Gardasil (HPV vaccine) researcher expresses strong doubts

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Terralthra
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Gardasil (HPV vaccine) researcher expresses strong doubts

Post by Terralthra »

The Bulletin wrote:Gardasil Researcher Drops A Bombshell

Harper: Controversal Drug Will Do Little To Reduce Cervical Cancer Rates
By Susan Brinkmann, For The Bulletin
Sunday, October 25, 2009
Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.

Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.

She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”

There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.

Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.

Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”

Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”

However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”

Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.

This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old “is a great big public health experiment.”

At the time, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”

“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

When asked why she was speaking out, she said: “I want to be able to sleep with myself when I go to bed at night.”



Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.

The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: "The rate of serious adverse events is greater than the incidence rate of cervical cancer."

Ms. Robinson said she respects Dr. Harper’s candor. “I think she’s a scientist, a researcher, and she’s genuine enough a scientist to be open about the risks. I respect that in her.”

However, she failed to make the case for Gardasil. “For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”
While this doesn't appear laced with the sort of anti-vaccine conspiracy theories, I'm pretty put-off by the researcher quoting numbers with no context. How many is 15k girls, percentage-wise? And how many of those suffered severe side effects, and how many minor ones? Also, the "deaths" number is highly HIGHLY misleading, given that none of the 44 deaths in the VAERS database were deemed linked to Gardasil, and half of them they couldn't prove a death occurred at all.

The article comments themselves are awash with flaming stupidity.
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Re: Gardasil (HPV vaccine) researcher expresses strong doubts

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Looking at the article, what the researcher seems to be saying is that the vaccine isn't going to be very helpful in reducing cervical cancer and HPV rates in the US, but would be more helpful in developing countries. The advantage of the vaccine, of course, is that it requires less infrastructure than the dedicated care facilities and medical assistance available in the US, let alone countries with a universal healthcare system. She's also warning about the lack of testing on under-15 girls. The people receiving the talk interpreted it as, seemingly, a warning that the side effects were fairly common and very severe, which is depressing. Based on the price of the Gardasil vaccine and its $1.4 Billion US profit in 2006-2007, the first year on the market, about 12 million doses were sold, or 4 million vaccination treatments. There have been three years on the market total, (06-07, 07-08, and 08-09) and assuming that sales stayed steady and didn't increase from year to year for a conservative assumption, then 12 million people would have been fully vaccinated by June 2009. Note that this is an incredibly rough and conservative assumption, but on the other hand, the article said girls, and Gardasil is intended, according to the CDC for 11-26-year-olds, with girls as young as nine being capable of receiving it, so without any further research, there is no way to know just how the CDC and VAERS determine what "girl" means, and what percentage of said individuals receive the vaccine as a proportion of the total vaccine recipients.

Source for the Gardasil sales: here.
The CDC website on Gardasil and the HPV vaccines in general: here.
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Re: Gardasil (HPV vaccine) researcher expresses strong doubts

Post by Darth Holbytlan »

To be fair to the researcher, it may just be the reporter quoting numbers out of context here. Bad science reporting is not entirely unheard of.

Some more detailed information is available from the FDA. Here are a few of the most relevant quotes:
FDA wrote:This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.
On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. 2009;302(7):750-757). The article describes 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. During this time period, the manufacturer, Merck and Co., has distributed over 23 million doses of Gardasil in the United States. The information contained in this update is based on the same information contained in the article published in JAMA. FDA will provide a future update to information on the number of reports of adverse events and doses distributed.
Because VAERS data are subject to many limitations of passive reporting systems, FDA and CDC also utilize additional surveillance tools. This includes the CDC’s VSD which incorporates eight large Managed Care Organizations, and now has health records linked to over 450,000 doses of Gardasil, and focuses on several potential risks: thrombotic events (blood clots), seizures, syncope, appendicitis, anaphylaxis, and GBS. Thus far, the VSD studies have not found safety signals or concerns for any of these events. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.
The numbers seem comparable to the ones in the article, if a bit older. There are at least 450K doses of the vaccine given in the subset of heath care organizations that are monitored, and only 11K minor reactions and 772 major reactions out of all vaccinations in the US, many of which are likely coincidences. The cervical cancer rate is roughly .008% (based upon 12K cases diagnosed a year with a population of 150M women in the US), and has a roughly 1/3 mortality rate.

article wrote:Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.
So 5% of HPV infections eventually result in cervical cancer? That's much higher than the overall rate, even taking into account that it is spread over many years. In fact, it's so high that I can't reconcile it with the rate of HPV infection, which is 1 in 4 from what I can Google up. In any case, the notion that this renders the vaccine unneeded seems like an odd conclusion.
There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.
I'd love to know where this estimate came from. Given that HPV is the primary cause of cervical cancer, and that vaccines are usually pretty effective (70% protection is common), I would expect a 70% vaccination rate to be highly effective, especially once herd immunity is factored in.
Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.
Yeah, I'm sure that the current 4% annual decline in cervical cancer is sustainable for 60 years. :roll:

If we assume that 450K is the entirety of vaccinations given, and that all of the 772 major complications were all attributable to the vaccine, I could see a case for it being dangerous, since it would produce them at about 20x the rate of cervical cancer. But those are ridiculous assumptions. Just looking at the sources for the VSD shows that it covers only a fraction of the country. (Based on Bakustra's estimate, it is 1/27th of the actual number.) And the complications attributable to the vaccine should be a fraction of those reported, just based upon the disposal of the 44 "deaths". I'd be shocked if that wasn't two orders of magnitude off the top at least.

Also, HPV is implicated in a number of cancers, not just HPV.

NB: From the CDC figures, "girl" means "female".

Edit: Hit post prematurely.
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Re: Gardasil (HPV vaccine) researcher expresses strong doubts

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Terralthra wrote: While this doesn't appear laced with the sort of anti-vaccine conspiracy theories, I'm pretty put-off by the researcher quoting numbers with no context. How many is 15k girls, percentage-wise? And how many of those suffered severe side effects, and how many minor ones? Also, the "deaths" number is highly HIGHLY misleading, given that none of the 44 deaths in the VAERS database were deemed linked to Gardasil, and half of them they couldn't prove a death occurred at all.

The article comments themselves are awash with flaming stupidity.
The researcher? Or the article itself.
I can't help but wonder how much of the impression is by the author of the article as opposed to the actual mood of the participants and the facts presentented.

It seems to be more that Dr Harper is arguing along the lines that said intervention isn't statistically useful. Viewed along the lines of cost/benefit, this would mean that government mandated vaccines programmes shouldn't include the vaccine.
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Re: Gardasil (HPV vaccine) researcher expresses strong doubts

Post by Cairber »

Harper is discussed here:
http://www.sciencebasedmedicine.org/?p=1723

She spoke at NVIC; I honestly have a hard time believing anything she says after that. Check out who was speaking there:

http://www.nvic.org/Events/schedule.aspx
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Re: Gardasil (HPV vaccine) researcher expresses strong doubts

Post by Guardsman Bass »

That's a good point; NVIC is pretty much anti-vaccine central. Hell, just look at some of the topics at that conference - half of them seem to be lessons in how to prevent mandatory vaccinations, with a healthy dose of homeopathy advocacy on the side.
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