In the summer of 2001, the Townsend Letter began a series of articles about the Office of Professional Medical Conduct (OPMC), the state medical board that disciplines New York physicians for substandard care. To date, this series has consisted of five articles about the operation of the OPMC, a digest of testimony at a New York Assembly hearing in 2002 on complaints of due process abuse by this regulatory agency, and a commentary on the Assembly hearing.

Why so many articles about the New York board? First, the OPMC, with jurisdiction over 60,000 physicians (one in ten licensed in the US), oversees virtually all types of care provided by MDs, ranging from treatments in community practice to state-of-the-art investigational therapy. Thus it serves as a case study, illuminating the proceedings of all state medical boards.

Second, New York has a relatively large number of physicians practicing complementary and alternative medicine (CAM). Despite increases in public and government acceptance of CAM in recent years, the OPMC has viewed and continues to view, the approaches of many of these doctors as unacceptable departures from treatment norms.

Third, numerous groups have expressed dissatisfaction with the OPMC for inconsistency and unfairness in its disciplinary proceedings. They include consumer protection and public interest organizations, medical societies and associations, and the bar associations of New York City and New York State. Additionally, legislative committees supervising the OPMC have faulted its performance, and the media have weighed in against the agency for weak penalties in cases of gross incompetence and negligence.

Fourth, except for occasional exposés or analyses by the media (chiefly newspapers), no mass-circulation periodical had extensively covered the OPMC. Appreciating the need to spotlight the agency’s questionable behavior, particularly its dealings with CAM, the Townsend Letter decided to maintain a spotlight on the New York state board in the hope that prolonged public exposure would accelerate reform.

Article One (“Introduction,” Aug./Sept 2001) reviewed the establishment of the OPMC within the New York Health Department over a quarter of a century ago, documented periodic complaints about its performance in disciplining mainstream doctors, and noted major reforms of the agency through 1991.
It featured the case of Dr. Joseph Burrascano, a mainstream specialist in infectious illness, who gives long-term antibiotic treatment to patients believed to be suffering from chronic Lyme disease. The OPMC had charged him with improper drug use (among other charges), and prior to publication, the hearing panel in his case had not yet reached a verdict. The first article termed Dr. Burrascano’s approach a “minority treatment” because the great majority of Lyme doctors adhere to a much shorter 30-day antibiotic protocol.

Key Points

Creation of the OPMC: A malpractice insurance crisis in the mid-1970s offered the New York Legislature the rationale to shift responsibility for determining medical misconduct from the New York State Education Department to the Health Department. The shift, occurring in 1975, split the responsibility for disciplining physicians between the two departments, leaving the final determination in disciplinary actions to the New York State Board of Regents, which heads the Education Department.

Complaints about the OPMC and reforms over the years: Changes in the OPMC’s authority since its establishment have resulted from requests for more power, funds, and personnel to expedite disposal of complaints. Yet despite additional power, infusions of funds, expansion of the agency’s staff, and removal of the Regents from the disciplinary process (1991), criticism concerning the agency’s backlogged cases, sluggish proceedings, due process abuse, and penalties commuted or dismissed on appeal, has continued.

The weak evidentiary basis for most commonly-used treatments: Modern outcomes research indicates that most commonly accepted treatments lack a solid “evidentiary basis for clinical decision making.”¹Estimates from different sources range up to 80%, and these findings have circulated via medical journals since the late 1970s. The first article raised the possibility that the OPMC ignores the weak evidence of efficacy for much community practice (the agency’s prime standard of care), in charging physicians using minority approaches with medical misconduct.

Consensus of expert opinion not reliable: The history of the OPMC reveals convictions won on expert testimony before hearing panels, which appellate panels have softened or overturned, thanks to testimony from different experts. The plain fact is that medical experts often differ among themselves. For instance, experts drafting guidelines will arrive, more often than not, at a consensus which hides disagreement on appropriate care. This results when some consensus group members rely on a data base conflicting with the data base of others. Or when all rely on the same base but interpret the data differently. Pointing out that the OPMC possesses the typical prosecutor’s mentality, the first article observed that zealous agency investigators and prosecutors shop for expert witnesses whose testimony supports misconduct charges, dismissing experts whose testimony to the contrary might clear doctors before complaints against them proceed to trial.

Article Two (“Complementary and Alternative Physicians,” October 2001) began with a report on attempts by the state medical boards to place HMOs under the boards’ jurisdiction. The report noted that the Federation of State Medical Boards (FSMB) advocated this expansion of power. The reason, as stated by the FSMB: doctors employed by insurance companies to make decisions on reimbursement for treatment need to be accountable to the public (i.e., the medical boards). The second article warned that such expansion by the state boards would inject them into disputes about appropriate care, and amount to third guessing of second guessing by HMO’s on problematic treatment decisions by doctors.

Article two then probed the OPMC’s disregard for the concerns and needs of patients, observing that the agency seems less interested in safeguarding patients from substandard physicians than it is in utilizing their cases to prosecute physicians whose therapeutic approaches deviate from community practice – even where the approaches appear safe, beneficial, and desired by patients.
The remainder of the second article examined the OPMC’s prosecutions of doctors who practice various types of complementary and alternative medicine (CAM). The examination suggested that the agency feels that CAM is a form of medical heresy, and equated its feeling with the dogmatic suppression of religious differences by late medieval inquisitors.

Article two ended with an account of the OPMC’s tactics in attempting to revoke the license of a high-profile CAM physician, Dr. Serafina Corsello. The agency had arraigned her for treatments it deemed inappropriate or unnecessary, and an administrative law judge had ruled her in default on a legal technicality, thereby avoiding a hearing on the facts.

Key Points

Appropriate care a contentious matter in mainstream medicine: The second article stressed that the issue of appropriate care has dominated a bitter debate over health care policy in the US for nearly two decades. In 1988, Dr. John Wennberg, a pioneer in tying analyses of results of treatment to formulations of policy, predicted that this debate would become “increasingly acrimonious and divisive, pitting physician against physician, specialty group against specialty group, and the profession itself against the payer and the government, with the patient lost somewhere in the rhetoric.”²

OPMC’s disregard of patients’ preferences re: treatment risks and benefits: Highlighting the OPMC’s prosecutions of physicians who give Lyme disease patients long-term antibiotic treatment, the second article reported that the agency chose nine patient files in building its case against one of these physicians. Five of these patients objected to selection of their files, disputed the charge of improper drug use, and credited the long protocol with substantially improving their condition. The potential risk – organ damage from long-term antibiotic care – mattered less to them than the relief they insist they’ve gotten under this protocol.

Article two reported that patients of other physicians the OPMC has prosecuted for treatment that departs from community practice, treatment apparently providing benefits unobtainable from standard therapy, have reacted similarly. The OPMC is blind to the needs of these patients and deaf to their expressed preferences. Narrowing its focus on the physician half of the doctor/patient relationship, the agency preoccupies itself with the risk a deviant physician may present rather than on the improvement his or her treatment may bring to patients.

OPMC’s bias against complementary and alternative medicine (CAM): Carrying forward its discussion of the OPMC’s penchant for involving itself with appropriate care, the second article concluded that the agency, confronted by CAM, regularly busies itself with de facto evaluations of CAM, ignoring treatment benefits, discounting even the paucity of reports of adverse effects. The likeliest reason? The agency regards CAM approaches not so much as departures from community practice as irksome challenges to standard care. One can’t conclusively demonstrate this, yet considering the many procedural irregularities in the agency’s cases against CAM physicians, they can reasonably be perceived as defensive reactions.

Article Three (“Medical Politics and Reform of the OPMC” Feb/March 2002) focused on competition in medicine. Briefly, selectively scrolling through history, the third article showed that competition between medical schools and groups is old hat, and proposed that it can be good (leading to improvement in care), or bad (inhibiting innovation by practitioners and access to care for patients).

A review of how modern-day politicians react to and resolve competition between special interest groups in health care followed the historical section. Next, the third article ventured observations on how politicians view the various shortcomings of the OPMC. It then concluded with advice on getting politicians to see that changes in the public’s view of medical knowledge, which strengthen the evaluative role of patients in treatment decisions, favor OPMC reform.³

Key Points

Absolute confidentiality of complaints to OPMC can mask anti-competitive motives: Article three conjectured that the place where competitive factors may underlie allegations of professional misconduct now appears to have moved from the courts to the state medical boards – in cases where departures from community practice fundamentally involve minority approaches to treatment (mainstream or alternative).

That change provided the secrecy provision on complaints to the state boards, which encourages physicians to take advantage of this administrative requirement and report doctors whose therapeutic approaches draw patients away from them. Of course, where physicians feel it opportune to complain about contending approaches, the complaints will arrive at the OPMC phrased in terms that obscure the competitive aspect.

Adjustments of the laws governing the OPMC: At a nutraceutical conference in New York City in 2000, a young lawyer-lobbyist offered his opinion on whether Congress might repeal the Dietary Supplement Health and Education Act of 1994 (DSHEA 94). “Public opinion still favors DSHEA,” he said, “They won’t repeal or gut it. They’ll make an adjustment” [emphasis added].
The third article revealed that over the past quarter of a century, whenever criticism of the OPMC’s performance peaked, the New York Legislature has “adjusted” the laws governing this agency. These expeditious reforms, extending the agency’s power and reach, have temporarily quieted interest groups who favor loosening, not tightening, restrictions on the OPMC’s disciplinary function.

The core matter for reform of the OPMC: In closing, article three predicted that prosecution of minority approaches to health care, denying patients access to treatment options when standard therapy fails, would be the core matter for the Legislature and administration to address in redirecting the OPMC to serve the entire New York patient population.

Article Four (“New York State Assembly Holds Joint Hearing on Disciplinary Process for MDs,” April 2002) digested testimony given at a New York Assembly hearing on the OPMC held in January 2002. This digest offered what few members of the public would ever get to hear or read – a detailed, accurate representation of complaints against the agency for due process violation. And it led off with a presentation least likely to show bias; testimony from the health law section of the New York State Bar Association. This testimony lent credibility to all the other complaints about unfair investigations and trials of physicians.

Article Five (“Reforming New York’s OPMC: Curative or Cosmetic Surgery?” July 2002) commented about the New York Assembly session on the OPMC. The point most worth emphasizing was conveyed through the following quotation from William Wardell, MD, an expert on the FDA:
“The medical profession should point out that existing drugs are inadequate to deal with most of the diseases we face. The object of legislation in this area should be to protect the public against all diseases, not just iatrogenic ones. In my opinion, the public interest would be well served by policies designed to stimulate the development and introduction of better medicines…it would be a historic and entirely feasible step if government agencies (including the FDA), were given formal mandates to do this.
“Public interest organizations should be educated to recognize the aforementioned point. The sick patient who needs more effective or safer therapy than is currently available will derive cold comfort from the present activities of the consumer groups who claim to represent his interests. If consumer groups fail to represent the patient’s paramount needs, a separate organization is obviously required.”⁴

Article Six (“Who Killed OPMC Reform in 2002?” October 2002) described the lobbying efforts in 2002 to legislate reform of the OPMC. These efforts succeeded in the Assembly but failed in the Senate. The reform package passed by the Assembly sought to increase the OPMC’s observance of due process protections for physicians. Republican Senators, who control that upper chamber of the New York Legislature, declined to pass a similar package, objecting to the Assembly package as a “doctor protection bill” rather than a “patient protection bill.”

The sixth article then delved into the Assembly/Senate (Dem/GOP) split that made it impossible to pass a bipartisan reform bill now (and in the foreseeable near future). It also looked at several related factors that combine to thwart reform: opposition by insurers unwilling to reimburse for long-term treatment of chronic Lyme disease, supported by Lyme specialists who reject the possibility that the infection can be chronic.

Article six ended with questions about the old-line consumer protection and public interest groups that allied themselves with the Senate GOP in killing the Assembly reform bill. The crucial question: How much of the public do they really represent?

Key Points

New York’s system for enacting laws: Offering reasons for defeat of the 2002 OPMC reforms, article six pointed one finger at the system for enacting bills in New York. This system vests control in three elected officials; the governor, Senate majority leader, and Assembly speaker. Little passes without agreement among all three.

When a majority of one chamber of New York’s bicameral Legislature belongs to one party; the majority in the second chamber belongs to the other party, passing a bill then usually depends on compromise between the Senate leader, Assembly speaker, and governor.

That triumvirate found it politically expedient this year, a gubernatorial election year, to disagree over whether reform of the OPMC to assure physicians due process protections is desirable. As long as Republicans hold the Senate, the Democrats the Assembly (these party holds are secure as locks), regardless of which party the governor belongs to, enactment of an OPMC reform package similar in purpose to the bill the Assembly passed this year, will remain an extremely iffy prospect.

OPMC and Lyme disease: Article six pointed a finger at another instrumental factor in defeating OPMC reform in 2002. This factor surfaced during an exchange at the Assembly hearing on Lyme in November, 2001. The speakers are Assemblywoman Maureen O’Connell (member of the Assembly Health Committee), and Kenneth Liegner, MD (associate editor, Journal of Spirochetal & Tick-Borne Diseases).

O’Connell: Why is there such an institutional block to understanding the pathology and the course of this illness?

Liegner: There is a type of social pathology going on here…. The interjection of the insurance industry has a great deal to do with the distortion of what would otherwise be a passionate but not a destructive debate within the medical community. Also, I think there’s a desire for things to be black and white. Ether you have it [Lyme] or you don’t…. Unfortunately, that’s just not the biologic reality of the illness….”

This notion pretty much got fixed in stone…. You must test positive or you don’t have Lyme disease – on an ELISA, mind you. And it’s just gotten sort of built into the literature. The physicians who published that and advocated that, practiced in that way. So for them to acknowledge that they might have been wrong, (A), it’s professionally embarrassing; (B), it opens them to tremendous litigation [malpractice]…. The best thing to do is to stonewall; put your troops together…circle the wagon trains, and try to insist that this is the way it is….

Article Seven (“Fundamental Reform of the OPMC,” December 2002) proposed three reforms. Because of differences between Democrats and Republicans concerning due process protections for MDs, which are likely to frustrate such reform in the foreseeable future, the reforms suggested in the 7th article addressed the OPMC’s prosecutions of physicians for “inappropriate” or “unnecessary” care, which appear on the rise.

Article seven reiterated the following pertinent points about defining appropriate care. (1) It’s a highly contentious area in mainstream practice; (2) Historically, the peer-review process has served to settle uncertainties about treatment; (3) The OPMC apparently lacks the expertise to distinguish between therapy that beneficially departs from community practice and therapy that can harm patients; (4) The agency’s standard for evaluating appropriate care remains community practice, despite recent research indicating that much community practice is not based on scientific evidence; (5) The OPMC ignores the preferences of patients in determining appropriate treatment, an attitude that runs counter to trends in medicine stressing that patients have the ethical right to choose between the risks and benefits of treatment.

The three reforms proposed in the seventh article all aim at controlling the OPMC’s appetite for evaluating appropriate care.

The first would instruct the agency to use a standard for effectiveness first proposed by the US Senate in its report on amendments to the FDA Act in 1962; that standard was “substantial” but not preponderant evidence for efficacy.

The second would instruct the OPMC to refrain from prosecution where patients expressly assume the risk of unproven therapy. Patients already have the right to make such a contractual arrangement between themselves and physicians in the civil courts. And legislation incorporating express assumption of risk has been introduced in the US Congress.

The third reform would discipline and fine the OPMC for wrongful prosecution in cases where appropriate care is at issue, and oblige the agency to reimburse exonerated doctors for all expenses in defending themselves.

Key Points

The OPMC’s problematic charges in cases involving appropriate care: Article seven noted that when the OPMC frames charges against doctors in such cases it may employ the terms “improper,” “incompetent” or “negligent.” (The agency seems to reserve the last two terms primarily for CAM practitioners.) 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.

OPMC lacks the expertise to evaluate appropriate care: Again inquiring into the OPMC’s de facto evaluations of minority approaches, the seventh article acknowledged that 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 scientific evaluation. Article seven protested, however, that the OPMC lacks experts equipped for such a specialized, sophisticated undertaking.

The Townsend Letter will publish an eighth article about the OPMC in its February/March issue. In effect, an afterword to the series, this piece will comment on the term “minority treatment” to denote any treatment that departs from prevailing mainstream approaches.

The commonly used terms “alternative” “complementary,” “unconventional,” and “unorthodox” don’t adequately reflect the process through which all new approaches pass en route to acceptance, regardless of whether they originate in or outside mainstream medicine.

An additional benefit of switching terms: “Minority treatment” has no record of pejorative or scornful use by the clinical research establishment as the others do; so under the term “minority treatment” truly unbiased trials of approaches departing from the norm may prove less difficult to arrange than they have been in the past.

This afterword will also comment on trends in society, medicine, and the courts that should eventually modernize the OPMC, chiefly through legislative reforms. These reforms would oblige the agency to (1) consider the shaky evidentiary foundation of most community practice when pursuing complaints against physicians who depart from the norm; (2) desist in acting against physicians whose “deviant” approaches injure no one and show plausible evidence of effectiveness; and (3) recognize that modern medical ethics gives patients the right to weigh, then choose treatment, rather than follow the dictates of physicians.

Last, this article will propose returning the OPMC to its primary, essential responsibility, which is to discipline demonstrably impaired, incompetent or negligent doctors. More and more, the agency has tended instead, to rule arbitrarily on the appropriateness, efficacy, or necessity of treatment given by physicians offering minority approaches to care
.
Unchecked, this tendency diverts personnel from closing the cracks in the disciplinary system that permit really “bad” doctors to slip through with minimal penalty. It also squanders public money on improper investigation and prosecution of “good” doctors – those whose departures help patients while causing little or negligible harm. Most important, the OPMC’s predilection for evaluation of minority approaches taken by physicians, particularly CAM doctors, can imperil patients whose health or lives depend on access to therapeutic options.

First and foremost, readers can acquire from these summaries crucial, dependable information that’s hard to come by. Too few people have even the slightest inkling of how much power the OPMC (and other state medical boards) have over the quality and accessibility of care. Or remotely know how inept and careless in observing due process protections New York’s medical police can be when disposing of complaints against providers of minority treatment. Or that the agency’s attitudes, policies, and rulings may, as a matter of fact, sometimes endanger rather than protect patients from injury and loss of life.

A second worthwhile use: These summaries supply a compact package of elementary information for persons too busy to order and read the complete articles. Moreover, one can present them in this form to government officials who may never have scanned a quick, comprehensive, up-to-date review of the history and operation of the OPMC.

One final comment on the Townsend series about the OPMC, including the summaries: No one article or series of articles by itself is likely to precipitate long-term reorientation of the OPMC’s thinking and conduct, forcing it to serve the concerns and needs of patients before attending to its own proclivities. The call for change must sound repeatedly, coming in unison from various groups now underserved by the agency, until the politicians, hearing that call loudly, amend (not adjust) the laws governing New York’s system for sorting out medical misconduct.

Acknowledgements

The New Jersey Health Freedom Coalition and Vincent LaRocca separately contributed funds to help write the summaries for all the articles in this series on the OPMC.

Correspondence:
Marcus A. Cohen, Founder & Director
HealthTrends
8 East 96th St. #1C
New York, New York 10128 USA
212-946-5136
Fax 212-348-8288

References
1. Wennberg JE, MO, Improving the medical decision-making process, Health Affairs Spring, 1988.
2. Ibid.
3. Richards E, PhD, The politics of therapeutic evaluation, Social Studies of Science, November, 1988.
4. Wardell WA, MD, PhD, Drug development, regulation, and the practice of medicine, JAMA, 9/9/74, Vol 229, No 11, 1460.

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