What would you do to save your sick or dying child?
For Aimee Hardy, mother of Josh Hardy, a young boy who sadly passed away at the age of 10 on Sept. 22, 2016, the answer was, and probably still is, everything. The story of Aimee Hardy and her social media efforts targeted at the biopharmaceutical industry are worth revisiting, for within are a number of teachable moments.
One Of The First Biopharma-Focused Social Media Controversies
Before the likes of Martin Shkreli, there was a social media firestorm that engulfed a biopharmaceutical company. Here’s a brief recap. In January 2014, Josh Hardy, a 7-year-old cancer patient, had a bone marrow transplant at St. Jude Children’s Hospital in Memphis, TN. Unfortunately, following the procedure Josh developed a number of complications, including an adenovirus infection that resulted from him having a compromised immune system. The doctors of St. Jude, having previously participated in the Phase 2 clinical trial exploring the activity of an experimental drug (brincidofovir) against adenovirus, believed this might be the only thing that might save the boy’s life. They recommended Josh receive the experimental compound under expanded access (i.e., a program that provides for the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediate life-threatening disease or condition who has no comparable or satisfactory alternative treatment options). Expanded-access requests by St. Jude to Chimerix, a 55-person company working to develop brincidofovir, were denied in both February and March. As a result, Aimee Hardy, Josh’s mother, took to social media to plead for help. Her Facebook post on March 6, 2014, fanned the flames of an anti-biopharmaceutical company firestorm the likes of which had not previously been seen, and expanded the issue to mainstream media. . Squarely at the center of this controversy was Ken Moch, then CEO of Chimerix, who received death threats (for not granting compassionate use of brincidofovir to Josh) that warranted the use of around-the-clock armed guards to protect him and his family.
So why this negative trip down memory lane, especially around the holidays?
Well, Moch, a member of Life Science Leader magazine’s editorial advisory board, sent me an article he recently published — Ethical crossroads: expanded access, patient advocacy, and the #SaveJosh social media campaign, Med Access @ Point Care, 12/14/2017. The peer-review journal article is 12 pages long (two pages devoted solely to references), and details the whole story, including the company’s expanded-access program that began back in March 2009. And since the words “peer review” might discourage many from reading this article, especially during a time when many of us are pressed for time preparing for JPM and the Biotech Showcase in January 2018, I thought I’d summarize what Moch covered.
For Biopharmas, Sometimes No Good Deed Goes Unpunished
The first compassionate use of Chimerix’s brincidofovir happened in March 2009, when the company provided the compound in an effort to help save a soldier who, after receiving a smallpox vaccination, had a life-threatening breakout of the vaccinia virus. After this event, along with the publication of the event by the CDC in May 2009, interest in and request for brincidofovir grew, leading to a significantly expanded-access program by Chimerix. Beginning in September 2009, the company received approximately 50 requests over a nine-month period for brincidofovir. In the next three months the company received an additional 50 requests, resulting in the FDA requesting Chimerix establish a formal “intermediate size” expanded-access program to be listed on clinicaltrials.gov. In February 2011, the company received an $88.1 million contract from the Biomedical Advanced Research and Development Authority (BARDA), a portion of which was to pay for the 200-patient clinicaltrials.gov expanded access protocol toward gaining insights into emergency situations analogous to a potential smallpox outbreak.
By late 2012, Chimerix, then a private company without any sales revenue, had provided expanded access to brincidofovir to about 430 patients (215 individual requests, plus 215 under the BARDA program). The company made the decision to discontinue its expanded-access program at the end of 2012 in order to focus its limited resources on gaining FDA approval for brincidofovir. Nonetheless, the company received 300 additional expanded-access requests, and in some cases, external pressure was applied for Chimerix to make just this “one-off” exception. But as a matter of course, the company took the approach that it should be either yes to all, or no to all, for why should one patient who happens to know someone of influence be more deserving than another.
Should Media Be Kept At A Distance During A Crisis?
But then in 2014, Aimee Hardy’s Facebook post that accused Chimerix of not being willing “to save a child’s life for money,” was just the type of underdog story, pitting a helpless family against an evil biopharmaceutical company, that major media outlets couldn’t help but get behind. Some of headlines included:
On March 9, 2014, CNN Anchor Deborah Feyerick introduced an 8-minute segment on Josh Hardy and the family’s request for brincidofovir by saying, “Incredible to think that a drug company has something to help and won’t give it out.” CNN Senior Medical Correspondent Elizabeth Cohen added, “It just breaks your heart to say he is in heart failure and he is in kidney failure. Now, I know you think – all of us think, why can’t they just give this little boy this drug? It’s called compassionate use. When a drug is being studied, a company can give it out.” Moch states, in the face of the growing storm, he attempted to explain the ethical dilemma Chimerix faced, but his efforts did not quell the rising uproar. One expert noted that whenever you have 140 characters to describe a complicated medical decision, its going to be oversimplified – “There’s a dying child, why won’t the drug company give the drug?,” and any nuance, even if present early on, rapidly gets rubbed out.
In emails (to me) about the experience, Moch says he pursued a strategy of open communication with all members of the media, even when certain reporters overtly misrepresented the content of their conversations. “I answered any and all calls from print and TV media and spent dozens of hours on the phone explaining the ethical complexities of the situation,” he wrote. “But for the most part they didn't listen to or care what the Chimerix position was, as it didn’t match with the ‘evil pharma company’ story line being played out.” When invited by CNN to do an on-the-air face-to-face discussion with Aimee Hardy, Moch declined, feeling it would not to be an appropriate venue to have a meaningful discussion. “In many situations, members of the media will ask questions and ignore your answers in order to write statements supporting their positions,” he noted. “It was only after the media frenzy had subsided that the ethical issues and complexities began to be discussed.”
This is a point Moch shares when giving talks (of which he has now done over 30) about his experience. “Earlier in my career I studied crisis management, and one of my primary influences was the vice chairman of Burson-Marsteller, a person who had been the primary external public-relations advisor to Johnson & Johnson during the Tylenol crisis of 1982 and to Union Carbide during the Bhopal, India, industrial disaster of 1984,” he shared. “Looking back at those formative discussions, there were many relevant points to the Chimerix crisis communication strategy:
When Given Lemons
There is much more to be learned from reviewing Moch’s most recent article. For example, during the crisis faced by Chimerix, the chairman of the MaxCure Foundation, Richard Plotkin, an advocate for Josh Hardy’s plight, is known to have stated, “I was going to get this kid the drug or I’d destroy Chimerix and Ken Moch.” And despite the company, Moch, and the FDA working furiously to develop a solution that did result in Josh Hardy eventually receiving the medication (which worked), and Moch being the one ending up out of a job, he didn’t sulk and disappear into the shadows when becoming an “accidental ethicist,” but embraced it.
Since moving on from Chimerix he has served on panels, given seminars, and taught classes with Richard Plotkin, the same man who once considered Moch to be his #1 enemy. He has coauthored articles with Arthur Caplan, Ph.D., NYU professor and leading expert on bioethics, which have helped shape how other companies approached expanded access (i.e., Johnson & Johnson). He has been active in voicing concerns around the Right-to-Try movement and pending legislation, and proponents who advocate for distribution of experimental medicines outside the FDA’s purview. And though Moch became CEO of Cognition Therapeutics in October 2016, he remains active in tackling ethics and serves as the current chair of BIO’s BioEthics Committee.
So, how will you respond when social media tools like Twitter and Facebook target you, your company, or your positions? Will you embrace the opportunity to shape the message, or will you continue to do what has always been done, yet expect a different result?