Healthy Skepticism Announcements
PharmedOut’s annual conference: Missing The Target: When Practitioners Harm More Than Heal
Thursday-Friday, June 14-15
Innovative Drugs: Hard Facts and Tribal Myths
Donald Light, PhD, University of Medicine and Dentistry, NJ
The pharmaceutical industry, the FDA and many specialty societies claim that most new drugs are "life-saving" innovations that must get to patients faster by approving them for patients use after fewer, earlier clinical trials. Faster approvals and fewer trials also reduce the allegedly huge R&D costs, widely put at $1.7 billion per new drug, as companies spend about 17% of revenues to search for important new advances. These drugs can and should be widely marketed so that as many patients can benefit as possible and so that companies can recover their huge R&D costs that lower prices in Europe, Canada and other affluent countries make Americans pay. Each of these statements will be measured against hard facts that do not support any of them. R&D and most marketing focus on minor variations approved as not inferior to comparators or better than placebo, with under-tested risks of harm. Will still lower standards for safety and effectiveness do more harm than good?
Underuse of Classic Drugs
Joel Lexchin MD, York University
Drug companies operate under a blockbuster economic model, which leads to aggressive promotion pushing the use of their new drugs at the expense of older better-studied products. Not only are new drugs not being compared to older ones in terms of effectiveness but less is known about their overall safety because of the limits of clinical trials. This talk will look at drugs in 4 classes - antibiotics, COX-2s, oral hypoglycemics and anti-hypertensives - and show how marketing lead to the use of less effective medications and medications with serious safety problems.
Exploiting Homeless Mentally Ill Patients in Drug Safety Trials
Carl Elliott MD PhD, University of Minnesota Center for Bioethics
For years pharmaceutical companies have paid marginalized populations to test the safety of new drugs. In recent years, however, specialized psychiatric trial sites have begun recruiting mentally patients from homeless shelters, boarding houses and recovery facilities. These subjects are often paid to test the safety of new drugs in Phase I trials, raising new ethical questions about exploitation of vulnerable populations.
Irrational Exuberance and Novel Pharmacology
Mark Helm MD MBA FAAP, Helm Benefit Design
A consequence of promotion of newer therapies and formulations is the potential for patient harm and “waste” of health care financial resources. “Newer” antipsychotic medications have been widely promoted over the past ten years. These costly medicines often represent a significant portion of pharmacy costs in public health coverage plans. Use of newer antipsychotics in pediatric and geriatric populations provides examples of major risks of irrational exuberance for “novel” pharmacology. This talk will illustrate potential risks arising from: use of new medicines for conditions where safety and effectiveness have not been studied, changes in treatment patterns favoring “new” medications over proven treatments, and inadequate information on direct patient harms.
Does Direct-To-Consumer Advertising Educate the Public to Misuse Medicines?
Barbara Mintzes PhD, Therapeutics Initiative, British Columbia
Direct-to-consumer advertising of prescription medicines (DTCA) is arguably the most intensive "educational" campaign the US public receives on health issues. On average, Americans spend over 100 times as long watching TV ads about medicines as seeing a doctor each year. These ads include powerful messages about how to recognize and treat everyday and serious health problems, thresholds for care, the role and value of medicines, and expected health effects. Because the aim is to sell a medicine, this "education of a special kind" consistently supports overuse of medicines. I will use examples of recent DTCA campaigns to illustrate the gulf between the scientific evidence on treatment effects, appropriate use, and advertising messages.
Radiation From Medical Imaging: A Hidden Epidemic
Rebecca Smith-Bindman, MD, UC San Francisco
Many clinicians are unaware of the amount of radiation delivered from CT scans and other medical imaging techniques and extant data regarding increased risk of cancer from radiation exposure. This presentation will cover the long-term risks of radiation from medical imaging, legislative and quality improvement efforts around CT imaging, and present a framework for reducing inappropriate imaging.
Regulating Medical Devices: A Historical Perspective
Suzanne Junod PhD, FDA
In drafting what would become the 1976 Medical Device Amendment, framers of the legislation sought to avoid some of the perceived shortcomings in the Kefauver Harris Drug Amendments which had been enacted after the thalidomide disaster in 1962. In particular, they wanted to minimize adverse effects on an industry characterized by change and innovation. At that time, however, there was no formal field of biomedical engineering while entrepreneurial zeal had begun to create indisputable regulatory issues. Two of FDA's first device "hires," in fact, were a pair of engineers from NASA who concluded after a week on the job that conditions in the biomedical industry at that time were "appalling" and that standard engineering practices including back up systems, redundancies, and performance standards were simply non-existent. Their insights, along with some early lessons learned "the hard way," helped determine the unique ways in which FDA came to perceive its role in regulating medical devices, ways which differed markedly from those adopted for the regulation of new drugs.
Cardiovascular Devices: The Role of Evidence in the FDA Approval Process
Rita Redberg MD, Archives of Internal Medicine and UC San Francisco
There has been a rapid increase in complexity and use of medical devices, an many of them are cardiovascular. While some of these are life saving, some are not, and even more have unknown clinical benefit. The current state of the quality of evidence prior to FDA approval of high-risk devices, with some examples and suggestions on how to improve this process so that patients could be more assured of benefits outweighing harms will be discussed.
The Supreme Court Strikes Back: IMS v. Sorrell – a Constitutional Right to Track Prescription Data?
Sean Flynn JD & Meredith Jacob JD, American University Washington College of Law
The Supreme Court ruled in IMS v. Sorrell that Vermont's law restricting the use of prescription data to target pharmaceutical detailing to doctors violated the First Amendment of the Constitution. How broad is the right recognized? What room is left for states to control commercial access to confidential medical data for marketing purposes?
Left To Our Own Devices: A Surgeon's Perspective
Amy Friedman MD, SUNY Upstate Medical University
A practical overview of the extent to which the typical clinician comprehends the Regulatory Pathway for Medical Devices will be presented. The extent to which clinicians are (or are not) familiar with the specific level of scientific data review that the Medical Devices they use in patients have undergone prior to gaining FDA clearance for human use will be illustrated. Two specific examples of medical devices that have been associated with significant patient harm, but were not previously recognized to be of concern will be used to illustrate the context of unknown patient safety and risk in the clinical arena.
The Failure of the DePuy ASR Hip Prosthesis: Implications for Medical Device Initiatives
Charles Bennett MD PhD & John Restaino DPM JD MPH, University of South Carolina School of Pharmacy
The use of metal-on-metal bearings in total hip replacements has seen a sharp decline after a decade-long increase in their use, due to the recall of DePuyʼs ASR prosthesis and the growing realization that metal-on-metal prostheses are associated not only with a high failure rates but also elevated systemic cobalt and chromium levels. In the U.S., the ASR XL total hip replacement passed through the FDAʼs 510(k) clearance process via the “substantial equivalence” route wherein companies need only to show that their product is similar to a ʻpredicateʼ device already on the market. In 2007 the Australian National Joint Replacement Registry reported that the ASR required revisions at a rate five times the expected rate at two years. Following years of denial by DePuy that ASR implants were failing, ASR hip prostheses were recalled from the U.S. market on August 24, 2010.
Penicillin and Panaceas
John Powers MD, George Washington University School of Medicine
The introduction of safe and effective antibiotics was one of the most important events of the 20th century in treating serious infections. However, inappropriate use and sales of antibiotics for self-resolving diseases where the effects of antibiotics are negligible or not present at all has resulted in increasing antibiotic resistance. While there is a need for new antibiotics these drugs must be safe and effective. Despite recent approvals of ineffective antibiotics or antibiotics with increased mortality compared to older drugs, pharmaceutical companies have pressured FDA to lower approval standards for antibiotics. This talk will outline FDA approval standards, show how antibiotic trials fail to meet those standards with examples from recent drugs approvals, point out the dangers in approval of ineffective and unsafe antibiotics and make suggestions for improvement in antibiotic trial designs to help make informed decisions for patients and clinicians.
Disclosure of Physician Industry Relationships: What Does It Accomplish? Data from Washington, D.C.
Susan Wood PhD, George Washington University School of Public Health
The District of Columbia is one of the few states requiring the pharmaceutical industry to report their marketing and advertising expenses, including gifts to all health professionals, institutions and organizations in DC since 2006. Analysis of this data shows that millions of dollars each year are given physicians, hospitals, professional organizations and advocacy organizations as part of the marketing budget of over 100 companies. This presentation will review the DC data and the potential impact on the quality of care in DC, as well as recommendations for policy steps to improve transparency and reduce conflicts of interest.
Federal Litigation
Julie Taitsman MD JD, Health and Human Services Office of the Inspector General
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) provides oversight for the Medicare and Medicaid programs. This presentation will offer an overview of OIG efforts, via audits, evaluations, inspections, and enforcement actions, to combat unnecessary or harmful medical care.
What Can and Should the States Do?
Sharon Treat, JD, National Legislative Association on Prescription Drug Prices
Federal regulation has lagged behind the actions of states that have led the way setting rules to keep pharmaceutical marketing safe and free of conflicts of interest. While the federal Affordable Care Act now requires disclosure of many drug and device company gifts and payments, some states go further. States have enacted legislation banning meals and other gifts, requiring disclosure of a broader range of payments, and limiting free samples for prescribers and rebate coupons for consumers. Other areas of interest include data-mining of prescriber records for marketing purposes, disclosure of clinical trial data, internet marketing of drugs to children and teens, electronic prescribing software, and academic detailing and other prescriber education initiatives. Pharmaceutical, data-mining, and Internet companies have all challenged statesʼ legal right to regulate and lobbied heavily to defeat these measures.
Conference Agenda
Thursday, June 14
Is There A Problem?
8:15 – 8:30 a.m. Welcome
Ray Mitchell, Dean of Medical Education Adriane Fugh-Berman MD
Georgetown University Medical Center
8:30 – 9:00 a.m. Innovative Drugs: Hard Facts and Tribal Myths
Donald Light PhD, University of Medicine and Dentistry of New Jersey
9:00 – 9:30 a.m. Does Direct-To-Consumer Advertising Educate the Public to Misuse Medicines?
Barbara Mintzes PhD, Therapeutics Initiative, British Columbia
9:30 – 10:00 a.m. Underuse of Classic Drugs
Joel Lexchin MD, York University
10:00 – 10:30 a.m. Irrational Exuberance and Novel Pharmacology
Mark Helm MD, Helm Benefit Design
10:30 – 11:00 a.m. Discussion 11:00 – 11:15 a.m. Break
11:15 – 11:45 a.m. Can Clinical Trial Data be Hidden?
Kay Dickersin PhD, Johns Hopkins University
11:45 a.m. – 12:15 p.m. Radiation From Medical Imaging: A Hidden Epidemic
Rebecca Smith-Bindman, MD, UC San Francisco
12:15 – 1:30 p.m. Lunch
1:30 – 2:00 p.m. Cardiovascular Devices: The Role of Evidence in the FDA Approval Process
Rita Redberg MD, Archives of Internal Medicine and UCSF
2:00 – 2:30 p.m. The Failure of the DePuy ASR Hip Prosthesis: Implications for Medical Device Initiatives Charles Bennett MD PhD
John Restaino DPM JD MPH
University of South Carolina School of Pharmacy
2:30 – 3:00 p.m. Left To Our Own Devices: A Surgeon's Perspective
Amy Friedman MD, SUNY Upstate Medical University
3:00 – 3:30 p.m. Discussion 3:30 – 4:00 p.m. Break
4:00 – 4:30 p.m. Do Device Manufacturers Belong in the Medical Center?
Tony Scialli MD, George Washington University School of Medicine
4:30– 5:00 p.m. Discussion
Friday, June 15 Is There A Solution?
8:00 – 8:15 a.m. Welcome
Ken Dretchen PhD, Georgetown University Medical Center
8:15 – 8:45 a.m. What Can and Should the States Do?
Sharon Treat, JD, National Legislative Association on Prescription Drug Prices
8:45 – 9:15 a.m. The Supreme Court Strikes Back: IMS v. Sorrell – a Constitutional Right to Track Prescription Data?
Meredith Jacob JD, American University Washington College of Law
9:15 – 9:45 a.m. Disclosure of Physician Industry Relationships: Data from Washington, D.C.
Susan Wood PhD, George Washington University School of Public Health
9:45 – 10:00 a.m. Break
10:00 – 10:30 a.m. Regulation of Promotion of Prescription Drugs
Thomas Abrams MD, Director, Office of Prescription Drug Promotion, Food and Drug Administration
10:30 – 11:00 a.m. Federal enforcement
Julie Taitsman MD JD, Health and Human Services Office of the Inspector General
11:00 – 11:30 a.m. Congressional oversight
Jack Mitchell, Chief of Investigations, U.S. Senate Special Committee on Aging
11:30 – 12:00 p.m. Discussion 12:00 p.m. – 1:15 p.m. Lunch
1:15 – 1:45 p.m. Penicillin and Panaceas
John Powers MD, George Washington University School of Medicine
1:45 – 2:15 p.m. Exploiting Homeless Mentally Ill Patients in Drug Safety Trials
Carl Elliott MD PhD, University of Minnesota Center for Bioethics
2:15 – 2:30 p.m. Break
2:30 – 3:00 p.m. Promoting Prudent Prescribing: A Culture of Resource Stewardship
Sharon Levine MD, Kaiser Permanente
3:00 – 3:45 p.m. Role of the Media (Panel) Moderator Paul Thacker, consultant
Shannon Brownlee, New America Foundation Claudia Collucci, Folha de Sao Paulo Thomas Burton, Wall Street Journal
3:45 – 4:30 p.m. Discussion
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