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.

Pharmaceutical Gift Reporting in the Texas Legislature

Recently I was asked by the office of Sen. Eddie Lucio, Jr. of the Texas Senate to testify on behalf of his Senate Bill 414, which would require that pharmaceutical companies report annually to a state agency all gifts to physicians of greater than $75 in value. I gave my testimony, focusing on the ethical issues related to pharmaceutical gifts, but was most interested to see the ammunition brought forth by the bill's opponents. Two of us (the other being the local director of Public Citizen) testified for the legislation, and four testified against.

Two represented the biotech industry, and seemed to be saying--if you burden our companies with this reporting requirement, we'll take our jobs elsewhere and leave a bunch of Texans unemployed. (One fellow, representing Genentech, when quizzed by one senator about the high costs of cancer drugs, actually had the gall to claim that there is not a single person in the U.S. who is denied access to any cancer drug due to inability to pay, given that his company has such generous charitable and discount programs.)

Other testimony offered against the bill [by a Texas ob-gyn who had a list of drug company relationships as long as your arm, and by the PhRMA general counsel] was that it is really unnecessary. The people giving the testimony almost laughed at those of us who imagined that luxurious meals with wine, travel, junkets to fancy resorts, etc. were still being given out by drug reps. You silly people, they insisted, don't you realize that those are things of the past? Don't you realize that due to the PhRMA 2003 code of ethics, and the AMA code of ethics, and the Inspector General's anti-kickback report from DHHS, that the drug companies simply never any more give out those lavish, expensive gifts?

My reply to this line of testimony (I did not have the opportunity to say this at the hearing, so I burden you with it instead) was--that sounds really great; show me the numbers. When I was doing the research for HOOKED, one of the most elusive numbers of all those that I and some of my colleagues searched for was the total value of all gifts given by the industry to physicians in the U.S. This figure is treated by the industry as totally hush-hush. The commonly quoted numbers on the cost of all pharmaceutical marketing in the US (which includes direct to consumer marketing and drug samples as well as gifts to physicians) are the figures from IMS Health that place these expenses as roughly $21-23B annually. Marcia Angell, in her book on the drug companies, has shown reason to believe that the true figures are nearly twice that. But my main point is that if prior to about 2002-2003, drug companies used to give out these lavish gifts; and then they all stopped; one would imagine that these total marketing figures would have gone down at least a little--say from $21B to $19B or something. To the best of my knowledge there has been no such dip.

If there really was a demonstrable dip in industry largesse to practitioners due to voluntary codes of ethics or related actions, I for one would be happy to set the record straight. But, as I say, please show me the numbers. So far as I know, the numbers are not there.

Sunday, March 11, 2007

New Study Highlights Docs' Denial Calls for Ban on Reps

Troyen Brennan and colleagues fired a major salvo across the bow of the pharmaceutical industry last January with a paper published in JAMA, calling on academic medical centers to adopt strict policies to police (and generally to prohibit) interactions between their staff physicians and drug detail people. The same group, affiliated with the Center on Medicine as a Profession at Columbia, now has published a study (lead author, Susan Chimonas) which extends their earler arguments and adds some suggestive data to back them up.

This new study consists of responses obtained from focus groups, involving 32 physicians in 3 U.S. cities. (Watch for defenders of the status quo to attack this study as having too small and non-representative a sample. But also note that a similar study by Prosser and Walley in the U.K. in 2003 came up with very similar findings. Chimonas and colleagues, why didn't you have the courtesy to cite this earlier study?) The Journal of General Internal Medicine thought the paper worthy of on-line publishing in advance of its print edition.

Chimonas and colleagues show that these physicians were very aware of the notion and meaning of conflict of interest, but that as soon as the issue of their relationship with drug detail people, and their acceptance of company gifts, was rolled out, they refused to apply what they knew about conflict of interest and instead retreated into extensive denials and rationalizations.

The Chimonas study, whatever its limitations, seems to support two major themes I address in HOOKED--the omnipresence of rationalization in physicians' thinking about relations with the drug industry; and the deeply entrenched "culture of entitlement" that convinces us docs that we have all these goodies coming to us, and no spoil-sport had better get between us and those free dinners and other gifts.

I most liked the focus groups' responses to the PhRMA code of ethics on gifts--the document that the industry defenders roll out to show, first, that there may have been abuses in the past but everything now is all fixed; and second, that if we will just let the drug reps and the docs alone, they will figure out good ethical behavior on their own. One disgrunted physician, upset at the goodies that he supposedly could no longer have (such as tickets to sports events or free golf games), called the PhRMA code of ethics the "Doofus Code." Another respondent objected strenuously to the code's disallowance of docs' spouses coming to the free "educational" dinners. Said this fellow, "I think it's ridiculous, insulting...not to be able to spend an extra hour or two with our wives while we're getting an education." (Earth to Physician: please feel free to spend as much time with you want with your wife, and to engage in any activity, educational or otherwise, while doing so. But where in the name of whatever did you get the idea that a drug company should pick up the tab for that time, and add the cost to your patient's prescription prices?)

Chimonas and company conclude their paper with the draconian conclusion that this denial and rationalization tendency runs so deep that no voluntary code of ethics will ever do the trick. Docs will have to be banned, somehow, from seeing reps and taking gifts. Period.

Chimonas S, Brennan TA, Rothman DJ. Physicians and drug representatives: exploring the dynamics of the relationship. J Gen Inter Med 2007; 10.1007/s11606-006-0041-z (e-published ahead of print).

Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295:429-33.

Prosser H, Walley T. Understanding why GPs see pharmaceutical representatives: a qualitative interview study. Br J Gen Pract 2003; 53:305-11.