Tag Archives: FDA

FDA approved Big Pharma drugs without effectiveness data

Consumers constantly are told how complicated it is to get a new drug on the market. After all, researchers have to jump through all sorts of hoops to assure safety before new therapies are approved for the public, right? It turns out they may be missing some of those hoops or not jumping through some of the most important ones.

In fact, huge red flags are being raised about how drugs are tested and approved in two new studies, including one just published in the May 4th issue of the Journal of the American Medical Association (JAMA).

A case in point: it turns out that only about half of the new prescription medications pushed onto the market over the last decade had the proper data together for the U.S. Food and Drug Administration – yet the FDA approved them anyhow.

Feds Want Glaxo Exec To Testify In Stevens Case

The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice.

Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month.

Seroquel Marketing Undeterred by Deceptive-Marketing Settlement

Google the word “depression” and the first search result you’ll get will be for the antipsychotic drug Seroquel XR.

Visit WebMD and you’ll find the home page hosts similar ads for Seroquel XR, above and adjacent to the lead news story.

Who would know that AstraZeneca inked the largest multi-state consumer-protection settlement on record relating to deceptive Seroquel marketing on March 14 for $68.5 million? And only a year after inking a similar settlement related to burying side effect and safety information for $520 million with the government!

Who would know AstraZeneca has already settled nearly 25,000 personal-injury lawsuits pertaining to Seroquel, with more to come, says ABC News?

Doctors’ Conflicting Interests Can Cost Money and Lives, and Hinder Medical Discoveries

The fact that doctors take money from pharmaceutical companies happens to be old news. But this time around, the docs in question come from Stanford University. Previous news stories reported that doctors receiving pharmaceutical funding hailed from Harvard, the University of Miami, the Medical College of Georgia and the University of Cincinnati College of Medicine.

More than a few of these doctors are psychiatrists who have received tax-supported, public National Institutes of Health and National Institute of Mental Health funding for clinical research, have participated in U.S. Food and Drug Administration advisory panels or have appeared on, or on behalf of, various not-for-profit psychiatric advocacy boards — some of which are heavily supported by the manufacturers of psychiatric medications.