DarshanTalks Podcast

Narrator: This is the Darshan Talks Podcast. Before this week's podcast, Is Off-Label Marketing by a Pharma Company a Bad Thing?, Darshan will introduce this episode with the recap for the week of Thursday, June 11th, 2020.

Darshan: As the stock market might tell you, we're starting to come out of what would normally be thought of as the depths of COVID. We're now starting to see regulatory agencies take the position that crisis, while it's still upon us, the balance has shifted from availability to making sure that products are actually safe and effective. The FTC just sent out 16 multilevel marketing companies a warning letter about coronavirus and essentially saying that they're making unsubstantiated claims. Apple has decided to start sharing COVID screening data with the CDC, which raises some privacy concerns, obviously. But, it's kind of interesting to start thinking about it. 3M sued an Amazon seller over fake N95 masks. Customs officers seized 10,000 coronavirus face masks in Philadelphia.

So, what we're really seeing is this trend of, okay, we know that we now have to live with COVID, how do we make sure that the products that are out there are safe and effective? What has also happened is that, we're starting to see the FDA start taking learnings from the pandemic, essentially. And Dr. Stephen Hahn, the head of the FDA, the FDA commissioner, has suggested that lessons learned during the pandemic will lead to permanent improvements at the FDA in process and policies. So they're starting to work with non-traditional manufacturers to increase the national stockpile of ventilators and personal protective equipment. And upwards of 100 emergency use authorizations were issued for the evaluation of new tests, devices, and potential therapies. In the same way, in the case of a public health emergency, the risk/benefit decisions were not as robust as usual, which meant that new data was incorporated, and the FDA is now revisiting some of those decisions to protect consumers from inaccurate tests.

Obviously, he remains sure that the FDA has measured up. I'm not sure I necessarily saw that when I was looking and talking to people. There seems to be a very high level of false positives, and potentially a bunch of false negatives as well. But we'll find out as the analysis starts happening.

The FDA also has expressed a general interest in allowing decentralized clinical trials. And they're talking about using more telemedicine for clinical trial participants. The question is, will this translate over into opioid and narcotic tests, which have had complications with telemedicine?

So if you are looking at what that means, state tuned. Obviously, the FDA is still looking at what they found so far. The FDA also started doing some of their own analysis for fiscal year 2019, and they identified that there was an 8.6% decrease in the number of drug manufacturing sites. So it went down from 4,676 in 2018, to 4,273, despite 382 new sites being added. And that was allegedly because of manufacturers that had no application products such as over the counter drugs and homeopathic products.

There was also a drop of inspections and compliance, and the investigators performed 1,258 drug quality surveillance inspections in 2019, from the 1,346 in 2018. So again, the question is, what's going on there from a manufacturing viewpoint? They did say that based on 10 point inspection score, the overall average for inspections in fiscal year 2019 was 7.4, with the average scores for the U.S. being higher than the rest of the world at 7.7-7.6. On the other hand, China had a score 7.0. And India and Latin America had scores of 6.8. Which really speaks to the level of quality that these countries need to start developing on.

Darshan: As some of you may have discovered I have an interest in art and in expression, and this podcast is going to talk a little bit about five artists whose installations involve pharma. The first artist is Robert Porzynski and he described his art as "My paintings are continuation of 20th century artists' traditions, serialism, objective and non objective abstraction, and the syntheses of these different visual languages continually lead to new and unexpected outcomes." His collection is called Pharmaceuticals. The second artist is an artist called Dominic Esposito. And Dominic is very interesting because he was responding to the opioid crisis, which is still ongoing. However, it seems to be caught up in what's going on with COVID. And what he did was, when the Sackler family was found to be heavily involved in the opioid crisis, he left what he described as the opioid spoon outside one of their facilities.

Darshan: And the impact of that was that it was seen by the entire world, and he was reacting to his own personal pain associated with the opioid crisis. And he described the opioid spoon as a dark and macabre symbol of hopelessness. And he left at the entrance of Rhodes Pharma. And I just thought that was a really interesting and moving piece. The third artist, and I seem to have a bend, to be fair, around pop contemporary art, so you may find that to be interesting. Beverly Fishman is the third artist I was thinking of, and she is a visual artist whose work explores the rule and representation of pharmacy and the pharmaceutical industry in contemporary culture. She creates sculptures, paintings, large construction installations with hyper saturated colors, and industrial like slick surfaces that evoke the design of pills, the combinations of drug cocktails, and the colors in the surfaces of drug advertising. She also comments on drug over-prescription and the dependence and the ways medications not only treat but define illnesses.

Darshan: So we've got three artists so far, Robert Porzynski, Dominic Esposito, Beverly Fishman. The fourth one is an artist called Ben Frost, and he's an Australian pop artist. And what he did was he took these boxes associated with these different drugs and actually painted on them and drew on them. And he took generic and brand named Valium, fentanyl, morphine, Oxy, Viagra, and other popular packages, if you flattened them, embellish them with acrylic paints in pop art, Lichtenstein inspired women, retro looking illustrated children, and pop culture characters from the Simpsons and Peanuts. I think that's kind of interesting. It's commentary almost. And the fifth one... So we've got Robert Porzynski, Dominic Esposito, Beverly Fishman, Ben Frost, and the fifth one is Damien Hirst. And if you're in the world right now around contemporary pop art, his work is very, very popular. He has several pieces and he's, he's pretty obsessed with pharmacy and pharma.

Darshan: He has a piece called Pharmacy, which is a room-sized installation representing a pharmacy. It was conceived as a site specific installation, and initially showed at the Cone Gallery in New York in 1992. He used glass fronted cabinets of the type found in a lab or hospital, stacked with pharmaceutical drugs as well as well as other objects, and he arranged them on shelves. So essentially it looks like a pharmacy when you look at it. He also did sculptures of 100 milligram Viagra tablets, and he had some [inaudible 00:03:49] bottles and [inaudible 00:03:52] syrup, et cetera, et cetera, et cetera. And they went from anywhere from $4,000 for additional 30, all the way to $30,000 and even a lot more. A set of 30 Warhol S prints depicting 30 milligrams morphine sulfate immediate release was also put out.

Before this week's interview with Kelly Willenberg on marketing events as networking tools in the life sciences, Darshan will introduce this episode with a recap for the week of Thursday, May 28th, 2020.

Darshan: So, as usual, this has been a busy week for COVID, and we'll talk a little bit about what are the updates in COVID based on what the FDA is doing. The agency took this opportunity to put out a guidance document called Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. It came out in March, and it talks about information on reporting serious, adverse events amongst patients with COVID-19, and this obviously impacts clinical trials on developing therapies, also for non-covered conditions. This also looked into real world evidence and real world data, and the FDA actually created a partnership with a private company, and they believe that data sources such as electronic health records, insurance claims, patient registries, and lab results, will be used to inform the national response to the COVID-19 pandemic. So, this is great.

Darshan: This obviously raises some privacy concerns, so we should be careful about that and to see what the impact of that is going to be. If you are going to be subject to it, something to consider is HIPAA privacy issues.

Darshan: The next question to look at is questionable test performance. And there are concerns that the COVID-19 diagnostic tests by Abbott ID NOW point-of-care test, it may result in false negative results. And the problem with this is a lot of people are using these tests as FDA-approved. They're, in most cases, never FDA approved. They're sort of permitted to be on the market. The question to then take is, if there's a high enough level of false negatives, you're now looking at problems of people who tested negative, still have the symptoms, and are now spreading it, because they have this false sense of security.

So, are the rapid actions of the FDA in the public interest or are they actually falling out of the public interest? And the FDA is, without a doubt, in a very tough spot, but obviously it becomes the question that they need to evaluate. And these are judgment calls. That doesn't mean that the FDA is sort of only looking at approvals. This is also the opportunity where the FDA is looking at shitty products. There are multiple groups that the FDA is sending notes to. They're working sometimes with the FTC, sometimes alone, and sending letters to companies such as Energetics, Noetic Nutraceuticals, Golden Road Kratom, White Eagle Native Herbs, and Benjamin McAvoy, an Amazon associate firm. And these were all making claims that they could cure or treat COVID-19, which is obviously problematic.

Darshan: If you have questions about what COVID-19 means to you, if you think I missed an important bit of news, feel free to reach out to me, or leave a comment, or hit the subscribe button.

Darshan: One second here. I'm almost done looking at something here. Sorry for the delay here.

Kelly: No problem. Hey Kelly.

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have Kelly Willenberg from Kelly Willenberg & Associates. I've known Kelly for a very long time, and we've been to many, many conferences together. We've worked together, and she is generally awesome. So she has my vote of confidence, if you will, but I'm really excited to have her on because she has some really unique perspectives to share. We're going to land up talking a little bit about conferences and we're going to land up talking about how those conferences are changing in this world of COVID and what the impact of that is and how we engage going forward. Kelly, you want to talk a little bit about what you do and how you work i...

Darshan: So now that we've reached a stage in the COVID virus situation where people have been at home the whole time, they've been drowning in their own thoughts. And this has been a time when mental health practitioners are questioning the impact on individual health. Here are five artists who are inspired by mental health conditions.

Darshan: The first is Jayoon Choi, and this person has created this art piece called The Bottom of the Anxiety. "There's a moment when you can't help but sink deep down, attacked by spiteful thoughts, 'Oh dear, I was the monster.'" So, it's when you start attacking yourself, that's what mental health conditions often feel like.

Darshan: Your Pain is My Pain by Paula Scotter. And this represents the dysfunctional patterns in relationships as the expectation that if you put someone else's needs before your own, somehow this will make you happy. You allow yourself to be treated badly and have fewer boundaries. And then you wonder why you feel so hurt and alone. And again, that reminds me of relationships I've been in. And right now with these close quarters, I imagine it feels familiar to a lot of people.

Darshan: The third artist is an artist, Emma Haddow. And she created a piece called Tiger Shark And Me Sit Down For Tea. And she describes her piece as, "I've struggled with anxiety and depression since I was a teenager. There have been times when it has crippled me and I was afraid of everything. I started to face my fears, my demons head on, and I still do. It's scary in the dark, but what's more scary to me is denying and suppressing what lurks beneath the surface. My mental health is good these days. My dark days are still here, but I no longer turn them away."

Darshan: The fourth piece is called Depersonalization, by Morgan Paige. So she responds to this by saying, "I drew this after I realized that I was experiencing episodes of depersonalization. I had been experiencing them for a while, but I never knew what it was. Once I found out that it had a name, it all made sense. It feels like you're detached from yourself. The head could eventually be reattached and I could feel like myself again."

Darshan: So you have four pieces so far is, At The Bottom of the Anxiety Swamp by Jayoon Choi, Your Pain Is My Pain by Paul Scotter, Tiger Shark And Me Sit Down For Tea by Emma Haddow, Depersonalization by Morgan Paige. The fifth one is a piece called Mind Vomit. "And this represents the daily conversation within my mind. Anxious thoughts, depressive thoughts, sub thoughts and thoughts about the thoughts, constant critical commentary and a tornado of darkness, numbness, and complete inner turmoil." So those are top five artist works inspired by mental health conditions. If you think I missed any pieces, feel free to leave a comment. If you think that there are artists that I should have talked about, please feel free to leave a comment. If not, just hit the like button.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast. With host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Narrator:

This is the DarshanTalks Podcast. Before this week's interview with Deena Bernstein on starting a super successful trial site, Darshan will introduce this episode with the recap for the week of Thursday, May 21st, 2020.

Darshan:

This week has been an interesting week from a news perspective. Things seem to be taking a turn, companies that were investing into vaccines saw a potential return because there was hope, and the hope then got snatched away. However, I've been speaking to other companies that are all talking about bringing some version of vaccines or therapeutic products to the market. So the general rule seems to be that companies in the life sciences still seem to be proceeding exactly the way they wanted. However, they are in some senses looking forward to accelerating as soon as the market's opened up in terms of the coronavirus allowing people to move around.

Darshan:

However, this has also resulted in some ramifications to companies that you hadn't considered. The event market for example. I did a podcast recently with Kelly Willenberg, who's going to talk about some of the experiences around marketing using events. So stay tuned for that. It's been a really interesting couple of weeks especially going from no changes all the way to seeing some hope and seeing that hope snatched away, and that is science. If this is not the example of how science actually proceeds, I don't know what is. People expect that the first drug you try works, people expect that the first vaccine you create might be ideal. And obviously everyone hopes that that's what it is. The entire world is literally looking forward to that. However, sometimes that doesn't quite work out. And I'm hoping that for all of our sakes, things get back to normal quicker. Events and event planning companies themselves are being hurt however, and it has resulted in the opportunity to talk to multiple people, there have been more zoom meetings.

Darshan:

So, overall what I've got is that, from a compliance perspective, this is a really good time to look back at your own efforts and take a step back and evaluate if all the steps were in place. If there weren't, you need to consider about why they weren't in the right places and fix those changes. If there's something else going on, maybe this is the opportunity to look back at your audit program and evaluate things that, the last time you did the audit you found problems. If you have questions, if you have concerns, feel free to reach out to me at, [[email protected] 00:02:34], that's [email protected]. I'd love to talk to you further.

Narrator:

This is the DarshanTalks Podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at, darshantalks.com

Darshan:

Hey everyone. Welcome to another episode of DarshanTalks, we have a special guest, we have Deena Bernstein. And Deena has 20 years of clinical research site operations experience. She joined Circuit Clinical Solution on August 2019, and is a senior strategic advisor, very impressive. [crosstalk 00:03:12]. She's actually helping with one of their products and she'll talk a little bit about that as well. What I love is also just her raw expertise. She started at Sheridan Clinical Research and helped create and develop a research program which supported an organization of over 6,500 physicians nationwide, which deployed research. Her last gig was VP of Qcare IQVIA, where she developed and operated the first SMO from the ground floor. She onboarded Qcare's first eight sites, and built the infrastructure for the business unit. She is a founding member of ACRP in Southeast Florida, she is part of WIN,

https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep187_top5-academics-twitter-covid19.mp3

Darshan: Here is the list of the top 10 academics that you should follow to learn about COVID-19. The first is, @ChangingtheWorld. That's Steffanie Strathdee, who is the Associate Dean of Global Health at the University of California, San Diego. The second is @aetiology. I'm used to seeing it pronounced as etiology, but this is the other version, I guess. She is professor at Kent State University, and that's Tara Smith. The third is Florian Krammer, who is the professor at the Icahn School of Medicine at Mount Sinai. The fourth is Marc Lipsitch, who is the director at Harvard Center for Communicable Disease Dynamics. That's @mlipsitch. The fourth is Tom Inglesby, who is the director at the Center for Health Security at Johns Hopkins Bloomberg School of Public Health. That's @t_inglesby. Then you could follow Ashish Jah, who is the director of the Harvard Global Health Institute, @ashishkjha.

The next person to talk about is Devi Shridhar, who is the Professor and Chair of Global Public Health at Edinburgh University Medical School and the Director of Global Gealth GP. She can be followed @devisridhar. You could also follow Sandro Galea, who is a doctor, a scientist, and Dean and professor at Boston University School of Public Health. He can be followed at @sandrogalea.

Then you have Jeremy Konyndyk, who is the senior policy fellow for the Center of Global Development. And he can be followed at @jeremykonyndyk. And then to round off, number 10 is Dr. Alison Bateman House, who is... She actually is responsible and helps with history and ethics of research on humans, access to investigational meds, and she can be followed @abatemanhouse. That rounds out to your list of 10 people who are academics that you should follow to learn about COVID-19.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshawn Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshawntalks.com.

COVID-19 has reshaped our daily lives, but how has it affected healthcare? Join Darshan Kulkarni as he talks with health IT expert Emmanual Fombu about some major changes happening in healthcare due to the pandemic. We'll talk about how the pandemic has resulted in an increase in demand for telehealth services and virtual clinical trials, and how long this trend might last.

Narrator:

This is a DarshanTalks Podcast. Before this weeks interview with Doctor Emmanuel Fombu on COVID-19's impact on telemedicine, Darshan will introduce this episode with a recap for the week of Thursday May 14th, 2020.

Darshan:

So this has been a bit of a slow week. People have been talking about COVID and people are starting to get restless, but I've done a bunch of different podcasts and the big takeaway has been that COVID is affecting how we're going to do business. I can think of three very clear ways COVID is going to affect business. All of them are not necessarily game changers as much as COVID has accelerated the direction of where we're going.

Number one, I think we're going to end up with more virtual working. And that means that your employees may not be sitting out of your office anymore, they may ask... No, no, no, they may demand that they sit out of their own houses, do their own work at their own time. So that, it's the end of your traditional 9:00 to 5:00 because little Johnny still has to go to school and he comes back at three O'clock and the mother or the father taking care of them wants to take that time off, take care of little Johnny, get him settled in and then go back to work.

The second thing we're looking at is an acceleration into decentralized trials. I've had a bunch of different conversations, and the big takeaway has been that decentralized trials are here. The question is, will they say? And I think that there's an argument to be made, that based on the investments that are taking place, decentralized studies will start making more of a footprint. I would be surprised if the decentralized trials go as quickly as people are expecting, not because they don't mean as much, but because all the investments aren't completely there yet, which means that, it becomes a nice add on, but I don't see it becoming a here-to-stay for the next year to two years at least.

Stay tuned and reach out to me if you think that I'm wrong about this. I could be wrong, leave a comment. The other thing that I think will be here to stay is this idea of patient centricity. And patients have now started looking online, and we've always been looking online for information, but patients are now going to say, "I want to be able to handle my life in the way that I want to handle it." And with that comes the concept of telehealth, with that comes the idea of how does one reach out and be understood by your clinicians, by your clinical trust staff in a way that meets them on their own terms. So, those are my big three take aways.

Another sort of bonus take away, is the fact that Zoom meetings, GoToMeetings, the other different formats out there on connecting virtually are likely here to stay. Companies are already talking about reducing their office footprint, companies are already discussing what are better ways to engage? Jeff Morgan actually came on here and said that they were going to reduce their footprint.

So if all that is true, the big question is going to become, how do I look professional when I'm in my own house? How do I make sure that my walls are clean? How do I make sure that my outfit doesn't clash with the Zoom background? How do I make sure that I stand out and look professional? There have been instances where people walk away from their Zoom meeting without their pants on,

Darshan: This is the list of top five LGBTQ leaders on Twitter, who you should follow to learn about COVID 19. Number one, I don't know if they themselves identify as LGBTQ or they see themselves as allies. And I also don't know ... Well, I wouldn't say that you're following them necessarily for the medical information, as much as some of the other information that may become relevant. The first person to follow is Dr. Rachel Levine, who is @SecretaryLevine. She is the Secretary of Health for the Commonwealth of Pennsylvania, and she is a transgendered individual and she is leading Pennsylvania's COVID 19 response. The second person to follow is Dr. Ron Holt, and he can be followed @DrRonHolt. He is a psychiatrist who is passionate about spreading awareness and support for the LGBTQ community. The third person to follow is Mark Plondon, and he is interested in social intersectional factors. He is a sexual health and HIV physician. He looks at the health and wellbeing if LGBTQ and other minorities. And you can follow him @markrplondon.

Darshan: The next person to follow is Kevin Imrie. You can follow him out @kimrie. And he is a medical educator, a hematologist and a physician and an LGBTQ advocate. And the last person on my top five LGBTQ leaders on Twitter list is a family physician. She's on various editorial boards. She focuses on digital health and LGBTQ care. Her name's Dr. Natasha Bhuyan, B-H-U-Y-A-N. And you can follow her @NatashaBhuyan Again, I don't know if any of them individually identify as LGBTQ or they may not necessarily identify, but they are leaders in the community and worth following.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter at DarshanTalks, or the shows website at darshantalks.com.