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Testimony to the FDA Gastrointestinal Drug Pharmaceutical Industry Influence on Medical Practice and the Use of Drugs Consumer Issues Conference: Pills, Potions, and Profits University of Wyoming October 5-7, 2011 Michael Carome, M.D. Deputy Director Public Citizen Health Research Group Tom Toles: Washington Post 8/4/03 Overview • Misprescribing/overprescribing of drugs • Statistics on drug promotion expenditures by drug companies • Advertising directed at physicians Misprescribing/Overprescribing • Off-label promotion of Drugs • Criminal and civil monetary penalties against the pharmaceutical industry • Propublica’s Dollars for Docs • Pharmaceutical companies influencing clinical practice guidelines Generating Drug Company Profits Misprescribing/Overprescribing of Drugs • Definitions: Prescriptions that are either entirely unnecessary, unnecessarily dangerous, or unnecessarily expensive. Prescriptions for which the risks outweigh the X = benefits, thus conferring a negative health impact on the patient. # of • More than 1.5 million people are hospitalized # of patients and 100,000 die each year from largely doctors treated with prescribing a drug preventable adverse reactions to drugs that a drug should not have been prescribed as they were in the first place. www.uwyo.edu/consumerconference 1 Seven Deadly Sins of (Mis)Prescribing Seven Deadly Sins of (Mis)Prescribing (cont.) • The disease for which the drug is prescribed is • Prescribing two drugs, each of which when used actually an adverse event to another drug. alone may be safe and effective, but together can • A drug is used to treat a problem that, although in cause serious injury or death. some cases susceptible to a pharmaceutical • Two or more drugs in the same therapeutic solution, should first be treated with common-sense category are used, the additional one(s) not adding lifestyle changes. to the effectiveness, but clearly increasing the risk • The medical problem is both self-limited and to the patient. completely unresponsive to treatments, such as • The right drug is prescribed, but the dose used is antibiotics, or does not merit treatment with dangerously high. certain drugs. • A drug is the preferred treatment, but instead of the safest, most effective – and often least expensive – drug, a less preferable alternative is used. Who is Responsible for the Misprescribing and Overprescribing of Drugs • The drug industry Statistics on • Physicians Drug Promotion Expenditures • The Food and Drug Administration by Drug Companies • Pharmacists • Patients Spending on Drug Sales in the U.S. Number of Prescriptions Sold in the U.S. www.uwyo.edu/consumerconference 2 Drug Promotion Expenditures in the U.S. Drug Promotion Expenditures in the U.S. Type of Estimate Percent • In 2004, estimated pharmaceutical marketing Promotion (US$ Billion) of Total expenditures in the U.S. was $57.5 billion (24.4% Samples 15.9 27.7 of drug sales). (Assuming same percent in 2010, marketing expenditures would have been $75 Detailing 20.4 35.5 billion.) DTC Ads 4 7 Meetings 2 3.5 • In comparison, drug companies spend about 13.4% on research and development. Journal ads 0.5 0.9 Other 14.7 25.5 Total 57.5 100 Gagnon MA et al. PLOS Medicine. January 3, 2008 Gagnon MA et al. PLOS Medicine. January 3, 2008 Advertising to Physicians www.uwyo.edu/consumerconference 3 Advertising Defined • ―the science of arresting the human intelligence long enough to get money from it‖ (Definition of advertising by Canadian economist, Stephen Leacock. The Garden of Folly, 1924) 1996 Ad from an Advertising Agency to Ad from an Advertising Agency to Marketing Marketing Departments of Drug Companies Departments of Drug Companies Commentary Regarding Advertising Agency Ad Commentary Regarding Advertising Agency Ad (cont) • [I]n the April, 1996, issue [of Lancet], William Douglas • …The poor prescribing of many physicians is McAdams, Inc, not only invents a new concept in surely influenced by drug industry spending on functional neuroanatomy– the hippocampus as ―the promotion. Perhaps the hippocampus mediates prescription-writing center of the brain‖—but also this drug-firm-induced disorder. The proposed promises that ―all our communications are focused on making the hippocampus respond positively to your pathophysiological mechanism of such product‖. The firm does so through creative and commercially driven prescribing is well educational programmes with ―a unique medical described in the advertisement: ―[the discriminator–an innovative, medically relevant idea that hippocampus] processes information by makes your customer see (and remember) how your connecting new concepts with the parts of the product is superior and unique.‖ Although recent research brain where gut instincts are formed, areas that has linked abnormalities of the hippocampus to influence emotional behavior and form schizophrenia and post-traumatic stress disorder, this memories‖. [emphasis added] advertisement contains the first suggestion that they are Wolfe S. Lancet 1996;348:632. also associated with misprescribing…. [emphasis added] www.uwyo.edu/consumerconference 4 You can call it the Catalyst specialty. Our proven approach reaches the specialists who are vital to your brand’s growth…and you success. If you demand performance, we’ll show you how our experts can push the limits for your brand…. FDA Drug Advertising Enforcement 1997-2007 FDA Warning and Notice of Violation Letters to Drug Companies Off-Label Promotion 157 160 140 140 120 108 100 89 73 80 60 27 29 40 24 24 22 20 20 0 Illegal stoppedads year per 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Off-Label Promotion - Background Off-Label Promotion –Analysis of Strategies and Practices by Kesselheim et al. (1) • FDA-approved drug label: indications for use (diseases and patient groups) and doses. • The researchers studied unsealed whistleblower complaints in ―qui tam‖ cases filed against drug • Physicians can prescribe any FDA-approved companies filed under the U.S. federal False Claims drug for purposes, patients, and doses Act that involved allegations of of-label marketing. outside those listed on the label (FDA does • Time period studied: January 1996-October 2010 not regulate the practice of medicine). • The researchers conducted structured reviews of the complaints and coded and analyzed the • Drug companies are prohibited by the FDA strategic goals of each off-label marketing scheme from engaging in direct promotion of ―off- and the practices used to achieve those goals, as label‖ use. reported by the whistleblowers. PLOS Medicine, April 5, 2011 www.uwyo.edu/consumerconference 5 Off-Label Promotion –Analysis of Strategies Off-Label Promotion –Analysis of Strategies and Practices by Kesselheim et al. (2) and Practices by Kesselheim et al. (3) • 41 complaints involving 18 cases settled for a total • Identified 3 mutually exclusive off-label marketing of $7.9 billion. strategies in the 41 complaints: • Drug companies: Parke-Davis/Warner-Lambert, Expansion to unapproved disease entities, 35/41 Serono, InterMune, Bristol-Myer-Squibb, Cell (85%); e.g., gabapention (Neurontin; Parke- Therapeutics, Orphan Medical, Medicis, Cephalon, Davis/Warner Lambert) approved for epilepsy, Eli Lilly, Pfizer, AstraZeneca, Ortho-McNeil- promoted for bipolar disorder/depression Jansen, Novartis (2), Forest, Allergan, Scios, Wyeth Expansion to unapproved disease subtypes, • Whistleblowers (n=55): 22/41 (54%); e.g., nesiritide (Natrecor; Scios) Pharmaceutical sales representatives, 39 (71%) approved for acute decompensated CHF, Sales or accounting managers, 11 (20%) promoted for chronic stable CHF Unaffiliated physians, 5 (9%) Expansion to unapproved doses, 14/41 (34%) PLOS Medicine, April 5, 2011 PLOS Medicine, April 5, 2011 Off-Label Promotion –Analysis of Strategies Off-Label Promotion –Analysis of Strategies and Practices by Kesselheim et al. (4) and Practices by Kesselheim et al. (5) • Identified 4 mutually exclusive categories of • Prescriber-related practices were the centerpiece of marketing practices in 41 complaints: the whistleblowers’ complaints: Self-serving presentations of scientific literature Prescriber-related, 41/41 (100%)* given physicians false or unbalanced study data supporting an unapproved use: 31/41 (76%) Internal business-related, 37/41 (90%)* Encouraged off-label use via direct financial incentives (e.g., honoraria and gifts): 35/41 (85%) Payer-related, 23/41 (56%) Free samples to promote off-label use: 8/41 (20%) CME seminars organized with speakers known to Consumer-related, 18/41 (44%) promote off-label use: 22/41 (54%) PLOS Medicine, April 5, 2011 PLOS Medicine, April 5, 2011 Off-Label Promotion –Analysis of Strategies Drug Detailing and Off-Label Promotion and Practices by Kesselheim et al. (6) Steinman et al. Study (1) • Internal business-related practices: reported to be • Drug detailing: visits by pharmaceutical sales company-wide, rather than work of individual representatives to physician offices. manager or group of managers: • Researchers analyzed data collected from physicians Intramural meetings and seminars in which by a market research company about detail visits for marketing practices were discussed: 27/37 gabapentin (Neurontin; Parke-Davis/Warner (73%) Lambert); obtained from documents subpoenaed in Development of brochures and other materials a qui tam whistleblower lawsuit alleging off-label for dissemination: 17/37 (46%) promotion. Often included specific efforts by the drug • Described characteristics and content of the detail manufacturer to conceal the off-label
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