Adriane Fugh-Berman is a professor in the department of pharmacology and physiology, and in the department of family medicine, at Georgetown University Medical Center. She is also the director of PharmedOut, a Georgetown University Medical Center project that promotes rational prescribing and researches the effects of pharmaceutical and medical device industry marketing on prescribing behavior and therapeutic choices. Additionally, she is the co-director of the M.S. in Health and the Public Interest Program at the Georgetown University Graduate School of Arts & Sciences.
Fugh-Berman graduated from American University with a B.A. in Literature and Environmental Studies and received a B.S. from the University of the District of Columbia. She received her M.D. from Georgetown University School of Medicine, after which she completed an internship in family medicine at Montefiore Medical Center.
Prior to joining Georgetown, Fugh-Berman worked as a medical officer at the National Institute for Child Health and Human Development, and with the Reproductive Toxicology Center. Fugh-Berman appeared on Netflix documentary "The Bleeding Edge", which highlights the dangers for patients of rushed technological changes in the medical devices field. A clip of her was featured on John Oliver's "Medical Devices" episode on HBO. Dr. Fugh-Berman is a professor at Georgetown University School of Medicine, where she also leads the PharmedOUT program. [1]
Dr. Fugh-Berman is a paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices. [2]
Fugh-Berman has published numerous studies [3] regarding the relationship between physicians and the pharmaceutical industry, off-label promotion, ghostwritten articles, and invented diseases. [1]
Dr. Fugh-Berman collaborates with Dr. Susan Wood at the George Washington University Milken Institute School of Public Health and the Washington DC Department of Health on the DC Center for Rational Prescribing, which provides free, industry-free continuing medical education and resources to physicians, physician assistants, nurses, and pharmacists.
Dr. Fugh-Berman is also an expert on botanical medicine and dietary supplements and directs Georgetown's Urban Herbs project, which maintains ecological gardens on campus that intermix edible, medicinal, and ornamental plants. She is the author of a clinical textbook, The 5-Minute Herb and Dietary Supplement Consult. [1]
Georgetown University Medical Center professor, Fugh-Berman, served as a paid expert witness in the lawsuit filed in 2017 by the State of Oklahoma against 13 major pharmaceutical companies for "damages linked to the opioid crisis. According to the original 2017 petition, Oklahoma said the sale of Oxycontin, by its manufacturer, Purdue Pharma, from 1996 to 2009, rose from $48 million to $3 billion. [4] According to a March 26, 2019 PBS News article, Fugh-Berman who works out of the University's Department of Pharmacology and Physiology, said that over time, "industry-generated narrative [became] conventional wisdom". PBS News wrote that "these deadly consequences didn’t happen overnight". Fugh-Berman said that the industry used "pervasive marketing tactics" to "influence conversations" between "patients", "doctors, medical school students and instructors". The article said that "One tactic that opioid manufacturers used to protect sales was the rebranding of substance use disorder as pseudo addiction — that patients who took opioid medication and later developed symptoms of addiction should be treated with more opioids. According to the PBS News March 2019 article, "while fewer doctors are writing opioid prescriptions" than they did prior to the mid-2010s, Fugh-Berman said that "it is nowhere near a reasonable level." PBS said that even in 2019, "opioid marketing continues to lead doctors to guide patients toward the drugs." [4]
Fugh-Berman has been critical of multiple popular pharmaceutical drugs and treatments, including testosterone replacement therapy [5] and flibanserin. [6] She has also criticized how the numerical values used to diagnose diabetes and high cholesterol have been lowered over time, and has criticized Eli Lilly for allegedly inventing premenstrual dysphoric disorder to sell its drug Sarafem. [7]
Fugh-Berman's mother Aline Fugh Berman (Chinese :傅曖泠) was the eldest sister of former U.S. Army Major General John Fugh, who was married to Connie Chung's elder sister June. Aline's younger sister, artist Dora Fugh Lee (Chinese :傅鐸若), is the mother of Shanghai-based attorney and property developer Handel Lee.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
The Pharmaceutical Benefits Scheme (PBS) is a program of the Australian Government that subsidises prescription medication for Australian citizens and permanent residents, as well as international visitors covered by a reciprocal health care agreement. The PBS is separate to the Medicare Benefits Schedule, a list of health care services that can be claimed under Medicare, Australia's universal health care insurance scheme.
Pharmaceutical marketing is a branch of marketing science and practice focused on the communication, differential positioning and commercialization of pharmaceutical products, like specialist drugs, biotech drugs and over-the-counter drugs. By extension, this definition is sometimes also used for marketing practices applied to nutraceuticals and medical devices.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Arthur Mitchell Sackler was an American psychiatrist and marketer of pharmaceuticals whose fortune originated in medical advertising and trade publications. He was also an art collector. He was one of the three patriarchs of the controversial Sackler family pharmaceutical dynasty.
Pharmaceutical sales representatives are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their drugs to patients. Drug companies in the United States spend ~$5 billion annually sending representatives to doctors, to provide product information, answer questions on product use, and deliver product samples. These interactions are governed according to limits established by the Code on Interactions with Health Care Professionals, created by the Pharmaceutical Research and Manufacturers of America (PhRMA). This code came into practice in 2002 and has since been updated to help define ethical interactions between health care professionals and the pharmaceutical companies
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
IMS Health was an American company that provided information, services and technology for the healthcare industry. IMS stood for Intercontinental Medical Statistics. It was the largest vendor of U.S. physician prescribing data. IMS Health was founded in 1954 by Bill Frohlich and David Dubow with Arthur Sackler having a hidden ownership stake. In 2010, IMS Health was taken private by TPG Capital, CPP Investment Board and Leonard Green & Partners. The company went public on April 4, 2014, and began trading on the NYSE under the symbol IMS. IMS Health was headquartered in Danbury, Connecticut.
The Faculty of Medicine is a medical school affiliated with Tel Aviv University, located in Tel Aviv, Israel.
Marcia Angell is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine. She is currently a Senior Lecturer in the Department of Global Health and Social Medicine at Harvard Medical School in Boston, Massachusetts.
PharmedOut (PhO) is a Georgetown University Medical Center project founded in 2006. It is directed by Adriane Fugh-Berman. The stated mission of the organization is to advance evidence-based prescribing and educate healthcare professionals about pharmaceutical marketing practices.
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by the British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products. It was published in the UK in September 2012 by the Fourth Estate imprint of HarperCollins, and in the United States in February 2013 by Faber and Faber.
Founded in 1990, Insys Therapeutics was an American specialty pharmaceutical company based in Chandler, Arizona. Its main product was Subsys, a sublingual liquid form of the drug fentanyl. Fentanyl is an extremely fast-acting and powerful opioid used to relieve peaks of pain in cancer patients.
There is an ongoing opioid epidemic in the United States, originating out of both medical prescriptions and illegal sources. The epidemic began in the United States in the late 1990s, according to the Centers for Disease Control and Prevention (CDC), when opioids were increasingly prescribed for pain management, resulting in a rise in overall opioid use throughout subsequent years.
The Consumer & Prescriber Grant Program was a grant program established with fines paid by Pfizer in the Franklin v. Parke-Davis trial for False Claims Act violations relating to off-label use of gabapentin.
Richard Stephen Sackler is an American billionaire businessman and physician who was the chairman and president of Purdue Pharma, a former company best known as the developer of OxyContin, whose connection to the opioid epidemic in the United States was the subject of multiple lawsuits and fines, and that filed for bankruptcy in 2019. It has been claimed that Richard Sackler's Purdue is among "the worst drug dealers in history" and the Sackler family have been described as the "most evil family in America". The company's downfall was the subject of the 2021 Hulu series Dopesick and the 2023 Netflix series Painkiller.
Massachusetts v. Purdue is a lawsuit filed on August 14, 2018, suing the Stamford, Connecticut-based company Purdue Pharma LP, which created and manufactures OxyContin, "one of the most widely used and prescribed opioid drugs on the market", and Purdue's owners, the Sacklers accusing them of "widespread fraud and deception in the marketing of opioids, and contributing to the opioid crisis, the nationwide epidemic that has killed thousands." Purdue denied the allegations.
The opioid epidemic, also referred to as the opioid crisis, is the rapid increase in the overuse, misuse/abuse, and overdose deaths attributed either in part or in whole to the class of drugs called opiates/opioids since the 1990s. It includes the significant medical, social, psychological, demographic and economic consequences of the medical, non-medical, and recreational abuse of these medications.
Scott E. Hadland is a Canadian-American physician and scientist who serves as a pediatrician, and addiction specialist at Massachusetts General Hospital and Harvard Medical School, where he is the Chief of the Division of Adolescent and Young Adult Medicine. He previously served as an addiction specialist at the Grayken Center for Addiction at Boston Medical Center.