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Conflict of interest at Yale

Conflict of interest at Yale

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Posted by Lynn Shepler, MD, JD on February 06, 2000 at 15:33:09:

In Reply to: Latest Campaign posted by Cheryl on February 06, 2000 at 09:40:16:

I don't know if anyone saw the recent JAMA article authored by Yale physicians who are either directly employed by SmithKline Beecham (Elyse Seltzer, MD) or who have taken monies from SmithKline and/or Connaught (Dr. Shapiro) --- the companies manufacturing the Lyme vaccines. What is remarkable about the papers that have come out of Yale is the abject denial in these publications of seronegative Lyme disease, asymptomatic or subclinical Lyme disease, or Lyme that is unrecognized or undiagnosed by physicians due to the misinformation propogated by Lyme "experts," --- or, most, importantly, chronic and late stage Lyme disease that does not meet the CDC surveillance criteria.

Certainly, this denial of other facets of Lyme disease is in keeping with the interests of the pharmaceutical houses and those physicians with financial interests in diagnostic testing procedures. To acknowledge that there is Lyme disease that cannot be detected with the standard two-tier testing protocol would jeopardize the interests of the pharmaceutical houses --- how would you know whether you are vaccinating someone who is or is not infected? If researchers at SmithKline acknowledged that it's impossible to know whether they're vaccinating already-infected patients, it would be impossible to interpret their data! The trials would be uninterpretable. Nor would the FDA likely permit trials to go on where unknown numbers of patients are innoculated but may well be infected. So, best to sweep these "unknowns" under the rug and persecute/prosecute physicians who hold dissenting positions! Of note, the physicians being prosecuted/persecuted by the New York OPMC are physicians who, unlike the Lyme "experts," hold no financial interests related to the commercialization of this disease.

The commercial interests of Yale University itself in the success of the SmithKline vaccine is noted in the following article found at the Yale website. One begins to wonder about the scientific integrity of research done at Yale on questions of Lyme disease when there is so much commercial pressure to come up with certain types of results or dogma about the disease that serve the commercial interests held by the University. Is this science? Or is this a twisted version of the disease that keeps insurance companies and big pharma happy????

UNIVERSITY MAKING A KILLING OFF DRUG PATENT:
AIDS DRUG HAS PRODUCED MILLIONS OF DOLLARS FOR YALE'S COFFERS
Yale Daily News Online, April 7, 1997

By Erin White, YDN Staff Reporter

They tried lopping off departments. Didn't work. They tried axing
faculty in one fell swoop. Didn't work either.

Yale's financial officers have looked into just about everything to try
to cut Yale's once $18.5 million deficit. But as they struggle to
squeeze the last $4 million out of that deficit by next year, financial
officers are getting a little help from an unexpected source -- drugs.

Skyrocketing royalty profits from an AIDS drug invented by two Yale
scientists have almost single-handedly doubled Yale's patent revenues in
two years. The University's most conservative projections put royalty
revenue at $18 million next year, up from $5 million last year, and $12
million this year.

"In the world of technology transfer, Yale has what we call a winner,"
said Louis Berneman, managing director of the Center for Technology
Transfer at the University of Pennsylvania.

Yale is hoping Zerit, the AIDS drug being marketed by Bristol-Myers
Squibb, can mimic one of the patents game's most fabled winners:
Stanford and the University of California's Cohen-Boyer gene-splicing
patent, recombinant DNA technology credited with launching the
biotechnology industry.

Last year alone, Stanford's patents income topped $43 million, with $31
million coming from Cohen-Boyer royalties, Stanford officials said.

And in the patents game, Yale still has a few tricks up its sleeve.
Patents officers are placing their bets on the success of a new
Yale-invented lyme disease vaccine, whose approval before the Food and
Drug Administration is pending.

And other school's patent office directors say David Kessler, Yale's new
medical school dean and former commissioner of the FDA, could give Yale
an edge in navigating the FDA approval process.

Drug companies -- not Yale -- apply to the FDA to approve Yale-licensed
drugs.

But even before Yale licenses the drugs, the University maps out a
preliminary game plan to see what information it would need to give
companies lobbying the FDA for approval.

With insider knowledge of what the FDA is looking for, Kessler could
give Yale planners pointers on what information to give and how to give
it, said Office of Cooperative Research Director Gregory Gardiner, a
former Pfizer executive brought in to head Yale's patents operation.

Other schools' patents directors said Kessler's expertise could play an
even larger role, including advising licensee companies on regulatory
strategies.

But Kessler's intimate knowledge of the FDA could prove to be a
double-edged sword in the patents game.

Strict conflict-of-interest laws govern Kessler's interaction with his
former colleagues at the FDA, limiting his ability to go before the FDA
on Yale's behalf.

And suspicion from other universities may make Kessler even more
hesitant to throw his weight around than the law requires.

"Officially there would be no [string-pulling], but behind closed doors
you never know what goes on in Washington," said Floyd Grolly, a manager
in Stanford's patent office.

Acutely aware of conflict-of-interest suspicions -- rather than letting
an assistant list Kessler's legal restrictions -- Kessler preferred to
address the issue himself in a telephone interview Thursday.

"I will be very circumspect ... I just want to be extremely careful,
even more strict than what the law requires," he said.

Copyright 1997, The Yale Daily News



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