How Tightly Do Ties Between Doctor and Drug Company Bind?
By ABIGAIL ZUGER, M.D.
Published: July 27, 2004
Source: New York Times
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."