Wednesday, March 22, 2006

THE OXYCOPS

By William Fisher

Wheelchairbound multiple sclerosis patient Richard Paey is serving 25 years in a Florida prison for “trafficking” 1/2 gram of OxyContin, even though the prosecutor concedes that Paey never sold any of his medications. In prison, he now receives more pain-killing drugs than he was convicted of having.

Dr. William Hurwitz, a pioneering pain physician, was tried and convicted of violating the Controlled Substances Act -- which is intended to curb the illicit use of drugs -- and is serving a 25-year term in federal prison. He was also fined $2 million.

These are but two of hundreds of cases in which, in its zeal to stamp out the illegal drug use, the U.S. Drug Enforcement Administration (DEA) is cracking down on doctors who prescribe medications to relieve chronic pain, and the patients who depend on these drugs to live normal lives.

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. Investigators have also seized doctors’ homes, offices, and bank accounts, leaving them with no resources for their defense.

In March 2004, DEA administrator Karen Tandy told Congress her drug warriors have "been successful in addressing OxyContin diversion as evidenced by a reduction in the rate of increase of OxyContin prescriptions being written and a leveling-off of OxyContin sales." But Ronald Libby, a professor of political science at the University of North Florida, told us he doubts that sales of opioids like Oxycodone have declined since 2004.

Drug diversion means the diversion of legal drugs for illicit purposes. Prescription drug abuse accounts for almost 30% of the overall drug problem in the United States, representing a close challenge to cocaine addiction. Sometimes these diverted prescription drugs end up for sale on the street, where they reap large profits for traffickers.

Starting in the mid-1990s, and ratcheting up in 2001, the DEA -- part of the U.S. Department of Justice (DOJ) -- has been leading an aggressive effort to eradicate the illegal "diversion" of certain prescription painkillers. A particular target has been OxyContin, one of a class of drugs known as opioids, which was aggressively marketed by its manufacturer, Purdue Pharma.

In 2001, the DEA launched a campaign called the "OxyContin Action Plan”. The DEA says the plan is necessary due to increasing abuse of prescription drugs, particularly by youth. The agency, which has teamed up with state and local authorities, typically employs law enforcement methods developed in the government’s “War on Drugs”, including aggressive undercover investigation, asset forfeiture, and informers. It says its goal is to stop violations of the Controlled Substances Law.

But critics charge that the DEA has focused too narrowly on doctors, exacerbating the already widespread problem of untreated or under-treated pain. As a result, well-meaning doctors are finding themselves subject to costly, potentially career-ending investigations. Several doctors and many of their patients have already been sent to prison.

The DEA maintains that only “criminal doctors” are being targeted, and that its efforts to prevent the sale of prescribed medications have no effect on the legitimate treatment of pain.

The pain-management community disagrees. Authorities say the DEA program reportedly is having a chilling effect on physicians, who are leaving their pain management specialties for safer practices, and on their patients, many of who literally cannot function without medication. The Village Voice newspaper reports that medical schools are now advising students to avoid pain management practice altogether.

Ironically, the DEA crackdown comes at a time when the medical profession knows more than ever about how to treat the chronic pain that makes life intolerable – sometimes impossible – for the estimated 50 to 70 million Americans who live in chronic disabling pain.

Until about 20 years ago, the medical profession knew little about pain management. Today, pain management has become a recognized medical specialty, and it is estimated that there are some 5,000 pain management doctors practicing in the U.S.

The DEA’s programs also come at a time when there are more effective pain-killing drugs on the market and when the Internet makes it easier than ever to obtain them.

The DEA’s dilemma is separating legitimate prescribers and users from drug dealers. And the DEA’s task is made more difficult, not only by its zeal, but by the fact that those investigating and prosecuting are not doctors but lawyers and law enforcement agents.

Before he was ever charged with a crime, Dr. Hurwitz recommended that the DEA “suspend current prosecutions against physicians who treat pain unless and until a review by a panel of nationally recognized experts in medical pain management has found that there is an absence of good faith by the physician. If only the physician's adherence to standards of care can be questioned, then the case is not an appropriate one for the criminal process, and should be referred to the professional regulatory authorities,” he said.

The Association of American Physicians and Surgeons, in a letter to the judge in the Hurwitz case, charged he was convicted on the basis of “false expert testimony”, which it described as “egregious.”

Their letter said, “That a tiny percentage of his patients then broke the law with their prescriptions does not justify imprisoning Dr. Hurwitz for the rest of his life. A conviction based on this false medical testimony should not stand….”

The Hurwitz situation is not isolated. Throughout the U.S., physicians have been prosecuted, jailed, or have lost their licenses to practice medicine. In addition to Hurwitz, Dr. Ronald McIver is serving 30 years, Dr. Freddie Williams is serving life, and Dr. James Graves received a 62-plus-year sentence for diversion in 2002.

According to Prof. Libby, who has become an authority on the subject, “Many doctors have been convicted and almost no one has been acquitted.” He told us, “Most attorneys tell their clients to cop a plea and not fight it in court.”

Richard Paey was convicted of fraudulently submitting multiple copies of opioid prescriptions to treat chronic pain. He was in New Jersey where his doctor treated him, but then moved to Florida where he was unable to find a physician to write prescriptions to treat his pain.

Frightened by what they term a “brutal display of executive power”, most doctors, including those in the field of pain management, have simply abandoned this sickest and most vulnerable segment of our population. Patients suffering from mild to moderate pain, and requiring low dosages of opioids may still find care, but those patients with high dosage requirements are increasingly shut out of care altogether.

In 2004 it was estimated that many of the 5,000 pain specialists in the United States, would not prescribe opioids. Those few medical practices that do treat chronic pain with opioids impose severe restrictions on patients’ freedoms. Prof. Libby told us that many doctors are now prescribing over-the-counter medications such as aspirin and Tylenol, “which are far more dangerous than opioids if taken in large quantities.”

The DEA claims it investigates less than one per cent of physicians who prescribe OxyContin or other drugs covered by the Controlled Substances Act. The agency reported arresting 34 doctors out of 963,385 registered doctors in 2003, for selling opioids to addicts or drug dealers for money, sex, or favors. That is less than 0.001% of the total number of licensed doctors, the DEA said.

But critics dispute that figure. Prof. Libby told us, “In 2001, the DEA carried 861 investigations of doctors. If we use this figure instead of 34 arrests it means that more than 17 percent of the roughly 5,000 doctors who treat pain patients were investigated. That means that than one out of every six doctors who treat chronic pain patients were under criminal investigation.”

A not-for-profit advocacy group, the Pain Relief Network, is suing to have the Controlled Substances Act declared unconstitutional, and is seeking to enjoin the DEA from enforcing the law against physicians.

To calm its critics, the DEA commissioned several pain specialists to work with
Federal officials to create 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.

But that understanding didn't last long. Late last year the guidelines were taken off the DEA's website. The agency claimed it wasn't bound by any standards or practices when it came to determining what physicians it would investigate.

Removal of the guidelines coincided with Dr. Hurwitz’s trial. The doctor’s attorneys attempted to have the guidelines admitted as evidence on the belief that Hurwitz's practice conformed to their parameters. They failed. A few weeks after Hurwitz's judge refused to admit the guidelines as evidence, the DEA renounced them, and essentially declared it had carte blanche to launch an inquiry.

David Jorenson, the academic pain specialist who headed the committee that
authored the original guidelines, sent the agency a sharply-worded rebuke. Three other professional associations representing pain specialists followed with a second letter. And the National Association of state Attorneys General wrote 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.

However, the DEA remains unmoved, 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.

Dr. Alexander DeLuca, MPH, a member of the American Academy of Preventive Health and a Policy Analyst and Board Member of the Pain Relief Network, told us, ”Relations between physicians and the DEA have probably never been worse in modern times.”

He added, “Law enforcement does not deserve a place at the table where physicians, social workers, and politicians of good will need to meet to deal with drug use and pain problems as public health, not criminal, matters.”