Autism / Autism Spectrum Support Group
Autism is classified as a neurodevelopmental disorder which manifests itself in markedly abnormal social interaction, communication ability, patterns of interests, and patterns of behavior. Although the specific etiology of autism is unknown, many researchers suspect that autism results from genetically mediated vulnerabilities to environmental triggers.
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udicial Watch Releases Analysis Of FDA Data Claiming Gardasil Vaccination
Can Lead To Serious Health Problems, Death
08 Oct 2007
The conservative group Judicial Watch on Thursday released an analysis of
FDA data that found Merck's human papillomavirus vaccine Gardasil might be
dangerous or fatal to young women, members of the group said, CQ HealthBeat
reports (Lubbes, CQ HealthBeat, 10/4).
Gardasil in clinical trials has been shown to be 100% effective in
preventing infection with HPV strains 16 and 18, which together cause about
70% of cervical cancer cases, and about 99% effective in preventing HPV
strains 6 and 11, which together with HPV strains 16 and 18 cause about 90%
of genital wart cases among women not already infected with these strains.
FDA in June 2006 approved Gardasil for sale and marketing to girls and
women ages nine to 26, and CDC's Advisory Committee on Immunization
Practices later that month voted unanimously to recommend that girls ages
11 and 12 receive the vaccine, which is given in a three-shot series
(Kaiser Daily Women's Health Policy Report, 7/10).
Analysis, CDC Data
According to Judicial Watch, 3,461 complaints about Gardasil have been
filed with FDA's Vaccine Adverse Event Report System since its approval
last year, and 11 women died after exposure to the vaccine. In addition,
some women developed severe health problems after receiving Gardasil, the
analysis said. Curtis Allen, a CDC spokesperson, said the agency has
confirmed four deaths that occurred after the patients received Gardasil,
but none of the deaths was linked directly to the vaccine. Allen said that
there have been fewer complaints about adverse effects associated with
Gardasil than there have been for other drugs.
Several of the reports to FDA of deaths of girls and women who received
Gardasil note that the patient had developed a blood clot. Allen said that
Gardasil is not known to increase risk of blood clots. He added that
Judicial Watch's analysis does not prove that Gardasil causes death and
that the reports of women who died after receiving the vaccine
statistically are normal within the population.
According to CQ HealthBeat, there is disagreement over the data in part
because the reports of adverse events come from several sources, including
health professionals and pharmaceutical companies, which are required to
disclose potential problems with vaccines, including rumors and third-party
information. The Judicial Watch analysis includes a report about a doctor
who at a conference heard about two patients dying after receiving
Gardasil. Another incident involved the death of a 17-year-old girl
immediately after receiving the vaccine, which was reported to FDA by "a
gynecologist who was informed of the case from another gynecologist. "
Reaction
Tom Fitton, president of Judicial Watch, said that if Gardasil is "as
dangerous as it seems to be, it does not seem to be good public health
policy." Kelley Dougherty, a spokesperson for Merck, said that it is
impossible to determine whether the reports are actual fatalities related
to the vaccine or rumors. The FDA only documents deaths that are reported
but the agency does not show cause and effect, according to CQ HealthBeat.
"There are no reporters that have a correlative effect," Dougherty said.
Allen said that Judicial Watch "is playing loose" with data on the vaccine.
Fitton defended the group's analysis and added that it has filed a lawsuit
against FDA to require the agency to provide more information about the
vaccine. "The reports are what they are," Fitton said, adding, "The CDC can
explain them away, and Merck can explain them away. I don't think it's just
randomness" (CQ HealthBeat, 10/4).
The analysis is available online.
Bloomberg/Austin American-Statesman Examines Sales of Gardasil
In related news, Bloomberg/Austin American-Statesman on Friday examined how
Gardasil "could become the best-selling vaccine in history" as Merck
"prepares to expand its use to men." According to
Bloomberg/American- Statesman, Merck has made $1.4 billion in Gardasil sales
in the drug's first year on the market. Merck is conducting studies to
prove that Gardasil can prevent HPV infection in men. If the vaccine were
approved for use in boys and men, annual sales of the vaccine could be as
high as $10 billion, according to Lisa Kelly, an analyst at Wood Mackenzie
Consultants (Cullen, Bloomberg/Austin American-Statesman, 10/5).
Reprinted with kind permission from http://www.kaiserne twork.org. You can
view the entire Kaiser Daily Health Policy Report, search the archives, or
sign up for email delivery at
http://www.kaiserne twork.org/ dailyreports/ healthpolicy. The Kaiser Daily
Health Policy Report is published for kaisernetwork. org, a free service of
The Henry J. Kaiser Family Foundation 2005 Advisory Board Company and
Kaiser Family Foundation. All rights reserved.
Article URL: http://www.medicaln ewstoday. com/articles/ 84804.php
Main News Category: Cervical Cancer / HPV Vaccine
Also Appears In: Women's Health / Gynecology,
udicial Watch Releases Analysis Of FDA Data Claiming Gardasil Vaccination
Can Lead To Serious Health Problems, Death
08 Oct 2007
The conservative group Judicial Watch on Thursday released an analysis of
FDA data that found Merck's human papillomavirus vaccine Gardasil might be
dangerous or fatal to young women, members of the group said, CQ HealthBeat
reports (Lubbes, CQ HealthBeat, 10/4).
Gardasil in clinical trials has been shown to be 100% effective in
preventing infection with HPV strains 16 and 18, which together cause about
70% of cervical cancer cases, and about 99% effective in preventing HPV
strains 6 and 11, which together with HPV strains 16 and 18 cause about 90%
of genital wart cases among women not already infected with these strains.
FDA in June 2006 approved Gardasil for sale and marketing to girls and
women ages nine to 26, and CDC's Advisory Committee on Immunization
Practices later that month voted unanimously to recommend that girls ages
11 and 12 receive the vaccine, which is given in a three-shot series
(Kaiser Daily Women's Health Policy Report, 7/10).
Analysis, CDC Data
According to Judicial Watch, 3,461 complaints about Gardasil have been
filed with FDA's Vaccine Adverse Event Report System since its approval
last year, and 11 women died after exposure to the vaccine. In addition,
some women developed severe health problems after receiving Gardasil, the
analysis said. Curtis Allen, a CDC spokesperson, said the agency has
confirmed four deaths that occurred after the patients received Gardasil,
but none of the deaths was linked directly to the vaccine. Allen said that
there have been fewer complaints about adverse effects associated with
Gardasil than there have been for other drugs.
Several of the reports to FDA of deaths of girls and women who received
Gardasil note that the patient had developed a blood clot. Allen said that
Gardasil is not known to increase risk of blood clots. He added that
Judicial Watch's analysis does not prove that Gardasil causes death and
that the reports of women who died after receiving the vaccine
statistically are normal within the population.
According to CQ HealthBeat, there is disagreement over the data in part
because the reports of adverse events come from several sources, including
health professionals and pharmaceutical companies, which are required to
disclose potential problems with vaccines, including rumors and third-party
information. The Judicial Watch analysis includes a report about a doctor
who at a conference heard about two patients dying after receiving
Gardasil. Another incident involved the death of a 17-year-old girl
immediately after receiving the vaccine, which was reported to FDA by "a
gynecologist who was informed of the case from another gynecologist. "
Reaction
Tom Fitton, president of Judicial Watch, said that if Gardasil is "as
dangerous as it seems to be, it does not seem to be good public health
policy." Kelley Dougherty, a spokesperson for Merck, said that it is
impossible to determine whether the reports are actual fatalities related
to the vaccine or rumors. The FDA only documents deaths that are reported
but the agency does not show cause and effect, according to CQ HealthBeat.
"There are no reporters that have a correlative effect," Dougherty said.
Allen said that Judicial Watch "is playing loose" with data on the vaccine.
Fitton defended the group's analysis and added that it has filed a lawsuit
against FDA to require the agency to provide more information about the
vaccine. "The reports are what they are," Fitton said, adding, "The CDC can
explain them away, and Merck can explain them away. I don't think it's just
randomness" (CQ HealthBeat, 10/4).
The analysis is available online.
Bloomberg/Austin American-Statesman Examines Sales of Gardasil
In related news, Bloomberg/Austin American-Statesman on Friday examined how
Gardasil "could become the best-selling vaccine in history" as Merck
"prepares to expand its use to men." According to
Bloomberg/American- Statesman, Merck has made $1.4 billion in Gardasil sales
in the drug's first year on the market. Merck is conducting studies to
prove that Gardasil can prevent HPV infection in men. If the vaccine were
approved for use in boys and men, annual sales of the vaccine could be as
high as $10 billion, according to Lisa Kelly, an analyst at Wood Mackenzie
Consultants (Cullen, Bloomberg/Austin American-Statesman, 10/5).
Reprinted with kind permission from http://www.kaiserne twork.org. You can
view the entire Kaiser Daily Health Policy Report, search the archives, or
sign up for email delivery at
http://www.kaiserne twork.org/ dailyreports/ healthpolicy. The Kaiser Daily
Health Policy Report is published for kaisernetwork. org, a free service of
The Henry J. Kaiser Family Foundation 2005 Advisory Board Company and
Kaiser Family Foundation. All rights reserved.
Article URL: http://www.medicaln ewstoday. com/articles/ 84804.php
Main News Category: Cervical Cancer / HPV Vaccine
Also Appears In: Women's Health / Gynecology,
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