Download The real purpose of samples

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.
Researchers Fail to Reveal Full Drug Pay
The CAGE Questionnaire
for Drug Company Dependence
• Have you ever prescribed Celebrex ?
TM
• 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 Lipitor
coffee mug?
If you answered yes to 2 or more of the above, you may be
drug company dependent.
TM
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’ Offices
12/31/2008, 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
“Doctors are too smart to be
bought by a slice of pizza“
 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. Abstract
Lurie N et al. J Gen Int Med 1990;5(3):240-243. Abstract
Wazana A. JAMA 2000 Jan 19;283(3):373-80. Abstract
**Sigworth SK et al. JAMA. 2001 Sept 5;286(9):1024-5. Abstract
McKinney WP et al. JAMA 1990 Oct 3;264(13):1693-7. Abstract
Ex-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 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
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 Stakes
differential 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)
The Evidence:
Branded Antidepressants
• 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;354:1231–42
2. March J. JAMA. 2004;292(7):807–820
3. IMS, IMS Health. 2010.
The 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
necessarily 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?
 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
The real purpose of samples




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
“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 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 universitybased 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
100%
100%
80%
60%
40%
20%
27%
11%
0%
Inaccurate
JAMA 1995;273:1296
Errors
Residents
favorable to
recalling single
company's drug
inaccurate
statement
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 industrysponsored 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/F
INAL.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