Ain't FDA Regulations Fun?

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 4 • September 2003

Ain’t FDA Regulations Fun?

The 29 August 2003 Science reports, in their “Random Samples” section, an article entitled “A Painful Separation,” which reflects poorly on the FDA’s approval process. The article reports that two scientists, Raymond Goodwin and Craig Smith, cloned the primary receptor for the inflammatory cytokine tumor necrosis factor (TNF) that led to the development of a blockbuster arthritis drug, Enbrel. But when the company at which they had worked (Immunex) was bought out by biotech “behemoth” Amgen, the two scientists had resigned, “victims of the merger.” Although Smith hopes to launch his own biotech company, Goodwin (at 52) has retired, “saying he no longer has the desire to push another compound all the way to market: ‘I don’t know if I want to work that hard.’”

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