When a drug has been adequately tested and has been found to have the effect claimed for it, this claim should be permitted even though there may be preponderant evidence to the contrary based upon equally reliable studies. There may also be a situation in which a new drug has been studied and its effectiveness established only to the satisfaction of a few investigators qualified to use it [emphasis added]. There may be many physicians who would deny the effectiveness simply on the basis of a disbelief growing out of their past experience with other drugs or with the diseases involved…. What the committee intends is…that safe new drugs become available for use by the medical profession so long as they are supported by a responsible body of opinion and scientific fact.

–Report, 1962 amendments of the Food, Drug, and cosmetic Act, US Senate (quoted in the Final Report, 8/15/90, of the National committee to Review current Procedures for Approval of New Drugs for cancer and AIDS.

This is the fifth in a series of articles about medical boards authorized in every state to discipline physicians for professional misconduct. Unlike medical societies and specialty certifying boards, which may oust or decertify members but not bar them from practice, these government agencies can revoke the licenses of doctors — a power which gives them considerable influence over both the quality and accessibility of health care.

All articles in this series have taken New York State’s board, the Office of Professional Medical Conduct (OPMC), as a case study. The Empire State has roughly 60,000 MDs, one of every ten physicians licensed in the US. (About 3/4 of the New York doctors actually practice. The rest conduct lab research, hold administrative positions, etc.)

In addition, New York has numerous hospital complexes, some world-renowned for specializing in certain diseases and/ or prominent as institutions at the frontiers of medical science. Therefore, New York’s physician population covers the gamut of standard and experimental health care. And thus most types of professional misconduct pass before he OPMC’s eye.

Prospects for OPMC Reform Concerning Due Process. Sniping at the OPMC for the manner in which it polices physicians started soon after transfer of the disciplinary process for MDs from the Education Department to the Health Department (1975). Critics of various stripes have been sniping at New York’s medical cops ever since.

Most of the criticism has centered on delays in processing complaints and for lenient penalties in instances of alleged flagrant incompetence, negligence, or unethical behavior by mainstream physicians.

Over the years, the majority of OPMC reforms have addressed the agency’s failure to meet expectations by expanding its reach, funds, and personnel. Recent dissatisfaction with the OPMC has again included questions about inconsistent rulings and puzzling recommendations for penalties. Now, though, much of the discontent springs from concern over alleged violations of due process by the agency.

In January 2002, the New York Assembly conducted an all-day hearing into complaints about these process violations. Then in June, the Assembly passed a bill meant to strengthen essential administrative trial protections for physicians. But the New York Senate, supported by long established public interest/consumer protection groups (and spurred perhaps by the insurance industry behind the scenes), refused to pass a companion bill. (The opponents felt the Assembly bill protected physicians far more than it did patients.)

Since Democrats have controlled the Assembly and Republicans the Senate for decades, and are likely to retain control of their respective chambers for the foreseeable future, chances of the two parties agreeing on a reform package that would minimize due process violations by the OPMC appear slight.

Rationale for the Proposed OPMC Reforms. Partly because of the aforementioned political impasse, the reforms proposed here bypass due process issues. Instead, they target a burgeoning tendency of the OPMC to investigate and prosecute MDs for treatment regarded by the agency as inappropriate or unnecessary. This tendency has the potential to disadvantage physicians — and, more important, patients — in a broader way than any OPMC failure to observe due process can do.

To understand why, one must realize that when the OPMC frames charges against doctors in these cases it often employs the terms “improper,” “incompetent,” or “negligent.” Such terminology fuzzes crucial distinctions between ineptly done procedures and incorrectly interpreted diagnostic tests that harm or may harm patients, and approaches to treatment that simply depart from community norms, causing negligible harm and sometimes providing benefits not obtainable under standard therapy.

One must also note that in the year the Legislature established the OPMC in the Health Department (1975), the legislators probably expected the agency to concentrate on incompetent, negligent, or otherwise unacceptable conduct by MDs (e.g., botched surgeries, misdiagnoses, mental or physical impairment, sexual abuse of patients).