John La Puma, M.D.

A pharmaceutical code of ethics — if it were ever hammered out — would have to arise from a detailed examination of the industry's vision, mission and principles. It would likely cover methodology, safety, marketing and pricing. It would certainly cover communication with patients and the public. It would be aspirational instead of dutiful. It would contain sanctions for breaches and measures for prospective monitoring. Adherence and breaches would be suitable topics for research and journals.

But waving even an asbestos code at the roaring flames of public opinion will not help. Could you imagine tobacco companies trying to use an industry-developed and approved code of ethics to defend themselves against claims that they aimed their advertising at teens?

In best interests of all

A code, instead, is the end-product of thoughtful deliberation about how best to serve all stakeholders. Within the industry, patients and physicians are stakeholders as much as are shareholders and investors. Obligations of truthfulness and integrity — minimal criteria for any company that seeks to do good, as all health care companies must — are especially powerful, and serve as the cornerstones for successful organizations.

The Pharmaceutical Manufacturing and Research Association has a code of marketing practice, but ethics isn't mentioned. Individual drug companies also have codes of marketing practice, but no codes of ethics. Other countries — Australia, New Zealand, Canada, United Kingdom — have industry trade associations with codes of marketing practices, but again, no codes of ethics.

Ethical guidelines are important to physicians because our patients trust us to do what's best for them. Ethics is important to industry primarily because it fosters trust.

Michael Drummond, Ph.D., professor of health economics at the University of York, U.K., writes that "health care decision makers are primarily interested in ethical standards because they want to trust papers and reports that they see, particularly if they are produced by individual pharmaceutical companies or sponsored by individual companies."

Many physicians receive communications from pharmaceutical companies every day — sometimes six or ten times a day. The interaction between physicians and industry has been scrutinized. Symposia, gifts and hospitality from industry have received at least as much attention as the effect advertising has had on physician prescribing habits. But "dear doctor" letters have escaped notice.

"To whom it may concern"

Dear doctor letters should not go unnoticed because they are important communications from industry to physicians. These letters usually report a labeling change, negotiated by the pharmaceutical company with the FDA. Terfenadine went through at least three dear doctor letters before it was withdrawn. Troglitazone has already had two. Dexfenfluramine only had two. So did fenfluramine. In fact, the FDA has withdrawn or persuaded manufacturers to withdraw five drugs since last year and all had been the subject of dear doctor letters not long before the government's action.

Note that industry relies on physicians to tell patients what industry writes. The legal doctrine of a "learned intermediary" — a carry-over from days when patients apparently didn't watch television or listen to the radio, much less search with Yahoo — makes physicians responsible for telling their patients about terfenadine's interaction with erythromycin, and phentermine-fenfluramine's with heart valves. From industry to health professionals to consumers — a transfer of information and responsibility.

Are physicians listening? To allow physicians to obtain informed consent from patients, industry must provide adequate information. Otherwise, how can patients understand and choose wisely, without coercion?

Doctors may find dear doctor letters unimportant rather than educational because physicians believe that promotion has little effect on prescribing habits.

Mistaken identity

In fact, a typical dear doctor letter could easily be mistaken for promotion. The name of the drug is usually trumpeted in bold. Its usual success in treatment is emphasized. The new problem is, by comparison, modestly discussed. Physicians may be liable for ignoring dear doctor letters, even though the letters could be mistaken for direct-to-doctor advertising.

But promotion works, and it can hurt companies if done unethically. In Australia, the maker of fluvastatin was fined $10,000 and forced to send letters of correction for opining that its drug was "the first-line statin that wins from the start." The Australian Pharmaceutical Manufacturers Association's code of conduct subcommittee said the promotional letter was inaccurate, misleading, inadequately substantiated and implied that the drug could be used contrary to approved indications.

The pharmaceutical industry needs the high road, not the low one. Industry should not make the mistakes of managed care. Managed care is not proud of ethics, imbued with the public trust or even respectful of doctor-patient relationships. Industry has a chance to speak about ethics and to let patients know what it stands for. It cannot afford to do anything else.

In The E-Myth Revisited, Michael E. Gerber, chairman of the E-Myth Academy — which is, among other things, a consulting service for small companies — writes that the single distinguishing factor of extraordinary businesses is their leaders' "insatiable need to know more.... The greatest businesspeople I've met are determined to get it right no matter what the cost.... [T]here is some vision, some higher end in sight that 'getting it right' would serve. An ethical certainty, a moral principle, a universal truth."

Gerber is right. For pharmaceutical companies to hold themselves out as great businesses, they need processes that result in honorable, enforceable codes of ethics.

Managed Care’s Top Ten Articles of 2016

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Shelley Slade
Vogel, Slade & Goldstein

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