Getting Celebrity Testimonials to Push the Envelope for Promising Products    
​[Thursday, July 30, 2020]
Celebrity endorsements and testimonials are a prominent way to market a medical product; our media and airways are filled with drug advertisements featuring famous people. But one could use celebrity testimonials to boost the prospects of an investigational product as well. ImmunityBio, Inc., a California company owned by Dr. Patrick Soon-Shiong, treated two celebrities with its experimental anti-pancreatic cancer combination drug, much before it launched a formal clinical trial for the same. Senator Harry Reid and TV celebrity Alex Trebek were treated with ImmunityBio’s experimental cancer drug under a compassionate program, and both reported remarkable results. The results of their treatment were not published in any scientific journal but released in the media. There are several interesting aspects of this development program by ImmunityBio. The experimental combination drug cocktail contains a new biologic, N-803, co-administered with 4-6 previously approved anti-cancer drugs. N-803 has never been formally evaluated to treat pancreatic cancer, based on publicly available information. The first trial with N-803 was published in 2015 with mixed results, and since then a couple of other Phase 1 clinical trials were conducted with the biologic. The results of none of these studies were widely published but in 2018 the company launched a Phase 3 clinical trial with the N-803-containing combo anti-cancer cocktail, as a first-line therapy for non-small cell lung cancer (NSCLC). The formal Phase 2 trial with the N-803 containing cocktail for pancreatic cancer was launched two months ago in May 2020. The two celebrities were treated sometime last year or earlier this year much before the Phase 2 trial was apparently cleared by the FDA but the news was released only after the Phase 2 trial launch with an intent to create a buzz for the ongoing trial. The news was used skillfully to say something the company can never say in its informed consent for the patients participating in the Phase 2 trial. Because these news reports were by independent organizations; there were no quote directly attributed to the company, assuring that the company need not worry about FDA accusing it of promotion of an investigational product. The celebrities were two of the four patients treated under the compassionate program; we have no news on the other two. Such reports would be scoffed by scientific publications as anecdotal data, likely why the company did not publish them, but would be of great interest to desperate patients looking for any hope. Late stage pancreatic cancer is an orphan indication. Clinical trials in this disease are very hard to recruit due to several competing trials. With the news, the new trial automatically gets a boost over its competition. They may have pushed the envelope but have so far stayed within the gray areas of the law where clinical trials can be promoted directly or indirectly, the way ImmunityBio did.