Beyond Josh Hardy
On July 22nd and July 23rd 2015, CBI.net held an industry conference in Bethesda, Maryland, identified as “Expanded Access Programs.” In attendance were representatives from the pharmaceutical and biotech industries, health care providers, patient advocates, government personnel [FDA], and Max Cure Foundation’s, Vice Chairman, Richard Plotkin.
On the 22nd, Richard was on a panel discussing the issue of “Patient Perspective on Compassionate Use and Early Access to Life-Transforming Treatment,” along with a representative from Abigail Alliance for Better Access to Developmental Drugs and one from The Leukemia & Lymphoma Society. On the 23rd he gave a presentation on the issue of “Social Media – Leveraging the New Channel for Advocacy, Access and Awareness.”
The issues covered related to the need to address giving terminally and seriously ill patients investigational drugs not yet approved by the FDA for marketing. The conference was promoted with respect to the changes resulting from government action relative to expanded access/compassionate use (recent legislation) and with respect to the global attention given to the issue of expanded access/compassionate use as a result of the Josh Hardy matter.
The promotional material for the conference goes on to say, “Never has this meeting been more timely or critical.” Hence, industry recognized the changing landscape in the field of expanded access/compassionate use, especially for children with cancer who do not have access to timely clinical trials.
Richard’s role in the Josh Hardy matter has been covered at length in prior blogs. However, as the impact of what was accomplished for Josh gets more and more public attention, Richard continues to receive accolades from many varied sources. In addition to being asked to give presentations to audiences from different backgrounds (medical, business, philanthropic and so on), he has been interviewed on National Public Radio and on CBS Radio, both programs being broadcast throughout the country, as well as being highlighted in print media. The latest was an article appearing in the Boston Globe Magazine on July 19th where the Josh Hardy matter was discussed in detail. The author, in discussing the role of Richard, stated:
“The family was introduced to Richard Plotkin, [characterized in the article as “an aggressive patient advocate who masterfully choreographed a PR siege against the company”], a former litigation lawyer who heads the Max Cure Foundation, which he founded after his grandson was diagnosed with lymphoma. With the same relentless energy once deployed in the courtroom, Plotkin plunged headlong into the Hardy cause, directing its PR campaign. ‘Josh was akin to my grandson, and if Chimerix withheld the drug, Moch and Chimerix became my enemies,’ Plotkin says.”
After denying over 300 prior requests for the experimental drug, Brincidofovir, between 2012 and March of 2014, and as a result of the effort led by MCF, Chimerix agreed to give the drug to Josh as part of a hastily formed phase 3 clinical trial for children with the life threatening Adenovirus, with Josh being the first patient.
The drug appeared to have saved Josh’s life (Josh is alive today, 1 ½ years following his receipt of the drug). Nonetheless, Ken Moch, former CEO of Chimerix who agreed to give Josh the drug, was fired by Chimerix for doing so less than 30 days after the drug was administered to Josh.
Since his firing, Ken Moch has been invited to speak to executives at upwards of 30 pharmaceutical companies and bio-tech firms who were fearful they might be the next “Chimerix” having to face a similar social media onslaught that had been orchestrated by Max Cure Foundation in the SaveJosh campaign. They wanted to better prepare for that contingency. Mr. Moch was asked at those meetings what the difference was between the prior over 300 requests for the drug that he turned down and the issue with Josh that caused his firing. His answer, as reported by him, was consistent, “Richard Plotkin.”
Since the Josh Hardy campaign, the phase 3 clinical trial for 20 children, with Josh as the first patient, has been expanded to 200 patients, mostly children, each of whom has the Adenovirus coupled with a compromised immune system. The results so far of this trial have been encouraging with what appears to be the reduction in the mortality rate for the enrollees being reduced from 80% to 35%. What this means is that, assuming 200 patients, it was expected that 160 (80%) would die from the Adenovirus infection. The preliminary conclusions are that the 80% rate was, as noted, reduced to 35%, meaning that of the 200 patients, 70 died (35%).
Hence, based on these preliminary numbers, in addition to Josh, 89 other lives appear to have been saved as a result of the establishment of the phase 3 clinical trial for children. Thus, MCF is credited with not only saving the life of Josh Hardy (now 8 years old), but also of 89 others, mostly children!