Subject: New England Journal of Medicine Editorial (guru)..
Date: Thu, 18 May 2000 115505 -0500 (CDT)
From: "Roy L. Beavers"
To: emfguru
--------------------------------------------------
Folks:
I got it..... Don't send it to me!!!!
Courageous Editorial...... That's all I'm going to say.....
Mark that ladies name: Dr. Marcia Angell
Roy Beavers (EMFguru)
roy@emfguru.com
.....It is better to light a single candle than to curse the darkness.....
NEW!!! Website... http://emfguru.com
...................People are more important than profits.................
_________________________________________________________________
The New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No.
20
EDITORIAL
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. ([7]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. ([8]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, ([9]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, ([10]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, ([11]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. ([12]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." ([13]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, ([14]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, ([15]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. ([16]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.
_________________________________________________________________
Copyright © 2000 by the Massachusetts Medical Society. All rights
reserved.
Archive provided courtesy of WaveGuide, http://www.wave-guide.org
Reprinted with permission of Roy Beavers, http://www.emfguru.com