Personalized Medicine Watch by John Russell
October 21, 2008 | Much of the effort around personalized medicine today is targeted at cancer—and for good reason. Cancer’s heterogeneity makes it very difficult to treat with single standard approach and FDA approval can sometimes be fast-tracked. However PM’s spread to other disease areas is speeding up, as evidenced by recent NIH grants totaling roughly $2.5 million to determine the genes that make serious muscle problems more likely for patients taking statin drugs.
The projects were approved this summer and announced Oct. 2. “Statins have a track record and are considered safe, although myopathy is listed as a possibility on the label. The rates of the severe form of this adverse event are low, although lesser versions are more common. Also, the majority of symptoms resolve if patients stop taking the drug. But with so many people taking the medication at ever-higher doses, the actual number impacted is large,” according to a report in amdednews.com.
In recognition of the need for answers, the National Heart, Lung and Blood Institute awarded two grants to the University at Buffalo, including $2 million to study the association between various genes and statin-induced myopathy and $110,000 to determine the commercial viability of a product to identify them in patients. The National Institute of Arthritis and Musculoskeletal and Skin Diseases provided $383,000 for characterizing the genes associated with statin myopathy.
This spread of NIH funding for personalized medicine initiatives is good for the field and a likely sign of things to come.
Along those lines, a new report, “Assessing Risk and Return: Personalized Medicine Development & New Innovation Paradigm,” has been released. Commissioned by the Ewing Marion Kauffman Foundation, the draft white paper was presented at the 2008 National Summit on Personalized Health Care, “Innovation in Health Care Delivery,” held Oct. 5-7, 2008, in Deer Valley, Utah, and hosted by Secretary of Health and Human Services Mike Leavitt.
“Even after typical ‘blockbuster’ drugs are marketed, only 30 percent of them achieve sales that match or surpass their multi-billion-dollar R&D costs,” said Lesa Mitchell, vice president of Advancing Innovation at the Kauffman Foundation and one of the study's authors. “Based on the high-profile successes of some stratified medicines, however, the biopharmaceutical industry is beginning to realize the deficiencies in the economics of the blockbuster business model. This is one driver of increased interest and investment in developing personalized medicines, a task often best pursued by small biotech companies.” For a full account is available in the press release.