The Max Cure Foundation’s advocacy efforts round out our three-prong mission and sometimes place members of our executive team at the forefront of the childhood cancer community on certain issues. The pending legislation emotionally labeled as the Right to Try law that has been a string of individual bills introduced in Congress, and already the law in some states, is one such example of how Max Cure’s advocacy efforts are aimed at working to help children with cancer. Vice Chairman Richard Plotkin has been an outspoken opponent of the Right to Try laws since his now famous efforts at securing a life-saving treatment for Josh Hardy who lay dying in a hospital room as a result of contracting an infection secondary to cancer treatment. Richard vigorously engaged in an all out effort to secure a drug through expanded access/compassionate use that had a high percentage chance of eradicating the virus Josh was fighting from a small pharmaceutical company in North Carolina.
Right to Try laws are emotionally based efforts that are allegedly meant to allow patients access to unapproved drugs when they are terminal and have no available treatments. These laws seek to move the use of experimental drugs outside of the oversight of the Food and Drug Administration. The underlying claim of proponents of these laws, including the Vice President Mike Pence, is that the FDA moves too slowly in the approval process as well as in connection with potentially granting access to drugs through the expanded access/compassionate care program.
Among the arguments in favor of Right to Try, which removes the FDA from the approval process, is not only the fallacious argument that it slows the process down, but also that it “rubber stamps” the applications submitted to it. That is not accurate, especially as it relates to terminally ill children. A random study demonstrated that 11% of the applications to the FDA were changed based on the recommendation of the FDA, potentially making the use of the experimental drugs more safe to be administered to those seeking the drugs.
Richard has spoken at numerous conferences as an invited panelist, at colleges, been interviewed and written about the topic, including this piece published by The Hill in an effort to remove the false pretenses of the Right to Try laws. The facts clearly demonstrate that the FDA’s mechanism of granting access to experimental treatments in a monitored and controlled environment through compassionate use waivers is not restricting the ability of terminally ill patients from the right to try. During the period of October 1, 2014 to September 30, 2015, the FDA considered a total of 1262 compassionate use requests and granted a total of 1256. A total of 6 requests were rejected. The benefit provided by the FDA through the granting of these waivers was that there was oversight and analysis of dosage levels, safety and efficacy for the patient that was granted access.
In his efforts to advocate against the potential disaster associated with the passage of the right to try laws, Richard has pointed out that if Congress were to pass one of these laws valuable data associated with the ability of all patients facing terminal illnesses would be lost. More importantly, the FDA would not be able to monitor or review negative effects of the administration of the drugs to ensure that citizens are protected. For children with cancer, a significant concern is that right to try laws actually reduce the potential number of drugs being developed for pediatric indications.
As the new congressional term gets underway, the right to try laws are being floated through the halls and no doubt will attempt to make their way to the floor of the House and Senate for a vote. Max Cure will be front and center in the fight to ensure that the truth about the negative impact of these laws is fully understood in the greater context of drug development and oversight. With the removal of emotions, mainly from those like the Goldwater Institute that create the fiction that patients are not provided access to “lifesaving” drugs, we will advocate to ensure that drugs and therapies are developed and moved forward in a safe and effective manner.
Ultimately, Max Cure’s advocacy efforts against right to try laws, as well as those efforts aimed at raising awareness of the lack of pediatric cancer drug development, are being marshaled by Richard, a trial lawyer with over 40 years of legal experience and Max Cure’s executive director Jonathan Agin, himself a lawyer with 17 years of legal experience. Max Cure’s advocacy mission moves quietly often times but when there is a need to roar loudly, we do so through the trusted guidance of two of the fiercest advocates in the land.