Pubdate: Wed, 08 Aug 2001 Source: Bristol Herald Courier (VA) Copyright: 2001 Bristol Herald Courier Contact: http://www.bristolnews.com/contact.html Website: http://www.bristolnews.com/ Details: http://www.mapinc.org/media/1211 Author: Beth Davies MANUFACTURER'S RESPONSE TO OXYCONTIN PROBLEM DISTURBING To the editor: Anyone who follows OxyContin's destructive path throughout the country (more than 25 states are reporting problems) can't help but be alarmed. The only thing more alarming is the response of Purdue Pharma, the drug's manufacturer. Purdue has assembled a four-person public relations team to put out the fire. The team, led by Dr. David Haddox, senior medical director, is seeking to prove that the death toll from OxyContin overdoses isn't as high as reported. One can't help but wonder: What, in Dr. Haddox's view, would be an acceptable number of deaths? Purdue is on a mission to treat untreated or under-treated pain, certainly a worthwhile mission. But the company went into "overdrive" in pursuit of its goal and soon created even more pain, devastating pain, to individuals, families and entire communities. The company may not have been prepared for this, but it should have been. Had Purdue not over-promoted the benefits and utility of OxyContin, the results might have been very different. Recalling the drug and reformulating it to lessen its abuse potential would be the responsible thing to do. Alternative drugs for severe chronic pain are already on the market, as many medical professionals will attest. There are no alternatives once a life has been extinguished by the drug. Purdue is no stranger to warnings from the FDA. From 1993 to 1996, the company received repeated warnings from the FDA's Division of Drug Marketing, Advertising and Communications, concerning its promotional materials for another of its drugs, MS Contin. A final warning letter in November 1996, written directly to Purdue's president, Raymond R. Sackler, MD, for the company repeatedly disseminating materials that contain unsupported claims that MS Contin is superior to other analgesics concludes, "Failure to respond to this letter may result in regulatory action, including seizure and//or injunction, without further notice." On May 11, 2000, the FDA released a letter from DDMAC which identified an advertisement for OxyContin by Purdue Pharma in the /{New England Journal of Medicine/} titled, "Proven Effective In Arthritis Pain." The letter warned that this ad was misleading as to the drug's effectiveness and did not properly disclose risk information. While profit maximization may be a legitimate corporate goal, there are ethical restraints that bind all corporations in a free society as to how that goal may be achieved. Among them is concern that the patient's health may not be unduly put at risk. Beth Davies St. Charles, Va. - --- MAP posted-by: Terry Liittschwager