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Rick J. Carlson, The Case Of BiDil: A Policy Commentary On Race And Genetics, Health Affairs Web Exclusive, October 11, 2005 [Abstract] [PDF] [HTML Version] [Reprints & Permissions]

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Response to BiDil Commentary

Mirta R. Goldstein, MBA, MSc   ( 12 October 2005 )

Correcting Carlson

Pamela Sankar, Jonathan D. Kahn   ( 18 October 2005 )

Re: Correcting Carlson

Rick J. Carlson   ( 14 November 2005 )

Response to BiDil Commentary 12 October 2005
Mirta R. Goldstein, MBA, MSc, Vice Chair Administrative Affairs Jersey City Medical Center Send comment to journal: Re: Response to BiDil Commentary mgoldstein{at}libertyhcs.org Mirta R. Goldstein, MBA, MSc	In his commentary, Rick J. Carlson states: "But these researchers at least offer an explanation for why BiDil proved to be more effective in a racially defined group." (W5-466). This statement is inaccurate since the trial for BiDil was conducted ONLY with African-Americans as subjects without other racial groups as controls. I am even surprised that this study passed the scrutiny of reviewers before publication in a reputable scientific journal. It is even more worrisome it passed scrutiny from the FDA. What the study really showed is the obvious: that patients with heart failure will do better if treated than if left alone with a placebo. As a matter of fact, this holds true with regards to any medical condition. The value of studying genetic differences due to race, which would improve patient care, is not in question. However, the case of BiDil pertains to the field of clever marketing and should not be interpreted as improvement of care, which can be achieved with the prescription of non-combined generic hydralazine and isosorbide dinitrate. We can only hope high scientific standards will prevail, particularly after public trust has been shaken by the commercialization of Vioxx.
Correcting Carlson 18 October 2005
Pamela Sankar, Assistant Professor of Medical Ethics University of Pennsylvania, Jonathan D. Kahn Send comment to journal: Re: Correcting Carlson sankarp{at}mail.med.upenn.edu Pamela Sankar, et al.	Carlson's commentary on our article, “BiDil: Race Medicine or Race Marketing?” misses the point of the article and makes repeated errors, perhaps because he is commenting on a subject about which his prefatory remarks explain he has “no particular expertise.” For readers interested in a more accurate understanding of the controversy over BiDil, a few points should be kept in mind while reading our article, Carlson's commentary, or any others on the topic. 1. Bidil did not prove to be more effective in a racially defined group. “More” implies a comparison, and the study conducted to win Bidil approval made no such comparisons. 2. The doctors conducting the A-HeFT study on BiDil made NO claims about any genetic basis for BiDil's efficacy. Indeed, the BiDil label specifies that its mechanism of action is unknown. Carlson's unwarranted leap to assume that BiDil shows a genetic basis to racial difference directly makes the point he is at such pains to contradict: namely, non-rigorous uses of racial categories in biomedical contexts will create misunderstandings about racial difference. 3. Carlson builds his critique around a false dichotomy between social and biological sciences. As our article shows, the main tension is between science (both biological and social) and commerce. The race-specific trial design and marketing of BiDil cannot be justified by any valid scientific analysis. It is driven by patent law and market protection. Of course, commerce and science always play a role together in drug development. BiDil, however, presents a troubling example of commerce distorting science. This has created precisely the sort of situation where uncritical observers such as Carlson misread the data and mistakenly assume a genetically based race-specific differential response to a drug that, in fact, should be made available in low-cost generic form to people with heart failure regardless of their race. 4. Finally, Carlson's assertion that "Pharmaceutical manufacturers pay the FDA very large sums to [move product]" is stunning. Such payments are made to enable the FDA to proceed quickly and efficiently in evaluating the safety and efficacy of drugs; that is the FDA's only mandate. Carlson seems to imply and applaud a situation where pharmaceutical corporations have bought and paid for FDA assistance in marketing their products without exercising an independent evaluation of the validity of their claims.
Re: Correcting Carlson 14 November 2005
Rick J. Carlson, Clinical Professor, Policy Programs University of Washington Send comment to journal: Re: Re: Correcting Carlson rickjcarl{at}aol.com Rick J. Carlson	I'm sorry to be slow in responding to Pamela Sankar, but perhaps I felt too chastened to reply sooner. Now, reflecting further, my clarifying points are but a few, so whoever reads this can determine whether I've been sufficiently "corrected": 1. The policy domain, as pretentious and fuzzy as it can be, was the domain of my commentary, one I've hung around in for over 35 years -- neither the science, as such, nor an academic research perspective. In the policy domain, I stand fully behind what I said, save one thing: If the FDA got the science wrong, as apparently Sankar believes, notwithstanding the views of the FDA crew, then the downstream marketing (labeling) decision was wrong, it would follow, and should always follow. End of story. 2. That said, I read as much of the science as I could, so I could, in turn, look at it in the context of the FDA's prior "scientific" decisions on safety and efficacy -- which decisions interpreted that science as "contextual" and problematic, as I did, rather than as textual, or determinative, which Sankar did, perhaps the way Scalia does with the Constitution. Sankar does have the bulk of the evidence in her favor, but not all of it. 3. Hence, on the one "policy" question -- the science having already been vetted, whether Sankar or I like the outcome -- I addressed, whether to "market" (label) BiDil to black Americans or not, I answered: in the absence of determinative science, the next and the "only" question before the FDA was how to best get a drug that works to people who need it; "yes or no," not "maybe." Sankar's answer, I presume, would be "maybe" and then try to "correct" the FDA. (By the way, irony aside in my reference to "moving product," the FDA has been intolerably politicized by the very act of Congress that gave Big Pharma the "right" to push the FDA to "move product" -- this is not "fox in chicken coop" but "fox" owning part of the coop!) What's "stunning" isn't that Sankar missed my irony but that she believes that Big Pharma's role is so benignly educational.