Pharmaceutical opportunism - Up front: news and opinion from independent minds - Brief Article

Humanist, Sept-Oct, 2002 by Karen Ann Gajewski

There are more corporate scandals than meet the eye. The headlines continue to scream about Enron, WorldCom, and Adelphia, and speculation mounts over investigations into Halburton, AOL/Time Warner, and other megacorporations. Now comes a thirty-two state lawsuit against Bristol Meyers-Squibb for allegedly violating federal and state antitrust laws by fraudulently securing patents for the anti-cancer drug Taxol and illegally manipulating regulatory and judicial proceedings.

The complaint filed June 4, 2002, claims that Bristol "repeatedly and deliberately misrepresented and concealed" the scientific research on Taxol to the U.S. Patent and Trademark Office, "thereby fraudulently obtaining two patents on methods of administering the drug." Then, knowing the courts had declared the patents invalid, Bristol misrepresented them in proceedings before the Federal Drug Administration to delay regulatory approval for competitors seeking to market generic versions--and then sued their competitors, charging them with patent infringement.

Taxol is based on a naturally occurring plant substance--paclitaxel--whose anti-cancer properties were developed through government-funded research. According to Eliot Spitzer, attorney general for New York, one of the states which spearheaded the investigation into Bristol, the company managed to monopolize the marketing of paclitaxel-based anti-cancer drugs until October 23, 2000, and until April 2002 was one of only two companies approved to sell such drugs.

Taxol cannot be purchased directly by consumers but must be administered by physicians and hospitals to patients suffering from breast, ovarian, and other cancers. A course of treatment of Taxol costs from $6,000 to $10,000, with a single dose costing approximately $1,625; on the other hand, a single dose of its generic version is about $1,200. Thus, while maintaining its monopoly, Bristol earned nearly $1 billion in 2000 from U.S. sales of Taxol; after generic versions became available in 2001, Bristol's Taxol revenues dropped to $545 million. As Spitzer put it, Americans "cannot tolerate anti-competitive and deceptive practices that allow drug companies to fatten their bottom lines illegally at the expense of people who depend on this drug."

Karen Ann Gajewski is the art director and an editor at the Humanist.