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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (23713)	5/21/2007 3:30:49 PM
From: zeta1961	Respond to of 52153

Peter here's the Avandia abstract..I have the full text if anyone wants it.. Published at www.nejm.org May 21, 2007 (10.1056/NEJMoa072761) Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. Methods We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes. Results Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06). Conclusions Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes

To: Biomaven who wrote (23713)	5/21/2007 3:31:52 PM
From: Arthur Radley	Read Replies (1) \| Respond to of 52153

When the lawyers get this one to trial, statements from Glaxo like this one will surely not make friends with the jury. Seems that Glaxo is admitting, that sure...30% of you might die or have a heart attack and if you happen not to be in this 30% group you will not suffered any adverse events, therefore, there is no problem with our drug. yahoo.reuters.com A study published in the New England Journal of Medicine said Avandia increased cardiac-related deaths and heart attacks. Dr. Robert Meyer, head of the FDA office that reviews diabetes drugs, said other data contradicted those findings. "FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies," Meyer told reporters during a conference call. "Further, the FDA does not know whether the other approved treatments in the same class of drugs ... have less, the same, or other greater such risks," he said.

To: Biomaven who wrote (23713)	5/21/2007 3:33:43 PM
From: former_pgs	Read Replies (2) \| Respond to of 52153

avandia: some more info: "We screened 116 phase 2, 3, and 4 trials for inclusion. Of these, 48 trials met the predefined inclusion criteria of having a randomized comparator group, a similar duration of treatment in all groups, and more than 24 weeks of drug exposure. Six of the 48 trials did not report any myocardial infarctions or deaths from cardiovascular causes and therefore were not included in the analysis because the effect measure could not be calculated. Of the remaining 42 studies, 38 reported at least one myocardial infarction, and 22 reported at least one death from cardiovascular causes. In these trials, 15,560 patients were randomly assigned to regimens that included rosiglitazone, and 12,283 were assigned to comparator groups with regimens that did not include rosiglitazone." ... "Myocardial Infarction and Death Table 3 reports the myocardial infarction events and deaths from cardiovascular causes that were reported in the 42 clinical trials we reviewed. There were 86 myocardial infarctions in the rosiglitazone group and 72 in the control group. There were 39 deaths from cardiovascular causes in the rosiglitazone group and 22 in the control group. Table 4 lists the odds ratios, 95% confidence intervals, and P values for myocardial infarction and death from cardiovascular causes for the rosiglitazone group and the control group. The summary odds ratio for myocardial infarction was 1.43 in the rosiglitazone group (95% confidence interval [CI], 1.03 to 1.98; P=0.03). The odds ratio for death from cardiovascular causes in the rosiglitazone group, as compared with the control group, was 1.64 (95% CI, 0.98 to 2.74; P=0.06). Table 4 also lists odds ratios and 95% confidence intervals for the pooled group of trials that were smaller and of shorter duration; results for the DREAM and ADOPT studies are shown separately." === As an aside, I think the FDA has to get serious about defining real risk - benefit ratios for drugs, especially ones that treat large populations. People like Nissen are making it a habit of scouring databases for their AE of choice. He's a CV guy who searches all drugs for CV events, some diabetes guy is going to search all drugs for signs of diabetes progression, etc... etc...

To: Biomaven who wrote (23713)	5/21/2007 4:50:23 PM
From: Ian@SI	Respond to of 52153

From CNBC discussion with analysts, MRK/Januvia is likely to benefit; Class effect is unknown; insufficient time in clinical studies to really know one way or the other given that diabetics will be taking these drugs for life.

To: Biomaven who wrote (23713)	5/21/2007 9:43:47 PM
From: Proud Deplorable	Read Replies (1) \| Respond to of 52153

Permit me I have a bit of knowledge of these 2 drugs.....Actos and Avandia are NOT safe to use. Further information is available in the book Worst Pils/Best Pills by Public Citizen which is THE Bible of Prescription Drugs and everyone who considers taking any prescription drug should own a copy no matter what! Actos and Avandia have a DO NOT USE flag on them. These drugs are too much like Rezulin which was banned for causing deaths and other lesser damage ;-) like liver toxicity etc. ------------------------------ DIABETES DRUG BANNED IN THE UK © What Doctors Don't Tell You (Volume 8, Issue 11) -------------------------------------------------------------------------------- A new drug for diabetes, troglitazone (Romozin), has been declared unsafe and banned in Britain. The decision has come after six people died and numerous liver injury cases were reported worldwide. Over 150 people have suffered reactions from troglitazone, out of the three hundred thousand patients worldwide who have been treated with the drug since its launch in October 1997. Reactions to the drug have ranged from severe liver damage to liver necrosis (cell death) and liver failure. Glaxo Wellcome, the company which markets the drug in this country, and the Medicines Control Agency believe that since the harmful effects and the risks cannot be predicted accurately, the drug would not be safe for some patients, particulary those with the type of diabetes known as type 2. Troglitazone is still available in the United States because the Food and Drug Administration (FDA) said that the benefits outweighed the risks - as long as patients receiving the drug are continuously monitored for signs of liver injury. The FDA has also suggested that a label should prominently display a warning of the drug's harmful side effects. G1axoWellcome has now withdrawn its application to market troglitazone across Europe (BMJ,1997; 315:1564). Copyright © 1997 What Doctors Don't Tell You (Volume 8, Issue 11)