Guest guest Posted August 30, 2006 Report Share Posted August 30, 2006 News Nature MedicinePublished online: 30 August 2006; | doi:10.1038/nm0906-986 News feature: A few good scientistsResearchers who have no financial entanglements with companies are a rare breed. Given that, asks Meredith Wadman, is the push to police conflicts of interest realistic? Meredith Wadman For the editors of the Journal of the American Medical Association, this has been a summer of discontent.In two short months, the prestigious medical journal has published four corrections detailing significant financial conflicts of interest that its authors had not previously revealed.The most damaging case involved a widely publicized paper that concluded that women who stop taking antidepressants during pregnancy are at an increased risk of relapse. On 11 July, The Wall Street Journal reported that 9 of 13 authors on the paper are paid consultants or lecturers for antidepressant makers—and had, in all, more than 60 different financial relationships with companies—but did not disclose those ties. The other offenses were somewhat more obscure, but no less clear-cut.The author of a report on big heart trials didn't reveal his consulting work for seven related drugmakers. Two writers of a review linking a rheumatoid arthritis treatment to increased risks of cancer and infections didn't state that they are being paid by Amgen to analyze a competing drug. And all six authors on a paper linking some migraines to an increased risk of stroke, heart attack and death didn't disclose their relationships with makers of pain or heart medications."We'll get killed," JAMA's editor-in-chief, DeAngelis, told the Associated Press when the fourth episode became public, speaking of damage to the journal's reputation. She declined to be interviewed for this article. The search for the untainted investigator is starting to become like Diogenes' quest to find an honest man. Arthur CaplanUniversity of Pennsylvania Despite the bad ink that has plagued JAMA, the journal is just one of many struggling to adapt to scientists' increasing entanglement with companies.Other journals are revisiting disclosure policies that are for the most part more lenient than JAMA's. Government agencies are setting stricter standards. Vigilance by advocacy groups, the press and even Congress is increasing—as are calls for serious sanctions against offenders."There is more alertness to violations," says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "There is a whole subcategory of people who study this now. And they're watching."Eroding trustAmong those keeping a close eye is the Center for Science in the Public Interest, a Washington-based advocacy group that in July called for a three-year publication ban on journal authors who flout disclosure guidelines."At some point, journals need to put some teeth into their policies," says son, the executive director of the Center. "Look at what JAMA has gone through. I hope that other journals won't wait to be burned."DeAngelis, writing in a 7 August editorial in JAMA, dismissed the idea of a publication ban, saying that it would simply drive offending authors to other journals. "It cleans our house by messing others," she said.But son and others say that greater transparency is essential as scientists increasingly forge close ties with the industry."The pressure that has been put on journals and on federal agencies really boils down to trying to build back public trust in the institutions of science," says Sheldon Krimsky, a Tufts University expert on conflicts of interest in biomedicine.Essential to rebuilding that trust, Krimsky argues, is the cultivation of a sizeable cadre of biomedical researchers with no commercial ties.Some government agencies, at least, are moving in that direction.In 2005, following embarrassing press reports of its scientists collecting undisclosed six-figure consulting payments, the US National Institutes of Health launched a controversial policy banning employees from consulting for biomedical companies, and obliging senior scientists to divest their stocks (Nat. Med. 11, 914–915; 2005).Then, in July, the US Food and Drug Administration (FDA) announced that it is modifying its policy on conflicts among external advisors who weigh in on drug approvals."We are going to aim to be much more transparent," said deputy commissioner Gottlieb, announcing the changes.Judgment callsMedical journals are also scrambling to revise their policies.The journal Neuropsychopharmacology—a product of the Nature Publishing Group, Nature Medicine's parent company—was also caught in a wave of bad publicity this summer.The journal's editor-in-chief, Nemeroff, and his coauthors did not disclose their financial ties in a paper that endorsed vagus nerve stimulation, a controversial, albeit FDA-approved, therapy for treatment-resistant depression. Nemeroff had recused himself from editing the paper, but the $15,000 device for the therapy is made by Houston-based Cyberonics—for which eight of the paper's nine authors, including Nemeroff, are paid consultants. Nemeroff says the authors' disclosures were in the original manuscript but were inadvertently dropped from the draft that went to press. "It was an oversight, nothing more," he says. "We are entirely and absolutely dedicated to full financial disclosure." He declines to say how much he is paid by Cyberonics.As a result of the incident, Nemeroff says he is considering adopting a new policy: requiring authors to provide a list of all their financial relationships with companies in every manuscript they submit. The journal now leaves it to authors to judge—and disclose—which of their financial interests are relevant to the subject of an article. "That's a judgment call that in this climate could be viewed as problematic," Nemeroff notes.The incident wasn't Nemeroff's first brush with this issue. In 2003, The New York Times reported that Nemeroff had lucrative financial ties to two companies whose drugs he had touted in a Nature Neuroscience review on mood disorders. These competing interests were not revealed to readers. Nor was the fact that Nemeroff held the patent on another treatment—a lithium patch—that he applauded in the article.But Nemeroff had not violated Nature Neuroscience's policies at the time, which didn't require financial disclosure from writers of reviews. That policy was changed as a result.The Nature research journals—which include Nature Medicine and Nature Neuroscience—do not impose sanctions on offending authors, and require authors to list their competing financial interests only after a paper has been accepted in principle. Authors are also given the option to declare that they have "too many" competing financial interests to list."We're probably too liberal about this," says , chief editor of Nature Medicine. "It's something that we would like to revisit, to see if there is any scope for change."At least one journal has decided to impose serious sanctions. In 2004, Environmental Health Perspectives, which is published by the US National Institute of Environmental Health Sciences, adopted a three-year publication ban on authors who willfully flout its disclosure policy. Burkhart, its editor, says that he hasn't needed to mete out the punishment because several breaches, for which he has published clarifications, have been "unintentional." The aim of the ban, he adds "is not really to punish but to deter."Presumed guiltyIs divorcing researchers from commercial interests realistic? Or even necessary?"A lot of people these days have competing financial interests. That is just a fact that surrounds modern biology," says . "It should not disqualify their ability to do transparent and honest science."Many others echo those sentiments, arguing that the recent incidents are fomenting a new McCarthyism in which researchers are wrongly presumed to be ethically tainted, and their work suspect, simply because of their financial associations with companies."It's what I call the conflict of interest cult," says Stossel, a Harvard University hematologist who publicly defends commercial relationships between doctors and companies."Transparency is a good thing, but the cult has carried it to an absurd extreme," Stossel says. "The purpose is to accommodate a vigilante informant culture that is out looking to discount you."Stossel and others argue that walling off researchers from the industry is not only unrealistic but bad for medicine."New drugs and devices are generally developed by companies, often with significant input from academic physicians and scientists. This sort of partnership is vital for medical progress," says Shaywitz, an endocrinologist at Massachusetts General Hospital.The FDA has used similar arguments to support its reliance on external advisers with commercial ties, saying that recruiting the best experts sometimes requires accepting some degree of conflict. The agency routinely grants its advisers conflict-of-interest waivers, allowing them to vote on drug approvals even when a company they are working for, or own stock in, has a stake in the decision.Most famously, a 32-member panel of external advisers voted by narrow majorities in February 2005 to recommend the continued sale of Vioxx and Bextra, two blockbuster painkillers clearly associated with increased risks of heart attacks and stroke. Shares of Merck and Pfizer, the drugs' makers, shot up in response to the news.One week later, The New York Times reported that 10 of the 32 advisers had consulted for the makers of the two drugs, or for Novartis, which was preparing to market a very similar pill. Had these advisers not voted, the committee would not have decided in the drugs' favor.Free passIn April, a study by the activist group Public Citizen—published, ironically, in JAMA—reported that 28% of about 2,000 FDA advisory panel members between 2001 through 2004 disclosed conflicts of interest.But the FDA declined waivers for only 1% of those scientists. Although the study didn't find a statistically significant relationship between the advisers' commercial ties and the panel outcomes, the House of Representatives had by June voted to bar the FDA from granting waivers.Under pressure, the FDA in July announced that it is revising the policy that governs waivers, aiming to codify decisions that have thus far been made using qualitative judgments.Deputy commissioner Gottlieb said that in some cases, the rules may actually be eased. For instance, the agency may allow experts who oversee the safety of a drug trial to participate in a panel judging that drug without getting a waiver, as is currently required. The agency will also make "more transparent" the legalistic, redacted documents it now posts to explain its waiver decisions, he said.The FDA will preserve the waiver-granting process because the best and the brightest experts often have ties to companies, he added. "If we do away with the waiver process," he said, "the truth is that we are playing it safe rather than playing it smart."Playing it 'safe' is, in any case, becoming increasingly difficult."The search for the untainted investigator is starting to become like Diogenes' quest to find an honest man," says Caplan, invoking the Cynic philosopher who is said to have spent his days wandering around ancient Greece with a lantern.Given this, Caplan says, perhaps the response to the recent incidents should be more measured."If you take it to an extreme, you start to say that no science that comes out of private industry is good, because it's commercial," he says, "and that can't be the right conclusion." Meredith Wadman writes for Nature Medicine from Washington, DC Article brought to you by: Nature Medicine Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 31, 2006 Report Share Posted August 31, 2006 I guess we shouldnt assume that scientists are favoring treatment options they endorse because of their side financial interests, but come on folks, what else would be the case here? Just like family doctors being wooed by pharmaceutical companies to prescrible THEIR drugs to patients. Its like that on all levels. Its wrong. How can you be an unbiased scientist conducting a study on something when you get stock incentives if the drug you are studying gets approved? Money is a huge, dirty, corrupting thing, yet most of us cant get enough of it. Its like politicians being bought off by lobbyists and constituents. Is everything tainted? Is there any more " pure " science being done for the sole purpose of bettering mankind? lisa --- " Vornan-19 (moderator) " wrote: > [http://www.nature.com/images/spacer.gif] News > [http://www.nature.com/news/images/spacer_pink.gif] > > [http://www.nature.com/images/spacer.gif] Nature > Medicine > Published online: 30 August 2006; | > doi:10.1038/nm0906-986 News > feature: A few good scientistsResearchers who have > no financial > entanglements with companies are a rare breed. Given > that, asks Meredith > Wadman, is the push to police conflicts of interest > realistic? > Meredith Wadman > [http://www.nature.com/images/spacer.gif] > [http://www.nature.com/news/images/spacer_pink.gif] > > [http://www.nature.com/images/spacer.gif] For the > editors of the Journal > of the American Medical Association, this has been a > summer of > discontent. > > In two short months, the prestigious medical journal > has published four > corrections detailing significant financial > conflicts of interest that > its authors had not previously revealed. > > The most damaging case involved a widely publicized > paper that concluded > that women who stop taking antidepressants during > pregnancy are at an > increased risk of relapse. On 11 July, The Wall > Street Journal reported > that 9 of 13 authors on the paper are paid > consultants or lecturers for > antidepressant makers—and had, in all, more than 60 > different > financial relationships with companies—but did not > disclose those > ties. > > > [http://www.nature.com/news/2006/060828/images/nm0906-986-I1.gif] > [http://www.nature.com/news/images/spacer.gif] > The other offenses were somewhat more obscure, but > no less clear-cut. > > The author of a report on big heart trials didn't > reveal his consulting > work for seven related drugmakers. Two writers of a > review linking a > rheumatoid arthritis treatment to increased risks of > cancer and > infections didn't state that they are being paid by > Amgen to analyze a > competing drug. And all six authors on a paper > linking some migraines to > an increased risk of stroke, heart attack and death > didn't disclose > their relationships with makers of pain or heart > medications. > > " We'll get killed, " JAMA's editor-in-chief, > DeAngelis, told > the Associated Press when the fourth episode became > public, speaking of > damage to the journal's reputation. She declined to > be interviewed for > this article. > > > [http://www.nature.com/news/images/columns_qt_left.gif] > The search for > the untainted investigator is starting to become > like Diogenes' quest to > find an honest man. > [http://www.nature.com/news/images/columns_qt_right.gif] > > [http://www.nature.com/images/spacer.gif] > Arthur Caplan > University of Pennsylvania > [http://www.nature.com/images/spacer.gif] > [http://www.nature.com/images/spacer.gif] Despite > the bad ink that has > plagued JAMA, the journal is just one of many > struggling to adapt to > scientists' increasing entanglement with companies. > > Other journals are revisiting disclosure policies > that are for the most > part more lenient than JAMA's. Government agencies > are setting stricter > standards. Vigilance by advocacy groups, the press > and even Congress is > increasing—as are calls for serious sanctions > against offenders. > > " There is more alertness to violations, " says Arthur > Caplan, director of > the Center for Bioethics at the University of > Pennsylvania. " There is a > whole subcategory of people who study this now. And > they're watching. " > > Eroding trust > > Among those keeping a close eye is the Center for > Science in the Public > Interest, a Washington-based advocacy group that in > July called for a > three-year publication ban on journal authors who > flout disclosure > guidelines. > > " At some point, journals need to put some teeth into > their policies, " > says son, the executive director of the > Center. " Look at > what JAMA has gone through. I hope that other > journals won't wait to be > burned. " > > DeAngelis, writing in a 7 August editorial in JAMA, > dismissed the idea > of a publication ban, saying that it would simply > drive offending > authors to other journals. " It cleans our house by > messing others, " she > said. > > But son and others say that greater > transparency is essential as > scientists increasingly forge close ties with the > industry. > > " The pressure that has been put on journals and on > federal agencies > really boils down to trying to build back public > trust in the > institutions of science, " says Sheldon Krimsky, a > Tufts University > expert on conflicts of interest in biomedicine. > > Essential to rebuilding that trust, Krimsky argues, > is the cultivation > of a sizeable cadre of biomedical researchers with > no commercial ties. > > Some government agencies, at least, are moving in > that direction. > > In 2005, following embarrassing press reports of its > scientists > collecting undisclosed six-figure consulting > payments, the US National > Institutes of Health launched a controversial policy > banning employees > from consulting for biomedical companies, and > obliging senior scientists > to divest their stocks (Nat. Med. 11, 914–915; 2005 > <http://dx.doi.org/10.1038/nm1302> ). > > Then, in July, the US Food and Drug Administration > (FDA) announced that > it is modifying its policy on conflicts among > external advisors who > weigh in on drug approvals. > > " We are going to aim to be much more transparent, " > said deputy > commissioner Gottlieb, announcing the changes. > > Judgment calls > > Medical journals are also scrambling to revise their > policies. > > The journal Neuropsychopharmacology—a product of the > Nature > Publishing Group, Nature Medicine's parent > company—was also caught > in a wave of bad publicity this summer. > > The journal's editor-in-chief, Nemeroff, and > his coauthors did > not disclose their financial ties in a paper that > endorsed vagus nerve > stimulation, a controversial, albeit FDA-approved, > therapy for > treatment-resistant depression. Nemeroff had recused > himself from > editing the paper, but the $15,000 device for the > therapy is made by > Houston-based Cyberonics—for which eight of the > paper's nine > authors, including Nemeroff, are paid consultants. > > > [http://www.nature.com/news/2006/060828/images/nm0906-986-I2.gif] > === message truncated === __________________________________________________ Quote Link to comment Share on other sites More sharing options...
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