Most Popular Choices
Share on Facebook 31 Printer Friendly Page More Sharing
General News    H4'ed 12/13/11

In Shocking "Pharmalateralism," FDA Strips Critic of Voting Rights

By       (Page 1 of 2 pages)   No comments
Message Martha Rosenberg
Become a Fan
  (84 fans)

(correction appears at end)

It's said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call it another "lighting option," 6 to quote Big Pharma studies and one to say it doesn't need changing, it just needs a better label. This week's hearings into birth control pills Yaz, Yasmin, Beyaz and Safyral confirm the FDA's dedication to pharmalateralism.

 

Bayer launched Yaz in 2006 as a pill that goes "beyond birth control" to treat acne and severe PMS, all the while avoiding the water retention of traditional birth control pills. But soon, previously healthy teenagers experienced "beyond birth control" effects they hadn't expected. Fifteen-year-old Katie Ketner had her gallbladder removed after taking Yaz, Susan Gallenos had a stroke and part of her skull removed and Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli, according to published reports.

 

The FDA could have held hearings into the safety of the Yaz ingredient, drospirenone, as early as 2002, instead of this week. That's when the newsletter, Worst Pills Best Pills, warned that drospirenone, just approved in the pill Yasmin, "has never before been marketed in the US," and could cause "serious heart and other health problems such as a change in acid balance of the blood and muscle weakness."

 

But instead of investigating the drug nine years ago, the FDA decided to ban the newsletter's editor, Sidney Wolfe , MD, head of the Public Citizen Health Research Group from voting at this week's Yaz hearings , because the newsletter had termed the drug a "do not use." The FDA accused Wolfe of an "intellectual conflict of interest."

Birth of a new drug
Birth of a new drug
(Image by Martha Rosenberg)
  Details   DMCA

 

This is not the first time the FDA has silenced Wolfe. During 2010 hearings about Jazz Pharmaceuticals' fibromyalgia drug Rekinla, Wolfe's microphone was turned off when he asked why the manufacturer's guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings. Was it not relevant?

 

Jazz's off-label marketing, "is a matter related to compliance and it's not a matter that's related to the topic under discussion today," explained Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products. The only significance of bringing up the wrongdoing case would be to, "impugn the sponsor in the hopes that the committee would be punitive towards them in your deliberations and recommendations regarding this application," said Rappaport. Why should a $20 million guilty plea affect future approvals?

 

Next Page  1  |  2

(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).

Rate It | View Ratings

Martha Rosenberg Social Media Pages: Facebook page url on login Profile not filled in       Twitter page url on login Profile not filled in       Linkedin page url on login Profile not filled in       Instagram page url on login Profile not filled in

Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

Go To Commenting
The views expressed herein are the sole responsibility of the author and do not necessarily reflect those of this website or its editors.
Writers Guidelines

 
Contact AuthorContact Author Contact EditorContact Editor Author PageView Authors' Articles
Support OpEdNews

OpEdNews depends upon can't survive without your help.

If you value this article and the work of OpEdNews, please either Donate or Purchase a premium membership.

STAY IN THE KNOW
If you've enjoyed this, sign up for our daily or weekly newsletter to get lots of great progressive content.
Daily Weekly     OpEd News Newsletter
Name
Email
   (Opens new browser window)
 

Most Popular Articles by this Author:     (View All Most Popular Articles by this Author)

Grassley Investigates Lilly/WebMD link Reported by Washington Post

The Drug Store in Your Tap Water

It's the Cymbalta Stupid

Are You Sure You're Not Psychotic Asks Shameless Drug Company?

Another Poorly Regulated "Derivative"--the Antidepressant Pristiq

MRSA and More. Antibiotics Linked to Obesity and Allergies, Too

To View Comments or Join the Conversation:

Tell A Friend