Overnight, Reuters, among others, reported this development from Merck's just filed SEC Form 10-Q:
. . . .Merck also said it was told in the second quarter that the SEC has concluded its formal probe of the company's actions involving Vioxx. That investigation began as an informal probe in November of 2004 and became formal in January of 2005. . . .
Good news, insofar as it goes. As ever, though, what these press reports omit is that Merck (per Page 58 of the Form 10-Q) has not cleared most of the other governmental civil and criminal probes on Vioxx [nor any of the remaining civil and criminal probes related to Vytorin/Zetia (a product-responsibility it shares with Schering-Plough)]:
. . . .In March 2009, Merck received a letter from the U.S. Attorney’s Office for the District of Massachusetts identifying it as a target of the grand jury investigation regarding Vioxx. Further, as previously disclosed, investigations are being conducted by local authorities in certain cities in Europe in order to determine whether any criminal charges should be brought concerning Vioxx. The Company is cooperating with these governmental entities in their respective investigations. . . . The Company cannot predict the outcome of these inquiries; however, they could result in potential civil and/or criminal dispositions. In addition, the Company received a subpoena in September 2006 from the State of California Attorney General seeking documents and information related to the placement of Vioxx on California’s Medi-Cal formulary. The Company is cooperating with the Attorney General in responding to the subpoena. . . .
Recall that it was only March 23, 2009, when we learned that Merck had received a Wells notice, regarding the Vioxx matter. So, in many ways, yesterday's press accounts are stories about the "tale" wagging the dog.
4 comments:
Check out this May 2005 Washington Post article on the resignation of Merck CEO Ray Gilmartin. Notice what the extensive quotations from Dennis M. (not J.) Erb, Ph.D. VP of Global Regulatory Development says.
http://www.washingtonpost.com/wp-dyn/content/article/2005/05/05/AR2005050501115_pf.html
I believe this is significant because Erb was several levels lower during the development and approval of Vioxx and was Merck's FDA liaison who's job it was to shephard it through the FDA including strategizing and meeting with FDA to discuss issues with FDA that could hold up approval of Vioxx.
Salmon
BTW love your graphic.
Salmon
Thanks -- checkin' it now.
Namaste
Wow -- from your Washington Post archived story link:
. . . ."Merck says the mission of its sales force is to educate doctors," said Rep. Henry A. Waxman (Calif.), the panel's ranking Democrat. "This sales force is given extraordinary training so that it can capitalize on virtually every interaction with doctors. Yet when it comes to the one thing doctors most need to know about Vioxx -- its health risks -- Merck's answer seems to be disinformation and censorship."
Dennis Erb, Merck's vice president for global regulatory development, said that company's actions were timely and appropriate, and that detailers were trained to be "accurate and balanced" in presenting information. He said Merck has conducted 70 clinical trials on Vioxx involving more than 40,000 patients, and the company is discussing with the FDA whether to apply for approval to resume marketing the drug.
"We believe Merck acted appropriately and responsibly to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine," he said. "And we promptly disclosed the results of these studies to the FDA, physicians, the scientific community and the media."
Erb defended Merck's policy of instructing its representatives not to tell doctors about the troubling cardiovascular results from a large 2000 clinical trial called Vigor. Until it withdrew Vioxx, Merck had argued that naproxen -- the control drug in the 2000 trial -- lowered cardiovascular risks, not that Vioxx raised them.
Erb said the FDA had not approved adding the trial results to the drug label and so they could not be discussed except by senior officials. But Erb acknowledged that the company did allow drug representatives to say that the 2000 trial had established that Vioxx helped reduce gastrointestinal bleeding. That policy led some congressmen to accuse Merck of disclosing the good news about Vioxx but hiding the bad. . . ."
I expect this is a pre-echo of what we'll see, should asenapine win FDA approval -- as you said, yourself, Salmon -- in about five years' time.
Namaste
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