FDA vs. Glaxo-Wellcome

From the FDA: GLAXO WELLCOME DECIDES TO WITHDRAW LOTRONEX FROM THE MARKETGlaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market. Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women. The FDA is advising patients taking Lotronex to contact their healthcare providers to discuss reatment alternatives.The company�s action follows a meeting held earlier today with the Food and Drug Administration (FDA) where the agency discussed with Glaxo Wellcome risk management ptions that included restricting the distribution of the drug or marketing withdrawal.Today�s action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex. Specifically, FDA has been concerned about reported cases of intestinal damage resulting rom reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation).As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation.FDA has been closely monitoring the drug since approval on February 9, 2000. Prior to approval, four cases of ischemic colitis were observed in clinical studies and were discussed at a November 1999 meeting of FDA�s Gastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in nature and reversible upon discontinuation of the drug. Between approval and June 1, 2000, FDA received seven post-marketing reports of serious complications of constipation. This resulted in the hospitalization of six patients, three of whom required surgery. During the same time period, FDA received eight post-marketing reports of ischemic colitis. This resulted in four hospitalizations, four endoscopic procedures, and no surgeries.On June 27, 2000, FDA convened a public advisory committee meeting where risk management options in response to the serious adverse event reports were discussed. No deaths were reported up to that date. The consensus of the advisory committee members was that both physicians and patients must be informed of the potentially serious adverse events associated with Lotronex.Following the meeting, FDA updated the healthcare professional labeling for Lotronex and required the drug�s sponsor, Glaxo Wellcome, to distribute a Medication Guide that warned patients directly about the risks associated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued "Dear Healthcare Professional" and "Dear Pharmacist" letters to advise these groups of the important new information.FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipation associated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemic colitis that required blood transfusion or surgery. Upon completing its recent analyses of the 70 cases, FDA's view of the options included marketing withdrawal or a restricted drug distribution program. The restricted drug distribution program would provide: (1) safe use of Lotronex in appropriately informed patients, (2) continued access to Lotronex by severely debilitated IBS patients under closely monitored conditions, and (3) continued clinical research into the benefits, risks, and safe and appropriate use of Lotronex. FDA recognized that the other available treatments for IBS may offer inadequate relief from a condition that can be severely incapacitating for some patients. At the conclusion of today�s meeting, Glaxo Wellcome informed FDA that it will voluntarily withdraw Lotronex from the market.............Now, there's a bit of difference of opinion on whether the FDA didn't accept Glaxo's offer of keeping Lotronex on the market (with strict controls), or Glaxo didn't accept FDA's offer of keeping Lotronex on the market. It depends on whose press release you read! What I do know from working in the industry, is that drug companies always voluntarily withdraw their products; the FDA can't withdraw drug products from the market. The FDA and the drug companies sit and talk about options, and in most cases, the drug company will take it's own protective measures and withdraw the products. But in most cases they do it with their backs to the wall; pinned there by the FDA. Drug companies will withdraw products for several reasons: 1) liability - if the FDA forces the company to send out warnings about a product, but it's still on the market and causes problems, guess who will be sued, 2) if the negative press will really hurt the company, it always sounds better to say, "We voluntarily withdrew the product in order to protect the public," 3) The FDA will sanction them if they don't withdraw the product. Every pharmaceutical company wants to stay in the good graces of the FDA, but they must weigh this with the market value of the drug as well, and the market value includes putting out a drug that's the first in it's class. I've read that Lotronex hadn't lived up to Glaxo's expectations in terms of revenue, so I think that may play a part in this.It's incredibly complex: Glaxo doesn't want to withdraw a drug that's a "ground-breaker," but yet they don't want their name tainted by reports of adverse events, because it will hurt the company. It's a fabulous thing for a drug company to be the first on the block with something. Every drug company wants to say they were the first to come out with a drug to treat something in a new and hopefully better way. But then again, if the drug is hurting people, then they don't want their name associated with it because it hurts revenue. Add to the mix the amount of dollars it takes to bring a drug to market - sometimes it's billions.I have a sneaky suspicion that Glaxo and the FDA could have worked something out to keep it on the market, but when push came to shove, neither could agree on the terms. And the fact that Lotronex hadn't met revenue expectations may have played a part in this decision. I am learning more about this every time I read a new press release.------------------Fear can hold you prisoner.......hope can set you free.Missycat >^.^<[This message has been edited by Missycat (edited 11-30-2000).]