An Ethical Framework for Clinician/Industry Interactions Mansoor Malik MD Howard University Hospital

An Ethical Frameworkfor

Clinician/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

Full Disclosure

• ~ 10 Lunches• ~ 12 Detail visits• ~ 8 Pens• ~ 1 Sticky pad• ~ 4 Dinners• ~ 2 Toys

2010 Gifts and Meals

But no:

• Theater tickets

• Resort junkets

• Golf excursions

• Turkeys or hams

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

Median BrandLaunched Prior to 1993(Older Drugs)

Larger brandLaunched 1997 to 1999(Newer Drugs)

Journal Advertising $5.00 $5.42

Sales Rep Detailing $1.72 $10.29

Physician Events $3.56

Direct to Consumer $0.19 $1.37

PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY

• 83.8% of all respondents reported some type of relationship with industry during the previous year

• 63.8% received drug samples• 70.6% food and beverages• 18.3% reimbursements• 14.1% payments for 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 GoalsCompeting Goals

Pharmaceutical Industry

Profit-making enterprise

Duty is to stockholders

Medicine

Advocate for patient interest

Duty is to patients

Primary Aims

Clinical Medicine Patient benefit Societal benefit

Academic Medicine Acquisition anddissemination ofknowledge

Medical Industry Financial gain

Positive Practices

Clinical Medicine Patient treatment Physician-patient relationship

Academic Medicine Research Education

Medical Industry Development of safe andeffective treatments

Sponsorship of educationprograms

Sponsorship of research

Negative Practices

Clinical Medicine Paternalism Boundary violations Incompetent practice Financial concerns

Academic Medicine Career development

Medical Industry Marketing bias in researchand education

Excessive profits

Oversight

Clinical Medicine Professional standards Moderate government

regulation

Academic Medicine Academic standards Minimal government

regulation

Medical Industry Extensive governmentregulation

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.

• What do physicians think of this

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

Percent Who Consider Appropriate

0

20

40

60

80

100

abxguide

conf.lunch

dinnerlect.

article pen social text CME luggage

Very appropriateSomewhat appropriate

Am J Med 2001;110:551

• 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

It is Just Free Lunch?

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

• How do you account for the discrepancy ?

• Cognitive Dissonance

Festinger’s Theory of Cognitive Dissonance

• When Prophecy Fails 1957

• Festinger, Riecken, & Schacter

Cognitive Dissonance

• Subjects are paid varying amounts of money (e.g. $1 or $100) for writing essays expressing opinions contrary to their own

• Those in the $1 group rated them more positively than those in the $100 group

• Less external justification and forced to internalize the attitude they initially opposed

Prophecy from planet Clarion : flee the flood

• House wife in Chicago Dorothy Martin, (Sister Thedra ), received messages in the form of automatic writing from alien from planet Clarion

• Believed that world would end in a great flood before dawn on December 21, 1954

• Group gave away everything and waited for the flying saucer

Failure of Prophecy from planet Clarion…

• The group begins an urgent campaign to spread its message to as broad an audience as possible.

• Reversal of its previous distaste for publicity

• Merged into Dianetics and Scientology ?

Dissonance Model

Two inconsistentcogntions (e.g., anattitude and a counter-attitudinal behavior)

State ofdissonance

Motivationto reducedissonance

Attitudechange

Dissonance Model

Two inconsistentcogntions (e.g., anattitude and a counter-attitudinal behavior)

State ofdissonance

Motivationto reducedissonance

Attitudechange

UNLESS Justificationfor counter-attitudinalbehavior

Dissonance Model

Two inconsistentcogntions (e.g., anattitude and a counter-attitudinal behavior)

State ofdissonance

Motivationto reducedissonance

Attitudechange

UNLESS Justificationfor counter-attitudinalbehavior

Cognitive Dissonance

• Subjects are paid varying amounts of money (e.g. $1 or $100) for writing essays expressing opinions contrary to their own

• Those in the $1 group rated them more positively than those in the $100 group

• Less external justification and forced to internalize the attitude they initially opposed

Moral of the Story

• No gift is too small

ResidentsResidents

Pharmaceutical marketers know that lasting Pharmaceutical marketers know that lasting habits and attitudes are formed early in habits and attitudes are formed early in physicians’ training (e.g., Wazana, 2000)physicians’ training (e.g., Wazana, 2000)Residents are more readily to attest to the Residents are more readily to attest to the possible impact on their peers (Keim, et al., possible impact on their peers (Keim, et al., 1993)1993)

SELF-SERVING BIAS

Samples are for the good of needy patients, right?

• Int. Med residents’ prescribing patterns of 5 drug class pairs were studied • Decreased use of unadvertised drugs• Decreased use of OTC drugs• Trend towards a decrease in use of less expensive drugs

-Adair RF, Holmgren LR, 2005

Industry and Research Funding

• Industry-funded studies are more likely to report positive outcome.

• Involvement of drug company employee has a much greater effect on outcome than financial sponsorship

FDA Approves Sale Of Prescription PlaceboSEPTEMBER 17, 2003

-Tungaraza T, 2007

Industry and Research Funding

• Study of NEJM and JAMA articles (2001)• 16.6%-32.6% of articles had one or more authors with

COI• 38.7% of drug studies had authors with COI• Strong association between authors with COI and

positive reported finding.

-Friedman LS, 2004

Ghostwriting

• JAMA study defined a ghostwriter as any unnamed individual who made substantive

• intellectual contributions or writing other than

• copy‐editing

• – 7.9 % in JAMA

• – 4.9 % in the Annals of Internal Medicine

• – 10.9 % rate NEJM

• – 7.6 % in The Lancet

• Flanagin at el; JAMA, July 15, 1998—Vol 280, No. 3

How reliable are marketing brochures

• Only 6% of the brochures contained statements that were scientifically supported by identifiable literature

• Tufts, A; BMJ 2004; 328 : 485

How reliable are marketing brochures

• Only 40% were compared to another treatment regimen

• 15% of the promotional marketing brochures presented data that was different from what was in the original published study

• Only 5 % presented a relative risk reduction while only 1 brochure presented an absolute risk reduction

• Cardarelli et al, BMC Fam Pract. 2006; 7: 13

How reliable are marketing brochures

• 122 GP in Pakistan

• Promotional materials covering 182 drugs

• One quarter (21%), false claims , no evidence to support

• exaggerated (32%), ambiguous (26%), and controversial (21%).

• Rohra et al, J Pharm Pharm Sci. 2006;9(1):50-9

• Health knowledge of both physicians and patients systematically distorted by views and models of disease that sell the most drugs

• –

False Claims Act Settlements

• AstraZeneca pays $520 million to resolve allegations that Seroquel was promoted for uses not FDA approved

• Alpharma Inc. pays $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug Kadian

• Warner–Lambert paid more than $430 million to settle illegal marketing charges for Neurontin

What now?What now?

Limiting gift size, educational incentives, and Limiting gift size, educational incentives, and mandatory disclosure are unlikely to eliminate mandatory disclosure are unlikely to eliminate bias because they rely on a faulty model of bias because they rely on a faulty model of human behavior (Dana & Loewenstein, 2003). human behavior (Dana & Loewenstein, 2003).

Movement towards “zero tolerance” threshold Movement towards “zero tolerance” threshold (Krimsky S, 2003)(Krimsky S, 2003)

Pharmaceutical Research and Manufacturers of Pharmaceutical Research and Manufacturers of America (PhRMA) Code of ConductAmerica (PhRMA) Code of Conduct

““Interactions between company representatives Interactions between company representatives and physicians should primarily benefit patients and physicians should primarily benefit patients and enhance the practice of medicine.” (2002)and enhance the practice of medicine.” (2002)

FDA Guidelines

• All marketing materials must be FDA approved, and information shared during marketing contacts may not exceed the boundaries of approved packaging information

• Sponsored speakers may answer questions, but may not initiate or perpetuate discussion of “off-label” drug uses

FDA Guidelines

• Sponsored speakers may only discuss information derived from accepted research methods or recognized expert consensus opinion

• Research studies involving a competitor’s drug must follow packaging guidelines for the drug

ACCME Guidelines forCME Programs

• Potential or perceived conflicts of interest regarding the topic of the presentation must be disclosed

• Presentations must include specific learning objectives

• The speaker’s qualifications must be appropriate to the topic covered

AMA Ethical Guidelines

• Any gift should benefit patients

• Gifts should be of minimal value and related to the physician’s work

• No gifts should be accepted with strings attached

AMA Ethical Guidelines

• Support for legitimate conferences or meetings (including faculty honoraria) is permissible

• Subsidies for individual physicians to attend meetings are not permissible

• Scholarships for residents and fellows must be assigned by the training program

Final Thoughts

• “You are in this profession as a calling, not as a business; as a calling which exacts from you at every turn self-sacrifice, devotion, love, and tenderness to your fellow-men. Once you get down to the purely business level, your influence is gone and the true light of your life is dimmed. You must work in the missionary spirit, with a breadth of charity that raises you far above the petty jealousies of life.

-Sir William Osler

Readings

• Lexchin J. Interactions between physicians and the pharmaceutical industry: What does the literature say? Can Med Assoc J 149:1401-07; 1993

• Rosner F. Pharmaceutical industry support for continuing medical education programs: A review of current ethical guidelines. Mt. Sinai J Med 62:427-63; 1995

• Wazana A. Physicians and the Pharmaceutical Industry: Is a gift ever just a gift? JAMA 283:373-80; 2000