Tuesday, February 9, 2010

Another County Heard From: An ACRE Perspective on Conflict of Interest and 'Political Correctness'

On a few occasions I have mentioned my colleague Dr. Avi Markowitz, chief of medical oncology at our medical center. Dr. Markowitz recently presented a Cancer Center Grand Rounds on “Academia and Industry.” As he’s a member of the Board of Directors of the Association of Clinical Researchers and Educators (ACRE), this talk promised to be a good summation of the position that I have opposed in this blog. I thought that a good way to present the ideas is to try to restrain myself and give Dr. Markowitz’s point of view as much as possible, perhaps then devoting a subsequent post to a rebuttal of specific points if need be. Where I was unable to stifle my responses, they appear below [in square brackets].
Suitable for a talk that vigorously defended, among other things, allowing industry to buy us lunch, there was free pizza and soda provided, courtesy of Fisher Scientific, a firm that primarily sells lab equipment; and the Fisher rep gave a short sales pitch before the grand rounds. This lunch was in line with the official UTMB policy, so far as I can gather, because the grant was prominently labeled as an “unrestricted educational” grant from the company to support the grand rounds.
Dr. Markowitz also started with his disclosure slide listing the 41 commercial firms he’s been associated with in his career, also accompanied by a statement of pride in all of those associations.
The subtitle of the talk (which I was not fast enough to write down in toto) prominently used the term “political correctness,” and in keeping with much ACRE material, AM returned regularly to this term. [As I do have a comment about the appropriateness of the ‘PC’ term, that will be the main issue I’ll take up briefly at the end.]
AM proceeded to a list of allegations that he finds offensive [suggesting thereby that these are the statements that his opponents actually make]—that physicians are for sale for a pen or a slice of pizza, that physicians would harm people for a fee, that physicians are too stupid to know if we are being biased, that if industry pays for it, it’s bad, that being a member of a company speakers bureau is bad, that being on an industry advisory board is bad, and that taking stuff from industry, including food, is bad. He alluded to data showing that delays in uptake of useful medicines by practitioners is a real problem, so therefore anything that interferes with industry marketing that might speed uptake potentially injures patients. He stated here that so long as a drug has gotten FDA approval, we can presume that it’s safe and effective, so there is then really no excuse not to promote its use. He added that in today’s world, if the industry did not pay top dollar, it could not get “real expertise” on pharmaceutical and scientific matters, so the amount paid for consultants, etc. should not be second-guessed.
In defense of providing food, AM mentioned the circumstances that arose here in Galveston following Hurricane Ike in September, 2008. The hospital was basically shut down, including the food services. Let me try to get the gist of his quote: “While a lot of staff were sitting at home collecting their paychecks, some of us, like me and my fellows, were here trying to get our clinic operations restarted. Some drug companies offered to send us food since we could not get anything to eat otherwise. I was told by a bureaucrat, one of the staff staying at home and collecting a paycheck, that this would be a violation of UTMB policy and so we had to refuse the food.”
That led to a long discussion of conflict of interest (COI). AM asserted that there is no generally accepted definition that measurably distinguishes benign from malignant forms of COI, so the term COI therefore becomes, with its negative connotation, a type of “insinuendo.” He reminded us that COI is ubiquitous in academics, where we all want to get raises and keep our jobs in addition to doing good science and patient care; hence “overlapping interests” and not COI would generally be the more accurate term. The legal principle should apply—innocent till proven guilty—whereas COI tends to label one as guilty until proven innocent.
AM then put up a slide that gave the definition of COI contained in the most recent IOM report on medicine and the pharmaceutical industry. He did not, however, discuss or analyze that definition. Instead, he noted that the IOM admitted that they could identify no data that showed that physicians and patients, themselves, view COI as a problem. This was a frank admission that the definition could not be data-based, and AM apparently felt that justified dismissing the definition out of hand for that reason. [AM asserted that there were data to show that patients, when asked if they were concerned about financial COI involving their physicians, denied any concern, and that the IOM ignored these data. On his side he denied that any data exist showing that patients are concerned about COI. I reviewed some of the data showing patient concern in HOOKED. I am aware of one study of cancer patients showing an apparent don’t-care attitude, but hardly believe that’s the totality of the data that exists.] “In science you are not allowed to reason without data,” AM said, [suggesting apparently that defining COI was a matter of science, and not, say, of ethics or policy.]
After some other comments AM turned to the Vioxx debate. While admitting that Vioxx was outside of his area of expertise, he cited several papers condemning the activities of Merck in that case, all written by physicians who admitted to having been paid by plaintiffs’ attorneys in anti-Merck lawsuits. AM then suggested that there was a double standard at play if some demand that those paid by Pharma disclose their conflicts, whereas there is no problem if others take more than $1M from plaintiffs’ lawyers. [The reasoning here seemed fallacious on several counts. By citing only those papers written by physicians with legal-fee conflicts, AM hinted that only people who were thus conflicted wrote papers critical of Merck. In fact there is a huge literature condemning what happened with Vioxx and the papers written by those physicians are only a small sampling. Second, there is a reason that these physicians wrote the few papers they did—as a result of the access to the legal documents, these physicians had evidence of ghostwriting and other things disclosed only as a result of access to internal company documents. The few papers that AM cited specifically dealt with company documents released as a result of legal discovery. Finally, there was no double standard. It is routine for journals to demand that authors list who pays them that could constitute a COI, but it is not usual to demand that the exact dollar amount be revealed. The plaintiffs’ lawyers’ advisors followed these same rules.]
AM mentioned that ACRE recently went toe to toe with the Council on Ethical and Judicial Affairs of the AMA and was pleased that they forced the draft on ethics and relationships with drug companies back to committee for the 3rd time. Who, we asked, is suited to determine our integrity for us? “Who is clean enough that they’re without sin?” [By this logic, no one could sit on a jury, because no one is so clean as to be without sin.] Among agencies that AM viewed as too conflicted themselves to be entrusted to tell the rest of us what integrity requires, he included the FDA, [apparently having forgotten that a few minutes previously, he had listed FDA approval of a drug as proof positive that the drug was both safe and effective.]
AM next asserted, “The real scandals in medicine have come not out of Pharma but out of academia.” He did not elaborate on this beyond an anecdote, of how he was involved once in a federally funded cooperative cancer trial, and a fellow mistakenly changed a drug dose in a way prohibited by protocol (due to a confusion as to what part of the protocol applied to the case). It took 8 months, AM reported, for the overseers of the trial to identify the protocol violation and notify him, by which time it was far too late to make any clinical changes (fortunately the patient was not harmed in any way by the minor dose change). By contrast, he stated from his experience commercially sponsored trials, had that been a company funded trial, the call would have come in 3 days.
AM next listed a set of truisms, including “the truth always comes out,” which he seemed to suggest meant that no company had any real incentive to conceal negative data. He proceeded to list advantages of partnering with industry: money, especially given limited federal research support; flexibility; scientific support; goal oriented; close monitoring; educational/CME support. “How do you develop a profitable drug? You invent something that works.”
In defense of industry’s making a profit, AM asserted that it’s the industry and not the government that develops new drugs—a point that he “proved” by listing how much money industry vs. government spends on clinical drug trials. [He did not address several studies claiming to show that a majority of drugs in important areas like cancer have their start in federally funded academic labs, not in industry.] He denied that drug companies make “excessive” profits by flashing a graph showing (I think) the net profit margins of a number of industries. Drug companies were near the top of the chart, but one of the handful of industries that were higher was brewers. AM then said that since the profit margin of the drug industry was slightly less than that of the beer industry, it could not be the case that drug companies earned excessive profits. He repeated the industry claims that if they did not charge the high prices they do today, they’d have no money to reinvest in R&D.
AM ended by listing Constitutional issues that he worries about due to the “moral bullying” in academia by the “politically correct” crowd, including violations of the First Amendment and of freedom of assembly (if people cannot gather for a company sponsored lunch). He used up all but 4 minutes of his hour giving the talk, and there were no audience questions in the brief time remaining.
[Had there been more time for questions, the one I would have asked AM would have been, “Please define ‘political correctness.’” I admit that there are some contexts where this term makes good sense. However, I think it is easy to misuse or overuse the term. In general, people use the term when they cannot think of a substantive ethical consideration to defeat their opponents’ case. Supposing that I support the rights of a minority group to do a certain thing. People who disagree with me, if they could think of a flaw in my ethical argument, would surely refute me by pointing out that flaw. So when the only thing they can say in opposition to my defense of minority rights is that I am being “politically correct,” it seems they are admitting that they have no substantive rebuttal. If that is so, then all “PC” can count as is an ad hominem argument—that is, being unable to attack my logic, they attack my motives instead. As AM objected to what he took to be the “insinuendo” aspect of COI, it was interesting that he saw nothing “insinuendo” about PC.]
I sent Dr. Markowitz a copy of the above text some time back and he did not reply to two offers to suggest amendments or initial reactive comments; so I have to assume that he will choose to comment on this post in the usual way if he wishes to.


Marilyn Mann said...


Thanks for putting yourself through this not-too-pleasant experience, all with the aim of enlightening your readers who were not able to be at Grand Rounds that day. I have had some small degree of exposure to these ACRE people, through reading their views as expressed in the Mayo Clinic Proceedings article, through reading Danny Carlat's description of their founding meeting, and through listening to a webinar that featured an ACRE member named Dr. Michael Weber. All I can say is that they seem to be a bunch of blowhards and I have trouble taking them seriously.

"there was free pizza and soda provided, courtesy of Fisher Scientific, a firm that primarily sells lab equipment; and the Fisher rep gave a short sales pitch before the grand rounds. This lunch was in line with the official UTMB policy, so far as I can gather, because the grant was prominently labeled as an 'unrestricted educational' grant from the company to support the grand rounds." OK, I'm a little confused by this. I have been assuming that an "unrestricted" educational grant was one where the sponsor (in theory at least) had no control over the content. If the company rep can give a sales pitch in connection with the program, then how can this be considered an "unrestricted" grant?


Sarah Miller said...

Ha.. I don't believe that there are ethics in pharma..! History has shows us this over and over again... Merck, Pfizer, etc...

Sarah Miller said...

"AM proceeded to a list of allegations that he finds offensive [suggesting thereby that these are the statements that his opponents actually make]—that physicians are for sale for a pen or a slice of pizza.." - what a ridiculous argument to make. The guy was just doing his job and you all got a slice of pizza out of it! Nothing more, nothing less..