Doing “What Works” Is Working

Basic science funding was partially restored in this weekend’s deal to avert a government shutdown. But don’t think for a moment that life science commercialization will easily survive the administration’s anti-science budget stance. The fight to stave off R&D starvation has just begun.

Mosquito-borne Zika has no respect for national borders nor will it enjoy a summer recess. New shared development strategy to spread the rising costs and risk of developing much-needed anti-viral drugs has changed the drug development game into a shared enterprise for pharmaceutical companies.  But fresh tactical approaches to vaccine development have not altered the old thinking of price-based B-D march-in crusader KEI’s Jamie Love and his Senate spokesman Bernie Sanders. They objected to an award of shared financial support to vaccine-maker Sanofi to help underwrite two-stage clinical trials that could produce concrete evidence of a potentially safe, effective and investible Zika vaccine by June. If Phase II testing is successful, NIH’s Dr. Fauci says the vaccine’s Phase III trials would require massive support from a yet unnamed drug company partner.

The US Army Office of Research and Technology Applications (ORTA) issued a letter last week reporting that the Army would pay much of this trial’s bill. The letter implied that granting Sanofi an exclusive license was a reasonable and necessary means to harness the capital and expertise needed to win FDA approval for an unproven technology. Sanofi was the only company interested in pursuing this collaborative Phase II research agreement.

Love and Sanders rottenly complained that an exclusive Phase II award might lead later to Sanofi’s charging for the vaccine “whatever astronomical price it wants.”  What Love and Sanders fail to say is how they propose to defend against a baby-maiming virus creeping up our nation’s coast. Worse, what they never seem to understand is that unless this new vaccine’s later stage development can attract private sector investment capital, there will be no such vaccine.

The Army, Dr. Fauci (and we suspect the pregnant US public), find Zika vaccine’s privately financed commercialization to be” in the public interest” as US law requires when awarding such exclusive licenses. In the real world, developing unproven life science technology requires government investment before it can attract private sector investment to fund its late-stage clinical testing and if FDA approves its subsequent commercialization. Public and private investments, like apples and oranges, are not the same. Both types are needed to develop anti-viral vaccines. Love’s and Sanders’ newfound love of competition is laudable. Their rote, repeated rhetoric is not. Until this vaccines’ chances for commercial success are better than remote, public funding support is the only way it will ever be developed. Doing what works is working.

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