|
|
|
|
|
|
|
|
|
|
|
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.
|
|