Thursday, July 05, 2007

Senate Aging Chairman Urges U.S. Registry of Gifts to Doctors

Congressional Quarterly
Senate Aging Chairman Urges U.S. Registry of Gifts to Doctors

Critics say physicians who speak at medical society meetings are so compromised by industry sponsorships that, in the words of an Ohio retinal surgeon, "we have reached the point where it would be more convenient for speakers to simply wear NASCAR-style jackets emblazoned with their sponsor's logos."

Concerns about industry marketing practices were addressed at a hearing Wednesday in which witnesses said much needs to be done to clear away an enormous web of conflicts of interest spun among physicians by drug industry marketing dollars. Most agreed that the federal government should publicize how much money drug companies are paying to individual doctors, but that should only be the first step.

Although the hearing by the Senate Aging Committee examined a wide array of drug industry practices that witnesses described as influence buying, the panel's chairman, Democrat Herb Kohl of Wisconsin, stuck largely to the idea of creating a national registry requiring disclosure of gifts and payments as his policy prescription for problems raised at the hearing. But officials with the Pharmaceutical Research and Manufacturers of America (PhRMA) and the American Medical Association (AMA) defended their voluntary guidelines on paying and accepting gifts, saying they have lessened abuses since the guidelines were adopted in 2002.

"It has been estimated that the drug industry spends $19 billion annually on marketing to physicians in the form of gifts, lunches, drug samples, and sponsorship of education programs," Kohl said in his opening statement. "These gifts and payments can compromise physicians' medical judgment by putting their financial interest ahead of the welfare of their patients."

In what he called a "view from the trenches," J. Gregory Rosenthal, an eye surgeon who is the chief of ophthalmology at The Toledo Hospital in Ohio, said drug industry influence is rapidly growing in the field of retinal surgery. "We are literally trading independent medical integrity for corporate profits," Rosenthal said. "This inappropriate influence . . . has created a schism in the retinal community between the majority of retina docs who want to take optimal and cost-effective care of their patients and the growing minority of strategically cultivated doctors willing to help corporate interests in exchange for valuable consideration of various sorts."

Rosenthal, who is part of a group of retinal physicians called "Physicians for Clinical Responsibility" that was founded to lessen undue industry influence, said research in the field used to be funded by "independent" sources but that now the drug industry dominates research funding. Drug companies have promoted the idea that only their data is valid "and is, in fact, the only data that should be considered in patient care," he testified. Recently, "there has been growing pressure to ignore any data" not coming out of industry-funded research, including efforts to "block" or "suppress" that other data, he charged.

"Research and the post-research marketing have been melded by recruiting doctors to do research" in a way that creates conflicts of interest by providing "cash to stock options to lab and professorship funding," he continued. "Doctors are then cultivated as 'Key Opinion Leaders' who are compensated for giving talks at meetings and other venues to support the corporation's interpretation of their studies." Even good research is "tainted and it is virtually impossible to know what and what not to believe," he said.

Medical journals and medical societies have become dependent on "unrestricted grants" from drug companies, he said. "In this context, 'unrestricted' means 'use this for whatever you want, but if you ever want another, don't displease us.' " Doctors face "a difficult choice. One path is to go along. With corporate money you can, for example, increase your income, increase your . . .prestige, build your practice, fund a department, and fund research and professorships. The middle ground is to look the other way. The hard choice is to fight back."

Tufts University Professor Jerome P. Kassirer, the former editor of the New England Journal of Medicine, testified that "the magnitude of drug promotion astonishes." One hundred thousand sales reps "visit doctors, residents, nurses, and medical students every day and ply them with free gifts, meals, and gadgets; medical meetings are mini-circuses, replete with enormous glittering displays and hovering attractive personnel." Kassirer added that "although couched as education, these marketing efforts are thinly disguised bribes."

But Robert M. Sade, testifying on behalf of AMA, said "there is a clear need for interactions between physicians and the pharmaceutical industry to ensure the free flow of valid scientific information. When the information is accurate and complete, physicians have the necessary tools to make the right prescribing decisions." AMA guidelines preclude acceptance of gifts of substantial value, he said. Any gifts accepted should be "related to the physician's work" or primarily benefit the patient, he said. "All gifts are not inappropriate," including free drug samples that can be provided to patients.

PhRMA Senior Assistant General Counsel Marjorie Powell said "pharmaceutical marketing and continuing medical education programs have drastically improved awareness of treatment options for Americans suffering from depression or diabetes, a disease that has reached epidemic proportions in the United States." She added that "to help ensure the accuracy of information provided to health care professionals, pharmaceutical research companies must comply with strict Food and Drug Administration regulations." PhRMA's marketing code "also provides guidance on how sales personnel can and should maintain ethical relationships in their discussions with health care professionals," she said.

Kohl said such guidelines are not being followed. "I intend to vigorously pursue stronger adherence to these guidelines" as well as pursue a national registry, he said. A spokeswoman said Kohl, along with Iowa Republican Charles E. Grassley, intends to develop a legislative proposal to create such a database.

But PhRMA's Senior Vice President Ken Johnson spoke out strongly against state laws that have created registries of gifts and payments. Laws in Minnesota and Vermont "do not recognize that safeguards already exist to make sure the information provided by company representatives is accurate and well-substantiated," he said. "America's pharmaceutical research companies must comply with strict Food and Drug Administration regulations and the U.S. Department of Justice enforces fraud, abuse and anti-kickback laws.

PhRMA hasn't taken a position on a federal registry in the absence of a legislative proposal on the matter, Powell said. But she said defining terms such as "gifts" and "marketing" in legislation would be difficult and subject to different interpretations. "It's important to recognize that all of what pharmaceutical companies convey to doctors is already thoroughly regulated," she added.

But Kassirer said "we must put more pressure on both the [medical] profession and the industry." He called for an Institute of Medicine study addressing conflicts of interest created by drug industry marketing while also endorsing disclosure of payments through a national registry. But disclosure by itself "doesn't solve the problem," he said. "The problem is the conflict, and disclosure doesn't solve the conflict."

1 comment:

Ramachandran said...

The Medical profession has lost its ethics & sanctity.
The patient & Medical treatment has been relegated to a distant Second place.
The Physician is self centered dancing to the tunes of big Corporates allured by the largesse they shower upon them in various forms.
They Prescribe drugs out of compulsion not out of choice , Branded ones than Generic to satiate the Coffers of Pharma giants and the resultant benefit they ( physician )accrue.
It is time ethics & sanctity is brought back to the profession.
( US market must get downsized, volume wise to a maximum 150 billion dollar industry relative to the population).
The basic research work , Discovery , Trials must be taken over by the Government to avoid bias like how the Space program is being done for the true benefit of Humankind.