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Research
for Sale
http://mercola.com/2000/may/21/research_for_sale.htm
The latest issue of the
esteemed New England Journal of Medicine (NEJM) contains an
editorial written by the fired editor which discusses 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.
The ties between clinical
researchers and industry include not only grant support, but
also a host of other financial arrangements. These include
researchers who serve as consultants, join advisory boards,
enter into patent and royalty agreements, promote drugs and
devices at company-sponsered symposium, and accept expensive
gifts and trips.
Although most medical
schools have financial guidelines, the rules are generally
relaxed not very strict, and are likely to become even more
so" she says. And it is not just individual researchers
who are being affected. Even academic institutions themselves
are becoming increasingly beholden to industry.
One of the excuses often
given for the close ties are that they are necessary to get
new drugs and devices from the laboratory to the marketplace.
However, the author largely disputes this assertion. Although
outright financial grants might, if properly done, have this
effect, she cites the fact that much of the financial rewards
and incentives are given to individuals rather than the
institutions. Companies may hire a researcher as a paid
consultant to obtain his goodwill, rather than to use his
expertise.
A separate report in the
same issue of the NEJM makes the case that there is now
considerable evidence that researchers with financial ties are
more likely to report favorable results than those without
such ties. Although this does not mean that they are
necessarily being "bought" or bribed, the financial
ties, along with a close relationship with a company, can have
subtle influences on scientific judgement, that are not
apparent.
Another issue brought up by
Dr. Angnell is the problem of conflict of commitment, meaning
that faculty who engage in extensive work for industry may not
have the time to devote to their students or to their schools
educational effort.
The
New England Journal of Medicine May 18, 2000; 342
DR.
MERCOLA'S COMMENT:
Corruption has run wild
in medicine. This is an EXCELLENT article by Dr. Angell and it
appears one week after the Journal's publisher, the
Massachusetts Medical Society, announced it would replace her
as editor with a prominent asthma researcher who has strong
ties to the drug industry. I am really surprised that they let
her publish it. Her replacment will be far more traditional.
The corruption and greed in medicine is out of control.
Progress has only made
this worse. Dot.com billionaires and technology offers the
promise of millions of dollars to researchers just for the
taking. This will be a serious problem with the genetic
engineering storms that will be shortly unleashed as a result
of the human genome project. This article is so good that I am
posting the entire article:
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
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.
References
1. Relman AS. Dealing with conflicts of interest. N Engl J
Med 1984;310:1182-3.
2. Keller MB, McCullough JP, Klein DN, et al. A comparison
of nefazodone, the cognitive behavioral-analysis system of
psychotherapy, and their combination for the treatment of
chronic depression. N Engl J Med 2000;342:1462-70.
3. Relman AS. New "Information for Authors" --
and readers. N Engl J Med 1990;323:56.
4. Scott J. Treatment of chronic depression. N Engl J Med
2000;342:1518-20.
5. Bodenheimer T. Uneasy alliance -- clinical investigators
and the pharmaceutical industry. N Engl J Med
2000;342:1539-44.
6. Faculty policies on integrity in science. Cambridge,
Mass.: Harvard University, February 1996.
7. Abel D. Harvard mulls easing rules on research. Boston
Globe. February 10, 2000:A1.
8. University and Small Business Patent Procedures Act of
1980.
9. Rothman DJ. Medical professionalism -- focusing on the
real issues. N Engl J Med 2000;342:1284-6.
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