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POPSNissen & Califf On Avandia, Last Year Googling around for information on meta-analysis, I came across this great conversation between two of the world's top cardiologists, Steven Nissen and Robert Califf, about Avandia, from a year ago. It's a great read.
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POPSFDA Looking Into Safety of RA Drugs TNF blockers like Remicade, Enbrel, Humira, and Cimzia are big sellers for drug companies. The FDA's investigation is preliminary -- part of the agency's effort to let consumers know about potential problems earlier. This was partly a response to the Avandia controversy. Click the link for the FDA's Early Communication.
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POPSDear Dr. Garnier Glaxo gets a warning letter from the FDA, which says the company didn't provide full and timely information about Avandia. "We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline said in a prepared statement. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."
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POPSDrug Rep Toys The Nexium flash drive, the Protonix cup, the Vytorin pocket protector, and (no joke) the Avandia stress ball. This site reviews the handouts given by drug representatives by doctors, and provides a nice little window into schwag-based marketing.
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POPSBad For Glaxo, Good For Merck The run of good luck Merck has had with regard to potential rivals has really been amazing. First, it's Januvia benefited from a regulatory delay of Novartis' Galvus. Then the safety controversy over Avandia further boosted Januvia sales. Now the main rival to Merck's Gardasil vaccine, Cervarix from GSK, faces another regulatory delay.
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POPSWeak Knees On Avandia The nuclear receptors triggered by Avandia and Actos, are really complicated, and lots of drugs that hit them have been non-starters because of side effects. Derek Lowe, a pharmaceutical chemist, takes a look at the latest worrisome result in mice -- by PPAR guru Ron Evans -- on his blog.
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POPSMerck's Big Risk: High Expectations So much has gone so right for so long. Merck has executed well, but it has also gotten very lucky. For instance, its diabetes pill Januvia would not be such a big product were it not for both the safety problems plaguing GlaxoSmithKline's Avandia and the regulatory delay of Novartis' Galvus. Earnings forecasts have just kept going up. Should investors start to feel cautious? Or can Merck really keep delivering when other drug stocks are not?
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POPSAvandia: Hanging By A Thread? Senator Charles Grassley said in a letter to the Food and Drug Administration that he has heard an FDA panel voted in private to keep Avandia on the market. The margin: One vote.
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POPSAvandia May Get Black Box It wouldn't be a surprise if Avandia does get a black box warning. But it is interesting to her that the battle is going on behind the scenes at the FDA.
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POPSAnother herbs vs. chemicals patent tragedy: Diviner's sage Needless to say, this isn't the first case of this. Big Pharma has a notorious history of sidelining natural therapies and cures in favor of making money with chemical treatments that often have negative long-term side effects (Prozac, Ritalin, Avandia, OxyContin). If they can't hold exclusive rights and make big profits, not only will they not seek government approval, they will often go so far as to have it declared illegal (marijuana).
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POPSFDA rejecting more drugs There are 2 sides here. First I can see that the FDA would want to protect their image, and the drug companies avoid lawsuits (which we just end up paying when they raise drug prices). Second -- I can see terminally ill people desperate to try anything. I don't believe that the courts should deny the dying as long as they stipulate an understanding of the nature of experimental drugs. People need to stop being so ready to "sue". I used the drug remicade (it was not experimental, the potential side effects were documented). I happened to be in the small percentage of people who could not tolerate it; I developed diabetes & some other side effects. That's just the way it was - I choose to take it, knew possible side effects - have to deal with it now. I am not joining any groups that are suing....would that give me my health back????
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POPSAvandia, Actos Get Heart Failure Warnings Not a surprise; this side effect is well-known for both of these drugs. Although laypeople often confuse heart failure and heart attacks, they are distinct. Heart failure is when the heart is chronically weak; heart attacks are when muscle tissue in the heart actually dies because it is starved of blood. So this is not the denouement of the Avandia controversy we've been watching for several months now. --Matt Herper
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POPSAvandia & The Trial Lawyers Pharma chemist Derek Lowe is asking the question. My answer: Sure, I think. The legal argument is called "failure to warn" not "the drug was yanked." Certainly, it hurts in court if your drug got yanked. But could a lawyer argue that Glaxo didn't work hard enough to disclose its meta-analysis? Remember, it was published on a Glaxo website for many months before Nissen did his analysis and it got noticed. --Matt Herper
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POPSFDA to review Avandia I HATED this medication when the doctor started me on it. Diabetics are suppose to watch their weight, but this stuff put the pounds on no matter how little I ate, or worked out. Thank God I'm in control with Lantus and Metformin now and don't need Avandia or Actos.
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