AAPS Comments on Federal Register notice of 1/18/05 Regarding Interim Policy Statement on the dispensing of controlled substances for the treatment of pain.
March 21, 2005
DEA Headquarters, Deputy Administrator
Re: Docket No. DEA-261N
The Association of American Physicians and Surgeons is a nonprofit professional association, founded in 1943, that represents thousands of practicing physicians in all specialties in all states, who care for millions of Americans.
Many of our members are now reluctant to prescribe controlled substances, especially for chronic "benign" (non-cancer) pain, out of fear of unwarranted investigation and prosecution. All Americans are, as a result, at risk of suffering unnecessary pain, often so severe as to preclude work or normal activity and even to lead to suicide.
We believe that the standard of care should be the Oath of Hippocrates: "I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone." If physicians are constrained from exercising their professional discretion out of fear of punishment, they cannot act as physicians. Increasingly, they are refraining from prescribing controlled substances even when they believe the prescriptions to be warranted, in their professional judgment.
Physicians will be paying far greater attention to the actions of the DEA and prosecutors than to mere words, especially after previous guidance (the "Frequently Asked Questions") was summarily withdrawn.
We suggest that the federal government demonstrate its commitment to the following policies, in order to restore Americans' ability to receive adequate pain treatment:
1. Good-faith prescribing should never be the cause of criminal actions. Bad faith (not just bad judgment) must be proved beyond a reasonable doubt. All convictions in which this defense was not allowed should be reconsidered, and such prosecutions dropped.
2. Perjured testimony must not be allowed. Convictions based on testimony shown to be false should be reconsidered, and such prosecutions dropped. Defendants deserve, at a minimum, a new trial that is not tainted by prejudicial false testimony.
3. Substandard care is not evidence of criminal intent. Expert testimony pertaining to the alleged "standard of care" should be inadmissible in a criminal case. Such testimony is relevant only in a civil context and is prejudicial in a criminal trial. Convictions that relied on such evidence should be reconsidered, and such prosecutions dropped.
4. Physicians who have a valid DEA registration are not "drug dealers." They have met government standards and ongoing requirements that qualify them to write legal prescriptions. The "usual course of medical practice" involves appointment books, records of each patient and each prescription, a medical office supervised by state licensure authorities, and a telephone listing. The "usual course of medical practice" has no codified requirements for physical examinations or other procedures, and sets no limits on dosage, number of patients seen, length of visits, or number of pills. Thus, laws that were designed for clandestine traffic by unlicensed dealers—such as those pertaining to quantities of a substance—are inapplicable. Convictions and sentences based on such laws should be reconsidered, and such prosecutions dropped.
5. Medical ethics forbids physicians to act as police investigator, judge, jury, and executioner in the course of treating their patients. Performing criminal background checks, or denying relief to a patient solely on the basis of a past criminal record, is not the role of a physician. If society decides that a person once accused of a crime is ineligible for pain treatment for the rest of his life or for a period of time, a law must be passed and sentence must be imposed by a governmental authority after due process of law. Convictions or sentences of a physician based on his patients' past or current behavior should be reconsidered, and such prosecutions dropped.
6. Behavior characterized as "red flags" could be signs of undertreated pain. Unrelieved pain may drive human beings to desperate behavior. While society imposes punishments for drug diversion or abuse, adequate titration of medications to relieve the pain is the proper and effective treatment for "red-flag" behavior (e.g. "doctor shopping") due to undertreated pain. Distinguishing the cause of the behavior is a matter of professional discretion, which is inherently fallible. Admitting the possibility that a patient may be misrepresenting a situation is not the same as knowing of and cooperating with the deception. A twinge of suspicion does not change a physician from a dupe into a co-conspirator. Convictions or sentences based on law enforcement's interpretation of "red-flag" behavior, even if vindicated retrospectively, should be reconsidered, and such prosecutions dropped.
7. The prosecution of physicians is not the answer to drug diversion. The only way to reduce diversion to zero is to refuse to prescribe any scheduled drugs, but this would mean that millions of patients would be deprived of appropriate pain relief. If a "balanced" approach to diversion is to be achieved, the resources devoted to prosecuting doctors should be proportional to physicians' contribution to the total drug problem. It is unclear what that contribution is, in the absence of data concerning the source of all drugs in the illicit trade of legal substances (including internet, offshore sources, or theft somewhere in the distribution chain), or the extent to which illegal substances such as heroin would replace interdicted prescription drugs. Studies are urgently needed. The government should also study how total drug commerce is affected by detaining a drug diverter as compared with stopping a physician from prescribing. The latter, of course, can be done administratively without the need to tie up costly law enforcement assets.
8. Prescribing under the supervision of State licensure boards should be a safe harbor from criminal prosecution. State agencies that rely on medical experts are in a better position to assess prescribing practices than lay DEA investigators or managed informants.
In summary, what the DEA has called "a critical balancing act" in promoting pain relief and preventing abuse of pain medications has become extremely unbalanced through the inappropriate use of criminal prosecution of physicians—as well as outrageous abuses in the course of such prosecution, including subornation of perjury.
Unless past wrongs are righted, prudent physicians will be hesitant to rely on assurances about future agency actions.
Jane M. Orient, M.D., F.A.C.P.