CHICAGO -- "We need to be holding their hand and
whispering in their ear Neurontin for pain, Neurontin for monotherapy,
Neurontin for bipolar, Neurontin for everything," sales reps at
Park-Davis, now Pfizer, were told in 1996 by senior executive John Ford.
"I don�t want to hear that safety crap either."
Eight years later a judgment against Pfizer under the False
Claims Act -- Neurontin could only be legally promoted for seizures and
post-shingles nerve pain -- awarded $430 million to the nation's attorneys general
who earmarked $21 million for development of educational products to immunize
prescribers against future Neurontin-style promotional misdeeds.
Earlier this month, representatives from 23 medical centers,
medical boards, accrediting agencies, the AMA, FDA, VA, the American Medical
Student Association, nurse and pharmacist organizations and attorney general
offices pooled their educational initiatives, some already institutionalized
into medical schools, at a Critical Prescribing Skills conference in Chicago,
hosted by the University of Illinois-Chicago (UIC).
Extraordinary for a medical meeting, Crestor and Vytorin
tote bags were absent and the conflicts of interest sheet the 150 participants
received on arrival showed 40 of 42 speakers had none. Rather than simply
bashing or banning the high flying detailing of drug sales reps responsible for
the Neurontin scandal, the doctor, pharmacist and nurse panelists suggested
incorporating the industry's own sales techniques in "academic
detailing" for better balance in teaching and learning about drugs.
A pharmaceutical marketing elective, for example, developed
from the settlement at the UIC College of Pharmacy by conference chairs, Bruce
L. Lambert, Ph.D., professor, Department of Pharmacy Administration and Gordon
D. Schiff, M.D., associate professor, Harvard Brigham and Women's Hospital uses
former sales reps to demonstrate how one-on-one encounters can become
The Chicago project, based at UIC and Cook County Stroger
Hospital, Chicago's only public hospital, leveraged the
institutions' formulary committees to help serve as firewalls to offset such
excessive pressure, says Dr. Schiff, former director of Clinical Quality
Research and Improvement at Stroger. "We invited sales reps to go on the
record and videotape their drug pitch, which we told them we would show
unedited to the formulary committee -- but there were no takers."
Prescribers were taught how to deal with patients who come
in waving ads since direct-to-consumer advertising was legalized in 1997.
"Doctors have a hard time saying no if a drug is effective, even if it is
expensive," said Audiey Kao, M.D., vice president of Ethics at the
American Medical Association which created two educational products, shown at
the conference. Doctors are "nervous" that rebuffed patients will go
elsewhere, agreed Richard Pinckney, M.D., professor at the University of
Vermont College of Medicine, whose project teaches prescribers refusal skills
and sends "secret shoppers" to ask for a brand name insomnia drug to
see how training worked.
Even though writing a prescription may seem quicker, "explaining
to a patient why a highly advertised drug might not be appropriate only takes
three minutes," says Dr. Pinckney "and the insurance savings could
pay for programs like these."
Based on documents uncovered in the Neurontin lawsuit,
tactics beyond detailing and advertising are used to promote drugs. Prescribers
who read secondary research may not realize the original research is fraudulent
or ghostwritten, said presenters, like a growing number of court-subpoenaed
papers now stored on University of California at San Francisco's growing Drug
Industry Document Archive (DIDA). And conflict of interest disclosures
themselves can be too numerous to list in print so they are only listed online.
"Without a paid subscription, you won't see authors' conflict of interest
disclosures for articles published in the New England Journal of Medicine but
you will see ads for Viagra," observed Dr. Schiff.
"Non-inferiority" studies purport to compare new
drugs to proven medicines, yet small studies or those with noncompliant
subjects can show drugs equivalent when they're not said presenters. And
promoting a drug by surrogate endpoints (e.g., altered test results) which
suggest but don't prove actual clinical outcomes of safety and effectiveness is
another problem, said Jerry Avorn, M.D., professor of Medicine at Harvard
Medical School. "We are spending billions on Vytorin to lower cholesterol,
yet the drug has not been proven to prevent heart disease and Avandia [a
diabetes glucose-lowering drug] causes a 40 percent increase in heart
attacks," said Dr. Avorn, who is author of Powerful Medicines.
The 62,000 member American Medical Student Association
(AMSA) is largely credited with focusing awareness on free gifts and lunches in
medical schools in 2002, especially after AMSA members refused a
pharma-supplied meal and produced an immediate mea culpa from a medical center.
In 2007, AMSA debuted its "scorecard" program which grades the
nation's 150 medical schools on their gift, consulting, speaker and disclosure
policies. (UIC got a D in 2009. Eleven schools got As.)
"The scorecard program has changed the landscape
because medical schools really understand grades," said Nitin Roper, MD, a
recent graduate and AMSA member. "Schools which originally wouldn't give
us their policies suddenly thought their grades were unfair. In a revealing
turn of the tables, one medical school contacted our student organization to
request its D grade be changed to a C+."
Many of the Neurontin settlement-funded educational projects
are CMEs, continuing medical education courses, which state medical boards
require doctors take to retain their licenses. Unlike continuing education in
other professions like law, CMEs are usually free to doctors because the
pharmaceutical industry underwrites their cost and, some say, shapes their
CMEs developed by a team led by David Cohen, Ph.D., professor
of Social Work at Florida International University, exploring the link between
psychotropic drugs and public health are approved by the Florida Bar, National
Association of Social Workers, the American Psychological Association and six
other professional bodies and 3,900 credits have been awarded. Seventy percent
of psychotropic drug prescriptions are funded by the government, says Dr. Cohen
whose study investigates the effect on psychotropic drug prescriptions of
social workers' restraint in referring children to psychiatrists. So far
results, tracked in nine Dade County foster care agencies, have been promising.
Another showcased project demonstrated modules developed by
the Consumers Union, an arm of Consumer Reports, which help consumers be wiser
in drug choices. One third of patients after viewing the modules asked to speak
to their doctors or pharmacists and 15 percent changed their drug choice, said
University of Minnesota researchers who studied the project's effectiveness.
On the same day, FDA Commissioner Dr. Margaret Hamberg
announced a "bad drug" initiative in which health professionals are asked
to report questionable ads, Thomas Abrams, director of FDA's Division of Drug
Marketing, Advertising and Communication (DDMAC), briefed the conference on FDA
regulation of drug ads, and, it turned out, fielded participant concerns about
too tepid enforcement.
Why would an FDA warning letter about illegal advertising or
even an FDA-ordered corrective ad campaign, as seen with the Yaz birth control
pill, reform pharma, asked conference chair Dr. Lambert, when billion dollar
settlements over Zyprexa and Bextra marketing haven't? "Doesn't the FDA
have the authority to seize a product or take stronger actions?"
FDA sanctioned "disease awareness" ads were also
questioned. "Why are ads which appear to 'educate' but really create and
monger diseases to sell drugs permitted by the FDA?" asked National
Women's Health Network Executive Director Cindy Pearson.
Many project investigators reported the doctors that they
worked with denied being affected by pharmaceutical gifts though felt their
colleagues were. But Gregory Eastwood, M.D., professor of Medicine at SUNY
Upstate Medical University and former Dean of the Medical College of Georgia,
movingly recounted a $1,000 gift he received from Pfizer as a young resident
"Even though it was a long time ago and I am aware of
Pfizer's mismarketing since then, I still have a warm spot in my heart for
Pfizer," he admitted. Dr. Eastwood is now Conflict of Interest Officer at
Martha Rosenberg is a Chicago columnist/cartoonist
who writes about public health. She may be reached at firstname.lastname@example.org.