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|American Society for Action on Pain|
article By Katherine Eban Finkelstein
Copyright Playboy Magazine, August, 1997
THE DEA IS BUSTING DOCTORS FOR PRESCRIBING DRUGS-AND PATIENTS ARE DYING IN PAIN
DONALD DEWBERRY, 44, a retired aircraft mechanic, went to Dr. John McFadden several years ago after two failed surgeries for degenerative disk disease. 7he pain in his neck was crippling, and even moving his eyes triggered it. Dr. McFadden, who is medical director of the Tupelo Pain Clinic in Tupelo, Mississippi, prescribed Dewberry narcotic painkillers known as opioids, which are highly effective and rarely addictive when taken to relieve pain.
Unfortunately for McFadden, he was under surveillance. Federal and state narcotics investigators first went to his red-brick clinic in 1987 on a tip from the Mississippi State Board of Pharmacy that he was overprescribing painkillers. They sifted through his inventory logs for evidence that narcotic medications had been diverted to the street for black-market resale. McFadden claims that only minor record-keeping errors were found. Yet because McFadden specialized in pain treatment (and therefore had prescribed narcotics such as Vicodin and Tylenol #3), he was subject to continuing suspicion. Over the next nine years, agents from the Mississippi State Board of Medical Licensure periodically investigated his prescribing habits.
A new front had been opened in the drug war, and patients in pain were potential enemies. Even though McFadden, the only pain specialist in northern Mississippi, administered legal medications of great benefit, his prescribing of narcotics targeted him as a suspect.
In March 1996 a state medical board investigator arrived at his clinic with a search warrant. "We had been expecting him. We knew he had to do his job, so we were friendly and said, 'You can look at any-thing you want,"' McFadden recalls. The agent seized the medical charts of 36 patients. Several months later McFadden was notified that the medical board had charged him with 11 counts of violating the Mississippi Medical Practice Act, including unprofessional conduct "likely to harm the public."
After two days of administrative hearings and 30 minutes of deliberation, the medical board-whose members are appointed by the governor-suspended McFadden's medical license and prohibited him from prescribing a variety of controlled substances on an outpatient basis. McFadden's censure has had a chilling effect in Mississippi medical circles. To avoid similar repercussions or scrutiny, other area doctors have virtually stopped prescribing narcotics. One doctor in Tupelo posted a notice in his waiting room: DO NOT ASK ME TO REFILL PAIN MEDICATIONS. In a doctor's office 40 miles away in Corinth, a sign read DON'T ASK FOR OPIOIDS.
McFadden's patients, meanwhile, were left in pain. When Dewberry returned to his longtime family practitioner in nearby Oxford and asked for a prescription, the doctor chewed him out. "'You're just an addict,"' Dewberry recalls him saying. He has since stopped taking medication, and the pain keeps him in bed: "I'm in this haze of fighting pain. I'm trying to raise two teenagers, and I have a mortgage on the house. But if I said, 'Heck, if it all falls to pieces . . .' then it does."
By almost any measure, America has lost its war on illegal drugs. Cocaine and heroin still cross the nation's borders. "Cat," or methcathinone, can be purchased in any city, despite endless law enforcement efforts to buy and bust. Meanwhile, the real threat from illegal drugs has fed America's opiophobia, an irrational fear of narcotic pain relief. Needing a winnable war, the government has cracked down in doctors' offices. Across the country, state agents, allied with the DEA, have staked out pain clinics under the assumption that wherever narcotics are prescribed, diversion of the drugs will soon follow. In pursuing this theory, the government has criminalized an entire class of patients and scared doctors into abandoning them.
As a result, pain is grievously undertreated. According to the National Chronic Pain Outreach Association, an estimated 34 million patients suffer chronic pain and lose 50 million workdays a year. Seven million of these patients cannot relieve their pain without opioids, but there are only approximately 4000 doctors in the country willing to prescribe them. A recent New England Journal of Medicine editorial noted that 56 percent of cancer outpatients and 82 percent of AIDS outpatients received inadequate pain treatment. Fifty percent of hospitalized patients with a range of illnesses also received inadequate pain treatment.
Our drug war has overshadowed our pain crisis because the former is fought by politicians, while the latter is lived by patients who are often confined to bed. In the absence of an effective pain lobby, politicians have been able to whip the public into an opiophobic frenzy. "All you have to do is scream about the drug hysteria, then everyone tucks his tail and runs," says Dr. Stratton Hill, a Houston pain specialist. "No politician wants the charge that he's soft on drugs." Late last year the Clinton administration challenged referenda in Arizona and California that would legalize the medical use of marijuana for easing the pain and nausea that are related to cancer and its treatment. This past March the president emerged from knee surgery declaring that he would not medicate his pain with narcotics.
While doctors may shrug off such proclamations, they cannot afford to ignore the investigative machinery that opiophobia has built. "We have established a bureaucracy to catch doctors making errors," says a leading researcher in pain treatment. "As a result, fear is endemic among physicians."
In 1984 Congress handed the DENS Office of Diversion Control discretionary power to revoke a doctor's registration to prescribe medicine. (In order to write prescriptions, doctors must be registered with the DEA.) The 1984 legislation enabled the government to yank this registration if a doctor commits "such acts as would render his registration . . . inconsistent with the public interest." This phrase, buried in the fine print of the Dangerous Drug Diversion Control Act, significantly expanded the ODC's latitude. Before 1984, the agency could revoke a doctor's registration for only three reasons: If he had falsified a prescription, was convicted of a felony relating to controlled substances or had his state medical license revoked, denied or suspended.
With the passage of the act, the rules changed overnight-from black-and-white to gray. Enforcers could pronounce guilt and revoke a registration simply by declaring that the public interest had been threatened. Suddenly, prescribing that was determined to be against the "public interest" was being used as prima facie evidence of diversion. The government had effectively criminalized narcotic pain treatment and had begun to practice medicine.
Since its creation in 1973, the ODC has had a dual function. It was charged with ensuring the availability of pharmaceutical drugs for legitimate needs and preventing their diversion for illegitimate sale and use. But the 1984 drug bill changed everything. Despite limited data on the origins or amount of diversion, the agency targeted doctors and patients, performing search and-seizure operations in the offices of baffled clinicians. The peremptory justice was supported by Orwellian logic:
Patients at pain clinics use narcotics.
Narcotics can be addictive.
Therefore, pain patients are addicts.
This new system encouraged doctors to suspect the motives of their patients. "As doctors, we believe in people, but the government expects each of us to be an FBI unit. We're supposed to trust no one," explains Dr. Frank McNiel, a family practitioner in Knoxville, Tennessee.
In deciding who to bust, investigators rely heavily on medication categories that were established in 1970 under the Controlled Substances Act. The DEA groups medications into five different "Schedules," depending on their potential for abuse. Schedule V contains some prescription drugs as well as over-the-counter cough medicines, which are rarely abused. Schedule IV includes benzodiazepines such as Valium. Schedule III contains anabolic steroids, some barbiturates and blends of aspirin and codeine. Schedule I includes heroin, LSD and marijuana, which have no medical use, according to the feds.
Overwhelmingly, the 1984 provision led agents to focus on Schedule 11. The painkillers here, including morphine and Dilaudid, have a high street value. Looking for a way to combat diversion, agents relied on the all-purpose "public interest" dictum. They used it as a preventive tool, to bust law-abiding doctors prescribing medication that might be diverted down the road. On both the state and federal levels, the distinction between enforcement and prevention collapsed, as did the distinction between criminal behavior and the treatment of pain. Once Schedule II drugs were involved, the DEA decided to shoot first and ask questions later.
Federal and state arsenals are now bristling with weaponry. The DEA performs long-range computer surveillance with the Automated Reports and Consolidated Orders System. This database logs every transaction between manufacturers and distributors of controlled substances. If a large quantity of barbiturates, for example, were distributed in a certain city, it could mean that an organized group had diverted the medication. Law enforcement authorities would launch an investigation.
States use their own monitoring apparatuses to track the prescriptions of individual doctors and their patients' habits. Some states require doctors to report even their terminal cancer patients as addicts if they are prescribed opioids for a certain period of time. In eight states, including California and New York, doctors who want to prescribe from Schedule II must order registered prescription forms that have multiple copies: The doctor retains one, the pharmacist keeps one and the third copy is sent to state health or narcotics-control agencies. Studies show that doctors in these states have decreased the amounts of Schedule II drugs they prescribe by 40 percent to 60 percent. Possibly, some of the drugs had been diverted and the crackdown was actually successful. But studies also have shown that doctors in these states increased their prescribing of less-regulated painkillers by almost the same percentages. These alternative drugs are often less effective in treating pain and can also be more dangerous to patients than are Schedule II drugs.
The scrutiny has led doctors to ration pain medicine and ignore pain -- necessary restraint in a world of diversion, enforcers would have us believe. "Even if you treat a patient with a terminal malignancy, it's irresponsible to write a prescription for 500 Dilaudid tablets," says Dr. James Winn, executive vice president of the Federation of State Medical Boards. "If the patient dies three days later, in a legitimate family the rest should be flushed down the commode. But sometimes a family member picks them up. We have a major drug problem in this country, and a lot of it comes from doctors."
The DEA provides no detailed record of the amount of diverted prescription drugs it recovers each year. The agency also lacks comprehensive data on the origin of the medication it seizes. Thus, despite Dr. Winn's assessment, there is little evidence to suggest that the narcotics which originate in doctors' offices are the same drugs which wind up on the street. In fact, DEA officials concede that the majority of black-market narcotics originate from crime rings in foreign countries, where the drugs are manufactured illegally.
In February ODC director Gene Haislip retired after 17 years, leaving behind an agency known for its intimidation tactics. Haislip maintains that legitimate prescribing has not been deterred at all by his policies. "I don't believe doctors would not prescribe because of there being a government report any more than they would not make money because they have to report it on their income tax," he claimed confidently in a speech that outraged doctors.
Despite this shaky analogy, the IRS doesn't destroy your livelihood, it simply takes a portion of it. A DEA fine, or even a protracted state medical board investigation, can threaten your medical practice, your income and the wellbeing of your patients. A state board ruling nearly ruined Dr. McNiel's life. A family practitioner who ran an outpatient clinic in Mosheim, Tennessee, McNiel vividly remembers the day he was first targeted. "In 1992 an investigator with a badge walked into my office and said I was under investigation. She had a list of patients and said she wanted to look at charts. She dug around for a few days, then disappeared." As McNiel puts it, her visit "encased the office in ice."
Working for 15 years as a missionary doctor in Honduras and Nicaragua, McNiel had witnessed all kinds of injustices. But nothing could have prepared him for what happened next. More than a year later, he received an official envelope that contained a long list of charges: "The only thing it didn't include was rape because they didn't think of it. They make you out to be the scum of the earth. This is devastating to a person's self-esteem." The medical board brought charges against McNiel of nontherapeutic prescribing in the cases of ten patients, in addition to mentioning, without any explanation, "other cases too numerous to count." The board, seemingly making no effort to conceal its arbitrary methods, also proposed more than $20,000 in fines.
National data suggest that such administrative intimidation is widespread. In 1994 state medical boards took action against 434 physicians for prescribing in violation of state medical practice acts, according to the Federation of State Medical Boards. However, the DEA, which often works with state medical boards, pursued only six criminal cases against doctors in 1994, according to information obtained from a database of justice Department files. Of these, only one doctor, from Puerto Rico, was found guilty.
The data from 1995 are similar. State medical boards took 392 actions against doctors for prescription violations. Only 11 cases were pursued by the feds that year, but there were no criminal findings. Two of the cases were dismissed because of minimal federal interest. The picture is the same at the state level. Last year in New York, the Bureau of Controlled Substances adjudicated 36 cases against doctors. However, 14 were civil cases, 14 had no charges issued and there was a smattering of warnings. Only one case was criminal.
Though these numbers seem small, each doctor works in a close-knit community. The flash of a badge can send shock waves through a hospital, or a state, and indelibly change prescribing habits. Some doctors in New York still shudder when they think of Dr. Ronald Blum, former deputy director of the Kaplan Cancer Center at New York University. In 1987 two state drug agents with guns and badges arrived at Dr. Blum's office. Though Blum was not arrested, the agents threatened to slap him with three record-keeping violations. Eighteen months later, he received a letter of warning and the investigation against him was dismissed. Nonetheless, Blum's "case" was used to bolster the statistics on state drug crackdowns.
The DEA, for its part, is quick to point out that its drop-ins on doctors are not arrests. An agency spokesperson explains: "It is important for people to realize that just because the DEA initiates an action, that doesn't mean there's criminal activity." Which is just the point.
A lawyer in Austin, Texas who has defended numerous doctors from overprescribing charges describes the agency's numbers game: "The DEA agents show up like a blitz, unannounced, in their little black jackets. They'll scare the you-know-what out of a doctor and get him to surrender his DEA registration. They get instant results for their own data, and they make a quick bunch of money for the government, a $25,000 fine. But the doctor is screwed, because he doesn't have his DEA number and can't reapply for a year. When he does, the medical board says, 'You gave up your DEA number. You must have done something wrong."' It is a rare doctor who, when threatened with these sorts of grave charges, will refuse to surrender his registration.
The Mississippi medical board that heard McFadden's case makes it clear that it hails administrative citations as victories. "We are number one in the country for bringing the most disciplinary actions per 1000 physicians," says Dr. Thomas Stevens, the board's executive officer. "I'm not proposing that we're the best in the world. But it might be a sign that we do a good job." Zealotry aside, the board's complaint counsel, Stan Ingram, contends that the hearings are fair. "The board members trying the case play no role in the investigation and have little knowledge of the facts prior to the hearing," he explains. In fact, a board member who is McFadden's neighbor was permitted to recuse himself; thus due process was protected.
Nonetheless, McFadden's son-in-law, Sean Milner, a Jackson, Mississippi based attorney, was appalled by the blatant conflicts of interest that riddled the hearing. For example, a state investigator collected the evidence and Ingram prosecuted the case; both are on the board's payroll. "It's the kind of justice you see in third world countries," Milner says. "The judges are the investigators. They hire the prosecutor. They sit as the jury, plus referee the match. How many cases do you think they lose?"The board did not demonstrate that patients had complained. It presented no evidence that McFadden had harmed patients. The board did enter evidence that McFadden kept incomplete records. On several occasions, for example, he prescribed from home when his patients had crises, then failed to enter those prescriptions into his office records. Yet the board's medical expert, a neurosurgeon, never addressed record keeping. Instead, he debated one of McFadden's diagnoses, then testified that in his opinion, McFadden had treated his patients in good faith.
"I don't want to use the term witch hunt, but I don't know how else to describe the Board of Medical Licensure," says a pharmacist who used to fill McFadden's prescriptions. McFadden has begun the arduous process of appealing the board's ruling.
It is now probably easier for a drug addict to buy black-market prescriptions on a street corner than it is for Dewberry to obtain a legal prescription for Vicodin. Meanwhile, there is no evidence that this policy has slowed real diversion, according to Dr. James Cooper, associate director of the clinical services research division at the National Institute on Drug Abuse. "It's misleading to say that diversion comes only from prescribing. The research data aren't available. No one knows the nature and extent of diversion from doctors' offices, thefts, forgeries and smuggling."
On paper, the DEA supports the use of opioids to treat pain patients. Its 1990 Physician's Manual states that narcotic analgesics have "a legitimate clinical use and the physician should not hesitate to prescribe, dispense or administer them when they are indicated for a legitimate medical purpose." In reality, the agency's crackdown has been so complete that obtaining legal pain medicine has become practically an underground activity. On August 10, 1996 the Virginia Board of Medicine revoked Dr. William Hurwitz' license, claiming he had overprescribed opioids. Many of his 220 patients, who suffer intractable pain and came from around the country to see him, have been unable to find new doctors. Several patients are being tracked by DEA agents; they speak to one another through Web sites. Two committed suicide because of the prospect of untreated pain. One recorded a final videotape, saying that his inability to find pain relief led him to seek death.
Dr. Hurwitz, 51, who obtained a law degree after he was first investigated in 1991, believes the state shouldn't interfere with a patient's right to treatment: "It is important to assess patient reliability. But I refuse to hold a moral screen over eligibility for medical care." Although some of his patients had prior addiction histories, he issued them prescriptions for clear medical needs. "I wanted to make sure that people were as functional and comfortable as possible," he says. "I felt the sheer force of numbers would protect us, by illustrating the need for pain treatment."
That illusion has been shattered. A dozen of his patients have contacted Dr. Jack Kevorkian in Detroit, who receives several hundred calls a week from patients suffering from intolerable pain. In April, Susan T., a registered nurse and a former Hurwitz patient, sent Dr. Kevorkian her final set of medical records.
Years ago, she had been vital and athletic. But searing pain in her legs and buttocks from a botched gynecological operation and a subsequent back injury left her unable to get out of bed. Her only relief came from Hurwitz, who had her up and walking with Percocet and morphine. Since his license was revoked, she has called more than 15 doctors. Most refused to treat her after she disclosed her connection to Hurwitz.
This experience led Susan to Kevorkian. She explains, "I'm pushing hard to get financial things in order, to set up a revocable trust and have my house cleaned out of extra stuff so my husband won't have to do it." Of course, she could take another patient's pain medication. But that would be diversion. "It's plain illegal and there's a line," says Susan. "Many things are worse than death. One of them is losing the last of your dignity."
Patients who need narcotics are often given less-regulated alternatives that are far more dangerous. Doctors who fear scrutiny rely heavily on antiinflammatory drugs such as arthritis pills, which can cause internal bleeding, liver damage and ulcers. One study has shown that these alternative medications kill 17,000 pain patients a year. Comparatively, the death rate from narcotic painkillers is "vanishingly small," says Dr. Brian Goldman, a University of Toronto researcher who has studied prescription drug diversion. "There is no gastrointestinal bleeding, or kidney or liver failure. An accidental death could be from respiratory failure, but pain triggers you to breathe."
Despite these facts, says Dr. Goldman, "the underlying logic is that death is better than addiction. 'Narcotics can addict you. The alternative drugs can kill you. Therefore, we should prescribe those."'
Doctors fear drug investigators and with reason. A 1987 DEA study showed that in states with a triplicate monitoring system, only 21 percent to 35 percent of physicians bothered to order the required forms. They simply chose never to prescribe drugs that created added scrutiny. As Michael Troyer, director of the National Chronic Pain Outreach Association, puts it, "Doctors do not want to be identified as treating pain patients for fear of being investigated."
In 1994 the DEA tried once again to augment its weaponry against legal narcotics. The agency drafted legislation, the Controlled Substances Monitoring Act, that would have required physicians to use government-issued prescription forms for all controlled substances. The Department of Health and Human Services deftly quashed the plan, noting that the DEA had submitted no evidence that the scope of drug diversion required such "drastic action." This defeat signaled a subtle ebb in public opiophobia.
Support for pain patients has been growing, partly fueled by outrage over regulatory excesses. Since 1989 ten states have passed intractable-pain treatment acts, supporting the medicinal use of narcotics for patients with severe pain. In Oregon, Republican state senator Bill Kennemer underwent a bitter personal experience that led him to sponsor what came to be known as the Compassionate Care Act. In 1990 his wife was diagnosed with terminal breast cancer, and she was in excruciating pain. After her third day on morphine, her oncologist said he'd have to take her off it: "'It's addictive,"' Kennemer recalls the doctor saying. "I looked this guy in the eye and said, 'What does it matter?' He said, 'I'll lose my license if I don't cut her off from morphine.'
"If you can't eliminate the pain, you have to medicate it," says Kennemer, who forged an alliance between the Oregon Catholic Conference, Citizens for a Drug-Free Oregon and the Oregon Right to Die group.
As patients secure their rights, doctors have also been emboldened to launch counterattacks. In 1994 the Florida Board of Medicine went after Dr. Katherine Hoover, charging that she had overprescribed controlled substances to seven patients. After a two year battle in which Dr. Hoover acted as her own lawyer, the appeals court chided the medical board for being "overzealous" and dismissed its case as "founded on a woefully inadequate quantum of fact."
Hoover had moved to West Virginia to run her family's farm and practice medicine. Given the Florida imbroglio, she was rigorous about documentation. She required her patients to sign a contract about the risks and benefits of narcotic pain relief, and she committed them to using a single pharmacy and not misusing their medication. However, it wasn't long before she heard from the West Virginia Board of Medicine.
The State Department of Health and Human Resources had filed a complaint with the board regarding Hoover's treatment of five patients whose pharmacy records had been singled out for review. The complaint alleged that she had prescribed in excess of her peers. Hoover points out, however, that she is the only internist in the area committed to pain management. Who, then, are her peers?
Hoover is defending herself once again. "I am not pretending to be a lawyer. I'm doing all of this because I'm a doctor," she says.
She has filed a $10 million suit against the State Department of Health and Human Resources and the West Virginia Board of Medicine, charging them with extortion, conspiracy to defraud and discrimination under the Americans With Disabilities Act. "Patients have a constitutional right to life, liberty and the pursuit of happiness," says Hoover. "How can you be happy when you're in that much pain?"
Several doctors are now considering following her lead and filing lawsuits against their medical boards for discriminating against pain patients. As Frank McNiel puts it, "A lot of the people hurting are not the ones who live on Functional Street. You've had three surgeries, you're on disability, you're broke and living in a trailer. You don't look like Mr. Yuppie, OK?" McNiel knows that if doctors want to treat pain patients, they may have to fight a court battle to do so.
In 1995 the Tennessee Board of Medical Examiners determined that McNiel had violated several provisions of the Tennessee Medical Practice Act and had a "co-dependent" relationship with his patients. The board labeled him an "impaired" physician, forced him to surrender his DEA registration and mandated he join a co-dependents' support group. After a prolonged hearing process that resulted in more than $100,000 in legal bills (which his malpractice insurance paid until the verdict came in and he was fired), his attorney's advice was simple: Put your head in the guillotine and let them drop the blade. However, McNiel appealed.
justice was served this past March. A state appeals court reversed and vacated the ruling, stating in its decision: "The conclusions of the board and its judgment are without necessary support of material and substantial evidence." McNiel succeeded in blowing up the board's opiophobic logic that when it comes to drugs, no proof is required: We would not accuse you if you were not guilty.
Despite his victory, McNiel still awaits a knock on his door: "I have a moral obligation not to ignore patients who come to me," he says. "But I'm terrified every time I write a prescription."
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