Visudyne

Many in the profession are seriously concerned that some physicians are willingly violating their integrity in personal profit-making ventures at the expense of patients' welfare. These excesses are not new, but they are far more widespread today than in the past, and their consequences are more profound.

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To find an explanation for the evolution of the profession over the past 50 years is no easy task. It is not enough to focus on the enormous increase in the amount of money that changes hands within and outside of the practice of medicine or just the scope of financial conflicts of interest, but as well on the societal and medical environment in which these changes took place. Many complex interwoven factors and events shaped today's health-care system. Not surprisingly, money has constantly influenced the directions our system has taken.

Financing their practices became a major source of physicians' frustration. They found themselves in an increasingly competitive small business, and few had real business experience or special administrative acumen. Instead of the usual billing practices for one patient at a time, physicians had to negotiate contracts on an annual basis with not one, but many insurers. Practice management became an entirely new field involving competitive advantage, market share, negotiation, and cost accounting. And while the cost of care was increasing, insurers were reducing physicians' fees, sometimes abruptly and without warning. The cost of running doctors' offices increased as did the cost of malpractice insurance. All of these rising costs made physicians more attentive to the risks of their economic well-being and survival.

Physicians' incomes, which were high relative to the average worker, began to decline. Between 1995 and 1999 salaries and wages rose for most workers, but not for physicians. In that period, the average primary-care doctor's income, adjusted for inflation, fell by more than 6 percent; average specialists' income fell by 4 percent. This decline almost certainly had an added effect on physicians' interest in compensating by finding other sources of income. Yet it was not only money that discouraged doctors.

They experienced frustrating payment delays, denials of claims, and increasingly complex and demanding regulations. Physicians whose bonuses depended on the number of referrals to subspecialists and on measures of productivity had higher levels of anxiety and concern that they might be compromising patient care than physicians whose bonuses were determined on the basis of the quality of care or of patient satisfaction.

Regrettably, some physicians also began supplementing their incomes by distributing products such as vitamins, herbs, food supplements, cosmetics, and household cleaners, or by practicing the techniques of "alternative and complementary" medicine. It's no wonder that doctors turned to sources of income other than patient care to maintain their standard of living. Cutbacks in reimbursement and increasing expenses, including malpractice insurance, put the squeeze not only doctors in medical centers but in community practice as well.

One doctor in Pinole, California, is a case in point. He had always made a modest living and had not spent lavishly on material goods. He had always taken plenty of time with his patients, prided himself on the care he gave them, and was unwilling to compromise on the approach he learned long ago. Yet his pace of practice simply wasn't geared to sustaining even a reasonable income and before long he had to re-mortgage his home to pay his bills.

These assaults on physician autonomy and income and the new permissiveness that overlooks (and even accepts) financial conflicts of interest as part of political and business interactions contribute to a greater willingness of practicing physicians to engage in outside activities that can compromise their integrity, such as participating in the marketing efforts of drug companies, taking part in clinical trials run by for-profit research firms, purchasing drugs and selling them back to patients at a profit, or helping pharmaceutical companies to market their products. Such financial incentives have led to compromises in professional integrity.

The current climate

Physicians do not exist in isolation; rather, they are subject to changes in the culture and to the norms of society. And the norms of society, with respect to conflict of interest, have changed remarkably.

In government, in the media, in the judicial system, in the securities business--to mention only a few--conflict of interest has become problematic, and despite occasional public outcries against blatant examples, serious conflicts are often tolerated. Fresh in the minds of many are profit-motivated financial conflicts of interest that led to the demise of major corporations such as Enron and the accounting firm Arthur Andersen. But similar conflicts are pervasive throughout society, and help to explain why they are tolerated in medicine.

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In an interview with Matt Lauer in March 2002 on the Today show, Lauren Bacall urged people to get tested for macular degeneration, a vision-threatening disease that afflicted a friend. She mentioned that Visudyne, a new drug, could treat the disease, but neither she nor Matt Lauer indicated that she had been paid by the drug's manufacturer, Novartis, to mention the drug. (1)

Ordinarily celebrities being paid by the pharmaceutical industry do not mention a specific drug: the drug companies' tactics are much more subtle. Instead, the entertainers are paid to appear in interviews to talk about a disease from which either they or one of their friends suffer: the audience is kept in the dark about the payments they receive.

Rob Lowe, Danny Glover, and Kathleen Turner all have been paid participants in these campaigns by pharmaceutical manufacturers to heighten the awareness of diseases for which the companies have new (and often expensive) drugs. (2)

Trust in medicine

The profession lost the public's trust when it was not accountable for the excesses of the fee-for-service payment system and when it did not speak out loudly enough against inappropriate restrictions of managed care. Many acted with disgust when newspaper and television stories documented examples of the free meals, trips to resorts, bonuses for enrolling patients in clinical trials, pseudoconsulting, and other financial deals.

Such financial conflicts of interest have created an atmosphere of public distrust, and even though people generally trust their own physicians, the profession has lost some of its previous exalted position. In fact, trust is the basis for the physician-patient relationship.

Patients must be able to trust their doctors. They should not have to be concerned that a doctor is recommending (or not recommending) a biopsy or a CT scan because the recommendation might be influenced by the doctor's financial arrangements. If they are asked to participate in a clinical trial, they should not have to wonder whether their participation is in the best interests of scientific medicine and not just in the best interests of their doctor.

What can be done?

Financial conflicts of interest threaten patient care, taint medical information, and raise costs. They create deception, impair physicians' judgment, and reduce their willingness to be their patients' advocates. They reduce professional dignity and integrity, denigrate the profession, and erode trust in the profession's practitioners, researchers, and institutions.

To reverse the exceptional toll that financial conflicts exact will take some doing. We must start with principles.

Ideally, adherence to the highest professional creeds would be the best approach. Professionalism is a lofty ideal, but regrettably it lacks specificity and has not held sway as the onslaught of industry money has deflected many physicians' internal moral compasses. Whatever is done must be based on one assumption and four fundamental principles. The assumption, a solid one, is that gifts and financial entanglements, even minor ones, influence behavior and promote bias.

The principles:

First, financial considerations must never be allowed to compromise physicians' decisions about the care of individual patients or the safety of subjects involved in medical research.

Second, because the integrity of scientific knowledge directly affects patient care, physicians' medical information must be free of bias generated by financial entanglements.

Third, the profession must be accountable for insuring that undue commercial influence does not make the cost of care so high that it excludes many from receiving it.

Last, we must aspire to the ideal of eliminating financial entanglements, but if physicians cannot or will not, we must have clear and enforceable methods that protect patients and complete disclosure about the conflicts.

Though disclosure of financial arrangements is not an ideal solution, openness, honesty, and transparency about any financial arrangements is a minimum requirement. The highest standard, and the one that would engender the most confidence, is elimination of financial conflicts of interest.

Curiously, even some commercial organizations reach this standard.

Wine writers for the Wall Street Journal described their policy as follows: For this column, we do not accept free wine, free trips, or free meals. We attend only events that are open to the public. We do not meet with winemakers when they visit New York. We buy all of our wines off retail shelves unless specifically noted otherwise. We shop, both in person and online, at retail stores all over the U.S., from Los Angeles to Chicago to Tallahassee, Fla. We taste wines blind unless noted otherwise. We believe wines should speak for themselves. (3)

Complete divestiture of all relations with industry may be the ideal, but I believe that it is unrealistic in the current political environment and because so much money is involved. Additionally, in some instances--for example, in creative and constructive scientific collaborations between physicians and industry--it could be counterproductive. I have no magic solutions to the heavy involvement of physicians with industry, but at the very least, all professional relations with industry must be based on the principles I described earlier, and they must be characterized by honesty, accountability, transparency, and openness.

Some physicians are embarrassed to take even a pen, a pad of paper, or a textbook. Others--perhaps the thick skinned or arrogant--would not be ashamed no matter who found out about their sponsored trips to resorts or their paid efforts on the part of industry. Some even brag about their "take."

In fact, other professions have far more stringent guidelines and rules from which medical organizations can learn.

Lawyers are subject to several layers of regulation and oversight by the American Bar Association (ABA), state bar associations, judicial review boards, strong professional norms, firm self-policing, background checks, and vigilant court officers.

According to the Model Rules of Professional Conduct, "a judge should disqualify himself or herself in a proceeding in which the judge's impartiality might reasonably be questioned." (1,3) If an attorney becomes aware of a conflict of interest that impairs his ability to represent a client, he is obligated to ask the client to find another attorney. Lawyers in violation of such professional canons face a variety of sanctions, ranging from dismissal of a case to disbarment. The adversarial court system is a potent influence in reducing the chance of serious conflicts. If an attorney in a case discovers a financial conflict of interest in an opposing lawyer, he can bring it to the attention of the court.

In medicine no such adversarial situation exists, but physicians' reputations are dear to them. Because financial conflicts are largely hidden, however, nobody can be embarrassed now by their arrangements with one more company. All the more reason to make the financial ties between physicians and industry public knowledge.

What more is needed?

I believe that proscriptions against financial conflicts have not gone far enough. Sometimes government must step in when markets usurp too much power, and when social problems get out of control. It has done so in many spheres including unemployment compensation, retirement benefits, and medical care for the elderly.

If the profession cannot be more accountable by its independent actions, government must intervene. It would be relatively easy to compel physicians and organizations (virtually all of whom receive federal funds in one form or another) to comply with more stringent conflict-of-interest regulations. I hope such intervention will not be necessary because regulations are likely to be heavy-handed and lack the nuances to preserve the benefits of physician-industry collaboration.

The quality of the pharmaceutical industry's products should speak for itself, without requiring massive marketing to physicians or marketing by physicians. The pharmaceutical industry has argued that its huge expenditures for marketing to doctors is directed mainly at educating physicians.

If that is truly their goal, I challenge them to contribute to a pool of educational funds that could be parceled out by an independent body in some equitable fashion. Contributors to such a fund would be recognized for their participation. This suggestion was not rejected out of hand when I suggested it to a senior executive of PhRMA. Surely, such a plan would be complex, but it is not an impossible dream. The pharmaceutical industry should want to avoid even the perception that its marketing efforts are tainting the very profession on which it depends for its success.

The process of clinical practice guideline development requires special attention because it has such an enormous impact on the quality of patient care. We must end the practice of perfunctory disclosures followed by business as usual. We must admit that the usual approach to announcing conflicts is often a sham. Some say that because so many of the top academic physicians are involved with industry they could never find enough people with sufficient expertise to deal with the complexities of the clinical problem. I call this the "fallacy of unique expertise."

I admit that when a product is brand new and no one else has expertise, perhaps the only ones with sufficient knowledge might be one or two experts. In such instances, we may have no choice but to listen to their judgments about the products. Nonetheless, this should be an unusual case. Often many others quickly develop expertise, and conflicted experts will not be needed to develop practice guidelines.

To make it easier for physicians and consumers to identify the physicians who have financial arrangements, a mechanism must be found, perhaps under the leadership of the AAMC, for hospitals, health centers, and academic medical centers, to contribute regularly to a voluntary, searchable Web-based registry of faculty members and associated physicians who have financial conflicts of interest.

Such a registry could include those on pharmaceutical company boards, advisory committees, speaker's bureaus, and recipients of grants. Names could remain from the time that the relationship begins and for two years thereafter. I recognize that such a list might only contribute to an existing culture of popularity and stature of conflicted physicians, yet it would be much easier with such a registry to identify who has the conflicts and how the conflict might have played out. I can also anticipate objections on the basis of privacy, yet there is already a precedent for such widespread disclosures: they are already required on many educational materials and by many journals. Universal Web-based disclosure is an idea worthy of further consideration.

Teaching about the effects of conflict of interest must start as students first walk through the doors of the medical schools, and it must be reinforced every year thereafter. Nearly all schools have courses in medical ethics, but conflict of interest is not a consistent part of these curricula.

Needless to say, the schools may find proscription of gifts and meals difficult to justify if their faculty are heavily involved with industry themselves. Students should be encouraged not to take gifts or interact with drug salesmen. House staff should pay for meals themselves rather than be obligated to drug salesmen and their companies. House officers must be encouraged not to meet with drug salesmen outside their institutions.

Only a few medical schools and training programs proscribe companies from providing free food and gifts, but those that do make an important statement to their students and trainees about professionalism.

References:

1. Petersen, M. "CNN to reveal when guests promote drugs for companies." New York Times, Aug. 23, 2002.

2. Kuczynski, A. "Treating disease with a famous face." New York Times, Dec. 15, 2002.

3. Gaiter, DJ, Brecher, J. "Seizing Nouveau's moment." Wall Street Journal, Nov. 28, 2003.

By Jerome P. Kassirer, MD

Jerome P. Kassirer, M.D. is distinguished professor at Tufts University School of Medicine and adjunct professor of medicine at Yale University School of Medicine. He served as editor-in-chief of New England Journal of Medicine between 1991 and 1999. He can be reached at jordan.bucher@oup.com

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