New Opportunities in Telemedicine: An Interview With Anjali Dooley

Narrator: This is the Darshan Talks Podcast. Before this week's podcast, Telemedicine and its New Opportunities, an Interview With Anjali Dooley, Darshan will introduce this episode with a recap for the week of Thursday, July 16th, 2020. Darshan: Hey everyone. Welcome to another episode of Darshan Talks. It's been a really interesting week so far. I am already looking at some new news and it says that the FDA was looking at an Indian pharmaceutical company, Vega Life Sciences, and they were upset that they were deleting data from faulty solvent testing. So again, there's a rule in general that if something isn't recorded, it didn't happen. However, the converse of that is not true, if you don't have it recorded, but if you've deleted it, it doesn't mean that it didn't happen. So keep that in mind. Obviously, that caused some problems for this company. Darshan: The other thing you should probably be looking at is how virtual clinical trials are becoming the new normal. I've done several podcasts that I'm happy to link to in here. Feel free to look at them, but people are talking about virtual clinical trials, and if they're becoming the new normal, are you ready for more of those studies? Darshan: Additionally, if you start looking at data privacy, CCPA is coming into effect and companies are asking whether they can have some delays, especially in light of COVID. However, California is not necessarily changing its mind about its enforcement deadline. Darshan: There are some other interesting issues. For example, there is a question about using the homeless population in phase one drug trials. And that borders on unethical. I'd love to hear your thoughts and comments on whether it's unethical to use homeless people in phase one drug trials, even if they want to be part of it. Similarly, there was a Washington Post article on a patient's experience in the coronavirus vaccine trial. And the reason I find that to be interesting is the fact that it reminds us that patients continue to talk even when the trial is on, so there's a whole discussion about, well, what happens if they unblind the study mistakenly? What is the impact of that? Well, patients are talking, whether or not you choose to accept that, it's still happening. Darshan: There's another writeup out there about this gentleman who was a sales rep for Novartis in 1999 and he ended up actually bribing doctors and wearing a wire for the feds. So for those of you who think that no one's listening, someone in your own office could be the one listening if you're behaving unethically. Darshan: There are some discussions about what happens when COVID meds come out. Bill Gates thinks that should go to those people who need it, not the highest bidder. The question is, who needs it? Is it the patients? Is it caregivers? Is it healthcare practitioners? Or is it the rich guy who can afford it? And obviously Bill Gates doesn't think it should be the richest guy, or woman, obviously. Darshan: There is an interesting article out there from UMass where a professor examines the ethics of biomedical research on soldiers. And that's always been an interesting conundrum. Can soldiers truly give informed consent? What does that look like? Is it a violation if your superior officer asks you, well, orders you to do it? Can you say no? Darshan: Additionally, there was a discussion about whether bioidentical hormones that are compounded are safe and efficacious. And it turns out the FDA did some research and they aren't happy with the evidence so far. So stay tuned about what this actually looks like in the future. Darshan: I may have discussed this before, but keep in mind that several companies are coming out and they're talking about whether they want to work with ...