March 5, 2004 - The Drug War Chronicle (US Web) The 2004 Federal Drug Strategy Drug Czar Makes It Official - It's War on Pain Patients, Doctors By Phillip S. Smith, Editor

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The Bush administration took direct aim at America's pain patients and pain doctors as it unveiled its 2004 drug strategy Monday. For the first time, the national anti-drug strategy will explicitly target the use of prescription painkillers for non-medical purposes.

With an estimated 75 million Americans suffering from chronic pain according to the American Medical Association, pain patients and the doctors who prescribe for them will now be ground zero in the war on drugs.

The 2004 federal drug strategy codifies and expands on what has been an accelerating federal effort to limit access to powerful pain relievers. Last month, the DEA announced it was seeking to move the hugely popular opioid pain reliever hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, which would greatly restrict patients' ability to obtain it. There has also been an ever-increasing number of federal prosecutions of doctors who prescribe pain medications, particularly opioids such as Oxycontin (oxycodone) and Vicodin (hydrocodone). The Association of American Physicians and Surgeons (AAPS), a doctors' organization committed to preserving doctor-patient privacy, last July identified more than 30 prosecutions of pain doctors, and more have occurred since then. The DEA, for its part, reported investigating more than 500 doctors last year over their prescribing practices.

"The non-medical use of prescription drugs has become an increasingly widespread and serious problem in this country, one that calls for immediate action," said John Walters, head of the Office of National Drug Control Policy (the drug czar's office - www.whitehousedrugpolicy.gov - or ONDCP) at a Monday press conference announcing this year's drug strategy. "The federal government is embarking on a comprehensive effort to ensure that potentially addictive medications are dispensed and used safely and effectively."

Those medications are dispensed in huge numbers, and despite Walters' warnings, they appear to be safe. According to health care information provider NDC Health, the opioid pain reliever hydrocodone was the nation's leading prescription drug, with 38 million people receiving more than 81 million prescriptions in 2002, while Purdue Pharma reported seven million prescriptions for its proprietary oxycodone formulation, Oxycontin.

While the number of times hydrocodone and oxycodone have been mentioned in the Drug Abuse Warning Network (DAWN) mentions of drug-related emergency room visits has indeed increased dramatically in recent years, so have the number of prescriptions written.

Hydrocodone prescriptions, for example, jumped nearly 50% in the four years from 1998 to 2002. And while DAWN listed 115,000 emergency room visits where narcotic analgesics (unspecified opioids, codeine, methadone, hydrocodone, oxycodone) were mentioned in 2002, less than 48,000 of them were for hydrocodone or oxycodone.

With nearly 100 million prescriptions for the two opioids written that year, that means that fewer than one prescription in 2,000 resulted in a hospital visit.

Walters identified two menaces to combat.

The first is "pill mills," he said, referring mainly to Internet-based pharmacies operating at the edges of the law, although the term has frequently been used by federal prosecutors to describe the practices of pain management physicians they have indicted.

The second menace is "doctor-shopping," or the practice of seeing multiple physicians in an effort to get more pills than one doctor will prescribe.

Only marijuana posed a greater drug abuse threat to the nation, Walters added. The crackdown on pill-popping will feature an attack on those Internet pharmacies and a federal push for states to enact prescription monitoring programs to help catch "doctor-shoppers." While Walters did not trumpet the pattern of prosecution of opioid-prescribing physicians, a fact-sheet presented by ONDCP did vow to continue "criminal investigations involving the illegal sale, use, and diversion of controlled substances," which is precisely what has landed doctor after doctor in federal court.

ONCDP will spend $10 million this year to expand prescription monitoring beyond the 20 states that currently have such laws. Walters said he hoped to add 11 more states to the list this year. It will also invest in web-crawler technologies to monitor and track down Internet pharmacies, according to the strategy.

And it will enlist the Food and Drug Administration to work along with the DEA to investigate drug diversion and internet pharmacies.

The crusade against prescription drug abuse is raising alarm bells among those concerned about its impact on the ability of people in real pain to get adequate treatment.

Even the staid American Medical Association expressed concern.

While the AMA praised the proposed crackdown on Internet pharmacies, it was much more cautious in embracing Walters' war on pill-poppers.

"Preventing prescription drug abuse is a vital goal; however, it is just as crucial to ensure that those in chronic pain have continued access to pain relief medications," said AMA trustee Rebecca Patchin, MD, in a statement Monday. "Some 75 million Americans experience chronic pain, and nearly one in 10 adults suffers from moderate to severe non-cancer pain. It is critical that in the rush to address drug abuse, we do not unintentionally discourage patients and physicians from appropriately treating chronic pain." The AMA would work with the federal government to seek "a balance between promoting pain relief and preventing prescription drug abuse," she added.

Other groups involved in pain relief work were not so confident of the federal government's good intentions. "It looks to me like the same strategy we've had all along," said AAPS head Dr. Jane Orient (www.aapsonline.org). "This persecution of pain patients is something that should frighten us all," she told DRCNet. "Drug Czar Walters talks about all these people abusing prescription drugs.

I know of patients here in Tucson who were in pain and took drugs from someone else's prescription because they couldn't get theirs filled.

Are they drug abusers?"

The impact of such a crackdown would have a disproportionate impact on those at the bottom of the social ladder, said Orient. "Even before this strategy was announced, there were patients who were desperate.

This will only make it worse. If you are poor and black and unemployed and uninsured, you may not get access to any drugs. I've seen emergency rooms that have signs saying "We don't prescribe to frequent flyers," meaning folks who repeatedly show up in emergency rooms.

But they go there because they have nowhere else to go," she said.

Orient was also leery of efforts to go after Internet pharmacies and to extend prescription monitoring programs. "It is probably unwise to get your prescriptions over the Internet from people you don't know," she conceded, "but for us, attacks on free enterprise are a problem.

As with the prescription monitoring, they appear to be saying it is necessary to crack down on everyone's freedom to get at this problem.

But they are trying to do the impossible. It's like using a sledgehammer to kill a fly. The fly gets away, but the sledgehammer does a lot of damage."

"We've seen this coming for a long time," said Siobhan Reynolds, director of the Pain Relief Network (www.painreliefnetwork.org), an organization of patients, family members, and others working to protect patients' access to adequate pain relief and physicians' ability to prescribe medically necessary amounts of opioid pain relievers. "The Justice Department and the DEA have come to believe that they regulate medicine. The drug czar is using this exaggerated and alarmist rhetoric about drug diversion in order to criminalize compassionate pain treatment," she told DRCNet. "They tried it against doctors in the criminal courts, but those cases are falling apart.

This is a last-ditch effort to push their agenda and get prescription drug monitoring nationwide so they can have an endless supply of patients and doctors to prosecute for their latest version of the drug war."

PRN and associated groups had already been lobbying Congress to hold hearings on the prosecutions of pain doctors, Reynolds said. "We've been working hard to create an opposition so that we would be in a position to oppose moves like this. We are calling on both the House and the Senate Judiciary committees to hold hearings to look into all of this," she said. "I believe that the members of Congress simply don't understand what is going on. The kinds of measures Walters is proposing should shock the conscience. They invade the privacy of every ill American and further institutionalize the role of doctors as drug cops," Reynolds said. "Society will bear great costs for no good reason because of the government's hysteria over prescription opioids," she added.