Financial connections between members of the profession and professional organizations and the pharmaceutical,
device, and biotechnology industries are increasingly common and can lead to biased medical decision making, higher costs of
care, and decline in the public’s trust of the profession. To preserve its reputation and its autonomy over medical decisions,
the profession must begin to police itself. (J Pediatr 2006;149:S43-S6) I believe that the medical profession has become excessively dependent on the largesse of the pharmaceutical industry, and
that the financial connections between doctors and industry are having a negative influence on the quality and cost of patient
care and the trust of the public. The involvement affects educational ventures, reference materials for the profession and the
public, clinical practice guidelines, day-to-day medical practice, and nearly all other aspects of medical care and research. In my
view, the profession’s response to these threats has been inadequate. American doctors train for many years, and many go into massive debt to become physicians. They then work long hours
and struggle in a complex health care delivery system to reduce the burden of illness. There is no other country where I would
prefer to get care for my family or myself. Our physicians, hospitals, medical centers, and medical professional organizations are
respected around the world. But doctors are human, and like the rest of us they respond to financial incentives. What follows
are selected examples in which financial incentives generated for physicians by the pharmaceutical, biotechnology, and medical
device industries have led to questionable practices and outcomes. They are part of a vast involvement between physicians and
industry.1 Anyone who watches the pharmaceutical ads on television is likely to conclude that the drug industry is spending most
of its promotional money to get them to ask their doctors whether Cialis or Nexium is right for them, but in fact, more than
80% of the $24 billion yearly advertising expenses of the industry for free samples, journal ads, and direct-to-consumer
advertisements is directed at doctors and other health care professionals. Doctors are bombarded with drug ads, drug salesmen,
pamphlets, and brochures. They are seduced (many say bribed) by free gifts, free entertainment, free education, and free meals.
There is nothing fundamentally wrong with advertising products, but when financial incentives yield inappropriate or dangerous
care, when they inordinately raise the cost of care, and when their effect is to damage the trust of patients in
the profession, they have gone too far. It is too easy to lay the blame on the companies, (though there is plenty of blame to go around). By themselves, the
companies are powerless, but they have willing accomplices, namely thousands of physicians in academic medical centers and in
private practice. We need not delve into ancient history to find striking examples in which questionable or flawed medical
decisions have been attributed to financial incentives from industry. In the spring of 2005, for example, we learned that a US
Food and Drug Administration (FDA) panel recommended by a narrow margin that Vioxx be allowed to return to the market
despite its recognized cardiovascular toxicity. The 10-panel members who had financial
arrangements with industry voted 9:1 to bring the drug back; panel members with no such
arrangements voted 12:8 against. If none of the conflicted members had voted, the drug’s
return would have been rejected by the panel.2 Recently, state Medicare managers became alarmed about the burgeoning use of From Tufts University School of Medicine,
Natrecor, a drug estimated to reach sales of almost $700 million this year. The drug was Boston, Massachusetts.
This article is based on testimony delivered approved by the FDA for hospitalized patients with acute episodes of heart failure, but it to the House of Representatives Ways and
Means Committee (Subcommittee onis widely being given by infusion, routinely and repeatedly, in many doctors’ offices
Health) on July 21, 2005. instead.3 The financial incentive for routine office use is a payment from Medicare of $500 Reprint requests: Dr Jerome P. Kassirer,
to $600 for each visit. Heart failure is a common condition, and infusing only one patient Tufts University School of Medicine, 136
Harrison Avenue, Boston, MA 02111.a day could yield $150,000 a year to a physician’s bottom line.
The experience with this drug provides an opportunity to explore physician moti-0022-3476/$ -see front matter
Copyright © 2006 Elsevier Inc. All rights
reserved.vation. According to expert cardiologists, routine use of Natrecor has limited (if any) benefits, and there is increasing
evidence that the drug damages the kidneys and may even
increase the death rate. Despite this information, many physicians continue to prescribe the drug. One possible conclusion
is that the doctors who use the drug by routine infusion are motivated by greed. Perhaps some are, but this explanation
may be much too simplistic. Some physicians probably first use the drug on one or two patients, were impressed with
the results, and because they are free to use any drug off-label,
began to use it on others. The reimbursement for the procedure may have had a major role in their decision, may have
played no role, or perhaps it had only a subconscious influence. The problem with conflict of interest is that we are
unable to fathom financially conflicted individuals’ motivations; psychologists tell us that people themselves might not
even know their motives. What we do know is that a powerful financial incentive exists to exploit the reimbursement system.
Influence on FDA advisory boards and the kinds of
perverse incentives in day-to-day practice represent only a small part of the ways that physicians’ financial involvement
with industry can affect clinical care and costs. Drug companies are precluded by the FDA from promoting off-label uses
of drugs, but physicians have no such prohibitions, and many, through their industry interactions, are in essence becoming
the modern drug reps.4 Industry implements physician marketing by a number of approaches. One is the funding of
product-promoting front organizations such as the National
Anemia Action Council and the Council for Hormone Ed-ucation.5,6 These organizations are funded by industry and
comprise many financially conflicted physicians. Prominent academics head them, and they hire academic physicians to
collect and edit medical content, which is distributed with the avowed purpose of educating doctors and improving patient
care. The material looks like medical content that doctors
might find in journals, but it does not undergo peer review. Although some of the content may be worthwhile, some is
overtly biased in favor of the sponsors’ products. Industry cannot do this kind of marketing without the willing partnership
with doctors. Of course, off-label drug use by physicians is not only legal, but in some instances a drug approved
only for one particular condition works quite well for others. At the same time, off-label use can have disastrous effects,
especially if the drug is widely used and only shows serious toxicity after widespread use. Our experience with the cardiovascular
complications of phen-fen is a sorry reminder of this scenario. Industry-funded educational lectures constitute still another
major source for flawed drug use and increased expense. The number of physicians appointed to drug company speakers
bureaus is growing. In 2004, the number of pharmaceutical company-sponsored meetings and talks that featured
doctors as speakers amounted to nearly 240,000, a four-fold increase over the previous six years.7 At present, industry pays
for well over half of the expense of doctors’ continuing medical education; virtually all the continuing education departments
in hospitals, medical centers, and medical schools rely on drug-company funding. Drug companies also pay individual
doctors to speak at national meetings, medical center conferences, and restaurant back rooms. Companies recruit
speakers known to be sympathetic to their products and give them further training. Although the speakers are usually told
that they are not obliged to mention the sponsor’s drugs, there is a natural sense of obligation to reciprocate for the $750 to
$4,000 honorarium. Some physicians say they feel subtle pressure to promote products because they want to stay on the
speakers list; others hold back from criticizing companies whose fees they receive. Harking back to the issue of the
cardiovascular complications of Vioxx, evidence emerged that several physicians on Merck’s speaker’s bureau were threatened
by a Merck senior vice president to stop telling their audiences about the risks of Vioxx; big brother had been
listening in on their lectures.8 Even when speakers honestly
believe that they are not promoting products, the presence of drug company representatives and drug brochure handouts at
a dinner lecture exposes any feigned attempt at objectivity. There is little doubt that company-sponsored lectures increase
the use of drugs mentioned in the lecture; given that the drugs
mentioned are usually the newest, most expensive agents and certainly not the generics, the physician lecturers are contributing
to the increased, and increasing, cost of medical care. Whether the recent attempts of the organization responsible
for accrediting physicians’ educational programs, the Accreditation Council for Continuing Medical Education, to sanitize
speakers’ presentations by applying increasingly stringent
regulations on financially conflicted speakers will succeed, is not yet known.9
Even more worrisome than the effect of bias on the part of individual speakers is the potential effect of financial conflict
of interest in the development of clinical practice guidelines. Similar to the broad influence of FDA decisions on
drug use, a statement from the American Academy of Pediatrics or the American Neurological Association on the treatment
of seizures, for example, would have a major impact on the use of the drugs recommended in a guideline report. Both
the public and the profession paid close attention 1 year ago when a clinical practice guideline issued by three prestigious
organizations, the American Heart Association, the American College of Cardiology, and the National Institutes of
Health, unveiled guidelines for cholesterol levels so stringent that millions of Americans at risk of heart disease would have
to take costly statin drugs to meet the proposed low limits. What the three organizations didn’t reveal initially was that
most panel members who helped write the recommendations had financial ties to the pharmaceutical companies that stood
to gain enormously from increased use of statins. The extent of the connections was stunning: Of the nine members of the
panel that wrote the guidelines, six had each received research
grants, speaking honoraria, or consulting fees from at least three and in some cases all five of the manufacturers of statins.
In response to criticism of the panel composition, the Heart Association said that the policy had been reviewed by many
S44 Kassirer The Journal of Pediatrics • July 2006 others, not just formulated by nine people, yet they did not
disclose the conflicts of any other reviewers. Even if they had,
such disclosures would tell us little about the objectivity of the statin recommendations.10
Professional societies rely heavily on financial support from the drug industry, and nowhere are society-industry
connections more evident than at yearly national meetings. Companies purchase attendance lists replete with the attendees
demographic information; they pay for cocktail parties, free e-mail kiosks, tote bags, meals, trinkets, and buses to
ferry people from hotels to convention centers. What the companies get in return is well shrouded, but company logos
on official society slides and publications reflect a minimal visible evidence of sponsorship. Especially problematic at
these meetings are company-sponsored talks by companypaid
speakers. Some are held only outside of the official program (but still approved by the society), and in other
meetings industry-sponsored are blatantly interspersed in the official scientific program. Once again, the drug companies
are not only to blame. Many medical societies solicit drug company support with flagrant come-ons that tout the benefits
to the companies of reaching their elite professional members.
Any consideration of loosening the ties between the profession and industry must take into account the extent of
the involvement. Although we have little definitive information on the pervasiveness of these arrangements, we have hints
that they are widespread. Medical journal editors complain that they are unable to find nonconflicted experts to serve on
their editorial boards or to write editorials and review articles;
financial connections of study authors listed in journal articles disclose as many as 10 to 15 companies for a single author.
And the statement by the Washington Legal Foundation, an organization devoted in part to protecting the pharmaceutical
industry from excessive regulation by the FDA and the Accreditation Council for Continuing Medical Education issued
the following statement: “It is widely acknowledged that most
of the top medical authorities in this country, and virtually all of the top speakers on medical topics, are employed in some
capacity by one or more of the country’s pharmaceutical companies.”11 If we take this statement at face value, which
would certainly be appropriate given the close relationship of this organization to the drug industry, it suggests that industry
has successfully co-opted an exceptionally high fraction of
the most authoritative and influential members of the profession. And what have leaders of the profession done to
counter a trend in which the profession has become increasingly beholden to industry, at times to the detriment of the
public that they have pledged to serve? Not much. Most professional organizations, including the American Medical
Association and the American College of Physicians have published ethical guidelines, but they allow physicians to
receive gifts and meals and are silent on the appropriateness of membership on speakers bureaus. Most have no proscription
against members’ involvement as consultants to industry for
marketing or for the development of educational materials. Most professional organizations have no rules about what
constitutes an ethical lapse, how they monitor their members’ conflicts, or how they deal with a member who violates an
ethical precept. I do not underestimate the achievements of the pharmaceutical,
biotechnology, and device industries. Neither do I want to stop the highly effective collaborations between academic
scientists and these companies. In my recent book, I made this comment: “Thousands of physicians effectively
collaborate with the pharmaceutical, biotechnology, and device industries to develop new diagnostic tools, prostheses,
and medications. I am not opposed to big business, to capitalism,
or to making money. Viewed from a long-term perspective, these industries have produced medications that
have extended life, prevented serious illnesses, and improved the quality of life of millions of people. The companies are
also a vigorous engine that accounts, in part, for our country’s phenomenal economic growth. Even if we were unwilling to
overlook some of the inappropriate behavior of drug, device,
and biotechnology companies, we would have to conclude that overall, the companies have produced a great many
products that benefit us.”12 This brief description covers only a small fraction of the
consequence of medical-industry financial connections. Flaws in research study design, bias in reporting of research, and risk
to patients in clinical trials constitute other serious consequences, and a constant promotion of expensive drugs
through free samples adds to the cost of care.13 It should be evident from these numerous examples that the medical profession
has become excessively dependent on the largesse of
the pharmaceutical industry, that these financial connections have a negative influence on the quality and cost of patient
care and the trust of the public, and that the profession’s response to these threats has been weak. By making tenacious
financial connections with physicians, industry has tainted the very profession that it relies on to appropriately use its products,
and, if anything, the companies are trying to tighten and
extend the connections, increasingly recruiting physicians to their marketing efforts.
During the height of managed care, the public became aware of the influence of payment incentives on the kind of
care they were receiving. They began to appreciate that they might be subjected to excessive testing when physicians were
paid on a fee-for-service basis and denied testing when physicians were working in a capitated system. Survey studies
show that the public is wary of physician involvement with industry, but nothing is a better guide to public awareness of
physician-industry connections than the media. Already, episodes of inappropriate behavior by financially conflicted physicians
have appeared in the comics in Dilbert and other
cartoons and on television on ER and The Simpsons. Already there seems to have been a public devaluation of medicine:
Instead of medical experts arguing scientific issues in the public domain, the press now publishes debates about psychiatry
between prominent Hollywood film actors, and commen-When Physician-Industry Interactions Go Awry S45
taries about the toxicity of vaccines and the cause of autism by
environmental lawyers.14,15 Given the extensive involvement, extracting medicine
from industry’s financial magnet will be extremely difficult, but I believe it must be done. Needless to say, Congress has
the clout to set new rules, yet I continue to favor vigorous action by the profession. Such action will be painful, but
probably less painful than inappropriate and more costly medical care or the opprobrium of a disenchanted public. I
believe that if the profession fails to act, Congress should.
1. Kassirer JP. On the Take: How Medicine’s Complicity with Big Business
Can Endanger Your Health. New York: Oxford University Press; 2004.
2. Harris G, Berenson A. 10 Voters on panel backing pain pills had industry ties. New York Times, February 24, 2005.
3. Saul S. Expert panel gives advice that surprises a drug maker. New York
Times, August 9, 2005, C1.
4. Kassirer JP. These two make quite a team. Washington Post, Outlook, October 10, 2004, B1.
5. National Anemia Action Council. Available online at: http://www. anemia.com. Accessed August 8, 2005.
6. Council for Hormone Education. Available online at: http://www. hormonecme.org. Accessed August 8, 2005.
7. Hensley S, Martinez B. Speaker programs come under the microscope again. To sell their drugs,companies increasingly rely on doctors. Wall Street
Journal, July 15, 2005, A1.
8. Documents suggest Merck tried to censor Vioxx critics. National Public Radio. All Things Considered, June 9, 2005.Available online at: http://
www.ahrp.org/infomail/05/06/vioxxNPR060905.php. Accessed August 8, 2005.
9. Accreditation Council for Continuing Medical Education. Standards for Commercial Support. Approved September 2004. Available online at:
http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf. Accessed August 8, 2005.
10. Kassirer JP. Why should we swallow what these studies say? Washington Post, Outlook, August 1, 2004, B3.
11. Popeo DJ, Samp RA. Comments of the Washington Legal Foundation to the Accreditation Council for Continuing Medical Education concerning
request for comments on the January 14, 2003 Draft “Standards to Ensure the Separation of Promotion From Education Within the CME Activities of
ACCME Accredited Providers”: Washington, DC: Washington Legal Foundation; January 29, 2003.
12. Kassirer JP. On the Take: How Medicine’s Complicity with Big Business
Can Endanger Your Health. Oxford University Press, New York; 2004:xvi.
13. Krimsky S. Science in the Private Interest: Has the Lure of Profits Corrupted
Biomedical Research? Lanham: Rowman and Littlefield; 2003.
14. Shields B. War of words. New York Times, July 1, 2005.
15. Kennedy R Jr. Autism, mercury, and politics. Boston Globe (Op-ed), July 1, 2005.
S46 Kassirer The Journal of Pediatrics • July 2006