Continued media coverage of the sunshine provisions in the Senate and House health care reform bills continued today as the New York Times reported that such efforts may not be enough. (They want more stories)
The sunshine provisions require the makers of drugs, medical devices and medical supplies to file annual reports to the government about their financial ties to doctors.
The legislation would also require the establishment of an online public database that patients could search, to see if their own physicians had been paid by the companies whose products the doctors prescribed.
Extreme radical pharmascolds believe this kind of disclosure and reporting is not comprehensive enough because there have already been instances “of doctors who, despite strict disclosure policies by their academic employers or the National Institutes of Health, failed to report payments from industry.” As we have covered such cases numerous times, the overwhelming majorities of such errors were never intentional, and were mostly due to confusion on the requirements by various journals and institution policies.
Internist and Stem Cell Ethicists Dr. Bernard Lo at University of California, San Francisco, who served as chairman of the IOM committee on Conflicts of Interest in Medical Research Education and Practice essentially called on “Congress to mandate industry disclosure of payments to all kinds of health care providers, medical researchers, medical institutions, professional medical associations, industry-sponsored foundations and disease advocacy groups.”
As the provisions in the Senate stand right now public disclosure of industry payments would be required to doctors and teaching hospitals, as well as ownership stakes in medical facilities and medical products companies. Groups not presently required to disclose include people like nurses and biomedical researchers or groups like professional medical associations.
Consequently, such a gap leaves open the possibility that Senator Charles Grassley (R-IA), a co-creator of the sunshine provision according to his spokeswoman is open to “expand the payment disclosure requirements to other medical players,”
According to the NYT article, “the health overhaul effort in the House goes further, calling for public disclosure of industry payments to a wide array of medical entities and medical professionals — a group as diverse as physicians, pharmacists, biomedical researchers, professional medical associations and health insurers.”
Proponents of such disclosure requirements believe that since these entities “are making determinations as to what procedures and drugs will be used,” sunshine provisions cannot leave any loopholes. For example, Representative Pete Stark (D-CA) believes that companies could give rebates to outpatient clinics to favor certain medical products over others, a scenario he uses to call for stronger measures.
In response to sunshine provisions, the Pharmaceutical Research and Manufacturers of America (PhRMA) told NYT “that any federal legislation requiring payment disclosures must be written in a way that did not imply that industry relationships with health care providers were automatically inappropriate.” Others who are skeptical of disclosure address the need for a federal database to use that would offer more detailed information than the few doctor payment listings now available to the public.
States like Minnesota and Vermont already require drug companies to report payments to physicians, and drug companies like Eli Lilly and Merck have introduced their own Web sites listing fees paid to doctors as we have previously written.
Eli Lilly and Sunshine – More Stories for Papers
Since Eli Lilly started reporting payments the first half of this year, they have paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.
A separate NYT article focused on payments from Eli Lilly to Dr. Manoj V. Waikar, a psychiatrist in Palo Alto, Calif., who is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine. So far he has received $74,850 for consulting and speaking at 51 events. The company caps payments at $75,000 for each health care provider in any calendar year. As a result of just $1,500 per event, the article tried to determine why Dr. Waikar received such payments.
Dr. Waikar wrote in an e-mail message to NYT that he received fees for speaking to other health care professionals about disorders like schizophrenia and depression, which can be treated with the Lilly drugs Zyprexa and Cymbalta respectively. Having spoken so many times about the treatment of such diseases that affect millions should not be underscored by payments he received for such services, when doing so is not only legal, but essential for improving patient care.
In addition, Dr. Waikar’s speaking need not be overly scrutinized because Stanford only prohibits full faculty members from participating in drug company speakers’ bureaus. Dr. Waikar, who is an unpaid adjunct instructor, was allowed to engage in these critical educational events because he did not use his Stanford title, as the school’s policy requires.
Stanford announced they are reviewing the policy for adjunct professors, which is not surprising given that Philip A. Pizzo, MD The Dean of the Stanford Medical serves on the board of the anti industry group Prescription Project (which the Prescription Project has since taken down the board names from their website – so much transparency for these guys).
Not only was Dr. Waikar following Stanford’s rules explicitly, he even indicated in his email to reporters that not only were the “drug company presentations standardized to comply with drug marketing regulations, he and other speakers provided suggestions on the content.” Moreover, Dr. Waikar acknowledged that he was even able “to answer questions from doctors in the audience, drawing from his own practice experience or opinions, as long as he explained the basis of his answers.” Evidence of such “spontaneity” only goes to show how unbiased his work truly was.
As a result of his service, Dr. Waikar has been contacted by many doctors after his talks to consult about difficult cases, especially from primary care providers who have to treat complex psychiatric problems. Having this ability to reach out to him could not have been possible if it were not for the support of such talks by Eli Lilly.
Misinterpretation of Disclosure
The work of Dr. Waikar should ring loud for proponents of more disclosure like Dr. Lo, who still maintain that drug companies control the content of such speeches. If there continues to be a push for more disclosure, as others have indicated, the government will only begin to use this information against doctors, which will in the end only hurt patients.
One anti industry pundit stated about this case and working with industry in general: “If you can live with public exposure of your accepting gifts and fees from the pharmaceutical and medical device and imaging industries, then go for it. But in a few years, this information will all be known, not just to you and the few people attending your seminars, but to your patients, to your employers and to the government." Look out they want to sick the government on physicians working to educate other physicians (ouch)
The problem with reports like the IOM report is that “disclosure requirements often omit information that could help clarify the relationship between physicians and the treatments the doctors prescribe.” This statement is from Lisa A. Bero, a professor of health policy at the medical school of the University of California, San Francisco. In other words, the problem is not always the doctors failing to report.
Regardless of Dr. Lo’s recommendations, even as the New York Times admits, the IOM report itself indicated that “the public could benefit when doctors and researchers collaborated with the industry to develop new and effective products.” Since the report makes such an acknowledgement of the value of researcher-industry collaboration, present disclosure policies are more than enough for the public to judge whether such relationships exerted too much influence on patient care.
In the end newpapers will sell more stories of physicians and others working with industry if they can expand the people covered. Americans love to hear specifics about others income, we love controversy.
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