OCTOBER 27, 2009 11:02PM

Gardasil Researcher Drops A Bombshell

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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.

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Perhaps the purpose is quite obvious, if you take a closer look. Sterilization.
this is quite the bomb........wow
This story is in newspapers all over the world, right on the heels of the announcement that a vaccine has now been developed for boys. The next few days should be interesting.
This is good news - there are actually honest researchers out there, not in thrall to the money men in Big Pharma. She will lose her funding, but at least she has alerted the public to the scam.
So many problems with Big Pharma. So much money involved.

So much bad science in the Alternative Medicine community. So much money involved.

Common denominators? Desperate people. Money.

Thanks for spreading the wordl
As with all things pharmaceutical, follow the money trail. It will lead you right to the center of decay, every time.
@ABlonde -- "announcement that a vaccine has now been developed for boys."

Not my boys.
"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"

No, that's NOT what Dr. Harper said.

Dr. Harper said:

"In developed countries where Pap screening systems have been effective for decades, the biggest value of the HPV vaccine will not be in preventing DEATHS from cervical cancer." (my emphasis)

That's because routine Pap smears identify precancerous cells that can be treated before they become cancerous, and identify early cancers that can be effectively treated with radical hysterectomy.

So while deaths will not decrease, we can look forward to a dramatic decrease in the number of cervical laser procedures for precancerous cells, and a dramatic decrease in the number of radical hysterectomies.

Sure, we could forget about preventing cervical cancer and just treat it when it develops (continuing to enrich the gyn oncologists) or we could prevent it with the vaccine. Prevention is better than even the most successful treatment.

Moreover, Dr. Harper reports that she has received money from both Merck and GlaxoSmithKline for consultation about and conducting clinical trials on the HPV vaccines. Her overall impression of the vaccine:

"This is a good vaccine and it is generally safe," she said
So, Gordon and/or Susan Brinkmann have been caught in a plain out, boldfaced LIE about what Dr. Harper said. Just flat out lied. I wonder how many of the people here who are mad at the mere implication that large corporations misrepresent products are going to denounce good ole Gordon/Susan here just as vocally for the blatant libel to further his/her own agenda.
Cue cognitive dissonance in 3..2..1...
I know Diane. She even wanted to have my job working on Gardasil. But she's really gone off the chain here in her assertions about both Gardasil and Cervarix. I have no idea why.

But her assertions are either lies (Gardasil was safety tested in young girls. That data is available in the label for the product and was submitted to the FDA) or misrepresentations (Gardasil was shown to prevent a necessary precursor of cervical cancer: CIN 2/3. You don't develop cervical cancer without first having this precancer stage. AND, you don't wait until it is at cancer to treat. You treat at precancer. So valid clinical endpoints were used.)

Diane knows that. Diane published articles touting the effectiveness of both vaccines. Diane received consultant payments from both Merck and GSK. And here's the best part, before licensure even for girls, Diane vaccinated her sons with Gardasil. If that isn't a vote of confidence, I don't know what is.

Also in that JAMA article mentioned, there was a great study done by the CDC looking at the safety reports. The conclusion was that Gardasil is a safe vaccine.

And no one seems to consider ALL demonstrated or potential benefits of HPV vaccination:

Reduced abnormal PAP smears
Reduced repeat PAPs due to abnormal PAPs
Reduced colposcopies
Reduced LEEPs, conizations etc
Reduced infertility from said procedures
Reduced preterm birth from said procedures
Reduced precancers
Reduced anal cancers (Yeah, like Farrah)
Near elimination of recurrent respiratory papillomatosis of the newborn
A major decimation of genital warts which ARE a major health problem
Decreased HIV risk (since it is being found that HPV increased risk of acquiring HIV)
Decreased emotional consequences of a stigmatizing diagnosis
And quite possibly, decreased tonsillar/laryngeal cancers which are on the rise due to HPV 16.

So my question is, if Diane saw fit to vaccinate her own sons, why does she think that HPV vaccination is so wrong for your teens and young adult children?

You can throw the Pharma shill gambit at me all you want, but my ethos is focused only on public health. I don't care who pays my salary. I would not work on a product I didn't believe in or didn't know to be safe. And I spent too many years putting bandaids on teens with STIs that I chose the opportunity to work on preventing one from doing damage in the first place.
I understand (all Internet-derived information is questionable) that 90% of all HPV cases resolve themselves within two years. In light of that fact... if it is a fact...

The sun came up in the east this morning, at least in the direction I've been TOLD is east... I am now questioning everything...
"90% of all HPV cases resolve themselves within two years. In light of that fact... if it is a fact... "

And all the cervical cancers come from the 10+% that don't.

But if you'd rather wait until women develop cancer and treat them then instead of practicing preventive medicine, that's your choice.
I understand (all Internet-derived information is questionable) that 90% of all HPV cases resolve themselves within two years. In light of that fact... if it is a fact...

Gordon that is indeed the truth, but the problem is that there are at least 30-40 genital HPV types of which 15-20 are oncogenic (HPV 16 & 18 are the real back actors causing 70% of all cervical cancers) so with a new sexual partner generally comes a new HPV infection. But we cannot predict or determine which women are in the 10% who are unable to clear their oncogenic HPV infection.

Currently PAP screening will generally find abnormalities so that they can be treated before cancer develops. But even after all these years of PAP testing, still only 81% of at-risk women have had a PAP smear within the past 3 years. And the other 19% either don't get screened because of access issues or don't get screened because they don't want to know. So in the US there are approx 330,000 cases of high grade (precancer) diagnosed annually and 10,000 cases of cervical cancer. And of the cervical cancer cases, about 3600 die. So that 10% of women who don't clear their infection is not an insignificant number. Sure if you could predict who those 10% are, you could be more targeted in your prevention approach, but since there is no way to know, the goal is to attempt to vaccinate prior to sexual contact to prevent infection with the real bad actors (16 & 18) in the first place.

And let's not forget genital warts. At least 1,000,000 new cases in the US annually. Sure it won't kill you, but who the hell wants anything growing on their genitals that doesn't belong there? The treatments are often painful and recurrent.

And finally, though we have treatments for cervical precancer, these treatments do involve having pieces of one's cervix cut off. Now I ask you, if you could prevent your daughter from having pieces of her cervix cut off by giving her a safe (despite the internet hype) vaccine, wouldn't you? As a mom, I would.

I know that there are tons of questions people have and there is as much incorrect information circulating on Gardasil as there is on H1N1 vaccination, and Diane has made herself the media darling with her current spin on things. But Diane was an investigator in our trial and GSKs trials for years and as I said, she vaccinated her sons. Her published articles and oral presentations at meetings supported the efficacy and safety of both vaccines. Why is she now talking out of both sides of her mouth? Diane is no "mouthpiece." She has her own agenda, whatever it is. I wish I knew what it was.
10% is also not a small number of women in the United States.
Thank you TeenDoc for your input, especially given your unique position of personal knowledge of Harper and your own involvement with the development of the vaccine. I was flummoxed when I began reading of Harper's about face, and I see that I'm not alone.

I wonder too about other cancers that may somehow be linked to warts, that we are still unaware of, and it will be interesting to see over time if the recipients of the vaccine suffer lower cancer rates (of unexpected types) during the course of their lives.