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Consortium tackles severe adverse events
October 2007
by Lisa Espenschade  |  Email the author
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CHICAGO—The newly formed, nonprofit international Serious Adverse Events Consortium (SAEC) hopes to bring pharmacogenetics one step closer to consumers by finding connections between drugs, side effects, and genetic markers.

The consortium includes Big Pharma and academic institutions in Europe and the United States, with the U.S. Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products playing consultative roles. SAEC will begin by leveraging existing data sets connected with drug-related liver toxicity and Stevens-Johnson syndrome and comparing them to control cases.

Janet Woodcock, FDA's deputy commissioner and CMO, told journalists in a teleconference that "the FDA has been struggling for three decades with serious adverse reactions to drugs," many of which have been pulled from the market or patient access because of fear of severe reactions considered idiosyncratic. Woodcock sees SAEC's efforts as a "part of personalized medicine that will per sonalize safety and make treatment safer by understanding individual benefits and risks, rather than [being] just population based."

Woodcock describes liver problems as "prime and feared" and says that eventual genetic testing for side effects could help establish some patients as "cheap dates" for insurance companies: if drugs are dosed to fit individual metabolisms and responses, some patients may require less. She also noted new genetic testing for pharmacogenetic markers for warfarin and said she expects to see more drug labels include pharmacogenetic information. "Because the science has become much easier to do, you can develop tests very expeditiously," she said, cautioning that it will take time before SAEC's work translates into new tests.

Arthur Holden, chairman and CEO of SAEC, says Stevens-Johnson syndrome will be studied first; he plans to release data to the public in Fall 2008 for validation in other studies. Drug-induced liver disease is more complicated, and he hopes to add more cohorts through collaboration. Founding pharma companies funding SAEC are Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development LLC, Pfizer, Roche, sanofi-aventis, and Wyeth. Holden says SAEC raised "millions of dollars of funding" through their memberships, but declined to provide a total. Holden is a veteran of other consortia, including SNPs and mouse sequencing, and is resigning his position as senior vice president of corporate and market development at Illumina Inc., effective mid-October in order to lead the effort.

Holden assured teleconference listeners that additional companies of various sizes will join, despite a uniform dues contribution. "This is an important area for many companies, regardless of size," he notes.
Holden also hopes to see additional government agencies and international research organizations join existing collaborators Newcastle University/DILIGEN, Eudragene, and Columbia University. Additionally, Expression Analysis won a competitive bid to perform SAEC's genotyping work; Illumina, a provider of SNP genotyping products and services, is also involved.

Paul Watkins, a professor of medicine, pharmacy and experimental therapeutics, and toxicology at the University of North Carolina, who served as an advisor to SAEC during its planning stages, sees severe adverse events as a huge public health problem that raises the cost of drug. Watkins told Drug Discovery News that "the real goal is to figure out why are these people different—these 1 in 10,000 people—and we think it's genetics."

Watkins says severe adverse events are particularly expensive to the drug industry in an atmosphere of growing individualization that doesn't lend itself to billion-dollar blockbusters. Drug companies understand they must join together, he says, using technologies and techniques like whole genome association studies. "That's only really been available in the last few years, and only shown to work in the last year," Watkins notes.

Watkins's own experience includes seeing potential wonder drugs pulled from human development because of severe adverse events, so he hopes SAEC's pioneering project can play a part in helping remove risks from drugs. "This is the first real worldwide effort to try to solve this problem. And it's risky; it may not work," he warns, particularly if there aren't enough data samples for significant advances.
 
Code: E100704

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