NYT article Ties Between Doctor and Drug Company

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How Tightly Do Ties Between Doctor and Drug Company Bind?

July 27, 2004
By ABIGAIL ZUGER, M.D.





My patient scanned the prescription I had handed her, then
idly glanced at the elegant ballpoint pen I had used to
sign it. The same drug brand name appeared on both.

She said nothing, but I knew just what she was thinking.


I had the same thoughts a few months before, listening to a
researcher at a medical conference present the results of a
new treatment combination for hepatitis C. The data were
unambiguous: The drugs were mediocre at best. Still, the
researcher methodically minimized the drugs' problems and
urged us all to begin prescribing them.

"I wonder whose pocket he's in," I muttered to myself.


Earlier this month, consumer groups raised exactly the same
issue when they questioned a federal panel's recommendation
that Americans at risk for heart disease sharply lower
their cholesterol levels. Most of the panel members had
financial ties to pharmaceutical companies that make
statins, powerful cholesterol-lowering drugs whose use will
soar with the new guidelines. Were the panelist's
recommendations truly impartial, or was their integrity
suspect? The consumer groups also criticized the press,
including this newspaper, for not explicitly addressing the
financial links. However, resolving these apparent
conflicts of interest is far from easy. It is becoming one
of the biggest medical challenges of the 21st century.
Sometimes drug company ties taint a doctor's or
researcher's judgment. Often though, they do not. How is it
all to be sorted out?

What Sinclair Lewis admiringly described 80 years ago as
"the cold, clear light" of medical science - a
single-minded impartial commitment to truth and human
welfare transcending all external influence - is becoming
hard to find. Instead, we often see only a refracted
spectrum of partisan interests that can be impossible to
reassemble into truth.

Is the nice pen I accept from a drug company an implicit
promise that I will prescribe the drug whose name is etched
on its barrel, or is it just a pen? Does the grant money a
researcher receives from a pharmaceutical company indicate
that the research will be subtly prejudiced, or is it just
money? And even when financial issues are not involved,
what about all the other less tangible factors that may
sway scientific judgments, from the philosophical
convictions of interest groups to individual researchers'
determination to enhance their own reputations?

These questions have escalated in our time, experts say,
because our society increasingly forces us to trust the
expertise of professionals who are strangers to us.

"We are now much more dependent on the judgment of others,
much less able to evaluate their judgment decision by
decision, and indeed generally know much less about those
individuals than we would have even 50 years ago," wrote
the philosopher Michael Davis in a 2001 book, "Conflict of
Interest in the Professions."

In medicine, the problem has been compounded by the
increasing public distrust of the pharmaceutical companies,
as controversy about drug pricing mounts. Meanwhile, the
fraction of biomedical research sponsored by the
pharmaceutical and other for-profit industries has soared,
rising to 62 percent in 2000 from 32 percent in 1980, as
government research support declines.

As medical research and business jostle ever closer,
medical journals are devoting quantities of editorial
commentary to the question of whether financial ties create
partisan research and, if so, what to do about it.

The problem appears real. One study, published in 1998,
examined dozens of articles about calcium-channel blockers,
a controversial family of blood pressure medications that
some doctors feel are dangerous for certain patients.
Authors who championed the drugs' safety proved far more
likely to have financial relationships with the
manufacturers than did the critics. A similar study linked
authorship of articles discounting the dangers of passive
smoking with financial ties to the tobacco industry.

Journals now usually ask researchers to enumerate all
relevant financial ties to the drugs, devices or tests they
study; these ties are then disclosed to readers in small
type underneath articles and commentaries.

Disclosing all competing interests has been widely hailed
as by far the best way to deal with the problem, but it is
an incomplete solution at best.

For one thing, some researchers, estimated at 5 percent to
10 percent in a recent study, whether by oversight or
design, simply fail to report their financial ties. While
some of these ties, like patent applications, are in the
public domain for any dogged consumerist to unearth,
others, like stock holdings, will remain invisible.

Even when research financing is fully reported, though,
industry support is not always a sign of suspect science.
Although some industry sponsors demand the right to vet
manuscripts before publication, many do not. Researchers
often have no way of supporting their studies without
industry money, and exercise impeccable honesty despite it.


"These funds go to university accounts, with nothing going
into my pocket," wrote one researcher, protesting the
implication that his drug company financing tainted his
data.

Further, divulging a researcher's financial support creates
a chicken/egg dilemma that is usually impossible for an
outsider to resolve. Is the researcher partial to a certain
drug because of a pharmaceutical grant? Or did the
researcher attract pharmaceutical support because of an
honest preexisting partiality to the drug? Or is the
researcher simply a legitimate world-class expert on the
drug or disease in question?

Then there is the problem of the research that never makes
it to publication at all. A study finding that a new drug
is no improvement over old ones is far less likely to be
accepted for publication than a study announcing a
breakthrough. Medicine may be shaped as much by what is
omitted from the medical literature as by what is included,
yet the public never sees the reject pile.

Finally, there are abundant conflicts of interest in
medicine that do not involve money. No disclosure policy
yet covers those. Consider the process of peer review, for
decades a sacrosanct ritual in which two or three
researchers weigh the suitability of another's work for
publication. More than one critic has pointed out that
reviewers may react favorably to research that supports
their own, and harshly to research that might undermine
their own academic reputation.

The same caveat applies to guidelines issued by
professional societies. Ask a radiologists' group how best
to screen people for colon cancer, and those doctors
suggest periodic barium enemas, a procedure performed by
radiologists. The gastroenterologists' association,
however, recommends periodic colonoscopy, a procedure
performed by gastroenterologists.

Data may also be adopted to support a moral stance. Some of
the loudest voices in the recent uproar over the dangers of
antidepressants in teenagers came from people in groups
philosophically opposed to all medication use for
psychiatric patients.

Experts hope that, in time, a policy of "transparency," in
which all such conflicting interests are exposed to public
view, will help to untangle them as well.

But these calls for transparency have yet to penetrate to
the individual doctor's office, still a black box where
conflicts of interest go virtually unchallenged. Studies
have shown that gifts from pharmaceutical companies, which
can include lavish trips and meals, often sway doctors'
prescribing habits. Some professional organizations gently
suggest that their members limit their acceptance of this
largesse to inexpensive trinkets, like pens, but more
draconian edicts have yet to be enacted.

Someday, though, perhaps transparency will be the rule in
the office too, and every doctor will greet new patients
with a mandatory set of suitable disclosures:

"I'm happy to meet you and must inform you that I hold lots
of stock in Pfizer and just bought some Bristol-Myers
Squibb. You should know that I am a registered Democrat and
attend no place of worship. My father had an idiosyncratic
near-fatal reaction to a common antibiotic and I've never
felt quite the same about that perfectly good drug ever
since. I have an aunt I adore who looks a bit like you, and
a cousin I never liked who favors the style of jeans you
are wearing today. A big payment on my son's college
tuition is coming due this Friday. I had an excellent lunch
today with a representative from Merck, am getting a
headache which your perfume is making much worse, and am
desperate to get out of here on time for a change. Now,
have a seat, and tell me what brings you in today."

http://www.nytimes.com/2004/07/27/healt ... 691a42cded

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QUOTE:
Pfizer slams dissident executive By Val Brickates Kennedy,
CBS.MarketWatch.com
Last Update: 3:44 PM ET Sept. 24, 2004

BOSTON (CBS.MW) -- Pharmaceutical giant Pfizer has issued a letter slamming
one of its senior executives for participating in a pro-drug importation rally
with a group of U.S. senators, claiming he is unqualified to comment on the
issue.

In a letter sent to Sen. Bryce Dorgan, D-ND, on Wednesday, Pfizer (PFE: news,
chart, profile) criticized one of its employees, Peter Rost, for
participating in news conferences on Capitol Hill promoting federal legislation that would
lift the long-standing ban on the importation of cheaper prescription drugs
from nations such as Canada.

"Dr. Rost has no qualifications to speak on importation, no responsibilities
in this area at Pfizer, no knowledge of the information and analysis Pfizer
has provided to the government on this issue, and no substantive grasp of how
importation may impact the safety of this nation's drug supply," Chuck Hardwick,
Pfizer's senior vice president for worldwide government and public affairs,
wrote in his letter dated Sept. 22.

"We believe he is doing a disservice to the American public and to those who
believe in informed debate by issuing a series of personal opinions and asides
that bear no resemblance to the facts regarding the risks of drug
importation," Hardwick added.

Rost, a Swedish physician, is a vice president of marketing for Pfizer. He
has said in various interviews that the pharmaceutical industry's lead argument
against drug imports -- that their safety cannot be effectively monitored --
is greatly exaggerated. He has maintained that he is speaking out as a private
individual, not as a representative of Pfizer.

The pharmaceutical industry has been strongly against drug imports, largely
because the bulk of its profits are made from the U.S. market, which has
virtually no price controls. The industry has argued that if U.S. profits are
slashed, it will not have the resources to finance expensive research and
development programs for new drugs.