is that these strains of HPV take 8 to 12 years or longer to develop into cancer and Merck has studied women in its clinical trials for less than five years. Because its test candidates “had normal baseline pelvic examinations” when the clinical trials began and were not likely to develop cervical cancer for 8 to 12 years, Merck has, essentially, created a vaccine that has proven to be 100% effective in preventing what isn’t there. [1]

Here is how Dr. Clayton Young explained Merck’s cancer treatment for cancer-free women in a letter to The American College of Obstetricians and Gynecologists: “The maximum median follow up in any of their studies is four years. However, the time course from CIN II to invasive cancer averages between 8.1 to 12.6 years. [2] Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate.”

Here’s what the federal agency, the National Cancer Institute, says about the progression of HPV: “Almost all women will have HPV infections at some point, but very few will develop cervical cancer. The immune system of most women will usually suppress or eliminate HPV. Only HPV infections that are persistent (do not go away over many years) can lead to cervical cancer.”

The American Cancer Society confirms the slow progression: “…most cases of CIN 3 are likely to progress to cervical cancer over a period of time that probably takes about 10 years if not detected and treated.”

On February 20, 2007, in an OpEd for the Rochester, New York Democrat and Chronicle newspaper, Dr. Morris Wortman and Amy Daggett explained further: “Invasive cervical cancer typically follows a succession of stages that starts with abnormalities detected on Pap smears. These pre-cancerous changes, called dysplasias, are caused by HPV types 16 and 18, as well as more than a dozen others. Gardasil protects against types 16 and 18 – which are responsible for an estimated 70 percent of cervical dysplasias. The other protection provided by Gardasil is against genital warts (types 6 and 11) which is a self-limiting and easily treated infection…It takes about 10 years for a cervical dysplasia to progress to invasive cervical cancer…Before state legislators begin mandating [Gardasil's] administration, they need to be reminded that apart from the potential risks, the long-term efficacy in reducing invasive cervical cancer is yet unproven.”

In short, we have a great slogan: “The first vaccine to prevent cancer.” What we don’t have is a vaccine proven to do that. We have lots of high priced public relations firms and lobbyists and nonprofit front groups touting this miracle vaccine while collecting Big Pharma’s money. But we don’t have any efficacy studies on how this genetically engineered vaccine will impact 11 and 12 year old girls for a cancer that the federal government describes as “rare” in the United States. In fact, cervical cancer affects less than one-tenth of one percent of women annually in the U.S.

And now we are learning of adverse events to adolescents and women who were led to believe they were taking a safe vaccine that would prevent cancer. According to Barbara Loe Fisher, President of the National Vaccine Information Center (www.nvic.org) “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give Gardasil in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine.”

With the seal of approval from the FDA and the Centers for Disease Control and Prevention (CDC), Merck’s marketing claims might have gone unchallenged. But then Merck overplayed its hand. It lobbied states to make the drug mandatory as a prerequisite for sixth and seventh grade girls to enter school and did so through a nonprofit called Women in Government. Merck and one of its largest rivals, GlaxoSmithKline, were both funding Women in Government. GlaxoSmithKline, along with Merck, had executives on the nonprofit’s Business Council. GlaxoSmithKline went so far as to issue a press release to PRNewswire on behalf of Women in Government. [3] The mystery of why two so-called competitors were both funding Women in Government was located in an SEC filing by Merck: “In February 2005, the Company announced that it and GlaxoSmithKline (GSK) entered into a cross-license and settlement agreement for certain patent rights related to HPV vaccines. Pursuant to the agreement, GSK will receive an upfront payment and royalties from the Company based upon sales of Gardasil….) [4]

Virginia became the first state to pass legislation to mandate this vaccine for girls entering sixth grade, although it is uncertain if the Governor will sign it. The Texas Governor, Rick Perry, tried to bypass the state legislature by signing an executive order mandating Gardasil for sixth grade girls. The state legislature has taken up overturning that order. Over 20 states have similar legislation pending.

Cervical cancer is a serious threat to women in other parts of the globe. But why Merck was targeting 11 and 12 year old schoolgirls in the U.S. with an unproven vaccine demands a full Congressional investigation with subpoenaed documents from Merck, GlaxoSmithKline, Women in Government and the FDA.

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Pam Martens worked on Wall Street for 21 years. (She has no stock position, long or short, in Merck or any pharmaceutical company.) She resides in New Hampshire and writes on topics that impact the public interest.

References:

[1] Gardasil HPV Quadrivalent Vaccine; May 18, 2006 FDA Licensing Meeting

[2] Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66. American College of Obstetricians and Gynecologists. Obstet Gynecol 2005; 106: 645-64

[3] GlaxoSmithKline Release: Cervical Cancer Elimination Focus of National Public Health Summit; Dated November 14, 2005. “The Summit is the latest step in Women in Government’s fight against cervical cancer….”

[4] Merck & Co., Inc. 2004 Annual Report

Mandatory Childhood Vaccine Legislation Ignores The Contaminated Culture That Created It

Written by Pam Martens, published at Alliance for Human Research Protection on 16/2/2007

A national furor has erupted over another executive order. This time, it’s not the President of the United States bypassing the legislative branch of government to pass laws, it’s the Governor of one of the three most populated states in the country. Rick Perry, Governor of Texas, has signed an order making it mandatory for 11 and 12 year old girls to be injected with a 3-shot regimen vaccine that’s been on the market less than 9 months. Ostensibly, the vaccine is to prevent some strains of human papillomavirus (HPV) that may cause cervical cancer, a cancer that occurs annually in less than one-tenth of one percent of women in the U.S.

The clinical trials for these 11 and 12 year old girls were limited to a few hundred individuals of this age group and tested only for immune response, not the efficacy of the drug in preventing the virus or cervical cancer.

The vaccine comes from the big pharmaceutical maker, Merck, which is currently facing down 27,400 lawsuits (as of 12/31/2006 according to its own SEC filings ) over another of the drugs the company touted as safe, Vioxx, just before it was taken off the market due to cardiovascular risk. The lawsuits allege, and produce damaging internal emails to back their assertions, that while Merck was telling the public and the Food and Drug Administration (FDA) about the safety of Vioxx, internal correspondence at the company was confirming it knew that Vioxx was causing heart attacks, essentially brushing it off as the cost of doing business and telling its sales force to “DODGE” questions arising from doctors about these risks.

According to the Wall Street Journal, this is a direct quote from an internal email from Dr. Edward Scolnick, chief of research for Merck at the time of the Vioxx subterfuge: In Vioxx, he wrote, “We have a great drug and like angioedema with Vasotec and seizures with Primaxin and myopathy with Mevacor there is always a hazard. The class will do well and so will we.” Experts now believe that as many as 140,000 individuals suffered heart attacks, strokes and other serious medical complications as a result of taking Vioxx. This business model of injury and suffering to some for the benefit of “the class” could certainly be challenged on many ethical fronts. But only a fool or a conflicted regulatory body would fail to see it as a cautionary red flag in the implementation of a vaccine for children for a disease they stand a 1 in 15,000 chance of getting later in life, with no clinical evidence that the duration of the vaccine will even last that long.

The adequacy of Merck’s internal ethical culture to market vaccines for children was further called into question in May 2005 when Congress released Merck’s training manuals for its sales force. The manuals gave the impression of being authored by a psychotic intelligence operative who moonlighted as a used car salesman. [*]

While this latest vaccine, which goes by the proprietary name Gardasil, was being fast tracked for review at the FDA, another government agency, the IRS, was fast tracking charges that Merck owed the Federal government over $2 Billion in back taxes. The amount Merck is anticipated to have to pay out for Vioxx lawsuits and back taxes could wipe out its cash reserves without an immediate infusion of big sales from some other blockbuster drug. Enter Gardasil, whose 3-dose regimen will cost a minimum of $360 per student.

With the stakes this high, Merck reached out to a non-profit group called “Women in Government,” a group funded by it and other drug companies that stand to benefit from the sale of Gardasil through the use of co-licensing agreements and royalty payments. On May 18, 2006, when the FDA held its hearing on whether to approve Gardasil, Kathryn Guccione, an employee of Women in Government, appeared at the hearing to ask the FDA to approve the vaccine. (Of the 9 public groups that spoke at the hearing, 6 received financial support from Merck.)

While acknowledging to the FDA that her organization received funding from Merck, Ms. Guccione also indicated that her group was responsible for recently getting 39 states to formally introduce legislation or resolutions calling attention to preventing cervical cancer. As more and more states jumped on this fast moving train, Women in Government, which had an executive from Merck sitting on its Business Council last year, rolled out the second phase of the project once Gardasil was approved in June 2006. The second phase was for their members, female state lawmakers across the country, to introduce the actual legislation that would mandate that six grade girls receive the Gardasil vaccine in order to enter school. At least 20 states now have this legislation pending, most of it introduced by members of Women in Government.

I sent an email to Women in Government asking for the specific dollar amount of funding they had received from Merck. Ms. Guccione responded in an email: “We leave it up to our supporters if they wish to share specific funding information.” The organization’s 990 tax form that is publicly available shows it has received over $5.7 million in total funds for the period 2002 through 2005. It does not list its donors’ names or the amount they have given.

But Women in Government was the tip of the iceberg. Merck was spending tens of millions of dollars funding other non profits (who engaged high profile celebrities), TV advertising and PR firms to create a saturated public climate ready to embrace a new mandatory vaccine.

And then there were Merck’s acknowledged lobbyists. The Associated Press has reported that one of Merck’s lobbyists in Texas, Mike Toomey, is the former chief of staff to Governor Rick Perry. This might help explain why a conservative Republican Governor would risk a tidal wave of conservative backlash by skirting the legislative branch to pass an order that is highly questionable on both a medical basis as well as parental rights.

The real clue may be buried in the hundreds of pages of documents related to Gardasil that reside on the FDA’s web site. On June 8, 2006, the FDA sent a letter to Merck approving its license for Gardasil. But there was a caveat. The FDA wanted more safety information gathered in a new study of 11 and 12 year old girls. The letter said: “…a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008.” This meant that Merck was going to need to enroll a large number of 11 and 12 year old girls and get the willing and informed signatures of parents who didn’t know about Merck’s history with Vioxx before December 2008. Enter the mandatory order from the Texas governor requiring mandatory vaccinations of sixth grade girls entering school in September 2008. On its face, this could be interpreted as a mandatory clinical trial on orders from the Governor of Texas to augment the inadequate one conducted by Merck.

As jaded as this chronology appears, an equally questionable role was played by the government agencies mandated to protect the public health.

The day after the FDA held its hearing on Gardasil, it met again to discuss its future mandates with outside experts. A transcript of that meeting quotes an FDA associate director of research, Dr. Kathryn Carbone, as follows: “When I arrived here 10 years ago, in fact, I was instructed never to mention the word ‘research’ and FDA in the same sentence.” A slide presented as part of this meeting now lists two goals for the FDA: (1) “Ensure the safety and efficacy of vaccines and related biological products for human use;” and (2) “Facilitate the development, evaluation, licensure and use of new vaccines and related products that positively impact the public health.”

Why should the FDA be concerned with licensing products for big pharma? Aside from the stated goal of ensuring the public health, it’s also big bucks for government workers.

According to the federal government’s Office of Technology Transfer at the National Institute of Health (NIH), researchers working for the FDA or NIH and are credited with an invention can “receive the first $2,000 received from a licensee. Next, they receive 15 percent of royalties received above $2,000 up to $50,000. Finally, they receive 25 percent of royalties in excess of the first $50,000 received each year. Each inventor cannot receive more than $150,000 in royalty payments for a calendar year.”

So the question arises: if you’re a government employee at the FDA and you know your government colleagues could earn millions over a lifetime for a drug invention, are you going to shoot down their license application; especially when your agency is strapped for funds and intramural grants from these sister agencies are keeping you afloat?

According to the Office of Technology Transfer, it collected $82.7 million in royalty payments from 882 license agreements or amendments in fiscal year 2006.

And guess where Gardasil originated; in a lab at a federal agency. According to an Office of Technology Transfer document, “The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Caner Institute (NCI)…Working with the NCI technology transfer office, the NIH Office of Technology Transfer (OTT) oversaw the patenting of the VLPs. OTT then sought a suitable [emphasis added] company with the necessary resources to formulate the vaccine and to conduct clinical trails. The technology was licensed to Merck….”

And this answers one more question: why was GlaxoSmithKline also funding Women in Government. It has its own competing vaccine in the pipeline. According to Merck’s SEC filings (and backed up by NIH documents) “In February 2005, the Company announced that it and GlaxoSmithKline (GSK) entered into a cross-license and settlement agreement for certain patent rights related to HPV vaccines. Pursuant to the agreement, GSK will receive an upfront payment and royalties from the Company based upon sales of Gardasil….)

If ever there was a message of hope to those downtrodden FDA whistle blowers and public citizens calling for an investigation of the regulatory structure of the FDA, surely this is it. And, hopefully, it comes before a pack of callous corporate owners of underwater stock options and Washington bureaucrats stick it to our Nation’s children.

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Pam Martens is an independent writer living in New Hampshire.

[*] Merck’s sales force training manuals and related documents: http://oversight.house.gov/features/vioxx/documents.as

Gardasil: We Must Not Ignore the Risks

Written by Renate Klein and Melinda Tankhard Reist, published on Online Opinion, 1/6/07

The much trumpeted inject-every-girl-free with Gardasil campaign has run into a bit of a snag. Four Melbourne schoolgirls were rushed to hospital recently after receiving the vaccine promoted as preventing cervical cancer.Sixteen other girls were reported sick. One student was left paralysed for six hours. “I couldn’t move at all,” she said. “There were girls dropping like flies.”

Similar reports are emerging from other schools.

Of course, the vaccine couldn’t be at fault. CSL, the company that makes Gardasil, said the reactions were due to “stress” and “anxiety”. The girls were all worked up. They’d got themselves into a state and panicked. The vaccine’s inventor, Ian Frazer, said it was a case of auto-suggestion.

We shouldn’t dismiss the bad experience of these girls just because we really want the vaccine to work. Women’s health is more important.

“We’re not aware of a problem with this particular vaccine” a Victorian Department of Health spokesperson said.

The spokesperson seemed blissfully unaware of at least three deaths in the US related to the vaccine. US Food and Drug Administration (FDA) records cite a physician’s assistant report that a female patient “died of a blood clot three hours after getting the Gardasil vaccine”. Two other girls, aged 12 and 19, died as a result of heart problems and/or blood clotting after receiving the vaccine.

A visit to the website of the United States National Vaccine Information Center also reveals real problems with the vaccine. The centre collects voluntary information about adverse reactions to vaccinations.

According to NVIC President Barbara Loe Fisher: “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a tetanus-diphtheria-acellular pertussis vaccination.”

The FDA has detailed 1,637 reports of adverse reactions to the vaccine. But as Fisher points out, very few adverse events are ever reported in the US. “If only 1 to 4 per cent of all adverse events associated with Gardasil vaccination are being reported, there could have been up to 38,000 health problems after Gardasil vaccination in 2006 which were never reported,” she says.

Other case studies published online describe cold sweats, difficulty in walking, disorientation, dizziness, dyskinesia, headache, hyperventilation, bronchospasms, pallor, paraesthesia, tinnitus and tremors.

Parents are right to question whether the vaccine is in the best interests of their daughters. A lack of trial data – especially on girls this age – suggests that Australia¹s rush to be the first country to provide a fully funded immunisation campaign was premature.

A recent editorial in the Journal of the American Medical Association stated: “it is important to emphasise that the vaccine is supported by limited efficacy and safety data.”

Do the girls and their parents know that Gardasil was tested on fewer than 1,200 girls under 16 and that most trials to-date were sponsored by Merck, which sells Gardasil in the USA? In fact only 5 per cent of the 25,000 women in Merck’s research – that is 1,148 – were girls younger than 16. Given that girls as young as 12 are targeted by the Australian mass immunisation campaign by all standards Gardasil is an untested product in this age group. Parents should be worried about these experiments in which their daughters are the guinea pigs.

Also, are they told that Gardasil is a genetically engineered vaccine?

Australian girls are taking part in what is really a major experiment. Antibodies produced in response to a vaccine can at times mistakenly attack normal body cells. This can lead to autoimmune diseases such as arthritis and multiple sclerosis. Does Gardasil carry this risk? We just don’t know.

Then there is the central question of whether Gardasil will actually prevent cervical cancer. There are more than 100 strains of the human papilloma virus (HPV). At least 13 of these can cause cancer. Gardasil vaccinates against only two.

Some research estimates that almost 80 per cent of the sexually active population is infected with dozens of HPV types, including the high risk strains 16 and 18. But in most cases a well functioning immune system and good nutrition clears the infection before cervical cancer develops.

With the rush to inject Australian girls with a drug of uncertain efficacy and safety, it’s important to keep the risk of cervical cancer in perspective. A recent US study concluded that less than one quarter of 1 per cent of all American women are at risk of infection with one of the HPV types associated with cervical cancer that Gardasil vaccinates against.

And there are other risk factors for cervical cancer such as smoking, malnutrition, a weak immune system, the pill, multiple sex partners and sex without a condom (although condoms do not entirely eliminate transmission of HPV). The recently reported increase in a rare throat cancer linked to oral sex is also associated with HPV.

Health authorities seem to prefer to offer needles than talk about changing behaviour.

Even Gardasil’s promoters note that pap smears are still necessary. And to totally eradicate HPV, all adolescents – including all boys – would have to be vaccinated. But as often happens, the burden falls on women.

The Therapeutic Goods Administration should have demanded long-term trials involving younger girls be conducted before Gardasil was approved.

Rushing this product on the market in Australia for mass immunisation might be good for CSL shareholders, with global sales from Gardasil estimated to amount to US$3 billion by 2010. But we just don’t know enough to say whether Gardasil really is “good news about cancer”.

At this stage, Gardasil administration is barely justified for anyone, let alone vulnerable pre-teen girls entering puberty.

Ian Frazer’s Patent Problem

Written by Ruth Beran, published by LifeScientist, 21/07/2006

As 2006 Australian of the Year, Professor Ian Frazer has become a household name. Famous already in the international scientific community, he has been ranked by readers of Readers Digest as the second most trusted person in Australia, beaten only by fellow scientist and last year’s Australian of the Year, burns specialist Dr Fiona Wood.

Frazer is most well known as the inventor of the cervical cancer vaccine, which received approval from the US Food and Drug Administration last month and is set to become commercially available in Australia later this year. Drug giant Merck is already marketing Gardasil to American women on its website.

While this should be a happy day for women all over the world and for the researchers responsible for its development, there is unrest within the international scientific community as to how much credit the individual researchers, including Ian Frazer, should be receiving. The issue reflects recent patent decisions that are causing equal disquiet.

Robert Rose, associate professor of medicine at the University of Rochester in New York, says Frazer has been given too much credit for the vaccine discovery.

“To say that the vaccine was developed in Ian’s laboratory is a stretch in the papillomavirus research community,” Rose says. “We certainly don’t want to take away from the sense of pride that Australia has in Ian’s work, but it’s not really correct in our view to see the vaccine as something he invented.”

The University of Rochester is one of four research institutions claiming to be responsible for original work leading to a cervical cancer vaccine. The other three are the US’ National Cancer Institute (NCI), Georgetown University in Washington DC and the University of Queensland. A Georgetown University Medical Center (GUMC) press release issued the day the FDA approved Gardasil explains researcher Richard Schlegel’s role in the vaccine’s development but says nothing about the other efforts involved.

GUMC claims that the vaccine’s technology was generated by a team from the university in the early 1990s and then licensed for commercial development.

“It’s a researcher’s dream … to see something that started as a very cerebral idea in the laboratory to advance through animal and clinical trials, gain FDA approval and ultimately have a major global impact,” Schlegel says in the press release. “It’s highly unlikely but extremely gratifying to see it through so far.”

Frazer is rather nonplussed about the claim and counter-claim, but insists he co-invented the vaccine with University of Queensland colleague Dr Jian Zhou in 1991.

“Jian Zhou died in 1999, but he was an equal partner in that transaction,” Frazer says. “People like to know who did things first. I’m not quite sure why. But if it makes people feel happy, I think we probably taught people significantly how to do things.”

Patent decisions

Frazer and Zhou filed a provisional patent covering their human papillomavirus (HPV) research in June 1991 and presented their findings at a scientific meeting in the US in September that year.

“When Ian made this breakthrough in early 1991, we were aware of what he was doing and immediately indicated our desire to be involved and to support him,” says intellectual property consultant John Cox, who works for the Australian biotechnology company CSL. From there, Merck negotiated a deal with CSL to exclusively license Frazer’s discovery and also non-exclusively licensed the National Institutes of Health’s NCI patents.

GlaxoSmithKline, on the other hand, exclusively licensed patents through the biotechnology company MedImmune from the University of Rochester and Georgetown University, and also non-exclusively licensed the National Institutes of Health’s NCI patents.

According to Matthew Rimmer, a senior lecturer at the Australian National University who specialises in intellectual property, what resulted was a “three-way battle between the University of Queensland and CSL Ltd, the University of Rochester, and the National Institutes of Health.”

In Australia, despite Frazer’s patent being lodged first, a recent decision handed down by the Australian Patent Office found that the scientists at the University of Rochester were the first to make virus-like particles (VLPs) from HPV16, a strain of human papillomavirus found in 50 per cent of cervical cancers.

VLPs contain no viral DNA so they are non-infectious but can be used to stimulate the immune system to produce antibodies to the virus. That makes their production a crucial part of creating an effective vaccine. The Australian Patent Office found that Frazer’s patent had not disclosed immunologically correct VLPs from HPV16.

“Therefore the later patent applications could be considered to be novel and inventive in light of the earlier 1991 Frazer patent,” Rimmer says. However, Frazer’s patent still stands.

“Our patent was granted in Australia, it is the dominant patent in Australia and covers all virus-like particles,” he said. “It is a generic patent, so anyone who wants to sell a vaccine in Australia made with virus-like particles has to get a licence to our patent.”

Cox agrees. “Certainly in Australia, regardless, the earliest and dominant patent is that granted to Frazer and that patent was not challenged.” In the US, Georgetown University was found to have the dominant patent for its contribution to the ‘background science’.

“Ironically, the Georgetown patent specifically said they did not produce VLPs,” Dr John Schiller, from the National Cancer Institute group that also filed HPV patents in the 1990s, says.

Despite the US patent decision currently undergoing an appeal, an agreement in February 2005 between Merck and GSK means that the cervical cancer vaccines continue to progress to market.

“Because of the level of uncertainty, Merck and GSK cross-licensed the important patents that they held in the area so that each had the ability to proceed to commercialise the vaccine,” Cox says. “The whole purpose of it was to make sure that the development of the vaccine wasn’t held up by patent squabbling and that has absolutely been achieved.”

“Patents are all to do with licenses and making money and selling vaccines,” Frazer says. “Which is quite a different business to scientific inventorship.”

Who was first?

Merck and GSK have independently developed two HPV vaccines. Both vaccines, which are nearly identical, are based on the ability of the L1 protein of HPV to self-assemble into virus-like particles (VLPs).

Merck’s Gardasil covers four major HPV strains: 16 and 18, which account for 70 per cent of HPV-related cancer cases, and strains 6 and 11, which cause 90 per cent of genital wart cases.

“Frazer and Zhou did their initial work with HPV16, which is the most important serotype,” Cox says. “Subsequently, when they completed their patent a year later, they included further data on … HPV6 and HPV11, which are the two dominant causes of genital warts in humans.” The provisional patent filed by Frazer and Zhou in 1991 and a subsequent paper published in Virology described their discovery of how to assemble VLPs using the L1 and L2 proteins of the human papillomavirus.

L1 and L2 are capsid proteins that make up the outside coat or shell of HPV particles. During early stages of HPV infection, they interact with surface molecules of human cells to gain entry for viral DNA.

“Frazer actually made an error in his first work,” Cox says. “He believed that you needed the L1 and L2 capsid proteins to make VLPs for HPV16. But he subsequently showed that you only needed the major capsid protein to make VLPs.”

John Schiller says Frazer and Zhou reached an erroneous conclusion that L1 alone does not assemble into virus-like particles. “Both of the vaccines … are based on L1 only VLPs,” he says.

Also, to clone a gene, you need a start codon and a stop codon. These codons inform the cell how long to make a protein. “The reason why Frazer and Zhou succeeded for the first time was that they made a rather interesting breakthrough,” Cox says. “They discovered the correct start codon.”

Three publications followed Frazer’s: Georgetown University, for research which did not make VLPs but showed that L1 was recognised by antibodies; the National Cancer Institute (NCI), which showed that L1 from bovine papillomavirus made VLPs which induced antibodies that prevented virus infection; and Rochester University, showing that L1 from HPV11 self-assembled into VLPs which were later shown to induce antibodies.

A fourth publication in the Journal of Virology in 1993 by the group at NCI showed that there was a so called ‘wildtype’ and ‘protoype’ strain of HPV16 and that the wildtype was needed to make functional VLPs.

“There was this belief in the world that Ian Frazer had used the so-called prototype and not the wildtype in making his VLPs,” Cox says.

Frazer did in fact use a wildtype, he confirms. “We subsequently showed that and sequenced it and filed that sequence with Genbank and deposited it in a genetic depository in the United States at the same time we filed the patent. So we actually used the right L1 code,” Frazer says.

Rose, however, says that if they did use the wildtype sequence, “there’s every expectation that their results would have been vastly different”.

Credit where credit is due

According to Rimmer, the cervical cancer patent dispute is a battle not only in terms of patent priority but also in terms of the apportionment of scientific credit and kudos between different players.

“In some ways the second issue is really a question for the scientific community to decide in terms of apportioning who should be given the credit,” he says.

While all groups involved acknowledge that contributions to the original research into HPV were made by various people, who deserves the most credit may never be resolved.

“I know that there were a large number of people worldwide that worked towards this and it was disconcerting to me as an individual that there was no effort made by Dr Frazer to make a similar acknowledgement,” Rose says. “He basically allowed the perception to grow that he was the sole inventor of the vaccine and that’s not accurate.”

Frazer queries whether it all matters in the long run. “No it doesn’t,” he says. “We’re going to get a vaccine. The vaccine will be of benefit to women. Who invented it probably doesn’t matter very much.

“I’ve had a fair bit of publicity for it in Australia. I’ll be the first to admit that that has helped the cause of medical research in Australia no end at all. The money will come in large measure to Australia and that’s also good, because it helps to argue a case for more funding for medical research (here).”