FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal

FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal Fri, 26 Mar 2004 Federal regulations require drug label warnings if there is “reasonable evidence” of a link between adverse effects and drug action. An article in the National Law Journal shows how s FDA’s chief counsel, Daniel…

Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry?

Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Fri, 19 Dec 2003 Carl Elliott is a clear eyed academic who teaches bioethics at the University of Minnesota . He is currently a visiting associate professor at School of Social Sciences at the Institute for Advanced Study at Princeton….

Natrecor found to worsen kidney function, hasten death – NYT

Natrecor found to worsen kidney function, hasten death – NYT Tue, 17 May 2005 Natrecor, a drug approved by the FDA for treating patients with heart failure, is being widely prescribed off label for unapproved uses. The drug is prescribed for so-called “tune-ups” in outpatient clinics – although that use…

Antidepressants Pregnancy Risk: Babies Adversely Affected

Antidepressants Pregnancy Risk: Babies Adversely Affected Sat, 5 Feb 2005 Thanks to the BBC 3-part Panorama series (beginning October 2002), it is no longer a secret that coming off SSRI antidepressants can cause serious symptoms of withdrawal in some users. Christopher Pittman is on trial for killing his grandparents while…

Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument

Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument Fri, 11 Nov 2005 In yet another federal case (Zikis v Pfizer)  involving the company’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer’s argument that it didn’t need to war…

FDA Tones Down Warning–Shyra Kallas an SSRI Suicide Victim

FDA Tones Down Warning–Shyra Kallas an SSRI Suicide Victim Fri, 4 Mar 2005 In his recent testimony before the Senate Health, Education, Labor, and Pensions committee, Dr. David Fassler, representing the American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP), misrepresented the scientific facts about…

Statin-Cholesterol Guidelines–Industry influenced?

Statin-Cholesterol Guidelines–Industry influenced? Wed, 14 Jul 2004 Scientific journal editors are scrambling about how to react to bad publicity emanating from public disclosure that the scientific reports they have published are likely to be biased because the authors’ had financial ties to the companies whose drugs / devices they report…

Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ

Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ Thu, 5 Aug 2004 A front page article in The Wall Street Journal reports that a second FDA analysis of 25 clinical trials of SSRI antidepressants in children was conducted after a…

Prescription Drug Industfry: The Insiders – AARP Bulletin

Prescription Drug Industfry: The Insiders – AARP Bulletin Wed, 10 Nov 2004 Three pharmaceutical industry insiders blow the whistle in one of the most important articles you’ll ever read about the unethical marketing of prescription drugs. Peter Rost, M.D, a top marketing executive at Pfizer, Arthur Kuebel, a salesman who…

FDA Asks Antidepressant drug companies to add Cautions on labels

FDA Asks Antidepressant drug companies to add Cautions on labels Mon, 22 Mar 2004 The FDA has “requested” drug companies to put prominent warnings on the labels of 10 antidepressant drugs, “to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the…