Under-treatment of Pain

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Pain Medicine: Dr. Hurwitz Denied Bail, to Sit in Prison Pending New Trial

Nationally-known pain treatment specialist Dr. William Hurwitz was denied bail pending retrial Wednesday. Hurwitz has been in prison since he was convicted in November 2004 on drug trafficking charges over his prescribing of large quantities of opioid pain relievers to patients, some of whom later admitted abusing and/or selling them. Hurwitz' conviction was thrown out on appeal, and he sought his freedom pending a new trial.

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Dr. Hurwitz in 1996 (photo courtesy Skip Baker)
Although Hurwitz had posted a $2 million bond to get out of jail after his arrest and complied with all its conditions, US District Court Judge Leonard Wexler, the same judge whose deficient instructions to the jury resulted in the verdict being thrown out, rejected a motion by Hurwitz' attorneys to free him. Judge Wexler said he was concerned Hurwitz might flee.

"Things have changed with respect to flight," Wexler said as he rejected the motion. "A jury has found him guilty of 50 counts... I think there is a risk of flight."

Hurwitz is probably the most prominent physician to be prosecuted in an ongoing federal crackdown on what authorities call prescription drug abuse and the over-prescribing of drugs such as Oxycontin and other pain relievers. His case mobilized more interest and support in the media and the medical community than any of the dozens of other cases of doctors prosecuted in the federal campaign.

He was convicted after Judge Wexler instructed jurors that they could not consider whether Hurwitz acted "in good faith" when prescribing. Hurwitz and his attorneys argued that the "good faith" defense was crucial to proving his innocence because he believed he was helping his patients by prescribing large amounts of pain relievers.

Prosecutors urged that Hurwitz remain jailed pending trial, saying he had reason to flee. "At least one jury found him guilty 50 times over," said Assistant US Attorney Gene Rossi. "He's about 60 years old, and the sentence that was imposed, 25 years, is essentially a life sentence. That is a strong incentive."

But Hurwitz' attorneys said he had not fled when out on bail before and he had a good chance of winning in the new trial. "He faithfully abided by every condition of his release," said defense attorney Lawrence Robbins.

The Robing Room, a web site that allows criminal justice professionals to rate judges, gives Wexler a mediocre 3.5 out of 10, though the sample size (only nine people, mostly criminal defense lawyers) is limited. Among the comments:

"This is one of the most mean spirited individuals I have ever met... He lacks judicial temperament and is not remotely as smart as he thinks he is, plus he does not listen."

"He is, quite simply, a terrible judge... A yeller, a browbeater, a one-sided unabashed prosecution lover... Doesn't pay much attention to legal citations that are clearly relevant procedurally... Mean and nasty, not very intelligent."

"Doesn't know the law and doesn't care."

Read David Borden's letter to Judge Wexler about evident flaws in the trial, sent prior to the original sentencing of Dr. Hurwitz, here.

Get further information about the Hurwitz case on the web site of the Pain Relief Network.

What's up with these "pain contracts"?

Spurred by the federal government's crackdown on prescription drug abuse, doctors around the country are resorting to "pain contracts" with patients in an attempt to protect themselves from charges they are Dr. Feelgoods. Such contracts typically require the patient to agree that "lost, stolen, or misplaced" drugs are not to be replaced and that the patient agree to be drug tested. Patients who refuse to sign such an agreement or who test positive for non-prescribed drugs--i.e. marijuana--are likely to be cut off. There is at least one chronic pain patient in the Veterans Administration system who is challenging the pain contracts. I will be writing about his ordeal next week. In the meantime, I sit and ponder: Who benefits from these contracts? It doesn't appear to be the patients, who are basically treated as criminal suspects for wanting to relieve their pain. And how does the Hippocratic Oath fit into this? I'll be digging into the whole sorry issue. Stay tuned.
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Welcome to the New Drug Scare of 2007

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http://www.stats.org/stories/welcome_drug_2007_sept27_06.htm

Southwest Asia: Proposal for Turning Afghan Opium Into Legal Morphine Gains Support

A proposal to license Afghanistan's illegal opium production and turn it into morphine for the legitimate global medicinal market picked up more support this week as the Italian Red Cross and the Afghan Red Crescent launched a campaign to promote the idea. While so-far scoffed at by the governments of Afghanistan, the US, and the NATO countries, the carefully researched licensing proposal from the Senlis Council, a European security, development, and drug policy think tank, has already won backing from some political figures in England and from the Italian government.

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the opium trader's wares (photo by Chronicle editor Phil Smith during September 2005 visit to Afghanistan)
The United Nations reported less than three weeks ago that despite ongoing eradication efforts, Afghan opium cultivation had increased a whopping 60% and would produce an all-time record 6,100 tons of opium this year. Afghanistan currently accounts for 92% of illicit opium production worldwide.

According to the UN, some 2.9 million Afghans are involved in opium growing, representing more than 12% of the population. The crop will bring in an estimated $3 billion this year, with farmers pocketing about $750 million and the rest going to traffickers and their allies, who range from the Taliban and Al Qaeda to government ministers, members of parliament, and provincial governors and warlords.

In a Monday press conference, the Italian Red Cross joined the campaign for the Senlis Council proposal. "This system we advocate provides for one part of the Afghan opium to be used to make legal morphine, rather than illegal heroin," Massimo Barra, president of the Italian Red Cross told reporters in Rome. To transform illicit poppy fields into licit ones would "reduce the importance of illegal practices in Afghanistan and would address the pain crisis in developing countries," where opium-based painkillers are needed to treat patients with cancer, AIDS and other diseases, Barra said.

The Afghan Red Crescent is also joining the call to adopt the Senlis proposal. The Crescent, the Italian Red Cross, and the Senlis Council also used the Monday press conference to announce the opening of a 50-bed hospital wing in Kabul for the treatment of drug addicts.

For Senlis Council executive director Emmanuel Reinert, who also addressed the press conference, eradication has proven ineffective and counterproductive because it is taking livelihoods away from hard-pressed farmers.

"Farmers right now do not have a choice; if they could, they'd want to do the right thing," he said, adding that it wouldn't be difficult to pay licensed farmers the equivalent of their net income from illegal cultivation. "The farmers will have the same financial incentive," Reinert said.

Feature: The DEA's New Proposed Policy Statement on Pain Prescribing -- What Does It Mean?

When the Drug Enforcement Administration (DEA) issued a new policy statement on prescribing controlled substances for patients suffering from chronic pain last week, it sought to redress the rising chorus of concern and complaints from health care workers and patients alike that its tough stance toward physicians prescribing opioid pain medications was resulting in a crisis in care for chronic pain patients. But if the activists and experts Drug War Chronicle talked to this week are any indication, the DEA's job in reassuring the pain care community is far from done.

The move comes after years of increasing prosecutions of physicians like Dr. William Hurwitz, a leading pain care practitioner in Virginia, who was convicted of being a drug dealer over his prescribing practices. (That conviction was recently overturned on appeal.) It also comes two years after the DEA shocked and dismayed the pain care community, including many academic pain specialists who had worked with the agency, by first posting and then quickly removing a series of "frequently asked questions" designed to assist physicians in staying within the good graces of the law. It is now commonly suspected in the academic pain community that the DEA pulled the pain FAQ at the request of the Justice Department because it would have aided Hurwitz's defense in his November 2004 trial, but the Justice Department hasn't confirmed that.

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Siobhan Reynolds, Frank Fisher, Ron Libby and Maia Szalavitz, at a September 17, 2004 Congressional Briefing convened by the Association of American Physicians and Surgeons (photo courtesy Pain Relief Network)
In a September 6 press release announcing the agency would loosen regulations on prescribing Schedule II drugs, DEA administrator Karen Tandy also unveiled the new policy statement on prescribing. "We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment, and studied their concerns carefully. Today's policy statement is the result of that collaboration. The policy statement reiterates the DEA's commitment to striking the proper balance to ensure that people who need pain relief get it, and those who abuse it, don't," said Tandy.

The policy statement outlines DEA's vision of how doctors can prescribe powerful pain medications, such as Oxycontin or fentanyl, without ending up being arrested and called a "drug dealer" by federal prosecutors intent on throwing them in prison for years. Such drugs must only be prescribed for a "legitimate medical purpose," the DEA said.

"We believe that the statement and proposed rule will help the medical professional ensure that only patients who need medication for pain relief get it. The statement reflects an awareness of patients' needs as well as the importance of preventing any illegal diversion of prescription drugs," Tandy continued. "Today's policy statement reaffirms that DEA wants doctors to treat pain as is appropriate under accepted medical community standards. Physicians acting in accordance with accepted medical practice should be confident that they will not be criminally charged for prescribing all appropriate pain medications," Tandy concluded.

Not everyone was buying what Tandy was selling, though. "This new policy statement is mere window dressing," said Dr. Frank Fisher, a California physician who underwent a years-long legal ordeal after being accused of murdering his patients through overprescribing. He was ultimately acquitted on all criminal charges, but he was ruined financially and professionally. "The problem is that physicians are intimidated and as a result we have a public health disaster with the under-treatment of chronic pain. This doesn't address the problem. We have to get treatment for those who are dying because they're not being treated. We have to find a rational way to regulate these substances, and I think there is a very good model with alcohol and tobacco, both of which are infinitely more dangerous than the opiates," he argued.

While Fisher was harshly critical of the DEA, he did concede that the proposed policy statement suggested the agency was concerned about a backlash. "It is telling," he said, "that the DEA now seems to be concerned about its image. In that sense, it's a sign of progress, but the DEA isn't really the problem -- the Controlled Substance Act is the problem. This is fiddling while Rome burns," he said.

"The DEA has been intransigent in its positions, and this is the first crack we've seen," said Kathryn Serkes, spokeswoman for the American Association of Physicians and Surgeons (AAPS), a 5,000-member, libertarian-leaning medical association that has long been active in the pain wars. "I think with the Dr. Billy Hurwitz case and everything else that has been going on in recent years, we are reaching the tipping point," she told the Chronicle. "Through getting our side out in the media and on web sites, through telling our stories, and through the work of activists like [the Pain Relief Network's] Siobhan Reynolds, the public gets it now. The media gets it now. We have seen a change in the stories. It's not just about horrible doctors killing patients anymore; the reporters are writing about the problem of pain."

That new understanding is even starting to percolate within the political class, Serkes said. "The politicians are starting to get it. The only folks who haven't gotten it are law enforcement and the courts. I think the release of this policy statement was a strategic move by the DEA in the face of Hurwitz's successful appeal of his conviction. If I were the DEA, I would certainly be looking for something to show we were being responsive. I'm sorry to sound cynical, but this looks like an obvious attempt by the agency to manipulate the situation. Still," she concluded, "we'll take what we can get. We're working on the good dog theory with the DEA -- praise the dog when it does something good even if it has some behavioral problems. Good dog, DEA, but you're still in the dog house."

Despite some broader issues with the DEA, Dr. Howard Heit, a Fairfax, Virginia, pain management and addiction medicine specialist who worked with the agency on the new policy statement was very pleased with the looser prescribing rules. "This is a tremendous step forward in the common goal of achieving balance between the DEA and health care professionals," he told the Chronicle. "It will ensure that patients who need Schedule II drugs get them and will help decrease the diversion of prescription drugs."

Heit divided his patients into two types: stable and problematic. "With stable patients, those with no aberrant behavior who follow all the agreements, I can now write sequential prescriptions for patients that I used to have to see every month," he explained. "Now I can see other patients because the stable patients don't have to come back unnecessarily. On the other hand, with my patients with problematic behavior, I want to see them every two weeks and more tightly control the medications. That prevents a greater quantity of medicine getting out that can be misused or diverted," he said.

"The DEA said they made a mistake in not allowing us to do sequential prescriptions," said Heit. "Now they are allowing us to do this. The DEA is responding to the health care community, and this opens up dialog that has been rather closed in the past two years. This is a step in the right direction. The rules of the game are being set up. The DEA has also stated they do not want to practice medicine, but it is their charge to enforce existing regulations. While I feel it is the prescriber's responsibility to know and follow federal regulations for prescribing controlled substances, it is also the DEA's responsibility to ensure that all DEA agents enforcing these regulations are knowledgeable about them."

Despite problems with the DEA in the past, particularly around the abortive pain FAQ in 2004, Heit said there was no option but to work with the agency. "The DEA isn't going away, the patients aren't going away, I'm not going away. We need to communicate with each other."

Dr. David Joranson of the Pain and Policy Studies Group at the University of Wisconsin Comprehensive Cancer Center, which had worked closely with the DEA on the abortive FAQ but not on this latest policy statement, was reluctant to render a verdict on it. "We're still analyzing the proposal and are trying to help people think through it," he told the Chronicle.

One point Joranson made was that much of the reporting about limitations on prescribing opiates is mistaken, and it isn't just the reporters getting it wrong. "There is currently no 30-day refill requirement," he said. "The DEA has clarified that there is no such requirement. There is not a word in the law or the regulations about that, and if everyone is saying there is, everyone is wrong." Even physicians are often mistaken about the law, he said. "The literature shows that medical professionals often have an inadequate understanding of the law and regulations regarding prescription practices."

Even though the DEA's own press release announcing the proposed policy statement said it "will allow a physician to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit, where medically appropriate," that press release is misleading, said Joranson. "The statement implies there is a supply limit now, but in fact a physician can prescribe any quantity of a controlled substance on a single prescription."

But Professor Ronald Libby, a University of North Florida political scientist who is writing a book on the clash between the imperatives of medicine and those of law enforcement, was not so sure patients would benefit from the relaxed prescribing rules. "General practitioners are already scared to death to write prescriptions in the first place because of the DEA," he told the Chronicle. "If they're afraid to write one prescription, why should we expect them to feel more secure writing three?" he asked.

"I don't see any real change in policy," said Libby. "Other than the 90-day prescription thing, I just don't see anything. The DEA is basically fulfilling its promise to replace the FAQ, and here it is. This is largely tokenism because the DEA is feeling the heat," he said.

Continuing discussions between the DEA and the health care community are not going to resolve the contradictions, said Libby. "I don't think you can get at the underlying issues unless and until there are congressional hearings on the DEA," he argued. "They're more secretive than an intelligence agency. It's almost impossible to get information from them, even for members of Congress."

[Editor's Note: Years ago I heard an analyst tell attendees at a forum that researchers at the federal Government Accountability Office liked to say DEA stands for "don't expect anything, don't even ask." -- DB]

But Libby doesn't see congressional hearings happening any time soon. "Let's face it. The drug warriors are in full bloom. The climate of the country is not conducive. They've managed to equate illicit drug trafficking with terrorism, and as long as that's the case and they include practitioners and patients in that war, the only way to move forward is to excise this diversion stuff from the war on drugs. But even though the pain foundations and people like the Pain Relief Network have been trying to get hearings for years, we can't get them. If the Democrats win the House, that might change, but members have to consider the fallout. If you take a hard-line position against the DEA, you become a target yourself."

"To view this as significant is to miss the point," said Siobhan Reynolds of the advocacy group the Pain Relief Network. "Pain patients have been suffering from an unbelievable crackdown, a reign of terror that has cost people their lives," she told the Chronicle.

It's very personal for Reynolds. One of those pain patients who died was her husband, Sean Greenwood, who succumbed earlier this month to Ehlers-Danlos Syndrome as he and Reynolds desperately traversed the country seeking adequate levels of prescribed pain medications for him. Because anti-terror precautions precluded them from taking medicines on airplanes, the family was forced to drive cross-country in search of a physician who would prescribe the massive doses Greenwood needed. He died in a motel room in a state Reynolds does not want to identify for fear of leading the DEA to the doctor they were seeking.

"People do not understand the enormity of what patients face," she said. "Because doctors are so afraid of law enforcement, they have projected their fear onto these patients and these drugs, so that sick people taking pain meds frighten hospitals and doctors. Sean needed a lot of hospital care, but they didn't focus on his medical problems because everyone is in the witch hunt mode about opiates. All the hospitals would talk about was giving him Narcan, as if the opiates were responsible for his medical problems," she said.

"My son watched his father die for no good reason," Reynolds continued. "He couldn't get into a hospital because of a government crackdown nobody is willing to admit is going on. No one can get the serious doses of pain medications that these really sick people need, and that's a real human rights catastrophe, and the DEA making a shiny new policy statement that basically says the same thing as before is not going to change anything."

What is needed, said Reynolds, is an all-out legal assault on the DEA's prescription drug control edifice. "We need multi-layered litigation with multiple plaintiffs going after different elements of this problem." But that will require a larger commitment from reformers than has so far been forthcoming. "We are in a gridlock of grief here, and nobody seems to care."

Making Sense of the DEA's New Proposed Policy Statement on Pain Prescribing

There are definitely mixed feelings in the pain medicine community when it comes to the DEA's new proposed policy statement on prescribing pain medications. While everyone is pleased that the agency has loosened up its prescribing rules—allowing doctors to write three one-month pain med prescriptions at a time—there is some dispute over whether the DEA's latest policy statement represents anything other than the agency doing business as usual. For Dr. Frank Fisher the new policy statement represents little more than "window dressing," he told the Chronicle this week. The problem, Fisher said, was that physicians are still intimidated by the DEA and as a result, chronic pain patients are going untreated. Siobhan Reynolds of the patients' and physicians' advocacy group the Pain Relief Network used the exact same word, "window dressing," to describe the new policy statement. Reynolds, whose husband, a chronic pain patient, died just weeks ago as the family traveled across the country seeking relief for him, talked about a DEA "reign of terror that has cost people their lives, including my husband Sean." But some physicians working in the pain management and addiction medicine fields have a much brighter view. Dr. Howard Heit, a Fairfax, Virginia, physician called the new prescribing rules "a great step forward." The DEA is "responding to the health care community," he said. There is much more. Look for a Chronicle article tomorrow that delves deeper into this. As for those Louisiana heroin lifers, I guess they'll just have to wait another week. None of the people who asked me so urgently to write about their plight three weeks ago have managed to return my repeated calls seeking more information.
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Heroin Lifers, DEA Pain Guidance, California Lowest Priority Initiatives

Those are the feature stories I think I will be doing this week. It doesn't always happen that way, though. Some readers may recall that I was going to do the Louisiana heroin lifer story last week, but I didn't manage to get ahold of any of the people critical to the story. I'm back on it again this week. Similarly, something may break during the week. This typically happens on Thursday, the day we're supposed to be wrapping up the Chronicle. I'll also be looking into the DEA's release last week of a new policy statement on pain management. Some reformers have hailed it as a victory for the movement, but others are not so sure, and neither am I. I'll be talking to a wide range of people who are involved in this issue to try to find out what this really means. Meanwhile, elections are only a matter of weeks away. I'll be taking a look this week at how things are going in Santa Barbara, Santa Cruz, and Santa Monica, the three California cities where "lowest law enforcement priority" marijuana initiatives are on the ballot. And, of course, there will also be the seven or eight shorter pieces we do each week.
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Karen Tandy Speaks the Truth...But Doesn't Mean it

USA Today's coverage of DEA's new pain medicine regulations (also blogged here) contains this unbelievable quote from DEA Administrator Karen Tandy:

"The DEA does not belong in the practice of medicine. We want doctors to be able to prescribe drugs when people are in pain. We're trying to give them a comfort level."

Truer words have never been spoken more disingenuously. Tandy has presided over an unprecedented assault on the medical profession. In two years' time, her agency has arbitrarily clarified, revoked, and revised the rules that determine when the most miserable among us will be offered relief. Immobilized by agony, the true victims of DEA's misguided witch-hunt have suffered in silence, some driven to suicide, as fear-stricken pain specialists trade in their Oxy for Advil.

Tandy has played doctor indeed, and she's done so capriciously; perpetrating a shell-game with policies that affect millions, seemingly to convict one doctor who should never have been targeted to begin with.

Nor has Tandy's negligent quackery been confined to the realm of pain-management. For a woman who, by her own account, "doesn't belong in the practice of medicine", Tandy has a lot to say about medical marijuana. And all of it's wrong.

If only she were a doctor...

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DEA Feeling the Pain

The DEA’s war on pain doctors got a facelift today as explained in their ironically titled press-release “Working Together: DEA and the Medical Community”.

From DEA.gov:

Today, DEA is unveiling a proposed rule that will make it easier for patients with chronic pain or other chronic conditions, to avoid multiple trips to a physician. It will allow a physician to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit, where medically appropriate. The Notice of Proposed Rulemaking is accompanied by a policy statement, “Dispensing Controlled Substances for the Treatment of Pain,” which provides information requested by medical professionals regarding DEA’s position on this important issue.

It’s nice to see the spirit of cooperation take hold at DEA, but recent history tells a different story. I’d bet the average pain management specialist feels less like a partner here and more like the groom at a shotgun wedding.

Indeed, this is a not-so-subtle attempt to smooth over the public relations nightmare that has resulted from the agency’s relentless harassment of pain management doctors:

Also new today, DEA is launching a new page on its website (www.dea.gov) called “Cases Against Doctors.” Everyone will be able to see for themselves the criminal acts committed by those few physicians who are subject to prosecution or administrative action each year.

The Cases Against Doctors page reeks of insecurity on DEA’s part, suggesting that widespread criticism may have affected Karen Tandy, who’s usually numb from heavy doses of self-righteousness.

Update: USA Today and Washington Post have the story. Both note the hostile relationship DEA has fostered with the medical community. Washington Post describes the regulations as an unambiguous concession to the medical community, which has generally gotten the cold shoulder from DEA on this issue.

Still, to the extent that DEA has capitulated here, it probably has more to do with last month’s reversal of the Hurwitz conviction than any sudden recognition that maybe doctors have useful ideas about how to define legitimate medical practices.

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Pain Medicine: DEA Set to Ease Restrictions on Schedule II Prescriptions

Under a proposed rule unveiled Wednesday, the Drug Enforcement Administation would allow doctors prescribing Schedule II drugs, such as morphine or Oxycontin, to fill prescriptions for 90 days instead of 30 days. Currently, pain patients can only get 30-day non-refillable prescriptions, requiring them to make additional visits to the doctor's office just to get a new prescription written. Doctors and patients have complained that the DEA's strict regulation of Schedule II drugs has forced doctors to limit their prescriptions, with patients going untreated as a result.

At a Wednesday press conference in Washington, DEA administrator Karen Tandy attempted to signal that the agency was hearing those concerns. "Today's policy statement reaffirms that DEA wants doctors to treat pain as is appropriate under accepted medical community standards," said Tandy in remarks reported by the Associated Press. "Physicians acting in accordance with accepted medical practice should be confident that they will not be criminally charged."

While the number of doctors who faced federal charges over their prescribing practices is relatively small, it is increasing -- from 38 in 2003 to 67 last year. Other pain management physicians have faced state criminal charges of administrative sanctions, and pain patient and physician advocacy groups complain that the agency is interfering with and having a chilling effect on the practice of pain medicine.

The move was welcomed by the American Medical Association, with AMA board member Dr. Rebecca Patchin telling the AP it was a step toward improving the care of pain patients. "Relieving suffering while doing everything we can to prevent the abuse of controlled substances reflects appropriate patient care, a standard which is easier to achieve when a strong patient-physician relationship exists," said Dr. Patchin. "We need to provide access to pain relief for patients with legitimate needs, and the DEA proposal would help in doing this."

Others were less sanguine. "Ms. Tandy states here, as she has on many occasions, that doctors need not fear criminal prosecution as long as they practice medicine in conformity with what these drug cops think is 'appropriate,'" said Siobhan Reynolds, president of the Pain Relief Network. "If that isn't a threat, it will certainly pass for one within the thoroughly intimidated medical community."

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