As part of the 2010 Affordable Care Act, federal regulators last year began requiring drug companies and device manufacturers to begin tracking doctor payments and gifts worth as little as $10. An online database of these interactions, including industry-sponsored doctor lectures and meals, will open Sept. 30 as part of the Physicians Open Payments Sunshine Act. Free drug samples left at doctors' offices won't be included.
The pharmaceutical industry and health care groups agree the relationships should be more transparent and information about them should be more accessible to the public.
More than a decade ago, many providers began limiting interactions on their own, with a few prohibiting drug and device representatives from dropping in uninvited. It was an effort to abate lawmaker and regulator scrutiny following a dramatic rise in drug spending and an increasing number of successfully prosecuted Medicare and Medicaid fraud cases involving drug companies.
"This really is all about manufacturers," said Lee Spangler, the Texas Medical Association's medical economics vice president. "The whole point is for the government and the public to discern how manufacturers get consumers to use drugs."
However, John Murphy, assistant general counsel for the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America, said he is concerned the database won't include explanations behind the relationships, possibly leading patients to assume the interactions are unethical. He said an information dump would be a disservice to patient communication.
"It's something our members take very seriously," Murphy said. "There were misperceptions about what is the appropriate industry interaction," he said, adding that there was some belief that doctors and drug and device companies should not work together at all.
Murphy thinks the Sunshine Act reporting tool could improve doctor and patient communication about drug and device research. Patients also might use the database to find researchers to help them get access to cutting-edge treatments.
"In theory, transparency provides for more informed patient-physician communication," Murphy said. "There's a significant amount of value in these interactions."
Before the Sunshine Act, doctors began limiting drug reps' access to their offices to negate the appearance of a conflict of interest. Research published in the Archives of Internal Medicine in 2010 indicated the number of doctors who accepted drug samples, food and beverages, reimbursements and payments dropped between 2004 and 2009. The study was based on surveys returned by nearly 1,900 doctors.
During that five-year period, the percentage of doctors who received drug samples dropped to about 64 percent from 78 percent. The number of doctors who accepted food and beverages in their offices fell to almost 71 percent from more than 80 percent. Those who received reimbursements for professional meetings dropped to about 18 percent from 35 percent. Doctors paid for consultations, speaking and clinical trial enrollments fell to about 14 percent from 28 percent.
A 2010 report by SK&A, an Irvine, Calif.-based health care market research firm, found 98 percent of physician offices were visited by as many as 20 drug and device reps every week. Nearly half of the 213,616 doctor offices surveyed said they require or prefer reps to make appointments before arriving, up from about 39 percent who required appointments in 2008.
About 23 percent of doctor offices said they banned drug and device rep access. It's unclear how many do in Texas.
"There are a lot of practices that are already doing this," Spangler said. "Physicians are being asked to be more efficient. They have got to focus on their customers' needs first. Pharmaceutical reps' demands for physicians' time takes time away from patients."
Doctors operate businesses and can't afford to lose money from appointments to spend time with drug and device reps, he said.
"They're not bringing in any revenue with that interaction," Spangler said. "This was just another way of advertising to the consumer."
For years, pharmaceutical and device representatives brought doughnuts and pizza to curry favor with Kelsey-Seybold Clinic staff and bought dinners to get face time with doctors to pitch their products.
"It was a very popular thing," said Dr. Patrick Carter.
Carter, Kelsey-Seybold's family medicine department chairman and care coordination and quality improvement medical director, oversaw the interactions, which the clinic banned at its 20 clinics in 2012. Now, drug and device reps must make appointments to meet with Kelsey-Seybold's 400 providers.
The clinic's doctors are permitted to attend pharmaceutical-sponsored dinners only at professional meetings. Years earlier, Carter prohibited acceptance of most free samples of drugs, many of which have less-expensive generic variations.
Before joining Kelsey-Seybold in 1994, Carter spent 10 years as an Army doctor and wasn't used to seeing drug and device reps in doctors' offices.
"All of a sudden, they were everywhere," he recalled.
He said he didn't like the appearance of a conflict of interest and didn't feel the reps taught him anything useful for his practice.
Carter also had seen plenty of research showing direct pharmaceutical company interactions with doctors led to higher prescribing frequency and higher costs.
He suspects other doctors and medical practices are considering implementing similar prohibitions, but few probably have done it.
"It's not illegal at all," Carter said of the interactions. "(The drug reps) have got a job to do."
Sugar Land primary care Dr. Elizabeth Torres allows pharmaceutical and device manufacturers to come by her office and drop off free samples, which she gives to patients. Reps stop in several times a week and spend a few minutes pitching their products.
Torres likes giving samples to ensure they are useful to patients before she writes costly prescriptions. Two different devices, pen-like injectors filled with insulin, help many of her patients with diabetes better control their disease because they are pre-loaded. Before, patients had to draw bottled insulin into syringes, which many were reluctant to do.
"The devices removed all of the uncertainty and fear," said Torres, president of the Harris County Medical Society. "More people are willing to accept the insulin. It helps patients be more compliant. It has revolutionized the care of diabetes."
Her patient Maria Bolander started using one device, Levemir, about a month ago. The 65-year-old teacher said she was stunned after Torres handed her several samples to try to ensure she could use the device.
"That's the first doctor who's ever done that for me," she said.
If not for drug reps introducing them to her, Torres said it could have taken much longer for her to discover the devices and help patients. Doctors in small offices like hers don't have time to attend many professional meetings and conferences, meet researchers and learn about new drugs and devices, she said.
"You can go to a meeting once a year," said Torres, who practices in a two-doctor office.
Torres also doesn't believe dinner or free drug samples could influence her judgment.
"I have to take them with a grain of salt, she said. "It's like an advertisement. New isn't always better and old isn't always better either. I'm very leery of new products. But I want my patients to have access to them if nothing else has worked."
©2014 the Houston Chronicle
