-Caveat Lector-
Dave Hartley
http://www.Asheville-Computer.com
http://www.ioa.com/~davehart
(2-Sep-99 press release: http://aapsonline.org/aaps/press/nrburton.htm .)
Rotavirus Vaccine Withdrawal Prompts Doctors to
Ask for Congressional Investigation of Vaccine
Approval Process
CDC and FDA May Have Ignored or Concealed Data About
Life Threatening Side Effects to Infants
WASHINGTON - The Association of American Physicians and
Surgeons (AAPS) has asked Rep. Dan Burton to initiate a
congressional investigation of the process by which all vaccines are
tested, approved, and recommended as mandatory by the CDC. This
action was prompted by the recent withdrawal of the rotavirus
vaccine after it was revealed that between the vaccine s approval in
August of 1998 and this July, at least 15 infants suffered life
threatening intestinal obstructions (intussusception) after receiving
the vaccine.
But what may be even more alarming is the rate of intussusception in
the clinical trials that were the basis for the vaccine s approval. A
search of the records by AAPS reveals that it was thirty times the
expected rate. But neither physicians nor parents were warned for
watch for symptoms of intussusception. Eight infants have needed
surgery, and one lost 7 inches of bowel.
In an 8/31/99 letter to Rep. Burton, chairman of the Committee on
Government Reform and Oversight, Jane M. Orient, MD, Executive
Director of AAPS, writes:
The situation with the rotavirus vaccine may be a clue to a far
more serious problem with the vaccine approval process. The
Surgeon General and CDC claim the vaccine s withdrawal
prompted by the VAERS [Vaccine Adverse Effect Reporting
System] reports received through July 1999.
But why was the vaccine approved in the first place when the
incidence of the serious complication of intussusception was
far higher in prelicensure trials than in the VAERS reports?
We must ask, what did they know and when they know it?
AAPS has been studying the reports and has concluded that
the FDA and CDC may have ignored or concealed data that
showed the problems from the outset.
Despite this evidence of potential problems, information from the
CDC web site, dated 3/23/99 reads: In studies that have been done
so far, rotavirus has been associated only with mild problems.
As increasing numbers of vaccines are being mandated, one has to
inquire whether the rotavirus story is the tip of the iceberg, said Dr.
Orient. Just how rigorous is the process of safety testing? What are
the guarantees of the integrity of the process? We believe the
process may be tainted by conflicts of interest.
The letter also calls for public disclosure of the approval process and
independent review of data, and supports a provision introduced by
Sen. Shelby that would require public access to all federally funded
research:
The tragedy of the rotavirus vaccine might never have
happened if the public had access to the data used by the FDA
and CDC in recommending the vaccine. The Shelby
Amendment, if properly implemented, would ensure that
federally financed research about vaccines could not be
withheld from the public.
...Sunshine is a disinfectant, and public access to such data
minimizes the opportunity for corruption, mistakes, and fraud
concerning such data.
Decisions about vaccines given to children should be made by
parents in consultation with the child's attending physician, not
mandated by a small group of experts with minimal accountability,
said Dr. Orient. While vaccines have been a very effective weapon
against certain infectious diseases, this is no reason to relax safety
standards or to override informed consent.
CONTACT: Kathryn Serkes (202) 333-3855
Note: Letter to Rep. Burton and data on rotavirus vaccine trials and
adverse effect rates are posted at www.aapsonline.org.
###
-- Jeff --http://www.wellnow.com
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Well Now Health Information Service
Box 15524 Atlanta Georgia [30333]
eFax: (419) 793-3043
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