COVID-19’s Impact on Patient Centricity: an Interview with Deborah Collyar

Narrator: This is the DarshanTalks Podcast. Before this week's episode, COVID-19's impact on patient centricity, an interview with Deborah Collyar, Darshan will introduce this episode with the recap for the week of Thursday, April 16, 2020. Darshan: So as usual, this has been a very busy week. COVID has kept its control over the news for the most part. But that's not to say that it hasn't been busy for other things. So we're going to discuss some of the conversations that are happening in other areas but that seem to have COVID ramifications or that COVID seems to be influencing in some ways. One of them is the idea of false promotion. The FDA basically came out on April 8th, and they sent out an update saying that there was a seller who was marketing chlorine dioxide products to prevent or treat COVID-19 and that there was no proof to this. That was actually hugely problematic. They were marketing it as miracle mineral solution for prevention and treatment of novel coronavirus disease 2019. Obviously that became problematic. Darshan: The other thing that was sort of interesting, similarly, is Dr. Stephen Hahn, who is a current director of the FDA, the commissioner of the FDA basically. He's the 24th commissioner. They issued a warning letter to Free Speech Systems LLC, doing business as InfoWars, for offering products fraudulently claiming to prevent, cure, diagnose, treat COVID-19, obviously hugely problematic. They were selling things like Super Blue Silver Immune Gargle, Super Silver Whitening Toothpaste, Super Silver Wound Dressing Gel, and Super Blue Fluoride-free Toothpaste, saying that they might help with the treatment or prevention of COVID-19. The FDA took the position that it's within their discretionary authority to stop this, so that was obviously a step in the right direction. Darshan: Interestingly enough, there are concerns that it's not just companies that have their own agendas but also people. And on an April 9th article, Jill Adams, who's a freelance contributor, says that physicians who are self-promoting are hawking unproven COVID-19 pandemic treatments. As usual, it usually starts off with Dr. Oz, but there is some argument that a Dr. Vladimir Zelenko is also doing something similar, which I think is interesting. You probably want to be careful if people who are saying that they have a treatment for COVID-19, because the truth is anyone who had a treatment for COVID-19 would probably be making a lot of money. It's not that the government's just trying to hold off on treatments. If anything, they're promoting off-label things that even haven't been proven yet. So I would caution people and take such statements with a grain of salt. Darshan: To change away a little bit, there have been other changes that are coming on. A lot of marketing changes obviously in general, one of which is the FDA put out a notice on the Prescription Drug Marketing Act. They put out a guidance document saying that they have some guidance on the donation of prescription drug samples to free clinics. That's going to be sort of interesting in the coming weeks to see how this gets incorporated. How should these free clinics that receive donated prescription drug samples be managed, if you will? And the FDA has a guidance on that. Darshan: On April 6th, the Department of Justice announced that Georgia-based MiMedx Group will pay a $6.5 million penalty... I guess it's not a penalty, but to settle civil allegation that the company submitted false pricing data, defective pricing for its human tissue grafts. The settlement involved allegations that MiMedx knowingly submitted false statements and disclosures to the VA regarding their commercial pricing practices, and that enabled MiMedx to charge the VA inflated prices for its human ...