Ah, esse monstro de olhos verdes..

Heartwire, o boletim do InfoHeart apresenta os problemas do foco na pessoa de Steven Nissen e, não no FDA e na Glaxo-Smith Kline no caso Avandia. O título acima é uma tradução tosca de Otello de Shakespeare, que os americanos popularizam como The Irish eyes of envy. Sim, a inveja é a aquilo que os caminhoneiros escrevem nos para-choques.

The media, the man, and his message: Nissen seeks to refocus scrutiny on rosiglitazone June 21, 2007Shelley Wood New York, NY - The first act appears to be over in the rosiglitazone (Avandia, GlaxoSmithKline) drama, but the media have not yet loosened their grip on the man who first sounded the alarm about the diabetes drug: Dr Steven Nissen (Cleveland Clinic, OH). Nissen's meta-analysis, published in the New England Journal of Medicine (NEJM) and reported by heartwire, propelled rosiglitazone into the spotlight, culminating in a congressional hearing earlier this month and an FDA hearing on July 30. Despite Nissen's repeated insistence that the focus should be on patient safety, not his methods or motives, newspapers and their editorialists—as well as alternative media—continue to take disparate views on the man in the middle of the maelstrom. Dr Steven Nissen An editorial in the Cleveland Plain Dealer insists Nissen is being victimized for championing the public good . "Nissen, and clinicians like him around the country, aren't sifting drug performance data so they can add to their scrapbooks of news clippings. They're doing it so they can add to the store of knowledge in the medical community, which can then improve care for patients," the Dealer asserts. "As it now stands, public-spirited doctors like Nissen, who are trying to save patients grief, can be accused of poking their noses where they don't belong. That's ludicrous." Other media outlets have profiled Nissen, emphasizing his lifelong activism in different spheres. A glowing portrait of Nissen on MedPageToday.com points out that he was a part of the college antiwar movement during the 1960s at the University of Michigan. "His years as a campus activist left him with an entrenched commitment to righting wrongs and a willingness to challenge the status quo, attributes that he has integrated into his medical career," Peggy Peck writes for MedPageToday. "And he never forgot the power of the press." Altruism not universally accepted Indeed, the mainstream media loves a whistleblower, but not all of the coverage of Nissen's role has accepted the notion of him as altruist. Earlier this week, the Wall Street Journal (WSJ) ran an editorial questioning the "larger political context" in which the rosiglitazone concerns were raised, noting that "Dr Nissen has a reputation as an adversary of the pharmaceutical industry" and that he "admitted that he consulted with several congressional committees" prior to the publication of his rosiglitazone meta-analysis. "Ostensibly serious medical research isn't supposed to be peer-reviewed by the Democratic majority," the WSJ editorial gibes. Nissen, for his part, has repeatedly rejected claims that politics had anything to do with it. "That's just not what happened," he told heartwire. "The scientific process proceeded in the usual way: the journal had the article reviewed by peer scientists, it was a very careful review, it was revised based upon those reviews, and it has absolutely nothing to do with politics, it was about patients. . . . If the reviewers had not recommended publication, I'm sure that the NEJM would not have published it." Other news coverage has implied that Nissen had a different, more personal, political agenda. On June 5, Boston Globe staff reporter Diedtra Henderson quotes critics who claim Nissen's motives stem from a desire to run the FDA, a charge Nissen flatly rejects. "I'm not running for anything," Nissen is quoted in the Globe. "I've got a great job here [at the Cleveland Clinic], and I'm not going anywhere." Nissen reiterated this point to heartwire: "Speculation about the FDA is a very common topic. I am very happy as the chair of CV medicine at the Cleveland Clinic: I have no interest in going anywhere else; I have my hands full. I'm certainly not interested in running for an office like the FDA commissioner, I don't know where that comes from, it certainly doesn't come from me." Headline news A sticking point for the media mania around Nissen has been his apparent eagerness to make headlines. That was also the charge levied by California Republican Rep Darrell Issa during the congressional hearing, where he accused Nissen of caring more for making a "public splash" in the media than informing the FDA directly of his concerns about rosiglitazone. Even earlier, a Bloomberg news report posted online when his meta-analysis was first published notes that Nissen "put the Cleveland Clinic's in-house television studio to good use this week, appearing on a dozen broadcasts across the world." Nissen agrees that his paper "had more than the usual amount of media attention," but, he insists, "We published this because of the science. It was certainly not about politics, it's certainly not about media. . . . Ninety-nine percent of the coverage of the rosiglitazone story has been very good and very responsible. It's a very tiny group that's making an effort here to make this about the messenger, not the message." Nontraditional media have their say The bulk of that negative press has come from independent bloggers and other nontraditional media, many with major conflicts of their own. One of the more novel was a video podcast on the popular video-sharing website, YouTube, that opens with the question, "What do you think about a doctor … who compares a diabetes drug to 9/11?" a reference to a comment Nissen made during an interview that aired on ABC's Nightline website. The one and a half minute video features Dr Michael Weber (SUNY, Brooklyn, NY) expressing his misgivings about how Nissen described rosiglitazone's risks in the media. But the YouTube video was funded by the Center for Medicine in the Public Interest (CMPI), a "research" organization funded by the pharmaceutical industry, and Weber's own ties to industry have been scrutinized in the past. Contacted by heartwire, Weber said he did not even know what YouTube was. He stated that he is a member of an external, unpaid advisory group of directors for the CMPI and that the CMPI approached him to do "a video," not the other way around. He also emphasized that his comments were not about the scientific validity of the study, but about how they were disseminated. "As far as I'm concerned, the full story about Avandia still isn't known, and the concerns that were raised by Dr Nissen may be something we need to find out about," Weber said. "I'm not criticizing or disputing the scientific data, and in fact the whole reason I agreed to be videoed was because I did get very upset when I saw that Steve had said that the Avandia situation was worse than what happened on 9/11. I found that to be the sort of hyperbole that is really unacceptable in discussing these sorts of issues, and as a New Yorker, the statement was particularly unacceptable." But Weber rejected any suggestions that he himself was conflicted in this particular circumstance. "I do consult for industry, and I have done research projects and been a part of research activities that have been funded by industry, and I've always fully disclosed or acknowledged those. In this case, there is really not an industry connection, because I have not in any way defended Avandia or defended the way the company that manufactures Avandia has managed the situation." Nissen says he hasn't seen the video and doesn't want to. "What can I say? We publish scientific work, we did this analysis not to address the YouTube audience but because we believe that providers and patients have a right to know that there are significant safety issues with rosiglitazone," he told heartwire. "If it in fact stimulates people to create YouTube videos, I can't do anything about that, but that's not the audience." Blogs and missed potential Other blogs, associated with online editions of newspapers and magazines, have also debated Nissen's role. Ivan Oransky, blogger for The Scientist online, pointed out that Nissen has twice in the past year been wrong about drugs that he thought "held promise": torcetrapib (Pfizer), and now rimonabant (Sanofi-Aventis), the latter unanimously panned by the FDA's advisory panel last week. Oransky's observations were subsequently picked up in the WSJ health blog by veteran reporter Scott Hensley, who observed that Nissen, "a frequent and outspoken critic of the drug industry," has an "imperfect crystal ball." Oransky, quoted by Hensley, writes: "I think it's worth noting the record of someone whose pronouncements on drugs are so often held up by drug industry critics and that make media headlines." This is not like handicapping horse races; it's about doing good scientific studies and reporting the results in a faithful and accurate fashion. Nissen calls this a "straw-man" argument. "I'm always enthusiastic about drugs that we're studying, but when results come in, we tell it the way it is," he told heartwire. "I don't predict the success of drugs, I study the effects of drugs. . . . I have no vested interest, personally, one way or another in whether a drug works or not. It's my job to report scientific results in a neutral fashion, and I never predicted that torcetrapib would be successful. I thought it had great potential, and that was a potential that didn't pan out." In the case of rimonabant, investigators, including Nissen, did not have data on psychiatric side effects of the drug. "I'm glad that those data were reviewed; I hope that it can be overcome, because I do think [rimonabant] has potential. But this is not like handicapping horse races; it's about doing good scientific studies and reporting the results in a faithful and accurate fashion." Biting the hand that leads For health reporters, Nissen is a rare gem in the parched, baked earth that is the medical/pharmaceutical beat. In a sphere where wooden interviews, cautious opinions, and technical jargon are the norm, Nissen speaks his mind and is deliciously quotable. At the major cardiology meetings when he's spoken at a press conference, Nissen will glide through the pressroom like he's hosting a garden party, offering opinions, warmly greeting reporters by name. Asked whether the proximity he's always enjoyed, even nurtured, with the press has come back to bite him, Nissen cordially steers the conversation back to where he insists it should remain. "The last thing in the world I want is for this to be about me. It has to be about the science. If there are criticisms of the manuscript, let them be directed at the science, not at the messenger." Yet even as the hue and cry dies down, many journalists following the rosiglitazone saga are left wondering if Nissen—always so frank with and accessible to the media—may, this time, have gotten more attention than he wanted. Which just goes to prove the adage: Be careful what you wish for, you just might get it.