Bill would expand law on medical disclosure

Fifteen years ago, with little fanfare or notice, the Legislature adopted an unusual law requiring drug companies to publicly report gifts and payments to doctors in Minnesota.

Now, as interest builds in the often-controversial ties between industry and doctors, Minnesota's law could be the first in the nation to include the makers of medical devices, the state's signature industry.

Sen. John Marty, DFL-Roseville, will hold a hearing today on the bill before the Committee on Health, Housing and Family Security.

Marty is an unabashed fan of the original 1993 law, but feels it has too many loopholes to be truly effective.

"Disclosure isn't enough," he said in an interview. "But it's a good first step."

In addition to expanding the disclosure requirement to cover device manufacturers, Marty's bill would require that the financial relationships be disclosed to patients, and it would ban gifts to doctors from device companies.

(A few exceptions are spelled out for doctors, clinic employees and their families, including free drug samples for uninsured or low-income patients; compensation for consulting services for "genuine clinical research" that does not exceed a standard hourly rate; and "reasonable" honoraria for those who appear at professional or educational conferences.)

Medical device makers have argued that, unlike pharmaceutical companies, they need close relationships with doctors to ensure high-quality patient care when their devices are used. Doctors need to be trained on new devices, and they sometimes invent them. In both those situations, the companies say, some type of compensation is required.

Fridley-based Medtronic Inc., the world's largest medical technology company, said in a prepared statement that it supports "federal and state efforts that bring an appropriate level of transparency around these [relationships.]"

"The Minnesota law in effect today was intended to address the pharmaceutical industry and does not take into account the unique nature of the medical device industry interactions with physicians, a critical element of ongoing innovation and patient safety," the company said.

Medtronic, as well as the Washington-based industry group AdvaMed, has supported the federal legislation. "A patchwork of state regulations will likely confuse the public and create unnecessarily burdensome and costly requirements for companies that offer medical treatments for patients in multiple states," Tom Tremble, AdvaMed associate vice president for government and regional affairs, said in a prepared statement.

Lee Greenfield, a retired Minnesota legislator, was a co-author of the 1993 law.

In Greenfield's view, a doctor who has a financial relationship with a drug company may not be entirely objective when prescribing medication, and may actually overprescribe drugs.

Since its passage, Minnesota's law hasn't always worked efficiently, according to Dr. Peter Lurie, deputy director of the Health Research Group of the consumer advocacy group Public Citizen. Until 2005, most of the drug companies' disclosure documents -- some of which were handwritten and barely legible -- were stuffed into boxes at the Minnesota Board of Pharmacy office on University Avenue.

Representatives from Public Citizen, and then the media, began requesting the documents, which had to be copied at 25 cents a page. Now, documents from individual companies are posted on the board's website as PDF files.

A Public Citizen analysis of the data found that, between 2002 and 2004, drug companies disclosed 7,290 payments to Minnesota doctors, totaling $22.4 million. Of these, 86 percent exceeded $100. The median was roughly $1,000, and most were for unspecified purposes.

Lurie said that he supports expanding Minnesota disclosure requirements to medical device companies, but said it's just as important to provide the public with an easy-to-use searchable database.

Cody Wiberg, executive director of the Minnesota pharmacy board, said he would like to build a new database for the disclosure and gift information, but said state funds are unavailable. Further, if Marty's bill becomes law, the state health department will be responsible for presenting the data to the public and enforcing the law.