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.
MORE FROM NEWSOK
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.”