It happens countless times a week in Oklahoma: a patient visits the doctor's office and leaves with a prescription.
But if the patient knew the doctor had received money from the pharmaceutical company for giving promotional talks about that drug or for researching the drug, would it make a difference?
Drug companies have handed out about $6.3 million to doctors across the state, according to The Oklahoman's analysis of information from national data compiled by the nonprofit investigative journalism group ProPublica.
Oklahoma City doctors make up the majority of those receiving money, with drug companies paying them about $4.8 million in the past three years. These include more than $10,000 for a series of speeches given by a doctor specializing in pain medicine and psychiatry, more than $225,000 to a sleep specialist and more than $740,000 to a research institute. Other payments were as little as $1.
Some drug companies recently began disclosing payments to doctors, for speeches, research, travel, meals and consulting. In order to address conflicts of interest created by drug marketing, all pharmaceutical companies will be required to disclose payments to doctors in 2013 so patients can look it up on government websites.
This comes against the backdrop of physicians both overprescribing drugs and finessing, if not actually concealing, negative research data to make a drug sound better than it really is, said medical ethicist Howard Brody.
He said the poster child in that category would be Vioxx, an arthritis and painkilling drug that became the industry's biggest drug recall in 2004. Researchers concluded it was responsible for up to 140,000 cases of heart disease and as many as 56,000 deaths during five years of aggressive marketing.
Merck & Co. recently agreed to pay $950 million and plead guilty to a criminal misdemeanor charge to settle allegations that it deceived the government about the drug's safety and illegally promoted the drug.
Conflict of interest concerns also result from drug companies paying doctors, said Brody, a medical doctor, author and director of the Institute for the Medical Humanities, University of Texas Medical Branch in Galveston.
“If the physician is going to be a true professional and not a hired gun, that physician is going to have to be independent. One has to prioritize what is good for the patient above ‘Will I, the doctor, make more money or will the drug company I work for make more money?' ” Brody said.
But Oklahoma City psychiatrist and pain specialist Dr. Siavash Nael, who received about $10,000 in drug company money for 10 speeches and about $13,000 to cover research project costs in 2010 and 2011, said the FDA restrictions are so strict that anonymous physicians are planted in the room to ensure lecturing doctors don't push a specific drug to other physicians in attendance.
“I'm not doing anything illegal or unethical,” Nael said. “I'm doing it for my own curiosity. I'm a teacher. I teach physicians, my colleagues, patients. If they put the information on a government website I don't worry about that. I think that's a very good idea.”
Brody said it is legitimate for a drug company to pay a doctor to conduct research as long as the payment covers precisely the costs of actually doing the research project.
But when physicians take money to do promotional talks, he said they become part of the company sales force and lose any status as independent scientists. When other doctors attending a speech ask about serious side effects, he suggested the paid doctor's answer may be biased.
“If they really want to keep getting that nice paycheck from the drug company ... better to soft pedal and say, ‘Oh the side effects aren't that bad,'” Brody said.
Nael said while that was true 10 years ago, the FDA has clamped down and will sanction both doctors and drug companies.
“We cannot be biased. We cannot soft pedal. We have to tell what is in the side effect profile,” he said.
A recent Consumer Reports survey found 72 percent of consumers polled indicated they think drug companies have too much influence on the drugs prescribed by doctors. Eighty-one percent said they are concerned about rewards drugmakers give doctors who write a lot of prescriptions for a company's drugs.
Jonathan Schwartz, a sleep and lung specialist who is also medical director of Integris' sleep disorders center, has received about $225,000 from Cephalon and Astra Zeneca from 2009 to 2011. But the money was donated directly to charity at his insistence.
“There are a lot of very good physicians who give talks for companies and they're not bad people because they get paid. You'd rather have qualified doctors with both research and clinical experience giving these talks,” said Schwartz.
Several years ago he stopped giving lectures for Cephalon when the drug company initially refused to donate his speaking fees to charity.
He said the company's drugs used for sleep disorders such as narcolepsy are excellent and he continued to prescribe them. But he wouldn't resume his talks until the company agreed to donate the money to Oklahoma charities and to document that on the Cephalon website, which is available to the public. Schwartz said he stopped speaking for Astra Zeneca two years ago when that company refused to donate his fees to charity.
Expensive to develop
“We're really baying at the moon. We're not addressing the problems,” said Dr. Mitchell Brooks, a Dallas orthopedic surgeon and radio show host.
He said the problem isn't that doctors are wined and dined by drug companies. Instead, it's that a drug costs an estimated $1 billion to reach the market due to over-regulation and cost-shifting, he said. In other countries, drug companies must sell drugs at bargain basement prices to the government or not sell them at all. The companies shift those costs to U.S. consumers.
And in Europe, he said, drug companies must simply show that the drug won't harm anyone. But under a three year or longer process, U.S. drugs must also be shown to be effective and its side effects determined through expensive human trials before the U.S. Food and Drug Administration will allow the drug to be marketed.
“If a drug company is going to invest $1 billion in a drug, they're going to want a return on their investment,” Brooks said.
“From the drug companies' perspective, they are in business to make a profit. There's nothing wrong with making a profit. It's become vilified in this country,” he said.
Doctors working for the nonprofit Lynn Health Science Institute in Oklahoma City received about $743,000 from drug companies Pfizer, Eli Lilly and Cephalon, the data show.
“If the drug companies didn't pay we wouldn't have the research. That's another way of saying we wouldn't have new drugs,” said Frank Willis, the institute's executive vice president.
He said drug company money doesn't go into the doctors' pockets; instead most is spent on paying patients who participate in the trials, along with costs of numerous tests, X-rays, technicians and similar expenses tied directly to conducting research. For his or her time, the doctor receives 10 to 20 percent of the drug companies' research money, he said.
Also, he said all trials are blind studies, meaning the researcher doesn't know who receives the drug being tested or the placebo or comparison drug. He, too, said he looks forward to the government websites containing disclosure information.
Brody said a particular type of clinical trial is troublesome, though legal. With a seed trial, the drug already has received FDA approval and the drug company invites doctors to participate in a research study, often to determine if the drug works for a different condition. Over time, the doctors become familiar with the drug and tend to prescribe it more frequently once the trial is complete. The trial is really a marketing tool.
“Some of this research is really phony,” Brody said.
“That's one of the problems. Disclosure is great but how fine-grained is the disclosure?”
Several experts said the current disclosure information on the Internet can easily be misunderstood.
Schwartz said the transparency provided by the government websites is a good idea but should apply to other professions as well.
“I hope that transparency and honest reporting will lead to other companies allowing speaker fees to be donated directly to charity, which will benefit both the community and the medical profession,” he said.
Wes Glinsmann, the Oklahoma State Medical Association's political affairs director, said ethics rules are strong and clear that patients have the right to choose their drugs and physicians have the responsibility to disclose any financial stake they have in drugs.
“While there is certainly a role for this research we need to make sure any conflicts of interest are fully disclosed to avoid any appearances of anything wrong,” he said.
Although most of the money reported in the database went to physicians, other practitioners, including nurses and pharmacists, also work with drug companies and are listed by ProPublica. Some pharmaceutical firms include these payments; others do not.
Drug companies paid universitiesDrug companies have paid the University of Oklahoma and Oklahoma State University a total of about $94,000 for research or other categories from 2009 to 2011, data show.
Pharmaceutical companies paid OU Board of Regents and other OU entities more than $81,000 for research, speaking and consulting, according to data derived from disclosures by drug companies Pfizer Inc., Eli Lilly & Co., and Merck.
“The University of Oklahoma has a long-standing policy that specifically addresses relationships between faculty and vendors, including speaking and consulting agreements. OU policy prohibits faculty from accepting speaking engagements to promote or endorse products or devices.
“Faculty can make scientific presentations through agreements that have been negotiated by the Office of Research Administration in compliance with the OU Physicians Professional Practice Plan, one of the offices charged with confirming compliance with OU policy. Additionally, OU faculty can be reimbursed for travel and meals related to scientific presentations,” according to a statement by Paul Sund, OU Physicians marketing director.
Pfizer paid OSU about $12,000 in 2010 for research, data show.
“The OSU Center for Health Sciences works with pharmaceutical companies to assist with advances in health care and medical research. As a research university, we operate a Clinic Trials Office that specifically works with drug companies to perform cutting-edge research for clinical drug trials. These latest scientific findings help shape the future of patient care and improve health outcomes,” said a statement from Kayse M. Shrum, OSU Center for Health Sciences provost and OSU College of Osteopathic Medicine dean.
“The OSU Center for Health Sciences operates under the overall OSU conflict of interest policy. No specific mention is made regarding pharmaceutical companies. In fact, we seek opportunities to perform clinical drug trials because of the important role they provide in medical education and research as well as their potential to help improve the quality of life.
“The two examples from the ProPublica database are pediatric vaccine trials that OSU conducted for Pfizer to help evaluate their effectiveness. Vaccine trials play a pivotal role in the advancement of disease prevention. The impact of serious childhood illnesses such as chickenpox and measles has been greatly reduced as a result of vaccines.”