Why You Can't Use Your Right to Try

The Availability Problem:Imagine you have cancer, or chronic pain, or a progressive degenerative disease of some sort. You have exhausted the traditional treatment options available to you, and none of them have worked. However, there are treatments that are still undergoing clinical trials which might help you. They are not fully approved yet, but your situation is dire and you don’t have time to wait another 10 years for the trials to finish. Can you access those treatments?In theory yes, you can access unapproved treatments through federal laws like the 2018 Right to Try bill, or through FDA pathways like “Expanded Access”. However these laws don’t mandate that the company making the drug gives it to you. And what you will find when you try to use your Right to Try, or Expanded Access, is that there are almost no treatments available for use.That’s why despite there being somewhere in the neighborhood of 13,000,000 Americans with terminal or serious illness, the FDA only grants about 2,000 Expanded Access requests per year, even though they approve 99% of all requests, typically within 24 hours. There just aren’t enough companies even bothering to apply.No one really knows for sure how many patients have been treated under Federal Right to Try laws. What we do know is how many companies with drugs going through the clinical pipeline have used data from treating patients with RTT, when submitting data for their treatments to the FDA. Even if we assume the usage numbers are 2-3X higher, they are still pretty abyssmal.Risk and Reward:But what is it about these pathways that makes companies avoid them like the plague? The answer is three words: Terrible Risk/Reward.The companies who own the rights to the treatment you want to access are called “Biotechs”. Now Biotechs are not like the big pharma companies you think of, they don’t make billions of dollars. In fact, they usually don’t make any money at all. They’re the small companies that do the research to get the dr