Healthy Skepticism

Laura S. Boylan, MD

Department of Neurology

New York University School of Medicine

Many thanks:

PharmedOUT (www.pharmedout.org)

No Free Lunch (www.nofreelunch.org)

The Problem

Zillions of dollars hang on our medical decisions.

Patients lives and health depend on our medical decisions.

Industry stakeholders will seek to influence our decisions to maximize revenue

Revenue maximization is different than health promotion.

Understanding how industry uses doctors' enthusiasm, status and self interest in order to sell products is an important step in cultivating a medical practice driven by patient interests.

Headlines 2007-2010

Researchers Fail to Reveal Full Drug Pay

Drug Maker Hired Writing Company for Doctors’

Book, Documents Say

The CAGE Questionnaire for Drug Company Dependence

• Have you ever prescribed CelebrexTM?

• Do you get Annoyed by people who complain about drug lunches and free gifts?

• Is there a medication loGo on the pen you're using right now?

• Do you drink your morning Eye-opener out of a LipitorTM coffee mug?

If you answered yes to 2 or more of the above, you may be drug company dependent.

Physician Payments Sunshine Act, 2009

Requires companies to begin recording any physician payments that are worth more than $10 in 2012 and to report them on March 31, 2013.

Sun Sets on Drug-Company Pens in Doctors’ Offices12/31/2008, WSJ

But the marketing goes on.....

Levels of Interactions:

• Clinicians– Gifts, food/meals, Samples– Meeting with reps– continuing medical education (CME)

• Researchers

• Medical Schools

• Professional societies; medical journals

Studies consistently show that promotion increases prescribing*

Studies consistently show that physicians do not believe that promotion affects prescribing**

*Chren MM and Landefeld CSl. JAMA 1994 Mar 2;271(9):684-9. *Chren MM and Landefeld CSl. JAMA 1994 Mar 2;271(9):684-9. AbstractAbstract Lurie N et al. J Gen Int Med 1990;5(3):240-243. Lurie N et al. J Gen Int Med 1990;5(3):240-243. AbstractAbstract Wazana A. JAMA 2000 Jan 19;283(3):373-80. Wazana A. JAMA 2000 Jan 19;283(3):373-80. AbstractAbstract**Sigworth SK et al. JAMA. 2001 Sept 5;286(9):1024-5. **Sigworth SK et al. JAMA. 2001 Sept 5;286(9):1024-5. AbstractAbstract McKinney WP et al. JAMA 1990 Oct 3;264(13):1693-7. McKinney WP et al. JAMA 1990 Oct 3;264(13):1693-7. AbstractAbstract

“Doctors are too smart to be bought by a slice of pizza“

Ex-reps speak outEx-reps speak out

During training, I was told, when you’re out to dinner with a doctor, “The physician is eating with a friend. You are eating with a client”.

Shahram Ahari* “The essence of pharmaceutical gifting…is ‘bribes

that aren’t considered bribes.”

Michael Oldani You are absolutely buying love.

James Reidy

*Fugh-Berman A and Ahari S. PLoS Med. 2007 Apr 24;4(4):e150. Full text Elliott C. Atlantic Monthly. 2006 Apr;297(3):82-93. Full text

The AMA Physician MasterfileThe AMA Physician Masterfile

Contains demographic data that the AMA has sold to industry continuously since the 1940s*

In 2005, licensing Masterfile information and other database product sales provided about 16% ($44 million) of the AMA’s revenue**

*Greene JA. Ann Int Med. 2007 May 15;146:742-8. Full text

**Steinbrook R. NEJM. 2006 Jun 29;354(26):2745-7. Abstract

AMA’s Prescription Data Restriction AMA’s Prescription Data Restriction Plan (PDRP)Plan (PDRP)

Few physicians know about it < 1% of doctors have signed up "Just giving them an option [to opt-out] alleviates

their concerns," explained the AMA’s senior VP of publishing and business services to Pharmaceutical Executive

Herskovits B. Pharm Exec Direct. 2006 Jul 19. Full text

High Stakesdifferential costs, 1 yr supply

• HCTZ $58, amlodipine (Norvasc) $920 (16x)

• Phenytoin $275, topiramate (Topamax) $4,800 (17x)

• Ibuprofen $96, Rofecoxib (Vioxx) $910 (Vioxx withdrawn due to cardiac risk)

• Fioricet (gen) $38, eletriptan (Relpax) $1,400 (37x)

• Comparative effectiveness studies have demonstrated equivalent effectiveness of generic antidepressants,1,2 but more expensive patented compounds hold the majority of the market share. 3

1. Rush AJ. N Engl J Med 2006;354:1231–422. March J. JAMA. 2004;292(7):807–8203. IMS, IMS Health. 2010.

The Evidence: Branded Antidepressants

The costs of promotionThe costs of promotion

In 2004, total promotion cost for Rx drugs was almost $30 billion

About $7 billion spent on detailing NIH budget FY 2008 is $29 billion* FDA budget FY 2008 is $2 billion**

West D. Changing lanes. Pharm Exec. 2005 May;25(5):154-162. Full text *NIH summary of the FY 2008 president’s budget, 2007 Feb 5. Summary**Summary of FDA’s FY 2008 budget. Summary

New drugs are not New drugs are not necessarily better drugsnecessarily better drugs

Most new drugs are me-too drugs, or combinations of old drugs

In general, generic drugs are safer than branded drugs simply because more information is available about them

Is promotion worth it?Is promotion worth it?

In 2006, the ten best-selling global pharma brands made $53.5 billion*

In 2001, the average return on investment per dollar spent on promotion was $12.70**

*Robins R. Successful Product Manager’s Handbook. Pharm Exec 2007 Mar 1;7:38-41.

**Niles S. Med Ad News 2004 Mar;23(3):1

“I only see reps for the samples”

Why docs like samples

Start treatment immediately Test tolerance to a new drug Reduce the total cost of a Rx Provide free medication to those who

can’t afford it

Why drug companies like samples

Increases “new starts” on a new drug Encourages switches from other drugs Patients usually stay on the sampled drug Increases prescriptions of the most

expensive, most promoted drugs

Gain access to physicians Habituate physicians to

prescribing targeted drugs Increase goodwill by enabling

doctors to give gifts to patients Serve as unacknowledged gifts to

physicians and staff

The real purpose of samples

“I Give Samples to Patients Who Can’t Afford Drugs”

• A study of 32,681 US residents from the 2003 Medical Expenditure Panel Survey (MEPS) found that in 2003

12% of Americans received at least 1 free drug sample

Poor and uninsured Americans were less likely than wealthy or insured Americans to receive samples

Cutrona. Am J Pub Health, 2008

Samples are a marketing toolSamples are a marketing tool

“…the manufacturer needs to figure out the right amount of samples the rep has to drop off in order to maximize the number of paid prescriptions written.”

Tsang J and Rudychev I. Medical Marketing & Media. 2006 Feb;41(2):52-8.

Bias in promotional materials

The Accuracy of Drug Information From Pharmaceutical Sales Representatives

• Setting: Noon conferences at a large university-based internal medicine residency program.

• Pharmacist tape-recorded comments made by drug reps prior to faculty lecture (106 statements, 13 conferences)

• Statement accuracy classified based on predefined criteria.

JAMA 1995;273:1296

The Accuracy of Drug Information From Pharmaceutical Sales Representatives

JAMA 1995;273:1296

11%

100%

27%

0%

20%

40%

60%

80%

100%

Inaccurate Errorsfavorable to

company's drug

Residentsrecalling single

inaccuratestatement

Epilogue: Do doctors need drug reps?

• MedicalLetter.com

• Micromedex.com

• MDConsult.com

Bottom Line

• Doctors insist they are not influenced by accepting gifts (including samples)

• Evidence proves otherwise

• This costs society and erodes the profession

NYU SOM Policy est 10/08

• No interactions with medical students and housestaff by pharmaceutical/device representatives allowed on the grounds of SOM or any of it’s teaching hospitals.

• Medical students and housestaff shall not be invited to industry-sponsored events by those involved in supervising, teaching, and/or evaluating them.

• No gifts on or off-site (zero dollar limit)

• Provision of Educational Funds and Scholarships must go through NYU programs.

• The provision of pharmaceutical samples to or by medical students or housestaff is prohibited.

• Students may report violations to the Dean for Undergraduate Medical Education and are assured of no repercussions for such reporting.

http://webdoc.nyumc.org/nyumc/files/gme/attachments/FINAL.pharma%20policy.10.24.08.doc

Where to Learn More …

• Pharmed Out www.pharmedout.org

• No Free Lunch www.nofreelunch.org

• AMSA’s PharmFree campaign www.pharmfree.org

• The Prescription Project http://www.prescriptionproject.org