أفضل بودكاسات Darshan (2025)

1
90. Kristin Weitzel: How to Use Cold Plunging for Ultimate Nervous System Control 1:16:13

4d ago1:16:13

1:16:13

What if three minutes in cold water could give you more confidence than years of therapy? In this episode of Extend, I sit down with Kristin Weitzel, a breathwork expert and cold plunge coach who has certified over 325 instructors worldwide in her approach to nervous system regulation. We explore how to use breathwork to downregulate your nervous s…

1
Should Sponsors Share Site Feedback? 4:53

3d ago4:53

4:53

Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the pr…

1
AI Marketing Playbook for Drug Companies 3:30

6d ago3:30

3:30

AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit? AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data own…

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89. Sara Szal, MD: Why 80% of Women Experience Brain Fog in Perimenopause (And How to Fix It) 55:02

6d ago55:02

55:02

What if the depression, brain fog, and weight gain you're experiencing isn't "just aging" but actually a treatable hormone deficiency? In this episode of Extend, I sit down with Sara Szal, MD, a Harvard-trained gynecologist who has revolutionized how we approach women's health. We dive into why 80% of women experience brain dysfunction during menop…

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Should Sites Be Ready on Standby? 5:24

9d ago5:24

5:24

Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors m…

1
Eastern District of PA Targets Pharmacies 0:43

11d ago0:43

0:43

The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enf…

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88. Ben Azadi: The $4.6 Trillion Healthcare Crisis and How to Reverse Metabolic Disease in 30 Days 38:34

11d ago38:34

38:34

93% of Americans are metabolically unhealthy and don't even know it. In this episode of EXTEND, I sit down with Ben Azadi, metabolic health expert and New York Times bestselling author who transformed his life by losing 80 pounds after facing obesity, depression, and pre-diabetes at just 23 years old. We explore how one out of every four healthcare…

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87. Layne Kilpatrick: The Shocking Truth About Microplastics Destroying Young Men's Hormones 56:44

13d ago56:44

56:44

What if I told you that an 18-year-old athlete had a testosterone level of 26 - when it should be near 1,000? In this episode of Extend, I sit down with Layne Kilpatrick, a pharmacist with over 30 years of experience who has been sounding the alarm about environmental toxins for years. We dive into the alarming decline in testosterone levels, how m…

1
Telehealth Done Right 3:32

14d ago3:32

3:32

The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant unde…

1
DOJ and HHS Launch FCA Fraud Task Force 6:20

17d ago6:20

6:20

In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working…

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86. Tracey Stroup, ND: Why the Ozempic Craze Almost Ruined Peptide Therapy (And How Functional Medicine Got It Right) 52:14

18d ago52:14

52:14

Did you know that functional practitioners have been using GLP-1 peptides safely for years—long before the Ozempic phenomenon hit mainstream medicine? In this episode of Extend, I talk with Dr. Tracey Stroup, a naturopathic doctor and peptide therapy expert, who reveals how the pharmaceutical industry's approach to semaglutide created unnecessary c…

1
Should Sponsors Cover Malpractice Insurance? 4:13

19d ago4:13

4:13

Darshan and Edye tackle a hot topic in clinical research budgeting: Should malpractice insurance be considered an overhead cost that sponsors cover? Edye explains both sides. Sponsors often argue that malpractice is simply a cost of being a physician, unrelated to research. Sites, however, may try to include it—at least partially—as part of trial-r…

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85. Cynthia Thurlow: What Your Doctor Isn't Telling You About Menopause and Metabolic Health 2:05:00

20d ago2:05:00

2:05:00

What if the symptoms you've been told to "just deal with" during perimenopause could actually be addressed? In this episode of Extend, I sit down with Cynthia Thurlow, a nurse practitioner who left traditional cardiology to focus on women's health and metabolic medicine. We explore why the medical system has failed women during menopause, the criti…

1
Instagram Post that Sparked FDA Warning Letter 4:44

21d ago4:44

4:44

In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindication…

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Why Are So Many Doctors Getting Arrested? 4:26

23d ago4:26

4:26

Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the Department of Justice is calling the largest healthcare fraud takedown in U.S. history. In July 2025, federal authorities charged 324 individuals in a…

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84. Dr. Nick Norwitz: Why 'Evidence-Based' Medicine Fails Most People (And What to Do Instead) 23:38

25d ago23:38

23:38

The top 10 grossing drugs only help 1 in 4 to 1 in 25 people who take them. Yet they're still considered "evidence-based" and prescribed to millions. In this episode of Extend, I talk with Dr. Nick Norwitz, who reveals why you can't rely on population averages to fix your individual health problems. We explore why the medical system isn't designed …

1
How to Run Compliant Pharma Speaker Programs 7:54

26d ago7:54

7:54

What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misunderstood but highly scrutinized parts of pharma marketing: speaker programs. These programs typically come in two forms—promotional (to raise product aw…

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83. Dr. Joel Kahn: Why Most Cardiologists Are Missing the Real Causes of Heart Disease 50:00

27d ago50:00

50:00

What if everything you've been told about preventing heart disease is only half the story? In this episode of Extend, I sit down with Dr. Joel Kahn, a pioneering preventive cardiologist who's spent decades challenging the traditional approach to cardiovascular medicine. We explore why the 1961 Framingham risk factors represent an incomplete picture…

1
Are You Picking the Wrong KOLs? 4:28

28d ago4:28

4:28

Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns. They unpacks two major red flags: High …

1
How KLF’s Client Base Evolved Over 20 Years 5:13

1M ago5:13

5:13

Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites. They discus…

1
FDA Pushback on Accelerated Gene Therapy Approvals 4:10

1M ago4:10

4:10

In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation. Edye breaks dow…

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82. Dr. Amy Shah: The Real Reason Women Lose Strength in Perimenopause (And How to Get It Back) 26:53

1M ago26:53

26:53

Why can't you open that jar anymore? Why does getting up from a chair feel harder than it used to? In this episode of Extend, I sit down with Dr. Amy Shah to explore the strength crisis happening to women in perimenopause. We dive into the simple tests that reveal where you're losing ground—and why most women are shocked by their results. We also s…

1
Your DEI Program Could Trigger an FCA Case 6:04

1M ago6:04

6:04

Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while rece…

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81. Dr. Zain Kassam: How Your Gut Bacteria Control Your Brain, Weight, and Longevity 1:18:19

1M ago1:18:19

1:18:19

What if I told you there's an organ in your body with more cells than the Milky Way has stars—and most doctors barely think about it? In this episode of Extend, I sit down with Dr. Zain Kassam, a gastroenterologist turned microbiome researcher who's pioneering how we understand the trillions of organisms living in and on us. We dive into why your g…

1
Teva’s Charity Partnership Scrutinized 2:20

1M ago2:20

2:20

A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential re…

1
Is There a “Right” Way to Calculate FMV? 12:50

1M ago12:50

12:50

Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide? Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculatio…

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80. Dr. Nayan Patel: Your Cells Are Drowning (And One Molecule Can Save Them) 34:55

1M ago34:55

34:55

Oxidative stress. Toxin overload. Immune dysfunction. These aren't separate problems—they're all symptoms of your body working overtime on one exhausting job. In this episode of Extend, I sit down with Dr. Nayan Patel, a pharmacist who's dedicated his career to understanding glutathione—the molecule your body produces more than any other. We break …

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Can Non-Physicians Own Clinical Trial Sites? 3:35

1M ago3:35

3:35

Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctri…

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79. Dr. Scott Sherr: Hyperbaric Therapy: This is How Pressure + Oxygen Unlock Healing 1:30:49

1M ago1:30:49

1:30:49

Low energy, brain fog, and poor recovery aren’t just part of getting older—they’re often signs that your cells are underperforming. And one major reason? They’re starved for oxygen. In this episode of Extend, I talk with Dr. Scott Sherr, a hyperbaric medicine specialist who helps patients and doctors worldwide use oxygen therapy to restore cellular…

1
The KLF Story You Haven’t Heard 8:35

1M ago8:35

8:35

In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan shares how the firm was born in the shadow of the 2008 financial crisis—at a time when job security was shaky and entrepreneurship felt more like a ri…

1
Why Telehealth Platforms Are Getting Sued 6:05

2M ago6:05

6:05

We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now. Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These t…

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78. Dr. Bill Rawls: Chronic Infections Don’t Go Away—They Go Quiet (Here's How to Reverse Them) 36:35

2M ago36:35

36:35

Fatigue, brain fog, joint pain, blood pressure that won’t budge, these aren’t isolated symptoms. They’re your cells signaling that something’s off. In this episode of Extend, I sit down with Dr. Bill Rawls, a board-certified OB/GYN who now focuses entirely on cellular health. We explore why most chronic illness isn’t about your diagnosis, it’s abou…

1
Should Clinical Trial Sites Be Paid Differently? 12:21

2M ago12:21

12:21

In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table? The conversation challenges the idea of flat-rate, standardi…

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77. Professor Tim Spector: Your Gut Bacteria Control Your Health More Than Your DNA 1:40:26

2M ago1:40:26

1:40:26

Your doctor says your health problems are genetic, so you're destined for the same fate. But what if that's completely wrong? In this episode of Extend, I'm joined by Professor Tim Spector, one of the world's leading microbiome researchers, to reveal the truth: your gut bacteria have more control over your health than your genes do. We explore Tim'…

1
How to Build an AI Compliance Program 5:46

2M ago5:46

5:46

In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond. Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if …

1
What the Big Beautiful Bill Means for Trial Sites 5:06

2M ago5:06

5:06

Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare …

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Co-Pay Mistakes Can Trigger DOJ Action 1:51

2M ago1:51

1:51

In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by: Routinely waiving co-pays without documenting financial hardship, Shipping unrequested supplies, Allegedly paying kickbacks to boost …

1
NIH Grant Denials Ruled Discriminatory? 6:12

2M ago6:12

6:12

Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconsti…

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76. Shawn Stevenson : This is What We Lost When We Stopped Eating Together 1:31:13

2M ago1:31:13

1:31:13

What if the real reason you’re gaining weight, feeling wired, or struggling to nourish your family isn’t about willpower—but the culture you live in? On this episode of Extend, I’m joined by Shawn Stevenson—nutritionist, bestselling author, and host of The Model Health Show—to explore how our food environment, not personal discipline, is fueling th…

1
Are Speaker programs supposed to be salesy? 1:31

2M ago1:31

1:31

Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met. To stay compliant, speake…

1
75. Dr. Grant Elliott: Still in Pain After the MRI, Meds, and PT? This Is How You Actually Fix Your Back 40:02

2M ago40:02

40:02

Back pain is one of the most common health issues—but it’s also one of the most misunderstood. In this episode of Extend, I’m joined by Dr. Grant Elliott, a physical therapist and founder of RehabFix, to unpack the real reasons people stay stuck in chronic pain and what it actually takes to recover. We break down why most diagnoses like sciatica or…

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74. Elissa Goodman: This is Why You Can’t Biohack Your Way Out of Burnout 1:16:47

2M ago1:16:47

1:16:47

You’re bloated. Tired. Anxious. Maybe even burnt out. You’ve tried the diets, the supplements, the meditation apps… But you’re still not healing. Why? In this episode of Extend, I’m joined by Elissa Goodman, a holistic health expert and cancer survivor, to explore the deep connection between gut health, inflammation, and overall well-being. We dive…

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DTP Compliance Just Got Tricky 2:52

2M ago2:52

2:52

The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance. In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare.…

1
Should You Use AI to Draft Informed Consent? 12:39

2M ago12:39

12:39

Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organiz…

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73. Dr. Robin Berzin: Why “Normal” Labs Are Failing Women (and What to Ask For Instead) 1:26:28

2M ago1:26:28

1:26:28

What if your bloating, fatigue, or fertility struggles aren’t separate issues, but signs of a deeper imbalance no one’s connected yet? In this episode of Extend, I’m joined by Dr. Robin Berzin, founder of Parsley Health, and we dig into how functional medicine uncovers the why behind your symptoms and why conventional care keeps missing it. We talk…

1
Could You Survive a Surprise Pharmacy Audit? 2:41

2M ago2:41

2:41

Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm. Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not …

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Self-Reporting in Clinical Trials 9:39

2M ago9:39

9:39

In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective a…

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72. Dr. Pedram Shojai: Why Your Physical Symptoms Are a Spiritual Wake-Up Call 35:59

2M ago35:59

35:59

What if the root cause of burnout, inflammation, and hormone dysfunction isn’t just physical—but energetic? In this episode of Extend, I sit down with Dr. Pedram Shojai—Taoist monk, doctor of Oriental medicine, and author of The Urban Monk—to explore how ancient wisdom meets modern health. We unpack why true healing requires addressing your qi (lif…

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$14M Fine Says This “Free” Offer Wasn’t Legal 3:40

3M ago3:40

3:40

In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid. This wasn’t just bad billing—it was a ma…

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71. Dr. Michael Breus: Why “Feeling Fine” Doesn’t Mean You’re Sleeping Well 1:31:50

3M ago1:31:50

1:31:50

What if your exhaustion, brain fog, or cravings aren’t a motivation problem—but a sleep problem no one’s diagnosed yet? In this episode of Extend, I’m joined by Dr. Michael Breuss, a sleep specialist, and we dig into why so many high performers are chronically under-recovered, why sleep disorders go undetected for years, and how wearables are both …

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