#LCSM Chat Topic 2/8/18: Right to Try Laws and CIMAVax

 

“Right to Try” laws for people with a terminal illness have been a longstanding issue and are currently on the books in 38 states. The lack of a federal law supporting this concept was touched upon in President Trump’s State of the Union address last week. On its face, offering liberal options that permit these patients to try any still investigational agent that has completed phase I testing seems like a benefit to patients who may be desperate for options. A couple of arguments in favor of it are available here:

While on its face, federal legislation supporting a “right to try” seems an obvious win for patients with a terminal illness like advanced cancer, this approach also has many thoughtful opponents.  A leading concern is that it would create a lack of accountability of the potentially significant or even fatal side effects of such a treatment. Treating physicians would not be liable in cases of malpractice, and insurers would not be beholden to cover the unknown potential complications if patients receive treatment under right to try laws.  Overall, there is reason to be wary that patients receiving treatment under “right to try” laws would reduce the normal level of safety regulation that should accompany drug development.

Moreover, opponents note that “compassionate use” protocols are an available mechanism that leads to approval of use of investigational agents for individuals for whom it may be appropriate 99% of the time, without foregoing the safety controls that should remain in place.  Finally, researchers are concerned that patients pursuing “right to try” will short-circuit the available but potentially cumbersome clinical trials that offer these agents to patients and move the field forward, ideally bringing them to the point of being approved and available more broadly to patients who need them.

Here are a couple of links to the arguments against “right to try”:

 

A related issue is the desire of many patients to pursue the “Cuban vaccine” known as CIMAVax.  This agent has been studied and demonstrated enough of a benefit for patients with advanced cancer that Cuba approved its use many years ago, though the evidence supporting it as a single agent is quite modest. It is now being studied in combination with the better established immunotherapy agent nivolumab (Opdivo) in a trial being conducted at Roswell Park Cancer Center in Buffalo, NY and has been the subject of mass media stories that describe how patients are flying to Cuba seeking it based on recommendations from online patient communities.  You can read more about it here:

These questions of whether individual liberties are the most important issue or whether these treatments may lead to harm to both the individual patient and to the development of these agents through controlled channels remain controversial.

Please join us for our next tweet chat on February 8, 2018 at 8 PM Eastern, 5 PM Pacific, when we’ll cover these meaty questions (led by moderator @JackWestMD):

  • T1) Is there a clear benefit to “Right to Try” legislation over today’s Expanded Use/Compassionate Use for investigational agents?
  • T2) Is federal legislation for a “right to try” a good choice to maximize options for patients even if it lowers safety controls for these agents?
  • T3) Is “right to try” legislation a strong choice if it removes safety regulations & doc/insurance liability to be eradicated?
  • T4) Should we be concerned that patients pursuing “Right to Try” will undermine clinical trials for investigational agents?
  • T5) Are pts who seek CIMAVax in Cuba informed & choosing well, even if against doc’s advice? Do they risk missing better treatment?
  • T6) Should #LCSM community define consensus view on “Right to Try” legislation or should we defer on speaking w/1 voice on debatable issues?

Please remember to include #LCSM in ALL your tweets so the other chat participants can see your comments. You can read a primer on participating in the chat here.  Hope you’ll join us!

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