While it s good to see that The New York Times is taking note of the crisis of antibiotic resistance, it is unfortunate that they could not be a little more honest. In their lead editorial in Sunday s paper (May 11th) they call attention to the problem and discuss their ideas about the reasons why we are now in this mess; however, they (intentionally?) omitted perhaps the most important reason why we find ourselves in this dangerous place the FDA.
ACSH s Dr. Josh Bloom explains, The Times lays the blame for this situation on pharmaceutical companies, leading the reader to conclude that it is simply not profitable enough for companies to discover new antibiotics (ABs) so they don t bother.
While this is technically correct, few people know the reason behind it. In the graph below, it is clear that antibiotics were certainly profitable enough in the past.
It is also clear that something happened around 2000 that brought new AB development to a screeching halt. What was it?
No one can answer that question better than ACSH advisor Dr. David Shlaes, the former head of infectious disease research at Wyeth. In his 2002 letter to the journal Clinical Infectious Diseases he describes how a foolish and arbitrary policy enacted by the FDA in 2002 solely for the purpose of improving the statistical power of AB trials more than doubled the number of patients required to run a phase III trial, making this much more expensive and time consuming. Predictably, virtually all major drug companies dropped out of the area in short order.
Dr. Bloom continues, It is certainly no coincidence that this dramatic falloff began at this time. Yet, it would be more than 10 years before the FDA would even acknowledge their mistake. In fact, it got even worse. In 2009, they even were proposing that a control group of people who had never taken an antibiotic be used. Last I heard they were looking on Venus.
Dr. Shlaes, in his blog Antibiotics- the perfect storm, comments on the consequences of FDA policy: No one will ever run trials in nosocomial (hospital acquired) pneumonia under the FDA s current. No one.
The Times editorial also mentions the prospect of untreatable gonorrhea, something Dr. Bloom wrote about nearly two year ago in the New York Post.
Dr. Bloom concludes, It is unfortunate that even during a real crisis one that was largely caused by bad government policy The Times cannot set aside its anti-pharmaceutical biases and tell the whole story.