Thursday, March 22, 2007

JAMA Study: Still Hard to Get Reports of Pharma Gifts

Dr. Joseph Ross and colleagues, several of whom represent the Public Citizen Health Research Group, have reported on the experience in the first couple of years in two states, Vermont and Minnesota, that have mandatory reporting laws covering gifts to health providers from pharmaceutical companies over a certain amount in value. Because the VT and MN laws require reporting at different thresholds, the authors elected to study gifts reported as greater than $100 in value, which is above the limit suggested by the current AMA code of ethics.

So the study could be viewed as trying to answer two questions: 1) how well are these state mandatory reporting laws working? 2) how well are physicians and drug reps adhering to voluntary ethical guidelines?

The answer to the first question was fairly plain. The authors could get data from the VT Atty. General only following extensive negotiations; and could get data from MN only by paying $0.25 pr page to photocopy all the individual paper reports. After they got the VT data with great difficulty, they discovered that nearly 2/3 of all the payments to physicians were covered by a loophole in the law that allows the companies to label any payment as a trade secret. In both states, the purposes of the payments were not easy to discern, leading to the problem that we do not know for sure which payments are outright gifts, and which are supposedly payments for work that the company contracted for (even though many "consulting fees," etc. are really disguised gifts anyway).

So the authors concluded that if the purpose of these state laws was transparency in these relationships between physicians and Pharma, the goal was not being achieved as the laws are currently enforced or implemented.

The difficulty in getting any meaningful data out of these reports hamstrung the authors in trying to answer the second question. As I said, a payment to a physician of $1000 could have been a bona fide payment for bona fide work performed; a fake "consulting fee" for meaningless work; or an outright gift; and in many cases we simply would not know with confidence which it was. Bearing all these obscurities in mind, in MN, the authors found 6946 payments to physicians that they could track, and of these, 6238 were for amounts greater than $100.

So while many uncertainties remain, I also think it is fair to say from these data that there is the suggestion of widespread ignoring of any ethical "rules" that limit the amount of allowable gifts.

Ross JS, Lackner JE, Lurie P, et al. Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota. JAMA 2007; 297:1216-1223.

1 comment:

Anonymous said...

One must ask themselves: If the pharma industry was truly regulated by thier internal controls, as they have stated in the past, along with following guideline on thier behavior when conducting business, they should have no reason to oppose this disclosure.