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Friday, May 09, 2008
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Click to go to the item or just scroll down the page. Judge Questions Purdue Pharma Plea Agreement Federal Court Fines Purdue Pharma, Executives Mixed Verdict But Bad News Overall For Dr. William Hurwitz Federal Re-Trial Starts For Doctor William Hurwitz International Pain Management Policies Commutation Urged After Paey Appeal Fails DEA's September 2006 Actions Regarding Pain Management Dr. William Hurwitz Granted New Trial Talk Show Host Rush Limbaugh Reaches Plea Agreement With Prosecution On Drug Charge Florida Doctor Found Guilty Of Manslaughter, Racketeering DEA Loses A Round: Control Over Painkiller Approval To Return To FDA Study: Minority & Poor Neighborhoods Lack Access To Pain Medications Too Tired To Fight: Doctor Cecil Knox Ends Legal Battle, Pleads Guilty Limbaugh Medical Records May Soon Be Going To Prosecutors US Attorney In SW Virginia Still Pursuing Case Against Purdue Pharma Chronic Pain & Opioids: Debunking The Myths Virginia Physician William Hurwitz Sentenced To 25 Years In Federal Prison Common Sense Unveils New Pain Management PSA DEA Issues New Guidelines For Pain Prescriptions Alabama Physician, Victim Of Early Oxy Hysteria, To Have License Reinstated Drug Control Policy Trumps Health Concerns & Common Sense: The Case Of Richard Paey ONDCP Releases 2004 National Strategy -- Feds To Clamp Down On Pain Prescriptions Federal Judge Rules Purdue Misled Officials To Win Patent Protection Fight Over Methadone Clinic Leads To State Legislation Restricting Methadone Availability It Can Happen To Anyone: Rush Limbaugh Admits To Addiction, Illegal Use Of Painkillers Plaintiffs' Attorneys End Effort To Merge Several Federal OxyContin Cases States Move To Create Prescription Tracking Systems With Federal Funds Purdue Suffers Setback As Federal Judge Sends Lawsuit Back To State Court Purdue Having Trouble Developing 'Abuse-Resistant' Oxy; Unknown When, If New Product Will Be Ready Purdue's Marketing Plan Outlined; Oxy Sales Outstripped Initial Projections Almost Six Fold Virginia Legislature Approves Creation Of Police-Run Prescription Database Oxy Ban? States Consider Legislation To Deal With OxyContin Worries Purdue Pharma Taken To Task At House Hearing On OxyContin An OxyConJob? Cleveland Free Times Claims Oxy 'Controversy' Is Media Generated Hysteria Virginia Town Uses Fingerprint System To Track OxyContin Prescriptions West Virginia Sues Manufacturer, Joins Four Other States In Establishing Monitoring Program FDA Panel To Study Further Restrictions On Oxycodone; Actions May Reduce Access To Patients In Need Purdue Pharma Discontinues High-Dose OxyContin Formulation US Drug Enforcement Administration Targets OxyContin NIDA Tries To Position Itself In Prescription Drug Misuse Debate OxyContin Controversy Goes Nationwide Information, Links To OxyContin's Manufacturer, Purdue Pharma |
The re-trial of Doctor William Hurwitz came to an end in July 2007. The doctor's sentence was reduced to less than five years. He was originally given 25 years. The Washington Post reported on July 14, 2007 ("VA Pain Doctor's Prison Term Is Cut To 57 Months") that "A prominent pain doctor who received a 25-year prison term three years ago for drug trafficking was re-sentenced yesterday to less than five years by a judge who concluded during his retrial that he helped far more patients than he hurt. The decision by U.S. District Judge Leonie M. Brinkema was a setback for federal prosecutors, who were seeking a life sentence for William E. Hurwitz. Hurwitz, 61, a former pain specialist based in McLean, was a key target of a far-reaching investigation into doctors, pharmacists and patients suspected of selling potent and addictive painkillers. He was convicted twice of trafficking in narcotics, first in 2004, and was sentenced to 25 years in prison. An appeals court threw out that verdict last year, saying that prosecutors had presented 'powerful evidence' but that U.S. District Judge Leonard D. Wexler improperly told jurors they could not consider whether Hurwitz acted in 'good faith' when he prescribed large doses of medicine. A second jury in U.S. District Court in Alexandria convicted Hurwitz on 16 counts of drug trafficking in April. He has been in jail for about 2 1/2 years." According to the Post, "Patient advocates portrayed Hurwitz as heroic, saying that he only tried to help suffering people who had nowhere else to turn. Hurwitz, a major figure in the growing field of pain management who was profiled on '60 Minutes,' said he viewed himself the same way as his supporters. He told Brinkema yesterday that he was part of a 'new enlightenment' of pain doctors and blamed his problems on a small number of patients. 'I was ill-prepared for those who set out to exploit my practice,' he said. But prosecutors said that Hurwitz prescribed excessive amounts of Oxycodone and other potentially dangerous narcotics -- in one case, more than 1,600 pills a day -- to addicts and others, some of whom sold the medication on the black market. 'He crossed the line from a healer to a dealer,' Assistant U.S. Attorney Gene Rossi said at the hearing yesterday. Brinkema seemed to lean toward the patient advocate side when she imposed her 57-month sentence yesterday. Although she said she agreed that Hurwitz had gone from being a doctor to someone who gave 'drugs to people for illicit means,' she said that the 'overwhelming majority' of his patients were legitimate and that Hurwitz had tried to help them. When she first took the case, Brinkema said she thought the dosages that Hurwitz prescribed were 'absolutely crazy.' But she said defense witnesses turned her around. 'An increasing body of respectable medical literature and expertise supports those types of high-dosage, opioid medications,' the judge said." The Post noted that "The first jury convicted Hurwitz on 50 counts, including trafficking that caused the death of one patient and seriously injured two others. Jurors acquitted him of nine counts and deadlocked on three. Before the second jury got the case in April, Brinkema dismissed the counts involving the patient who died and the two who were seriously injured. The second jury found Hurwitz guilty on 16 counts and acquitted him on 17 trafficking counts, and Brinkema dismissed the remaining 12 counts. Brinkema's sentence was much lower partly because several of the dismissed charges would have brought Hurwitz a minimum prison term of 20 years. Brinkema also recalculated federal sentencing guidelines in ways that lowered the sentence, accepting the defense's argument that Hurwitz was not completely at fault because his patients had duped him." A federal judge is challenging the plea agreement entered into earlier in 2007 between prosecutors and Purdue Pharma, the manufacturer of OxyContin. The Roanoke Times reported on June 20, 2007 ("Oxycontin Agreement Challenged By Judge") that "A federal judge is raising questions about a plea agreement that calls for $634.5 million in fines -- but no jail time -- for the illegal marketing of OxyContin, a powerful painkiller that doubles as a street drug. Before sentencing three Purdue Pharma executives next month, U.S. District Judge James Jones will consider responses to 16 questions he recently submitted to federal prosecutors and company officials. One of the questions: Why should the executives not be sent to jail? 'While it certainly is appropriate for the corporate officials to be held accountable for the actions of the company, a sentence of incarceration ... would be unusual,' prosecutors responded in court filings." According to the Times, "Following a six-year federal investigation, company president Michael Friedman, chief legal officer Howard Udell and former head of medical affairs Paul Goldenheim agreed to pay a combined $34.5 million in fines. The company will pay another $600 million as part of an agreement that calls for Jones to place its top officials on probation. It's unusual for a judge to have so many questions about a plea agreement. Although Jones asked prosecutors to justify what the plea agreement calls 'non-incarcerative sentences,' it was unclear whether his question indicates any concerns about the lack of jail time." The Times noted that "Prosecutors agreed that it would be 'legally difficult and burdensome' to identify possible victims of OxyContin abuse in the context of a criminal proceeding against the company. Complicating the issue further is the fact that the guilty pleas by Friedman, Udell and Goldenheim included no admissions that they did anything wrong -- or even knew of wrongdoing by other company officials. Rather, the charges hold them responsible simply because of their positions as top company executives. In the flurry of court filings generated by Jones' list of questions, prosecutors also defended their decision not to seek incarceration. The misdemeanor charges to which the executives pleaded guilty carry up to one year in jail; the company pleaded guilty to a felony charge. Such charges are rarely used in the misbranding of pharmaceuticals, the government stated, and the negotiated plea agreements will 'serve as a strong warning' to other drug companies. In addition to raising questions about jail time, Jones also requested detailed information on Purdue's financial holdings. Some critics have said the monetary penalty to be paid by the company represents just a small fraction of its OxyContin profits. But according to federal prosecutors, the $634.5 million in fines accounts for about 90 percent of the company's profits from the time the drug went on the market in 1996 until 2001. The fine is the country's third largest to be assessed against a pharmaceutical company, according to the U.S. Justice Department's Office of Consumer Litigation." The manufacturer of OxyContin, Purdue Pharma, and a few of its executives were allowed to plead guilty in federal court to misleading the public about the drug and were given hefty fines. The Associated Press reported on May 11, 2007 ("OxyContin Maker, Execs Fined $634.5M") that "Purdue Pharma L.P., its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said. The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin. 'With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public,' Brownlee said. 'For these misrepresentations and crimes, Purdue and its executives have been brought to justice.'" According to AP, "The U.S. attorney said the guilty pleas were entered Thursday morning in U.S. District Court in Abingdon, about 135 miles southwest of Roanoke. In an unusual move, Brownlee said, company chief executive officer Michael Friedman, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanor count of misbranding the drug. Of the total fine, $34.5 million was levied on those three. The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement." The AP noted that "Investigators from a number of state and federal agencies worked together on an investigation of Purdue Pharma and began to subpoena company records in 2002, Brownlee said. 'From these millions of records, they picked out probably 300 to 500 documents and pieced together a case,' he said. The Food and Drug Administration was part of the investigation. A spokesman for Connecticut Attorney General Richard Blumenthal said the agency had not acted on a citizen petition Blumenthal's office filed more than three years ago. The petition raised concerns about misbranding and called for stronger warnings and fuller disclosure about OxyContin's dangers." Though acquitted on several charges, former pain specialist Dr. William Hurwitz was found guilty on several drug trafficking charges in his retrial in federal court. The Washington Post reported on April 28, 2007 ("Pain Doctor Is Guilty Of Drug Trafficking") that "Federal jurors in Alexandria found William E. Hurwitz guilty of 16 counts of drug trafficking, determining that he prescribed massive quantities of medicine to patients in chronic pain. The 12-member jury acquitted Hurwitz on 17 other trafficking counts, but Hurwitz faces up to 20 years in prison for each count on which he was convicted. He will be sentenced July 13. U.S. District Judge Leonie M. Brinkema dismissed the remaining 12 counts, saying she did not want jurors to have to come back Wednesday to resume deliberations, prosecutors said. The jury would have been unable to deliberate sooner than that because a juror had travel plans. The verdict marked perhaps the final step in the long legal and medical odyssey of Hurwitz, a major figure in the growing field of pain management who was once profiled on '60 Minutes.' He was convicted on similar charges in U.S. District Court in 2004, but an appeals court threw out that verdict. Yesterday's conviction came after a retrial." According to the Post, "Richard Sauber, a lawyer for Hurwitz, said defense attorneys are 'disappointed in the verdict. We think that Dr. Hurwitz was a doctor first and foremost and not a drug dealer.' He added that Hurwitz 'saved a number of lives.' Sauber said he did not know whether the defense would appeal. Last week, Brinkema dismissed the counts involving the patient who died and the two who were seriously injured, leaving 45 counts for the jury to decide. During the four-week retrial, prosecutors argued that Hurwitz was a common drug dealer whose McLean waiting room was filled with sleeping and incoherent patients with track marks on their arms. The prosecution presented 41 witnesses, including 12 former patients who had been convicted of drug crimes. 'He crossed the line from a healer to a dealer,' Assistant U.S. Attorney Gene Rossi told the jury in closing arguments April 18. Defense lawyers presented testimony from 10 former patients of Hurwitz. The defense portrayed him as a medical pioneer, a caring and courageous doctor who just wanted to help people in unbearable pain." The Post noted that "In the first trial, jurors convicted Hurwitz on 50 counts -- including trafficking that caused the death of one patient and seriously injured two others. They acquitted him of nine counts and deadlocked on the final three in a 62-count indictment. Hurwitz was sentenced to 25 years in prison. But the U.S. Court of Appeals for the 4th Circuit overturned that verdict last year and granted Hurwitz a new trial. A three-judge panel ruled that prosecutors had presented 'powerful evidence' but that U.S. District Judge Leonard D. Wexler improperly told jurors that they could not consider whether Hurwitz acted in 'good faith' when he prescribed the large doses of medicine." The re-trial of Dr. William Hurwitz began April 2007 in federal court. According to John Tierney of the New York Times ("Trafficker Of Healer? And Who's The Victim?", April 27, 2007), "The case of the United States v. William Eliot Hurwitz, which began in federal court here on Monday, is about much more than one physician. It's a battle over who sets the rules for treating patients who are in pain: narcotics agents and prosecutors, or doctors and scientists. Dr. Hurwitz, depending on which side you listen to, is either the most infamous doctor-turned-drug-trafficker in America or a compassionate physician being persecuted because a few patients duped him."
Tierney wrote:
Tierney noted that "Even Dr. Hurwitz's supporters acknowledge that he is not the ideal doctor to be the representative for the cause of pain patients. Although his expertise in pain medicine is well respected, some say he was gullible and reckless to the point of incompetence. But the traditional punishments for such mistakes are malpractice settlements and the loss of a state medical license, not a federal investigation and 25 years in prison. 'Doctors are trained to treat patients, not to be detectives,' says Dr. James N. Campbell, a Johns Hopkins University neurosurgeon specializing in pain, who will be another witness for Dr. Hurwitz. He says that doctors have already reacted to the D.E.A. crackdown by changing the way they deal with the many Americans -- at least 50 million, by several estimates -- who suffer from chronic pain. 'Opioids were a revolution in pain treatment during the 1990s, but doctors are now more reluctant to use them,' Dr. Campbell says. 'If a doctor perceives there's a 1 in 5,000 chance that a prescription will lead to a D.E.A. inquiry -- just an inquiry, not even an arrest -- he's not going to take the chance. So the victims are the patients.'" The Pain Policy Study Group at the University of Wisconsin has assembled a set of profiles for countries around the world detailing basic information about pain drug control policy, administration, and availability. To access this tremendous resource click here. Richard Paey, an MS sufferer and chronic pain patient, was unsuccessful in appealing his 25-year sentence. The St. Petersburg Times reported on Dec. 7, 2006 ("Man Loses Case, Wins Sympathy") that "He's been on 60 Minutes. A New York Times columnist has championed his cause. Even those who prosecuted and convicted Richard Paey sympathize with the wheelchair-bound man serving 25 years for drug trafficking - for obtaining the drugs he needs for his debilitating pain. Count among those sympathizers the 2nd District Court of Appeal. The problem, a majority of the court ruled Wednesday, is that they can't help Paey. They upheld his conviction and sentence by a 2-1 vote, but passed on this advice: Get the governor to commute the sentence." According to the Times, "Such advice from an appellate court is rare indeed, said University of Florida law professor Michael Seigel. 'The court looks at a situation that it thinks is unfair,' he said. 'It's powerless to do anything about it. So the only thing it can do is to make an appeal to the governor, who does have the power to do something about it.' Appeals to the Florida Supreme Court and the U.S. Supreme Court are possible. In the meantime, Paey's attorney, John Flannery II of Virginia, said he took the court's advice right away, filing a petition with the governor's office Wednesday. It is unlikely Gov. Jeb Bush will be able to act before his term expires at the end of the year, but Flannery wants to start the process for Gov.-elect Charlie Crist." The Times noted that "Flannery did find solace in Associate Judge James Seals' blistering dissent that the mandatory minimum sentence Paey received was 'cruel and unusual.' The Hudson man was arrested by the Pasco County Sheriff's Office and the federal Drug Enforcement Administration in 1997 after buying more than 1,200 painkillers with fake prescriptions. The 48-year-old has multiple sclerosis and chronic pain since a 1985 car accident and failed surgeries. But Paey possessed more than an ounce of the drugs. Regardless of whether he tried to sell them, under Florida law he is a drug trafficker. Before his 2004 conviction, he rejected a plea deal - on principle - that would have meant just house arrest." The US Drug Enforcement Administration published two notices regarding pain management in the Federal Register on September 6, 2006. The first is a policy statement titled "Dispensing Controlled Substances for the Treatment of Pain." According to the Summary, "On January 18, 2005, DEA published in the Federal Register a solicitation of comments on the subject of dispensing controlled substances for the treatment of pain. Many of the comments that DEA received asked the agency to elaborate on the legal requirements and agency policy relating to this subject. This document provides such information." According to DEA, "One of the chief purposes of this document is to make clear that the longstanding requirement under the law that physicians may prescribe controlled substances only for legitimate medical purposes in the usual course of professional practice should in no way interfere with the legitimate practice of medicine or cause any physician to be reluctant to provide legitimate pain treatment. DEA also wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability)."
DEA makes very clear that they are not issuing a set of guidelines by clarifying federal policies with this statement. They state:
"It is certainly appropriate for physicians and medical oversight boards to explore these types of questions. However, for the following reasons, it is not appropriate for DEA to address these questions in the form of a guidance document (or to endorse such a guidance document prepared by others). "First, one cannot provide an exhaustive and foolproof list of 'dos and don'ts' when it comes to prescribing controlled substances for pain or any other medical purpose. As discussed above, the fundamental principle under both Federal and State law is that a controlled substance must be dispensed by a physician for a legitimate medical purpose in the usual course of professional practice. Throughout the 90 years that this requirement has been a part of United States law, the courts have recognized that there are no definitive criteria laying out precisely what is legally permissible, as each patient's medical situation is unique and must be evaluated based on the entirety of the circumstances. DEA cannot modify or expand upon this longstanding legal requirement through the publication or endorsement of guidelines. "Second, as stated earlier in this document, DEA's authority under the CSA is not equivalent to that of a State medical board. DEA does not regulate the general practice of medicine. The responsibility for educating and training physicians so that they make sound medical decisions in treating pain (or any other ailment) lies primarily with medical schools, post-graduate training facilities, State accrediting bodies, and other organizations with medical expertise. Some states also have continuing medical education requirements for licensing. Physicians also keep abreast of the latest findings by reading peer-reviewed articles published in medical and scientific journals. DEA, however, has neither the legal authority nor the expertise to provide medical training to physicians or issue guidelines that constitute advice on the general practice of medicine. "For these reasons, DEA is not proposing any medical guidelines on prescribing controlled substances for the treatment of pain." The second notice issued by DEA on Sept. 6, 2006, is a notice of proposed rule, titled "Issuance of Multiple Prescriptions for Schedule II Controlled Substances.". According to the Summary, "DEA is hereby proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance. DEA is requesting public comment on this proposed rule." (Written comments to DEA must be postmarked, and electronic comments must be sent, on or before November 6, 2006.) Dr. William Hurwitz, the Northern Virginia physician whose case became a cause célèbre in pain management and drug policy reform circles, was granted a new trial by the 4th Circuit Court of Appeals in August 2006. The New York Sun reported on Aug. 24, 2006 ("Doctor In VA Drug-Trafficking Case Granted New Trial") that "Medical groups are hailing a federal appeals court's decision to grant a new trial to a Virginia doctor accused of drug trafficking for prescribing large quantities of narcotics to his patients. The 4th Circuit Court of Appeals ruled Tuesday that jurors at the 2004 trial of Dr. William Hurwitz of McLean, Va., were improperly prevented from considering whether he acted in good faith. He was convicted on 50 counts and sentenced to 25 years in prison. An appeals court judge, William Traxler Jr., wrote that the jury should have been told that Dr. Hurwitz committed no crime if he had a reasonable, good-faith belief that the prescriptions were appropriate medical care. 'A doctor's good faith in treating his patients is relevant to the jury's determination of whether the doctor acted beyond the bounds of legitimate medical practice,' Judge Traxler said. 'The district court effectively deprived the jury of the opportunity to consider Hurwitz's defense.'" According to the Sun, "Prosecutors argued that Dr. Hurwitz wildly overprescribed pain-killing drugs such as OxyContin and Dilaudid, giving one patient prescriptions for more than half a million pills over a 40-month period. The government also said there was evidence the physician suspected that some of his patients were selling a portion of their prescribed medicines. Defense attorneys contended that Dr. Hurwitz acted within professional standards and that patients suffering from long-term pain can require extremely high doses of narcotics because smaller doses often become ineffective over time. The defense acknowledged that Dr. Hurwitz had been disciplined by state medical boards, but said those agencies "were back in the Stone Age."" The Sun noted that " A past president of the American Academy of Pain Medicine, Dr. Scott Fishman, said his group has not formally endorsed or rejected Dr. Hurwitz's methods, but filed an amicus brief because the court proceedings put all doctors in jeopardy. "On the surface, this is a case that appears to be an issue around a doctor who is at the extreme of practice, if not over the line," Dr. Fishman, a professor at the University of California at Davis, said. "It was about whether he got a fair trial. We felt if we didn't stand up in this case, future legitimate appropriately prescribing physicians could be prosecuted as drug dealers. We're trying to protect patients." A libertarian-oriented physicians group, the American Association of Physicians and Surgeons, offered a more robust defense of Dr. Hurwitz. "Billy Hurwitz is an accomplished physician at the cutting edge of medicine, trying to help his patients," a lawyer for the group, Andrew Schlafly of Far Hills, N.J., said. "This guy published articles in medical journals. He had a medical approach." Mr. Schlafly said federal prosecutors overreached by using the criminal justice system to control doctors. "The federal government has no business mischaracterizing a doctor as a drug dealer and interfering in the states' regulation of the practice of medicine," the lawyer said." A copy of the appeals court's decision can be downloaded by clicking here or from the CSDP site. The Hurwitz case was allegedly what prompted the DEA to withdraw its guidelines for pain management prescribing practices, which it had issued a few months before the doctor's conviction. The Washington Post reported on Nov. 30, 2004 ("New DEA Statement Has Pain Doctors More Fearful") that "Advocates for aggressive pain management said the DEA's abrupt turnaround appeared to have been triggered when defense lawyers tried to introduce the earlier pain guidelines in the trial of Hurwitz, the McLean doctor, in late September. The DEA took the document off its Web site soon after. About two weeks later, U.S. Attorney Paul J. McNulty, who is prosecuting Hurwitz, filed a motion asking that the guidelines be excluded as evidence, saying that they do "not have the force and effect of law." U.S. District Judge Leonard D. Wexler ruled in favor of the government." According to the Post, "An extensive effort to ease tensions between physicians who specialize in treating pain and the Drug Enforcement Administration over the use of morphine-based painkillers has backfired -- leaving many pain doctors and patients more fearful than before that they could be arrested for practicing what they consider good medicine. The DEA triggered the new impasse this month when it published a statement clarifying its position on a number of issues central to pain medicine. The document discusses when a doctor is at risk of being investigated for alleged prescription drug diversion, whether patients with known drug problems can ever be prescribed narcotic painkillers and whether doctors can give patients prescriptions to be filled on a future date. On all these issues, the new DEA position is at odds with a set of guidelines negotiated over several years by DEA officials and a group of leading pain-management experts. Those guidelines were posted on the agency's Web site in August as part of an effort to reassure doctors who properly prescribe narcotics, but several weeks later the document was abruptly removed and described by the agency as inaccurate and unofficial." For more on the Guidelines, see DEA Withdraws Its Pain Prescription Guidelines. Rightwing radio talk show host Rush Limbaugh reached a plea agreement with prosecutors in Florida in which charges will eventually be dismissed. The Los Angeles Times reported on April 29, 2006 ( "Limbaugh Deal Avoids Drug Prosecution, Defense Says") that "Radio talk-show host Rush Limbaugh was booked on drug charges in Florida on Friday, and his lawyer said that Limbaugh had agreed to a deal enabling him to avoid prosecution in the prescription abuse case if he continued treatment for addiction problems and avoided any other run-ins with the law. Limbaugh, a conservative darling and liberal bete noire, was booked, photographed and fingerprinted in Palm Beach, Fla., then shortly thereafter released on a $3,000 bond, according to a posting on the Palm Beach County Sheriff's Office website. A spokesman said there would be no further comment. The apparent deal caps a three-year investigation into allegations originally aired by a housekeeper at Limbaugh's Palm Beach mansion, who told the National Enquirer that the radio host had abused OxyContin and other painkillers. Prosecutors began looking into potential 'doctor shopping' by Limbaugh, who received about 2,000 pain pills prescribed by four doctors over a six-month period - all from a pharmacy near the Palm Beach house. The charge on the sheriff's website was listed as 'fraud - - conceal info to obtain prescription.'" According to the Times, "Prosecutors could not be reached for comment late Friday. But legal analysts said it appeared Limbaugh had eluded any criminal conviction in the much-publicized case. 'They slapped his hand, and that's all,' said Debra Opri, a celebrity lawyer and frequent television analyst. 'So absolutely it's a victory for Limbaugh,' Opri said. 'He doesn't have to stand trial. He just gets to say, 'Hey, I'll keep my nose clean. I don't have any priors, and I don't anticipate any futures.' And that's it. He walks.'" The Times noted that "Although many of his fans voiced sympathy and support, detractors saw hypocrisy, noting that Limbaugh had been a staunch proponent of cracking down on drug users. 'Drug use, some might say, is destroying this country,' Limbaugh said in October 1995 on a television show he had at the time. 'And so, if people are violating the law by doing drugs, they ought to be accused and they ought to be convicted and they ought to be sent up.'" A Florida physician was found guilty of manslaughter in early March 2006. The Palm Beach Post reported on March 7, 2006 ( "Luyao Guilty Of One Death, Trafficking") that "A suspended Port St. Lucie doctor who was one of the first in the nation to be charged with causing the deaths of patients from prescription drug abuse was found guilty Monday of manslaughter in one of those cases. After listening to more than two weeks of testimony and deliberating for 3 1/2 days, a six-member jury also found Asuncion Luyao, 64, guilty of racketeering and five counts of trafficking in oxycodone. The single manslaughter conviction was linked to the death of Fort Pierce resident Julia Hartsfield, 52, a patient of Luyao's from 1996 until she died in 2001. The jurors acquitted Luyao of five other manslaughter counts and one other trafficking count, but the verdict probably means she will spend the rest of her life in prison." According to the Post, "Inside the small St. Lucie Circuit courtroom packed with her family, relatives of some of her patients and spectators, the petite grandmother stared straight ahead with her hands clasped together as she listened to the verdict. These six jurors were able to do what six picked to decide the case last year could not. Her original trial on the same charges ended in a mistrial after jurors failed to reach a unanimous decision on any of the counts. On Monday evening, jurors said they had studied all 200 exhibits sent back to the jury room. 'Every single person read every single file and then we basically hashed it out,' said juror George Dietz of Port St. Lucie. Prosecutors argued that a motivation to make money drove Luyao to stop functioning as a legitimate medical doctor and became a 'drug dealer with a prescription pad.' But her defense attorney said she was a caring and compassionate physician who was 'taken in' by some patients who lied to her in order to get prescriptions. He argued she might have been naive, but her actions weren't criminal. Luyao faces a maximum sentence of 30 years in prison on each of the racketeering and trafficking charges. The manslaughter charge carries a maximum penalty of 15 years in prison. Luyao will be sentenced April 21." The Post noted that "These six jurors were able to do what six picked to decide the case last year could not. Her original trial on the same charges ended in a mistrial after jurors failed to reach a unanimous decision on any of the counts." According to the Post, "Prosecutors alleged Luyao ran a 'pill mill' from her office in the old Village Green plaza, where she gained a reputation as a doctor who would prescribe large doses of powerful, addictive narcotics with few questions asked and little to no examinations. If her patients were addicted, prosecutors argued, they would continue to pay a required $80 fee for each return visit required for a refill. An undercover investigator with the state attorney general's office testified that he visited Luyao six times during five months, posing as a painter with nonexistent back and hip pain. She prescribed him OxyContin on each visit, even though he said she never examined him thoroughly or received records of his alleged injuries. The five trafficking counts that Luyao was convicted of were linked to five of the undercover investigator's visits to her office. The jury acquitted Luyao only on the trafficking count connected to the investigator's first visit. Neither prosecuting nor defense attorneys changed their overall strategies for the retrial, but both were able to get in some new information this time that the original jury didn't hear." The Post reported that "Defense attorney Joel Hirschhorn called it an 'odd verdict' and said he plans to appeal. 'I think the jury tried hard, but that doesn't mean I can't be bitterly disappointed,' Hirschhorn said. 'This could put someone behind bars for the rest of her life for something I'm not convinced is a crime, but unfortunately the state of Florida has made it so.'" The Science Of HurtThe cover story in Harvard Magazine's Nov-Dec 2005 issue is "The Science of Hurt," by Kathleen Koman. Download and read a PDF copy of this tremendous article. A potentially significant shift in federal pain management and drug control policy occurred in early November 2005. The Washington Post reported Nov. 5, 2005 ( "Drug Enforcement Agency Stripped Of Role On New Painkillers") that "A House-Senate conference committee yesterday dropped a controversial provision that gave the Drug Enforcement Administration authority to review, and potentially block, the sale of all new prescription narcotics. The legislation, promoted by Rep. Frank R. Wolf (R-Va.) and attached to a multi-department appropriations bill, passed last year with little notice. But this year the Food and Drug Administration, many drug makers and doctors who treat pain patients objected to renewing it, and the provision was stripped from the bill. Opponents said the provision was an unwarranted intrusion by a law enforcement agency into the FDA's drug-review system. Pain specialists also said the DEA reviews could jeopardize development of new drugs needed by patients with chronic pain." According to the Post, "John Scofield, spokesman for the House Appropriations Committee, said the provision was dropped at the request of the Senate, which did not include it in its version of the appropriations bill. The dispute over the measure, and the almost $50 million in additional DEA funding attached to it, reflect a wider debate over the DEA's proper role in monitoring the use of prescription painkillers. The agency has arrested scores of doctors, pharmacists and other health-care workers accused of negligence or willful diversion in dispensing prescription narcotics that were later abused. Pain doctors complained that, as a result, many physicians have stopped prescribing needed painkillers." Previously ( "DEA Is Opposed On Painkiller Approval") the Post reported that "The provision, included in H.R. 2862, says no new drug containing controlled substances such as morphine, oxycodone and hydrocodone will be allowed on the market unless the DEA has 'reviewed and provided public comments on labeling, promotion, risk management plans, and any other documents' related to the drug. Before the provision was passed last year, the DEA's role with prescription drugs was primarily to decide how much of a controlled drug each company got to make, and then to monitor the use of those drugs on the market. Now, however, the DEA must sign off on any new FDA-approved medications containing controlled substances before they can be sold. In its report on the bill, the House Appropriations Committee expressed concern that 'drugs more powerful than OxyContin will be approved with similar risk management and labeling plans as OxyContin. . . . The Federal government must ensure that new high-risk drugs do not become easily available to illegal drug dealers and abusers.' The new bill gives the DEA $201 million to spend on preventing prescription drug diversion, an increase of more than $47 million from last year."
A study in the Oct. 2005 edition of the Journal of Pain finds that
minority and poor neighborhoods are likely to lack access to pain
medications. The University of Michigan Health System
announced on Oct. 10, 2005 (
"Pharmacies In Minority And Low-Income Areas Less Likely To Carry
Sufficient Supplies Of Pain Medications"):
An abstract of the article, "Differences In Prescription Opioid Analgesic Availability: Comparing Minority And White Pharmacies Across Michigan," from the Journal of Pain's website appears below.
"Differences in Prescription Opioid Analgesic Availability: Comparing Minority and White Pharmacies Across Michigan
The Senlis Council, an international drug policy think thank based in Europe, finally issued its controversial recommendations regarding Afghan opium in Sept. 2005. Reuters reported on Sept. 25, 2005 ( "Afghanistan Not Ready For Legal Opium - Minister") that "Afghanistan, the world's biggest producer of illicit opium and heroin, is not ready to adopt a controversial proposal to use its opium to help ease a global shortage of painkillers, its counter-narcotics minister says. The Senlis Council, a Paris-based non-governmental organisation, has suggested licensed Afghan opium production could be used to produce morphine and codeine and is to a launch a feasibility study on the proposal in Kabul on Monday." Opposition to the idea also comes from the UN drug fighting agency, the United Nations Office on Drugs and Crime. According to Reuters, "The United Nations Office on Drugs and Crime (UNODC) has also rejected the Senlis Council proposal, saying it risked creating confusion among farmers and raising false expectations. Senlis has estimated the worldwide shortage of morphine and codeine at about 10,000 tonnes of opium equivalent a year, while Afghanistan produces roughly 4,000 tonnes of opium a year. However, the UNODC, while conceding there is a shortage of narcotics for medical purposes, says lawful production of opiates worldwide had considerably exceeded global consumption in the past years and could be increased should demand increase." The shortage of opiate medicines even hits the nations which currently produce legal opium. The San Jose Mercury News reported on July 15, 2005 ( "Crime And Politics Of Opium Trade") that "India is the world's largest producer of legal opium, the raw material for codeine, morphine and other painkillers. But corruption and red tape have left thousands of Indians such as Nevatia to die in agony. And strict licensing hasn't stopped drug gangs from diverting opium meant for medicines to smuggling routes shared by heroin and morphine traffickers, gun-runners and Islamist militants, police say. 'Organized crime and politics join together in this to make life miserable,' said A. Shankar Rao, zonal director of the Narcotics Control Bureau, a national police unit." According to the Mercury News, "Mala Srivastava, the federal official who oversees the licensing system, denied that it had serious flaws. 'Whatever little diversion there is is internal,' she said. 'We have never heard of Indian opium, or Indian heroin, traveling abroad.' But the U.S. State Department's annual report on narcotics-control strategy calls India 'a modest but growing producer of heroin for the international market.' In an effort to keep opium out of criminal hands, India's federal and state governments license every step of the process, from growing poppies to stocking and transporting the painkilling drugs they produce. But officials who issue the permits often don't answer the phone, are away from their desks or let applications languish for weeks, doctors and pharmacists complain. Sometimes hospitals run out of morphine while waiting for permit applications to work their way through the bureaucratic labyrinth. 'We have so many patients suffering,' said Dr. Dwarkadas K. Baheti, a pain-management specialist at Bombay Hospital, in India's largest city, Mumbai. 'After two or three months, suddenly we have no morphine left, and for the next month, none is available.'" The Mercury News noted that "But licensing hasn't stopped traffickers, aided by corrupt officials, from getting opium and other drugs, Rao said. 'With the support of local police and politicians, they convert this opium into 'smack,'' slang for heroin, said Vinod Kumar Shahi, a lawyer in Lucknow, capital of northern India's Uttar Pradesh state. Shahi has learned a lot about the drug trade in 20 years of defending many of the region's top gangsters. By helping traffickers, police can earn 50 times their official monthly salary of about $230, Shahi said. So they pay large bribes to superiors to be posted at police stations in the opium belt of northern India, he said. Tons of tarlike opium gum are skimmed off India's legal supply each year and sent to ad hoc chemists. With a plastic tub, a cup and chemicals easily found on the black market, they make the low-grade heroin base known as 'brown sugar' on the street. There, illegal morphine is worth as much as 25 times what the government pays for it, Rao said. India is a transit country for almost-pure Afghan heroin, which is smuggled in from neighboring Pakistan, often in inflated tire tubes that are floated across rivers along the border. The high-grade heroin produced from Afghan opium accounts for about 87 percent of the world supply, according to the United Nations. Indian drugs also go south to Sri Lanka, where guerrillas with the Liberation Tigers of Tamil Eelam use money from heroin trafficking to fund their war for independence. Meanwhile, those who need the painkilling peace that opium-based drugs brings go without." Download the Senlis Council's Feasibility Study on Opium Licensing in Afghanistan for the Production of Morphine and Other Essential Medicines from here, or from the Senlis Council's website. Ronaoke, Virginia physician Cecil Knox brought his legal battles with the federal government nearer to an end in early September, 2005. The Roanoke Times reported on Sept. 2, 2005 ( "Roanoke Doctor Pleads Guilty In Federal Court") that "Knox had faced 95 charges, including racketeering, mail fraud and multiple counts that his prescriptions of opioid medications such as OxyContin were outside the scope of legitimate medical practice and led to death or serious bodily injury. Knox today pleaded guilty to racketeering, health care fraud and two counts of illegal distribution of marijuana." According to the Times, "Following an eight-week trial in 2003, a jury sitting in Roanoke acquitted Knox on some charges but deadlocked on others. Plans for a second trial were complicated last year when Knox suffered a relapse of non-Hodgkin's lymphoma. A federal judge ruled in April that Knox had recovered enough to stand trial a second time, and a court date was set for October in Abingdon." The Times noted that "Sentencing has been set for November. As part of the plea agreement, Knox will face a maximum of 12 months in prison. The sentencing also includes the possibility of an alternative to incarceration. Knox also agreed to surrender his medical license and his DEA registration number." After a great deal of legal wrangling, Rush Limbaugh's medical records may soon be going to the prosecutors in the ongoing drug investigation of his drug use. The South Florida Sun-Sentinel reported on July 6, 2005 ( "Limbaugh's Records Might Soon Go To Prosecutors") that "A Palm Beach County judge appears close to releasing at least some of Rush Limbaugh's medical records to prosecutors, saying Tuesday he could be done reviewing them by the end of the week. The documents are expected to revive a criminal investigation into the conservative talk show host's prescription drug use. In a two-paragraph ruling, Circuit Judge Thomas Barkdull also denied Limbaugh's request to restrict who on the prosecution team may view the records. Suggesting a record handover was imminent, Barkdull at the end of Tuesday's hearing requested prosecutors provide him with three evidence bags for the documents." The move comes as no surprise to Limbaugh's defense team. According to the Sun-Sentinel, "'We assumed from the first hearing that some of the records would go to the state,' Limbaugh's attorney, Roy Black, said outside the courtroom. 'The only question is which records.' Prosecutors had sought access to all of Limbaugh's medical records as they investigated whether Limbaugh engaged in 'doctor-shopping,' illegally obtaining overlapping prescriptions from different doctors. Limbaugh, 54, of Palm Beach has not been charged with a crime. Prosecutors cited prescriptions Limbaugh received in March 2003 and September 2003 to get search warrants for his medical records from four doctors in Florida and California. According to the warrants, Limbaugh picked up 1,733 hydrocodone pills, 90 OxyContin pills, 50 Xanax tablets and 40 pills of time-release morphine during that time. Limbaugh, citing privacy rights, fought against granting prosecutors access to the sealed records. He lost appeals that reached the Florida Supreme Court." Limbaugh's attorneys are also fighting to restrict access to the records to a very limited few on the prosecution. The Sun-Sentinel noted that "Barkdull last month ruled that he would privately review the records to determine which 'fall within the scope' of the search warrants. Those will be given to prosecutors. Any others will be turned over to Black. Prosecutors were ordered not to disclose the information to anyone outside the investigation. Black then sought to restrict who on the prosecution team should have access to any records released to the State Attorney's Office, blaming prosecutors and law enforcement for media leaks. 'This case has become a soap opera,' Black said. 'They have taken a course of conduct to destroy him personally.' Black argued in court documents that only three people for the prosecution, the trial prosecutor and two police officers who executed the warrants, should have access. Assistant State Attorney James Martz countered that it was incomprehensible for a suspect to dictate how prosecutors pursue a case." Federal officials may be continuing their pursuit of Purdue Pharma regarding its marketing of the painkiller OxyContin. The Roanoke Times reported on June 14, 2005 ( "OxyContin's Maker Under Investigation In Southwest Virginia") that "Federal authorities in Southwest Virginia are investigating the drug company Purdue Pharma for its marketing of the painkiller OxyContin, a company spokesman confirmed Monday. 'Purdue has total confidence in the honesty and integrity of its officers and directors, and is cooperating in that investigation,' said Purdue Pharma spokesman Tim Bannon. 'We are aware of nothing that should reasonably lead to charges as a result of this investigation.'" The US Attorney's office was unwilling to confirm the investigation. The Times reported that "Heidi Coy, spokeswoman for the U.S. Attorney's Office in Roanoke, declined to comment Monday, citing the office's policy of neither confirming nor denying an ongoing investigation." According to the Times, it is speculated that the investigation has to do with Purdue's marketing of the drug and when they became aware of its abuse potential. The paper noted that "An attorney in New York City, Paul Hanly, said one of his clients was subpoenaed to testify before a federal grand jury in Abingdon in early 2004. He described his client as a legal assistant who worked in the head office of Purdue Pharma in Stamford, Conn. He declined to identify his client. Federal prosecutor Randy Ramseyer interviewed Hanly's client about when company officials became aware of the abuse of OxyContin, Hanly said. Ramseyer did not ultimately call Hanly's client to testify before the grand jury, Hanly said. He does not know why. Ramseyer, who is based in Abingdon, could not be reached for comment Monday. Hanly said his understanding was that the investigation concerns when Purdue Pharma officials found out about the widespread abuse of OxyContin. Purdue Pharma has maintained that company officials only knew about isolated cases of abuse until the winter of 2000, when they were alerted to problems by the U.S. Attorney in Maine, Hanly said. But Hanly said internal documents his client knew about showed that company officials knew that people were crushing, snorting and injecting OxyContin dating back to 1997 and 1998. They also knew that the abuse was widespread, Hanly said. He also represents several hundred clients around the United States who have sued Purdue Pharma after they became addicted to OxyContin. Company officials continued to sell billions of dollars worth of OxyContin even though they knew early on it was being abused, according to Hanly." The Times noted that "Although questions about Purdue Pharma's marketing of OxyContin have been raised by critics of the company, lawsuits filed by people who claimed they became addicted to the drug while taking it as patients have mostly been unsuccessful. Last year, a federal judge in Abingdon dismissed lawsuits filed by three men who claimed the company over-promoted the painkiller while ignoring its risks - rendering them addicts while reaping billions in sales. In dismissing the cases, U.S. District Court Judge James Jones said the lawsuits were not the proper forum to address several questions, one of them: 'Did Purdue oversell OxyContin, for its own profit?'" Indeed, the judge's decision in that case seemed to be less an exoneration of OxyContin than an admission that it would be difficult to pin the blame on only one drug. As the Roanoke Times reported at the time ( "OxyContin Suits Dismissed"), "Judge James Jones dismissed lawsuits in which the three Southwest Virginians claimed that OxyContin manufacturer Purdue Pharma overpromoted the prescription painkiller while ignoring its risks - rendering them addicts while reaping billions in sales. Although other judges across the county have dismissed OxyContin lawsuits, Jones took the unusual step of inserting a personal observation into a 39-page opinion filed in U.S. District Court in Abingdon. 'As a trial judge hearing criminal cases, I am unfortunately all too familiar with the human misery caused by the abuse of prescription drugs, particularly including OxyContin,' Jones wrote. 'Lives wasted, families disrupted, communities devastated, because of misuse of these drugs. Did Purdue oversell OxyContin, for its own profit? Does the relief afforded by high-dosage opioids to those with severe, life-altering pain outweigh the risks of harm from addiction? These cases do not answer those questions,' Jones wrote, granting Purdue Pharma's request to dismiss the lawsuits filed by Brummett, Deckard and McCauley. The men claimed they became drug addicts after relying on OxyContin to ease their pain from the back-breaking jobs of coal mining and construction. But because all three used other opium-based drugs, a jury would not have been able to determine whether it was OxyContin alone that caused their suffering, Jones ruled." Chronic pain is a progressive disease of the nervous system. Read more about this often-misunderstood and misreported subject in "Chronic Pain & Opioids: Debunking the Myths," by Frank B. Fisher, MD. Copies are also available in PDF. This piece is also the basis for one of CSDP's public service ads, Debunking the Myths parts 1 and 2. As ever, the ad is also available as a PDF. Virginia pain specialist William Hurwitz, MD, was sentenced to 25 years in federal prison in April 2005. The Richmond Times-Dispatch reported on April 15, 2005 ( "Pain Doctor To Serve 25 Years") that "A prominent doctor convicted of using his pain clinic as a front for drug trafficking and prescribing massive amounts of opiates to patients was sentenced to 25 years in prison yesterday. William E. Hurwitz, 59, whose pain clinic in McLean drew patients from more than 39 states, was convicted in December on 50 counts, including drug trafficking resulting in the death of a patient, health-care fraud, and illegal drug distribution."
According to the Times-Dispatch, "Hurwitz attracted a national following as an aggressive advocate of high-dose opioid treatment for patients, once touting his theories on '60 Minutes.' About 100 of Hurwitz's supporters packed the federal courtroom in Alexandria, and several testified that Hurwitz saved them from debilitating pain that other doctors were unwilling to treat. 'I was sick as a dog. I was 90 pounds soaking wet, and I wanted to die. If not for that man, I would be dead' said Eyssel Gurganus of Goldsboro, N.C., pointing to Hurwitz. 'I had been to 36 doctors, and every doctor is afraid of prosecution.'" Attorneys General From 30 States Unite To Protest DEA's Disavowal Of Its Pain Management Prescription GuidelinesThe National Association of Attorneys General sent a letter signed by 30 state attorneys general to the Justice Department to protest the DEA's disavowal of its pain management guidelines, pulled from their website in 2004 (see To Be Or Not To Be -- DEA Pulls Pain Prescription Guidelines From Website, Cites 'Misstatements' -- Says Document Didn't Have Force Of Law Anyway," below). The text of the letter follows. A PDF copy of the NAAG letter is also available.
Common Sense for Drug Policy unveiled a new Public Service Ad on the pain management issue in early January 2005. The ad focuses on the DEA's rejection of guidelines for pain management prescribing. The ad cites a Washington Post article on the subject in which "Dr. David Joranson, head of the University of Wisconsin Group, says the 'DEA's abrupt withdrawal of support for the [Guidelines] without consulting with coauthors about their concerns, raises questions about what advisory role, if any, the pain management community can expect to have with DEA.' The agency's changes, he says, 'are likely to interfere in medical practice and pain management.'" This ad, scheduled to run in winter 2005, is also available as a camera-ready PDF. Dr. William Hurwitz, a northern Virginia physician, was convicted on several counts in a federal court in December 2004 in a case which has sent shockwaves through the medical community. As Jacob Sullum wrote in the Washington Times on Dec. 27, 2004 ( "Chilling Conviction"), "I have to admit I'm impressed by the achievement of the federal prosecutors who call McLean, Va., pain doctor William Hurwitz "a major and deadly drug dealer." Though the evidence at his trial made it clear Dr. Hurwitz was not a drug trafficker, they still managed to get him convicted. The prosecutors did not dispute Dr. Hurwitz had helped hundreds of patients recover their lives by prescribing the high doses of opioids they needed to control their chronic pain. Instead they pointed to the small minority of his patients - 5 to 10 percent, by his attorneys' estimate - who misused the drugs, sold them illicitly, or both. The prosecutors did not claim Hurwitz, who could receive a life sentence, got even a dime from illegal drug sales. Instead they cited his physician income, which they said was boosted by fees from patients faking or exaggerating their pain. The prosecutors did not allege Dr. Hurwitz had any explicit arrangement with those patients. Instead they described a "conspiracy of silence," carried out by "a wink and a nod." The evidence was, unsurprisingly, ambiguous at best, with plenty of room for reasonable doubt. Yet prosecutors got the jury to overlook their case's obvious weaknesses and convict Hurwitz, in essence, of trusting his patients too much. That verdict sends a clear message to doctors that it's better to err on the side of suspicion. Knowing they could be prosecuted for believing a patient who turned out to be an addict or a dealer, doctors will be even less inclined to take the risk, compounding the already appalling problem of people in needless pain because physicians are afraid to help them." Sullum noted that "More to the point, the jury was not supposed to decide if Hurwitz was a good doctor; that's an issue for the state medical board. The jury was supposed to determine if Hurwitz intentionally fed the black market in opioids. The evidence indicates he prescribed in good faith, intending to treat pain, and so his drug trafficking conviction is a chilling precedent. Writing in USA Today during Hurwitz's trial, Karen Tandy, head of the Drug Enforcement Administration, said, 'Doctors acting in good faith and in accordance with established medical norms should remain confident in their ability to prescribe appropriate pain medications.' Notice that 'good faith' is not enough to keep the DEA at bay. Doctors also have to prescribe 'in accordance with established medical norms,' as determined by the DEA, and prescribe only those medications and dosages the DEA deems 'appropriate.' With reassurances like that, who needs warnings?" The federal criminal prosecution of northern Virginia physician Dr. William Hurwitz went to the jury in early December, 2004. As reported by the Richmond Times-Dispatch on Dec. 9, 2004 ( "NVA Jury Set To Get Painkiller Case"), "A federal jury was asked yesterday to decide between two widely disparate descriptions of a prominent Northern Virginia doctor accused of fueling a black market in potent prescription drugs. Did Dr. William E. Hurwitz, as prosecutors alleged in closing arguments, look the other way when he learned some of his patients were selling and abusing the medications he prescribed for them? Or, as defense lawyers contended, is Hurwitz a caring, courageous physician who was duped by a small number of patients enrolled in a practice that helped hundreds of other people deal with their chronic pain? After a six-week trial and hearing from more than 75 witnesses, the jury is to begin deliberations this morning on a 62-count indictment against Hurwitz. If convicted of the most serious charges, the McLean doctor could be sentenced to life in prison." The Times-Dispatch noted that "The charges against Hurwitz stem from a two-year federal investigation into doctors, pharmacists and patients who allegedly marketed in potent prescription drugs, primarily OxyContin, a widely abused and highly addictive painkiller." In a story published Dec. 7, 2004 ( "Pain Doctor Accused Of Drug Trafficking Testifies"), the Times-Dispatch reported that "William E. Hurwitz, on trial in U.S. District Court, acknowledged that he prescribed massive amounts of opiates for some of his patients but said he always had a medical reason for doing so. Hurwitz testified that he knew some of his patients were drug abusers who were illegally taking cocaine or abusing his prescriptions. But he said he felt compelled to continue treating them with drugs such as OxyContin - or at the very least to refrain from abruptly canceling their prescriptions - because of the withdrawal they would suffer after taking such high doses. 'Abrupt termination of these medicines is tantamount to torture,' Hurwitz testified. Hurwitz frequently prescribed 100 tablets or more of OxyContin for his patients as they developed tolerance to lesser doses. Court testimony during the trial indicated that at least one patient received a prescription for 1,600 pills a day." According to the Times-Dispatch, "Some of Hurwitz's patients were using the prescriptions they received to deal drugs; many have struck plea bargains and testified against him at trial. Prosecutors have played audiotapes to the jury that they say are proof that Hurwitz knew these patients were dealing drugs and that he turned a blind eye. Hurwitz testified that he did not know any of his patients were dealing drugs. Expert witnesses have testified for both prosecutors and the defense, differing on whether Hurwitz's prescriptions were medically justified. Among the doctors to testify on Hurwitz's behalf was Russell Portenoy, chairman of the pain management department at Beth Israel Medical Center in New York and considered one of the world's leading experts on pain management. Hurwitz treated nearly 500 patients from 39 states in the late 1990s through 2002, receiving a $1,000 initiation fee and monthly fees of up to $250 for each patient in the practice." In addition, as the Times-Dispatch reported in a Dec. 8, 2004 story ( "Pain Doctor's Pay Entered At Trial"), "They also charge that two patients who came to him seeking legitimate pain treatment were prescribed such massive amounts of drugs that he is to blame for their overdose deaths. Hurwitz's lawyers contend those patients died of other causes. They acknowledge that at times Hurwitz prescribed massive amounts of opiates to the patients enrolled in his clinic, but say it was part of an emerging medical trend that encourages high-dosage opiate treatment for pain management." The case has repercussions in the policy world as well. The Washington Post reported on Oct. 21, 2004 ( "DEA Withdraws Its Support Of Guidelines On Painkillers") that "Advocates for aggressive pain management said the DEA's decision appears to have been triggered when defense lawyers tried to introduce the guidelines in the upcoming drug-trafficking trial of William Hurwitz, a McLean physician. In late September, Hurwitz's defense team sought to introduce them as evidence. Several weeks later, the DEA took the document off its Web site and said it was not official policy. Twelve days after that, U.S. Attorney Paul J. McNulty, who is prosecuting Hurwitz, filed a motion in the case asking that the guidelines be excluded as evidence, again saying that they do 'not have the force and effect of law.' 'It seems pretty clear that they felt they had to try to get rid of the guidelines because they supported so many parts of our case,' said Hurwitz's defense attorney, Patrick Hallinan. 'If the Justice Department followed the guidelines, there would be no reason to arrest and charge Dr. Hurwitz.'" The DEA announced in early October that its recently issued document, "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel" (see DEA Issues New Guidelines For Pain Prescriptions below), has been pulled from circulation. According to the DEA's notice, "The document contained misstatements and has therefore been removed from the DEA Web site. DEA wishes to emphasize that the document was not approved as an official statement of the agency and did not and does not have the force and effect of law. DEA recognizes that the proper use of controlled substances in the treatment of pain remains an extremely important issue. Accordingly, DEA intends to address this matter in the future." In August 2004, the Drug Enforcement Administration issued guidelines for physicians regarding prescription of pain medication. According to an Associated Press report carried by the Wisconsin State Journal on Aug. 12, 2004 ( "Doctors Get Guidance On Painkillers"), "Many doctors hesitate to prescribe narcotics, which are heavily regulated because they can be abused by addicts. The guidelines issued Wednesday, written by leading pain specialists together with the DEA, stress that the drugs are safe for the proper patient - -- and pledge that doctors won't be arrested for providing legitimate therapy." AP reported that "They come at a crucial time, said co-author David Joranson, pain policy director at the UW Medical School. Fewer doctors are willing to prescribe narcotic painkillers, known as opioids, partly because of the government's high-profile crackdown on prescription-drug abuse. Some pharmacies won't stock them for fear of burglaries. 'In some ways, pain management and the use of pain medications has become a crime story when it really should be a health-care story,' Joranson said. The key message from the guidelines: 'These are legitimate treatments. They're essential for good medical care,' said Dr. Russell Portenoy, pain chief at New York's Beth Israel Medical Center and a well-known pain specialist. June Dahl, a UW-Madison professor of pharmacology, called the guidelines 'a great step toward reducing the barriers' to the treatment of severe pain. She added that doctors have been reluctant to give adequate doses because of 'excessive fear' they might be investigated. 'It's amazing how much confusion there still is. There is a reluctance to give adequate doses. It kind of seems unbelievable that there is a reluctance to treat people who are dying, especially since there's no evidence that you can get addicted.' The story notes that "The DEA is distributing the guidelines to agents and prosecutors to help them distinguish aggressive pain management from drug diversion. A lot of opioid-taking patients in a practice shouldn't by itself signal suspicion, the guidelines advise, while long-distance prescribing and lots of premature refills might. Fear of the DEA isn't the only obstacle. Many nonspecialists simply don't know much about opioids. Consider Cynthia C. Hildt, 65, a retired New York teacher who hunted relief for disabling back pain for 20 years before Portenoy prescribed morphine. Recently another doctor asked if she wasn't afraid of addiction. 'I said, I seem to have the choice of living with this unconscionable pain or taking a pill that will help, and I don't believe that addiction is a worry under those circumstances,' Hildt said. Indeed, the new guidelines stress that when prescribed properly for serious pain, opioids hardly ever lead to addiction. 'Clearly, the risk is small unless someone has a history of substance abuse,' Dahl said. About 30 percent of Americans suffer chronic pain; for as many as a third, it can be disabling, Portenoy said. How many need opioids but are undertreated? About 40 percent of cancer and AIDS patients and the terminally ill, populations where opioids are considered optimal care, he said." The DEA's publication, "Prescription Pain Medication: Frequently Asked Questions and Answers For Health Care Professionals, and Law Enforcement Personnel," is available as a PDF and can also be downloaded from the DEA Diversion Control Program website. A physician who was a victim of the hysteria over Oxycontin is getting his license back, the Gadsden Times reported June 16, 2004 ( "Herrera Could Be Reinstated Next Week"). According to the Times, "Gadsden physician Pascual Herrera Jr. could get his medical license back as soon as next week, according to a lawyer for the state Medical Licensure Commission that revoked his license three years ago. Medical Licensure Commission attorney Wayne Turner said Tuesday that the commission may have no choice but to reinstate Herrera's license that was revoked in 2001 during the OxyContin scare in Gadsden, a situation a state senator said he "probably" reacted to politically. The commission meets June 23 in Montgomery."
The Times reported that:
The Times further reported that:
The Times noted that:
"No evidence was presented to the commission that
Herrera prescribed OxyContin to any of the three dead youths,
who were not named.
According to the Times:
For more about the Herrera case, you can check out this page on the AAPS website on Dr. Herrera's delicensure. Richard Paey is a patient suffering from chronic pain who ran afoul of the law because of his efforts to get adequate medication. As reported by Florida's Weekly Planet on June 16, 2004 ( "Mandatory Madness"), ""You know when you have a toothache and the pain is so severe that you absolutely have to be seen immediately by a dentist?" says the man in the wheelchair. "Imagine if you had to grin and bear it for an undetermined period of time. You can't see straight. You think you'll pass out, and sometimes you do. And sometimes you pray you will." Richard Paey, chronic pain patient, is describing how bad his body can hurt. He suffers from what is often called "failed back syndrome," an inoperable condition that has sentenced him to a life of pain that most of us hopefully will never have to comprehend. This is not his only sentence. On March 5, he was convicted of 15 counts of drug trafficking, obtaining a controlled substance by fraud and possession of a controlled substance, which earned him a mandatory minimum of 25 years in state prison and a $500,000 fine. This is what Richard Paey did -- or, more accurately, this is what a jury found Richard Paey ( pronounced "Pay" ) guilty of: fraudulently obtaining prescriptions of Percocet ( which contains the opiate oxycodone ) and Lortab ( which contains another opiate, hydrocodone ), each of which exceeded 28 grams. That's the magic number, 28 grams. Illegally possessing this amount gets you 25 years. It's the same mandatory minimum as 28 grams of heroin." The Planet reported that "Paey is not doing time for just the opiates. Each of his Percocet pills contained 5 mg of oxycodone and 325 mg of acetaminophen ( Tylenol ). For sentencing purposes, though, the latter substance was weighed in as well. Eighty-five of his pills weighed 28 grams. If Paey were sentenced for just the oxycodone, he would've needed 5,600 Percocet tabs to earn a quarter-century behind bars. From January to March of '97, he bought 1,200 from area pharmacies. This inflated numbers game is just one perplexing fact in the strange and scary case of Richard Paey, 45, husband and father of three, convict. Consider also that Pasco sheriff's deputies surveilled him for weeks and never found any evidence that he sold a single pill. Yet the state attorney's office charged him with trafficking -- because it could. In Florida, you can be charged with trafficking certain drugs, oxycodone and hydrocodone included, without actually peddling them. You merely need to possess them illegally. For its part, the State Attorney's Office in Pasco offered Paey several plea deals -- including, early on, house arrest and probation, then shorter prison terms. For various reasons, each deal went south. Some onlookers have characterized Paey as stubborn, saying that he put one foot in a prison cell by not jumping at the state's plea offers. Paey came close to cutting a deal several times, mostly at the urging of his wife, Linda, and his lawyer, but his heart wasn't in it. Paey has maintained all along that he did nothing criminal, that he was only medicating his own severe pain, which required large doses, and that his scripts -- written, faxed and phoned in by a doctor in New Jersey -- were legitimate. After one mistrial and another guilty verdict vacated by a judge who said Paey had not been competent to stand trial, he was convicted during a third proceeding. The jury was not permitted to know that Paey was facing a stiff mandatory minimum. One juror held out for acquittal but was eventually swayed toward a guilty vote when the jury foreman convinced him that the defendant would get only probation. The judge had no choice but to issue 25 years." Richard Paey's case is truly tragic. As the Planet reported, "On Feb. 11, 1985, Richard Paey was driving on Philadelphia's pocked and frantic Schuylkill Expressway, on his way to class at the University of Pennsylvania law school, when he got into a wreck that sandwiched his car between two others. He went to the ER the next day. Directly after the accident, Paey began taking sizeable doses of opiate pain relievers. A few months later, he underwent his first back surgery, but that only offered about a year's worth of limited relief.In 1987, he signed on for another operation. Unbeknownst to him, he received a fusion procedure that included an experimental "pedicle screw" implant that had been turned down for approval by the FDA. The implants became the focus of a high-profile class action lawsuit that was covered by the TV show 20/20. Linda Paey said her husband never received a settlement because he got involved after a statute of limitations passed. His back went from bad to worse. He'd get spasms that would hamper his breathing. The pain was always present, often excruciating. But that didn't prevent Paey from carrying on with life. He finished law school, then did a short stint as a law clerk, but had to quit because, among other limitations, he couldn't lift the hefty law books. He never took the bar exam. Paey learned that further surgery was not an option, that to remove the screws in his back could cause paralysis. He tried to stay game, but eventually reality sunk in. "You had a young, virile guy thinking that all you need to do is have the will and you can make it happen," Linda Paey says. "The pain, you could control that. He was convinced he could mentally muscle his way through this problem and continue to work. Ultimately, he had to face facts that he just wouldn't be able to do it. Those years were hell." Paey went on Social Security disability in 1989, his career dreams dashed. The Paeys moved to Columbus, a town in central New Jersey. There he found a doctor, a general practitioner named Stephen Nurkiewicz, who prescribed him ample doses of medication, including opiates such as Percocet and Vicodin."
As the Planet notes, however, there are many tragic cases
like his:
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