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 the 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 Reforms in this article. 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).

      In contrast, it's unlikely that the legislators anticipated the OPMC spending much effort and time on evaluating the appropriateness of treatment. Appropriate care and defining and constructing guidelines for appropriate care didn't become highly visible issues in medical circles until the early 1980s, when meta-analyses of the results of commonly utilized treatments indicated that the majority had little rigorous evidence to confirm their effectiveness.¹

      The OPMC, however, has since proceeded to take action against physicians for "inappropriate” and "unnecessary” care, as though unmindful of the suspect evidentiary basis for much community practice.

      In short, despite the weakness revealed by outcomes research, community practice remains the agency's primary standard for judging whether certain therapeutic approaches that depart from the norm amount to medical misconduct.

      The OPMC's Problematic Standard for Determining Appropriate Care. The second in this series of articles about the OPMC quoted a 1989 interview with James S. Todd, MD, senior deputy vice president of the American Medical Association (AMA). He favored replacing practice standards with practice "parameters.” The nub of Todd's opinion bears repeating here:

      "No one knows how to define a standard of practice, but we can clearly define appropriate indications and methods of treatment that allow room for the infinite variation of patients and diseases.”² Todd's "parameters” would permit greater flexibility in dealing with the variations.

      The view just quoted dates from 1989. A year later, an editorial on clinical guidelines in the Annals of Internal Medicine offered a more comprehensive view of the difficulty in defining appropriate care:

      "Clinical guidelines…provoke contention. What began as a well-intentioned scholarly endeavor with practical value can end up pitting physicians in practice against academicians, medical societies against each other, doctors against regulators, and payers against doctors…. Whoever sets guidelines should expect disagreement. Indeed, they should encourage it…. If the disagreement is on the interpretation of evidence, that is all for the good; but if it is on who is allowed to define what is the correct practice of medicine, then we are all in trouble.”³

      It would seem that where pillars of the medical establishment make allowances for "the infinite variation of patients and diseases,” and even encourage different points of view on how to treat particular conditions, New York's OPMC looks at determinations of appropriate care as a relatively clear-cut, easy-to-manage matter.

      Moreover, this agency shows no qualms about increasingly entering into medical territory largely outside its jurisdiction. Historically, the peer review process (publication of treatment data in journals and presentation of clinical results at scientific conferences) has served as the customary forum for resolving uncertainties about treatment – not the state medical boards.

      The OPMC's Attitude Toward Risks Patients are Willing to Take for Treatment Benefits. Besides employing a flawed standard in attempting to separate inappropriate from appropriate treatment, to weed unnecessary from necessary care, the OPMC ignores the feelings of patients about the risks and benefits inherent in choosing treatment.

      As a matter of fact, except as sources of complaints and as cases that provide evidence to convict physicians of misconduct, patients don't count for much with the OPMC.

      To cite one telling example: The agency has selected cases of patients who, in fact, have never complained about a doctor, who've in fact benefited from that doctor's approach, and used the records in those cases as evidence against the doctor – much to the dismay and anger of the patients involved.⁴

      Citing another example: The OPMC may investigate and prosecute physicians for incompetence or negligence even when doctors don't injure a patient. In civil court, on the other hand, injury to a patient is an indispensable prerequisite for beginning a malpractice suit.⁵

      A discussion in the second article in this series analyzed the OPMC's preoccupation with the physician's side of the doctor/patient relationship in investigating misconduct on the part of physicians. That article quoted several authorities on growing trends contrary to the agency's positions on patients, trends that foster participation of patients in decisions about treatment and on the risks they're willing to take to gain benefits.

      John Wennberg, MD, Professor of Medicine, Dartmouth Medical School, was the first authority quoted. A pioneer in outcomes research, Dr. Wennberg has long advocated patients' preferences over physicians' in medical decisions. In an article published in 1990, he observed:

      "For most conditions rational choices among treatments require that individual patients understand the predicaments they face. The predicaments arise because there is seldom a single correct answer to a medical problem. Most conditions or illnesses entail a number of morbidities, symptoms, and disabilities. Outcomes research will clarify the probabilities of the various outcomes for the various treatments, showing many to be effective in some respects that are important to patients…. As we improve in our ability to do this, patients will be shown to differ in their degree of concern about their predicament, and the outcomes they want will differ accordingly; they will also differ in the risk they are willing to take to get what they want” (emphasis added).⁶

      Stanley J. Reiser, MD, supplied the second quote. An expert on medical ethics at the University of Texas Health Science Center (Houston), Dr. Reiser has credited the modern medical ethics movement and modern outcomes research as the forces revising the role of patients in medical decision-making. In a piece published in 1993, he wrote:

      "A basic feature of the outcomes movement is the prominence given to the judgment by patients of how a therapy has affected their lives. The movement recognizes that in the final analysis, only the patient can decide if a treatment is successful…. In constructing diseases, we have created population-centered, objective, and statistical interpretations of illness that have devalued the distinctive experience of patients [emphasis added].”⁷

      Today's OPMC is out of step with such trends and falling further behind the pace of change where recognition of patients' feelings and wishes about the risks and benefits of health care are concerned.

      Opponents of this year's OPMC reform package dismissed it as a "physician protection bill, not a patient protection bill.” One could label the OPMC – in light of its fixation on standards and misconduct by doctors, its virtual disregard of patients in the disciplinary process – "a physician prosecution agency, not a patient protection agency.”

      Before turning here to proposals for reform that could discourage the OPMC from its sorties into appropriate care, one more quote about medical risk from the second article in this series may be illuminating. It's by Professor Peter Temin, a medical economist at the Massachusetts Institute of Technology, from his 1980 study on the regulation of drugs by the FDA:

      "Taking your medicine is a risky business. It is one of many in an uncertain world. There are ways to reduce the risk from taking medicine, but each reduction has a cost. The risk can never be eliminated entirely, and the pursuit of riskless therapy will become ever more costly without reaching its goal. Any other, more realistic goal implies the acceptance of some risks. The question then, is how risky this aspect of life should be, or, conversely, how many choices should be reserved to the people?” ⁸ [emphasis added].

      Doubtless, some supporters of the OPMC see its incursions into appropriate care as valid attempts by government regulators to reduce the risks from therapies whose effectiveness is still a matter of further scientific evaluation.

      But the OPMC lacks personnel equipped for such a specialized, sophisticated undertaking. Where academic experts, through training and experience are apt to tread with caution, New York's medical police are more likely to blunder, applying outdated criteria and thereby making an unpalatable hash of the job.

      Proposals for Long-Term Reform of the OPMC. The three proposals for long-term OPMC reform which follow would curb the agency's roving into evaluations of appropriate care and reorient it more toward patients' needs, particularly patients unable to respond to treatments in community practice.

      Reform 1 derives from the US Senate's report on the 1962 amendments to the federal Food, Drug, and Cosmetic Act. Those amendments authorized the FDA to consider efficacy as well as safety in approving new drugs.

      That report clearly indicated that the Senate wanted new drugs to become available for general use if the evidence for effectiveness rested on "a responsible body of opinion and scientific fact.” They termed this threshold "substantial evidence” and asked the FDA to permit medical claims "even though there may be preponderant evidence to the contrary based upon equally reliable studies.”⁹ (For the full quotation, see the beginning of this article.)

      Professor Temin's book about drug regulation contains a chapter recounting how the agency interpreted the threshold for approval and prevailed in the US Supreme Court when pharmaceutical companies challenged the FDA's interpretation.¹⁰

      Nonetheless, it's worth considering an amendment to the New York Public Health Law that instructs the OPMC to look for "substantial evidence” of effectiveness (as opposed to preponderant evidence), when any of its staff itches to charge physicians with "inappropriate” or "unnecessary” care. Worded unambiguously, that change might limit the agency's investigations and prosecutions to doctors whose conduct in treating patients is demonstrably injurious.

      In 1988, George Bush, then Vice President of the US, appointed a blue-ribbon committee to review FDA procedures for approving new drugs for cancer and AIDS. That committee issued 20 recommendations in 1990.

      The committee's fourth recommendation, quoting from the 1962 Senate report on the intent of Congress with respect to the statutory definition of "substantial evidence” of effectiveness in approving drugs for marketing, also commented on the risks attendant on expediting general access to drugs that lack conclusive proof of efficacy:

      "The committee recognizes that, by making new drugs available for marketing at this early stage, when there is substantial evidence but not yet definitive evidence of effectiveness, there is an attendant greater risk of serious adverse reactions that have not yet been discovered. Cancer and AIDS patients have made it clear to the committee, however, that in light of the seriousness of the diseases involved, they are willing to accept this greater risk [emphasis added]. Earlier approval of new drugs will mean that the patient will bear greater responsibility along with the physician, for understanding and accepting the risks involved.”¹¹

      Twelve years ago, that eminent panel of medical authorities¹² acknowledged the willingness of patients unresponsive to accepted therapeutic approaches to try approaches that are not conclusively proven in the hope of gaining relief – despite the potential for adverse effects. As of this writing, the OPMC continues to ignore the need for reasonable therapeutic options for patients with grave or chronic illness, risky though these options may be in some instances.

      Reform 2 would oblige the OPMC to recognize that patients have the right to assume the risk of treatment that departs from community standards. This is inherently a contractual arrangement, requiring informed consent by the patient, though not necessarily in writing.

      There's precedent for express assumption of risk in the courts, chiefly from two appellate opinions in malpractice cases in the federal court in New York (Second Circuit, Southern District), one in the late 1980s, the other in the early 1990s.¹³

      There's precedent, too, in bills introduced into the US Senate and House of Representatives in 1994 (sponsored, it should be mentioned, by the leaders of both political parties in the Senate). Under the title "The Access To Medical Treatment Act,” these bills essentially incorporated the federal appellate court rulings on express assumption of risk. But they also contained provisions that would safeguard patients from manifestly unsafe remedies, and provisions that would regularly provide updates on outcomes data that bolster evidence of good therapeutic results.¹⁴

      Reform 3 would restrict the OPMC from prosecuting doctors whose departures from community practice have histories of generally safe usage and are undertaken only after these doctors have fully informed patients about the potential downside of therapies not conclusively proven effective.

      Further, reform 3 would impose a penalty for wrongful prosecution, which should include some form of disciplinary action for OPMC staff found guilty, a fine of the OPMC for lax supervision of its staff, and full reimbursement of legal expenses for physicians wrongfully prosecuted.

      Members of the medical establishment reading this proposed third reform may infer that "wrongful” prosecution as described here would apply in almost all cases to practitioners specializing in minority treatment (mainstream and alternative approaches that deviate from the norm). For them, this article closes with another quotation from the 1989 interview with Dr. James S. Todd, the AMA official. He was speaking about malpractice, about "bad doctors” (a favorite term of the current New York State Health Commissioner who lets the OPMC define "bad” in every way convenient to investigators and prosecutors):

      "Many of the malpractice litigation problems today are not with ‘bad doctors.' The problems are with the good doctors who are on the front lines and treating complicated cases, using frontier medicine with often unpredictable results. Every doctor in the country today is doing things routinely that he never heard about in medical school or residency.” ¹⁵ [emphasis added].

      Reform 3 would oblige the OPMC and Health Department staff, including hearing panel members, to consider that Dr. Todd's distinction reflects the essential reality of medical practice today.

      One More Article to Come. For persons unfamiliar with how state medical boards operate (most of the public surely), five articles utilizing New York's board as the optimal case study might seem to blanket the subject.

      Unavoidably, in writing a long series, information and observations get introduced without further discussion. The sixth article about the OPMC, in the next issue of Townsend Letter, will tie up important loose ends. Appended to that article, readers will find summaries of the previous articles in this series.

Acknowledgments

      The New Jersey Health Freedom Coalition and Vincent LaRocca separately contributed funds to help research and write the fifth in this series of articles on the OPMC.

Correspondence:

Marcus A. Cohen
Founder & Director, HealthTrends
8 East 96th St. #10
New York, New York 10128

212-427-0707 (direct)
212-946-5136 (voice mail)
Fax 212-348-8288

References

1.   Wennberg JE, MD, AHCPR and the strategy for health care reform, Health Affairs, Winter 1992. The very first paragraph fingers "two fundamental defects” in health care; (1) "weaknesses in the clinical science that occur because medical ideas and theories are not well tested; and (2) weaknesses in the ethical basis for clinical decision making that allow the physician's preferences for outcomes and treatments to dominate the choice of treatment when the right of choice properly belongs to the patient.” At the time of publication, Dr. Wennberg was director of the Center for the Evaluative Clinical Sciences, Dartmouth Medical School, Hanover, New Hampshire.

      Zuger A. New way of doctoring by the book, The New York Times, 12/6/91. A pertinent excerpt: "Studies suggest that only a very small fraction of the decisions doctors make are actually based on firm evidence that a given test or drug is the best possible approach for patients.”

2.   Interview by editors, James S. Todd, MD, American Medical News, 1/6/89.

3.   Editorial, Clinical practice guidelines, Annals of Internal Medicine, 11/1/90.

4.   Noble HB, Lyme doctors rally behind a colleague under inquiry, The New York Times, 11/10/00.

5.   Millock P. Esq., Definitions of professional medical conduct under the New York State education law. New York Dept. of Health (memorandum), 2/6/92,

6.   Wennberg JE, MD, Outcomes research, cost containment and the fear of health care rationing, The New England Journal of Medicine. 10/25/90.

7.   Raiser SJ, MD, The era of the patient, Journal of the American Medical Association, 2/24/93.

8.   Temin P, PhD, Taking your medicine: drug regulation in the US, Harvard University Press, 1980.

9.   US Senate report on the amendments to the Food, Drug, and Cosmetic Act, 1962.

10. Temin P, PhD, op. cit., Chapter 6.

11. National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS, Final report, 8/15/90.

12. Composition of the National Committee: Chair, Louis Lasagna, MD, Dean, Sackier School of Graduate Biomedical Sciences, Tufts U.; Members: Theodore Cooper, MD, PhD, CEO, The Upjohn Co.; Gertrude Ellon, DSc, Scientist Emeritus [and Nobel laureate], Burroughs Welcome Co.; Emil Frei, III, MD, Director & Physician-in-Chief, Dana Farber Cancer Institute; Samuel Hellman, MD, Dean, Biological Sciences, Pritzker School of Medicine, U. of Chicago; Peter Barton Hutt, LLM, Covington & Burling; Charles Leighton, MD, Sr. VP, Medical & Regulatory Affairs Worldwide, Merck Sharp and Dohme; Thomas C. Merigan, Jr, MD, Becker Prof. of Medicine, Stanford U. Medical Center; Henry C. Pitot, MD, PhD, Director, McArdle Laboratory for Cancer Research, U. of Wisconsin; Executive Secretary: Dr. Elliott H. Stonehill, National Cancer Institute

13. Schneider v Revici, Appellate opinion, 1987; Boyle v, Revici Appellate opinion, 1992. in unanimously ruling on Schneider and reaffirming on Boyle, the Federal circuit judges remarked:

      "Appellees contend that it is against public policy for one expressly to assume the risk of medical malpractice and thereby dissolve the physician's duty to treat a patient according to community standards. We first note that the ‘public policy' referred to…is defined solely by statute…and appellant points to no statute imposing limitations upon such express agreements. Moreover, we see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment. While a patient should be encouraged to exercise care for his own safety, we believe that an informed decision to avoid surgery and conventional chemotherapy is within the patient's right to determine what shall be done with his own body.”

14. Congressional Record – Senate, 5/19/94, S6130-S6132. Also, unattributed, Concept paper access to medical treatment act, c. 1994.; and Jaffe RA, Esq., Memorandum, 5/17/94.

15. Interview by editors, James S Todd, MD, American Medical News; 1/6/89.

Search our pre-2001 archives for further information. Older issues of the printed magazine are also indexed for your convenience.
1983-2001 indices ; 1999-Jan. 2003 indices
Once you find the magazines you'd like to order, please use our convenient form, e-mail subscriptions@townsendletter.com, or call 360.385.6021 (PST).