Clinical Research with COVID19: An Interview with Christina DiArcangelo

Narrator: This is the DarshanTalks Podcast. Before this episode's interview with Christina D'arcangelo on clinical research with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, April 23rd, 2020. Darshan: It's been a really interesting week again and COVID has done everything to make it more interesting. For example, there are some articles out there talking about how COVID is now stalling clinical trials for everything except COVID. There have been some discussions that patients themselves aren't even coming to the hospital because they're afraid of getting COVID, so the question is where are these patients going that don't have COVID-like symptoms. A lot of people are saying that they're actually either just passing away at home. Others are saying that this is impacting the actual clinical trials, so that's an interesting, unexpected result of COVID. So keep that in mind as you continue. Darshan: This was also the week in which the Department of Justice announced that Logan Laboratories, Logan Labs, in Tampa, Florida, and Tampa Pain Relief Centers, Inc., a pain clinic also based in Tampa, agreed to pay, along with former executives, a total of $41 million to resolve alleged violation of the False Claims Act for billing Medicare, Medicaid, and Tricare for medically unnecessary urine drug testing. So again, keep in mind that performing a service is not enough. Was there a good reason for the service itself? Darshan: This week, the EEOC, the Equal Employment Opportunity Commission, also put out some rules and put out some information around what they consider important for the purpose of the Coronavirus. So if you have some questions about that, feel free to reach out. I'd be happy to send you the link to that. Darshan: This was also one of those weird weeks where they announced unusual things. In Nebraska, a pharmacist was arrested for an alleged conspiracy to use explosives, specifically Molotov cocktails, to firebomb and destroy a competitor pharmacy. That just seems unusual. That's sort of not the point of this. So I just thought that was interesting to note. Darshan: Also, on April 16th, Novartis lost its bid to toss a former employee's revised False Claims Act suit after New York, sorry, a New Jersey federal judge said that the ex-worker's alleged conversation with his boss supported claims that he was fired for objecting to a potential kickback scheme involving express scripts. So stay tuned. This should get interesting. Is Novartis in trouble again is something we need to look out for. Darshan: As usual, COVID-19 is keeping us interested. The FDA has taken the unusual step of allowing compounding of necessary hospital drugs for COVID-19 and this includes drugs like Cisatracurium and Precedex. There are a bunch of them, including Fentanyl and Furosemide, et cetera, so keep that in mind. That should be interesting as the days come through. Darshan: Again, the FDA is also taking other unusual steps. They've said that developers can release digital products for psychiatric disorders without a 510 K Submission during COVID-19. That's going to be interesting because that changes the expectation of requirements around COVID-19. The guidance that came out and it says that this device availability may increase patient access to digital therapeutics while individuals are following stay-at-home orders orpracticing social distancing without the need for in-clinic business during the COVID-19 public health emergency. Remember, this basically is for a limited period. You may still need to go back, so stay tuned. You might be able to reach out if that's something you have, feel free to call us. Darshan: April is also the National Minority Health Month and that actually talks...