The US Senate has passed a Right To Try bill that will allow terminally patients to bypass FDA approval when seeking access to experimental medication.
The bill, which expands on compassionate-use legislation passed in states across the country, will give patients the right to request trial drugs directly from pharmaceutical companies. Currently patients must submit an application to the FDA before approaching manufacturers.
The bill also ensures that patients are charged no more than the production cost for the drug, while providing pharmaceutical companies with a degree of legal protection if the patient experiences harm from the treatment. Safety issues that occur in compassionate-use cases must be reported to the FDA, the proposed legislation states.
“Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives,” Senator Ron Johnson of Wisconsin, the author of the bill, said in a statement after the unanimous Senate vote.
Bioethicists are sceptical. Alison Bateman-House, of NYU Langone Medical Center, called the bill “inherently deceptive” because it simply says patients can ask drug companies for the treatments. Companies often are reluctant to provide unapproved products for a variety of reasons, and the FDA has an efficient system to handle requests for experimental drugs, she told the Washington Post.
In a scathing blog post, bioethicist Craig Klugman criticised Right To Try advocates for bypassing “logical arguments, reason, and good facts”:
“...A pure market approach to pharmaceutical distribution sacrifices safety, accurate labeling, scientific approaches to treatment, and protecting the public from harm. In their winner-takes-all arena, there must be winners and losers. If right-to-try wins, then we all lose”.
Sunday, August 13, 2017
In a recent article in the American Journal of Bioethics, bioethicist Art Caplan and three colleagues call for a complete overhaul of the venerable Belmont Report (see below). This is the 1979 US government report which set out three famous principles which have governed human research ever since: respect for persons, beneficence, and justice.
Most government reports are already gathering dust within a few months after their publication. But the Belmont Report’s influence has been enormous, as it shaped the bioethical framework for clinical and research decision-making in the US and many other countries as well.
Caplan & Co make a good case for revising the standards in the light of experience and changing times. But it comes at an awkward moment: the Trump Presidency. What kind of commission would Mr Trump create to study this issue? Perhaps a noisy and truculent one, a bull in the bioethics china shop. Be careful what you wish for?
|NEWS THIS WEEK|
|IN DEPTH THIS WEEK|
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605