Healthy Skepticism Library item: 13550

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
Organon Allegedly Covered Up Raplon Side Effects
Pharmalot 2008 Apr 15
http://www.pharmalot.com/2008/04/organon-covered-up-raplon-side-effects/

Full text:

Here’s more trouble for Schering-Plough. The drugmaker just spent $14.3 billion to buy Organon, which now faces allegations that the number and severity of serious adverse events associated with its troubled neuromuscular blocking agent known as Raplon were not disclosed before or after FDA approval, according to a whistleblower lawsuit filed in federal court in New Jersey. The episode, by the way, took place while Schering-Plough’s senior vp for global fertility, Hans Vemer, headed Organon.
The lawsuit was filed by a former Organon employee, Jeff Feldstein, who was hired as associate director of antithrombotics several months after the drugmaker received approval to market Raplon in August 1999. The drug was designed to paralyze a patient’s throat to allow a tube to be inserted in the trachea and allegedly induced paralysis much faster than an older generic that cost less than $1 per unit, compared with $20 for a unit of Raplon.
Besides being more expensive, Raplon also caused a severe form of bronchospasm that was likened to having a “clamp over the airway” or a chest that “felt like concrete,” according to the suit. In these instances, the bronchial tubes would close and patients could suffocate or die if the closure wasn’t reversed. Raplon was administered to about one million people before Organon voluntarily withdrew the drug in March 2001. By then, there were five deaths, including two children, and 53 serious cases of bronchospasm, according to court documents. “We believe this case is without merit and we will vigorously defend Organon,” a Schering-Plough spokesman tells us.
In his suit, Feldstein alleges that Organon failed to disclose to the FDA concerns about serious bronchospasm that were expressed by Raplon clinical trial investigators prior to the drug’s launch. Following a 1998 meeting in Dallas with Phase III investigators, Jonathan Deutsch, who headed Organon’s director of hospital products, wrote an e-mail to Deborah Shapse, Organon’s vp of medical services, that bronchospasm was “heatedly discussed…as a potential problem that needed to be addressed prior to launch.”
Even though the investigators ran a double-blinded trial that compared Raplon with the older generic, they were worried because of the unusual severity of the adverse reactions, according to the suit. In his e-mail Deutsch goes on to write that “Michael may be correct in not wanting to draw attention to bronchospasm.” The suit alleges he was referring to Michael Navinsky, who headed Organon’s marketing. And he added that another Organon exec suggested a treatment protocol should be in place before launch, although Feldstein alleges this never occurred.
As a result of the meeting, an Organon employee approached Carol Hirshman, an anesthesiology professor at Columbia University, to conduct a mechanism-of-action study to determine the cause of the serious bronchospasm, according to the suit. Hirshman agreed, but Organon allegedly failed to authorize the study and dropped the matter. She proceeded anyway with an NIH grant and published her work in 2003. (Look here).
The extent of the danger didn’t become known, though, until after Raplon was widely used and Organon, meanwhile, blamed adverse event reports it received on improper insertion of endotracheal tubes by doctors, according to the lawsuit, which also maintains that Organon’s behavior caused false claims to be submitted to Medicaid and Medicare. Feldstein first filed these charges in 2002, about the same time he filed a wrongful termination lawsuit against Organon. The US Attorney in Boston subsequently declined to join the whistleblower charges, which he is now pursuing independently.