May 212012

FTC sued Skechers over advertisements by Skechers that its shoes' caused muscle toning and weight loss. Skechers had clinical studies showing that its shoes did cause weight loss and muscle toning.

FTC found that the studies were biased. They were conducted by a chiropractor paid by Skechers. The data was inconclusive and possibly showed that the participants wearing Skechers shoes gained weight!

In the final settlement dated 5/16/2012, Skechers agreed to pay $40 million dollars fine. FTC further ordered that any future claim has to be substantiated by TWO independent clinical studies. The studies may be sponsored by the company but have to be done by independent groups and have to include control participants etc..etc..

Would it not be nice to apply the same standards to drugs?

The FDA requires only ONE clinical study to approve a drug or medical device. The study is always conducted by someone paid by the drug company and very often the company employees play a prominent role in conducting the clinical trials. The results of the study are analyzed a hundred different ways. If the drug is statistically better than placebo in one of these different analysis, then the FDA approves the drug!

 Posted by at 12:51 pm
May 132012

Following in the footsteps of Merck, Glaxo, and Pfizer, Abbot paid fine of over a billion dollars. Abbot also pleaded guilty to misdemeanor charges in the marketing of Depokote. The company admitted that it trained thousands of sales staff to market Depakote to nursing homes as a way to subdue elderly patients suffering from dementia. Despite negative findings during clinical studies (side effects with no patient benefit), Abbot went ahead with its elaborate scheme to market the drug to nursing home patients. The company also gave kickbacks to doctors who  prescribed the drug to elderly patients.

We will never know how many hundreds of thousands of elderly patients suffered nausea, dehydration and pain from Depokote. Until and unless a successful class action suit is brought on their behalf they are not going to get any of the above financial settlement. Even if a class action suit is successful most of the money will go to the attorneys, with only a little bit will trickling down to the patients and their families.

Unfortunately none of the million dollar earning drug company executives will go to jail. They will continue to make millions. The total government settlement of $1.6 billion is less than one year of Depokote sales earning.

In November 2011, Merck pleaded guilty to misdemeanor charges and paid fine of about $1 billion dollars. Merck had engaged in illegal promotion of its drug Vioxx for Rheumatoid Arthritis.

In November 2011, in one of the largest settlements of its kind, GlaxoSmithKline PLC paid the U.S. government $3 billion to settle several long-running criminal and civil investigations into the company, including allegations that Glaxo marketed some drugs illegally and defrauded the Medicaid program.

In September 2009, Pfizer, Inc., and its drug subsidiary Pharmacia & Upjohn Company, Inc. paid $2.3 billion to settle criminal and civil health care fraud charges brought by the U.S. Department of Justice. Whistleblowers uncovered fraud and "off-label" use of Pfizer drugs that were not approved by the FDA.


 Posted by at 8:22 am