Yesterday, President Obama signed into law the 21st Century Cures Act — one of the few pieces of major legislation to get passed into law in the past 12 months with significant support from both political parties here in the US.
The 21st Century Cures Act runs to 1,000+ pages of legislation and incorporates a whole range of elements — including US$1.8 billion in funding for Vice President Biden’s “Moonshot” against cancer; funding for the war on heroin and opioid addiction; US$1.5 billion for a brain research initiative; and US$1.4 billion for precision (i.e., “personalized”) medicine. The good news is that this is a major shot in the arm for cancer research and some important other issues. The less good news is that it comes with all sorts of potential benefits for commercial manufacturers of drugs and medical devices that may not necessarily be in the best interests of patients, and it will take time to see how those issues play out.
From a prostate cancer-specific point of view, there is nothing in this legislation that assigns money to any major prostate cancer initiative. The prostate cancer research community and its supporters will have to work out how to battle for their share of the pie along with every other group of cancer researchers and patients around the country. As a consequence, it will be a while before we can tell whether there are going to be any identifiable and direct benefits for the prostate cancer community from this piece of legislation. What we can be sure about, however, is that a variety of organizations (most notably the Prostate Cancer Foundation) will already have been working hard behind the scenes to do whatever they can to channel some of the new funds into initiatives that do indeed have direct, potential benefit for prostate cancer research and therefore for prostate cancer patients.
Filed under: Uncategorized | Tagged: 21st, Century, Cures, funding |
THE "NEW" PROSTATE CANCER INFOLINK 
I suspect a fair amount of the immuno-oncology research will find its way to prostate cancer. It is an enormous market so both the researchers and big pharmas are already focused on finding effective immunotherapy treatments.
I’ve read that it may relax FDA rules for proving efficacy for drugs and medical devices, particularly that randomized clinical trials will no longer be held up as the gold standard. I have no idea if those concerns are founded or not. We shall see.
For what it’s worth, here’s a link to an NIH article praising it in the NEJM, and here’s a link to a “Public Citizen” article pointing out its faults.
Allen:
During all of the discussions about the development of the 21st Century Cures Act, the FDA has made it abundantly clear that it will remain committed to the concept of the safety and the efficacy of new forms of treatment for all disorders based on the historic relative benefit vs. relative risk standards they have used for most of the past 60 years. There are those that would like to get rid of those standards and allow approval of new drugs based solely on safety, but I am far from sure how one could assess safety without doing relatively large randomized trials vs. at least a placebo.