“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, after thousands were harmed or killed from such off-label marketing — Neurontin could only be legally promoted for seizures and post-shingles nerve pain — a judgment against Pfizer awarded $430 million to the nation’s Attorneys General who earmarked $21 million for training products for prescribers to help prevent future Neurontins.
Last week 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).
No snappy Crestor or Vytorin tote bags were seen among the 150 participants and conflict of interest sheets revealed 40 of 42 speakers had none. But conference attendees were less interested in bashing drug reps’ high flying sales tactics than learning from them and even incorporating them into their own drug teaching and learning as “academic detailing.”
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 psychologically coercive.
A 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 content.
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.