Money + Science = Ethics Problems on Campus.
(corporations supporting research brings up ethical issues)
The Nation, March 22, 1999 v268 i11 p11(1)
The third most dispensed drug in the United States is a thyroid
medication called Synthroid. Eight million Americans suffering from
hypothyroidism take Synthroid every day, paying a premium for Knoll
Pharmaceutical's top-selling brand name rather than buying the much
less expensive generic alternative. As is the case with most brand
leaders, Knoll's enormous success with Synthroid is entirely
dependent on its continuing ability to convince its users and the
healthcare community that its drug is worth the extra cost. This the
company has done brilliantly for decades, despite any real proof of
Synthroid's superiority.
In the late eighties, the company (then known as Boots
Pharmaceutical) had good reason to believe it was on the verge of
obtaining such proof. A clinical pharmacist at the University of
California, San Francisco, named Betty Dong published a limited
study that strongly suggested Synthroid would beat out its
competitors in a blind, randomized trial. The company approached
Dong, offering her the full $250,000 needed to pay for such a long
and complex study.
Alas, the study backfired on the company. To the surprise of nearly
everyone, including Dong, the results suggested that Synthroid was
no more or less effective than three much cheaper competitors. All
four were what scientists call "bioequivalent."
But the company had a trump card. As the study's sponsor, it had not
only been able to design the protocols of the drug trial; it also
had exclusive access to the prepublished results of the study as
well as final approval over whether the study could ever be made
public. Not surprisingly, with the results so threatening to its
marketing efforts, Knoll set out to thwart the study. In addition to
delaying its publication in a scientific journal by many years,
effectively destroying the relevance of its data, the company also
undermined the study's message by pre-emptively publishing the UCSF
data in a different journal with a different (much friendlier)
conclusion. Then Knoll waged a massive PR campaign against the real
study, "Bioequivalence of Generic and Brand-name Levothyroxine
Products in the Treatment of Hypothyroidism," by Betty J. Dong et
al., after it was finally published in the spring of 1997 in the
eminent Journal of the American Medical Association (JAMA).
A massive class-action lawsuit followed the publication of Dong's
JAMA report, alleging on behalf of all Synthroid users that Knoll
had defrauded them of hundreds of millions of dollars in inflated
costs. The company has offered to settle for a sum close to $100
million-which would be the largest cash settlement for a
class-action suit of its kind in history. And yet, even with such a
fantastic price to pay, one can only conclude that in the end Knoll
has benefited tremendously from its brash interference in the
academic research process: A hundred million is but a small fraction
of the profits the company made from Synthroid during the years it
was suppressing the study. And by its ability to taint Dong's study
with controversy over the years, Knoll was able to nullify any
would-be effect. "Sales continue to grow very rapidly," Carter
Eckert, Knoll's president, told me when I visited him at the
company's rural New Jersey headquarters. "Our position has been
Betty Dong's case, while extraordinary, is not isolated. In Toronto,
liver specialist Nancy Olivieri was threatened with legal action by
the Canadian drug giant Apotex if she published criticisms of its
drug L1, concerns that had emerged from a clinical trial the company
was sponsoring. In Providence, Rhode Island, Brown University's
director of occupational medicine, David Kern, was pressured both by
a local company and by his own university not to publish his
findings about a new lung disease breaking out at the company's
plant (Kern did publish his data, and the disease Flock Worker's
Lung was officially recognized by the Centers for Disease Control in
September 1997). In Winston-Salem, North Carolina, hypertension
expert Curt Furberg and three colleagues resigned from a major
Sandoz-funded study of calcium channel blockers, a controversial
class of drugs purported to decrease the risk of heart attacks,
rather than cave in to company pressure to spin negative results in
a positive light. "I have seen people in industry asking for
stranger and stranger things in private funding, as far as control
is concerned," says Gregory Gardiner, Yale's senior director of the
Office of Cooperative Research. Indeed, these sensational cases may
well be only the visible tip of a broader crisis in academic
science. Over the past two decades, university-industry partnerships
have become a ubiquitous feature of biotech research, and with this
new closeness has come a raft of new concerns about whether the soul
of academic science is being slowly eaten away. "We need to be
vigilant," suggests Gardiner, "to make sure nothing is happening to
university science." ...
Full Text COPYRIGHT 1999 The Nation Company Inc.