BIAS AND CONFLICTS OF INTEREST IN ADDICTION RESEARCH
As recently discussed in an editorial in the New England Journal of Medicine and reiterated in an interview on NPR’s Weekend All Things Considered (listen to the interview with "real player" at the link on the web page called "special links to important web sites" on the left border pages menu), Marcia Angell, editor-in-chief of the journal, discusses how business interests (drug companies, and treatment industries such as device manufacturers) influence medical research. I include her editorial below. One issue she inadvertently left out of this discussion is the conflict of interest in research of various forms of "therapy" used in so-called psychological and psychiatric entities. This form of conflict of interest is not perceived as biased by medical industry because it is done by thousands of individual treatment "professionals." Nonetheless, this group of individual therapists is an enormous industry desiring research rationale for their jobs and "treatments." Researchers for this group of therapists and rehab hospitals are under the same financial influences as researchers for drug and medical device companies. The same conflict of interest rules Dr. Angell calls for in the case of The New England Journal should be seen as relevant to this industry as well, including their journals, where peer review is deeply suspect. Of course, these rules don't apply to them to the detriment of all addicts who are often coerced into these bogus treatments by the beneficiaries of those treatments, so-called "treatment providers."
Listen to the interview as Dr. Angell mentions the emphasis on drug treatments instead of research into cause of disease as well as non-drug treatments. Read the editorial (below) and then explore on your own the conflicts of interest involving practically all addiction research being done and published in our country today. See who’s supporting the National Council on Alcoholism and Drug Dependence (NCADD), the Long Island Council on Alcoholism (or other local councils), the only existing watch dogs addicts have to protect them from research and treatment bias. These groups are more concerned with their funding than with the addictions and addicts they profess to support. For example, when I recently called the NCADD, one of the routing extensions went directly to the American Society of Addiction Medicine.
Moreover, the U.S. government, clearly biased by its own addiction paradigm and need to control addictions, funds 85% of the country's drug addiction research according to Alan Leshner, head of NIH's National Institute on Drugs and Alcoholism. Much of this funding is aimed at finding drugs and programs to control addicts rather than to help them. Additionally, various massive health oriented foundations are funding research that promote their personal views on addictions. These entities buy scientists and research companies to do their specified research. The researcher's and business's financial well being is determined by their producing the required results. You tell me that there's no conflict of interest here. Peer review is additionally done by biased "experts" involved in the same conflicts of interest and lucrative treatment modalities, not hardly disinterested scientists!
Lastly, media outlets such as newspapers, TV news and magazine shows, magazines for public consumption, and publishing houses concoct programs and publish books and stories according to their biases and conflicts of interest. Two good examples of this were the shows by 20/20 on alcoholism and PBS's Bill Moyers special on addictions, both biased and way off base, yet highly influential to public opinion.
Conflict of interest is one of our major problems.
IS ACADEMIC MEDICINE FOR SALE?
In 1984 the Journal became the first of the major medical journals to require authors of original research articles to
disclose any financial ties with companies that make products discussed in papers submitted to us. (1) We were
aware that such ties were becoming fairly common, and we thought it reasonable to disclose them to readers.
Although we came to this issue early, no one could have foreseen at the time just how ubiquitous and manifold
such financial associations would become. The article by Keller et al. (2) in this issue of the Journal provides a
striking example. The authors' ties with companies that make antidepressant drugs were so extensive that it would
have used too much space to disclose them fully in the Journal. We decided merely to summarize them and to
provide the details on our Web site.
Finding an editorialist to write about the article presented another problem. Our conflict-of-interest policy for
editorialists, established in 1990, (3) is stricter than that for authors of original research papers. Since editorialists
do not provide data, but instead selectively review the literature and offer their judgments, we require that they
have no important financial ties to companies that make products related to the issues they discuss. We do not
believe disclosure is enough to deal with the problem of possible bias. This policy is analogous to the requirement
that judges recuse themselves from hearing cases if they have financial ties to a litigant. Just as a judge's disclosure
would not be sufficiently reassuring to the other side in a court case, so we believe that a policy of caveat emptor is
not enough for readers who depend on the opinion of editorialists.
But as we spoke with research psychiatrists about writing an editorial on the treatment of depression, we found
very few who did not have financial ties to drug companies that make antidepressants. (Fortunately, Dr. Jan Scott,
who is eminently qualified to write the editorial, (4) met our standards with respect to conflicts of interest.) The
problem is by no means unique to psychiatry. We routinely encounter similar difficulties in finding editorialists in
other specialties, particularly those that involve the heavy use of expensive drugs and devices.
In this editorial, I wish to discuss the extent to which academic medicine has become intertwined with the
pharmaceutical and biotechnology industries, and the benefits and risks of this state of affairs. Bodenheimer, in his
Health Policy Report elsewhere in this issue of the Journal, (5) provides a detailed view of an overlapping issue --
the relations between clinical investigators and the pharmaceutical industry.
The ties between clinical researchers and industry include not only grant support, but also a host of other financial
arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory
boards and speakers' bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles
ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow
themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the
Although most medical schools have guidelines to regulate financial ties between their faculty members and
industry, the rules are generally quite relaxed and are likely to become even more so. For some years, Harvard
Medical School prided itself on having unusually strict guidelines. For example, Harvard has prohibited researchers
from having more than $20,000 worth of stock in companies whose products they are studying. (6) But now the
medical school is in the process of softening its guidelines. Those reviewing the Harvard policy claim that the
guidelines need to be modified to prevent the loss of star faculty members to other schools. The executive dean for
academic programs was reported to say, "I'm not sure what will come of the proposal. But the impetus is to make
sure our faculty has reasonable opportunities." (7)
Academic medical institutions are themselves growing increasingly beholden to industry. How can they justify
rigorous conflict-of-interest policies for individual researchers when their own ties are so extensive? Some
academic institutions have entered into partnerships with drug companies to set up research centers and teaching
programs in which students and faculty members essentially carry out industry research. Both sides see great
benefit in this arrangement. For financially struggling medical centers, it means cash. For the companies that make
the drugs and devices, it means access to research talent, as well as affiliation with a prestigious "brand." The
time-honored custom of drug companies' gaining entry into teaching hospitals by bestowing small gifts on house
officers has reached new levels of munificence. Trainees now receive free meals and other substantial favors from
drug companies virtually daily, and they are often invited to opulent dinners and other quasi-social events to hear
lectures on various medical topics. All of this is done with the acquiescence of the teaching hospitals.
What is the justification for this large-scale breaching of the boundaries between academic medicine and for-profit
industry? Two reasons are usually offered, one emphasized more than the other. The first is that ties to industry are
necessary to facilitate technology transfer -- that is, the movement of new drugs and devices from the laboratory to
the marketplace. The term "technology transfer" entered the lexicon in 1980, with the passage of federal legislation,
called the Bayh-Dole Act, (8) that encouraged academic institutions supported by federal grants to patent and
license new products developed by their faculty members and to share royalties with the researchers. The
Bayh-Dole Act is now frequently invoked to justify the ubiquitous ties between academia and industry. It is argued
that the more contacts there are between academia and industry, the better it is for clinical medicine; the fact that
money changes hands is considered merely the way of the world.
A second rationale, less often invoked explicitly, is simply that academic medical centers need the money. Many of
the most prestigious institutions in the country are bleeding red ink as a result of the reductions in Medicare
reimbursements contained in the 1997 Balanced Budget Act and the hard bargaining of other third-party payers to
keep hospital costs down. Deals with drug companies can help make up for the shortfall, so that academic medical
centers can continue to carry out their crucial missions of education, research, and the provision of clinical care for
the sickest and neediest. Under the circumstances, it is not surprising that institutions feel justified in accepting help
from any source.
I believe the claim that extensive ties between academic researchers and industry are necessary for technology
transfer is greatly exaggerated, particularly with regard to clinical research. There may be some merit to the claim
for basic research, but in most clinical research, including clinical trials, the "technology" is essentially already
developed. Researchers are simply testing it. Furthermore, whether financial arrangements facilitate technology
transfer depends crucially on what those arrangements are. Certainly grant support is constructive, if administered
properly. But it is highly doubtful whether many of the other financial arrangements facilitate technology transfer or
confer any other social benefit. For example, there is no conceivable social benefit in researchers' having equity
interest in companies whose products they are studying. Traveling around the world to appear at
industry-sponsored symposiums has much more to do with marketing than with technology transfer. Consulting
arrangements may be more likely to further the development of useful products, but even this is arguable. Industry
may ask clinical researchers to become consultants more to obtain their goodwill than to benefit from their
expertise. The goodwill of academic researchers is a very valuable commodity for drug and device manufacturers.
Finally, it is by no means necessary for technology transfer that researchers be personally rewarded. One could
imagine a different system for accomplishing the same purpose. For example, income from consulting might go to a
pool earmarked to support research or any other mission of the medical center.
What is wrong with the current situation? Why shouldn't clinical researchers have close ties to industry? One
obvious concern is that these ties will bias research, both the kind of work that is done and the way it is reported.
Researchers might undertake studies on the basis of whether they can get industry funding, not whether the studies
are scientifically important. That would mean more research on drugs and devices and less designed to gain
insights into the causes and mechanisms of disease. It would also skew research toward finding trivial differences
between drugs, because those differences can be exploited for marketing. Of even greater concern is the
possibility that financial ties may influence the outcome of research studies.
As summarized by Bodenheimer, (5) there is now considerable evidence that researchers with ties to drug
companies are indeed more likely to report results that are favorable to the products of those companies than
researchers without such ties. That does not conclusively prove that researchers are influenced by their financial
ties to industry. Conceivably, drug companies seek out researchers who happen to be getting positive results. But I
believe bias is the most likely explanation, and in either case, it is clear that the more enthusiastic researchers are,
the more assured they can be of industry funding.
Many researchers profess that they are outraged by the very notion that their financial ties to industry could affect
their work. They insist that, as scientists, they can remain objective, no matter what the blandishments. In short,
they cannot be bought. What is at issue is not whether researchers can be "bought," in the sense of a quid pro quo.
It is that close and remunerative collaboration with a company naturally creates goodwill on the part of researchers
and the hope that the largesse will continue. This attitude can subtly influence scientific judgment in ways that may
be difficult to discern. Can we really believe that clinical researchers are more immune to self-interest than other
When the boundaries between industry and academic medicine become as blurred as they now are, the business
goals of industry influence the mission of the medical schools in multiple ways. In terms of education, medical
students and house officers, under the constant tutelage of industry representatives, learn to rely on drugs and
devices more than they probably should. As the critics of medicine so often charge, young physicians learn that for
every problem, there is a pill (and a drug company representative to explain it). They also become accustomed to
receiving gifts and favors from an industry that uses these courtesies to influence their continuing education. The
academic medical centers, in allowing themselves to become research outposts for industry, contribute to the
overemphasis on drugs and devices. Finally, there is the issue of conflicts of commitment. Faculty members who
do extensive work for industry may be distracted from their commitment to the school's educational mission.
All of this is not to gainsay the importance of the spectacular advances in therapy and diagnosis made possible by
new drugs and devices. Nor is it to deny the value of cooperation between academia and industry. But that
cooperation should be at arm's length, with both sides maintaining their own standards and ethical norms. The
incentives of the marketplace should not become woven into the fabric of academic medicine. We need to
remember that for-profit businesses are pledged to increase the value of their investors' stock. That is a very
different goal from the mission of medical schools.
What needs to be done -- or undone? Softening its conflict-of-interest guidelines is exactly the wrong thing for
Harvard Medical School to do. Instead, it should seek to encourage other institutions to adopt stronger ones. If
there were general agreement among the major medical schools on uniform and rigorous rules, the concern about
losing faculty to more lax schools -- and the consequent race to the bottom -- would end. Certain financial ties
should be prohibited altogether, including equity interest and many of the writing and speaking arrangements. Rules
regarding conflicts of commitment should also be enforced. It is difficult to believe that full-time faculty members
can generate outside income greater than their salaries without shortchanging their institutions and students.
As Rothman urges, teaching hospitals should forbid drug-company representatives from coming into the hospital to
promote their wares and offer gifts to students and house officers. (9) House officers should buy their own pizza,
and hospitals should pay them enough to do so. To the argument that these gifts are too inconsequential to
constitute bribes, the answer is that the drug companies are not engaging in charity. These gifts are intended to buy
the goodwill of young physicians with long prescribing lives ahead of them. Similarly, academic medical centers
should be wary of partnerships in which they make available their precious resources of talent and prestige to carry
out research that serves primarily the interests of the companies. That is ultimately a Faustian bargain.
It is well to remember that the costs of the industry-sponsored trips, meals, gifts, conferences, and symposiums
and the honorariums, consulting fees, and research grants are simply added to the prices of drugs and devices. The
Clinton administration and Congress are now grappling with the serious problem of escalating drug prices in this
country. In these difficult times, academic medicine depends more than ever on the public's trust and goodwill. If
the public begins to perceive academic medical institutions and clinical researchers as gaining inappropriately from
cozy relations with industry -- relations that create conflicts of interest and contribute to rising drug prices -- there
will be little sympathy for their difficulties. Academic institutions and their clinical faculty members must take care
not to be open to the charge that they are for sale.
Marcia Angell, M.D.