By Charles Mueller

The current draft of the 21st Century Cures Act that is being promoted by the House Energy & Commerce Committee is not going to deliver on its promise to keep this country as the leader in medical innovation.  It can’t because the draft legislation completely misses the real problem the US faces when it comes to medical innovation.  The problem is our approach to developing new medicines, devices and treatments.  This draft legislation, while certainly changing the medical regulatory environment, does nothing to fix the system.

The case for this argument is actually made in the first white paper put out by the House Energy & Commerce Committee.  The white paper starts by pointing out that of the 10,000 known diseases there are currently only 500 treatments.  It then goes on to quote Dr. Francis Collins as saying it takes “around 14 years and $2 billion or more” to develop a new drug and “more than 95% of [such] drugs fail during development”.  The House Energy & Commerce Committee believes the solution to this problem is to create a regulatory environment that will allow drugs and devices to be essentially streamlined to market (aka the patient).  Somehow nobody thought twice about the last thing Dr. Francis Collins said, “95% of the drugs fail during development”.  When you spend approximately $30 billion a year on medicine and you are only getting 500 treatments for 10,000 diseases (and 95% of your projects fail), the system is not just bad, it is also bad science.  Our approach medical science and developing medical treatments is not working.

Some might argue that this draft legislation does some good things to improve the current system, and while this may be true, improving a broken system still leaves you with a broken system.  This idea that streamlining the development of drugs and devices is going to rapidly close the gap between our current treatments for diseases and the known diseases is just plain wrong.  Streamlining the same old process will just mean you get the same results faster.  This is the definition of insanity and if we really want to fix our approach to developing medical breakthroughs, we need to totally change the system.  Let’s try DARPA processes, directed research on larger scales, or other disciplines like physics to search for new treatments.  Let’s get outside the box and examine other models to approaching the development of medical science and treatments that we have not tried yet. 

The 21st Century Cures Act has great intentions, but as written, it will accelerate the pace of drug development failure.  This piece of legislation will flood the market with new treatments like lung cancer drug Iressa, which was fast-tracked by the FDA because it can shrink tumors despite the fact it does nothing to improve patient survival.  Streamlining drug and device development is not going to bring 21st century cures.  Streamlining existing processes is not the answer. 

What we need is a new system, a new approach that will actually do what the 21st Century Cures Act promises: Build a foundation for 21st century medicine. 


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