Alexander DeLuca, M.D.
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Pain Killer
 

 
Frank B. Fisher, M.D., Pain Relief Network; Harvard Medical Alumni Bulletin; Winter 2006.
Identifier: http://www.doctordeluca.com/Library/WOD/WPS7-Fisher/PainKillerFisher06.htm
Source: http://www.painreliefnetwork.org/article_detail_T6_R262.html
 
Related resources:  Drug War Journalism and Advocacy Library 
 
See also:
Troubles Linger for Acquitted Doctor Heberle -
Lisa Thompson; Erie Times-News; 2006-05-30
 

The Collapse of Medical Ethics and Standards for Pain Management - Frank Fisher, M.D.; Cato; 2005
 
No Convictions - But His Practice is in Ruins - Eric Snider,  Weekly Planet, 2004-06-21
 
The Trials of Dr. Frank Fisher: the Cost of Exoneration -
WAR ON PAIN SUFFERERS Special Collection #7
 
War on Doctors and Pain Crisis Weekly - RSS feed:   HTML view:
 

 
[Full Text of this Article in Adobe PDF format]

A murder investigation typically begins when a body is found; only then is the killer hunted down. The case against me was different. State officials examining financial records concluded, on the basis of the amount of opioid analgesics I prescribed, that I had flooded the community with dangerous drugs. Convinced I had committed murder, they went looking for bodies.

Typical of my alleged murder victims was Rebecca Mae Williams, a 37-year-old who had suffered from incurable low-back pain. After exhausting alternative treatments, I had successfully controlled her pain with 80 milligrams of OxyContin twice a day, a dose that had allowed her to enjoy an active life.

The day Becky died, she had taken her usual dose before going furniture shopping with her boyfriend. As their small truck rounded a curve, the driver's door flew open, and David, who was driving, fell out. The truck crashed into a tree, and the impact exploded my patient's heart, fractured her skull, broke her neck, and eviscerated her. Yet on the basis of an impossibly high level of oxycodone measured in a blood sample - later found to be contaminated - the county medical examiner asserted that Becky had died of a drug overdose.

A quarter century after receiving my acceptance into Harvard Medical School, I found myself sitting in a jail cell in Redding, California. I had just been arrested and charged with the murder of three patients. With my bail set at $15 million, it didn't look like I would be getting out any time soon.

My arrest broke new ground. Before the criminal prosecution would conclude years later, I would be accused of murdering nine people, including several I had never even met. Back in 1999, no pain-treating physician had ever been accused of murder. Score another first for Harvard.

A Painful Dilemma
I first learned about chronic pain during my third-year rotation through the orthopedic surgery service at Massachusetts General Hospital. There I spent a week with one of the surgeons. Nearly all his patients suffered from severe chronic pain, and I watched him treat them with understanding and compassion. Then, at the end of each visit, he did something shocking: He prescribed opioid analgesics. In 1976, that just wasn't done.

From that surgeon I learned that opioid analgesics have a unique power to impart quality of life to people with chronic pain. I saw that these substances are safe, effective, and non-addictive when administered properly to manage chronic pain. And I came to understand that people with chronic pain should be treated with dignity, respect, trust - and enough pain medication to allow them to lead normal lives.

The following week I spent with a knee specialist whose approach to the regulatory quagmire surrounding pain and opioid analgesics was more typical: simple avoidance. The week after that I spent in the emergency room, where an orthopedic resident warned me to be on the lookout for the "drug seeker" and demonstrated elements of the physical exam intended to expose the lies patients tell about their pain. One trick he taught me was to place my hand surreptitiously beneath the contralateral heel during the straight-leg-raising test, allowing me to measure patient effort and, presumably, integrity.

The idea of not trusting patients - and denying pain relief - introduced an adversarial element into the patient-doctor interaction, which made me uneasy. When I asked the resident why he refused to prescribe opioid analgesics, he said bluntly, "If you prescribe those things, you'll lose your license."

His statement was not entirely accurate. Years later I would lose my practice, my house, my reputation, and even my freedom. My license turned out to be the only thing I didn't lose, although the regulatory system prevented me from using it for almost seven years.

Crossed Signals
After I finished my training, I relied on disciplinary reports to assess the state regulatory climate. In those reports, published by California's medical board, I read about the ruined careers of physicians accused of "overprescribing." Throughout the 1980s I remained convinced that the regulatory environment was as harsh as the orthopedic resident had described. Not prescribing controlled substances appeared to be the only pragmatic choice.

During the next decade, I worked in various community clinics and on American Indian reservations. The entire time I practiced medicine as if the primary imperative of medical ethics was the survival of the physician. I felt like an imposter, and I had no idea why.
Pain management, in the meantime, was undergoing a revolution. Researchers had discovered that cancer patients receiving opioid analgesics didn't often become addicted, only physically dependent. In 1995, a headline in the Medical Board of California's Action Report declared that the undertreatment of chronic pain was more problematic than its overtreatment. Beneath the headline was a set of guidelines for treating chronic pain with controlled substances. I believed the reign of terror directed at palliative-care physicians had finally ended.

I was mistaken. Within weeks of incorporating the medical board's guidelines into my practice, I learned I had become the target of a criminal investigation. The board had apparently failed to inform law enforcement that times had changed.

Relief Efforts
Other Shasta County physicians remained skeptical of the medical board's pronouncement and wanted nothing to do with pain patients taking opioids. I considered backing out of pain management but ultimately decided to continue helping people with this valuable treatment. As a result, by the end of 1997 I had acquired most of the patients in the county who suffered from severe chronic pain. Although these patients represented only 5 to 10 percent of my total patient population, I had effectively become a specialist.

Mindful of the "drug seekers" I'd been warned about, I established a screening procedure so selective that it turned away 60 percent of applicants without my even seeing them. Those accepted into the pain management program had access to a multidisciplinary treatment team that included surgeons, physical therapists, chiropractors, and an acupuncturist. Each patient had to undergo regular psychological evaluation. And acceptance into the program didn't ensure continued treatment. Patients who could not follow the program's guidelines were discharged. By the time I was arrested, some 600 former patients were on the ejected list.

Throughout this time I believed good medical record documentation would protect me. That turned out to be another mistake.

New Leases on Life
Although I treated pain more aggressively than most physicians in my community, I still deliberately underprescribed opioid analgesics. My patients suffered as a result. In September 1997, though, the California legislature enacted the California Pain Patients' Bill of Rights, which stated: "A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act...."

I remember thinking as I read the bill that it was a good law and that someone should test it. Then, unwittingly, I became that someone.
After the passage of the new law, I decided I would no longer violate my obligations as a physician by systematically undertreating my patients. When I adopted the clinical strategy of titration - gradually increasing the dose to achieve optimal therapeutic effect - it never occurred to me that the attorney general would consider my decision a manifestation of criminal insanity.

I was too distracted - and elated - by the dramatic therapeutic results of my decision. Most of my patients were experiencing startling improvements in functioning. After being titrated to 400 milligrams of OxyContin per day, Penny, a wheelchair-bound patient disabled by fibromyalgia, abandoned her chair, tapered her opioid analgesics to zero, and enrolled in truck- driving school.

The remission of Penny's pain was part of a larger trend I observed among my severely affected patients. During 1998, a predictable time-dosage curve emerged. Initially, over a period of several months, opioid dosages steadily increased, as did my patients' functional gains. Then dosages and functioning plateaued. Finally, the unexpected occurred: Opioid dosages began to drop, without any urging on my part, while functioning remained optimal.

Many of my patients with chronic pain appeared to be headed for remission, if not cure. But before this experiment could play itself out, the state attorney general terminated it by having the police handcuff me at my clinic and throw me in jail.

The Law Won
Physically, jail is uncomfortable. Each inmate receives a one-inch-thick mattress, just slightly softer than the concrete slab it rests upon. Acoustically, jail is a nightmare, with noises echoing forever until they finally embed themselves into the psyche. And psychologically, jail is hell. The fluorescent lighting is never turned off, so day and night blend. Jail - with only two hours a week spent outdoors in a cage - allows no seasons. Worse yet is the nagging feeling of dread. I felt trapped, and there was no end in sight. I realized then I was gaining a glimpse into the psychological suffering that pain victims endure.

On the third day of my incarceration, I was unexpectedly called out of my cell to meet with a visitor. Patrick Hallinan, a highly sought-after criminal defense attorney in the Bay Area, had heard about my arrest from my brother and had driven three hours from San Francisco to see me. My case was an injustice, he said, and he was willing to represent me. For the first time, I believed everything would work out.

My preliminary hearing was the equivalent of a trial. The lead prosecutor was a career bureaucrat with a reputation for winning elder-abuse cases. His first witness was a family practitioner from a neighboring community health center who served as the primary source of the state's information about pain management. She had already articulated her formulation of the case against me for the local paper: "The majority of patients were on doses that we had never seen before. Some of the doses we thought were incompatible with life."
Soon after my attorney began his cross-examination, however, this witness admitted that she lacked even a minute's worth of training in pain management. He led her to repeat her public claim that each patient has a certain dosage of opioid analgesics that will surely kill him.
The trap had been set. Asked to read aloud several lines from the OxyContin product literature brochure, this witness read a statement asserting what all competent pain-treating physicians know - pure opioid agonists have no ceiling dose.

The trap was now sprung. Gesturing to the gallery of the courtroom, which was packed with my patients, my attorney identified the "walking dead." All very much alive, my patients began howling with laughter. The state's case had just sustained irreparable damage.
Next, the prosecutor called to the stand the founder of the pain management center at the University of California, Davis Medical Center. When asked about the quantities of OxyContin I had prescribed, the physician responded, "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 that Fisher ever had in all the records that I've got." The witness finished his testimony by stating that I appeared to have practiced medicine in good faith. Later, the bailiff chuckled as he escorted me to a holding cell. "Sometimes it goes well in court," he said, "but never that well!"

Over the next several months, as the prosecution sent an army of investigators across the county to try to unearth evidence that would prop up their faltering case, the hearing stretched out to 21 days of testimony. During that time, my defense didn't have a single bad day in court. Each witness the prosecution called dug the hole they were in deeper.

As the prosecution's case fell apart, multiple incidents of police and prosecutorial misconduct surfaced. A witness was threatened in an attempt to coerce testimony favorable to the prosecution. A conspiracy to violate Miranda rights was exposed. A witness recanted, and the prosecutor was caught knowingly eliciting false testimony from one of his investigators.

During a cross-examination on the final day of testimony, my attorney lured the government's last witness, a police investigator from the attorney general's office, into remarking upon the atmosphere in my clinic. The agent wasn't supposed to have known what went on in my clinic because, until this point, the prosecuting attorneys had withheld the fact that they had sent agents to my clinic to scam for drugs.
After the agent's admission, my attorney walked behind me, placed his hands on my shoulders, and bellowed, "And not one of them got anything, did they?" The agent just hung his head and muttered, "Not that I know of."

On July 15, 1999, the hearing finally ended. The judge dismissed all five murder charges, reducing three to man-slaughter. (One of the manslaughter counts was for a young man who wasn't even my patient, but the judge told me he suspected I had something to do with the death.) The judge dropped my bail from $15 million to $50,000 and told me not to practice medicine until the criminal charges were resolved.

I'll always remember the day I got out of jail. It had been a rainy winter morning when I entered; on the day I was released the temperature reached 110 degrees. I felt I had been through a time warp.

At least 50 of my patients were waiting to greet me. After they had finished congratulating me and I had given a brief interview to the media, I rode off in my brother's car. As we pulled away, my patients jubilantly waved their canes in the air.

A Matter of Principle
Prosecuting my case had cost taxpayers at least $5 million. Now the state was eager to cut a deal, have me confess to some minor criminal transgression, and move on. Yet I never even considered taking a deal. I had done nothing wrong, and I wasn't going to lie and say I had. In addition, I felt the integrity of medical practice in general was at stake. What had been done to me was an exaggerated version of what is still happening to well-intentioned physicians across the country. I paid for my decision by being kept out of practice for nearly seven years.

Fortunately, I didn't have any dependents. I moved in with my parents and went to work on winning my case. My lawyer turned his conference room over to me to use as a war room. Over the next few years, I became a fixture in his office, gathering and organizing more than 300,000 pages of materials to bolster my case. Occasionally he would run me out of his conference room. "Frank, you've got to get out of here," he'd say. "I have a paying client coming in."

On the morning of January 14, 2003, almost four years after my arrest, my trial began. The judge opened the proceedings by asking the prosecuting attorneys whether they were ready. They weren't.

That morning, after four years of attempting to bluff me into a deal, the state finally admitted it didn't have the evidence necessary to proceed. The judge dismissed all the remaining charges, and the trial was over before nine o'clock the first morning.

But my troubles weren't over. The state attorney general robbed me of yet another year and a half of my professional life by prosecuting me for an alleged $150 upcoding theft - or billing fraud - from Medi-Cal, California's Medicaid agency. All the while prosecutors in his office kept assuring the media they would soon refile the murder case against me. They never did.

A week after the upcoding case went to trial in May 2004, the jurors retired to deliberate. Within minutes, uproarious laughter could be heard coming from the jury room. The jurors soon emerged and acquitted me on all counts. One juror later told a reporter he believed the whole thing had been a witch hunt.

By the time of my acquittal on May 18, 2004, I had faced criminal charges for a total of six years, to the day. The criminal phase of my ordeal was over, but the state attorney general had one more gambit: to go after me through the state medical board. He failed there as well, but not before robbing me of another two years of practice.

Three wrongful-death malpractice lawsuits had spun off from the original murder charges, and I now had to contend with them. All three were dismissed before trial, and the court ordered two of the three plaintiffs to pay part of my legal expenses. Collecting on these judgments is unlikely, but the symbolic victory remains sweet.

The Deep End
Throughout my ordeal I had kept in touch with many of my patients. When I visited them in their homes I witnessed how the disease of chronic pain devastates their lives. I also learned the strategies they adopt for simple survival. Many physicians believe their patients take pain medications as prescribed. But I found that patients who are undertreated tend to bunch their medications into a single dose to achieve the threshold effect that allows them to function. During the resulting window of opportunity, they accomplish essential tasks, such as shopping, paying bills, and, if the pain has not yet taken over again, a little housecleaning or socializing. In contrast, when patients receive an adequate supply of medication, they can enjoy all activities all the time, a freedom the rest of us take for granted.

While spending time with patients, I learned that freedom is not the only advantage that opioid analgesics offer those in severe pain. These medications also enhance survival. In the end stages of chronic pain disease, massive weight gain is typical. This gain is attributable to inactivity, as it hurts even to move, and likely to high levels of stress hormones as well. This weight gain can be abrupt - and extreme. One of my patients gained more than 100 pounds in less than a year. People who had known her for decades did not recognize her.
As the disease progresses, metabolic syndrome often develops. Blood pressure soars and type 2 diabetes emerges. Because chronic pain kills slowly, death is attributed to these secondary disease processes, rather than to uncontrolled pain.

A more abrupt lethal outcome of chronic pain is suicide. Following my arrest, one patient became so distraught she drove her car onto a nearby railroad track and waited for the train.

Another patient, Jeff, was a 32-year-old single father who suffered from chronic pain following a motorcycle accident. Steel plates held the bones of one leg in place, and with each step he took the bones ground together. His life became just barely tolerable with 2,400 milligrams of oxycodone a day, a dosage that allowed him some mobility while his orthopedic surgeon fought to save the leg.
After I was arrested, no physician in the county would prescribe Jeff opioid analgesics in quantities sufficient to allow him any quality of life. In desperation, he allowed his orthopedic surgeon to amputate the damaged leg, but his pain syndrome only progressed. He decided to solve his dilemma by committing suicide, leaving a teenage son to fend for himself.

Sharing the Pain
Recently, it has become popular to attribute the pain crisis to a war waged by law enforcement against physicians. The Controlled Substances Act of 1970 contained language intended to establish a safe harbor within which the physician could legally participate in the distribution of controlled substances as "an individual practitioner acting in the usual course of his professional practice." The authors of this act were mistaken in assuming that distinguishing between what is medical practice and what isn't would be obvious: When the police see drugs and money changing hands, they see a crime in progress.

Every attempt to resolve the problem of undertreated pain has been, in essence, an attempt to draw a bright line between legal medical drug distribution and criminal misconduct. These attempts are fundamentally misguided because they focus on physician conduct, while criminal drug distribution on the part of a physician is primarily a matter of intent. At the end of the day, illegal drug distribution by physicians is a thought crime.

Each year, many physicians lose their licenses and some receive long prison sentences. William Hurwitz has drawn a 25-year sentence in federal prison, for example, while James Graves continues to serve a 63-year sentence in Florida.
Yet most of the victims of this aspect of the war on drugs are patients, not physicians. Patients' lives are destroyed by the millions, and the costs to society are enormous. Chronic pain, a leading cause of adult disability in the United States, costs the economy $100 billion a year in lost productivity. While opioid analgesics are categorically safe when taken as prescribed, 100,000 arthritis sufferers are hospitalized, and 16,500 bleed to death each year from gastric ulcers caused by nonsteroidal anti-inflammatory drugs.
Physicians have the power to control chronic pain and for the most part choose not to exercise it, either as individuals or as a profession. If too many doctors choose not to control pain, the ethics of the profession as a whole are compromised, without a single physician having behaved unethically.

The central question that society faces in respect to the pain crisis is whether opioid prohibition and the attendant war on drugs can be rehabilitated through incremental symptomatic reform, or if a new regulatory paradigm will be necessary. Two schools of thought have arisen around this controversy.

One argues that a combination of education and legislation will produce a kinder, gentler world in which pain patients will one day be spared the ravages of the war on drugs. The second school of thought views opioid prohibition as a fundamental flaw in social policy, one that precludes access to pain care. Attempts to shore up the safe harbor for medical prescribing are regarded as exercises in futility. The underlying concern is that despite the intent of the Controlled Substances Act to create a safe harbor for prescribing, the act makes opioids both legal and illegal, ensuring that criminal prosecutions of well-intentioned physicians, however rare, will inevitably occur.
This second school of thought understands that physicians are both risk sensitive and risk averse. If an ironclad guarantee does not accompany the offer of a safe harbor, the mere possibility of criminal prosecution will chill prescribing, no matter how much education takes place or what official assurances are offered.

Many fear that ending opioid prohibition will result in social chaos. This concern overlooks the fact that opioid analgesics are profoundly dysregulated, and that chaos already reigns in the pain management realm. The centerpiece of the current regulatory paradigm is a concept called "the principle of balance." This principle requires controlled-substance-prescribing physicians to maintain a balance imagined to exist between the needs of their patients and the government's perceived obligation to protect willful substance abusers from the adverse consequences of their own reckless behavior.

This approach to balance has several problems. First, it has recently come to light that most pharmaceuticals diverted into the illicit market come not through physicians' offices, but through such sources as pharmacy robberies. One of my alleged murder victims was a man whose niece had broken into the house of one of my patients, stolen some OxyContin pills, and given the pills to her uncle in exchange for a night's lodging. The man died after injecting a mixture of the pills with an overdose of an antipsychotic medication.
Second is a problem with medical ethics. When physicians are compelled to serve the interests of the government rather than those of their patients, history teaches us that the outcome is never good. In fact, it can be so bad that it seems reasonable to suggest that the health of a society can be measured by the extent to which it allows the patient-doctor relationship to serve the interests of the patient exclusively.

Strong Medicine
Now, seven years after my arrest, the criminal prosecutions and wrongful-death lawsuits I endured have all been resolved in my favor. My no-admissions settlement with the state medical board has finally cleared the way for my return to practice. A former patient offered to provide me with a building in which to set up my next community health center, but death threats cancelled our plans. I do not yet know what direction my next run at clinical practice will take. While I do know I won't be prescribing controlled substances, I will be working to resolve the flaws in social policy that drive the pain crisis, with the hope that someday I will once again be able to treat patients with chronic pain effectively.

I now find myself in demand as an expert witness and analyst in cases against other physicians accused of overprescribing opioid analgesics. I also donate time as a consultant to the Pain Relief Network, an advocacy organization for people with chronic pain and physicians who are persecuted for trying to help them. But most important, I no longer feel like an imposter within the medical profession. I cured that malady with opioids, not by taking them, but by prescribing them for my patients.

Frank B. Fisher '78, a consultant with the Pain Relief Network, can be reached at frankbfisher@sbcglobal.net

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Dr. DeLuca's Addiction, Pain, and Public Health Website

Alexander DeLuca, M.D.

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Originally posted: 2006-06-24

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