Professional casualties
in America¹s war on drugs


By DAVID B. BRUSHWOOD
Am J HealthSyst Pharm. 2003; 60:2004-6

The metaphor of warfare has frequently been used in descriptions of government actions to 'combat' the scourge of drug abuse in American society. As in any war, there is 'collateral damage' to innocent victims. The 'war on drugs' has, at times, victimized pain patients and those physicians and pharmacists brave enough to meet patients' needs for high doses of opioid analgesics. A recent case from California serves as a chilling example of how misguided law-enforcement authorities can confuse pain management with drug diversion.


Background

On February 18, 1999, a Shasta County, California, physician was arrested at his community health clinic. A local pharmacist and his wife were also arrested at their pharmacy. Physician Frank Fisher, Pharmacist Stephen Miller, and Madeline Miller were all charged with three counts each of first-degree murder. Two additional counts each of first-degree murder were later added to these charges. Bail was set at $15 million for Fisher and $3 million each for the Millers.

California Attorney General Bill Lockyer, commenting on the arrests, used language usually reserved for dramatic busts of large illicit drug rings.

"We are prosecuting what was a highly sophisticated drug-dealing operation," he said "We are shutting down suppliers of a highly addictive drug that has been improperly allowed to saturate the community."1

The authorities were apparently concerned by large amounts of opioids and other controlled substances being prescribed and dispensed by Fisher and Miller. They were also suspicious of the high doses being prescribed. This concern existed despite language in California law stating, "A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed necessary to relieve severe chronic intractable pain."2

Reports of drug overdoses treated in area emergency departments had led to the belief that Fisher and Miller were illegally diverting controlled substances.

Madeline Miller was a pain patient of Fisher's and a pain advocate in Shasta County. She aggressively fought for the rights of patients when Medi-Cal disallowed payment for pain medications and other drugs. Serving as a supposed 'link' between her physician and her pharmacist husband, and through zealous advocacy for those whose condition was similar to her own, Madeline Miller put herself on the radar screen of agents who were suspicious of Fisher's practices.

Stephen Miller was a community pharmacist who had practiced in vari ous settings since his graduation from Oregon State University. Shasta Pharmacy was located in a corner of what had once been a grocery store. After the grocery store moved out, the pharmacy was left by itself in a large building, isolated from the former grocery area by a chain-link fence. His wife's chronic pain condition, and his caring approach to practice, led him to be particularly sympathetic to the needs of patients in pain.

After graduating from Harvard Medical School, Frank Fisher worked in various settings in underserved communities, including Indian reservations. The clinic he established in Shasta County was not intended to be a pain clinic. It served the needs of all patients and employed various therapists to supplement the medical care provided by Fisher. Because he was willing to use the 'principle of titration'3 in his dosing of opioids to the level needed for effective analgesia without adverse effects, Fisher found himself caring for many patients in severe pain.


Legal case

Physicians and pharmacists charged with major felonies in small communities usually do not have the benefit of a defense led by an experienced trial attorney who is knowledgeable about drug use and abuse.

The Fisher‹Miller case was different. Through family contacts, Fisher arranged representation by Patrick Hallinan of San Francisco, a leading criminal defense lawyer whose previous clients include author Ken Kesey, the Soledad Seven, and Black Panther Eldridge Cleaver.

The defense of the case focused on Fisher's medical practice. If insufficient evidence were shown to charge Fisher with murder, then this conclusion will also be reach for the Millers.

Preliminary hearings ordinarily last only a few hours. A long preliminary hearing usually lasts two to three days. The preliminary hearing for Fisher and the Millers lasted five months, during which seven weeks of testimony was given. The hearing was so long because the judge had other matters to address on many days of the week, as did the attorneys. Fisher and the Millers remained in jail the entire time.

Very early in the preliminary hearing, the tone was set when a star witness for the government, a pain-management expert who was critical of numerous clinical judgments made by Fisher, said, "The absolute numbers don¹t bother me a bit. I'll repeat that. The absolute numbers don't bother me a bit. I have cases of my own that I can show on higher doses than any patient Dr. Fisher ever had in all the records that I've got."

Another expert testified she believed Dr. Fisher's doses to be lethal, but she later admitted that she enforces a "no narcotics" policy in her clinic and has no training in pain management.

Hallinan's experience led him to believe that the government had probably conducted "sting" operations on Fisher, sending to him informants pretending to be in pain and trying to trick him into prescribing them opioids they did not need. Yet no evidence of such operations was presented by the government.

When Hallinan inquired of witnesses regarding such sting operations, his suspicions were confirmed. On at least seven occasions, Fisher had been challenged to inappropriately prescribe for informants, and he had refused every time.

One of the five people allegedly murdered by Fisher and the Millers was a pain patient who had been a passenger in a tragic automobile accident. She suffered multiple massive trauma to her brain and other vital organs. Because the coroner detected oxycodone in her tissues at the time of her violent death, the conclusion was that Fisher and the Millers had murdered her. Another alleged murder victim was not a patient of Fisher or the Millers but had died from abusing medications stolen from a Fisher/ Miller patient by a friend.

As the government's testimony progressed through the preliminary hearing, and as Hallinan elicited recantations and admissions from those testifying, the media coverage began to shift. Although the deputy attorney general continued to refer to the defendants as street pushers, the media reported that the husband of one alleged murder victim was actively raising money to fund the defense.

"They gave my wife 18 months to live 4 years ago," he said. "She lived 4 years because of Frank. He got her out of bed."4

Another story reported that Fisher lived frugally, that he rented his home and drove a 20- year-old car, and that he had spent 20 years treating indigent patients.

Medical experts were quoted explaining that there is no standard upper limit on opioid doses applicable to every patient and that prosecutions of pain management practitioners have a "chilling effect" on the provision of necessary medications to chronic pain patients.5

At the end of the preliminary hearing, the judge had heard what he needed to know. All murder charges against Madeline Miller were dismissed and she was released. The murder charges against Fisher and Stephen Miller were reduced to manslaughter. Bail for Fisher and Stephen Miller was reduced from millions to zero. They were released on their own recognizance, subject to the condition that they not practice medicine or pharmacy until the matter was resolved.

For three and one-half years Fisher and Miller watched the legal process grind itself out through meetings, delays, and court appearances. On January 14, 2003, just shy of four years since their arrest, the remaining manslaughter charges against Fisher and Stephen Miller were dismissed when the deputy attorney general admitted to the judge that the state lacked sufficient evidence to proceed with trial. The deputy attorney general promised that the criminal charges would be refiled within two weeks. But months have passed and that has not happened. Fisher and Miller still have matters to clear up regarding their medical and pharmacy licenses. They hope to re-establish their practices soon.


Discussion


There is a constant balancing act in the regulation of controlled substances, because regulation that is too strong will restrict access to appropriate medications for legitimate medical needs, while regulation that is too lax will permit diversion of prescription drugs to illicit use. The goal of regulation is to prevent diversion without restricting pain management or other appropriate patient care. To do this, practitioners and regulators have tried to create a "safe harbor" for pain management practice, outside the storm of drug-control suspicion, distrust, and enforcement. It isn't working.

The enactment in many states of legislation called the Intractable Pain Act has produced sympathetic and compassionate ink-on-paper, but the policies and procedures of law enforcement have been largely unaffected.6

On the bright side, many state boards of medicine and pharmacy have taken to heart the provisions of the 'Model Guidelines for the Use of Controlled Substances in the Treatment of Pain.'7 These agencies are no longer the everyday threat they once were, but in some states they continue to harass their own licensees.

It is a confusing situation for regulators and law enforcement. 'Addiction' and 'physical dependence' may seem similar to some, but they are in fact very different. Legitimate pain patients who become physically dependent on opioids will freely, but incorrectly, admit to being addicts.

Despite the absence of any law forbidding prescribing or dispensing of opioids to addicts who are in pain, and despite the fact that pain patients do not meet the diagnostic criteria for addiction, law enforcement officials reach the horrifying (to them) conclusion that physicians and pharmacists who supply opioids to chronic pain patients are supporting addiction.

Concerns among officers of the law are understandably increased when they discover that drug diverters lie to physicians and pharmacists, sometimes very well and very successfully.

The authorities also know that employees of physicians and pharmacists steal drugs and prescriptions and that rogue employees fraudulently authorize access to medication by people who have no legitimate need for it. On occasion, legitimate patients, and their friends and family, sell their medication because it is of value and because they are in dire economic circumstances.

Given these realities, it is perhaps understandable that law enforcement authorities see physicians and pharmacists as the prime culprits in the diversion of controlled substances.

At first blush, the solution to this misunderstanding is simple. Increasing communication between health care and law enforcement should avoid 'false-positives,' in which pain patients are mistaken for drug diverters, as well as 'false-negatives,' in which drug diverters are given access to drugs they should not have. But there are barriers to increased communication.

There are reasons why health care providers and law enforcement do not consult with each other immediately when something seems amiss. A legacy of distrust makes health care providers reluctant to draw attention to themselves and perhaps implicate themselves in wrongdoing by requesting a consultation with an enforcement official.

In law enforcement, the focus is on catching criminals, not on teaching criminals how to avoid being caught. Early consultations are contrary to the culture of discreet surveillance and massive force when the time is right.

Somehow this stalemate must be broken. The Fisher Miller case is not unique. Physicians Stan Naramore (Kansas), Jong Bek (Indiana) and Robert Weitzel (Utah) have all been charged with murder in the deaths of pain patients and subsequently absolved of the charges. Physician James Graves (Florida) was charged with murder and convicted of manslaughter. His appeal will be heard soon. Physicans Spurgeon Green (Georgia), Denis Deonarine (Florida), and Jesse Henry (New Mexico) are all facing murder charges in the alleged deaths of their patients from the toxic effects of prescribed opioid analgesics. Many other physicians and pharmacists are facing lesser criminal charges.8

The radical approach of permitting health professionals to continue to practice despite concerns, and waiting for the opportunity to charge them with serious criminal violations, threatens the quality of both medical care and law enforcement.

A stepwise approach to regulatory oversight of pain management practice seems needed. When suspicions first arise that a physician or a pharmacist may be inappropriately prescribing or dispensing and that diversion may be occurring, law enforcement could offer a diversion consultation. If the problem is not resolved, then investigators could test the practice through informants posing as pain patients. If drugs are prescribed and dispensed to informants, then an expert panel of peers could determine whether any standard of care is being followed. If no standard of care is being followed, then a second expert panel could determine whether patients have died as the result of drug use. Only if the inquiry reaches this stage and if the answer is yes would the matter proceed to criminal prosecution. Otherwise, the physician or pharmacist would be permitted to continue to practice, perhaps on the condition that appropriate continuing-education programs be completed.

One day there may be a technological diagnostic method of differentiating legitimate pain from substance abuse or diversion. Just as laboratory values and certain types of imaging can facilitate other diagnoses, the best answer may eventually lie in some as yet undiscovered objective test.

For the present, health care professionals and law enforcement officials will simply have to find ways to work together better, and legislatures must provide a statutory framework for that to occur.

The Fisher/Miller case is an extreme example of a common problem. It is a case of a system-related errors from which lessons must be learned and improvements made to prevent similar errors in the future.



References1. Geissinger S. Attorney general announces arrest of pharmacy owners. Sacramento, CA: Associated Press State and Local Wire; 1999 Feb 19.
2. Cal. Bus. & Prof. Code §2241.5 (2002).
3. Portenoy RK. Opioid therapy for chronic nonmalignant pain: clinicians¹ perspective. J Law Med Ethics. 1996; 24:296-309.
4. Doctor charged with killing patients says he¹s innocent, could be linked to others. Redding, CA: Associated Press State and Local Wire; 1999 Mar 8.
5. Hall C. Prosecutors raise Shasta County toll as painkiller-murder hearing opens. San Franc Chron. 1999; Apr 28:A6.
6. Ziegler SJ, Lovrich NP. Pain relief, prescrip-tion drugs, and prosecution: a four-state sur-vey of chief prosecutors. J Law Med Ethics. 2003; 31:75-100.
7. Federation of State Medical Boards of the United States. Model guidelines for the use of controlled substances in the treatment of pain. www.fsmb.org (accessed 2003 Aug 28).
8. Association of American Physicians and Sur-geons. Actions against pain physicians. www. aapsonlin.org/painman/actionsagainst.htm (accessed 2003 Aug 28). David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME).
For information about ASLME pain policy projects, go to ASLME.




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