- Oh, what a tangled web! Now that Congress is sifting
through the issues surrounding vaccine safety, the politicians might want
to determine whether the vaccine policy experts they and the government
health bureaucracy rely on are too one-dimensional in their thinking, and,
in some cases, much too close to industry for comfort.
- Lately, there has been a swell of complaints from groups
and individuals about vaccine side effects and the lack of long-term scientific
studies and safety data on vaccines. And, at a time when there are about
200 vaccines in the pipeline, concern is mounting that high-profile vaccine
advocates and the lobbies they represent have an inordinate influence on
the setting of government vaccine policy.
- These days, it's obvious to everyone except Rip Van Winkle
that the pharmaceutical industry funds a wide range of medical ventures
- everything from symposia to scientific studies to hospital research institutes.
So it's common that physicians who are "players" will have some
form of relationship with industry. For my taste, this union has gotten
way out of whack, but for the sake of argument, let's regard it as the
standard medical bedrock of our times.
- Planetary Alignment Problem
- These ties that bind must be looked at more closely,
however, when the players are on committees established to help government
set health policy. In the vaccine arena, two of the key groups offering
recommendations are the Advisory Committee on Immunization Practices (ACIP),
overseen by the U.S. Centers for Disease Control and Prevention, and the
so-called Red Book Committee of the American Academy of Pediatrics. (The
FDA, which evaluates the safety and efficacy of vaccines, has its own scientific
- Medical advisory committees usually have mechanisms to
disqualify members from voting on a product when they have a potential
conflict of interest. Let's allow that these mechanisms work for specific
vaccine evaluation. Those working on a vaccine bow out when that vaccine
is up for discussion and vote. So everything is just fine, right?
- Does the Earth spin around Jupiter?
- Dr. Samuel Katz of Duke University
has made a great contribution to vaccination efforts and the development
of new vaccines. This week, I asked him whether he is so much an advocate
for vaccines (for example, hepatitis B) that he can any longer see the
forest for the trees when it comes to safety issues.
- Loyal, But Objective?
- Katz has served as chair of both the ACIP and the Red
Book committees. He co-chairs a group called the Vaccine Initiative, which
is an information and advocacy group that benefited from start-up funds
from at least six vaccine manufacturers. He is listed as an advisory board
member to the Immunization Action Coalition (which includes the Coalition
for Hepatitis B), an advocacy group that receives funding from several
vaccine makers, including SmithKline Beecham, Merck and Wyeth-Lederle.
- Katz, soft-spoken and friendly, said
he is sensitive to the issue of the appearance of conflict of interest
and that he is determined to be objective when it comes to his involvement
with any vaccine recommendations. Katz feels strongly that his colleagues
take the same cautious approach when it comes to vaccines. He also allows
that "there is much we don't know about vaccines, and a lot of research
must be done."
- Here is a brief take from Katz's presentation on May
18 to a congressional committee looking into vaccine safety:
- "As a parent, grandparent, and physician, I feel
great sympathy for the people who testified on the first panel. I wish
we could find the true causes for serious, complicated and often vexing
medical conditions such as multiple sclerosis and autism. But the fact
is, there are no scientifically sound studies that demonstrate current
immunization recommendations are a cause of autism, diabetes, asthma, inflammatory
bowel diseases, SIDS, multiple sclerosis or any number of acute or chronic
- I reminded Katz of this statement and the fact that not
having evidence for a link between vaccines and illness doesn't mean there
isn't a link; rather, in this case, it means not having enough research.
He answered that there is enough research to at least conclude that most
vaccines are not likely to be related to disease.
- Show Me the Data
- We didn't get a chance to get into the details of his
claim because he had a meeting. But since it's a claim that I reject as
mysterious, given the paucity of appropriate science on the potential link
between vaccines to disease, I am issuing Katz the following challenge:
Send me abstracts of the molecular studies that you deem sufficient to
nullify concern about complex reactions to vaccines. In other words, show
me the compelling biological science upon which your views rest.
- I am issuing the same challenge to
Dr. Bruce Gellin, staff director for the Vaccine Initiative, which Katz
chairs, and whose aim is to "serve as a source of comprehensive information
on vaccination and vaccination-related issues for parents, health-care
professionals and the media." Scrutinizing the group's Web site, I
found strong advocacy for vaccines and not much else, although Gellin emphasized
on the phone that much needs to be learned about vaccines.
- In one item on the Vaccine Initiative Web site, I read
that Katz and his co-chairman, Dr. Louis Sullivan, formerly head of the
federal health department, are informing doctors that some issues are brewing
about vaccines. "These events can be opportunities to reinforce the
tremendous value of immunization to the individual and society while assuring
that safety concerns are being appropriately investigated and addressed,"
they write, pointing out that materials to convey this message to the media
are available from the Vaccine Initiative. How remarkably instructive.
- (Gellin informed me this week that his group no longer
accepts funding from manufacturers because money from a major foundation
made it unnecessary. "We always felt sensitive about our start-up
funding," he said. Gee, isn't that terrific, I thought.)
- Loose Ends
- One vaccine advocate I didn't reach this week - at his
office or by e-mail - is Dr. Neal Halsey of Johns Hopkins University. Like
Katz, he is a vaccine pioneer and served on ACIP and the Red Book committees.
He, too, is an advisor to the Immunization Action Coalition and the Hepatitis
B Coalition. Halsey is also director of the Institute for Vaccine Safety,
which he founded at Johns Hopkins to provide a forum on vaccine safety,
among other things. According to a Johns Hopkins' spokesperson, the institute
receives funds from Merck, SmithKline Beecham, North American Vaccines,
Connaught/Pasteur Merrieux and Wyeth-Lederle.
- Maybe when Halsey makes it back to his office, he can
also send me scientific abstracts that will nullify concerns about long-term
effects of vaccines on the immune system. Maybe his institute can investigate
why there is such poor data on the subject.
- What do I make of all this? I don't think it's very pretty.
The scene has more to do with politics than vaccine science. Unfortunately,
the quality of human life is at stake; somehow, we had better get beyond
- Nicholas Regush produces medical features for ABCNEWS.
In his weekly column, published Wednesdays, he looks at medical trouble
spots, heralds innovative achievements and analyzes health trends that
may greatly influence our lives. His latest book is The Breaking Point:
Understanding Your Potential for Violence
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