The FDA Grapples with Rules for Social Media
Podcast: November 20, 2009

Earlier this month pharmaceutical companies joined with Internet companies for a hearing on social media held by the U.S Food and Drug Administration. At issue in the two day hearings was what if any regulations need to be put into place to control how drug and device makers promote their products online in forums ranging from blogs to Twitter. The lack of regulatory clarity has left many pharmaceutical companies cautious about wading into this brave new world. The hearings followed warning letters sent by the agency to 14 companies in April about their marketing of drugs online because they failed to include risk information. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a partner and director of global healthcare at Porter Novelli about why pharma companies want to engage with customers through social media, the regulatory issues surrounding its use, and why the questions raised by the industry’s use of social media will not be solved by simple answers. Read More Here

DeCode Defunct
The weekly round-up of failed trials, missed targets and other business mishaps.
DeCode Genetics, the groundbreaking Icelandic firm that sought to use the genetics of the island nation’s population to develop new diagnostics and therapeutics, said it will for bankruptcy. DeCode filed for relief under Chapter 11 of the United States Bankruptcy Code with the United States Bankruptcy Court for the District of Delaware to facilitate the sale of substantially all of its assets. Read More Here

Divesting to Invest
Bristol-Myers Squibb divesting Mead Johnson stake before end of 2009.
Bristol-Myers Squibb will sell its last non-biopharmaceutical holding, a majority stake in Mead Johnson Nutrition, the company said. The pediatric nutrition company produces Enfamil baby formula and is a leading supplier of children’s nutritional products globally. Bristol-Myers’ move, part of a wider healthcare divestment strategy, will help the company improve its overall financial position and open the door to the pursuit of strategic business development opportunities, says CEO James Cornelius. Read More Here

A Personalized Medicine Proving Ground
Ignite Institute receives key backing from Virginia.
Virginia Governor Timothy Kaine announced $25 million in funding that will help support the Ignite Institute, a newly established non-profit research institute that seeks to become the nation’s proving ground for personalized medicine. The institute says it will focus on applying biomedical and technological innovations to enable individualized healthcare. To that end, it also said it has formed a partnership with Inova Health System, which includes $25 million in funding for the venture. Read More Here

Breakfast of Champions
Promising pharmaceutical agents emerge as sports doping products.
A new class of yet-to-be approved drugs in development to treat a variety of diseases are being used by athletes to enhance their performance, according to researchers at the German Sport University Cologne in Germany. They found that non-steroidal and tissue-selective anabolic agents such as Selective Androgen Receptor Modulators or SARMs are being sold on the black market. The availability of authentic SARMs was recently demonstrated for the first time by the detection of the drug candidate Andarine in a product sold over the Internet, according to the study published in the journal Drug Testing and Analysis demonstrated for the first time by the detection of the drug candidate Andarine in a product sold over the Internet, according to the study published in the journalDrug Testing and Analysis. Read More Here

Niacin Beats Zetia
Cholesterol study questions impact of Merck’s Statin.
A small study is causing a big splash in the multi-billion dollar world of cholesterol treatments. The test, pitting a prescription form of the B vitamin niacin against the prescription drug ezetimibe, found that niacin significantly shrank artery walls when taken in combination with a statin. The commercial version of ezetimibe by contrast, sold by Merck as Zetia, showed no measurable change in arterial plaque build-up. That result could give doctors pause for thought and has already created a stir among Merck investors concerned about the study’s impact on already-declining Zetia sales. Read More Here

Unlocking the Genetics of IBD
Largest gene study of childhood inflammatory bowel disease identifies five new genes.
An international research team has identified five new gene regions that raise the risk of early-onset inflammatory bowel disease. The study, published inNature Genetics, is characterized as the largest, most comprehensive genetic analysis of childhood-onset of the condition. The findings were based on genome-wide association studies on DNA from over 3,400 children and adolescents with IBD, plus nearly 12,000 genetically matched control subjects, all recruited through international collaborations in North America and Europe. Read More Here

Treating Down Syndrome
Early intervention with existing drugs that boost norepinephrine may counter effects of the disorder.
Drugs boosting levels in the brain of the neurotransmitter norepinephrine may be able to help counter the memory deficits that hinder the cognitive development in people with Down syndrome, according to a new animal study published in Science Translational Medicine. Hindered memory-making robs the brain’s ability to collect the experiences needed for normal cognitive development, say the Stanford University School of Medicine and Lucile Packard Children’s Hospital researchers behind the study. Read More Here

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