Right to Try

Hopefully the penguin picture shows up. I promise a few others in days to come.

 Some of you are probably familiar with the so-called Right to Try legislation that is currently sitting in a House committee. It's intent is to make drugs that have not yet been approved by the FDA available to patients with life-threatening illnesses who have no other options. The stories are all heart-rending, but this is a complicated and painful issue with important consequences for us all.

  The stories are about dying children or adults with rare conditions; the common link is that they have no other treatment options left, and that they have someone heard about one or another drug that is being developed, but that has not yet secured FDA approval. We have a long and careful process in our country that all drugs need to manage. Yes, it takes a long time, sometimes a very long time. But also yes, it is the only way to be certain that drugs on the market are safe and have proven that they can be helpful to humans in certain situations.

  Cost, of course is another whole issue, as many of these drugs cost a fortune. Sometimes pharma companies will give them at no cost, called Compassionate Use. The larger issue, I think, is that using them before they have been through the standard process distorts any science that we rely upon. Think about it: every single cancer drug that any of us have received has been carefully studied, so we can be confident that it is going to be safe (in spite of side effects, I know) and might be helpful. 

  This is from STAT:

Physicians, ethicists urge Congress not to pass ‘right to try’ legislation
By Ike Swetlitz @ikeswetlitz

WASHINGTON — Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks harming patients’ health.
The letter was drafted by Alison Bateman-House, associate professor of medical ethics at NYU Langone Health, along with some of her colleagues. It is addressed to the leaders of the House Committee on Energy and Commerce, the committee currently considering a so-called “right-to-try” bill. The letter was circulated for online signatures on Thursday, and organizers said they planned to send the letter on Feb. 5.
The Senate passed a right-to-try bill in August, which would allow patients with life-threatening conditions access to drugs that have not been approved by the Food and Drug Administration. The bill is now sitting in a House committee. FDA Commissioner Scott Gottlieb has expressed reservations about the bill, but President Trump seems to support it.
The 40-plus signatories of the draft letter, however, say they are strongly opposed.

Read more: https://www.statnews.com/2018/02/01/physicians-ethicists-congress-right-to-try/