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WASHINGTON -- When drugs consumed to lose weight or enhance sex create patient
complications, federal regulators and drug companies act fast -- pulling the
products from shelves in the wake of warning news reports. But when the drugs
are childhood vaccines and the results encompass death or permanent disability,
little happens. There is no urgency among regulators and few headlines.
Some critics think one reason is an interaction between the
federal government and huge pharmaceutical firms that at times resembles a huge
public policy machine -- an engine so imbued with good intentions, the
protection of children from disease, that any end justifies the means. That any
publicity about immunization reactions is intolerable because it will reduce the
efficiency of the effort.
Peter Meyers, an attorney who runs a George Washington
University clinic on vaccines for aspiring lawyers, said, ``It is certainly
clear to me that all of these public health officials involved in the vaccine
industry -- bureaucrats and pediatricians -- have an institutional interest not
to let scare stories out because they persuade people not to get vaccinated.''
Members of the vaccine hierarchy, Meyers said, ``are not fair
and unbiased -- they are tilted to denying deaths because it is in their
institutional interest.'' As a new century approaches, federal health officials
and vaccine makers face a lot of promise and a lot of problems, including how to
wedge about two-dozen new vaccines into an already crowded schedule for infants
and toddlers.
``We're going to take an already cumbersome schedule and add
more individual vaccines,'' wrote Johns Hopkins University international health
professor Dr. Phillip Russell recently. ``It will inevitably result in a
detriment to the public's ability to be immunized.'' The Johns Hopkins professor
asked some pointed questions: ``Why are we still using 1950s technology? Why do
we not have combination vaccines we need and should have? Why haven't we been
able to use the tremendous power and potential of the biotechnology industry and
industrial research to produce new vaccines?''
The answers, he asserts, ``are partly economic, partly
regulatory, partly societal, and in this country, partly governmental
incompetence. This complex situation is going to get much worse before it gets
better.'' Reflective of government problems with vaccines is a congressionally
ordered database that's supposed to record vaccine reactions. It's called VAERS
for Vaccine Adverse Event Reporting System.
An analysis of the VAERS database, received by Gannett News
Service through a Freedom of Information Act request shows: -- One-third of the
nearly 80,000 reports filed between 1990 and 1997 involved the DTP vaccine, a
childhood vaccine for diptheria, tetanus and pertussis, or whooping cough. A
total of 876 deaths were recorded after children received the DTP vaccine, a
vaccine that is still on the market although a safer alternative exists. Of
those, 291, or 33 percent of the deaths reported after a DTP shot, were within
24 hours of the vaccination.
Some batches or ``lots'' of DTP are associated with more
reactions and deaths than others. Some batches triggered as many as 227 reports
of ``serious'' reactions and four lots of DTP received reports of 10 or more
deaths. The FDA calls these trends a ``coincidence.''
The stunning fact: No such reactive lot -- called ``hot lots''
by parents and their lawyers -- has ever been pulled off the market by the FDA.
The FDA leaves it to the drug firms to pull a lot on a voluntary basis.
Another revelation: The lot sizes of vaccines vary widely, but
are said under federal regulatory language to be ``proprietary'' or confidential
information between the FDA and the pharmaceutical companies under the Federal
Trade Secrets Act. Without this information, it is impossible to calculate a
true reaction rate using the VAERS data. The FDA says only that lot sizes can
vary from 20,000 to 700,000 doses, according to VAERS literature.
``VAERS is the front line of vaccine safety surveillance,''
according to the two public health officials in charge of it: Susan Ellenberg,
the director of the FDA's Division of Biostatistics and Epidemiology, and Dr.
Robert T. Chen, chief of Vaccine Safety and Development for the CDC's National
immunization program, the two federal officials in charge of VAERS.
If that's true, the front line may be a weak barrier to ensure
that the 4 million American children who are vaccinated each year are receiving
the safest vaccines possible. Because VAERS is a ``passive'' database, meaning
no attempt is made to confirm or deny reports, it is virtually impossible to
prove that a vaccine actually caused a reaction.
What's more, 40 percent of the VAERS reports are first sent by
doctors and other vaccinators to the pharmaceutical companies, not the
government health agencies, according to Ellenberg. When asked if the FDA trusts
the vaccine-makers to honestly report, Ellenberg said she does.
``No pharmaceutical company is interested in keeping an unsafe
or deadly product on the shelves,'' she said. The FDA even denies the existence
of so-called ``hot lots.'' Some lots ``will receive more reports than others
simply due to chance,'' reads VAERS literature. Some scientists disagree. ``I
think there are hot lots, I really do,'' said Dr. John Menkes, head of the
Pediatric Neurology Department at Cedars Sinai Hospital in Los Angeles. ``Some
lots are more likely to produce neurological disorders than others.''
Not so, said Ellenberg. ``No lot has been found to be
unsafe,'' she said. ``We look at the number of deaths in a lot and have not
found anything that has ever led us to take action,'' said Marcel Salive, chief
of the FDA's epidemiology branch.
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