Talks and Public Comments

2024

Judy Butler, PharmedOut's Research Fellow, testified in opposition to FDA approval for donanemab at a Peripheral and Central Nervous System Drugs Advisory Committee Meeting on June 10th, 2024. Our written comment is here. | PDF
Dr. Fugh-Berman was a guest on the GeriPal podcast, “How Pharma Invents Diseases,” on May 16, 2024. Listen here!
Dr. Fugh-Berman presented “How Pharma Invents Diseases” for Georgetown University Medical Center’s Pharmacology and Physiology Seminar Series on March 21st.
PharmedOut submitted a comment to the FDA on the Research, Abuse, Diversion, and Addiction-Related Surveillance (RADARS) system on January. PharmedOut stressed that RADARS "has a terrible history of involvement in creating and maintaining dangerous overprescribing of opioids." Our comment was featured in "Groups Blast FDA's Opioid Abuse Surveillance Proposal" in MedPage Today on January 3.
Caroline Renko, PharmedOut’s Project Manager, testified at the FDA Listening Session on Advisory Committee Meetings on June 13th. Her testimony was quoted in Pink Sheet and you can watch her testimony on here on YouTube.
Caroline Renko also testified at the Federal Trade Commission's (FTC) public meeting on August 1st. Caroline argued that continuing medical education (CME) should be regulated as advertising and that this is a consumer protection issue. You can watch her testimony here at the 1:25:40 mark.
Dr. Fugh-Berman debated Dr. Michael Ybarra, an emergency department physician who is Vice President and Chief Medical Officer of PhRMA, at George Washington University School of Medicine on June 28th.

2023

PharmedOut submitted comments to the Federal Trade Commission on the Health Breach Notification Rule on August 8. The written comment can be found here. | PDF
Patricia Bencivenga, PharmedOut’s Special Projects Coordinator, testified in opposition to full FDA approval for Leqembi (lecanemab) at the Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee Meeting on June 9th. Her written comment can be found here. | PDF
Caroline Renko testified in support of nonprescription use of Opill (norgestrel), a once daily oral contraceptive to prevent pregnancy at the Food and Drug Administration’s Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee Meeting on May 9, 2023. Her testimony can be found here. | PDF
Caroline Renko testified at the Food and Drug Administration’s Peripheral and Central Nervous System Drug Advisory Committee on Biogen’s amyotrophic lateral sclerosis (ALS) drug, tofersen, on March 22nd. Find her public comment here. | PDF

2022

Patricia Bencivenga testified at an Obstetrics, Reproductive, and Urologic Drugs Advisory Committee on October 18, 2022 regarding whether or not Makena (hydroxyprogesterone caproate) should be withdrawn from the market. Our written testimony here. | PDF
Dr. Fugh-Berman testified at the Psychopharmacologic Drugs Advisory Committee on June 17, 2022 on the use of pimavanserin to treat hallucinations and delusions associated with Alzheimer's disease psychosis. Our written testimony here. | PDF
Judy Butler and Dr. Fugh-Berman submitted a public comment to the Centers for Disease Control on their proposed Clinical Practice Guideline for Prescribing Opioids on April 14, 2022. Our written testimony here. | PDF
Dr. Fugh-Berman and Tim Rey MS submitted testimony before the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee regarding intravenous tramadol on February 15, 2022. Our written testimony here. | PDF
Dave Stanke, Judy Butler, and Dr. Fugh-Berman submitted a public comment to the Centers for Medicare and Medicaid Services regarding coverage for aducanumab on February 4, 2022. Our written testimony here. | PDF

2021

Dave Stanke, Patricia Bencivenga, and Dr. Fugh-Berman testified at the Center for Medicare and Medicaid Services (CMS) public hearing on the National Coverage Determination Analysis for Monoclonal Antibodies that Target Amyloid for the Treatment of Alzheimer’s Disease. Along with Sophia Phillips, the team also submitted written testimony advocating against CMS coverage of Aduhelm.
Dr. Fugh-Berman gave a public seminar lecture on "How Drug Companies Affect Medical Knowledge" for the Health and the Public Interest program at Georgetown University. You can view the seminar here.
Along with other members on the board for Physicians for Responsible Opioid Prescribing (PROP), Dr. Fugh-Berman and PharmedOut fellow, Judy Butler, signed a letter addressed to the American Medical Association refuting some of their recent claims that the US "no longer has a prescription opioid-driven epidemic" and their stance on the CDC Guidelines. The BMJ covered the story here.

2020

Dr. Fugh-Berman testified at a Joint Meeting of the FDA Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products Advisory Committees on September 11, 2020. The meeting's focus was to determine if Purdue's reformulation of Oxycontin as abuse-deterrent actually had any effect on abuse or misuse. Dr. Fugh-Berman testified that “what abuse-deterrent formulation prevents is criticism” and “the best way to prevent addiction and overdose deaths is through fewer opioid prescriptions.” Dr. Fugh-Berman's written testimony can be accessed here.

2019

PharmedOut's Petition in Support of the CDC Guideline
PharmedOut's Ben Goodwin testifies at the HHS Pain Management Best Practices Inter-Agency Task Force | May 9, 2019 (Video)
- - - Transcript
PharmedOut's project manager Sophie Krensky testified in front of the DC Council on behalf of the DC Center for Rational Prescribing (DCRx) as part of the solution to address the opioid epidemic in Washington, DC. You can watch her testimony here (skip to 2:02:30).

2017

The PharmedOut team spoke with conference-goers at the International Conference for Nutrition in Medicine, where Dr. Fugh-Berman presented on overpromotion of drugs for preventive medicine.
Dr. Fugh-Berman presented at the California Society of Addiction Medicine's conference on social psychology techniques used to manipulate physicians' therapeutic choices and overprescription of opioids.
Adriane Fugh-Berman and Nick Mendola testified at the FDA Public Meeting on Patient-Focused Drug Development for Sarcopenia. Both argue that age-related muscle mass loss is not a disease that needs drug treatment, but a normal condition best treated with exercise. The transcript is available here. Dr. Fugh-Berman's testimony starts on page 117 and Nick Mendola's testimony starts on page 122. The meeting was covered in Congressional Quarterly's Roll Call by Andrew Siddons.
Dr. Fugh-Berman participated in a POLITICO panel on Trump's FDA, discussing the future of drug regulation, "real-world data", and surrogate markers. Video of the panel is available here.

2016

Dr. Fugh-Berman did Grand Rounds on the effect of pharmaceutical promotion in prescribing at Mount Sinai's Department of Family Medicine and Community Health on June 10. A video of her talk is available here.
At the Lown Institute's 2016 Conference on April 16-17, Dr. Fugh-Berman held a workshop with Roy Poses MD of Brown University and the Foundation for Integrity and Responsibility in Medicine. Slides for their presentation, "Overtreatment and Deceptive Drug and Device Promotion in the Context of Health Care Corruption" are available here, and highlights from the entire conference can be seen here.

2015

Dr. Fugh-Berman testified to the Federal Trade Commission on the advertising of homeopathic products. She addressed the misleading labeling and promotion of homeopathic remedies, the high potential for a placebo effect, and the importance of randomized controlled trials, stating "there is no alternative science." A video of the panel is available here, and Dr. Fugh-Berman's testimony begins at 1:53:30.
Dr. Fugh-Berman testified at an FDA hearing on homeopathic product regulation on April 20. Her remarks, especially regarding the lack of evidence on homeopathic products' effectiveness and the misleading practice of stocking them next to proven remedies, were picked up by CNN, U.S. News & World Report, Forbes, Washington Examiner, and MedPage Today.
Dr. Fugh-Berman participated in the Capitol Hill panel discussion on January 14 on "The Physician Payment Sunshine Act: What Have We Learned? What More Must Be Done?", hosted by the National Coalition on Health Care. The panel of health care experts contributed different perspectives to this issue, and Dr. Fugh-Berman call the Sunshine Act "a success" that could go further; namely, to expand disclosure requirements to advanced practice nurses, physician assistants, and organizations, who are increasingly becoming the main recipients of industry payments. Watch CSPAN's coverage of the event here, and read coverage by MedPage Today, Medill On The Hill and Fierce Practice Management.

2014

Footage of FDA's female sexual dysfunction workshop in October, including the PharmedOut testimony that we covered last month, is now available online.
October 27 and 28: PharmedOut Project Manager Alessandra Hirsch and volunteer staffperson Rebecca Holliman testified at the FDA's Patient-Focused Drug Development Meeting on Female Sexual Dysfunction. They shared their concerns about Sprout Pharmaceuticals' "Even The Score" campaign for flibanserin from a young woman's perspective. They spoke about the many factors that affect libido, and how flibanserin "inherently implies that a woman who isn’t in the mood has something clinically wrong with her," Hirsch said, and asked, "do I lose the right to say no because there is a pill to 'fix me'?" Holliman noted that "a pill or device in a market with no infrastructure to educate women about the non-medical components of arousal is dangerously open to abuse."
Dr. Fugh-Berman testified at the FDA's hearing on September 17 on testosterone therapy and cardiovascular risks. As many of you know, "Low-T" treatments were in the news earlier this year as a growing number of men had heart attacks while using the drug. In response, the FDA Advisory Committee convened to determine future labeling requirements on testosterone products. Dr. Fugh-Berman spoke to the Committee about the overuse of testosterone in normally aging men. She called this "a public health concern" and said "the current labeled indication of testosterone therapy is so broad and vague that any man with a single low testosterone level [when tested] can be diagnosed with hypogonadism. Testosterone levels can vary hourly, daily, weekly, and seasonally. Levels are affected by exercise, sexual activity, handling a gun, handling a baby, marriage, divorce, and the performance of one’s favorite sports team. Given that the diagnostics are questionable, and the benefits are unconvincing, are any life-threatening risks of testosterone worth taking?" We were pleased that at the end of the meeting, the Advisory Committee voted to change the label on testosterone in order to limit its use!
On May 22nd and 23rd, Dr. Fugh-Berman addressed the CME committee at the Roger Williams Medical Center and presented Grand Rounds at both Roger Williams and Hasbro Children's Hospital/Department of Pediatrics at Alpert Medical School of Brown University in Providence, RI.
May 19: Dr. Fugh-Berman spoke on an American Society for Men's Health panel at the American Urological Association's annual conference. The topic was cardiovascular risks of testosterone therapy. Drugwatch covered some of the debate arguments here.

2013

December 11-12: Dr. Fugh-Berman was an invited speaker at the 2013 FDA/CMS Summit for Biopharma Executives in D.C. Dr. Fugh-Berman took part in the "Beyond the 'Label': Promotion in the Facebook Era" panel with Mit Spears, Executive VP and General Counsel to the Pharmaceutical Research & Manufacturers of America (PhRMA) and Coleen Klasmeier, Partner at Sidley Austin LLP. About 300 representatives from industry and government attended.
October 11: Dr. Fugh-Berman presented "Why Lunch Matters" at an American Medical Student Association (AMSA) Medical Professionalism symposium, held at the Rowan University School of Osteopathic Medicine in Stratford, NJ. At the end of September, Dr. Fugh-Berman also lectured at a Global Health Conference in Berlin.

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