Gardasil: ‘A Catalog Of Horrors?’
12 CommentsBy Ed Silverman // May 24th, 2007 // 6:07 am
That’s the comment made by Judicial Watch’s Tom Fitton in discussing adverse events associated with Merck’s HPV vaccine. The conservative watchdog group yesterday issued a press release decrying Gardasil and the 1,637 side effects so far reported to the FDA, which the group obtained through a Freedom of Information Act request.
All totaled, there were 371 serious reactions, including three deaths. Of 42 women who received Gardasil while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities. Most of the adverse reactions - 77 percent - are typical, but there were also reports of paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. Two of the deaths involved blood clots, but the women were taking birth control pills, which can cause clotting. Gardasil, by the way, isn’t recommended for pregnant women.
“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,†Fitton intones. “Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports.”
Fitton’s description, which some may think is over the top, is nonetheless likely to resonate with a wide array of people. Conservative groups oppose HPV vaccination because they fear it runs counter to promoting abstinence. Many parents are simply unsure whether Gardasil is safe or has been tested sufficiently. And while many docs and public health advocates favor vaccination, others worry the vaccine may dissuade women from getting Pap smears.
So far, two million to three million women may have received the vaccine, The Wall Street Journal reports. Most adverse events involve minor side effects such as pain at the site of injection, itching and dizziness. Merck has distributed more than five million doses of Gardasil in the US since its introduction last June.
Karen Riley, an FDA spokeswoman, tells the paper that the agency was closely monitoring the adverse events associated with Gardasil, including the pregnancy complications, but “we haven’t seen anything at this point that would suggest we’d make any changes in the product.”
Dick Haupt, Merck’s executive director of medical affairs, tells the Journal that miscarriages likely had nothing to do with Gardasil. However, one of the 18 women was diagnosed with an abnormal fetus, and a test conducted on another woman during her pregnancy showed an increased risk of fetal defect. There is no report on the outcome.
Congenital anomalies were an issue during the FDA’s review last year. In clinical trials, there were five cases of birth defects among women who received the vaccine within 30 days of conception, the paper reports. Merck says they didn’t fit any pattern and were unlikely to be connected to the vaccine.
Fitton, of course, is having none of it: “It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug.â€
Further reading…
Judicial Watch;
The Wall Street Journal (subscription required).[tags]Gardasil, Merck[/tags]
Shannon
The fast track of this drug seems to coincide with Merck’s settlement with the IRS. I deeply question the process of getting FDA approval and the clinical trials; or lack of. To say that this drug is a cure is totaly fabricated….no drug can promote a cure…..scare tactics….
To subject our young girls to this is criminal.
Merck will have made billions before this drug will be pulled…..like Vioxx…….They know this…..
reality
With all due respect, Shannon, your statements are quite at odds with reality.
First, lack of trials? The 2 main trials enrolled about 17,000 patients for 3-5 years, and are continuing to follow them for 10-15 years, I think. Do we know all of the long-term side effects at this point? Of course not — that’s why there’s drug safety monitoring. But this is the case with all drugs. Also, the deaths are by no means new news — they are reported right there in the NEJM papers — no one is hiding anything.
The adverse events, even serious ones, are likely idiosyncratic and rate, and the type that you will see with any drug if studied long enough. It also doesn’t mean it’s related to the drug.
One thing I found “humorous” (not ha-ha funny) was that the first AE in the report was a girl who fainted from the shot — obviously not a drug-related AE. And that, plus their obvious axe grinding, is part of the problem with JW’s “analysis.” I imagine them there saying, Joe McCarthy-style, “I stand here, in my hand with over 1600 reports of adverse events…”
If anyone is introducing scare tactics, it’s Judicial Watch — it’s their M.O.
Second, no one, at least not Merck or any scientist, ever said this was a cure. However, the results speak for themselves: For unexposed women, the vaccine prevented close ~100% efficacy against strains 16 and 18. Even in patients already exposed to HPV it was 70% effective.
reality
Re: adverse events, I meant to say that the serious ones like Guillain Barre and Bells Palsy are likely idiosyncratic, and are not necessarily drug-related.
Laurie
The FDA readily admits to not doing drug safety monitoring to any extent that would be considered adequate. To say “The adverse events, even serious ones, are likely idiosyncratic and rate, and the type that you will see with any drug if studied long enough. It also doesn’t mean it’s related to the drug.” does not do the public any justice. Pharma claims of “you can’t prove a causal link” are getting pretty old. A child given a vaccine who has a reaction within a short time frame is about as “causal” as one is going to get.
Denial of the potential adverse reaction is a disservice to the public. Making a decision require full disclosure of the risk/benefit ratio. Denying the risks, however small, are not in any patients best interest.
The FDA has a severe problem. The trust in the agency is gone…and along with it the trust in new drugs.
mhatrw
To summarize this published, peer-reviewed medical journal article: http://content.nejm.org/cgi/content/full/356/19/1991
1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.
2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.
3. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.â€
4. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.
This is all directly from the article linked above.
I myself would add that the use of a highly pharmacologically alum adjuvant as the sole “placebo” in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the “placebo”) is highly problematic.
Finally, even though we don’t have any decent quantitative numbers concerning GARDASIL’s safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.
reality
First of all, let me just say that I was primarily responding to the first poster, who was clearly misinformed.
Regarding the idiosyncratic comment, perhaps I was too glib, but for JW to start throwing these things out to the public as though they’re occurring at high rates is dishonest.
I understand the comments about the 17% and the general population, but I think focusing on that population sort of defeats the purpose of the vaccine — that you use it in an unexposed population and look at the strains for which the vaccine is actually intended. I did not originally see the statement in the editorial about the possibility of other strains “filling the niche”…very interesting.
Shannon
Please explain as to why the stage 111 clinical trials are conducted in other countries and with few subjects.
As far as a reality check…I’m very informed and stay informed…..For a drug company to lobby and market for a mandate as a required immunization for school-aged girls raises deep concerns. By doing this the states/schools will be responsible for subsequent issues related to the vaccine.
Laurie
Reality, I think what really bothered me most about Gardisil was the push to mandate. If you had a young female child, who was not sexually active, would you want a school telling you that you HAVE to give a vaccine? For those who choose to give Gardisil, that is their choice, But when mandating is pushed it’s a HUGE red flag for me. If a parent is comfortable with the potential risks, then that’s fine. For those that are NOT comfortable with those risks, to be forced to give it to their child is not ethical.
reality
Shannon, I apologize for calling you misinformed, but your first post is more of a stream-of-consciousness rant with primarily baseless accusations. You also didn’t say anything about the mandatory vaccination in your post. I’m also not a fan of the mandating aspect, and I thought Merck handled it very poorly. Of course, it wasn’t just Merck, but also the CDC’s recommendation.
As to where the studies were conducted — 12,000 patients at 90 sites in 13 countries. Now, I don’t know how many patients were enrolled in each site, but the simple average is 133 — that seems like a pretty decent number. Why in other countries? More sample diversity? Less sampling bias? Many large trials are multinational. Is there something you’re hinting at that I’m not getting?
Also, getting the shot for a non-sexually active young girl is exactly who benefits most, as the data show! Remember, they’re vaccines — they’re meant to prevent, not treat. Once patients are sexually active and exposed, the efficacy drops by 50%.
Finally, things like mandating have been used by many — not necessarily the people here — as red herrings, to defer that what people are actually uncomfortable with: SEX. If this were a vaccine for a non-STD, I think things would be very different. But you have a lot of uninformed/misinformed nonscientists going on talk shows pretending to care about or understand the science behind the vaccine, when in reality, their agenda is about abstinence, etc.
Shannon
reality….first please address the coincidence with Merck and the IRS…..I was wrong to think that you were aware of the mandiate/target of our young people….perhaps your were missinformed…As to the target for clinical trails…..The market for Gardasil suggest the US is substitanial …..(not 3 world, etc.) …….Also to suggest that the clinical trials were conducted ie……..multinational sounds good for some but not for me. What we are concern about is this country…
Merck is targeting/lobbying for this country….because the market is hugh…for the USA…..THE BOTTOM LINE IS “MONEY”..
As a parent my first and formost is my children. This drug is not “a good thing” and I will not support it…….The bottom line “reality” who really benifits………. Can we really say our children??????????
Shannon
Need I say more….Who has done the marjority of the clinical trials…..”Glaxo”……They have applied for accelerated review for Merck’s Gardasil……..need I say more………..Let me say that I undersand the cost s of new drugs …And I applaud all drug companies for their religous perservance of “new drugs”…..the costs is unbeliebable………… But….. We must weigh the complete benifits for this vaccine ………do we know enough……I think not…Three years trials + …..is not enough……………… And I do not think future trials will change the outcome……..Can we say beyong three years is enough??????????? …..No…..The outcome is uncertain….and to say at this stage that they will follow these studies…..can you say that you will risk your daughters to the unknown of Gardasil………….If someone can help me with this drug, please help…I’m only a consumer/mom….and passionate about this topic/vaccination.
reality
Shannon -
I came here to discuss the medical facts and findings from the Merck studies, which are at odds with the claims you made in your first post about lack of adequate study or that Merck claimed this was a cure.
I can’t comment on the coincidence about the IRS and Merck. I’m not familiar with it, and don’t know, and frankly, neither do you. Anything else is rampant speculation and conspiracy theorizing. The strength of the study results really make this sort of thing quite unlikely.
I was fully aware of the attempt to mandate the vaccine, however, you did not mention this in your initial post, which is why I didn’t address it. I did, however, address it later. The reason they’re “targeting young people” is because that’s who’s most responsive to the effects! You don’t wait to give MMR shots to senior citizens, you give it to kids to prevent infection. Likewise, the results of the Gardasil studies clearly showed that immunization before disease exposure had a much greater effect. And since kids are sexually active at younger and younger ages these days, it would need to be given early on. There’s nothing sinister here — it’s the way vaccines are designed to work.
The reason multinational trials are done is because health is a global issue. You may only care about the US, but physicians, scientists, and multinational companies like Merck, and Pfizer, and every other major Pharma company, as well as the FDA and foreign drug agencies sure care.
You may not believe this, but a 3-year study of 12000 patients is enormous, and many drugs are approved with shorter durations and fewer patients. Not to mention, there is a 10-year follow-up for side effects for these patients. What you’re asking for just simply isn’t feasible and doesn’t happen. All drugs at approval still have lots of unknowns about them — sometimes you learn things years down the road and they get warnings or get pulled. Some side effects won’t show up until 5 or 10 years down the road. You just don’t know. But the approval is based on an overall risk/benefit ratio.
As a parent, you were well within your rights not to vaccinate your kids with an HPV vaccine. I can see that you are passionate about this, but with all due respect, your arguments all revolve around passion and not science and the reality of drug trials.