Conflicts of Interest:Understanding the Impact of Relationships with Industry

Douglas S. Diekema MD, MPHCenter for Pediatric Bioethics, SCRI

Professor of PediatricsUniversity of Washington

Conflict of Interest: “a conflict between the private interests and the official responsibilities of a person in a position of trust.”

Merriam-Webster OnLine Dictionary 2005

“When honest human beings have a vested stake in seeing the world in a particular way, they’re incapable of

objectivity and independence.”

--Max H. Bazerman, Professor at Harvard Business School

Gardiner and Roberts. New York Times, March 21, 2007.

Three Messages

• Industry uses techniques to influence and alter your behavior

• These techniques are disguised so that you are not aware that you are being influenced

• You are susceptible

Three Messages

• Industry uses techniques to influence and alter your behavior

• These techniques are disguised so that you are not aware that you are being influenced

• You are susceptible…especially if you don’t think you are

Relationships with Industry are Pervasive

• 94% of physicians have some kind of relationship with industry

• 67% of US Med Schools have relationships with Industry

• 65% of clinical departments receive Industry funds for CME

• 37% of clinical departments receive Industry funds for residency/fellowship programs

Campbell et al. NEJM 2007; 356:1742 and JAMA 2007; 298:1779

Drug Company Spending 2004

• $28-57 Billion a year on promotions• 83% of marketing targeted at prescribers• $61,000 per year per physician• 25% of Revenues: Marketing & Promotion• 13% of Revenues: R & D• 81,000 sales reps• 1 sales rep for every 8 physicians (or 10

prescribers)

Light & Lexchin. BMJ 2012; 344:e4348

Drug Company Marketing

• The $5.5 billion spent to market to MDs exceeds all US medical school spending to educate medical students

• Marketing begins even before product development and permeates the process

• Marketing Works!

Marketing “is almost as scientific as anything we do.”

Gerald LeubackFormer President of Pfizer

Clark, The Want Makers: The World of Advertising

Marketing

• Advertisements: Journals and Direct to Consumer

• Pharmaceutical Rep Visits, Meeting “Carnivals”

• Gifts, mugs, pens• Disguised as Social Events• Disguised as Education• Disguised as Research• Disguised as Consultation

Marketing Disguised as Research

• Peer-reviewed Journal Articles with industry sponsors

• Review articles and editorials written by experts with industry ties

• Consensus panels, FDA review panels with most members tied to industry

• Drugs in search of a disease: short stature, sleep disorders, level of cholesterol requiring treatment, pre-hypertension, social anxiety disorder, erectile dysfunction etc.

Studies Comparing Topical Prostaglandins

• 39 publications reviewed• 10 Non-industry studies: Abstract

conclusion matches results• 29 Industry-sponsored studies: 62%

don’t match• 90% of industry-funded studies had

pro-industry abstract conclusions

Alasbali et al. Am J. Ophthalmol 2009; 147: 33-38

Marketing as Education

• Drug companies fund >60% of CME• Medical Education and Communication

Companies (MECCs)• Educational Seminars/Symposia• Some Patient Advocacy Groups are industry “fronts” that provide “education” and speakers

• “Consultant” Arrangements

An Example: Neurontin

• FDA approved as add-on when other drugs failed for seizures

• Pretty small market?

• How do you expand the market?

Neurontin: “Publications Strategy”

• Sponsor small research projects involving off-label uses (many overseas)

• Prepare journal articles• Pay academics to “author”• “Authors” and “Experts” paid to

disseminate the results (as speakers)• “Consultant” physicians paid to attend

those talks

Angell. The Truth about Drug Companies, 156-60.

Did it Work?

Prescriptions for the drug increased 70% among physicians

attending dinner meetings

“It is widely acknowledged that most of the top medical authorities in this country, and virtually all of the top speakers on medical

topics, are employed in some capacity by one or more of the country’s pharmaceutical

companies. That is how it should be.”

--Washington Legal Foundation comments at ACGME hearing,

Jan 2003

Kassirer, On the Take, 19.

Detailing: Merck & Vioxx

• Sales reps told to provide only “approved” (i.e. favorable) study results to MDs and forbidden to provide those raising safety questions

• Trained reps to identify “opinion leaders”for educational events: those who could provide a favorable view of company products

Detailing: Merck & Vioxx (2)

• Sales reps told to track whether physicians attending educational events subsequently prescribed more company products

• Counseled and taught to use “subliminal” sales techniques

• Not unique to Merck

Waxman NEJM 2005; 352: 2576

Commercial Detailing Techniques

• Reciprocation (Gift-giving)• Commitment/consistency• Social validation• Authority• “Building a bridge of similarity” with customer• Friendship/Relationship/Liking• Scarcity

Aust NZ J Med 1998; 28: 306-310Cialdini. Influence: The Psychology of Persuasion. NY: Quill, 1993

The Emotional Brain

Whether we like it or not, we are strongly motivated to act based upon what makes us feel good and what makes us feel bad

Positive Feelings make us more receptive to message

• Food• Gifts• Flattery• Identifying common ground• Positive social relationship• Want to know what YOU think

New York Times Story

Gimme an Rx! Cheerleaders

Pep Up Drug Sales

November 28, 2005

“We want to identify the emotions we can tap into to get that customer to take

the desired course of action.”

--Ernestine McCarren, Ad agency executive

Abramson, Overdosed America 155.

The Bias Blind Spot

Pronin et al. Personality & Soc Psychol Bull 2002; 28:369.

The Bias Blind Spot

• We have the impression we see issues and events “objectively”

• We underestimate the degree to which we are influenced by cognitive and motivational bias and overestimate the degree to which others are influenced by bias

• We see ourselves as more perceptive of influences on behavior and judgment than others

Pronin et al. Personality & Soc Psychol Bull 2002; 28:369.

“I have never been bought. I cannot be bought. I am an icon, and I have a reputation for honesty

and integrity, and let the chips fall where they may….It is true there are people in my situation who could not receive a million-dollar grant and

stay objective. But I do.”

--C. Everett Koop, defending a grant from Schering-Plough to

the Koop Foundation

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

Perceived influence of pharmaceutical reps on Prescribing Practices

Am J Med 2001;110:551

A little38%

A lot1%

None61%

P<.0001“You” “Other Physicians”

The Gift Relationship

• Researchers say gifts and pharma reps do not influence them.

• Researchers believe other Researchers are influenced

• Researchers behavior changes based on interactions with pharmaceutical reps– Requests for formulary changes– Changes in prescribing behavior

• Pharma reps say freebies are a highly effective strategy for increasing sales

Gifts: A Broader View

• Free CME• Food, Dinners• Travel opportunities• Free goodies• Research Grants• Opportunities to consult, speak

Gifts and Social Science

• Any gift imposes a sense of indebtedness• Perceived obligation to reciprocate

influences behavior• This tendency has survival value and

generates positive emotions (strong motivational effect)

• Occurs regardless of size or value of gift

Don’t buy it?

• Mail Surveys that include a check or $1

• Store that gives small gift on entry sees significant increase in sales

• Birthday card sent by insurance agent• Small gift (return address labels)

accompany requests for donations• Bring bottle of wine to dinner party

What about small gifts?

• Usually coupled with a discussion about the gifter’s product

• Opens the door to communication and promotes a friendly relationship between the two parties

• Likely to be more attentive and receptive to those who provide gift

• May feel need to reciprocate (by giving them my time and attention if not by using their product)

Cornell Candy Study

• School of Hotel Administration• “Sweetening the Till: The use of candy

to increase restaurant tipping”• Experiment 1: Giving customers candy

increased tips from 15.1% to 17.8% of bill (p=.0001)

• Attributed to the “customers’ need to reciprocate for the gifts of candy.”

Strohmetz et al. J App Soc Psychol 2002; 32: 300.

Cornell Candy Experiment 2

• No Candy 19% tip• One candy 19.6% tip• Two candy 21.6% tip

• Offered one piece of candy and then “spontaneously” suggested they take a second piece:23% tip

Strohmetz et al. J App Soc Psychol 2002; 32: 300.

Gifts: Bottom Line

It’s about the relationship!

Summary

• Researchers do not believe they are influenced by industry

• Researchers are influenced by industry

• The more gifts a person receives, the more likely he or she is to believe they are not influenced

Summary

• Denial, self-deception, and failure to attend to the dangers of relationships with industry is the greatest problem

• Humility is essential: If you realize how easily you can be influenced, you are more capable of defending yourself

• Recognition of the danger, attention to the methods that pose the danger allow one to be on guard

Who is on your rope team?

References

• Jerome Kassirer, On the Take: How Medicine’s Complicity with Big Business can Endanger your Health. Oxford, 2005.

• Marcia Angell, The Truth about Drug Companies: How they Deceive us and what to do about it. Random House 2004.

• John Abramson, Overdosed America: The Broken Promise of American Medicine. Harper Collins 2004.

• Abramson & Starfield JABFP 2005; 18: 414