Wednesday, December 11, 2013
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As noted by an August 20, 2009 Medill Reports article, "In July, an advisory panel recommended to the FDA the ban of the painkillers Vicodin and Percocet. A month later, one thing the experts still haven't recommended is an alternative" ("Docs Cringe at the Thought of Painkillers Taken Off the Market"). Additionally, "On June 30, another FDA advisory panel recommended reducing a single adult dose of any acetaminophen from 1,000 milligrams to 650 milligrams - and making Tylenol available by prescription only." The recommendations resulted both from the panel's concerns about the prescription pain relievers' addictive properties as well as the effect of one of their active ingredients, acetaminophen, on users livers. However, the doctors with whom Medill, an arm of Northwestern University, seem relatively united against the recommendations, questioning both the panels' major concerns: addiction and liver damage. They also worry about the fates of the "100 million people currently liv[ing] with pain in the U.S."
As Dr. Paul Christo, "a pain specialist at the John Hopkins University School of Medicine" told the news outlet, &qout;I think removing pain medication off the market is not the answer and it will expand the epidemic of pain in this country." Moreover, "Christo beileves that painkiller addiction is blown out of proportion." Although he acknowledges that "[p]atients are at risk with opioids and some do get addicted," he does not "think it's as high as the public thinks." He even discusses the ways in which he deals with pain patients who have histories of addiction: the doctor "may still prescribe the meds they need but [he] may also require that they...engage in counseling to prevent relapses," saying that effective monitoring methods do exist. Moreover, Christo states that "The prevalence of any addiction is about 10 percent" - even for those who have never had problems with licit or illicit drug abuse.
Medill claimes that "Even more than concerns about addiction, experts question the effect of opiod[sic]/acetaminophen compounds - commonly found in painkillers - on the liver." The article reports that "some doctors" thus "have mixed feelings about the possible ban;" Dr. David Perry, director of the Pharmacology Graduate Program at George Washington University warns that "the presence of acetaminophen is toxic in high doses." However, Perry also cautions readers that "anything could be toxic" including Vitamin C and "even so-called natural products."
Doctors' largest worry, however, appears to relate to the lack of alternatives available for treating pain. The article briefly mentions medical marijuana, citing not only its low risk of addiction but also the "baggage" the drug carries. As Perry states, "I don't see a good product on the market right now that would fulfill that niche of mild to moderate pain control in a tablet that you can take orally and at home." Additionally, the article contends that alternative options exist, but "they don't work for everyone." For instance, Ibuprofen and aspirin, though they "work for many people" are hard on other patients' stomachs. Oxycodone does not contain acetaminophens, but "it's very addictive," according to the article.
Still, concerns and all, doctors like Perry presume "that the FDA will back off on the issue of a ban." However, others "wonder if the ban is imposed, whether popular over-the-counter medications could be next on the list." For its part, the "FDA declined to comment" on the issue, so it could be a while before doctors, patients, and advocates are informed of its decision.
Pain Relief Network's Siobhan Reynolds Alleges Misconduct in Grand Jury Investigation
Activist and president of a pain patient advocacy group, the Pain Relief Network, Siobhan Reynolds has "filed a complaint with the Justice Department alleging prosecutorial misconduct in a grand jury investigation of her role" in an ongoing legal battle involving Dr. Stephen Schneider and wife Linda Schneider, "who were indicted in December 2007 on 34 counts [...] of unlawfully prescribing painkillers and overbilling for services at their clinic in [a] Wichita[, KS] suburb," the Associate Press reported on July 10, 2009 ("DOJ Eyes Kan. Complaint Against Federal Prosecutor"). The latest in a series of related legal filings, Reynolds' July complaint alleges "possible ethics violations by Justice Department employees," primarily Assistant U.S. Attorney Tanya Treadway, who - as discussed below - has relentlessly pursued Reynolds over the last few years in hopes of either slapping her with an obstruction of justice charge or using her personal information to gain insight into the Schneider defense team's case. Neither the "Justice Department in Washington, D.C." nor "the U.S. attorney's office in Kansas" has yet "confirmed whether the complaint was filed;" in fact, according to the AP report, both offices specifically declined to do so.
Reynolds is being assisted by both her own organization and the American Civil Liberties Union, which filed an amended motion to quash a March 2009 subpoena that the parties claim infringes upon Reynolds' right to free speech and represents a gross misuse of the grand jury system. Unfortunately, as AP states, "U.S. District Judge Julie Robinson rejected [in early June] the ACLU's motion asking the judge to reconsider an earlier ruling declining to quash the subpoenas." In short, Treadway's subpoenas remain valid despite Reynolds' and the ACLU's efforts to dismiss them, and - though she has not yet - Reynolds will likely be forced at some point to comply with them.
FDA Considers Banning Popular Prescription Pain Medications and Putting New Dose Restrictions on Over-the-Counter, Acetaminophen-Containing Drugs
As CNN reported on June 30, 2009 ("FDA Advisors Vote to Take Vicodin, Percocet Off Market"), an FDA advisory panel voted in favor of "eliminating prescription drugs that combine acetaminophin with narcotics -- such as Vicodin and Percocet -- because of their risks for overdose and severe liver injury." The panel also "advised the FDA to lower the maximum daily dose of acetaminophen in over-the-counter and prescription medications, and to address the formulations and dosing recommendations for children." Among other recommendations, the panel suggested that, if the FDA chooses not to remove the aforementioned medicines from pharmacy shelves, it could "lower the amount of acetaminophen" in drugs that combine acetaminophin and narcotic painkillers and "take some action to ensure that subscribers and patients are aware of the potential liver damage posed by taking these products." Although it typically follows advisory committee recommendations, CNN informs readers that it "is not required" to do so.
However, as Ohio newspaper the Columbus Dispatch reported on July 20, "Confusion and concern have followed news that the [FDA] is considering" the changes discussed above ("FDA Inquiry into Painkiller Perplexes Patients"). Interviews with local doctors confirm that patients should, as one physician stated, "talk to their doctors while the FDA decides what to do." However, "Many patients are nervous that tried and true drugs might go off the market, leaving them struggling to manage pain." The physicians who spoke with the Dispatch stressed that patients should not worry excessively but rather "take acetaminophen seriously, read labels, and understand that it's fine as long as it's not taken in excess." Moreover, the Dispatch's sources reached the consensus that "it would be a mistake to take Vicodin and Percocet off the market."
Sources at the FDA stated that "Changing dosing regulations on Tylenol would take years [...], and the agency is well aware of the concerns of people who rely on Percocet and Vicodin." FDA spokesperson Karen Riley suggested that "this will be a measured response [...], adding that labeling changes would be an option that could happen relatively quickly."
Pain Activist Goes Head-to-Head with Federal Prosecutors Over First Amendment Rights, ACLU Provides Support
When federal prosecutors served activist and Pain Relief Network president Siobhan Reynolds with an excessively broad subpoena in March of 2009, the unrelenting pain patient advocate hit back with her own motion to quash the order, which she filed on April 9, 2009, according to a May 15 feature in that week's Drug War Chronicle ("ACLU Backs Pain Activist's Effort to Quash Subpoena Issued in Kansas Case").
US Assistant Attorney Tanya Treadway has, since 2007, stopped just short of litigationally harrassing Reynolds as a result of advocacy she performed on behalf of pain management physician Steven Schneider, who - along with his wife, Linda Schneider - was arrested in late 2007 after federal agents raided the couple's pain clinic and home in an attempt to prosecute them for "unlawfully prescrib[ing] pain medications." Treadway's most recent subpoena "demands that Reynolds turn over all correspondence with attorneys, patients, Schneider family members, doctors, and others related to the [...] case," as well as "bank and credit card statements showing payments to or from clinic employees, patients, potential witnesses and others, including virtually every attorney Reynolds knows." The Chronicle states that the "subpoena is supposedly part of an obstruction of justice investigation aimed at Reynolds," who "became a thorn in Treadway's side" after she traveled to Kansas to aid the Schneiders, "whom she sees as being hounded by overzealous federal drug warriors." Treadway, on the other hand, views Reynolds' advocacy as evidence of her "sycophantic or parasitic relationship" with Steven and Linda Schneider; the prosecutor claims that Reynold's activism constitutes an attempt to "further the Pain Relief Network's political agenda and her own personal interests."
However, according to the ACLU, which stepped in to assist Reynolds with her legal battle, "the subpoena should be withdrawn because it threatens Reynolds' First Amendment rights and amounts to little more than a 'fishing expedition' aimed at finding out information about the Schneider's defense." The civil liberties group filed an amended motion to quash the subpoena in early May of 2009. ACLU attorneys claim that the prosecution's actions "constitute an abuse of the grand jury process [and] would have 'a chilling effect' on Reynolds' constitutionally protected speech." Additionally, the ACLU contends that the subpoena represents further "misuse of the grand jury process because it is aimed at invading the defense camp of the Schneiders." In lay-speak, Reynolds' ACLU advocates have argued not only that the defendant simply exercised her right to free speech in her Schneider-related advocacy efforts but also that the prosecution is attempting to illegally snoop around for clues about the Schneiders' legal strategy.
Although the "motion was heard on Tuesday (5/12)," according to the Chronicle, "there is no word back from the judge yet," and because "[p]roceedings were conducted 'under seal' at Treadway's behest," the parties are barred from publicly discussing the matter.
The Chronicle feature provides a more detailed account of the case's history - particularly where Reynolds' and Treadway's involvements are concerned. Many of the legal documents - including Treadway's Reynolds-aimed subpoena, Reynolds' initial motion to quash the grand jury subpoenas, and the ACLU's amended motion to quash them - are also available for public online viewing.
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 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."
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 Hurt
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 Guidelines
The 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
You can get more information about Pain Management issues by checking out Drug War Facts: Pain Management.
The Office of National Drug Control Policy released its 2004 national drug control strategy and budget reports on March 1, 2004. The Associated Press reported in the Guardian newspaper ( "Anti-Drug Strategy To Include Pain Killers") that "President Bush's national anti-drug strategy will for the first time target the use of pain relievers, sedatives and stimulants for nonmedical purposes, a problem that has exploded in the last decade. A key part of the strategy being released Monday involves government efforts to help states develop monitoring systems to track a patient's use of prescription medicine. The monitoring programs flag cases that indicate a pattern of abuse, such as 'doctor shopping,' where a patient gets prescriptions for drugs from multiple physicians. Prescription medicine now ranks second, behind marijuana, among drugs most abused by adults and young people, said the report by the White House's Office of National Drug Control Policy. It cited a recent study by the Health and Human Services Department. Twenty states have prescription monitoring programs, the report said. John Walters, director of the drug policy office, said he expects to expand the program to 11 more states by next year. About $10 million in federal funds will bankroll the expansion."
The federal General Accounting Office released a report on the marketing of Oxycontin in early January. The Associated Press in the Richmond Times-Dispatch reported on Jan. 23, 2004 ( "Maker Of Oxycontin Minimized Its Dangers In Videos For Doctors") that "The maker of OxyContin sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug, congressional investigators said yesterday. The General Accounting Office also said that in 1998, Stamford, Conn.-based Purdue Pharma failed to submit one of the videos to the Food and Drug Administration for review, as required, when the company started circulating it to thousands of doctors. The company said its failure to send the video to the agency was an oversight. It did submit a 2001 video for FDA examination, but the agency did not review it 'because of limited resources,' the report said. On the 1998 video, a doctor says less than 1 percent of people who take pain relief medication like OxyContin become addicted. That's a figure the FDA says has not been substantiated. The FDA looked at the later video after GAO investigators inquired about it. The agency said it 'appeared to make unsubstantiated claims regarding OxyContin's effect on patients' quality of life and ability to perform daily activities and minimized the risks associated with the drug.' The FDA also publicly cited Purdue Pharma last year for overstating OxyContin's safety in print ads."
The GAO report,
"Prescription Drugs: OxyContin Abuse and Diversion
and Efforts to Address the Problem"
(GAO-04-110 December 19, 2003)
A text copy of the GAO report can be accessed by clicking here.
Purdue Pharma suffered a major loss in federal court in early January 2004. The New York Times reported on Jan. 6, 2004 ( "Judge Says Maker Of Oxycontin Misled Officials To Win Patents") that "Purdue Pharma, the maker of the highly profitable painkiller OxyContin, deliberately misled federal officials to win patents protecting its drug, a federal judge ruled yesterday. The ruling helps clear the way for a cheaper generic version and could lead to more lawsuits. The decision by Judge Sidney H. Stein of Federal District Court in Manhattan came in response to a suit brought by Purdue against Endo Pharmaceuticals Holdings, which had filed an application to sell a generic version of OxyContin. Robin Hogen, a Purdue Pharma spokesman, said the company was "surprised and disappointed" by the ruling and planned to appeal. The ruling spells trouble for Purdue, which derives more than 70 percent of its $1.8 billion in annual revenue from OxyContin. Generic pills often grab 80 percent of a branded drug's sales within just a few months. When Endo introduces its pill, much of Purdue's business could disappear. And two more generic companies are waiting to introduce their versions of the pill."
According to the Times, "Endo said that Purdue's many patents on OxyContin were invalid. To win its patents, Purdue told the patent office that OxyContin was unique because 90 percent of patients taking the medicine got pain relief by taking very little medicine - from 10 milligrams to 40 milligrams. But during the course of the trial, Dr. Robert F. Kaiko, OxyContin's inventor, acknowledged that he had done no clinical studies and had no evidence to support this claim. Purdue admitted that Dr. Kaiko's 'discovery' was made solely in his head but that it was valid even though the company was unable to prove it to be true. Internal company documents from 1993 show that Purdue executives concluded that the claims that the company were making for OxyContin 'weren't anywhere close' to being proved and were 'clearly Bob Kaiko's vision.' In his ruling, Judge Stein wrote that 'Purdue made a deliberate decision to misrepresent to the P.T.O. a 'theoretical argument' and an 'expectation' as a precisely quantified 'result' or 'discovery.''
The Times goes on: "The F.D.A. grants five years of exclusive selling rights to any drug that wins its approval. After that, companies generally rely on patents to maintain the monopolies that allow them to charge high prices. Purdue's initial five years of exclusive selling rights ended in 2000. Since then, it has been able to continue charging high prices for OxyContin because of its patents - patents that were won fraudulently, Judge Stein ruled. Caroline Manogue, a spokeswoman for Endo, said that her company might wait for an appeals court ruling before introducing its version of the drug, a process that could take more than a year. After Endo sells its version for six months, other companies can enter the market. Teva Pharmaceuticals and Impax Laboratories both have tentative approval from federal regulators to introduce versions of the pill then."
The loss could be even more costly for Purdue. The Times reported that "Judge Stein's finding that Purdue deliberately misled the United States Patent Office could lead to lawsuits from state attorneys general and consumer groups contending that Purdue's actions cost American consumers billions of dollars. Mr. Hogen of Purdue denied that the company had misled the Patent Office. Steve Berman, a lawyer for the Prescription Access Litigation Project, said that Judge Stein's summary of the OxyContin patent case described 'a classic situation that I'm sure will result in litigation in the imminent future P.A.L.'s whole mission is to spot these kinds of cases and institute litigation on behalf of consumers,' Mr. Berman added. In a similar case, the Bristol-Myers Squibb Company agreed a year ago to pay $670 million to settle claims that it improperly stymied generic versions of two medicines. Purdue's introduction of OxyContin is based on the simple idea that patients suffering from chronic pain like to get a full night's sleep. Oxycodone, a popular and powerful narcotic, is effective for only four to five hours. OxyContin delivers a steady stream of oxycodone over 12 hours. The Food and Drug Administration approved the drug in December 1995."
As the reported use of opiates including OxyContin has increased in some rural parts of the US over the past few years, so has demand for treatment services. Yet in spite of the increased need, some in these communities are fighting access to methadone treatment.
Some residents of Roanoke, VA are fighting a proposal to locate a methadone clinic there. The Roanoke Times reported on Sept. 24, 2003 ( "Roanoke County Gets Ready To Fight Drug Clinic") that "The Roanoke County Board of Supervisors is gearing up to fight a proposed methadone clinic at the corner of Ogden Road and Colonial Avenue. 'We will certainly do everything in our power,' board Chairman Joe McNamara told a citizens' task force Tuesday. Later, the board went behind closed doors to discuss probable litigation related to the clinic."
The fight is also being carried out in the state legislature. The Roanoke Times reported on Jan. 4, 2004 ( "Legislators Plan To Submit Bills Restricting Methadone Clinics") that "First there was community agitation, then the threat of litigation, and now proposed legislation. Such has been the reaction in the past four months to proposed methadone clinics in the Roanoke Valley. When the General Assembly convenes next week , two legislators plan to submit bills that would prohibit methadone clinics from opening within a half-mile of a school. Legislation proposed by Sen.-elect Brandon Bell, R-Roanoke County, and Del.-elect William Fralin, R-Roanoke, would also require the state agency that regulates drug treatment centers to notify the jurisdiction where a clinic is planned within 15 days after an application for a state license is filed. Bell and Fralin suggested the legislation as candidates in September, when a planned methadone clinic in Roanoke County near Green Valley Elementary School stirred up strong neighborhood opposition."
This opposition to increased availability of treatment services for opiate addiction comes at the same time as increased concern in the state and region regarding OxyContin and other prescription drug abuse, particularly opiates. The Roanoke Times reported on Dec. 11, 2003 ( "114,000 Prescriptions Put In Database") that "More than 114,000 prescriptions filled at pharmacies across Western Virginia have been entered into a database designed to identify drug abusers who con doctors into giving them painkillers. The prescription monitoring program, which was approved as a pilot program by the General Assembly last year, began operation in September. Authorities hope that by tracking prescriptions for drugs such as OxyContin and methadone, they will be able to curb the practice of 'doctor shopping,' in which drug abusers go to multiple physicians and feign ailments in order to obtain their drug of choice. Since it began Sept. 11, the database has grown to include more than 114,000 prescriptions filled at about 300 pharmacies in a region that stretches from Appomattox County to the westernmost tip of the state."
There is also certainly demand for such a clinic in rural Roanoke County, VA, a demand attributed by some to prescription drug abuse, particularly Oxycontin. The Roanoke Times reported on Jan. 4, 2004 ( "Methadone A Booming Business In Western VA") that "Four years ago, there were no methadone clinics in Virginia west of Richmond. Now there are three. Soon there may be six. The proliferation of the treatment programs, which dispense methadone daily to help addicts break their dependence on other drugs, is attributed to the region's long-standing problem with prescription drug abuse that peaked around 2000 with the emergence of OxyContin."
This increased demand has led to some support for a methadone clinic locally. The Roanoke Times editorialized on Sept. 12, 2003 ( "End The Commute For Recovering Addicts"), "INSTEAD of traveling 100 miles to Galax or 120 miles to Charlottesville for treatment, recovering drug addicts in the Roanoke Valley need help closer to home. A plan by Life Center of Galax to open a satellite methadone clinic in Southwest Roanoke County is a sensible solution to eliminating the lengthy commute for addicts of opium-based drugs trying to turn their lives around. Because the Roanoke area is the urban center of Southwest Virginia, situating a treatment facility here will provide easier access for more of those needing help in the region. About 70 patients from the Roanoke Valley are now enrolled in Life Center's program in Galax. Officials have received calls from as many as 100 others unable to begin treatment because they cannot make the daily visits, which the program initially requires. Once the clinic is fully operational, Life Center expects 200 to 300 patients to regularly visit the Roanoke County site."
A sidenote: Some areas are reporting an increase in methadone-related deaths, specifically related to use of the pill form of methadone -- the sort prescribed to pain patients, distinctly different from the liquid form used in methadone clinics. The Roanoke Times, in its Dec. 11, 2003 story "114,000 Prescriptions Put In Database," reported that "While OxyContin abuse remains a problem, authorities have since noticed a growing problem with methadone, a synthetic narcotic that is used as a painkiller and a form of treatment for addicts of opium-based drugs. Last year, 62 people died from methadone overdoses in the western half of Virginia, said Dr. William Massello of the medical examiner's office in Roanoke. The methadone that caused the overdoses appeared to have been tablets prescribed by physicians for pain, Massello said, and not the liquid form of the drug that is used by methadone clinics such as the ones that have generated controversy in the Roanoke Valley."
The Roanoke Times reported on July 20, 2002 ( "Methadone Deaths Rise In Western VA") that "'We're theorizing that perhaps because of the bad publicity that OxyContin has received, there are physicians who are switching to methadone' to treat pain, Massello said. The pharmaceutical black market is driven primarily by 'doctor shoppers' who fake ailments to obtain drugs from multiple physicians and then sell them on the street. Another theory is that prescription drug abusers are being forced to turn to other drugs such as methadone because increased law enforcement efforts have made it harder for them to find OxyContin on the street. 'I still think OxyContin is the drug of choice,' said Tazewell County Commonwealth's Attorney Dennis Lee, who serves on a state task force studying prescription drug abuse. 'But in a pinch, people will buy methadone and use it also.'"
For more information about methadone, read the Methadone section of Drug War Facts. You can also find out more by checking out the Methadone, Buprenorphine, and Heroin Addiction Treatment Update section of this site.
Noted talk-show host Rush Limbaugh has confessed to illegally purchasing and using opioid painkillers. The Sarasota Herald-Tribune reported on Oct. 11, 2003 ( "Limbaugh Says He's Addicted To Painkillers, Will Check Into Rehab") that "Conservative commentator Rush Limbaugh announced during his radio program Friday that he is addicted to painkillers and is checking into a rehab center to 'break the hold this highly addictive medication has on me. You know I have always tried to be honest with you and open about my life,' Limbaugh, who lives in Palm Beach County, said during a stunning admission aired nationwide. 'So I need to tell you today that part of what you have heard and read is correct. I am addicted to prescription pain medication.""
The reports of Limbaugh's illegal drug use first appeared in the National Enquirer. According to the Herald-Tribune, "The tabloid had interviewed Wilma Cline, who said she became Limbaugh's drug connection after working as his maid. She said Limbaugh had abused OxyContin and other painkillers. Law enforcement sources who spoke on condition of anonymity confirmed to The Associated Press that Limbaugh was being investigated by the Palm Beach County state attorney's office."
According to the report, "Limbaugh said he started taking painkillers 'some years ago' after a doctor prescribed them following a spinal surgery. His back pain stemming from the surgery persisted, so Limbaugh said he started taking pills and became hooked."
The Daytona Beach News-Journal noted in an Oct. 14, 2003 piece ( "Let's Learn The Right Lesson From Rush Limbaugh's Fall"), "In 1995, perhaps in response to criticism that blacks are far more likely than whites to go to jail for the same type of drug offense, Rush Limbaugh issued one of the moralistic edicts for which he is famous: 'Too many whites are getting away with drug use. The answer is to ... find the ones who are getting away with it, convict them, and send them up the river.""
Drug policy reformers, including CSDP, disagree with that sentiment, and contend that treating drug use as a crime is backward, counterproductive, and wrong.
As the News-Journal opined, "But we have had enough of warehousing drug abusers in jail cells. We continue to build more and more jails, but the real abuse is the way we underfund drug rehabilitation facilities and programs. People like Limbaugh should be sentenced to rehabiliation, not jail. No, it's not a magic bullet. Limbaugh reportedly has been through some form of rehab twice. But in 2001 the Centers for Disease Control reported that more than one-quarter of inmates in American jails were there because of drug offenses, or more than 1.5 million people. In many cases, these people are like Limbaugh -- not criminals, but drug users more likely to harm themselves than others. Many had jobs and functioned well in daily life. They were nonviolent. Although unlike Limbaugh, many of these people probably were recreational users, not addicts, who were unlucky enough to be caught. It's too soon to say if Limbaugh has been humbled enough to change his mind since 1995; it will be sad if he hasn't. We can't afford anymore of the hypocrisy that lets celebrities like Limbaugh go to voluntary rehab -- and ordinary people go to jail."
To search the MAPINC archive for more stories about Rush, click here.
Attorneys in a suit against Purdue Pharma, manufacturer of OxyContin, have withdrawn their motion to have dozens of federal suits against Purdue consolidated and heard through multidistrict litigation. The Roanoke Times reported on June 27, 2003 ( "Lawyers Drop Federal Effort To Merge Oxycontin Cases") that "Earlier this year, three lawsuits in U.S. District Court in Abingdon were put on hold because of the possibility that pretrial proceedings would be heard by a single judge appointed to handle all such cases nationwide. The lawsuits accuse Purdue Pharma, a Connecticut company that makes OxyContin, of overpromoting the prescription painkiller while playing down its addictive side. Litigation was stayed earlier this year when the plaintiffs in a South Carolina OxyContin case filed a motion to have the lawsuits heard through multidistrict litigation, which is used to consolidate the handling of discovery and other pretrial proceedings in similar claims nationwide. But the plaintiffs recently withdrew their request, allowing the cases to be handled individually in their respective courts, according to Tim Bannon, a spokesman for Purdue Pharma. The company had objected to multidistrict litigation because it thought each case was different, Bannon said. Dropping the process 'enables the cases to be tried on the merits, and we think the merits favor us,' Bannon said."
According to the Times, "Purdue Pharma has contested claims raised by more than 200 lawsuits filed against it, saying that those who misuse OxyContin should not be allowed to recover damages - or to infringe on the rights of legitimate patients who need the medication. About 30 lawsuits have been dropped or dismissed, Bannon said, and the company has yet to settle a claim or lose a case in court." The Times reported that "William Eskridge, an Abingdon attorney who represents Purdue Pharma in the three lawsuits filed in Virginia, said it's likely that the stay will be lifted and the cases will proceed toward trial. One trial that was to begin in October was postponed earlier this year because of the request for multidistrict litigation. Had the process been used, the cases would have returned to their original courts for trials if they survived the consolidated pretrial proceedings."
Several states are putting together prescription tracking systems in order to keep tabs on people receiving -- legally -- the painkiller OxyContin. The Lexington Herald-Leader reported on Nov. 29, 2002 ( "Project Targets Drug Abuse") that "Kentucky is one of nine states that will share a $2 million federal grant to enhance or begin programs that detect prescription drug abuse. Neighboring Ohio, West Virginia and Virginia will obtain money to begin similar detection programs. Pennsylvania, California, Massachusetts, Nevada and Utah also will share the grant."
Kentucky is one of the states seeking to improve its tracking system. According to the Herald-Leader, the new system "would allow for immediate recording of pharmacy transactions, an improvement over the month delay in getting data from Kentucky's current prescription tracking program. Kentucky started a program three years ago called KASPER -- Kentucky All Schedule Prescription Electronic Reporting -- to track controlled substances dispensed by pharmacists. Despite KASPER, drug abuse remained prevalent along the state's border since five neighboring states do not monitor sales of potent painkillers such as hydrocodone and OxyContin."
Virginia is one of the states working to create its first tracking system. The Bluefield Daily Telegraph reported on Nov. 30, 2002 ( "Database To Track Drug Prescriptions Nears Fruition") that "A computer database to track drug prescriptions in southwestern Virginia, designed primarily to catch abusers of OxyContin, could be operational by early next year if the state receives a federal grant, officials said. Virginia has applied for a $180,000 grant from the Justice Department to help fund the creation and maintenance of the database, which was approved under a two-year pilot program by the General Assembly earlier this year."
According to the Daily Telegraph, "Only drugs listed as Schedule II by the Food and Drug Administration would be monitored in the database that would include 300 pharmacies from Appomattox to Lee counties. Schedule II drugs are those considered highly addictive, such as morphine, OxyContin and methadone. The database skirts doctor-patient privacy issues by making the information available only to police who have already begun an investigation into a specific doctor or patient. Robert Nebiker, director of the Health Professions Department, said officials are negotiating with a software contractor to create the database."
A federal judge ordered that a Tazewell County, VA lawsuit over OxyContin be sent back to state court. The Bristol Herald Courier reported on Nov. 12, 2002 ( "OxyContin Lawsuit Sent Back To State") that "The lawsuit, filed by Shelby and Harold Cordill of Tazewell County, was one of two pending in U.S. District Court in Abingdon over the potent narcotic painkiller. But in a written ruling last week, U.S. District Court Judge James Jones sent the case back to Tazewell County Circuit Court for trial. Jones had taken the matter under advisement after a hearing in September."
Purdue Pharma, the drug's manufacturer, sought to have the suit remain in federal court. Previously, they had successfully fought to keep an unrelated suit from returning to Lee County, VA. However, "In the Cordills' case, the judge agreed to remand the matter because he found that they had properly sued a doctor and medical clinic based in Virginia. Without those defendants, the case could not have moved forward in state court, because the drug companies are headquartered elsewhere. The Virginia defendants were Dr. Jamal Sahyouni, a Richlands doctor who prescribed OxyContin to the Cordills, and Clinch Valley Physicians, which runs the medical clinic where Sahyouni works."
Purdue Pharma will not have a 'abuse-resistant' formulation of its top-selling pain medication OxyContin available next year as it had previously planned, citing problems with the method it was using. According to an AP report in the Deseret News on June 20, 2002 ( "Snag Delaying Development Of Abuse-Resistant OxyContin"), "One method under consideration is to put the narcotic blocker naloxone in OxyContin tablets. If the tablets are crushed and injected, naloxone would enter the bloodstream to block the OxyContin's effects. That wouldn't block other forms of abuse, but Purdue Pharma had called it an important interim step that it hoped to begin selling next year. A competing painkiller, Talwin NX, uses that approach. But Tuesday, Purdue Pharma announced that clinical trials found, among other problems, that naloxone sometimes blocked pain relief for patients who took the combination tablets correctly. Purdue Pharma said it won't be seeking Food and Drug Administration approval this year and will do further research to see if naloxone is worth pursuing. The company is focusing on another method: turning OxyContin into a capsule that contains lookalike beads of the painkiller and another narcotic blocker, naltrexone. Swallow the capsule and only the OxyContin beads should dissolve, providing proper pain relief. The hope is that if an abuser crushed all the beads - chewing, injecting or snorting them - naltrexone would be released to block the high."
Federal researchers note that what the company is attempting is difficult, and in fact may not be possible. As the News reported, "Creating abuse-resistant painkillers is 'very difficult and very complex,' said Dr. Cynthia McCormick, FDA's chief of addictive products. 'We haven't seen to date any proposed formulation by any company that we would say is absolutely, 100 percent effective in preventing abuse.' Some critics have called for OxyContin to be banned, at least until an abuse-resistant version is developed. The FDA isn't considering that, McCormick said, noting that other painkillers are abused, too."
Purdue Pharma's major product, OxyContin, proved to be much more popular than the company's marketers had imagined, according to an article in the Wall Street Journal. The Journal on May 16, 2002 ( "Painkiller's Sales Far Exceeded Levels Anticipated By Maker") reported that "The maker of OxyContin had so underestimated the sales potential of the widely abused painkiller that in 2000 the drug generated revenue that was eight times more than projected, internal company documents show. Over the first five years of marketing, OxyContin sales totaled nearly $2 billion, sharply higher than the company's initial forecast of about $350 million. The drug's popularity sent Purdue Pharma LP scrambling to expand production, marketing and its sales force. At the same time, other drug prospects for the closely held firm fell through, elevating OxyContin's importance to Purdue's future."
According to the Journal, "The company's sales projections and marketing assumptions were laid out in 1995 in an internal product launch plan as well as in documents filed with the Food and Drug Administration." The Journal reports that "Originally, the documents show, Purdue had hoped to direct its sales force of 350 to devote 70% of their primary sales calls to OxyContin immediately after the drug's introduction, and reduce that number to 40% in the fifth year. Today, however, about 80% of such sales calls are to sell OxyContin. In 2001, the drug provided about 80% of Purdue's net sales of $1.47 billion, according to documents and company officials."
Purdue's marketing strategy targeted doctors who prescribed large numbers of painkiller's. "Armed with data on individual doctors' prescribing habits, Purdue divided physicians into groups and targeted those already high on the list for prescribing other painkillers. The launch plan details how many sales calls each of Purdue's representatives were supposed to make each week, and also how representatives were supposed to call on the hospital committees that decide on which drugs to use. The plan called for Purdue to use the 'Speakers' Bureau' -- a stable of doctors, now numbering about 1,000 -- to give lectures during hospital programs about the benefits of OxyContin. The plan describes common methods drug makers use to build support for a new drug, although most manufacturers are loath to disclose their tactics. One such tactic: Mailing doctors information on the new drug along with a reply card that can be sent back to the company if the doctor is interested in seeing the drug stocked at a local pharmacy. The company can then use the reply cards to encourage local pharmacies to stock the drug."
Purdue's marketing plan does call into question one of their assertions regarding Oxy's promotion. "The administrator of the DEA recently testified that OxyContin abuse was due, in part, 'to aggressive marketing and promotion' of the drug. Purdue says that it is unrealistic to expect the company to flag particular doctors, and that local law-enforcement officials or state medical boards are in a better position to investigate questionable prescriptions."
The Virginia General Assembly "passed legislation Thursday that would allow state police to establish a database to monitor prescriptions of painkilling drugs such as OxyContin in Southwest Virginia," according to a story in the Roanoke Times on March 8, 2002 ( "House OKs OxyContin Database"). The Times reported that "The monitoring program was a key recommendation of the state's Prescription Drug Abuse Task Force, established last year by former Attorney General Mark Earley. The bill, sponsored by Sen. William Wampler Jr., R-Bristol, was originally intended to establish a statewide program. The House amended the measure, opting instead for a two-year pilot program limited to the state's Health Planning Region III, which covers far Southwest Virginia and the city of Radford and the counties of Bedford, Floyd, Franklin, Giles, Henry and Pulaski. Montgomery County and the Roanoke Valley are not included."
According to the Times, "Under Wampler's bill, the Department of Health Professions would establish the program and would notify the attorney general's office or local prosecutors of possible criminal activity by drug buyers, doctors or pharmacists. Pharmacists would be required to enter prescriptions of addictive medicines into the database. The state police's drug task force would control access to the information." The bill was approved by the House on a 59-40 vote, and the amended measure was passed by the Senate 35-0 with one member abstaining. The bill goes to Gov. Mark Warner (D) for his signature.
A Florida court found Doctor James Graves guilty of manslaughter and other charges in mid-February, 2002. The Rocky Mountain News reported on February 20, 2002 ( "Panhandle Doctor's OxyContin Conviction To Send Message") that "Graves, 55, of Pace, was the first doctor in the nation convicted of manslaughter or murder for deaths from OxyContin. He is facing a maximum of 15 years in prison on each of four counts of manslaughter and five counts of unlawful delivery of controlled substance. He also faces 30 years for racketeering."
The US Drug Enforcement Administration trumpeted the conviction. According to the News, "The prosecution of Dr. James Graves, convicted Tuesday in the deaths of four patients, was part of a national crackdown on the abuse of prescription drugs. He was convicted in state court in nearby Milton. 'It's going to send a very strong message to the medical community that they treat these very potent drugs - to include OxyContin but there are others - with respect,' said Laura Nagel, head of diversion control for the Drug Enforcement Administration." The News reports that "The DEA, working with state law enforcement agencies, in recent years has focused more attention on prescription drugs partly because of OxyContin. The agency blames OxyContin alone for 117 deaths in the past two years and suspects it is the likely cause in 179 others." (Ed. Note: To put those numbers in perspective, visit Drug War Facts: Causes of Death. Also, consider this: According to the federal Drug Abuse Warning Network in its report "Drug Abuse Warning Network Annual Medical Examiner Data 1998," published in March 2000, oxycodone (the active ingredient in OxyContin) was mentioned in medical examiner reports in 255 deaths in 1999, and 167 deaths in 1998; codeine, another opiate, was mentioned in ME reports in 1,392 deaths in 1999, and 1,238 deaths in 1998; Prozac, also called Fluoxetine, was mentioned in ME reports in 302 deaths in 1999, and 219 deaths in 1998.)
The prosecution likened Graves to a drug dealer. The Eugene (OR) Register-Guard reported on February 20, 2002 ( "Doctor Faces Prison Term For Deaths By Painkiller"), "Prosecutor Russell Edgar estimated that Graves, who testified that he had up to 1,000 patients at his pain management offices in Pace and Brewton, Ala., brought in $500,000 a year." According to the Register-Guard story, Edgar said of Doctor Graves that "'He's no different than a drug dealer.'"
The Rocky Mountain News reported that "At least two other doctors are facing charges of causing the deaths of patients who took OxyContin. Dr. Frank Fisher is set for trial next week in Redding, Calif., on three manslaughter counts, and Dr. Denis Deonarine of West Palm Beach, Fla., could face a death sentence if convicted of first-degree murder in an overdose death. No trial date has been set for Deonarine. Dr. Theodore Parran, a specialist in internal and addictive medicine who testified against Graves, expects more manslaughter prosecutions."
According to the News, "Dr. William Hurwitz, a pain management physician in McLean, VA, has a different view and is worried that legitimate doctors also have reason to worry because of the verdict. 'There's almost a standard of strict liability for any mistakes that are made or deviations in proper behavior by patients,' Hurwitz said. 'That has a chilling effect and should have a chilling effect on primary care physicians to sort of venture tentatively into managing pain.'"
Some state legislatures are considering various sorts of measures in response to concerns over OxyContin. As the Wall Street Journal reported on Feb. 20, 2002 ( "Drug Crackdown"), "Lawmakers in Florida, Kentucky, Ohio and Pennsylvania are considering a range of measures, including proposals to tighten physicians' standards for prescribing addictive pills, set up prescription-tracking systems to catch fraudulent users and strengthen sentencing laws for offenders. Maine has adopted tougher penalties for illegally selling OxyContin and other prescription drugs, according to the National Conference of State Legislatures, while government studies were launched in Louisiana and Virginia to study possible legislative action."
A state senator in West Virginia has backed down from his attempt to ban the drug's active ingredient, oxycodone. According to the Charleston Daily Mail on February 21, 2002 ( "Chafin Backing Down On Proposed Drug Ban"), WV State Senate Majority Leader Truman "Chafin's bill would make oxycodone a Schedule I drug under the Uniform Controlled Substances Act. That includes drugs with a high potential for abuse and no currently accepted medical use. It then would not be available in any form to West Virginia patients." The Daily Mail reports that Chafin "may either schedule a public hearing or make his bill a study resolution instead."
Chafin's attempted ban had been criticized strongly by a state officials, pharmacists, and doctors. The Daily Mail story noted that "The executive director of the West Virginia Board of Pharmacy also said that banning oxycodone is not the answer to an epidemic of abuse. 'No one can deny that abuse and illegimate use of narcotic medications is a serious problem that needs an appropriate solution,' William Douglass Jr., also legal counsel for the pharmacy board, said in a prepared statement. 'To prevent terminally ill patients who are in need of legitimate pain management from obtaining a drug that effectively relieves their pain is not the answer.'"
The Morgantown Dominion Post reported on February 21, 2002, that ( "Worry Arises Concerning Oxycodone Ban") "While West Virginia needs to take aggressive action on OxyContin abuse, an outright ban on the drug's main ingredient may not be the best course of action, the state Bureau for Public Health commissioner says. 'OxyContin and related narcotics are very useful in pain management, particularly in end-of-life care,' Dr. Henry Taylor said Tuesday. 'We need to balance the benefits of pain management with the problems caused by addiction and suffering.'"
According to the Daily Mail story, "Chafin said he now believes there is some benefit to the use of oxycodone in certain clinical, in-hospital situations." The Daily Mail notes that "Oxycodone is used several drugs critical in treating pain after back surgery, with cancer patients and with women after they give birth via Caesarean section. Some of the other preparations with the ingredient are Tylox, Percocet and Percodan."
Lawmakers and other officials accused Purdue Pharma LLP, manufacturer of OxyContin, of being too successful at promoting their drug. As reported in the Myrtle Beach, SC Sun News on Dec. 13, 2001 ( "DEA Reproves OxyContin Maker"), DEA Administrator Asa Hutchinson "told a House Appropriations subcommittee that the drug maker's 'aggressive marketing practices' have made the drug more readily available. The number of OxyContin prescriptions has grown and reached 5.8 million in 2000. Hutchinson said Purdue Pharma gave its sales representatives incentives to sell large quantities of the drug and said the company took doctors on expense-paid retreats to encourage them to prescribe it. "
Purdue mounted its defense. "Purdue Pharma Executive Vice President Paul Goldenheim rejected claims its marketing has been improper. 'That is simply not the case,' he said. Goldenheim said the company spends significant time educating doctors about proper use of the drug. He noted that the company worked with the Food and Drug Administration to strengthen warnings on OxyContin package inserts and helped law enforcement officials develop placebo tablets used in sting operations."
Unfortunately for Purdue, members of Congress holding the hearing seemed to be unconvinced. The Louisville, KY Courier-Journal reported on Dec. 12, 2001 ( "House Members Say Firm Did Little To Halt OxyContin Abuse") that "Rep. Hal Rogers -- facing an epidemic of OxyContin abuse in his Eastern Kentucky district -- said yesterday that he'll seek an investigation of how the manufacturer marketed and promoted the powerful painkiller. Rogers, R-5th District, joined Rep. Frank Wolf, R-Va., in calling for a General Accounting Office investigation after clashing at a hearing with a top official of Purdue Pharma, the Stamford, Conn. based manufacturer of OxyContin. Rogers and Wolf said the company was too aggressive in marketing the drug, sold in time-release pills for treatment of chronic pain, and has failed to act to halt the abuse."
The exchanges between Rogers and Goldenheim grew animated, as
the Courier-Journal reported:
The Drug Enforcement Administration on Oct. 23, 2001, joined with a coalition of "21 pain and health organizations calling for more awareness and education about OxyContin, a legal pain medication that, in the past year, has prompted arrests, illegal peddling and deadly addictions," according to the Cincinnati Enquirer on Oct. 24, 2001 ( "DEA Joins Oxy Coalition"). According to the Enquirer, "In February, federal law enforcement officials arrested 200 people in Eastern Kentucky" for OxyContin, the state's largest drug bust ever. They note that "The stigma that has become attached to OxyContin has some pharmacists fearful of distributing it for legal reasons and fearful of stocking it for security reasons. These fears have become another way the medication has become difficult for pain patients to obtain."
According to the DEA's release on the statement ( "DEA To Join Pain Advocates In Issuing Statement On Prescription Pain Medications") Administrator Asa Hutchinson said that "We' don't want to cause patients who have legitimate needs for these medications, to be discouraged or afraid to use them. And we don't want to restrict doctors and pharmacists from providing these medications when appropriate." This sentiment may come as a surprise to the people of California, where two days later on October 25th, DEA agents raided the Los Angeles Cannabis Resource Center, a clinic for medical marijuana patients in West Hollywood. (For more on the LACRC story, read "Staff of W. Hollywood Medical Marijuana Clinic Protest DEA Raid" from the AP, also this piece from the New York Times, "US Cracks Down On Medical Marijuana In California". Also check out this Medical Marijuana update on this site.)
Purdue Pharma, manufacturer of OxyContin, announced on August 8, 2001 ( "International Patent Application To Be Published On Abuse-Resistant Pain Reliever Being Developed By Purdue Pharma") that has been working to develop "a pharmaceutical formulation that combines an opioid pain reliever with a 'sequestered antagonist' that would work to help prevent the medication from being abused."
As the Roanoke, VA Times explained on August 9, 2001 ( "Drug Maker To Change Recipe"), "If the new formula proves successful, it wold preserve the drug's potent painkilling ability while adding a new ingredient -- a second drug that would counteract the first one only when the pill is crushed into a powder and then snorted or injected." Specifically, "it would be embedded with microscopic 'beads' of naltrexone, a narcotic antagonist that counteracts the medicine. The beads would be coated with a chemical to keep them from dissolving, so the pain medication will work just like OxyContin if taken as directed. But if the pill is crushed or chopped up, the coating on the beads would break, releasing the naltrexone and cancelling the drug's effects."
The Times noted that "It could take up to three years for the new drug to undergo clinical studies and receive approval from the Food and Drug Administration. Meanwhile, OxyContin will remain on the market. Although Wednesday's announcement is not expected to affect lawsuits against Purdue Pharma or efforts by law enforcement to restrict legal use of the drug, pain management experts said it might reduce some of the stigma they say has been unfairly associated with OxyContin."
The New York Times reported on July 21, 2001 ( "State Won't Cover Painkiller") that Vermont "Gov. Howard Dean said a state welfare program would stop paying for prescriptions for the painkiller OxyContin." According to the Times, "The decision to cut off OxyContin coverage affects about 70 people, and is the first such action by a state."
The state of Vermont is reported to have very high rates of legal prescription drug use, according to a story in the Times Argus on July 8, 2001 ( "Vermont Ranks High In Prescribed Drug Use"). The Times-Argus reported that "According to recent statistics compiled by the federal Drug Enforcement Administration, Vermont ranks second in the nation for per capita consumption of Ritalin, used to treat attention deficit disorder in children." Additionally, "Vermont is 14th in the nation for per capita consumption of oxycodone, an opiate derivative used as a painkiller. Consumption of that drug in Vermont is about six times greater than in Illinois, which ranked the lowest."
The Times-Argus story quotes Jeff McKee, the director of treatment for Rutland Mental Health Services, an organization that provides drug counseling, saying "'It's not surprising that as the availability has increased, more winds up in the streets. We have seen, in the last few years, the increased use of Ritalin and Oxycontin as street drugs.'" According to the Times-Argus, "McKee said teenagers now are abusing a wider range of drugs than in the past. He said it is not uncommon to see teenage clients who have recreationally used Ritalin, which when snorted gives the user a cocaine-like high, or OxyContin, which has an effect similar to heroin when snorted or injected."
Is OxyContin abuse really a major threat? Or has the media hyped this story beyond reason? According to a story in the Cleveland Free Times on May 2, 2001 ( "OxyCon Job"), the answer is more likely the latter. As the Free Times reported, "Taken together, all of these stories (and countless others) have misleadingly and preemptively proclaimed a major epidemic of OxyContin abuse — it is said to now be 'the street drug of choice' in many cities — and trumped up the threat it poses to public safety. Rather than just covering a danger, in many cases they appear to be causing it, advertising to abusers the existence of a new drug, and how to get and use it. Which is bad enough. What's worse, the media hype is also creating a panic that makes doctors and legitimate users needlessly afraid of utilizing an important advance in the treatment of pain."
The Free Times points out that OxyContin abuse has for the most part taken hold in rural areas among working class people -- areas where prescription drug abuse has been a problem for years. According to the Free Times, "Also, demographic and economic conditions in Appalachia have contributed to an established, long-term problem with prescription drug abuse in the region. In general, the population is older, Fisher says, and many suffer from chronic illnesses and debilitating diseases born of years working in the mines, increasing both the number of addicts and the supply of such drugs."
The Free Times also looked into the reports of deaths arising from
use and abuse of OxyContin. They found that the reports of large numbers
of Oxy-induced deaths are incorrect.
Pulaski, Virginia, has become the first town in the country to use a fingerprint security system to keep track of people who are receiving legally prescribed OxyContin. The Roanoke Times reported on June 11, 2001 ( "Pulaski Hopes Fingerprint System Will Stamp Out OxyContin Abuse") that "The Pulaski Police Department is providing the six pharmarcies in town with fingerprint kits. Pharmacists will ask customers requesting OxyContin prescriptions to dip their forefinger in invisible ink then stamp it on special paper. The prints will be attached to the prescriptions and kept at the pharmacy. If officers find out that a prescription has been stolen or falsified, they can identify a suspect from the prints."
The Times notes that "The fingerprint system, manufactured by the South Carolina-based company CrimeBite, is already used in several grocery stores before payroll checks are cashed. If a check comes back as counterfeit or stolen, management can find the perpetrator through their fingerprint. Lydia del Rossi, president of CrimeBite, said Pulaski is the only town she knows of that is using the invisible fingerprint system to target OxyContin abuse. Some psychiatrists in Louisiana use the system when they disperse narcotics in Louisiana. But OxyContin isn't the only drug officers are worried about. Fingerprints may also be taken before several other narcotics are administered. Pharmacists will meet with officers July 18 to decide how the kits will be used."
Suit Filed In Kentucky Against Manufacturer, Seeks Class Action Status; Similar Attempts In Two Other States
Attorneys in southeastern Kentucky have filed suit against Purdue Pharma. According to the Lexington, KY Herald-Leader on June 22, 2001 ( "OxyContin Maker, Others Sued By Kentucky Plaintiffs"), "The suit, filed in Clay County by attorneys Bill Hayes of Middlesboro and Peter Perlman of Lexington, is apparently the first in Kentucky targeting OxyContin. Lawsuits that make similar claims are pending in Virginia and West Virginia. The Kentucky action names five living plaintiffs and the estates of two others it claims died of OxyContin overdoses, but seeks certification as a class-action suit, creating the potential for many other users of the drug to join."
Also named in the suit, according to the Herald-Leader, are "a Harlan urologist charged in February with illegally prescribing OxyContin; and Pineville Community Hospital." The Herald-Leader reports that the doctor "allegedly prescribed OxyContin to some of the people named in the suit, and the hospital was allegedly the supplier through its pharmacy, the suit says. The lawsuit says Purdue Pharma used coercive and inappropriate tactics to market its drug; 'courted and seduced' doctors with free trips to get them to prescribe the drug; and failed to properly warn of possible negative effects."
West Virginia Sues Manufacturer, Joins Four Other States In Establishing Monitoring Program
The State of West Virginia has filed suit against the manufacturer of OxyContin and another major pharmaceutical manufacturer. According to the Charleston, WV Daily Mail on June 8, 2001 ( "WV Chosen To Participate In Project To Stop OxyContin Abuse"), "Mississippi, West Virginia and three other states have been chosen for a federal prescription monitoring and pilot program aimed at stopping abuse of the painkiller OxyContin, officials said." The Daily Mail reported:
"The Drug Enforcement Administration approached the State Board of
Pharmacy about the computerized reporting system on June 1, said board
executive director Buck Stevens. Stevens said pharmacies would only
participate on a voluntary basis.
The manufacturer of OxyContin, Purdue Pharma, "plans to pay for part of the project, said company spokesman Jim Heins. 'We're not denying there is abuse of OxyContin,' Heins said. 'But the majority of patients are not abusers. Many of these people who overdose are taking multiple drugs and drinking alcohol.'"
West Virginia is also filing a lawsuit against both Purdue Pharma and Abbott Laboratories, according to a report in the New York Times on June 12, 2001 ( "West Virginia: State Sues Drug Maker"). The state claims in its suit "that they aggressively tried to get doctors to overprescribe the drug while failing to warn of its potential for abuse. The drug has been linked to at least 120 overdose deaths nationwide."
FDA Panel To Study Further Restrictions On Oxycodone; Actions May Reduce Access To Patients In Need
The Atlanta Journal & Constitution reported on June 3, 2001 ( "FDA Panel Will Study Uproar Over OxyContin") that a US Food & Drug Administration panel "will meet in the fall to consider whether oxycodone, the generic name for OxyContin, and other opioids need more restrictions." Dr. Russell Portenoy, a member of the board of the American Pain Foundation and the chairman of pain management and palliative care at Beth Israel Medical Center in New York, who has been asked to serve as a consultant to the FDA panel, told the J&C: "'Because of the pervasive fear of these drugs in this country, what I would call the stigmatism of these drugs, stories about (misuse) may drive regulators and those in law enforcement to take actions that are not warranted and would have the unintended effect of reducing access to patients who need them.'"
Purdue Pharma Discontinues High-Dose OxyContin Formulation
OxyContin's manufacturer is beginning to cut back on distribution of its most powerful available formulation. According to the Washington Post on May 12, 2001 ( "Shipment Of Potent Pain Pills Suspended"), Officials at Purdue Pharma LP, of Stamford, Conn., said the company won't sell the 160-milligram OxyContin pills while it works to prevent widespread abuse, especially in Appalachia. The 160-milligram pills -- which hit the market less than a year ago -- are much more dangerous than the more common 80-milligram, 40-milligram and 20-milligram pills, and doctors said that they could easily kill a first-time user." The Post notes that "The move comes just days before a scheduled meeting of the National Association of Attorneys General, at which officials are expected to discuss ways of controlling prescription drug abuse, especially abuse of OxyContin." The effect of this move is also being questioned. According to the Post, "DEA officials said yesterday that pulling the 160-milligram pills will do little to address the growing problem, largely because the high-dose tablets account for about 1 percent of OxyContin sales and rarely have been seen on the streets."
US Drug Enforcement Administration Targets OxyContin
The Federal government is urging the manufacturer "of a
widely abused narcotic painkiller to limit how it distributes
and markets the drug, which has played a role in more than
100 fatal overdoses in several states," according to
an article in the May 1, 2001 edition of
The New York Times (
Asks Painkiller Maker To Help Curb Wide Abuse").
According to the Times:
NIDA Tries To Position Itself In Prescription Drug Misuse Debate
In April, the National Institute on Drug Abuse (NIDA) launched "a campaign against misuse of legally prescribed drugs." The Journal of the American Medical Association reported in its May 1, 2001 issue ( "Mixed Message on Prescription Drug Abuse"), "At a press conference announcing the effort to raise awareness about the dangers of these drugs, representatives from pharmacies and drug manufacturers joined NIDA director Alan I. Leshner, PhD, at the podium. All offered obligatory support for the endeavor, which at the moment amounts to a collection of pamphlets, Web sites, and other educational materials. Lacking any fixed agenda other than drawing the attention of the Washington media the parade of spokespersons balked at questions about the true scope of the problem and how to remedy it." The article goes on:
"'Determing illegitimate use is challenging,' said
Thomas Menighan, RPh, president of the American Pharmaceutical
Association. 'We can't view every patient as a potential
abuser.' Leshner himself seemed to undermine the message of
the rally by forcefully stating, 'Very, very few people who
use prescription drugs develop addiction.'
OxyContin Controversy Goes Nationwide
Media reports have taken the controvery over OxyContin, the painkiller manufacturered by Purdue Pharma LLP, nationwide. Newsweek reported in its April 9, 2001 issue ("How One Town Got Hooked"), "Oxy has taken hold in other rural Appalachian states and in New England, places where it's tougher to get more familiar street drugs like heroin and crack. The drug's maker, Purdue Pharma, says it is appalled by the widespread abuse of the drug, a form of synthetic morphine. 'When this drug is used properly, it has the potential to save lives. When it's abused, it has the potential to take lives, just like any other strong medication,' says Dr. J. David Haddox, Purdue Pharma's medical director." Some even argue that the media may be fueling an over-reaction. See, for example, "Oxycon Job: The Media Made Oxycontin Drug Scare," from the Cleveland Free Times on May 4, 2001.
Authorities in some southeast US states in late 2000 and early 2001 started reporting cases involving OxyContin. According to The Roanoke (VA) Times in August of 2000, OxyContin is "becoming the street drug of choice in the New River Valley and rural areas west of Roanoke." According to a story in the Washington Post on March 14, 2001 ( "Illegal Sale, Use Of A Painkiller Alarms Officials"), "Virginia officials are considering creating a database to monitor the distribution of the prescription painkiller OxyContin amid new police warnings that Northern Virginia is becoming a clearinghouse for the illegal sale of the narcotic."
The alarm continues to mount. A story in The San Francisco Chronicle from February 10, 2001, headlined "Alarm Over Abuse of New Drug" describes how "Harried police detectives in dozens of rural areas in Eastern states are combatting what they say is a growing wave of drug abuse involving a potent painkiller prescribed for terminal cancer patients and other people with severe pain." The interest in Oxy has gone international, as the Irish Independent reports on the arrest of more than 200 people, including doctors and nurses, arising from an investigation into an Oxy ring based in eastern Kentucky.
Boston Globe reported on March
Tears Through Maine"):
Information, Links To OxyContin's Manufacturer, Purdue Pharma
Meanwhile, concerns are growing over misuse of the codeine pill Vicodin. A number of entertainers have reported use of the drug, most notably the rap artist Eminem, but also Friends star Matthew Perry. As Time Magazine noted on March 19, 2001 ( "The Latest Trendy Drugs Are Old-Fashioned Painkillers"), "The trend has quickly spread from Hollywood to the heartland." The magazine reports that "Last month Ventura County, Calif., issued a grand jury indictment alleging that Hell's Angels used a youth gang called the Outfit to sell more than 700,000 Valium and Vicodin tablets throughout the region -- all supplied, according to the charge, by an Air Force clinic employee. But you can also ask your doctor for the pills, and he may not scrutinize too carefully the validity of your request."
For a clearer perspective about the OxyContin controversy, read this article from the Cleveland Free Times from May of 2001, "OxyCon Job". Also, for an additional perspective on medication, safety, and law enforcement, consider this CSDP news brief on the Medical Marijuana controversy.