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Gardasil Vaccine Researcher Drops Bombshell_Philadelphia Bulletin

ALLIANCE FOR HUMAN RESEARCH PROTECTION

A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org 

FYI

Dr. Diane Harper, the lead researcher in the development of two human

papilloma virus vaccines, Merck's Gardasil and GlaxoSmithKline's Cervarix,

injected sobering facts about these much promoted vaccines. Indeed, Dr.

Harper, who analyzed the data, raised serious doubts about the medical

justification for use of the HPV vaccines in Western-industrialized

countries where current screening has all but wiped out the death rate from

cervical cancer:

Speaking at the 4th International Public Conference on Vaccination (Oct.

2-4) Dr. Harper explained 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."

Dr. Harper, who also serves as a consultant to the World Health

Organization, further undercut the case for mass vaccination in

industrialized countries by saying that "four out of five women with

cervical cancer are in developing countries."

Furthermore, she said, there have been no efficacy trials in children under

the age of 15: "It is silly to mandate vaccination of 11 to 12 year old

girls. There also is not enough evidence gathered on side effects to know

that safety is not an issue."

To date, 15,037 girls have officially reported adverse side effects from

Gardasil to the U.S. 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.

In Britain, 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.

Bottom line: "The rate of serious adverse events is greater than the

incidence rate of cervical cancer."

So why are public health agencies in the US and the UK promoting the

vaccines for young girls when the risk / benefit ratio is clearly tilted

against its use????

This is but another example of aggressive marketing skewing public health

policy, overriding good medical practice and the dictum, "First, do no

harm." The case lends  further support for increased public distrust.

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677

720.txt

The Philadelphia Bulletin

Gardasil Researcher Drops A Bombshell

Harper: Controversial 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 Guillain 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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ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org

FYI

Please note that some of the conclusions (value judgments) that were made in

the Infomail re: Gardasil, http://www.ahrp.org/cms/content/view/642/9/

should NOT be attributed to Dr. Diane Harper, whose presentation at the

International Public Conference on Vaccination, was more nuanced than the

Philadelphia Bulletin reported.

Dr. Harper presented the following facts:

1. "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;"

2. "There have been no efficacy trials in girls under 15 years."

 "There also is not enough evidence gathered on side effects to know that

safety is not an issue."

3. "To date, 15,037 girls have officially reported adverse side effects from

Gardasil to the U.S. 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 did not draw conclusions about whether (or not) to

vaccinate--except to say, "It is silly to mandate vaccination of 11 to 12

year old girls" given the lack of efficacy and safety data.

Her approach is to educate by laying out the facts, leaving individuals free

to chose whether or not they want their daughters to be vaccinated with the

HPV vaccine, Gardasil.

Dr. Harper did not explicitly raise serious doubts about the medical

justification for use of the HPV vaccines in Western-industrialized

countries. What she said was that "the benefits and risks of both Pap

screening and HPV vaccination needed to be reviewed and the value that each

of the four components of the decision were personal and had to be made by

each person deciding in what way she would participate in cervical cancer

screening."

The reported British adverse event data were not cited by Dr. Harper, as

these were cited in the British press after her talk:

In Britain, 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 statement: "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." is not Dr. Harper's statement

but rather a quote from a published article by authors who are scientists at

the National Cancer Institute:

See: Castle PE, Solomon D, Saslow D, Schiffman M.  Predicting the effect of

successful human papillomavirus vaccination on existing cervical cancer

prevention programs in the United States, Cancer. 2008 Nov 15;113 (10

Suppl):3031-5.

Finally, the statement that I characterized as the bottom line:

""The rate of serious adverse events is greater than the incidence rate of

cervical cancer."

should read: "The REPORTED rate of serious adverse events is greater than

the incidence rate of cervical cancer."

I hope these corrections clarify the distinction between what Dr. Harper

stated and the conclusions that I and others may have drawn:

"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.

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

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to unsubscribe send a message to Infomail1-leave@ahrp.org

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