The New England Journal of Medicine
May 18, 2000 — Vol. 342, No. 20
Is Academic Medicine for Sale?
by Marcia Angell, M.D., editor,
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
companies.
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 people?
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.
