Important Q&A on Gardasil – Peg Luksik, PhD

Gardasil

By Peg Luksik, PhD

Important Questions and Answers

Introduction

Gardasil is a vaccine for 4 types of HPV developed by Merck.  It is currently being marketed to parents as a way to “protect your daughter’s future from cervical cancer and genital warts”.  In fact, on the Merck web site for Gardasil, the vaccine is headlined as “the only cervical cancer vaccine.” (Appendix A, p 1) Merck is also involved in an intensive state-by-state lobbying campaign to have Gardasil mandated for girls as young as 9.  (Appendix B)

Is Gardasil a “cervical cancer vaccine”?

No.  Gardasil has no effect on cervical cancer whatsoever.

Does Gardasil actually “protect your daughter’s future from cervical cancer and genital warts”?

No, it doesn’t.

Why not?

Gardasil offers SOME protection against SOME of the Types of HPV that have been linked to cervical cancer.

There are over 40 Types of HPV, and 15 of them have been linked to cervical cancer and/or genital warts.  Gardasil has been developed to vaccinate against the 4 Types that have the highest correlation with cancer and genital warts.

However, unlike the smallpox vaccine, for example, Gardasil does not grant full immunity to those 4 Types of HPV.  Additionally, in the studies offered to the FDA in Merck’s application for approval, data indicated that Gardasil MAY INCREASE your daughter’s risk of developing cervical disease if she already had one of the relevant strains of HPV at the time of vaccination (Appendix E, p13 & 25).

Gardasil offers no protection against the other 11 strains of HPV that have been linked to cervical cancer.  Those strains currently account for 30% (Appendix A, p6, Appendix B, p8) of the diagnosed cervical cancer cases.  The continuing potential risk for the non-vaccine strains has led the FDA to require that Merck conduct further studies to determine whether the long-term effect of Gardasil will be nothing more than a shifting in the dominant cancer-linked HPV strains (Appendix C, p1 & 7).

How does Gardasil work?

Like other vaccines, Gardasil stimulates the body to produce antibodies to protect the person from getting the virus when they are exposed to it.  There must be enough antibodies in the blood to protect against infection when an exposure happens.  The antibodies remain in the blood for some period of time, and the protection remains in effect as long as enough antibodies are there.  Some protections last for a lifetime, so the vaccine does not need to be repeated. Others require periodic booster shots to ensure that enough antibodies remain in the blood to protect against infection.  The level of antibodies can be measured through a blood test.  It is reported as a Titer count.

To determine the duration of effectiveness of a vaccine, one needs to know what Titer count is necessary to ensure protection against the disease, and how long that Titer count will be maintained through a vaccination.

What Titer count is needed to protect my daughter against HPV?

Merck doesn’t know.

Its testing data indicates that Gardasil elevates the Titer count for the 4 Types of HPV targeted.  It also indicates the Titer count drops after 7 months and continues dropping until 24 months post-vaccination.  The studies only report Titer count levels for 36 months.  Merck states that because so few subjects were tested, and therefore too few disease cases developed, they were unable to establish the minimum antibody levels necessary to protect against clinical disease caused by the 4 Types of HPV Gardsil targets. (Appendix D, p5)

How long will Gardasil’s protection last?

Merck doesn’t know (Appendix D, p5).

Does that mean that a little girl vaccinated as a 9-year-old could lose all protection before she becomes 14?

Merck doesn’t know.

How can Merck “not know”?

Data for this information comes from the testing done to develop a vaccine.  The drug company conducts studies on patients, with some of them receiving the vaccine and some of them receiving a placebo (saline solution or sugar cubes).  The subjects are then studied over time to observe the differences between the two groups in both the effectiveness of the drug and any side effects in may produce in someone taking it.

In the case of Gardasil, there have been not enough subjects, nor enough disease cases, nor enough time to know the answers to these questions (Appendix D, p5).

How many subjects were there?

It varied by age.

Generally, Merck conducted their studies on women from the ages of 16 to 23.  Merck reported that they conducted 4 placebo-controlled studies that evaluated 20,541 women, with about half receiving the “placebo”.  The women were followed for 4.0 years in the first study, 3.0 years in the second, 2.4 years in the third, and 2.0 years in the fourth study.

Then how was Gardasil approved for little girls under 16 years of age?

Results were based on small testing populations in 2 studies.  Study #016 included only 506 girls from 10 to 15 years of age (Appendix E, p19).

In Study 018, Merck reported the following numbers of subjects to the FDA (Appendix E, p20):

9 year-old girls – # evaluated: 67

10 year-old girls – # evaluated: 131

11 year-old girls – # evaluated: 165

12 year-old girls – # evaluated: 142

13 year-old girls – # evaluated: 165

14 year-old girls – # evaluated: 150

15 year-old girls – # evaluated: 109

Merck reports that the total number of children from 9 to 15 years of age who were tested was 1,121 (Appendix D, p7).

The company states that the effectiveness of Gardasil on this population is “inferred” (Appendix D, p7).

“Inferred?”

Yes.

Merck is lobbying to mandate the administration of a vaccine to little girls that they only “INFER” will be effective?

Yes.

What are the side effects?

Unclear, but some indications are troubling.

Why?

Because an accurate determination of side effects is determined in clinical trials by comparing the group that received the vaccine to a placebo group of equal size who received no medication in their injections.

Wasn’t that done?

No.

Wasn’t there a placebo group?

Yes, but it did not receive only a saline injection.  In all but 10% of the subjects, the “placebo” group received the same aluminum-containing base as the Gardasil group (Appendix D, p11).  Merck received permission from the FDA to treat the aluminum-containing group as the “placebo” group when it reported comparative side effects (Appendix F, p1).

Is the aluminum-containing base safe?

Although widely used, it has never been tested for safety.  There has been research from around the world dating back to at least the 1980’s questioning its links to neurological and arthritic conditions (Appendix F).

So there was no group that received a neutral placebo?

Merck reports that 320 subjects received a saline placebo, and 3470 received the aluminum-containing placebo.

Were any comparisons made?

Merck reports saline results only for injection site reactions measured for no longer than 5 days.  It does not report saline results for later reactions, or systemic (not just local injection site) reactions.

In the data that IS reported, those receiving Gardasil experienced:

173% more pain

350% more swelling

203% more erythema (redness and inflammation)

517% more pruritus (itching)

than the saline group (Appendix D, pp11-12).

In the product information insert, Merck reports cases of arthritis (juvenile, rheumatoid, and reactive) and lupus among the test subjects after Gardasil treatments.  They do not report the ages of those affected, nor how many doses each received.

Is there any other information available on side effects?

Yes.

The Vaccine Adverse Effects Reporting System (VAERS) is a federal data base where patients and/or health care professionals can report adverse effects from a vaccine.  The VAERS is a passive reporting system, meaning that data is only received when individuals voluntarily submit it.  The government therefore considers that vaccine side effects are underreported by a factor of over 90%.

The VAERS lists 82 cases of Gardasil related adverse effects between July and December 2006.  These side effects included local effects such as pain, swelling, inflammation, and itching.

They also included severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, seizures, muscle weakness, tingling and numbness in hands and feet and joint pain, and Guillain-Barre Syndrome (Appendix G).

What about pregnant or breastfeeding mothers?

Congenital anomalies were reported in women who became pregnant within 30 days of Gardasil injection, including pyloric stenosis and club foot (Appendix D, p9, Appendix E, p25).

Merck does not know whether vaccine antigens or antibodies are excreted in breast milk (Appendix D, p9).

Merck reports that an increase in acute respiratory illnesses (300%) in breastfeeding infants whose mothers received Gardasil within 30 days of breastfeeding (Appendix D, p10).

Why the push for mandating?  Is cervical cancer a huge problem?

Merck calls cervical cancer the second leading cancer in women around the world.  But in the United States, it’s 14^th, accounting for less that 1% of the cancers diagnosed here, with about 10,000 diagnosed cases per year nationally.  The median age of those diagnosed is 48, leading many to question how a vaccine with an unknown effectiveness duration, given to pre-teen girls, will result in a decrease in cervical cancer rates.

The American Cancer Society reports that cervical cancer rates have dropped by 70% in the past 30 years because of Pap tests, leading to early detection and successful treatment (Appendix H).

Interestingly, Merck did not test Gardasil to see if it causes cancer.

So who is pushing to mandate Gardasil?

Merck is.

The company is aggressively lobbying in every state, including employing Texas Governor Perry’s former Chief of Staff to lobby in Texas.

Why?

Some insight might be gained from The Wall Street Journal. On 2/7/07, the WSJ reported that Merck was desperate for cash.  With estimates that the settlements Merck will owe for its Vioxx litigation will amount to approximately $970 million, and the expiration of some of its patents, Merck faces a huge cash flow problem.

But if Gardasil is mandated, Merck will generate sales of approximately $1 billion in the first year alone, with 5 year revenue projections of up to $4 billion (Appendix I).

NOTE:  On February 21, 2007, Merck announced that it has cancelled its lobbying efforts to make Gardasil mandatory (Appendix J).

QUESTION:  Why is Gardasil considered safe enough for little girls, but not for little boys until Merck conducts “further study?”  Since HPV is a sexually transmitted disease, don’t both halves of the sexual partnership need to be vaccinated for a vaccine to be considered “effective” in eliminating its spread?

Appendix A:  http://www.gardasil.com

 

Appendix B:  http://ahrp.blogspot.com/2007/02/more-about-mercks-help-pay-for-viox.html

 

Appendix C:  http://www.ahrp.org/cms/content/view/466/27/

 

Appendix D: Gardasil package insert, page 5: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

 

Appendix E:  VRBPAC Background Document, May 18, 2006 VRBPAC Meeting

 

Appendix F:  http://www.909shot.com/PressReleases/pr62706gardasil.htm

 

Appendix G: http://www.909shot.com/Diseases/HPV/HPVrpt.htm

 

Appendix H:  American Cancer Society, Cancer Facts & Figures 2005

 

Appendix I:  http://ahrp.blogspot.com/2007/02/merck-lobbies-states-to-mandate.html

 

Appendix J: http://www.lifesite.net/ldn/2007/feb/07022109.html