Antibiotics: The Perfect Storm by David M. Shlaes

By David M. Shlaes

Antibiotics are really miracle medications. As a category, they're one of many purely ones that really therapy affliction instead of such a lot medicinal drugs that in basic terms support relieve signs or keep an eye on affliction. simply because micro organism that reason critical sickness in people have gotten increasingly more immune to the antibiotics we have now at the present time, and since they're going to finally turn into proof against any antibiotic that we use for remedy or for the rest (like vegetation, animals, etc.), we'd like a gradual offer of recent antibiotics energetic opposed to the resistant micro organism that come up. however the antibiotics industry isn't any longer beautiful for big pharmaceutical businesses, the prices of improvement are skyrocketing due to ever extra stringent requisites via the regulatory corporations and discovering new antibiotics lively opposed to resistant traces is getting more durable and more durable. those forces are all combining to disclaim us those miracle medications after we want them the main. I offer a couple of attainable paths to defend from this ideal storm.

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Of interest, a representative of the European regulatory agency (EMEA) was present at the 2006 FDA meeting and presented data from Europe and recent European decisions related to Ketek. In Europe, approved drugs are routinely re-examined on a regular basis. (We will come back to this in our chapter on Modest 40 4 The FDA Proposals, Chapter 7). The European Medicines Agency (EMEA – the FDA for Europe) had just completed its review of Ketek including substantially more safety data than was available at the time of the 2004 approval of Ketek by the FDA.

In the 1980s, the US began to experience an epidemic of MRSA infections in hospitals. 2 shows that in the early 1980s, only about 10% of ICU isolates of staph were MRSA. Today, that number is over 50% and the MRSA is not just limited to the ICU. MRSA is found in all areas of our hospitals. Vancomycin has become the drug of choice for the treatment of MRSA infections. Linezolid was introduced to the market in 2000 and in 2003 daptomycin was marketed. Both are also active against MRSA but only linezolid can be given as a pill.

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. It provides an important alternative to therapy for patients who are allergic to the penicillin type antibiotics or who cannot tolerate the quinolone antibiotics.

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