FDA panel that approved Yaz and Yasmin had ties with industry

Dr. Sidney Wolfe is the founder and Director of Health Research at the consumer advocacy group Public Citizen, and is also the author of the  consumer guide called “Worst Pills/Best Pills” Among the drugs mentioned in this guide under the “worst” section are birth control pills containing the synthetic hormone called drospirenone, listed with cautionary warnings “due to the increased risks of blood clots, heart attack, stroke, sudden cardiac death, or gallbladder injuries”.  An article posted on the Worst Pills website revealed that studies funded by the drug industry found lower risks of blood clots than did studies that were publicly funded.

There are, in fact, over 10,000 individual lawsuits pending over injuries and deaths related to drospirenone/ethinyl estradiol tablets. You may know them better as Yaz (or Yasmin in Canada), as well as Ocella (generic Yasmin). New safety warnings published last April in the British Medical Journal now suggests a two to five-fold increased risk of thromboembolic or blood clot-related injuries in women taking birth control medications that contain drospirenone, which generally provide no greater benefits than those seen with older, safer birth control pill formulations without drospirenone.   Continue reading

Big Pharma’s “Pay for Delay” tactics keep generic drugs off the market

It takes a ton of time and money for a pharmaceutical company to produce a new drug.  Some companies claim an average of 12 years and over $350 million just to get one new drug from the research lab to your medicine cabinet.  And only then does a brand name drug starts to finally make money for its maker.  But after a number of years in the marketplace (usually between 7-12 years in the U.S. and up to 20 years in Canada), that brand name drug’s exclusive patent protection expires, thus opening the market to competition from cheaper generic forms of the same drug.  When generic drugs become available, the market competition often leads to much lower prices for both the original brand name drug and the generic forms.

So when a drug falls off the patent cliff, drugmakers stand to take a substantial hit to their profits from then on.  The bigger the blockbuster drug, the bigger that financial loss will be.  Continue reading

Bayer sued for false prostate cancer prevention claims in its multi-vitamins

bayer vitaminsBayer’s recent ad claims have become a real headache for the German drug company. The Center for Science in the Public Interest filed a lawsuit on September 30 against Bayer over ad claims for its One A Day Men’s Health Formula multi-vitamins. Bayer says that because its product contains selenium, it may reduce the risk of prostate cancer, which CSPI said has been proven false.

The nonprofit health advocacy group said it reached out to Bayer in June 2009, asking it to alter its marketing materials following the results of an eight-month clinical trial that showed that selenium does not prevent prostate cancer. It also showed selenium may actually have harmful affects such as an increased risk of diabetes. CSPI reported that Bayer threatened to sue for libel after the group spotlighted the alleged flaws in Bayer’s claims.  And no wonder – Bayer pocketed almost $24 million in sales on this product during the past year.

Bayer might want to visit the Mayo Clinic website before it launches that libel suit.  Mayo Clinic doctors apparently agree with CSPI:

“Some companies have suggested that daily doses of the mineral selenium, vitamin E or both may have helped to prevent prostate cancer. But further study has shown these supplements have no effect on prostate cancer. In some cases, these supplements may cause side effects or lead to other health conditions.”

Learn more:  Why Prostate Cancer is Big Business, or about the Bayer lawsuit