Stop This Act of Terror!
March 5, 2015
The Highs and Lows of Childhood Cancers
March 13, 2015
As a result of my involvement as one of several members of the Coalition Against Childhood Cancer (CAC2) that played a significant role in saving the life of 7-year old Josh Hardy last March, I am continuing to receive the oft-stated “15 minutes of fame.”
Earlier this month, on March 4th, I was interviewed by Brooke Gladstone for her syndicated radio program on National Public Radio (NPR) called, “On The Media”. The interview will air in New York City (93.9 FM) on March 27th and on 500 other NPR stations around the country following that date. It will appear on line on March 27th.
Ms. Gladstone had earlier interviewed Kenneth Moch, former President of Chimerix, who orchestrated on behalf of the company the formation of the clinical trial that not only saved Josh’s life, but also saved the life as of November, 2014, of 38 other children with compromised immune systems suffering from the identical Adenovirus plaguing Josh. These children were added to the clinical trial following March 12, 2014, when Josh was given the first dose of the drug, Brincidofovir.
Ken Moch was a hero. Chimerix fired him in April – one month following his brainchild of forming with the FDA the phase 3 clinical trial. His firing was presumably for failing to follow company policy of not distributing the drug to others outside the ongoing trials on adults then underway. Josh’s life (as well as the lives of the other 38 children) was saved; Chimerix stock increased in value; and the success of the clinical trial should expedite bringing the drug to market. Ken Moch was “collateral damage.” (Ken Moch will not admit his resignation was forced but there is no doubt in my mind he was).
Back to the interview on NPR: Ms. Gladstone challenged me, suggesting that our efforts in saving Josh slowed down the ongoing clinical trials that sought to bring the drug to market – to save countless lives of others, suggesting that our efforts to save Josh caused the death of others. I told Ms. Gladstone that that issue was never raised with me by Mr. Moch during our two very contentious telephone conversations on March 7th and 10th, 2014, and is not supported by the facts. I referenced not only the 38 children whose lives were saved as a result of the recently started clinical trial with Josh as the first patient but also to the likelihood that the success the drug has shown in that clinical trial ought to have accelerated bringing the drug to market. Hence, saving more lives than otherwise would be the case.
Ms. Gladstone also sought to challenge me on the ethical issue, asking if I thought it was ethical to give the drug to Josh (with the media – cable, network, social and print – being used as a vehicle to accomplish that goal). I interpreted her question to suggest the extraordinary use of the media through my foundation, The Max Cure Foundation, and others was not ethical – getting the word out about this “cute and sympathetic” 7 year old boy in a baseball cap with a compromised immune system and Adenovirus having one chance to live – the unapproved drug manufactured by Chimerix.
I told Ms. Gladstone that it is not fair (or ethical) to favor one child over countless others who will die without the drug and that I wish every child with a compromised immune system who develops Adenovirus could be treated with Brincidofovir – but that is not possible for the experimental drug. I rhetorically asked Ms. Gladstone to assume I was walking on the beach and witnessed ten children being swept out in the ocean in a rip tide to their inevitable deaths. I told her to assume I had the ability to save one of those children but could not get to the child, return her or him to land, and to then venture out again to attempt to save a second, third and perhaps more of the drowning kids. Was she suggesting, I said, that I should keep walking on the sandy beach, allowing all ten kids to drown? That it was unfair or unethical for me to risk my life to save one of the ten drowning children? She did not answer.
I told Ms. Gladstone that when I was asked by CAC2 to get involved, I treated this “assignment” as if it were one of my cases I handled as a trial lawyer over my 40 year legal career that was shortened when Max, my grandson was diagnosed with cancer and when, with my family, we formed The Max Cure Foundation. I told her it was my strategy to make Ken Moch into the villain (all such stories needed a villain – a person to blame for the predicament in which Josh found himself) that was allowing a 7-year-old boy to die (in the face of St. Jude’s strong belief that the drug would save his life – as it did). I told her of my two contentious telephone conversations with Ken Moch and that he hung up on me in the second.
I told her of Max Cure’s 3 day social media campaign (March 9th – March 11th), with Erica Bailey, our social media guru, getting no more than 30 minutes/night of sleep and that our efforts alone in the #SaveJosh campaign reached 1.1 million people on Facebook and 400,000 on Twitter. I told her that the #SaveJosh campaign reached Brazil, France, England, Germany and the Middle East and that I was interviewed by a German Television Station. The millions of folks supporting Josh in the media and otherwise prevailed. Ken Moch was the hero – Ken Moch was fired! The Josh Hardy matter has caused the Government, industry, healthcare providers, ethicists, lawyers and others to revisit how experimental drugs are made available to the public outside of clinical trials.
The interview ended with Ms. Gladstone, saying, “I understand you and Ken Moch are now friends.” I told her I am privileged to call Ken a friend – and that I toasted his efforts over a bottle of Champagne when we met recently for lunch in New York City.
In addition to the NPR interview, on February 26th I was on a panel at Harvard Medical School dealing with the ethical and legal issues confronting society as a result of the Josh Hardy matter – addressing medical students, professors, ethicists and others (including my wife and my law school roommate, a corporate lawyer in Boston) in the packed room – including my new friend, Ken Moch, who attended the forum and was a valuable contributor to the discussion following my presentation to the group on the Josh Hardy matter and the presentation of a person from industry (Novartis Pharmaceutical Company) giving the industry perspective on the issues involving experimental drugs being given to persons outside of a clinical trial. And back in November, I presented the Josh Hardy matter to a graduate class at Texas A & M (Mays Business School). I guess my 15 minutes of fame has turned into 45 minutes – I hope I have not embarrassed myself!
Author: Richard Plotkin, Max Cure Foundation Vice-Chairman
