New England Journal of Medicine 5/18/00

[Guest guest]

List:

Does anyone think that conventional medicine can clean its own house?

Allopathic medicine has almost become synonymous with moral turpitude. Lets

watch this play out. I can tell you right now what will happen -- the same

thing that happened when limits were placed on campaign contributions. The

money got " soft " . More money than ever changed hands, the " right people "

aways got the benefit of big money, but their hands were clean and there was

no clear paper trail. Few people are more creative than conventional

physicians when it comes to creating situations that require honoraria,

stipends, junkets, foundations, and grants. When they launder it through a

501C3 they don't even have to pay taxes.

I was really disappointed when posted his death-warrant statistic

in quotes as if it were official. When attribution was requested, he admits

that it was " hypothetical " and lamely tries to go on the offensive. ,

please don't post any statistics unless you are willing to provide a source,

state who paid for the research, list all the affilitations of the

researchers and statisticians, and lastly be able and willing to provide the

raw, uncoded records.

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The New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No. 20

Is Academic Medicine for Sale?

by Marcia Angell, M.D.

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 , 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.

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. 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.