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Long article, however since much of what we read and are interested in for
news/health issues, I do feel it is important to share this.
news/health issues, I do feel it is important to share this.
Ana
Research for Sale
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
https://articles.mercola.com/sites/articles/archive/2000/05/21/research-for-sale.aspx
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 gain say 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.
https://articles.mercola.com/sites/articles/archive/2000/05/21/research-for-sale.aspx