The National Vaccine Information Center

Merck’s marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed…

Washington, D.C. — The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) to just say “no” on June 29 to recommending “universal use” of Merck’s Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.[1] A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [4 5] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. [6 7] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.”

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

“There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” said Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.”

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction. As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting .[11]

What’s the Truth About HPV and The Cervical Cancer Vaccine?

I’m a young woman concerned about my health, about preventing illness, and about the well being of young women everywhere. With these concerns in mind, I looked into Merck pharmaceutical company’s new product, Gardasil, a vaccine that claims to prevent cervical cancer by preventing infection with Human Papilloma Virus (HPV).

Experts say HPV is a sexually transmitted disease that may cause some forms of cervical cancer. The concept behind the Gardasil vaccine is that if women avoid HPV infection, they will avoid developing the forms of cancer HPV is thought to cause.

Gardasil works by introducing “dead” HPV virus into our bodies through series of three injections that cause us to produce HPV antibodies. It is believed that these antibodies will protect us from contracting HPV if it is passed on to us during sexual intercourse.

After reading up on HPV and Gardasil, I have a lot of questions. For example:

How do we know the HPV vaccine prevents cervical cancer if girls get shots at age nine as recommended, but don’t become sexually active for another 10 or more years?

Since most cases of cervical cancer in the US appear in women over age 35, and the vaccine was tested for only four years, how did Merck prove Gardasil works?

If HPV is a sexually transmitted disease, why is there no HPV test for men?

If there are no HPV tests for men, how can experts claim millions of men have HPV?

Why do most abnormal Pap smears indicating HPV infection become normal with further testing—and without any treatment for HPV?

If only .0055% of American females are diagnosed with cervical cancer each year, does it make sense to give 100% of all women in the US vaccines of unknown safety and efficacy?*
I believe that you and I have a right to receive answers to these questions so we can make an informed choice about the Gardasil HPV vaccine. In searching for answers, what I’ve found so far is that leading experts on HPV and Gardasil are either unwilling or unable to provide them. Not even when offered money for their time and trouble.

The following exchange between me and Dr Richard Frieder is one example of an expert that wouldn’t answer questions about HPV and Gardasil, even though he’s an outspoken advocate of the vaccine ­ and not even when I offered $2,500 for his time!

I’m a working mother of two and not the type of person to hand out thousands of dollars in exchange for a photocopy of a medical study, but I really wanted some answers. If you have or can find the answers that Dr. Frieder didn’t provide, please send them on. I will be glad to make a donation in your name to any of the women’s charities linked to at this site.

With appreciation and in solidarity,
Casey Cohen
weekendvegan@hotmail.com

Outspoken Gardasil Expert Silenced by Simple Questions
August 21, 2006 Letter from Casey Cohen:

Dear Dr Frieder,

I read with great interest your article about the new HPV vaccine Gardasil (“Protect Your Daughter From Cervical Cancer”) that appeared in the Santa Monica Mirror.

I recently had an abnormal Pap smear, and like the patient you mention in your article, I too was frantic. But my first step was to go for another Pap smear rather than ago into a total panic, and I’m glad I did.

The second Pap was normal, and a third was normal as well. What concerns me now is that I have since discovered that almost every woman I know has had a similar experience, that is, an abnormal Pap followed by a normal Pap. wonder, does this mean that the abnormality resolves itself or that the first Pap was incorrect? Is there a medical explanation for why abnormal to normal Paps are such a common experience?

Since my almost panic, I’ve become interested in HPV and have been doing some research. Rather than leading to greater understanding, I am confused by the difference between what I’ve read and what you write. Your article states that HPV affects “over 20 million American men and women.” I could not find a study that gave information on numbers of men diagnosed with HPV. Could you please send me or refer me to some data on how many American men actually have HPV?

I also wonder how HPV is tested for in men. Can you shed some light on this? My own gynecologist said she’s never heard of HPV testing for men. This seems odd to me since HPV is described as a sexually transmitted disease. Shouldn’t men take charge of their health by testing, too? Do you test for HPV in men? And do you know how often cancer follows a positive HPV screening in men?

I’m also having difficulty locating a study that demonstrates a causal relationship between HPV and cervical cancer. All I can find are studies that indicate a correlation, but no causation. I’ve asked three doctors about that, including the one who did my Pap smears, and she can’t find any studies that demonstrate causation, either, so we both need your help! About the new Gardasil vaccine, your article says that it has “no known side effects.” Does this mean no known immediate side effects or no known long-term side effects?

One last question, and this may be stupid, but how does anyone know the HPV vaccine prevents cervical cancer if you get the shot at age nine (as you suggest) but don’t become sexually active for another 10 or more years, and most cases of cervical cancer (from what I’ve read) appear in women over age 35?

I look forward to gaining insight on this important topic and thank you for very much for your time.

Sincerely,
Casey Cohen

PS How is the “frantic patient” in your article doing?

August 31 Reply from Dr Frieder
Dear Santa Monica Mirror reader,

Thank you for your email and your interest in my article. I’m very glad that this subject is getting attention and provoking your good questions. As far as providing you with further information, I’m sorry but I just don’t have the time to respond to all of the inquiries that I’ve received. I’m a private physician with limited time. If you have specific concerns regarding your own health, I’d be happy to see you for a consultation. If you’d like an appointment, please call my office.

If you have general questions regarding the subject of HPV and Cervical Cancer, I’d suggest that you research the following web sites: www.richardfrieder.yourmd.com www.webmd.com www.acog.net www.gardasil.com

Thanks again for your interest. I apologize for this form letter, and hope you’ll understand. Best wishes,
Richard Frieder, MD

PS. Ms. Casey, Your letter indicates a great deal of insight and curiosity. I think you’ll find the answers in these references.

August 31 Letter from Casey Cohen
Dear Dr Frieder,

Thank you for your reply. I appreciate you taking time from your busy practice to write to me.

Unforunately, I do not live in the Santa Monia area. I was passing through on my way to San Francisco and picked up the Mirror at a market. A consultation is not possible for me.

What is possible is to recompense you for your time in providing me with the answers and references I seek. Also, if you are affiliated with or support a charity, I would be happy to make a donation on your behalf in exchange for your help in providing answers to my questions.

Please let me know if I may reimburse you for your time. In the meanwhile, I would appreciate a reference for the number cited in your article of 20 million American men and women with HPV. I assume you have this close at hand since the article appeared in the August 24-30 edition of the Mirror.

Thanks again for your time.

Gratefully,
Casey

September 1 Letter from Dr Frieder
Hi Ms. Cohen,

I’m enclosing the Gardasil product information found on their web site for your review. This is citation with regard to 20 million Americans who have had HPV. I don’t know the specific literature that they used, but this fact is common knowledge, as is the fact that HPV is the cause of cervical cancer, and is supported by a large body of literature.

I’d really encourage you to get guidance in this area from your regular OBGYN. He/she really should be able to answer all of your questions. I’d be happy to have a phone consultation with you regarding your questions if that is your preference. I can also provide you with research studies if you wish, but this would be costly, and you can get the same information yourself.

Best wishes,
Richard Frieder, MD

September 2 Letter from Casey Cohen
Hi Dr Frieder,

Thank you for referring me to the Gardasil web site.

While the site is interesting, the information there seems geared toward promoting the vaccine and does not answer my specific questions. For example, Gardasil says the 20 million number of HPV carriers cited in your article is an estimate, not an actual case count. It also notes that the claim that “50% of sexually active people catch HPV” is an estimate, rather than an established fact.

The site gives no explanation as to why the HPV vaccine is only for “girls and women ages 9 to 26” or why it might be prohibited for use by boys and men. Why would a vaccine for a sexually transmitted disease be restricted to use only among females?

The site also gives no information on HPV testing for men or even a link to where one can learn more. Do you test the male partners of the women in your practice who come up positive for HPV or recommend a lab where their husbands and boyfriends can go? What test does a man ask for to screen for HPV?

The site does state that “cancer of the cervix…is caused by certain types of HPV” but again, without a reference.

As I mentioned, I’ve spent many hours searching for references to what you, my own doctor and other experts call common knowledge, without finding the studies or data upon which this common knowledge is based. I am an intelligent person who can find my way around the internet and a library yet the most basic information seems uncommonly hard to find. At this point, I’m reaching out to you, an expert in your field and an advocate for Gardasil, and offering to pay you for your help, directly or through a donation to the charity of your choice.

Would $2,500 suffice as recompense to answer the questions in this email? Please let me know.

With thanks,
Casey

September 3 Letter from Dr Frieder
Hi Ms Cohen,

You’re clearly a very intelligent and educated person with many good questions. I’m afraid I can’t help you any further in this matter. I respectfully refer you to the resources that I’ve given you for your further investigation.

Richard Frieder, MD

September 3 Letter from Casey Cohen
Dear Dr Frieder,

I don’t understand. You are the author of a published article that enthusiastically promotes the new HPV vaccine but are unable to answer a few simple questions about the vaccine or HPV despite a generous offer to compensate you for your time.

Can you at least give me the name of the HPV test used for men and the name of just one study that demonstrates HPV causes cervical cancer? In exchange, I will send the offered recompense of $2,500 to The Make a Wish Foundation, a charity which brings joy to the lives of children with terminal illness.

Thank you,
Casey

As of today’s date, Dr Frieder has never responded to my questions or offer for a donation to the Make A Wish Foundation, and I’m still waiting for an expert on HPV to reply to my concerns. Can you help?