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OxyContin: Background & News

US Attorney In SW Virginia Still Pursuing Case Against Purdue Pharma

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."

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General Accounting Office Finds Problems With Marketing Of Oxy, Says Purdue Seems To Have Made 'Unsubstantiated Claims' About Drug And Its Safety

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) concluded:
"Purdue conducted an extensive campaign to market and promote OxyContin using an expanded sales force and multiple promotional approaches to encourage physicians, including primary care specialists, to prescribe OxyContin as an initial opioid treatment for noncancer pain. OxyContin sales and prescriptions grew rapidly following its market introduction in 1996, with the growth in prescriptions for noncancer pain outpacing the growth in prescriptions for cancer pain from 1997 through 2002. By 2003, nearly half of all OxyContin prescribers were primary care physicians. DEA has expressed concern that Purdue's aggressive marketing of OxyContin focused on promoting the drug to treat a wide range of conditions to physicians who may not have been adequately trained in pain management. Purdue has been cited twice by FDA for using potentially false or misleading medical journal advertisements for OxyContin that violated the Federal Food, Drug and Cosmetic Act (FD&C Act), including one advertisement that failed to include warnings about the potentially fatal risks associated with OxyContin use. Further, Purdue did not submit an OxyContin promotional video for FDA review at the time of its initial distribution in 1998, as required by FDA regulations. Therefore, FDA did not have the opportunity to review the video at the time of its distribution to ensure that the information it contained was truthful, balanced, and accurately communicated. FDA reviewed a similar video in 2002 and told us that the video appeared to have made unsubstantiated claims about OxyContin and minimized its risks.
"Several factors may have contributed to OxyContin's abuse and diversion. OxyContin's controlled-release formulation, which made the drug beneficial for the relief of moderate-to-severe pain over an extended period of time, enabled the drug to contain more of the active ingredient oxycodone than other, non-controlled-release oxycodone-containing drugs. This feature may have made OxyContin an attractive target for abuse and diversion, according to DEA. OxyContin's controlled-release formulation, which delayed the drug's absorption, also led FDA to include language in the original label stating that OxyContin had a lower potential for abuse than other oxycodone products. FDA officials thought that the controlled-release feature would make the drug less attractive to abusers. However, FDA did not recognize that the drug could be dissolved in water and injected, which disrupted the controlled-release characteristics and created an immediate rush or high, thereby increasing the potential for abuse. In addition, the safety warning on the label that advised patients not to crush the tablets because a rapid release of a potentially toxic amount of the drug could result--a customary precaution for controlled-release medications--may have inadvertently alerted abusers to a possible method for misusing the drug. The rapid growth in OxyContin sales, which increased the drug's availability in the marketplace, may have made it easier for abusers to obtain the drug for illicit purposes. Further, some geographic areas have been shown to have a history of prescription drug abuse and diversion that may have predisposed some states to the abuse and diversion of OxyContin. However, we could not assess the relationship between the increased availability of OxyContin and locations where it is being abused and diverted because the data on abuse and diversion are not reliable, comprehensive, or timely."

A text copy of the GAO report can be accessed by clicking here.

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Federal Judge Rules Purdue Misled Officials To Win Patent Protection

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."

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Plaintiffs' Attorneys End Effort To Merge Several Federal OxyContin Cases

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."

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Purdue Suffers Setback As Federal Judge Sends Lawsuit Back To State Court

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."

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Purdue Having Trouble Developing 'Abuse-Resistant' Oxy; Unknown When, If New Product Will Be Ready

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."

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Purdue's Marketing Plan Outlined; Oxy Sales Outstripped Initial Projections Almost Six Fold

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."

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Oxy Ban? States Consider Legislation To Deal With OxyContin Worries

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."

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Purdue Pharma Taken To Task At House Hearing On OxyContin

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:
"Goldenheim defended Purdue Pharma's response to the rise in abuse of OxyContin but was scolded by Rogers.
"'Your company did nothing and people were dying!' Rogers said.
"Goldenheim said that addressing the illegal use of the drug was his company's 'highest priority.'
"But Rogers pointed to reports about a sudden increase in OxyContin prescriptions from a clinic in Myrtle Beach, S.C., where lines formed outside the doors and cars jammed the parking lot.
"'It is obvious to me if you got that kind of spike in one location of the country, you ought to pay attention to it, and you didn't, did you?' Rogers asked.
"Goldenheim said the company noted the situation and talked to physicians and pharmacists about making sure only legitimate patients were given the drug.
"'Our powers are limited here,' he said.
"'Oh, give me a break!' Rogers interrupted, citing a fourfold increase in OxyContin addicts at the clinic in the past 18 months."

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DEA Joins The Oxy Team: Law Enforcement Should Not Interfere With Treatment Of Legitimate Patients, Hutchinson Says

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.)

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Purdue Pharma Developing Formula To Discourage Misuse; New Ingredient Would Block Opiate, Lead To Withdrawal

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."

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Vermont Cuts Off State Welfare Funding For OxyContin Prescriptions; State Has High Rates Of Legal Prescription Drug Use

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."

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An OxyConJob? Cleveland Free Times Claims Oxy 'Controversy' Is Media Generated Hysteria

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.
"For confirmation, the Free Times turned to David W. Jones, executive director of the Kentucky State Medical Examiner’s office. He asserts that 'as far as deaths go, I've heard different numbers in different places at different times; I have no idea where these people are getting their facts and figures.' While he stresses that not every drug-related death is necessarily reported to his office, according to his data there were 27 oxycodone-related deaths in the entire state in 2000 (oxycodone is the active ingredient in OxyContin).
"Of course, at first glance, 27 deaths over 12 months in a single state - even one at ground zero in the spread of OxyContin abuse - certainly seems noteworthy, and appears to support the implication that the number of Oxy abusers in Kentucky has exploded. But Jones parses the numbers further.
"Two of the 27 victims, he explains, were found to have both oxycodone and alcohol in their bodies, with death caused by the interaction of two nervous system depressants. What's more, 23 others also had a head-spinning multiplicity of other drugs in their systems, including highly potent prescription painkillers such as Dilaudid and Fentanyl, as well as powerful illegal drugs like cocaine and heroin. In the final analysis, Jones reveals, only two of the 27 fatalities can be shown to have been due to the effects of oxycodone alone - not just two in eastern Kentucky, two in the entire state.
"As for Virginia, medical examiner Massello, so loquacious in publicly proclaiming an 'epidemic' in his state, becomes notably tightlipped when asked by the Free Times for further details about his cases, though he does admit that a 'significant number' of victims had multiple drugs in their systems.
"J. David Haddox, senior medical director at Purdue Pharma of Norwalk, Conn., which is required by law to report any information about adverse reactions to the Food and Drug Administration (FDA), says his people haven't had any better luck in getting answers: 'I don't quite understand how they can report the information to the newspapers but can't explain it to us.'
"And there's more. Oxycodone is the opiod agent in at least 40 separate brand-name prescription medications besides OxyContin. While it is the strongest oxycodone formulation in terms of milligrams per pill, there is absolutely no way of telling, Jones explains, whether an oxycodone-related fatality was due to OxyContin or another drug.
"Other jurisdictions report similar findings. The Free Times has obtained a confidential table of drug-related deaths from 1996 to the present in Blair County, Pa., which encompasses the city of Altoona, prepared by the county coroner. Her data shows that of the seven oxycodone-related deaths in her jurisdiction in the last five-plus years, six involved the presence of multiple drugs, often including heroin, and one was a suicide.
"In fact, not everyone who dies from an oxycodone overdose does so accidentally. For the long-suffering, often terminal patients who comprise the vanguard of legitimate OxyContin users, suicide by opiate overdose often seems like a painless way to escape a life of terrific suffering. Such suicide cases are often lumped in with accidental overdoses in compilations of Oxy-related deaths, making the already-inflated numbers appear even greater.
"Even when the deaths can be reliably confirmed, for the most part they do not point to a vast increase in the overall number of prescription drug abusers. Rather, for the most part, the evidence of multiple-drug usage implies that a substantial majority of OxyContin abusers are longstanding drug addicts who have either switched to Oxy from other prescription or illegal drugs, or took it occasionally as a substitute for other, more preferable, drugs in short supply in their particular geographic area, such as rural Kentucky.
"'Most of these people have been abusing prescription drugs for a while, and have just switched over to OxyContin,' says Kentucky state Rep. Jack Coleman, a legislative expert on prescription drug fraud and abuse and a member of the recently formed state OxyContin task force. 'The problem is not particularly the abuse of OxyContin,' he adds. 'It's with prescription drug abuse in general.'"

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Virginia Town Uses Fingerprint System To Track OxyContin Prescriptions

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."

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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."

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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.
"'We have not been asked officially and the board's directors have not given official approval,' Stevens said. 'But the DEA is moving aggressively on this OxyContin issue. They want to create a model project for the country.'"
"Florida, Ohio and Virginia were also chosen to participate in the DEA project, which is in the preliminary stages.
"Nationally, 16 states have prescription monitoring systems, but only two, Kentucky and Utah, are computerized."

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."

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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.'"

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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."

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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 ( "U.S. Asks Painkiller Maker To Help Curb Wide Abuse"). According to the Times:
"Federal officials have also been in talks about withdrawing or modifying a claim that the painkiller, OxyContin, may be less prone to abuse than similar narcotics.
"The moves come as officials at the Drug Enforcement Administration start what they describe as the agency's first effort to curb misuse of a specific prescription drug. Previously, the agency had sought to reduce abuse of classes of drugs, but officials of the drug enforcement agency said the abuse problem involving OxyContin was so grave that it required unique action.
"Terry Woodworth, a top official at the agency, said it was concerned that the promotion and distribution of OxyContin by its manufacturer, Purdue Pharma L.P., to doctors like general practitioners might have led to its wide misuse. The government has said that no prescription drug in the last 20 years has been so widely abused so soon after its release as OxyContin."

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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.

The Boston Globe reported on March 23, 2001 ( "Painkiller Tears Through Maine"):
"OxyContin was first sold in late 1995, and now tops $1 billion in annual sales, outpacing the impotence drug Viagra. The pill is popular because of its time-release mechanism that slowly pumps its soothing, numbing effects over 12 hours, whereas most painkillers require multiple doses throughout a day. But crush the tablet and snort it, as addicts do, and its power is unleashed in a single, euphoric wallop.
"The transition from patient to addict, whether voluntary or not, is happening with alarming regularity, authorities say."
The Globe quotes Matthew Erickson, an assistant attorney general in Maine who investigates drug crimes, to explain the difficulty in this issue: "My dad was in an automobile accident a month ago and was prescribed OxyContin. It's a wonderful drug when used appropriately. The whole issue is complicated for that reason."

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Information, Links To OxyContin's Manufacturer, Purdue Pharma

The manufacturer of OxyContin, Purdue Pharma L.P., has mounted a defense of their product, including this Statement on Diversion of OxyContin Tablets.

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