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"What we have here is a
failure to communicate." These are the last words spoken the moment before a
Southern prison warden fatally shoots the irrepressible convict played by Paul
Newman in the now classic film "Cool Hand Luke." The first impression an
objective, third party might have in reading Dr. Heit's editorial in this issue
of Pain Medicine is that a similar failure might explain the precipitous,
bizarre, and inexplicable revocation by the Drug Enforcement Administration
(DEA) in early October of 2004 of its endorsement of and support for
Prescription Pain Medications: Frequently Asked Questions and Answers for Health
Care Professionals and Law Enforcement Personnel (hereinafter FAQ), a document
that had been unveiled with much fanfare merely 2 months earlier. But closer
scrutiny of the chronology of events suggests that the communication breakdown
theory is highly improbable.
As Dr. Heit points out [Healthcare
Professionals and the DEA: Trying to Get Back in Balance;
Heit; 2006], the FAQ was the product of years of collaborative effort
among experts in the field of pain medicine and representatives of the DEA that
worked through no fewer than 20 drafts. The DEA was sufficiently comfortable
with the final version of the document that it placed it on its Website, as did
another major contributor to the project, the Pain and Policy Studies Group at
the University of Wisconsin (PPSG). Nevertheless, 2 months later the DEA sought
to justify its renunciation of the FAQ by asserting that it "contains
misstatements of law and other statements which could create confusion about the
applicable law and create misleading perceptions about physician's obligations
to remain within the bounds of accepted medical practice."1 For the DEA to
expect reasonably intelligent persons to accept the proposition that its
leadership had suddenly discovered "misstatements of law" in the FAQ that were
not apparent in the drafting process is beyond insulting.
As Dr. Heit notes, the DEA's interim policy statement (IPS) published the next
month in the Federal Register identified several alleged misstatements in the
FAQ that purportedly justified its unilateral rejection of the product of this
collaborative effort.2 While Dr. Heit focuses his remarks on the "Do Not Fill
Until" (DNF) prescription issue, the IPS also sought to retrench from the
proposition that physicians would not be targeted by the DEA merely because of
the number of patients in their practice who received opioids, the volume of
prescriptions patients received, or the duration of opiod therapy. The DEA
asserted that it "can investigate merely on suspicion that the law is being
violated, or even just because it wants assurances that it is not." The IPS also
sought to impose a much higher level of scrutiny and suspicion on physicians who
contemplate prescribing opioids to patients who are "known or suspected
addicts."
There is much about the DEA's conduct since August of 2004 that legitimately
calls into question prior representations by its leadership that it recognizes
and respects the compelling need for balance between the goal of ensuring that
patients who need opioid analgesics to manage their pain receive them in a
medically appropriate manner, and the goal of deterring or discovering drug
diversion. The DEA's participation in the issuance in 2001 of the Consensus
Statement calling for a balanced policy on prescription pain medication,3 and
its diligent pursuit of the FAQ consensus document through many months of
collaborative effort and multiple revisions, sent a very favorable and
encouraging message to the pain medicine community. What has transpired since
sends exactly the opposite message, particularly the most recent pronouncement
by the DEA after ostensibly considering the many comments to the IPS that it
solicited in January of 2005.4 Among the many thoughtful commentaries received
but largely ignored or discounted by the DEA was a 16-page discussion and
analysis of the relevant issues and concerns submitted by the PPSG, one of the
primary contributors to the FAQ. Among the eminently reasonable requests of the
DEA set forth in this document were: 1) reaffirmation of the appropriateness of
the DNF approach to opioid prescribing; 2) reassurance to practitioners that
legitimate pain management practices will not be viewed as indicators of
addiction; 3) clarification of what constitutes unlawful conduct under the
Controlled Substances Act; 4) avoidance of propagating fear in law-abiding
practitioners; and 5) appointment of an advisory committee to assist the DEA in
promoting balance in the regulation of the use of controlled substances.5
Serious concerns about the current attitudes and practices that appear to
prevail within the DEA extend beyond the bounds of the pain medicine community.
On January 19, 2005, 29 members of the National Association of Attorneys General
(NAAG), the organization that represents the chief legal officers of the states,
signed a letter to the administrator of the DEA expressing concerns that the
revocation of the FAQ and the issuance of the IPS are "likely to have a chilling
effect on physicians engaged in the legitimate practice of medicine."6 In March
of 2005, NAAG followed up on that letter by submitting its own detailed
commentary on the IPS that made some of the same recommendations to the DEA as
the PPSG comments, including the appropriateness of DNF prescriptions for
opioids and the need for an advisory committee.7 If those at the top of the DEA
hierarchy can be so manifestly indifferent, if not hostile, to the insights and
perspectives of such groups, then perhaps, regrettably, we are tilting at
windmills when we in the pain community continually beseech the DEA to genuinely
embrace the concept and public policy of balance, and to acknowledge the
critical need to wage a war on pain with the same degree of conviction and
determination as it brings to the war on drugs.
Footnotes:
1. Letter dated
October 4, 2004, from William Walker, Deputy Assistant Administrator of the
Office of Diversion Control to David E. Joranson, Director of the University of
Wisconsin Pain and Policy Studies Group,
available at:
http://www.medsch.wisc.edu/painpolicy/
2. Drug Enforcement Administration, Dispensing of Controlled Substances for the
Treatment of Pain. Federal Register, 69: 67170–67171, November 16, 2004.
3. DEA, 21 Health Care Organizations News Release, October 23, 2001,
available at:
http://www.lastacts.org/
4. Federal Register 70: 50408–50409, August 26, 2005.
5. Letter from David E. Joranson to DEA Deputy Administrator dated March 11,
2004,
available at:
http://www.medsch.wisc.edu/painpolicy/
6. Letter from National Association of Attorneys General to Karen Tandy, DEA
Administrator, date January 19, 2005,
available at:
http://www.doctordeluca.com/Library/WOD/NAAGtoDEAreFAQ.pdf and also
from:
http://www.naag.org/
7. Communication from 32 state attorneys general to DEA Deputy Administrator
dated March 31, 2005,
available at:
http://www.doctordeluca.com/Library/WOD/NaagFinalDeaComment032105.pdf
and also from:
http://www.naag.org/
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