[Congressional Record (Bound Edition), Volume 151 (2005), Part 5]
[Extensions of Remarks]
[Pages 6973-6975]
[From the U.S. Government Publishing Office, www.gpo.gov]




DRUG ENFORCEMENT AGENCY MUST RESTORE BALANCE BETWEEN PRESCRIPTION DRUG 
        ABUSE AND PROVIDING PATIENT ACCESS TO NEEDED MEDICATIONS

                                 ______
                                 

                          HON. CHARLIE NORWOOD

                               of georgia

                    in the house of representatives

                        Tuesday, April 19, 2005

  Mr. NORWOOD. Mr. Speaker, I think there is little doubt that our law 
enforcement agencies should conduct themselves, in fulfilling their 
founding purpose, in a manner that is consistent with their mission of 
serving the American people. In this light, I am submitting for the 
record an article by Radley Balko, a policy analyst with the Cato 
Institute, entitled ``Bush Should Feel Doctors' Pain''. The article 
suggests that the need to protect patients, while attempting to prevent 
diversion and misuse of prescription drugs is arguably out of balance.
  There is no doubt that prescription drug abuse, particularly the 
abuse of prescription pain medications, is a serious public health 
problem. I have been one of the most vocal advocates on the necessity 
of this body to address the abuse of prescription medication by 
patients, crack down on the practice of ``doctor shopping'' and 
prosecute those medical professionals that harm responsible pain 
management by violating their responsibility to the highest standards 
of their profession.
  Consequently, the Drug Enforcement Agency (DEA) should absolutely 
take appropriate steps to stop criminals from diverting these 
medications and exploiting those who would abuse them. But, it must 
also recognize that over 30 million Americans suffer chronic pain and 
need access to proper pain management by legitimate medical 
practitioners if they are to lead normal and productive lives.
  However, in its seemingly single-minded pursuit of ``bad doctors,'' 
the DEA appears to be showing its lack of proper understanding, 
inability, or unwillingness, to strike a proper balance between these 
two public policy goals. I am worried that this failure is scaring 
responsible doctors away from prescribing legitimate patients from 
obtaining needed medications, causing these patients and those who love 
and care for them untold harm and unnecessary distress.
  Congressmen Whitfield, Pallone, Strickland, and I have introduced 
H.R. 1132, a bill that would assist and encourage the States to 
establish a controlled substance monitoring program. These Prescription 
Monitoring Programs would assist physicians, pharmacists, and other 
healthcare professionals by providing them with prescribing information 
that would help them to detect abuse and diversion tactics and prevent 
``doctor shopping''. This legislation also would permit law enforcement 
to review this prescribing data, but only where they certify that the 
requested information is related to an individual investigation 
involving the unlawful diversion or misuse of schedule II, III, or IV 
substances, and that such information will further the purpose of their 
investigation.
  It appeared that the DEA realized it should not, indeed could not, 
dictate proper medical practice in the prescribing of pain medications. 
Last August, after working with a panel of distinguished physicians 
specializing in pain management, the DEA published guidelines for 
physicians who treat pain with opioids. These guidelines were designed 
to assure legitimate medical practitioners that they would not face 
prosecution simply because they prescribed such medications or treated 
a large number of patients in pain. Given the disturbing trend of 
doctors shying away from prescribing necessary medication due in large 
part to the issues discussed, the DEA should not act in a way that 
would further limit patients' access to needed pain management 
medications.
  Within weeks, the DEA abruptly withdrew these guidelines without 
explanation in a transparent attempt to avoid jeopardizing a pending 
high profile prosecution. Strong objections came from the medical 
community and from 30 state Attorneys General. I am also including a 
copy of their letter sent to the DEA in which they raise their 
objections.
  However, the DEA has not relented in its pursuit of doctors it 
considers to be practicing bad medicine in a field of practice that is 
still evolving and requires a certain latitude for the exercise of 
sound medical judgment. In effect, the DEA is doing the very thing it 
should not do, determine what is acceptable medical practice.
  The chilling effect the DEA's actions are having on physicians 
engaged in the legitimate practice of medicine is undeniable. Effective 
pain management has become all too difficult to obtain because many 
doctors are afraid to prescribe adequate levels of opioids for fear of 
investigation and prosecution. This is simply unacceptable, as a member 
of the healthcare community for over thirty years and a patient who has 
known the need for proper pain management.
  Yes, the DEA should continue to work with the appropriate state and 
local authorities to pursue those who abuse the trust that was placed 
in them when they obtained a medical license. Yes, we should be 
cracking down on those patients who seek to circumvent and abuse the 
system to abuse prescription medications. But the DEA must lead the 
charge to restore the balance between these different but certainly not 
mutually exclusive public health goals. By assuring legitimate medical

[[Page 6974]]

practitioners that they will not be investigated or prosecuted simply 
because they prescribe a certain kind of medication or have a 
successful practice, will better serve the American people, 
particularly those many millions who are needlessly suffering in pain.

                                           National Association of


                                            Attorneys General,

                                 Washington, DC, January 19, 2005.
     Karen P. Tandy,
     Administrator, Drug Enforcement Administration, Alexandria, 
         VA.
       Dear Ms. Tandy: We, the undersigned Attorneys General, 
     write to express our concern about recent DEA actions with 
     respect to prescription pain medication policy and to request 
     a joint meeting with you. Having consulted with your Agency 
     about our respective views, we were surprised to learn that 
     DEA has apparently shifted its policy regarding the balancing 
     of legitimate prescription of pain medication with 
     enforcement to prevent diversion, without consulting those of 
     us with similar responsibilities in the states. We are 
     concerned that state and federal policies are diverging with 
     respect to the relative emphasis on ensuring the availability 
     of prescription pain medications to those who need them.
       Subsequent to DEA endorsement of the 2001 Joint Consensus 
     Statement supporting balance between the treatment of pain 
     and enforcement against diversion and abuse of prescription 
     pain medications, the National Association of Attorneys 
     General (NAAG) in 2003 adopted a Resolution Calling for a 
     Balanced Approach to Promoting Pain Relief and Preventing 
     Abuse of Pain Medications (copy attached). Both these 
     documents reflected a consensus among law enforcement 
     agencies, health care practitioners, and patient advocates 
     that the prevention of drug abuse is an important societal 
     goal that can and should be pursued without hindering proper 
     patient care.
       The Frequently Asked Questions and Answers for Health Care 
     Professionals and Law Enforcement Personnel issued in 2004 
     appeared to be consistent with these principles, so we were 
     surprised when they were withdrawn. The Interim Policy 
     Statement, ``Dispensing of Controlled Substances for the 
     Treatment of Pain'' which was published in the Federal 
     Register on November 16, 2004 emphasizes enforcement, and 
     seems likely to have a chilling effect on physicians engaged 
     in the legitimate practice of medicine. As Attorneys General 
     have worked to remove barriers to quality care for citizens 
     of our states at the end of life, we have learned that 
     adequate pain management is often difficult to obtain because 
     many physicians fear investigations and enforcement actions 
     if they prescribe adequate levels of opioids or have many 
     patients with prescriptions for pain medications. We are 
     working to address these concerns while ensuring that 
     individuals who do divert or abuse drugs are prosecuted. 
     There are many nuances of the interactions of medical 
     practice, end of life concerns, definitions of abuse and 
     addiction, and enforcement considerations that make balance 
     difficult in practice. But we believe this balance is very 
     important to our citizens, who deserve the best pain relief 
     available to alleviate suffering, particularly at the end of 
     life.
       We understand that DEA issued a ``Solicitation for Comments 
     on Dispensing of Controlled Substances for the Treatment of 
     Pain'' in the Federal Register yesterday. We would like to 
     discuss these issues with you to better understand DEA's 
     position with respect to the practice of medicine for those 
     who need prescription pain medication. We hope that together 
     we can find ways to prevent abuse and diversion without 
     infringing on the legitimate practice of medicine or exerting 
     a chilling effect on the willingness of physicians to treat 
     patients who are in pain. And we hope that state and federal 
     policies will be complementary rather than divergent.
       Lynne Ross, Executive Director of NAAG, will contact you 
     soon to arrange a meeting at a mutually agreeable time, 
     hopefully in March when Attorneys General will be in 
     Washington, DC to attend the March 14-16 NAAG Spring Meeting. 
     We hope to meet with you soon.
       Thank you.
           Sincerely,
         Drew Edmondson, Attorney General of Oklahoma; Gregg 
           Renkes, Attorney General of Alaska; Mike Beebe, 
           Attorney General of Arkansas; Richard Blumenthal, 
           Attorney General of Connecticut; Thurbert E. Baker, 
           Attorney General of Georgia; Tom Miller, Attorney 
           General of Iowa; Gregory D. Stumbo, Attorney General of 
           Kentucky; Terry Goddard, Attorney General of Arizona; 
           Bill Lockyer, Attorney General of California; Robert 
           Spagnoletti, Attorney General of District of Columbia; 
           Lisa Madigan, Attorney General of Illinois; Phill 
           Kline, Attorney General of Kansas; Charles Foti, 
           Attorney General of Louisiana; Steven Rowe, Attorney 
           General of Maine; Michael A Cox, Attorney General of 
           Michigan; Jeremiah Nixon, Attorney General of Missouri; 
           Jon Bruning, Attorney General of Nebraska; Wayne 
           Stenehjem, Attorney General of North Dakota; Roberto 
           Sanchez Ramos, Attorney General of Puerto Rico; Joseph 
           Curran Jr., Attorney General of Maryland; Mike Hatch, 
           Attorney General of Minnesota; Mike McGrath, Attorney 
           General of Montana; Patricia Madrid, Attorney General 
           of New Mexico; Hardy Myers, Attorney General of Oregon; 
           Patrick C. Lynch, Attorney General of Rhode Island; 
           Henry McMaster, Attorney General of South Carolina; 
           Mark Shurtleff, Attorney General of Utah; Darrel 
           McGraw, Attorney General of West Virginia; Paul 
           Summers, Attorney General of Tennessee; William 
           Sorrell, Attorney General of Vermont.
                                  ____
                                  

                     Bush Should Feel Doctors' Pain

                           (By Radley Balko)

       Since the late 1990s, the U.S. Drug Enforcement 
     Administration has allied with state and local law 
     enforcement agencies to stamp out abuse of the painkiller 
     OxyContin. Citing rises in emergency room episodes and 
     overdoses associated with the drug (both of which have been 
     roundly disparaged by critics), the DEA insists its 
     ``Operation OxyContin'' is a necessary reaction to the 
     diversion of the prescription narcotic for street use.
       Unfortunately, despite frequent robberies and burglaries of 
     pharmacies, doctors' offices, and warehouses where 
     prescription medications are stored and sold, the DEA has 
     focused a troubling amount of time and resources on the 
     prescriptions issued by practicing physicians. It's easy to 
     see why. Doctors keep records. They pay taxes. They take 
     notes. They're an easier target than common drug dealers. 
     Doctors also often aren't aware of asset forfeiture laws. A 
     physician's considerable assets can be divided up among the 
     various law enforcement agencies investigating him before 
     he's ever brought to trial.
       Over the last several years, hundreds of physicians have 
     been put on trial for charges ranging from health insurance 
     fraud to drug distribution, even to manslaughter and murder 
     for over-prescribing prescription narcotics. Many times, 
     investigators seize a doctor's house, office, and bank 
     account, leaving him no resources with which to defend 
     himself. A few doctors have been convicted. Many have been 
     acquitted. Others were left with no choice but to settle.
       All of this has been happening just as the field of chronic 
     pain management has made some remarkable progress. The 
     development of opium-based narcotics like OxyContin (also 
     known as ``opioids'') has been a Godsend to the estimated 30 
     million Americans who suffer from chronic pain. Opioids are 
     safe, effective, and, contrary to conventional wisdom, very 
     rarely lead to accidental addiction when taken properly. Most 
     of the medical literature puts the rate of such addiction at 
     less than one percent.
       The DEA's campaign puts law enforcement officials in the 
     troubling position of determining what is acceptable medical 
     practice in a field that's dynamic, still emerging, and 
     relatively experimental. The very fact that any course of 
     treatment ``beyond the normal practice of medicine'' can be 
     cause for cops to launch a career-ending investigation is 
     enough in itself to stifle innovation in palliative therapy.
       The high-profile arrests and prosecutions of physicians (up 
     to 200 per year, by one estimate) have caused many doctors to 
     under-prescribe or refuse to see new patients. It corrupts 
     the candor necessary for an effective doctor-patient 
     relationship. Many physicians have left palliative therapy 
     for less controversial practice. The Village Voice reports 
     that medical schools are now advising students to avoid pain 
     management practice altogether.
       To calm its critics, the DEA commissioned several pain 
     specialists to work with federal officials to put together a 
     set of guidelines for physicians who treat pain with opioids. 
     These guidelines were posted on the agency's website, and 
     most doctors were led to believe that following the 
     recommendations would keep them safe from prosecution. For a 
     short time, experts, doctors, and drug warriors had reached a 
     compromise.
       But it didn't last long. Late last year the guidelines 
     mysteriously disappeared from the DEA's website. Their 
     removal coincided with the trial of Virginia pain specialist, 
     Dr. William Hurwitz, whose attorneys had attempted--and 
     failed--to admit the guidelines as evidence on the belief 
     that Hurwitz's practice conformed to their parameters. 
     Hurwitz was eventually convicted, and faces a life sentence 
     later this month.
       A few weeks after Hurwitz's judge refused to admit the 
     guidelines as evidence, the DEA renounced the contents of the 
     brochure, and in a brief explanatory note made clear that the 
     agency wasn't bound by any standards or practices when it 
     came to determining what physicians it would investigate. The 
     agency essentially declared it had carte blanche to launch an 
     inquiry.
       The renunciation sent shockwaves through the medical 
     community. One doctor told the Washington Post that ``over 90 
     percent'' of patients and doctors could be subject to 
     prosecution under the DEA's new rules. Rebecca J. Patchin, 
     who serves on the board of the American Medical Association, 
     told the

[[Page 6975]]

     Post, ``Doctors hear what's happening to other physicians, 
     and that makes them very reluctant to prescribe opioids that 
     patients might well need.''
       David Jorenson, the academic pain specialist who headed up 
     the committee that authored the original guidelines, sent the 
     agency a sharply-worded rebuke. Three professional 
     associations representing pain specialists followed with a 
     letter of their own. And last January, the National 
     Association of state Attorneys General also sent a letter to 
     the DEA, expressing concern that the agency was overstepping 
     its bounds, and interfering with the legitimate treatment of 
     pain. The letter was signed by 30 AGs from both parties.
       The DEA remains obstinate, insisting its revocation of the 
     guidelines did not represent a shift in policy, and that its 
     pursuit of doctors should have no effect on legitimate pain 
     treatment, despite that the experts it originally consulted 
     say otherwise.
       The attorneys general letter to the DEA in particular 
     presents a challenge for the Bush administration. The White 
     House claims to value the principles of local rule, states' 
     rights, and federalism. But those principles seem to flitter 
     away when it comes to drug policy. The Justice Department, 
     for example, has repeatedly gone to court to prevent states 
     from allowing physician-assisted suicide and medicinal 
     marijuana, in some cases going so far as raiding convalescent 
     centers and asserting the supremacy of federal law in 
     prosecuting those who grow marijuana in states where it's 
     permitted.
       Thirty state AGs have said that federal drug policy is 
     interfering with legitimate medical practice. The White House 
     now has two choices. It could order the DEA to end its 
     pursuit of physicians, and leave medical policy to state 
     governments and medical boards, where it belongs.
       Or it could stand by the DEA's troubling anti-opioid 
     campaign, and watch as more well-intentioned physicians go to 
     jail, and millions of Americans continue to endure 
     unnecessary grief.

                          ____________________