Posted on November 21, 2007 by Trevor Butterworth
Trevor Butterworth
On October 18, The European Medicines Agency announced (pdf) that “having assessed all the data,” the benefits of the antidiabetic medicine Avandia (along with rival Actos) outweighed the risks. The Agency added:
“However, the prescribing information should be updated to include a warning that, in patients with ischaemic heart disease, rosiglitazone [Avandia] should only be [...]
Filed under: Avandia, Diabetes, Endocrinology, Food and Drug Administration, Pharmaceuticals, Risk | Tagged: Chuck Grassley, enate Finance Committee, Glaxo, GSK, John Buse, Max Baucus, Tadataka Yamada | No Comments »
Posted on November 11, 2007 by Trevor Butterworth
Trevor Butterworth
The current issue of Biocentury, a trade publication that covers the pharmaceutical industry, should be essential and chastening reading for the journalists, editors and politicians who helped turn a limited, problematic study on the risks of the diabetes drug rosliglitazone (brand name Avandia) into a major international health scare.
In a comprehensive report on the [...]
Filed under: Avandia, Diabetes, Endocrinology, Food and Drug Administration, Meta Analysis, Statistical Analysis | Tagged: Annals of Internal Medicine, Biocentury, David Graham, HbA1c, Medstar Research Institute, New England Journal of Medicine, Steve Nissen, Steve Usdin | 1 Comment »
Posted on November 9, 2007 by Trevor Butterworth
Trevor Butterworth, Huffington Post
Take several critics of the way the FDA ensures the safety of drugs, rush a flawed study into print, characterize the results as catastrophic, rope in drug regulation warriors on Capitol Hill, rant about the evils of Big Pharma, talk to a credulous, statistically-illiterate media, and voila - you have Vioxx II, [...]
Filed under: Avandia, Diabetes, Endocrinology, Food and Drug Administration, Meta Analysis, STATS on Huffington Post | Tagged: Avandia, heart attack, New England Journal of Medicine, Steve Nissen | No Comments »
Posted on November 9, 2007 by Trevor Butterworth
Trevor Butterworth
A Food and Drug Administration advisory panel recommended in a 22 to 1 to one vote that the diabetes drug Avandia remain on the market, with additional warnings about cardiac risk, but not the most extreme drug warning – a black box – in the FDA arsenal.
The recommendation, which is non-binding but almost certain [...]
Filed under: Avandia, Diabetes, Drugs, Endocrinology, Food and Drug Administration, Statistical Analysis | Tagged: David Graham, Glaxo Smith Kline, New England Journal of Medicine, New York Times, Steve Nissen | No Comments »
Posted on November 9, 2007 by Trevor Butterworth
Trevor Butterworth
The line between the New York Times editorial page, which has been highly critical of the FDA’s handling of the potential risk from the diabetes drug Avandia, and the health news pages appears to have disappeared in the Times’ coverage of the forthcoming FDA hearings on the drug… more
Originally published July 27, 2007
Filed under: Avandia, Diabetes, Endocrinology, Food and Drug Administration, Meta Analysis, Statistical Analysis | Tagged: , Bruce Psaty, Nature Clinical Practice, New England Journal of Medicine, New York Times, Steve Nissen, The Lancet | No Comments »