Big Pharma can entice medical practitioners to prescribe expensive patent drugs -- even when they're dangerous
Until 2010, when the Physician Payments Sunshine Act passed, requiring doctors to disclose payments, the only thing better than working for Pharma was being a doctor wined and dined by Pharma.
Pfizer jetted 5,000 doctors to Caribbean resorts where they enjoyed massages, golf and $2,000 honoraria charges to sell its painkiller Bextra (withdrawn from the market in 2005 for heart risks). GSK sent doctors to lavish resorts to promote Wellbutrin, the Justice Department charged. Johnson & Johnson bestowed trips, perks and honoraria on Texas Medicaid officials to get its drug Risperdal preferred on the formulary, a state lawsuit charged. Bristol-Myers Squibb enticed doctors to prescribe its drugs with access to the Los Angeles Lakers and luxury box suites for their games, California regulators say. In China GSK is charged with using a network of 700 middlemen and travel agencies to bribe doctors with cash and sexual favors, and Victory Pharma, an opioid drugs maker, was charged with treating doctors to strip shows. Nice.
Of course, Pharma reps did as well as the doctors. Thanks to their Barbie and Ken doll looks and the free samples, gifts and lunches they would bring medical staff, they would often waltz in to see the doctor before the sick and waiting patients. Some had their own lounges at medical offices. Since the 2010 sunshine law, part of the Affordable Care Act, went into effect in 2013, drug companies must display the doctors and groups they pay on their websites. That includes their payments to faux grassroots groups like Go Red For Women and the National Alliance on Mental Illness, or NAMI, which are widely seen as Pharma fronts. But will it make a difference? For years, doctors have also begun presentations with slides detailing their Pharma funding but it doesn’t seem to alter their credibility or audience cynicism.
When it comes to acknowledging the influence of gifts and money on behavior, doctors, like everyone else, suffer from self-delusion. Most say they believe it affects the other guy, not them, and many become offended at the idea that they are “for sale.”
“My prescribing never changes because once a month a drug rep brings in a tray of sandwiches,” Maria Carmen Wilson told the Tampa Bay Times. (Wilson was Eli Lilly’s number-two earner in Florida in 2009, the paper reports.) It’s tempting to ask such doctors that if the largesse doesn’t affect them, when was the last time they prescribed the competitor’s pill? Would anyone believe or even read the journalism of a reporter who accepted an honorarium or speaker’s fee from the subject she reported on? Even if she claimed it didn’t influence her?
Trips to resorts and strip clubs will likely continue to diminish under the Physician Payments Sunshine Act, but there are many other ways, often sneaky, that Pharma can entice doctors to prescribe its expensive, patent drugs.
1. Spying on Prescribing
Like the NSA spying program, shameless spying on doctors’ prescribing habits spares almost no one. Recently, the full sweep of IMS Health Holdings’ prescription data mining was revealed by ProPublica, which reported that its collection includes over 85 percent of the world’s prescriptions and “comprehensive, anonymous medical records for 400 million patients.” In 2007, there was a backlash against another seller of medical information: the AMA itself. By selling the names, office addresses and practice types of almost every doctor in the US to marketing firms the AMA netted almost $50 million a year, the American Medical Student Association and the National Physicians Alliance charged at the AMA’s convention. The database of 900,000 doctors does not violate privacy, counters the AMA, since doctors can opt out.
Psychiatrist Dan Carlat wrote in the New York Times that he was “astonished at the level of detail that drug companies were able to acquire about doctors’ prescribing habits” and that his drug reps told him “they received printouts tracking local doctors’ prescriptions every week.” A 2011 Supreme Court ruling found the collection and dissemination of prescribing behavior was “speech” and protected by the First Amendment. (See: a corporation is a person.)
2. Continuing Medical Education Courses
In order to keep their state licenses and satisfy insurance regulations, doctors must enroll in a certain amount of CMEs—continuing medical education courses. Not surprisingly, these classes are often “taught” for free by Pharma-funded specialists, sparing doctors from having to pay for them but providing the objectivity of a time-share presentation.
One such class, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough,” funded by Seroquel maker AstraZeneca was taught by former Emory University psychiatrist Charles Nemeroff, who lost his department chairmanship due to unreported Pharma income. Another CME called “Bipolar Disorder: Individualizing Treatment to Improve Patient Outcomes,” was “taught” by Trisha Suppes, who admits to funding by Abbott, AstraZeneca; GlaxoSmithKline, Janssen, Novartis, Pfizer, Wyeth, Bristol-Myers Squibb, Eli Lilly, Shire and four more Pharma companies. Another CME, “Individualizing ADHD Pharmacotherapy with Disruptive Behavioral Disorders” was taught by the Johnson & Johnson-funded Robert L. Findling and refers to Risperdal or its generic version, risperdone, 13 times. Many CMEs teach doctors about the lucrative new disease category of Adult ADHD and how to keep kids from going off their ADHD meds when they get to college. Ka-ching.
3. Ghostwriting
Being published in medical journals is essential to academic doctors but researching, writing and reworking papers is a formidable job. Luckily for doctors, Pharma is willing to help—as long as they write what Pharma wants. In just three years, medical writers associated with Parke-Davis, which became Pfizer, wrote 13 papers extolling the benefits of Neurontin, including in the prestigious Cleveland Clinic Journal of Medicine, in the names of the “author” doctors. Medical writers at Wyeth, also now Pfizer, wrote more than 50 papers pushing the now discredited Hormone Replacement Therapy (HRT) in the names of doctor “authors.”
“Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” asked one article in the Journal of Women’s Health. Guess what it concludes? “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease,” another ghostwritten paper is titled, despite HRT’s established heart risks, appearing in the Archives of Internal Medicine. And despite HRT’s links to dementia, another paper, which also ran in the Archives of Internal Medicine, was titled “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”
4. Speakers Bureaus
Few things combine the ego stroking and fast cash of being paid to speak—and Pharma has no trouble finding takers at $750, $1000 and more per pop. Psychiatrist Dan Carlat wrote in theNew York Times that his experience speaking about Wyeth’s Effexor degenerated as he sensed skepticism and contempt in the audience. “I feared I had become—a drug rep with an M.D.” A district manager soon expressed reservations (“My reps told me that you weren’t as enthusiastic about our product at your last talk”) and Carlat ended his speaking career.
In her book, The Truth About Statins, cardiologist Barbara Roberts echoes Carlat’s experience. She agreed to speak about Pfizer’s Lipitor and gender-specific aspects of heart disease in women, but told Pfizer “that I wasn’t interested in just getting up in front of a bunch of doctors and plugging one or another of Pfizer’s medicines.” Declining to use Pfizer-supplied slides, she created her own slides for the speeches “until one night a regional manager attended one of my talks—and suddenly I was no longer invited by Pfizer to give lectures.”
Carlat and Roberts are in the minority. Despite academic restrictions, faculty at many top institutions including division chiefs “stay on the industry lecture circuit, where they can net tens of thousands in additional income,” reported ProPublica in 2010. Even at the prestigious Cleveland Clinic where the chairman of cardiovascular medicine, Steven E. Nissen, calls industry-paid speakers “whores,” the practice flourishes, ProPublica reported.
5. Clinical Trials
Pharma-funded clinical trials can be paydirt to doctors, yielding as much as $10,000 per patient in some cases. In 2010, Sen. Charles Grassley (R-Iowa) addressed the frequent conflict of interest of doctors accepting major Pharma revenue while also accepting NIH money, our tax dollars. The medical institutions where the doctors work also are swimming in Pharma money. It is a situation exacerbated by the “technology-transferring” Bayh-Dole Act of 1980 which dangled the riches of “industry” before medical institutions just as the former were floundering and the latter was booming, says Marcia Angell, former editor-in-chief of the New England Journal of Medicine. ”Harvard’s Clinical Research Institute (HCRI), for example, originally advertised itself as led by people whose ‘experience gives HCRI an intimate understanding of industry’s needs, and knowledge of how best to meet them,’” writes Angell, “as though meeting industry’s needs is a legitimate purpose of an academic institution.”
Not all clinical trials are kosher. Another sneaky way Pharma gets doctors to prescribe its drugs is to set up faux clinical trials to influence doctors. A 1995 study billed as assessing the safety, efficacy and tolerability of Neurontin was nothing but a ruse to get the 772 participating doctors to prescribe the drug, said an article in the Archives of Internal Medicine, because it gave them familiarity and experience with the drug. (This indirect sales job parallels what is said to happen with speaker’s bureaus: the speakers may not convince anyone else, but they begin prescribing the drug themselves.) In addition to misleading the doctors who thought the trials were valid, the study also misled the patients who did not know it was a marketing, or “seeding” study, and whose participation was overseen by investigators with insufficient training and clinical experience. Eleven of the 2,759 patients in the trials died, 73 suffered severe adverse events and 997 experienced less serious side-effects.
Graham
No comments:
Post a Comment