Moms Ask FDA To Rescind Gardasil Approval
41 CommentsBy Ed Silverman // October 25th, 2010 // 11:05 am
Taking a direct approach with the FDA is all the rage these days. For instance, aggrieved investors recently created an online petition to implore the FDA to investigate staffers for their input into a recent panel meeting for the Arena Pharmaceutical diet pill (see this). And now several parents, who formed a non-profit to protest widespread use of Merck’s Gardasil vaccine for HPV, have written the agency to demand that approval be rescinded.
In its letter, SANE Vax argues that the FDA permitted Merck to use “an inappropriate primary endpoint and unreliable HPV genotyping methods” evaluating efficacy. You can read the letter here to learn more, but basically the group maintains that less serious cervical lesions were permitted as an endpoint and they cite National Cancer Institute reports to bolster their contention this was an erroneous decision.
“The FDA has approved a vaccine which is being marketed as a cancer vaccine, when in fact it has only been proven to prevent ‘not a true biologic entity,’ in the words of the NCI, the inventor of the current HPV vaccine technology and the co-developer of Gardasil,” SANE Vax writes to FDA commish Margaret Hamburg. “The situation is exacerbated because the FDA and the NCI have not attempted to encourage development of a reliable HPV genotyping method for post-license monitoring of the effects of Gardasil vaccination on the epidemiology of HPV infections in the American population.”
In a separate letter to Jack Stapleton, who chairs the FDA Vaccines and Related Biological Products Advisory Committee, over the same concerns in advance of a meeting next month in which the panel will review Merck’s request to have Gardasil approved to prevent anal dysplasia and anal cancer (see this).
This is only the latest effort in a campaign by SANE Vax and a related group called TruthAboutGardasil to unravel Gardasil approval. Gardasil was endorsed for females aged 9 to 26 to prevent four strains of HPV, two of which are found in about 70 percent of all women with cervical cancer. The vaccine has been controversial, though, because Merck lobbied states surreptiously for mandatory vaccination; the price tag is high; some parents remain skittsh that the vaccine offers a green light for teenage sex and, in particular, side effect concerns continue to generate publicity.
Public health officials, however, have strongely endorsed Gardasil and a rival vaccine, GlaxoSmithKline’s Cervarix, as safe and important public health tools. Nonetheless, the FDA earlier this year postponed a decision to broaden Gardasil usage to women between the ages of 27 and 45 until Merck provides more data (look here). Meanwhile, vaccination rates continue to rise among teenage girls, according to a recent US Centers for Disease Control and Prevention survey (see this).
industry insider
Public pressure does indeed work. Using Meridia as an example, Gardasil should be off the market by 2020.
riv
Gardasil should never have been on the market. Women are so disposable in this industry.
Leslie Carol Botha
Thank you, Ed for covering this story. We appreciate your assistance and support in getting this message out to the public.
Ginger Taylor
as of this week…
84 deaths associated with the vaccine
20,101 adverse reactions reported.
And it may not really prevent cancer.
AnneS
I agree, it should never have been on the market. Mark Blaxill wrote an in-depth 3 part series at Age of Autism on the subject:
http://tinyurl.com/2dfrtz8
Ken Kramer
If HPV was not transmitted primarily through sexual contact we would not be having any of these debates. Ed said it nicely in his article “some parents remain skittsh that the vaccine offers a green light for teenage sex and, in particular, side effect concerns continue to generate publicity.” A vaccine is not a green light for teenagers to engage in sex, but it appears to be a great excuse for parents.
Karen Reina
In general, I support any and all vaccines in the name of public health, but this particular vaccine’s approval may be an example of how industry got ahead of itself. In any case, this is an excellent case study on the growing influence of patients on healthcare policy - a trend I applaud.
riv
Ken Kramer I suggest you start lobbying to have all males including your sons vaccinated with Gardasil, and of course, you teach them condom use and responsible sex practices. You, most certainly, never have unprotected sex.
Anne PME
Thanks Ed.
Glad that I am not the parent of a teenage daughter who needs to sort all of this out.
ol cranky
@ Ginger:
Can you put your data into perspective? You say: “as of this week…
84 deaths associated with the vaccine
20,101 adverse reactions reported.”
When I see numbers like this, I have no choice but to ask how many patients were exposed as well as for more details about what I assume you are saying are known/[reasonably] suspected adverse drug reactions
vince
If as the lead researcher on this noted HPV vaccination is ‘one big public heath experiment’ and will notreduce cervical cancer rates as reported here http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt” Gardasil Researcher Drops A Bombshell
Harper: Controversal Drug Will Do Little To Reduce Cervical Cancer Rates”
By Susan Brinkmann, For The Bulletin
Than any side effects appear excessive
riv
Amanda now lives with an autoimmune disease, and her doctors say it was the vaccine:
http://www.cbsnews.com/video/watch/?id=5251444n&tag=contentMain;contentBody
“(With pap smears) you have a very low chance of having cervical cancer, so being one less means nothing, because you were never going to be one anyway”.
Cassandra
vince,
Let’s at least try to show some realism here. What The Bulletin gives us here is a free interpretation of a scientific talk by the /Assistant Editor/ of /The Population Research Institute/, which despite its grand title is nothing more than a conservative pressure group. Both her qualifications and her objectivity seem to be distantly removed from those required to make a reliable interpretation of the data. Personally, I do not even trust such a source to be truthful.
To make the claim that there is little need for a vaccine because only 5% of those infected by HPV will develop cervical cancer anyway is perfectly outrageous. It is true that pap smears already help a lot to reduce the cancer rate, but to extrapolate current trends in cancer incidence reduction unchanged over the next 60 years is little short of ridiculous. And all this skates VERY lightly over the nature of the treatment for those who do develop cervical cancer, which in the worst case is hysterectomy and even in the best case will put the patient through a lot of suffering.
Mrs Robinson seems also to be rather dismissive of the health and lives of people in the third world, who do not have the benefit of the health infrastructure that can provide regular pap smear and reliable treatment of suspect cases.
GrammaKnows
“side effect concerns continue to generate publicity”
When did paralysis and death become downgraded to merely “side effect concerns”?
Let me rephrase that, WHEN DID PARALYSIS AND DEATH BECOME MERELY “SIDE EFFECT CONCERNS” IN DIALOGUE ABOUT MARKETING A PRODUCT?
No excuses for “vaccines save lives”, no more dialogue about how MANY deaths would be acceptable in order to keep a product on the market. VACCINES KILL AND MAIM. FDA gives PERMISSION for vaccines to kill and maim.
Stop making excuses for murder and assault in the name of profit masquerading as public health.
Cassandra
Actually, correction: It turns out the “4th International Public Conference on Vaccination” at which Dr. Harper allegedly made her statements is not a genuine scientific conference at all, but a gathering of the faithful organized by the NVIC.
Dr Harper’s motivation to speak at such an event is unclear: She may have foolishly believed that it is possible to have a genuine dialogue what pseudo-scientists. What happened instead is that she was outrageously misquoted, and then saw this misinformation spread over numerous media outlets and websites by pressure groups. I think we can safely assume that she will not repeat this experiment.
Ken Kramer
Cassandra,
Do not waste your energy on rational, fact-based arguments. They appear to fall on deaf ears. Some people cannot be reasoned with, ever.
Ken
vince
Fact check time. Diane Harper was a lead researcher on this vaccine . The quotes are her’s she has expressed similar concerns elsewhere. The Bulletin story was written by a reporter. Why did Dr. Harper speak out about this vaccine. From a CBS interview http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5253431.shtml….“If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “…… there is no reduction in cervical cancers, …. She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. ….
just a girl
It amazes me how everyone has an adverse opinion on all treatments. You should interview women who are in there late or early 40’s who have been dignosed with cervical cancer due to HPV that has stayed dormant for several years and had clean pap smears!
Maybe in 20 years interview all the boys and girls who did not receive the vaccine oh it will be the ones who did not qualify for a free vaccinations, our public health care sector vaccinates. Public should educated themselves and not rely on companies or public sector opinions.. I wonder how many people this could help or save from having adverse reactions to a very sexual young adult population.
Cassandra
Ken,
Indeed. The problem is that a real public debate is suffocated by this kind of intellectual pollution. Researchers who might want to raise points of genuine concern face the risk that their words will be quoted out of context, misrepresented and abused — a potential career killer for young scientists. Others will refrain entirely from participating in public debate altogether because, as you correctly say, some people cannot be reasoned with. But that path leads to decision-making behind closed doors, which only further erodes public confidence and enhances distrust in science.
I agree that it is a waste of time to argue with some people. As a scientific community we should, however, attempt to hold to account media (such as The Bulletin) who are willing to publish drivel such as this without any critical comment. Statements such as “But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.” are next-of-kin of “Close family friend says Brad and Angelina want a divorce.” Surely journalistic ethics should draw a line somewhere?
And there is something deeply worrying about the ability of pressure groups with zilch scientific credentials to call themselves “Research Institutes” or “Information Centres”. While people’s right to free speech must have as few limits as possible, it should not extend to this kind of fraudulent practice. In most countries, an individual pretending to posses academic or even medical credentials for which he or she does not have the correct qualification, would be open to criminal prosecution. It is not obvious why it such activities should go unpunished merely because they are done collectively.
riv
Dear Cassandra
You first accredited Dr. Harper’s words to someone else, whom you then did a character assassination on.
You then make assumptions about Dr. Harper.
The 5 percent statement is for women in the western world.
Dr. Diane Harper has made several similar statements. She’s been interviewed and quoted on this extensively by different sources.
The treatment for dysplasia really isn’t onerous. It’s the fear-mongering that’s the most difficult.
You make a lot of assumptions Cassandra. First about Dr. Harper, and then about posters here.
riv
Dysplasia isn’t cancer and blips on one’s pap aren’t dysplasia. And neither necessitate a hysterectomy.
Women are not often told that though. Hysterectomy is an easy surgery any ham handed gyne can do, and oh so very lucrative.
But back to Gardasil. It doesn’t treat cervical cancer. Not right after it’s been given, and certainly not 60 year’s from now. Is that what you were implying Cassandra?
Ken Kramer
Cassandra
To try and answer your question. The numbers of the uniformed, misinformed, and not-interested-in-being informed will always outnumber those who take the time to hear and assess the data from all sides. Thus, their voices will be louder and in greater numbers. It is frustrating but, unfortunately, a fact we all have to live with.
riv
I had to check back into your article Ed, to find out what you had said, since Cassandra plays fast and loose with quotes.
You should know the major body against vaccine are feminists, who have been through this over and over, and done some research themselves. We find out HRT is harmful (in any dose for any length of time), hysterectomy is done for frivolous reasons and doing so damages women’s health and can lead to ovaries shutting down, breast cancer is often “not”, mammograms cause cancer, money raised to treat cancer apparently doesn’t since the cure today is the same as the cure 50 years ago. And Gardasil (Cervarix et al) does not treat cervical cancer. Women are not going to be cash cows for this industry any longer.
Look further when you attribute dissent to one American type activism Ed. It’s not all right or left. There is a huge advocacy among feminists for fact-based information on women’s health issues, and informing and educating women on the real end points of much of what is delivered to them as science.
Ken Kramer
WOW. I am shocked that modern medicine has done no good for women in the past 100 years. I guess all those lives saved by Herceptin http://www.medicalnewstoday.com/articles/31791.php) and all those beautiful children born to mothers through in vitro fertilization are all part of an evil master plan.
Is medicine and science perfect? Absolutely not. Have mistakes been made? Yes. But let us dispatch with the victimization talk as it belittles us all.
M Helm, MD
No matter what, the best way to prevent cervical cancer (and all other sexually transmitted diseases for that matter) still remains the following: (In order of importance)
1) have only one sexual partner per lifetime, who also has only one sexual partner - you. If you or your partner has more than five sexual partners, you are at increased risk of HPV infection (and specifically cervical cancer).
2) Use latex condoms and/or other barrier methods during all sexual activity - always and everytime.
3) Men are affected by HPV as well, and this is how these viruses are passed from person to person. A man who has had sexual relations or close contacts with any person with a (first or second-degree)history having of HPV, abnormal pap smears, cervical, penile or several other types of cancers may be a carrier of HPV, and may represent a risk to other persons. Men and women with these risk factors should be avoided as sexual partners for the person without these exposures. Since HPV infection is associated with other sexually transmitted disease, this precaution could likely be extended to exclude as a sexual partner any person with a personal STD history or any person with a close personal relationship with a person with a prior STD. (At this point, the dating pool starts to get pretty small.)
4) Because the cervix is especially vulnerable to infection with HPV early after puberty. Women should delay onset of sexual activity until well after puberty is completed, and normal cervical tissue changes during puberty have been completed.
In other words, the only way to be assured of being “one less” to to avoid any and all situations where one would be exposed to HPV. Since you can’t see it, this is harder than it sounds. The good news is that a diligently applied strategy to avoid cervical cancer would also reduce all other STDs, and virtually eliminate the “unwanted pregnancy” problem.
Now, who thinks the four point strategy above is a realistic and sufficient option for most people (not just people in your family)?
Important policy questions include: Is the strategy above a reliable enough primary prevention strategy that it should be the only tool offered (screening by Pap smear is a secondary prevention strategy - reducing the severity of a condition AFTER it occurs)? Is there a need for more protection against HPV infection, cervical cancer and other HPV-related cancers? What are other primary prevention strategies which would be useful in preventing HPV (and other STDs)?
And a few other things should always be remembered:
1) There are many strains of HPV, several are associated more strongly with cervical (penile, or other) cancer risk, a few of these strains are the targets of the vaccines. The vaccines may or may not prevent cancer. All abnormal Pap smear findings do not lead to cancer, and one hopes that no abnormal pap smear finding would would be ignored.
2) Most high risk HPV infections resolve without leading to cancer. Vaccination may reduce the incidence of genital warts, or may change the distribution of HPV strains in circulation. The future unintended consequence is that if abnormal Pap smear (or other screening test) findings become more rare, there may be changes in the aggressiveness of treatment or follow-up. These changes will also have consequences.
3) The interaction of virus characteristics, host defense and timing of exposure may be more important predictors of cancer development risk than any single factor (such as HPV strain) alone.
4) The developing world presents unique challenges. Visual inspection with acetic acid appears to be a useful tool relative to Pap smears which are largely inpractical in many poorer countries. It is likely that cervical cancer diagnosis and treatment in developing countries will lag behind the developed nations, with or without the availability of effective (but expensive) HPV vaccines.
5) New methods for identifying HPV infection will likely be developed and commercialized. These will also likely be too expensive for routine use the developing world.
I will refrain from commenting on whether or not Pap smears are over- or under-utilized (or both) in the US.
This debate has to move beyond simplistic “Vaccine Good” or “Vaccine Bad” pronouncements based on individual ideology/belief. Please note, that I’m not expressing an opinion on either side of this debate.
riv
Now, who thinks the four point strategy above is a realistic and sufficient option for most people (not just people in your family)?
##
Really, that’s not the issue. The issue is whether or not Gardasil et al are effective at preventing cervical cancer.
We should LOOK for some medical intervention for cervical cancer other than PAP smears and surgeries, along with a push to what you’ve outlined in your four steps. Maybe we could divert some of that marketing money?
Those are WOMEN sparring and sensible options, which I note are almost universally trashed by men (even those who use a woman’s sood).
The issue is, Gardasil et al do not prevent cervical cancer, the risk is too high for using them, and we are innundated with marketing not science on this issue.
Let’s REALLY look at saving women’s lives. That’s not what’s being done in most instances.
And let’s stop conflating the western population needs with third-world countries.
Ken Kramer
The defense rests
Cassandra
The good news is that somebody actually asked Dr. Harper herself to clarify her opinions. Which is what ANY decent journalist ought to have done before printing the rendering of it by third parties with an obvious agenda of their own:
http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html
Congratulations to Marcia G. Yerman.
Cassandra
Fortunately, at least one journalist has been professional enough to ask Dr. Harper for her opinions, instead of reproducing renderings of her statements by third parties with an obvious agenda: http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html
Congratulations to Marcia Yerman. This is altogether more nuanced. The question this doesn’t yet answer for me if whether vaccination during or before puberty offers valuable protection, taking into account M Helm’s statement that the time of highest vulnerability is immediately after puberty, and any protection offered by the vaccine has a limited duration.
riv
Thanks for posting that. As far as I can see, she validates the points I made here, one after the other, including the little benefit this vaccine presently offers over existing treatments. Did you think you’d posted something I hadn’t seen before? Her quote which I posted is (also) from that statement.
Since the vaccination offers very little protection, I think you have your answer regarding vaccination during puberty, pre-puberty, post puberty, or any time later: it doesn’t vaccinate against cervical cancer. The rest of what we know about its performance for its licensed use is so qualified as to be almost meaningless–my comment, but validated by Harper’s comments too.
Also, I repeat, the treatments for cervical cancer are not as onerous as you seem to wish on us, and for many years have been done in about one hour including recovery in a doctor’s office in most jurisdictions in the western world. Science again, not fear-mongering.
Cervical cancer is RARE in Canada or the U.S. And treatment for it can be done in about one-hour, including recovery time, in a doctor’s office. Hysterectomy isn’t required, but I am touched by your concern for women in this context. Over one-half million women are hysterectomized each year in the U.S. alone. Only a fraction of those are for cancer. Of any kind.
riv
I think this site is useful when those affected by a drug or medical treatment, and those who are part of the research or delivery can discuss it rationally. But when sales people spam this with their nonsense and really, just plain juvenile stupidity, it makes me wonder Ed, what is your point with Pharmalot, and do you think you still achieve it?
There is such a divide between what the salespeople who post here are willing to brush under the carpet with shocking disregard for the harm their misinformation may cause, and what the consumer and much of a growing number of concerned healthcare professionals strive for. You can’t be unaware of that. So I ask again, what is your purpose with Pharmalot Ed, and are you achieving it, particularly in this new permutation?
riv
I should add, I don’t mean to imply that the pharma “people” are stupid, just what they are saying and doing here, which is not ONLY stupid, but dangerously so. It just beggars belief.
Ed Silverman
Hi Riv,
Not sure what you mean by new permutation. The only thing that’s changed is the underlying ownership. First, it was Advanced Publications, which published The Star-Ledger of New Jersey, where I worked for many years and conceived the site. Then I owned the site myself for a stretch before selling it a few months ago to Canon Communications. But the approach hasn’t changed.
During that time, I’ve been the person in charge of content and have attempted to provide the same mix of news, analysis, original reportage, interviews and some other sorts of things. And I’ve looked to offer the same topics as I have when the site began. So am I achieving what I hoped? If the site offers useful info and, for some, a place to sort things out, then the answer is yes.
Hope this helps,
ed
riv
You’re doing good Ed. I always enjoy your essays. We’ll leave it at that. Literally.
R. Boyce
Thanks for the article Ed. What most people do NOT know is how dangerous this vaccine is. There is a VERY LARGE subset of individuals that will experience life-threatening illness post-Gardasil. It’s a group that have PK deficiencies (pyruvate kinase, G6PD, anemia, HH, HFE gene, etc. - many names but the same genetic and/or environmentally-caused deficiencies). My daughter had Gardasil and was recently diagnosed as POST-menopausal. This was after she lost hair, had severe pneumonia, dehydration, migraines, etc. Currently, she is NOT ovulating, although she still has regular menses. I thank God every day that I figured this out. I found this link below over a year ago … What I initially did not have proof of, I do now today. Gardasil is a vaccine that will cause sterility/fertility issues. I plan to fight this vaccine until it’s off the market. I don’t know who ever believed this was a valid vaccine but it seems more to me like a vaccine of mass destruction.
http://www.wipo.int/pctdb/en/wo.jsp?wo=1999034825&IA=US1998027658&DISPLAY=DESC
So everyone that posts here should pass this information along … will the FDA ever step up and recall this vaccine? What is our world coming to?
publicRightToKnow
Thanks for posting this. Please e-mail me at:
rv14oi(AT)gmail(DOT)com
Rosemary Mathis
Thanks for this article. My daughter was disabled by Gardasil. I wish someone had told me prior what could happen to her. Her doctor said only redness and swelling at injuction site. Boy, was he wrong. Duke University confirmed her vaccine injury.
Go to http://sanevax.org/ and read the stories of injury and death.
The FDA and CDC need to do their jobs and pull this vaccine off the market. But to do that, they have to admit they are wrong for releasing it to begin with.
Bee
Thank you so much for your article and the people who are trying to get others to listen about the dangers of Gardasil. My daughter was partial paralyzed and gravely ill after getting Gardasil. VAERS still has her listed as having ALS; which takes the blame off the pharmaceutical company of course. We now know her illness is not ALS(thanks to God for answering our prayers). We know for sure Gardasil caused her illness. You just don’t have a normal, healthy, active 12 year old child who runs and jumps, plays basketball,karate x 4-5 years, rides scooters, etc..who gets a vaccine then within 2-3 weeks loses her balance to walk and falls to the ground can’t stand up and muscles start withering away. Not to mentioned the headaches, tingling sensations, electrocuting type pains, loss of feet movement/sensation, absent reflexes, rapid heartrate, fainting, ? seizure activity and twitching all over. Yes, definitely Gardasil caused my child’s illness.
Amy G
Last week I received a post card from our family clinic, a panic alert to advise me that, I am a lousy mother who has not protected her child from HPV with a Gardasil vaccination and that HPV can lead to CERVICAL CANCER ….”Oh My, I am a horrible mother.”
I have gone the rounds with our family physician on my opinion of this vaccine. 1) It does not protect against all HPV viruses 2) It does not eliminate Cervical Cancer 3) It may give young women and teens the idea that they don’t need regular exams because they may believe they have eliminated cancer risk 4) The best way to prevent developing cervical cancer is regular pelvic exams
The postcard did not say “by the way, India has banned Gardasil after 4 deaths in girls were possibly linked to Gardasil”. Or that there have been reports of death and other adverse events reported in the USA as well. It failed to mention how extremely rare it is for someone to die from cervical cancer also….. Hmmm, what is the motivation to tell me I’m a bad mother who has failed to protect her daughter? could it be $$$$?
Marci
It will be interesting to see if Gardasil will ever be taken off the market. Their legal department would be reluctant for obvious reasons. It’s harder to sue a drug that’s still being sold to the public. Prempro is a perfect example. It’s still being taken by too many desperate women despite it’s known dangers.
Lucy
riv, great postings - could not have said it better myself. I’ve been following these posts and can’t help noticing that Cassandra has been noticeably silent after “discovering” Marcia Yerman’s interview of Dr. Harper. (I found that interview a couple of months ago and forwarded the link to everyone I know.) The most revealing parts of the interview are the Q and A & the most alarming but not surprising, answer from Dr. Harper is this one:
Q. Recent reports state that Gardasil may have triggered MS (Multiple Sclerosis) in some girls receiving the vaccine. What are your thoughts on this?
A. “Neurologists at the American Neurological Association have indeed concluded that Gardasil is temporally associated with autoimmune attacks on the neurologic system. The range of neurologic disorders is unknown.”
Also, look at Gardasil’s Patient Insert which can be found at http://www.fda.gov/cber/label/gardasilLB.pdf . When you get to the website, scroll down to Product Information, click on Package Insert, then go to page 14, para. 13.1. There you will find this disclaimer: “Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity”. If Merck says they don’t know if Gardasil is carcinogenic or genotoxic, should we all not sit up and take notice??