21st Century Cures Act
oracknows | December 7, 2016Well, it’s done.
Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, I knew the bill’s passage was inevitable since after the election, when Senate Majority Leader Mitch McConnell stated that the bill was a priority. I knew it even more when the Senate linked the bill to the “Cancer Moonshot” initiative spearheaded by Vice…
oracknows | November 20, 2016It’s been two weeks since Donald Trump unexpectedly won the Presidential election despite losing the popular vote. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here many times dating back to 2007, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled not just once, but twice. As you might imagine, I was not pleased.
Leaving…
oracknows | May 20, 2016it was less than a year ago that I described a bill wending its way through Congress called the 21st Century Cures Act “old vinegary wine in a new bottle.” The reason I characterized the bill that way was because it really was nothing new and it rested on a very old fallacy, namely that the only way to speed up medical “innovation” is to weaken the FDA and its standards for drug and medical device approval, which is exactly what the 21st Century Cures Act would do if passed into law. It’s basically the American cousin to the British Saatchi Bill, which in essence proposed to do very similar…
oracknows | September 8, 2015I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single "gene chip," and to assess the relative abundance of every RNA transcript, coding and noncoding (such as microRNAs) simultaneously through next generation sequencing (NGS) techniques was considered, if not science fiction, so far off in the future as to be unlikely to…
oracknows | August 16, 2015The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform,…