Analysis of: "The Myth of the 'Chilling Effect' -
Doctors Operating Within Bounds of Accepted Medical  Practice Have Nothing to Fear From DEA" 
a DEA press release published October 30, 2003

[My sincere thanks to the membership of the PAIN_CHEM_DEP listServ, moderated by Dr. Ian Buttfield, for their generous and thoughtful criticism much of which I have incorporated in major  revisions of this document between 12/06/2003 and 12/09/2003. Special thanks to Drs. Farkas, Hurwitz, and Weitzel for their time and assistance.]

Table of Contents:

What is the "Chilling Effect"
The "Bounds of Accepted Medical Practice
The text of "The Myth of the Chilling Effect"
A table, six pie charts, and Denominator Abuse
Conclusion
 

A 2003 Drug Enforcement Agency DEA press release entitled "The Myth of the Chilling Effect" is a very interesting document. It is brief; a mere 182 words, and contains a table and six pie charts. 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.

What is the "Chilling Effect"
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' is the withdrawal by physicians from the appropriate treatment of pain resulting from fear of litigation.

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 the risk of being accused, 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 a less effective and more toxic Schedule IV or V medication regimen when a trial of Schedule II drugs would be in the best interests of a particular patient. At the very least, some degree of suspicion and mistrust will almost surely arise in any medical relationship involving controlled substances.

There is very little a well-intentioned physician can do to mitigate this risk - even experts in the medical treatment of addiction and pain cannot make the crucial distinction, the identification of the 'legitimate pain patient,' with confidence. [PAIN_CHEM_DEP listServ discussion, circa 11/2003] 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, medically, false.

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). [Orient, AAPS Correspondence with DEA, 2003 and  White, "US compares VA pain doctor to 'crack dealer,'" Washington Post, 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 the 'chilling effect,' the under-treatment and non-treatment of pain in America.

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The "Bounds of Accepted Medical Practice"
The CSA makes it a federal offence to prescribe controlled substances to a drug addict for the purposes of treating or maintaining their addiction, except in the situation 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 the legacy of the Harrison Narcotics Tax Act of 1914 and this is the historical crux of the war on drugs, the war on doctors, and the pain crisis in America. [See: "A Tax Act Gone Terribly Wrong" in  DeLuca, 2004, "War on Drugs, War on Doctors, and the Pain Crisis in America."]

"Our grievous error was in allowing the narcotics addict to be pushed out of society and relegated to the criminal community. He isn't a criminal. He never has been. And nobody looked on him as such until the furious blitzkrieg launched around 1918 in connection with the enforcement of the Harrison Act… Narcotics-users were "sufferers" or "patients" in those days; they could and did get relief from any reputable medical practitioner, and there is not the slightest suggestion that Congress intended to change this - beyond cutting off the disreputable "pushers" who were thriving outside the medical profession and along its peripheries... There commenced a reign of terror. The medical profession was shamelessly bullied and threatened, until it withdrew... as the addict's last point of contact with society." [King, "The Narcotics Bureau and the Harrison Act: Jailing the Healers and the Sick," Yale Law Review, 1953]

Paragraph one merely states that "the vast majority of practitioners registered with DEA comply with the requirements" of the CSA.

Paragraph two outlines the mission of the DEA's Diversion Control Program (DCP), "to prevent, detect and investigate the diversion of legitimately manufactured controlled substances" and the requirement that "doctors to become registered with DEA in order to prescribe, dispense or administer controlled drugs to their patients for legitimate medical reasons."

Paragraph three, in its entirety: "The DEA may initiate an investigation of a practitioner upon receipt of information of an alleged violation of the provisions of the CSA and may pursue sanctions against the practitioner based upon the facts determined from that investigation."

Paragraph four presents the first data directly relevant to the topic of the press release and prepares the reader to consider the table and pie charts that comprise the remainder of the document: "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. The pie charts pictured put this in graphic perspective."

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A table, six pie charts, and Denominator Abuse
The table and charts comprise the meat of the press release and make, somewhat obliquely, the point as stated in the beginning of this analysis. Here is the table which presents partial Fiscal Year (FY) 2003 data:
 

The table is presented without caption or discussion except what is contained in paragraph four quoted above. The point to be taken away, apparently, is that because the DEA initiates action against only a small percentage of doctors therefore doctors operating within the bounds of accepted medical practice have nothing to fear.

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 DEA 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 "Denominator Abuse."

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 CS or even possesses the special prescription blanks 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 complete 2002 DEA data set,  "[in] 2002, according to Dr. Joel Hochman, director of the National Foundation for the Treatment of Pain, the DEA investigated 622 physicians, brought charges against 586, and in 426 cases medical licenses were revoked 'for cause.'" [Meier, "What is the risk in long-term opioid use?" 2003]  Hochman estimates that the number of physicians practicing "chronic opioid therapy" was 5000 in 2002. If we were to use these numbers 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 for practitioners of chronic opioid therapy, orders of magnitude higher than the DEA-reported statistic.

Please Note: I am NOT saying that Dr. Hochman's estimate of 5000 physician practicing chronic opioid therapy is correct. I do not know exactly how he arrived at that number or whether, even if it was reasonably derived, it in fact represents an appropriate denominator to compute the desired rate. 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 extremely difficult it is, given the available DEA data, to construct even simple rates that are more enlightening than misleading.

The rest of the press release is pie charts. The first pie chart simply represents the second row, "Actions Against MDs" of the table. The second breaks down the first row of the table, "Investigations Initiated" into subcategories. The remaining four pie charts are the same as the first for the years 1999 through 2002. Given the denominator abuse problem discussed above, none of the pie charts contributes anything intelligible to a discussion of physician risk, the "chilling effect" or the problem of the under-treatment of pain.

Conclusion
This paper analyzes the DEA press release entitled "The Myth of the 'Chilling Effect' - Doctors Operating Within Bounds of Accepted Medical Practice Have Nothing to Fear From DEA" which was published on 10/30/2003.

The 'chilling effect' is the withdrawal by physicians from the appropriate treatment of pain resulting from fear of litigation.

The title-statement of the DEA press release is false, because the denominator chosen to compute the rate statistic it is based on is incorrect, an example of "Denominator Abuse."

Regardless of how the rate statistic is computed, a "chilling effect," as operationally defined in this paper, is not a solely a function of the risk as defined by an appropriate rate, even if that could be determined. Severity of risk 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 behave in reaction to the fear of litigation.

"The Myth of the 'Chilling Effect' presents data and purports to be a reasoned analysis of the 'chilling effect' phenomenon. But as Dr. William Hurwitz has pointed out in a 12/07/2003 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, 12/07/2003 message to PAIN_CHEM_DEP listServ]  

I call this misleading confusion of outcome for index event, "Outcome Obfuscation."

One can only conclude that this DEA press release is grossly and purposefully misleading.

[END]