The Paradox of Clinical Trials (Limitless Possibilities)

The curse of the horrible diagnosis.  We would all like to believe that the latest miracle would be available to us if we or one of our loved ones needed it.  We ache for those who cannot access the miracle – or for whom the discovery will come too late.

The good news is that we live in a time unlike any other where such miracle drugs and therapies are available. With more seemingly under development by researchers across the Nation, including many being worked on here in Arizona.

In light of these discoveries and more that may soon follow, the policy debate around making these available sooner has begun.  For example, a series of state level policy efforts over the past couple of years has aimed to create state law that requires insurers and providers to make these available.  Some of these were passed by state legislatures, and in Arizona ours was approved by the voters in 2014.

Now another such effort is moving through the US Congress that would begin to forge a national answer to this issue – the 21st Century Cures Act.  Recently passed by the House Energy and Commerce Committee, the new bill would “help fund medical research and relax regulations related to the discovery, development and delivery of new drugs.”

Some see problems with these policy efforts, believing them to be more flash than substance or weakening longstanding protections against things that might do us harm. Nor is it clear that the laws that have passed have done much to increase the availability of miracles.  We don’t know of anyone who has yet benefitted from Arizona’s new law, and there are few reports of helping anyone in any of the 12 states that have passed these laws. Similar bills have been introduced in more than 20 other states.

The paradox remains that there is a shortage of folks accessing miracles through pathways that are legal and available.  By this, we are referring to clinical trials of new drugs or treatments that sponsors are trying to find patients to test, after an initial set of research that allows them to be so assessed.  Our friends in the research community tell us that they are actually facing a shortage of people willing to be part of clinical trials.

It is such a big issue that it is an ongoing topic at their leadership convenings. Here is what AzBio said about how we, in Arizona, measure up in the clinical trials landscape.

Do we need these highly political and public new laws to help diffuse the miracles to those in need?  How do we balance these with the protections that we built to protect the public from dangerous products?  Or, can we work within the law and unused opportunities to do more to promote miracles of healing?

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