Category Archives: FDA
Europe refuses to approve diet pill already approved here
Remember fen-phen? If you don’t, it was a diet pill that basically did the equivalent of dropping your heart valves into a Vitamix and hitting pulse. For whatever reason, it seems like most diet drugs seem to come with serious heart risks. European regulators are more risk averse than their American counterparts, and they have [...]
Zoloft, Topamax, and Birth Defects
What do Zoloft and Topamax have in common? They’re both widely prescribed to women of childbearing age, and they are both associated with certain types of birth defects. Several women have contacted me recently who believe their childrens’ birth defects may have been caused by Zoloft or Topamax. I’m in the process of reviewing their [...]
The Menaflex Debacle Proves That Preemption Is Bad Policy
The tort “reform” crowd often argues that if a federal agency approves a product, the manufacturers of that product should be immune from suit. For instance, drug manufacturers always argue that since the FDA said that a drug was safe and effective, then the drug is safe and effective and no one should be able [...]
See The Actual Ghostwritten Documents
Thankfully, someone is putting all of the Wyeth ghostwriting documents online. Arrangements are underway for posting the ghostwriting documents disclosed through the intervention of PLoS Medicine and the New York Times. While you look forward to exploring the parallel universe of ghostwriters, guest authors, and ghost handlers, PLoS Medicine will release selected documents on this [...]
Another Good Article About Wyeth’s Ghostwriting
The hardest-hitting one I've seen yet. Naturally, it's not from a U.S. source. Advertising on the Internet proves how respectable ghostwriting has become. Thewritersforhire.com,based in Houston, posts prices for book manuscripts — $25,000 to $65,000 for a 250-page book. The Writers' Union of Canada, having determined which of its members will accept ghostly commissions, can [...]
