Right-to-try laws needed in New York
For years clinics have been effectively treating patients with stem cell therapy, but the law has not kept pace with the developments. As legislation lags behind, people are being prevented from receiving promising new treatments and are often forced to go abroad when they run out of options in the U.S. One should be able to make their own decision for which kind of medical treatment they want.
It may take more than ten years to go through the FDA approval process. Terminal patients don’t have that long to wait. Laws need to be passed that allow patients access to cutting-edge medical care, including stem cell therapy.
Many States Already Passed
Many states in the U.S. have passed right-to-try laws which give patients the option to use experimental treatments. They are allowed to use pharmaceuticals that have passed through phase three FDA trials. These drugs have already passed the safety profiles required but have not passed the efficacy tests.
As director of Park Avenue Stem Cell (PASC) operating in New York, I am calling for New York State to pass right-to-try laws, particularly those relating to stem cell therapy. Texas has recently amended its right-to-try law and has now officially recognized stem cell therapy, allowing people to receive treatment if no other options are available. New York needs to do the same.
Need for Immediate Access
Recently the issue of right-to-try was debated on a national level when President Donald Trump encouraged the passing of a federal right-to-try bill. Detractors believe that such a bill would only offer false hope to patients and keep the FDA out of the loop. Supporters believe that terminally ill patients should have a right to try treatments, even if they are still experimental.
Detractors of right-to-try laws mention the FDA’s expanded access program which allows terminal patients access to experimental treatments. What they do not take into account is that application is costly, time-consuming and complicated. When it comes to clinical trials, not many people gain access to these. The right-to-try law allows a patient immediate access treatment which is essential if they are terminal. The legislation, particularly in relation to stem cell therapy, is lacking and needs to address this issue.