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.
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MAP posted-by: Terry Liittschwager