Tschuess

I apologize for the wholesale pasting, but thought a number of you might be interested in the content, especially those who do not have access to the NY Times.

July 27, 2004
COMMENTARY
How Tightly Do Ties Between Doctor and Drug Company Bind?
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 ble
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."