Payment disclosures: 'Compliance in name only'
- Article by: JANET MOORE
- Star Tribune
- July 5, 2009 - 10:00 PM
Every spring, they trickle in: reports from dozens of drug companies disclosing how much they paid Minnesota physicians in consulting fees the previous year.
This year is no different. Some 86 drug companies made hundreds of payments totaling $13 million to Minnesota practitioners -- defined as anyone who can prescribe drugs.
But if consumers want to review the records, they will have to be patient. The Minnesota Board of Pharmacy won't post them online for a few weeks. Even then, the most dogged researcher may be flummoxed by documents that are sprawling, hard to search and often vague.
And reformers who hoped that payment disclosure would curb inappropriate ties between companies and doctors may be disappointed. The records are sometimes incomplete and inconsistent. Doctors say they are often inaccurate. Enforcement for companies that don't comply has been nonexistent, even though the law allows a fine of up to $10,000 and revocation of a company's license to sell drugs in Minnesota.
"It's like looking for a needle in a haystack,'' said Peter Lurie, deputy director of Public Citizen's Health Research Group, a Washington, D.C., consumer organization that has used the files. "It's compliance in name only.''
Enforcement of the 1993 law lies with the 11 staff members at the tiny Pharmacy Board whose primary task involves inspecting pharmacies, licensing pharmacists and investigating consumer complaints. The board has no budget to create a searchable database of the records or to publicize their very existence. Just posting the documents on the Internet often requires the staff to work nights and weekends.
"It hasn't been a real high priority for us," said Cody Wiberg, the board's executive director. "When we look at how we devote our resources, do we go after a drug manufacturer who might not report? Or do we go after a pharmacist who is stealing Vicodin or a pharmacist who shows up to work drunk?"
No standardized reports
Some companies don't make enforcement any easier.
The Pharmacy Board requests that companies submit the records on searchable spreadsheets. But several firms, including drug giant Eli Lilly, sent their information in file attachments that cannot be searched electronically.
Companies are also instructed to provide the name of the practitioner receiving the payment, the amount and the reason. But there is no uniform manner for describing the reasons for payments, nor do the explanations reveal much detail. Most companies list "honorarium," "promotional speaker fees," "consulting," or "travel reimbursement."
Some explanations seem bizarre. One company attributed a payment to "washing medical device parts."
As a result, some doctors complain that while they favor transparency, the descriptions are often misleading, even inaccurate.
Dr. Stephen Lane, a ophthalmologist with Associated Eye Consultants in the Twin Cities and Wisconsin, received about $210,000 last year from several companies, including Alcon and Bausch & Lomb. Although the companies indicated Lane was paid for "professional consulting services," he said most of the money paid for clinical trials testing new drugs to treat eye diseases. Most of that money, he said, pays for staff to manage the studies.
"The payments were made for a legitimate reason," Lane said. "But people believe it's sinister, it's like we're seen as corporate whores."
Overall, Indianapolis-based Lilly doled out the most money: 83 payments totaling $1.93 million. Some companies listed payments as small as $1.
Most recipients were doctors, many of whom are influential leaders in their fields, but several dentists, nurse practitioners, even veterinarians, also received money.
One of the top earners last year was Dr. Randall Schapiro, a nationally known neurologist at the Minneapolis Clinic of Neurology in Golden Valley. The records indicate he received about $306,000 in payments from companies such as CSL Behring and Accorda Therapeutics.
Schapiro, who retired in December, said much of the money paid for clinical research on drugs treating multiple sclerosis. "The money never went to me -- it went to my office and paid for my overhead. I have no idea where that number came from," he said.
Schapiro said the information often is inaccurate. "I know colleagues who have done research and they're not on the list,'' he said.
Undaunted by these challenges, Sen. John Marty, DFL-Roseville, has proposed retooling Minnesota's disclosure law to include payments by medical device companies.
His effort was thwarted this year by the state's signature industry. Med-tech giants Medtronic Inc. and Boston Scientific Corp. argued before legislators that pending federal legislation requiring payment disclosure from drug and device companies is a more logical solution. Several companies, including Fridley-based Medtronic, have agreed to voluntarily post the information on their corporate websites in the near future.
As more states adopt disclosure laws like Minnesota's -- to date, five others have -- the companies argued that a patchwork of varying requirements could prove cumbersome and expensive. Time-consuming and needless regulation, they argued, could threaten an engine of the Minnesota economy.
The bill never made it out of committee.
"The industry went ballistic over it," said Marty. "I don't want to stop companies from working with physicians to improve products, but I do think in some cases consulting money influences their prescribing habits."
Other proponents of disclosure agree. A recent report by the Institute of Medicine claims disclosure by doctors and medical researchers is the first step in identifying and managing conflict of interest. But the report also says disclosure must be standardized to help institutions judge the risk that a relationship poses and to ease the burden for those who must do the reporting.
For his part, Dr. Schapiro thinks disclosure of payments isn't terribly helpful to patients. He doesn't mind the information being disclosed, but he added: "The problem is interpreting what it all means."
Star Tribune staff writer Patrick Kennedy contributed to this report.
Janet Moore • 612-673-7752
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