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 13, 2007 by Trevor Butterworth
Rebecca Goldin Ph.D
A recent flurry of interest in the benefits of breastfeeding has led to some rather scary messages from the press: if you don’t nurse — or if you don’t nurse enough — your baby will have all sorts of problems, from obesity to leukemia. Parents are being told point blank: formula kills. A [...]
Filed under: Breast Feeding, Diabetes, Nursing, Risk, Statistical Analysis, Uncategorized | Tagged: Department of Health and Human Services | No Comments »
Posted on November 12, 2007 by Trevor Butterworth
Trevor Butterworth
Undoubtedly New York Times reporter Gardiner Harris knows how to report; and, it is reasonable to presume that his editors – who provide the six layers of editing that every Times article must endure - recognize good reporting when they see it. The problem with Gardiner’s coverage of the various controversies surrounding the diabetes [...]
Filed under: Avandia, Diabetes, Food and Drug Administration, Pharmaceuticals | Tagged: Gardiner Harris, New England Journal of Medicine, New York Times, Steve Nissen | 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
From Wired: Why would the FDA allow a pharmaceutical company to continue to sell an apparently dangerous drug? The answer is not simple, and at a time when mistrust of the government’s relationship with the healthcare industry seems to be increasing, the subtleties can get lost in daily news reports… more
Originally published August 2, [...]
Filed under: Avandia, Diabetes, Drugs, Food and Drug Administration, Statistical Analysis, risk analysis | Tagged: heart attack, Wired | No Comments »
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 »
Posted on November 9, 2007 by Trevor Butterworth
Trevor Butterworth, Huffington Post
As another major scientific journal criticizes the methodology behind a study in the New England Journal of Medicine (NEJM) that prompted a nationwide panic over a popular diabetes drug, it turns out that the doctor who authored the study, Steven Nissen MD, delivered a blistering attack on those very methods seven years [...]
Filed under: Avandia, Diabetes, Meta Analysis, Pharmaceuticals, Statistical Analysis, risk analysis | Tagged: Avandia, heart attack, New England Journal of Medicine, Steve Nissen | No Comments »