Organon Allegedly Covered Up Raplon Side Effects
7 CommentsBy Ed Silverman // April 15th, 2008 // 9:58 am
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.
FBP
It indeed appears that the woes are continuing to mount for Schering-Plough. What is very puzzling is why in the world they would purchase Organon? They certainly should have known about these allegations, given that one of their own current employees headed Organon when these misdeeds allegedly took place. Did they not perform due diligence? Did they not ask the former head of Organon in the US about his knowledge of these activities? This is very curious. And why would a company with recent problems of their own that they had just settled take on more problems by buying Organon. This appears to be either a bad business deal or a lack of concern regarding these allegations.
More and more, we’re seeing that companies apparently have very little regard for patient safety. It certainlt seems like this happened in this case. Were they so bent on making money that they failed to bring this information forward? If so, this is absolutely horrible. Hundreds of patients may have suffered through an unnecessary ordeal because of this. It seems likely that more trouble is in the wind for Schering-Plough.
Dan
To speculate- Schering purchases organon to deny wrongdoing associated with that particular company by Schering. Seems this has occured in the past.
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Concerned
It’s amazing to me that this story has not gained much interest. Perhaps because it simply reinforces “business as usual” for these pharma companies. I, for one, cannot believe the levels that these companies will stoop to in order to generate revenues. You put something on the market that has the potential to harm patients and you fail to warn the practitioners of the problem. Why? Because you don’t want to have anything impact the market in a negative way. I just read the same thing about the fen/phen disaster. The marketer in charge didn’t want anything to get out about Pulmonary Hypertension in young women because the market for the drug could be cut by 50%. So she would rather continue to have young women take a combo of drugs so that she can make a lot of money than risk her market share.
With Raplon, the guy in charge of the US at Organon was reported to have touted the drug as a major advance at the launch, all the while not revealing anything about the dirty little secret. Then what happens? The docs that are concerned get terminated! So much for caring about patients. Responsible, ethical professionals bring forth issues that they are concerned about and the pharma companies get rid of them. I’ve heard about this happening so many times that it cuases one to wonder. Will ethics and morals ever have a place in American business, specifically drugs, tobacco and oil? Rake the public over the coals at your whim! You’ll never have to pay for your misdeeds. That’s what the big execs think and until somebody somewhere takes them to task, they’ll continue to do it.
Melonie Davis
You will always have deaths when new products come into the market, especially for intubation. Bronchospasms occur in a certain portion of the population when administered NMBA’s
I sold this product and it was an excellent drug, when used on the appropriate patients at the right dose. The risks must outweigh the benefits, and I believe that is what you must look at. There are plenty of physicians that are ignorant and don’t know what doses, etc these medications should be dosed at.
Remember, the only reason that there are any advances in medicine, is because the PHARMACEUTICAL companies take all the years and risk of marketing, research, development, legal regulations, etc and decide to try and make a go of it. The Government does not discover any new medications, and the insurance companies certainly do not. Organon is like any other company, taking on tremendous risk and trying to make new medications that help people, and be profitable.
Laurie
“Organon voluntarily withdrew the drug in March 2001″
How to you call a drug “excellent” when even the manufacturer removed it from the market? In an intubation situation I would take the lower risk of bronchospasm over speed.No reason to intubate someone you can’t get air into after your done.