Physician Payment Sunshine Act: Clinical Research Professionals Concerned About Impact on Medical Innovation

In our continuing coverage of the Physician Payment Sunshine Act, we turn our attention to an article authored by Gary A. Shangold, M.D., chairman of the Association of Clinical Research Professionals Board of Trustees, and Michael J. Koren, M.D., immediate past president of the Academy of Physicians in Clinical Research. They write, lost in all the confusion surrounding health reform is Open Payments, and the law will bring negative impacts to medical innovation and the vitality of American clinical research.

The following highlights several of their critiques regarding Open Payments:

RESEARCH-RELATED PAYMENTS MISLEADING

“If we reported other income in the same manner Open Payments requires research payments to be reported, we would report that fast food cashiers are earning much more than $15/hour as we would attribute to them all the cash that their register takes in and hide the fact that they were only paid at or slightly above minimum wage. Clearly one can see how inaccurate such a representation would be and if we want true transparency in research payments, Open Payments needs to change and not report the equivalent of what the fast food cash register took in but what payments the physician actually received that actually would be of interest to a concerned patient.”

COMPLIANCE COSTS DIVERT RESEARCH FUNDS

“According to the Federal Register, estimated costs associated with compliance with the act are $269 million in year one and $180 million annually thereafter, which most people believe is grossly underestimated. This means that time and money spent to ensure compliance with Open Payments will be diverted from patient care, research budgets, clinical trials and other areas of education and innovation that propelled our industry into such a vital position within the U.S. economy. And, like many other parts of the act, the Centers for Medicare & Medicaid Services (CMS), the government bureaucracy in charge of facilitating this law’s implementation, fails to properly account for hours spent disputing disclosures with a manufacturer or time spent discussing them with an interested patient.”

Shangold and Koren point out that Open Payments will make physicians and researchers less likely to collaborate with industry at all: “According to a 2010 survey conducted by the Association of Contract Research Organizations (ACRO) and the Academy of Physicians in Clinical Research (APCR), 13 percent of respondents would be ‘less likely to participate’ or ‘would not participate at all’ in future clinical research trials. This is truly unfortunate for the patients who want to (or need to) enroll in studies of promising new therapies.”

HARMFUL TO QUALITY OF CARE

“Diminished research funding and a skeptical group of physicians, other clinical research professionals and patients could be a real threat to medical advancements that could change the quality of health care for the better.”

They point out the way Open Payments reports data offers consumers little context to understand how research dollars are spent, leading to consumer skepticism and apprehension on the part of research hospitals or other potential participants in a clinical trial if it could damage their reputation.

Shangold and Koren point out that Scientific American states: “No empirical data has tied researchers’ financial interests in a study to negative outcomes for patients.” And in a startling admission, CMS says that they “have no empirical basis for estimating the frequency of such problems, the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the cost of medical care.”

RESEARCH BENEFITS COULD BE LOST

“In following, we believe that research collaborations are fundamentally different than the offering of rewards for selling more prescriptions and should be viewed in a different light. Modern medicine would not be where it is today without clinical research. Think of every drug, device or other therapeutic product or procedure you and your loved ones have received. These life-changing products did not simply appear out of thin air. Manufacturers often spend years (and even decades) and millions (and even billions) of dollars working with clinical researchers, physicians and other medical practitioners to create the evidence for each product needed that will make a real difference in patients’ lives … Hindering clinical trials in any way, as does the current methodology of Open Payments, is not in society’s best interest.”

NO BENEFIT FOR PATIENTS

Shangold and Koren address that the Open Payment methodology, especially for research, is not appropriate for timely informing patients. They point out: “[i]nformation is reported annually for payments of the prior year and posted on the government website on June 30 of each year (excepting the first year being Sept. 30 to work out the kinks). This means that patients will be informed of the payments anywhere from 6-18 months after the payment is made. Also, for certain kinds of research, the public disclosure can be delayed up to four years. Therefore by the time the patient finds out about the payment through this system, it is at a minimum six months but up to four years after the care has been given. This is clearly too late to take any of that information into consideration for the treatment they need that day. All it would seemingly help with is to foster more lawsuits and more bad press.”

CALL FOR LEGISLATIVE CHANGE

“When including research payments in the manner they did, lawmakers neglected to consider the debilitating consequences it will have on physicians, clinical researchers, the medical field as a whole and–most of all–patients. Lawmakers should embrace a legislative or regulatory solution that adjusts Open Payments in such a way that compliance will not detract from clinical researchers’ ability to do their jobs, allows medical research to continue advancing for the benefit of patients and timely informs (not misleads) patients of the true relationship when manufacturers and physicians/hospitals collaborate for research purposes.”