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

To: former_pgs who wrote (23716)	5/21/2007 5:44:41 PM
From: IRWIN JAMES FRANKEL	Read Replies (2) \| Respond to of 52153

>>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." ==== Thanks pgs, A couple of comments: - With an n > 27,000 they did not establish by statistical significance an increased risk of death, P=0.06; and - although they did show statistical significance for increased risk of MI, PROVIDED you do not penalize the analysis (set P lower than 0.05) for selecting the effect AFTER seeing the data or for the selection of the data to be used or for noise introduced by combining heterogeneous* studies; and - statistical significance aside, it is clear that the "effect" being measured is very small since a huge N produced only marginal P-values. Unfortunately, the lack of significant effect will be lost as the media feasts at the frenzy they create and the benefits of rosiglitazone are overshadowed by the controversy. ij PS - I have no horse in this race although I once owned AMLN and think Byetta will be a major beneficiary. * No doubt they would claim that they did this all fairly.

To: former_pgs who wrote (23716)	6/11/2007 9:53:52 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 52153

FOR IMMEDIATE RELEASE P07-99 June 4, 2007 FDA Announces New Advisory Committee to Address Risk Communication The U.S. Food and Drug Administration (FDA) today announced a new advisory committee designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public. The Risk Communication Advisory Committee will; help FDA better understand the communication needs and priorities of the general public; advise FDA on the development of strategic plans to communicate product risks and benefits; and make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences. “Communicating the risks and benefits associated with FDA-regulated products is essential to help consumers and health care professionals make informed decisions,” said Randall Lutter, Ph.D., FDA’s acting deputy commissioner for policy. “The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions.” Establishment of the new Risk Communication Advisory Committee stems from the Institute of Medicine’s (IOM) 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. The report recommended that Congress enact legislation establishing a new advisory committee to address how FDA communicates information about the efficacy, safety and use of drugs and other FDA-regulated medical products. FDA agreed with the value of such a committee and acted promptly to establish it through more speedy administrative procedures. FDA also expanded the scope of the committee to cover communication of risks and benefits of all products regulated by the agency. The advisory committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals. Two related Federal Register notices are being published, one announcing the establishment of the new advisory committee and the other requesting nominations for members to serve on the committee. For information: fda.gov and fda.gov. Nominations for advisory committee members received on or before 45 days after the Federal Register publication will be given first consideration for membership. For more information: An overview of FDA advisory committees www.fda.gov/oc/advisory/default.htm FDA’s full response to the IOM report www.fda.gov/oc/reports/iom013007.html