An Ethical FrameworkforClinician/Industry Interactions Mansoor Malik MD Howard University Hospital
The CAGE Questionnaire for Drug Company Dependence • Are you Carrying a pen with a drug company logo? • Do you get Annoyed by people who complain about drug lunches and free gifts? • Are you planning to Go to a drug company event this week? • Do you drink your morning Eye-opener out of a coffee mug given to you by a drug rep? If you answered yes to 2 or more of the above, you may be drug company-dependent.
Q1: What percentage of residents surveyed were carrying items • with a pharmaceutical company logo or product brand on • them? • a) 79% • b) 88% • c) 97%
97% of residents surveyed were carrying items with a pharmaceutical company logo or product brand on them. • 98% of residents surveyed had also eaten at least one pharmaceutical company-provided meal sometime in the • previous 12 months. Chern M-M, Landefeld S. Physician’s Behavior and Their Interactions With Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary. JAMA, 1994, 271:0,684-689
During one six-week period, a medical resident reported being offered: • “12 free breakfasts, 18 lunches, 16 branded pens, a branded eyeglasses cleaner, 2 penholder necklaces, branded pill holders, post-it pads, notepads, a pocket Physicians Desk Reference, correction paper rips, a coffee mug, a poster, a highlighter, a copy of the DSM-IV, a giant clip/fridge magnet, a ruler, a water/oil globe, a “History of Viagra” book, and even a Viagra soap dispenser. • Silver-Isenstadt J. National Physicians Alliance testimony to District of Columbia Health Committee (18 October 2007).
Q: What percentage of residents surveyed acknowledged that • the gifts and meals can influenced prescribing patterns? • a) 79% • b) 87% • c) 91%
91% of residents surveyed acknowledged that the gifts and meals can influence prescribing patterns, they decrease objectivity and increase the possibility of prescribing being done based on decisions other than the best interests of the patient.
Full Disclosure • No financial conflicts
~ 10 Lunches ~ 12 Detail visits ~ 8 Pens ~ 1 Sticky pad ~ 4 Dinners ~ 2 Toys But no: Theater tickets Resort junkets Golf excursions Turkeys or hams Full Disclosure 2010 Gifts and Meals
Aims and Objectives • Review physician-industry interactions: • Impact • Perception • Ethics • Review Cognitive Dissonance • Review Ethical Guidelines • Practical Strategies • Pedagogical Implication
Landscape • Increased scrutiny of physician/industry relations • High profile cases • Restrictive laws: Vermont and Massachusetts
Physician Payment Sunshine Act • Passed with Patient Protection Affordable Care Act • A transfer of anything the value of which is more than $10 • Gift; Food; Entertainment; Travel or trip; Honoraria; Research funding or grant; Education; Research; profit distribution; consultation/speaking fees • Will be enacted 2013
Physician Payment Sunshine Act • Name; Business address; Physician specialty; National provider identifier: Disclosed and made available to public • Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment.
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY • Healthcare in US is a Two Trillion dollar Industry • In 2000 – Pharma spent $11 billon on promotions • $5 billion went to sales representatives • An estimated $8000 to $13,000 per year on each physician. • Wazana, Ashley, JAMA, vol 283; pp 373 – 380.
Economic Issues 2011 Sales of Prescription Drugs • Expected to top 880 Billion Globally • 7 % increase since 2008 Pharmaceutical Research and Manufacturers of America (PhRMA)
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY • Annual marketing budget of US drug industry: $57.5B • $61,000 per physician • Considerably greater than total budgets of all US medical schools and residency programs Gagnon and Lexchin, PLoSMed5(1), 2008
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY • With a ratio of 1 industry representative for every 4.7 physicians. • Average physician sees about 10 pharmaceutical sales representatives each month • Greene J. AMA Spearheads Gift Education Crusade. American Medical News 2001
Return on Investment from Marketing Strategies for each dollar spent in 1999
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY • 83.8% of all respondents reported sometype of relationship with industry during the previous year • 63.8% received drug samples • 70.6%food and beverages • 18.3% reimbursements • 14.1% paymentsfor professional services • Campbell, Arch Intern Med. 2010;170(20):1820-1826
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY • Industry provides 60% of funding for biomedical research — which is more than all of the National Institutes of Health–funded research combined. • Industry provides more than 50% of funding for continuing medical education, which amounts to about $3 billion annually.
Economic Issues Research and Development Costs 2002 • 24.2% of total sales are spent on research and development Pharmaceutical Research and Manufacturers of America (PhRMA)
Economic Issues Promotional Costs 2002 • 12.9% of sales (PhRMA) vs • 22% of sales (Nofreelunch.com) Unrestricted education grants are tax-deductible charitable contributions, not promotion costs
Economic Issues Are Medicines Too Expensive? • Research and development costs are high • A single lawsuit can be catastrophic • Patent protection is time-limited
Economic Issues Are Medicines Too Expensive? but • Pharmaceutical stocks are considered among the most profitable and consistent investments available
Economic Issues Are Medicines Too Expensive? but • High profitability is essential for the maintenance of an aggressive research and development program
Why Do We Do It? • Contacts with industry are unavoidable • Physician Desk Reference • Prescription of proprietary drugs • Sponsorship of professional meetings • Advertisements in professional journals • Response to academic activity
Why Do We Do It? Contacts with industry are desirable • Sponsorship of educational programs • Sponsorship of professional organizations • Sponsorship of research • Notification of product availability • Exposure to proprietary information • Academic input into research and marketing
But... Industry’s priorities differ from those of clinical and academic medicine Is it possible to benefit from industry contacts without compromising the integrity of clinical and academic medicine?
Competing Goals Pharmaceutical Industry Profit-making enterprise Duty is to stockholders Medicine Advocate for patient interest Duty is to patients
Major Dangers • Clinical compromise • Research bias • Academic corruption
What is ‘Conflict of Interest’ in the clinical setting? • When interests of the clinician do not align with the interests of their patients.
Industry Interactions with Physicians Marketing Contacts • Physician detailing • Lunch/dinner meetings and presentations • Advertisements
Industry Interactions with Physicians Educational Programs • Unrestricted education/research grants • Industry-sponsored symposia • Patient education materials • Journal sponsorship
Industry Interactions with Physicians Contract Services • Scientific advisory boards • Marketing advisory boards • Speakers bureaus • Research design, participation, and publication
An industry representative invites you and a guest • to dinner and a lecture at an upscale restaurant at • The Mall. Following dinner, you also receive a gift certificate for shopping at The Mall. • Should you accept this offer?
Non-Maleficence and Beneficence • When developing new products, industry is required to demonstrate that a new product: • is safe • provides a benefit to patients
Respect for Autonomy • Protection from Intrusion into the Physician-Patient Relationship • MD influenced to prescribe certain product • Patient should know of any relationship between MD and company whose product is being recommended
Distributive Justice • Fair or just distribution of rights and responsibilities, such as: • to each an equal share • to each according to need • to each according to merit
Fiduciary Relationships • “Fiduciary” is often used to describe the patient-physician relationship because: A) patients place their trust and well-being in the hands of physicians B) physicians are responsible for the welfare of patients C) physicians respond to patients’ actual (vs. perceived)needs D) physicians are responsible for controlling patient/third party payer expenses for medications and other medical services
Physicians and Conflicts of Interest • Because of the fiduciary nature of the patient/physician relationship, it is generally expected that physicians should avoid conflicts of interest that may undermine patient care. • For actual or perceived conflicts that cannot be avoided, disclosure may function as the primary mechanism to reduce the effect of the conflict.
Attitudes and practices of medicine housestaff toward pharmaceutical promotions • Survey of 117 1st and 2nd year residents at a university-based IM training program. • Attitudes towards 9 types of promotion assessed. • 90% response rate (105/117 residents). Am J Med 2001;110:551
Attitudes and practices of medicine housestaff toward pharmaceutical promotions Am J Med 2001;110:551
It is Just Free Lunch? • Survey of 105 residents at an Internal Medicine residency program: • Judged appropriateness based on cost • All who viewed lunches/pens as inappropriate had accepted them • 61% believed that industry contact did NOT affect their own prescribing • 16% believed that others in their program were unaffected -Steinman MA, 2001Arch Intern Med. 2003;163:2213-2218
What do patients think? • Patients thought gifts more influential and less appropriate than physicians. • Half of patients were unaware of gifts to doctors from industry. • Of those who were previously unaware, 24% had an altered perception of the medical profession. -Gibbons RV, et al, 1998
What do patients think? • Patients surveyed thought “it is not alright” for physicians to accept: • Dinner at a restaurant 48.4% • Baby formula 44.2% • Coffee Maker 40.7% • Ballpoint pens 17.5% • Medical books 16.9% • Drug Samples 6.9% -Blake RL, Early EK, 1995