Monday, May 5, 2008

Another Conflicted Defense of Conflicts of Interest

It seems to be the season for defenses of financial relationships among medical academics and health care corporations to appear in the media. The latest example appeared last week in the Boston Globe as an op-ed [Shaywitz DA, Auseillo DA. Scientific research with an asterisk. April 29, 2008.]

Like other articles in this genre, the authors incorporated a number of logical fallacies into their arguments.

In particular, they attacked a series of straw-men. Consider, to start,

The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.

The straw-man above is in italics. The argument is much more broad than most of the critiques of academic-industry relationships of which I am aware. Most critiques refer not to
"industry" in general, but to particular kinds of industry, usually pharmaceutical, biotechnology, or medical devices. Most critiques refer not to all "researchers," but to those who do clinical research (involving live patients), not basic biomedical research. Most critiques refer not to all "partnerships," but to partnerships that involve industry paying the academic institution and/or the researcher. Furthermore, most critiques are not of a general "taint," but of specific effects of such conflicts of interest.

For example, what we have said on Health Care Renewal is that clinical research (as opposed to basic biomedical research) supported by companies whose products or services are being evaluated by the research tends to be biased. Research sponsors may find ways to manipulate the design, implementation, analysis, and/or reporting of the research in ways that increase the likelihood of results favorable to their products or services. Research sponsors may suppress research whose results are not so favorable. Thus, we most recently recommended considering the requirement "that all clinical research be conducted at true arm's length from organizations and people with vested interests in promoting particular products or services assessed by such research."

The article contained other versions of this straw-man, e.g.,

Unfortunately, industry critics often lose sight of the big picture, and routinely stigmatize pharmaceutical researchers and their academic collaborators.

However, the criticisms of which I am aware were of specific researchers and/or research projects, not all "pharmaceutical researchers and their academic collaborators."

Furthermore,

Senior university researchers who might contribute considerable wisdom to drug discovery efforts are reviled in the press if they associate with industry in any way....

Again, I have not heard academics criticized for simply associating with industry in any way shape or form. We and others have criticized specific kinds of association in specific circumstances. For example, we and others have criticized senior academics who are paid by industry speakers' bureaus to give talks that are thinly-disguised marketing pitches, especially when the slides for these talks are provided by the companies' marketers, and the talks are reviewed by company representatives. (See, for example, the case of "Dr Drug Rep," and the case of an academic physician serving as a "front man for the drug.")

The article actually opened with an even grander straw-man,

Consider an academic scientist - we'll call him Louis - who receives funding from the beverage industry, the textile industry, and the livestock industry, and ultimately generates profound new scientific insights, beneficial both to the sponsoring companies and to the world as a whole. Are these accomplishments diminished because the work was industry funded? Should Louis - Pasteur - have an asterisk next to his name?


Well, of course not. Note how this argument was picked for emotional appeal. Who would dare insult the great Pasteur? In fact, this is a tremendously stretched analogy. Pasteur was an academic, but not a physician. Although my knowledge of his work is elementary, it appeared almost none of his extensive research would now be called clinical, except his experimental inoculation of a single human against rabies done late in his career. He did do applied research, but on plants and animals. He was never funded, as far as I can tell, by a company which produced medicines or medical devices. I cannot find any evidence that he was ever paid by a company to evaluate that company's products.

While shredding these straw-men, the authors also made assertions that are simply unsupported by evidence. For example,

There is a need for more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.
Even more striking,

Pharmaceutical research is tightly regulated, and industry-sponsored clinical studies are typically performed in a rigorous, consistent, and transparent fashion that would be the envy of many academics.

Obviously, although some industry-sponsored clinical research is doubtless excellent, this assertion ignores the many cases of manipulation and attempted suppression of research that have come to light in the last few years. A few of the most recent examples discussed on Health Care Renewal were the manipulation of the reporting of Study 329 (of paroxetine), and manipulation of the mortality results from trials of rofecoxib.

At this point, it would surprise no one that both of the authors of this op-ed work directly or indirectly for industry. The Boston Globe article identified Dr Shaywitz as a "management consultant." According to a post by Ed Silverman on PharmaLot, Dr Shaywitz works for the Boston Consulting Group, whose clients include pharmaceutical companies. Dr Ausiello was identified as a member of the board of directors of Pfizer Inc. An earlier post on PharmaLot had also noted he is "on the advisory boards of Promedior, Proventys and Pulmatrix."

As Collier noted, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.] Maybe this is why someone as distinguished as Dr Ausiello (who is also physician-in-chief of the Massachusetts General Hospital, and Jackson Professor of Clinical Medicine at Harvard) would sign onto such a series of unsupported arguments. The failure of the conflicted defenders of academic medicine's financial entanglements with health care corporations to be able to made evidence-based, logical arguments is in itself an argument against such conflicts of interest.

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