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David ShlaesRSS Feed of this column.

Ph.D in Microbiology and M.D. from Case Western Reserve. BA, Biology-Chemistry (Magna cum laude) from Lawrence University. Formerly Vice President, Infectious Diseases, Wyeth Ayerst Research, Chief... Read More »


There has been much press lately about President Obama’s plan to address the growing crisis of antibiotic-resistant bacterial pathogens. And I agree with many that there is much to like in the plan.  But I also find a number of key deficiencies that will lead us nowhere.

The goals of the plan are all laudable –

I just came back from Boston and the annual meeting of BAARN – the Boston Area Antibiotic Resistance Network symposium held at the Broad Institute.  The meeting was interesting but the atmosphere was funereal. Many of those losing their jobs with the closure of Cubist’s research center in Lexington, Mass were there as were many whose jobs are threatened at AZ’s facility in Waltham, Mass.

One major topic of discussion during the breaks was – where will all the antibiotic research go?
Recently a study was published in the Milbank Quarterly analyzing the voting patterns of FDA Advisory Committee members with apparent conflicts of interest.

Europe is so far ahead of the US in its thinking on antibiotics and antibiotic resistance that we should all be ashamed.

For the last 15 years, Europe has led the way on the regulatory front making antibiotic development a top priority for its regulatory body the European Medicines Agency.  None of the recent US administrations going back to Bill Clinton nor the FDA itself ever made such a statement nor have they acted in a way commensurate with this thinking.

The FDA released its long-awaited Draft Guidance on hospital-acquired pneumonia recently. Their guidance has not changed since I wrote a blog about my last meeting with the FDA antibacterial drug development task force back in September of last year.

To reiterate what I stated back then . . .