Doctors and Drug Companies Copyright 2011

The Problem Drug companies spend a lot of money to influence doctors’ prescribing patterns It works This leads to medical practice that is more based on publicity and promotions than on scientific evidence

How it works At morning report, a senior faculty member is working through a case with the residents and interns. "First we saw these symptoms. Now that the lab results are back. How does that change what we think?" There are bagels and juice, provided by a drug company. A representative of the drug company offers the residents pens, notebooks, and little stuffed toys, all with the company logo prominently displayed. Morreim H. Prescribing under the influence.Prescribing under the influence.

How it works Doctors say of such marketing: "It doesn’t influence me at all“ They underestimate the efficacy of such tactics The goal is simply to get the names of products in front of the physicians Morreim H. Prescribing under the influence.Prescribing under the influence.

Doctors think of themselves, but not their colleagues, as impervious Survey sent to 397 members of ACOG Asked about gifts and free samples Most doctors thought that they would not be influenced but that their peers would Morgan et al. J Med Ethics

Is it proper to accept gifts? Morgan et al. J Med Ethics

Would a gift influence you? Morgan et al. J Med Ethics. 2006

Would a gift influence other doctors? Morgan et al. J Med Ethics

Percent of residents in each year who thought it appropriate to accept free lunch Very inappropriate Very appropriate Schneider et al. Acad Med. 2006;81:

House staff tend to see peers, not selves, as corruptible Steinman et al. Am J Med

Maintaining irrational views MDs had positive views of detailing despite knowing it presented a conflict of interest To reduce cognitive dissonance they: – avoided thinking about the conflict – said that interactions did not affect MDs – told how they remained impartial – said that meetings were educational – said meetings benefitted patients Chimonas et al. J Gen Int Med

"The evidence suggests that self-interest has a tendency to bias independent judgment in unconscious ways." - David Korn, MD, AAMC

Free samples biggest piece of marketing budget Donohue et al. N Engl J Med Direct-to-Consumer Advertising

AMA guidelines allow certain types of small gifts Gifts are permitted if they: –benefit patients –are of minimal value –relate to the physician’s work –are educational medical-ethics/code-medical-ethics/opinion8061.shtml

AMA guidelines allow drug companies to sponsor conferences Subsidies for meetings should be given to the conference's sponsor, not to individual participants Physicians should not accept subsidies for travel, lodging, personal expenses or their time Scholarship funds should go to students who are selected by the academic or training institution Gifts should not be accepted if there are "strings attached" medical-ethics/code-medical-ethics/opinion8061.shtml

American College of Physicians and of Internal Medicine more strict “The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged” “Physicians should not accept gifts, hospitality, services, and subsidies from industry if acceptance might diminish, or appear to others to diminish, the objectivity of professional judgment”

Campbell. Arch Intern Med Policies seem to be changing doctors’ behavior

Does it matter?

Effects of marketing A review of 29 empirical articles on the effect of industry interactions led to the following conclusion: “Although some positive outcomes were identified (improved ability to identify the treatment for complicated illnesses), most studies found negative outcomes associated with the interaction” Wazana. JAMA

Marketing ’ s negative effects on medical care Inability to identify wrong claims about medication Positive attitude toward pharma representatives More prescribing of new drugs, less of generics Increasing overall prescription rate Wazana. JAMA

Do visits by drug company reps influence prescribing practices? 165 Danish general practitioners were visited by drug representatives 832 times from April, 2001 to July, 2003 The reps promoted Symbicort Turbohaler Over the study period, these doctors treated 54,080 patients with asthma drugs Sondergaard, Family Medicine. 2009

What percentage of prescriptions were for the Turbohaler? Before first visit by drug rep: 15% After third visit by drug rep: 28% Sondergaard, Family Medicine. 2009

Physicians with access to free samples tend to prescribe drugs that are more costly and that differ from their drugs of choice

The effect of free samples 29 internal-medicine residents made 390 decisions to start drug therapy over six months in an urban clinic Half of the residents, randomly selected, agreed not to use available drug samples Five drug class pairs were chosen for study prospectively Highly-advertised drugs were matched with drugs commonly used for the same indication that were cheaper, generic and/or OTC Adair, Holmgren, Am J of Med. 2005

Access to free samples led to more prescriptions of advertised drugs Adair, Holmgren. Am J of Med

Even small gifts (i.e. pens) influence prescribing patterns 352 third- and fourth-year students Two medical schools with different policies toward drug marketing Subjects assigned to treatment were exposed to small branded promotional items for Lipitor (atorvastatin) Implicit Association Test (IAT) used to gauge attitudes toward Lipitor and Zocor in exposed and control groups Grande et al. Arch Intern Med

Different responses to promotional items at different schools Note: Univ. of Penn restricts drug marketing; Univ. of Miami does not Grande et al. Arch Intern Med

Conclusion “Subtle exposure to small pharmaceutical promotional items influences implicit attitudes toward marketed products among medical students. We observed a reversal of this effect in the setting of restrictive policies and more negative school-level attitudes toward marketing.” Grande et al. Arch Intern Med

American Medical Student Association (AMSA) campaigns to end drug- company gifts In 2002, the AMSA launched its “Pharmfree” campaign and adopted the following standards: “All medical students should learn about the ethics of drug company interaction with health professionals and make the rational, informed decision to eschew "free" gifts from the pharmaceutical industry throughout their training careers.”

AMSA grades medical schools based on conflict of interest policies The American Medical Student Association each year grades U.S. medical schools for their conflict-of-interest policy – or lack thereof Grades are based on policies addressing drug samples, gifts, payments for consulting or speaking, funding of education and other factors

2009 grades cover the gamut A – 12 schools B – 46 schools C – 20 D – 13 schools F – 30 schools I (incomplete) - 28 schools

ProPublica, a website, now provides lists of individual doctors who have taken money from drug companies Type a physician’s name into the database and find out how much he or she was paid by the seven drug companies during 18 months in 2008 and 2009 ProPublica also is producing a series of stories titled “Dollars for Docs” about drug company influence over physicians, medical practice and medical education

Legislative initiatives

In Congress The Physician Payment Sunshine Act, part of the Affordable Care Act, requires drug and medical-device companies to report all payments to doctors and teaching hospitals that exceed $100 annually. DHHS will post the records on a web site. Payments related to clinical trials or product development agreements for new products can remain confidential for four years or until product approval, whichever comes first.

In statehouses Vermont, Minnesota, W. Virginia, California, Maine, Massachusetts, and Washington D.C. have laws limiting gifts from drug companies to doctors, and/or requiring disclosure of some gifts and expenditures.

Trends are clear Professional society guidelines are more and more restrictive Laws and regulations demand disclosure Traditional means of promoting drugs are gradually changing

Lessons for the practitioner Drug companies work harder to influence you than you work to resist their efforts Studies show that you are more malleable than you think you are Smaller gifts are as powerful as bigger ones Gifts will be made public

Resources The Pew Prescription ProjectThe Pew Prescription Project - This initiative of the Pew Charitable Trusts aims to promote consumer safety through reforms in the approval, manufacture and marketing of prescription drugs, as well as through initiatives to encourage evidence-based prescribing. The Pew Prescription Project conducts rigorous nonpartisan research related to federal oversight of drug safety to better illuminate problems and potential solutions. PharmFreePharmFree - In 2002, the American Medical Student Association launched a campaign to end gift-giving relationships between physicians and the pharmaceutical industry. The site has ratings of medical-school conflict-of-interest policies, news articles, information about state and federal legislation and a guide on getting involved in the issue. RCT finds medical residents prescribe costlier drugs when free samples are available: Adair RF, Holmgren LR. Do drug samples influence resident prescribing behavior? A randomized trial. Am J Med Aug;118(8):881-4.Do drug samples influence resident prescribing behavior? A randomized trial Drug gifts lead docs to seek additions to formulary: Chren MM, Landefeld CS. Physicians’ Behavior and their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary. JAMA. 1994;271(9): Physicians’ Behavior and their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary The American Medical Association’s guidelines to physicians on accepting gifts from industry: Code of Medical Ethics. Opinion – Gifts to Physicians from Industry Opinion – Gifts to Physicians from Industry

Resources (cont’d) Essay argues that doctors can’t help but be swayed by favors from drug companies: Dana J, Loewenstein G. A Social Science Perspective on Gifts to Physicians from Industry. JAMA. 2003;290(2): A Social Science Perspective on Gifts to Physicians from Industry RCT finds 4 th -year medical students tend to be swayed by drug marketing: Grande D, Frosch DL, Perkins AW, Kahn BE. Effect of exposure to small pharmaceutical promotional items on treatment preferences. Arch Intern Med May 11;169(9): Effect of exposure to small pharmaceutical promotional items on treatment preferences Study by business-school faculty takes position that drug-rep detailing leads to relatively few additional prescriptions: Mizik N, Jacobson R. Are Physicians ‘Easy Marks’?: Quantifying the Effects of Detailing and Sampling on New Prescriptions. Management Science. 2004;50(12):1704.Are Physicians ‘Easy Marks’?: Quantifying the Effects of Detailing and Sampling on New Prescriptions O’Reilly KB. Drug industry ties to doctors weaken as disclosure, gift rules spread: More physicians are saying no to free lunches, drug reps and consulting relationships, new data show Nov 29.Drug industry ties to doctors weaken as disclosure, gift rules spread: More physicians are saying no to free lunches, drug reps and consulting relationships, new data show. A review of 29 studies concludes that gifts influence practice: Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA Jan 19;283(3):373-80Physicians and the pharmaceutical industry: is a gift ever just a gift?