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Whistle-blower lawsuit alleges Schering-Plough failed to reveal problems with a drug that killed five people, including two children, and seriously injured 53 others.

Schering-Plough recently spent $14.3 billion to buy the drug company Organon, and now must face allegations that serious “adverse events” associated with Organon’s neuromuscular blocking agent Raplon were not disclosed before or after FDA approval back in 1999. After five people died, including two children, and at least 53 others suffered severe bronchospasm, Organon withdrew Raplon from the market in March 2001.

Raplon was designed to paralyze a patient’s throat to facilitate intubation — inserting a breathing tube into the trachea — and claimed to induce paralysis faster than older generic drugs that cost less than $1 per unit compared with $20 for a unit of Raplon. Problems arose when patients receiving Raplon suffered serious bronchospasms that stopped their breathing.

According to Ed Silverman’s Pharmalot blog on the subject, the Raplon problems occurred when Schering-Plough’s senior vp for global fertility, Hans Vemer, was still the top man over at Organon. The whistle-blower, Jeff Feldstein, a former Organon employee, first filed his charges in 2002, about the same time he filed a wrongful termination lawsuit against Organon. The US Attorney in Boston declined to join the whistleblower charges at that time, so Feldstein now is pursuing the case independently.

Feldstein’s lawsuit in federal court in New Jersey alleges that Organon executives knew of the serious problems with Raplon and instead withheld the evidence from the FDA in order to get approval. As well as failure to disclose, Feldstein also claims that Organon’s behavior caused false claims to be submitted to Medicaid and Medicare.

Schering-Plough, of course, vehemently denies the charges, saying it will “vigorously defend Organon”. However, the evidence offered by the suit, including copies of internal memos, strongly suggests that Organon ignored the warning bells expressed by clinical investigators prior to the drug’s launch.

If it is determined that Organon did fail to disclose to the FDA its concerns about bronchospasm, it will be yet another blow to Schering-Plough, already suffering from its partnership with Merck over the Vytorin and Zetia debacle. Then there’s the $435 million settlement in 2006 for federal civil and criminal charges that it illegally promoted several drugs for off-label use, and defrauded Medicaid — the third such settlement for Schering in just two years. Schering Sales pled guilty to one count of conspiracy for making false statements to the government and paid a $180 million criminal fine as well.

So, yes, the FDA has some changes to make to prevent these kinds of situations, and they need to do it fast. New policies are needed to jolt Big Pharma enough to wake up and smell the fire and brimstone. It’s time for new business models, both at the FDA and for Big Pharma.

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