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The misleading use of an incorrectly computed rate statistic.
A 2003 Drug Enforcement Agency DEA press release entitled
"The Myth of the Chilling Effect" [DEA,
is a very interesting document. It is
brief, a mere 182 words in seven sentences formed into four paragraphs, and
contains a table and six pie charts. Every sentence is entirely true, and
the text as a whole is odd only in that the content of the first three
paragraphs make no particular point regarding the "chilling effect" the
document purports to debunk. The overall message is: "DEA only brings
actions against a miniscule proportion of doctors, therefore actions against
doctors for violations of the Controlled Substances Act (CSA) cannot be
causing other doctors to seek to avoid such actions by failing to use opioid
analgesics appropriately or by refusing to prescribe them at all."
Let's start with the title. What is a
"chilling effect"? The phrase does not exist in most dictionaries as such.
"Chilling" is an adjective meaning 'so scary as to cause chills and
shudders,' and as a verb "chill" can mean 'to depress or discourage.' Let me
propose the following working definition of a "chilling effect" that is
consistent with what the DEA is addressing in its press release:
The Chilling Effect:
The withdrawal, for fear of litigation, by physicians from the
appropriate treatment of pain.
It is important to note that much of the
public health damage here is caused not by the doctors accused of
wrongdoing, rather it is caused by doctors-in-good-standing who, faced with
a patient in pain and therefore at risk of being targeted by the DEA, modify
their treatment in an attempt to avoid regulatory attention. This
distortion of the doctor-patient relationship is complex and can be gross or
subtle. Examples include a blanket refusal to prescribe controlled
substances even when clearly indicated, or selecting less effective and more
toxic non-controlled medications when a trial of opioid analgesics would be
in the best interests of a particular patient. At the very least, some
degree of suspicion and mistrust will surely arise in any medical
relationship involving controlled substances.
There is very little a well-intentioned
physician can do to mitigate this risk, to correct these distortions in
medical values, ethics, and in the doctor-patient relationship that always
arise in the course of treatment for pain and/or substance abuse problems.
Even experts in the medical treatment of addiction and pain cannot make the
crucial distinction, the identification of the 'legitimate pain patient,'
[PAIN_CHEM_DEP listServ, 2003]
Quite simply, the core presumption, that the
states-of-being: 'legitimate pain patient,' 'drug abuser,' 'diverter,'
'frequent flyer,' etc., are mutually exclusive and dichotomous is,
The legal punishment for mistaking a drug abuser for a pain patient can be
extremely severe; doctors are being threatened with 28-year prison terms
(Dr. Hasman), have been likened to "crack dealers" (Dr. Hurwitz) and tried
as "drug kingpins" (Dr. Bordeaux).
& Kaufman, 2003] On the other hand, mistaking
a pain patient for a drug addict, and thereby committing the error of
failure to appropriately treat pain, is highly unlikely to have any legal
consequences at all. This set of legal and psychological imperatives with
their attendant severe punishments has created a near ideal environment for
manifestation of a "chilling effect," which inexorably leads to the
under-treatment and non-treatment of pain in America.
The Controlled Substances Act (CSA) of
1972, which supersedes and replaces the Harrison Act and all intervening
federal drug legislation, makes it a federal offence to prescribe controlled
substances to a drug addict for the purposes of treating or maintaining
their addiction, except where the physician holds a separate DEA license to
provide methadone maintenance. This is what defines the "bounds of accepted
medical practice" referred to in the subtitle of the DEA press release under
consideration. Defining the medical treatment of addiction as 'outside the
bounds of accepted medical practice' is a legacy of the Harrison Narcotics
Tax Act of 1914 as discussed earlier in this paper.
The one table contains the only comprehensible data in the DEA press release
and makes, somewhat obliquely, the point as stated in the beginning of this
analysis. Here is the table which presents partial Fiscal Year (FY) 2003
Total registrants = 963,385
% Total Registrants
Actions Against MDs:
Arrests of MDs:
The table is presented without caption
or discussion except what is contained in paragraph four:
Since FY 1999 the DEA registrant
population has continually increased reaching almost 1 million doctors (as
of June 30, 2003). During this same time, DEA has pursued sanctions on less
than one tenth of one percent of the registered doctors..."
We are talking about risk here and the
appropriate statistic is a rate. The Numbers in the table above can
correctly be used as numerators to compute this statistic, however, Total
registrants is not the appropriate denominator because the
denominator used must include only physicians who could possibly come to DEA
attention. I call this misleading use of an incorrectly computed rate
Having a DEA license is necessary but not sufficient to put a physician at
risk of investigation, loss of license and arrest. The other requirement for
being a physician-at-risk, thereby earning a rightful place in the
denominator, is prescribing controlled substances in regimens that DEA finds
questionable, and this number is far, far smaller. It should be noted in
this regard, that DEA licensure is commonly required for hospital employment
or privileges regardless of whether a physician ever intends to prescribe
controlled substances or even possesses the special prescription pad
necessary to do so.
Exactly how much smaller is the appropriate denominator? The answer is open
to interpretation and affected by assumptions; only the DEA could provide
the precise number and they do not publish this datum. For example, using
the full year's numbers from the same 2002 data set, 622 physicians were
investigated, charges were brought against 586, and in 426 cases medical
licenses were revoked "for cause."
Dr. Hochman, a pain specialist and the Executive Director of the National
Foundation of the Treatment of Pain, estimates that the number of physicians
practicing "chronic opioid therapy" was 5000 in 2002. This estimate is
somewhat close to the "3000 pain specialists" estimated by Eric Chevlen.
we use Hochman's "5000 doctors practicing chronic opioid therapy" number to
compute the rate statistic (and assuming that all in the numerator are also
members of the denominator): 622/5000 = 0.1244 = a DEA
investigation-or-action rate of 12.44 percent, orders of magnitude higher
than the incorrectly computed DEA rate statistic of "less than one tenth
of one percent of the registered doctors." The comparable rate using Chevlen's
"3000 pain specialists in the U.S." is 20.73 percent of at-risk
physicians had DEA action initiated against them in 2002.
I do not know exactly how either Hochman
or Chevlen arrived at that their estimates. If reasonably derived, either
estimate could be a statistically appropriate denominator to compute a risk
statistic. On the other hand, the DEA's choice for the denominator is most
certainly wrong. I am trying here to give a sense of how important it is to
be explicit about one's assumptions in these matters and of how difficult it
is, given the available DEA data, to construct even simple rates that are
more enlightening than misleading. Regardless of how the rate statistic is
computed, a "chilling effect," as operationally defined in this paper, is
not a solely a function of risk as defined by an appropriate rate; severity
of risk, highly publicized trials of prominent physicians, and the perceived
rationality or irrationality of the DEA criteria used to set the "bounds of
accepted medical practice" also play a significant role in how physicians
react to the fear of litigation.
Finally, as Dr. William Hurwitz pointed
out in a December 7, 2003 message to the PAIN_CHEM_DEP listServ, the DEA
presents statistics relating only to their actions against doctors and not
the consequent distortion of medical practice that is the 'chilling effect'
they are claiming to examine. "The same purportedly low rate of disciplinary
action cannot logically serve as an index of both cause and effect. How can
one determine if there has been a chilling effect without looking at what
doctors really do? There has been no attempt by the DEA to do so."
[Hurwitz, 2003] I call
this misleading confusion of outcome for index event, "Outcome
One can only conclude that The Myth
of the Chilling Effect DEA press release is grossly and purposefully
misleading, and statistically childish.
DEA. The Myth of the
"Chilling Effect" - DEA Press Release. Department of Justice, Washington DC,
Orient JM. AAPS
Correspondence with DEA. American Association of Physicians and Surgeons,
Inc, Tucson, 4-23-2003. (Available:
White J, Kaufman M. U.S.
Compares Va. Pain Doctor to 'Crack Dealer'. Washington Post, Section B3,
Hoffman J. What We All
Need To Do. National Foundation for the Treatment of Pain . 2003.
Chevlen E. A Bad
Prescription from the DEA; The drug agency's misguided campaign against a
painkiller. The Weekly Standard, 6/4/2001. (Available:
Hurwitz W. The same
disciplinary rate cannot serve as an index of both cause and effect.
PAIN_CHEM_DEP listServ moderated by Dr. Ian Buttfield . 12-7-2003.
I hope you found this document helpful. The "Understanding
Drug War Statistics" series continues with Part
6: "Flash Trash"