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.