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David M. Shlaes's Antibiotics: The Perfect Storm PDF

By David M. Shlaes

ISBN-10: 9048190568

ISBN-13: 9789048190560

ISBN-10: 9048190576

ISBN-13: 9789048190577

Antibiotics are actually miracle medications. As a category, they're one of many simply ones that really remedy affliction rather than such a lot medications that purely support relieve signs or regulate disorder. simply because micro organism that reason critical sickness in people have gotten increasingly more proof against the antibiotics we have now this present day, and since they're going to finally turn into proof against any antibiotic that we use for therapy or for the rest (like vegetation, animals, etc.), we want a gradual provide of latest antibiotics lively opposed to the resistant micro organism that come up. however the antibiotics industry is not any longer appealing for giant pharmaceutical businesses, the prices of improvement are skyrocketing as a result of ever extra stringent standards via the regulatory organisations and discovering new antibiotics energetic opposed to resistant lines is getting tougher and more durable. those forces are all combining to disclaim us those miracle medications after we desire them the main. I supply a couple of attainable paths to defend from this ideal storm.

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Sample text

Those of us actually treating patients with infections were always puzzled by this worry since we knew from the evidence of our own eyes that the antibiotics were effective for most serious infections. The FDA wanted us to reduce that margin to 10%. When you compare the patient numbers for the two circumstances, the 10% margin required more than twice the patients (and therefore about twice the cost) compared to the 15% margin. Remember, we are talking about a theoretic maximum difference between the two drugs, not the actual difference.

How does the FDA contribute to the perfect storm for antibiotics? Guidance documents from the FDA can be helpful in that they tell everyone the kinds of things they need to do in order that the FDA will approve the product in question. They are currently issuing a series of guidances for the design of clinical trials for antibiotics 32 4 The FDA that make it difficult, and at times impossible, to actually carry out the proposed trials. But if these guidance documents mandate studies that are not feasible – where are we?

No. This point was driven home recently by the scandal over the FDA handling of a new antibiotic, Ketek (telithromycin). Even Congress got involved. This is a story I have followed closely and I was present at the final FDA meeting dealing with this new antibiotic. The Ketek story illustrates the effect of political pressure on the FDA process, FDA’s inconsistent treatment of branded compared to generic antibiotics, and, in my view, their lack of leadership in general. Ketek, or telithromycin, is an antibiotic designed to overcome antibiotic resistance in respiratory pathogens.

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Antibiotics: The Perfect Storm by David M. Shlaes

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