40% of cancer patients in the U.S. attempt to join a clinical trial to get access to potentially lifesaving treatments, but only 3% succeed

See Winning the Right to Save Your Own Life: As the FDA dawdles, 24 states pass ‘right-to-try’ laws giving terminally ill patients access to drugs by Darcy Olsen, president of the Goldwater Institute, is the author of “The Right to Try,” out this month from HarperCollins. Excerpt:

"According to the Boston-based Center for Information and Study on Clinical Research Participation, 40% of cancer patients in the U.S. attempt to join a clinical trial to get access to potentially lifesaving treatments, but only 3% succeed. Hundreds of thousands of patients who want access to promising new medicines cannot get them—and are forced to deteriorate or die while the drugs wind their way through the FDA.

The lack of access to lifesaving drugs is not limited to cancer. Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease that kills about 40,000 Americans each year. There were no effective treatments until InterMune, a U.S. company, developed a breakthrough therapy called Esbriet. The FDA finally approved it for use in the U.S. in October 2014—nearly five years after an FDA advisory committee had recommended approval. Meanwhile, Esbriet was available in Japan seven years earlier, in Europe four years earlier, and in Canada two years earlier.

According to President Obama’s Council of Advisors on Science and Technology, it now takes, on average, 14 years to bring a new drug to market in the U. S.—up from eight years in the 1960s. As a result, Americans with terminal illnesses typically are forced to rely on treatments that were developed 10 or 15 years ago, with cutting-edge innovations and cures locked behind the bars of archaic federal policy.

Americans with terminal illnesses are supposed to have access to investigational drugs through the FDA’s “compassionate-use” program, but that’s not happening either. The FDA claims that it approves nearly all applications for compassionate use, roughly 1,800 last year. What the agency neglects to mention is that 99% of patients never complete the application process. Why? In part, because the application process is so complex it takes an average of about 100 hours to complete. Another obstacle is that, under the rules of the compassionate-use program, companies can’t charge for treatments above cost, so there is little financial incentive to participate.

This is why the “right-to-try” movement at the state level is so important. Right-to-try legislation, once passed by state lawmakers and signed into law, allows patients with terminal illnesses access to investigational drugs that show promise in clinical trials but still may be years away from receiving FDA approval."