Yes, I know, maybe this blog and Health Care Renewal should simply merge and be done with it. But I was quite impressed with Roy Poses' detective work:
http://hcrenewal.blogspot.com/2011/01/key-opinion-leader-services-companies.html
Dr. Poses was checking out some facts related to another issue when he came across mention of a type of firm neither he nor I had previous heard of. He here posts his findings about three commercial outfits that cater to drug companies and similar firms, and offer their services to find and manage key opinion leaders (KOLs) in medicine.
Dr. Poses's main point is that these KOLs continue to imagine that the drug companies want their expertise and opinions, when in fact the companies regard them as marketing devices pure and simple. (Or, as in his polite phrase, "idiots.") The marketing stuff that the KOL handlers use on the drug companies to peddle their services try to sugar-coat it as much as they can, but it takes little sophistication to read between the lines and see that they are appealing purely to sales potential.
The implicit message in these marketing messages seem to be that you can view KOLs as either sheep or goats. Sheep are like, well, sheep. You herd them and then you shear them. The handling firms promise that they'll get you a whole lot of sheep, and herd them in the direction you want them to go. Goats, on the other hand, are pesky critters with much more of a mind of their own. They can be troublesome and get into things they're not supposed to. The handling firms promise that if you are dealing with the goat species of KOL, they'll help you to manage them so that they stay out of trouble.
The comment that I would add to this comes from HOOKED, where I belatedly learned that if you check out the website of a large medical meeting (in my case, the annual meeting of the American Academy of Family Physicians, my own specialty society), you'll see that it is really two parallel websites. There is one for the docs and another for the advertisers and others who want to rent booths and sell their wares. The doc website is what you'd expect, all about the great things you'll learn, plus of course the fun you can have visiting the city where the meeting is held, especially if youbring your family. The advertiser website is another beast entirely. It basically says that we have this captive audience of docs, all of whom we can lead around by the nose at will, and if you rent a booth in our exhibit hall, we'll lead all those docs direct to your booth, and then your sales will skyrocket. Plus when those docs go home they'll tell all their envious colleagues, who did not get to go to our meeting, what they saw at your booth, and then your sales will skyrocket even more.
It seems simply to be assumed that the docs will never read the advertisers' parallel website.
Friday, January 7, 2011
Thursday, January 6, 2011
Dr. Steve Nissen on Lack of New Drugs
Thanks to a faithful reader for calling my attention to this nice 6-minute video interview with Dr. Steve Nissen, cardiologist at Cleveland Clinic:
http://www.washingtonpost.com/wp-dyn/content/video/2011/01/06/VI2011010603537.html
The reporter for Bloomberg asks Dr. Nissen--isn't it bad for medicine that drug firms are in jeopardy of losing profits in coming years due to a shrinking dug pipeline and fewer new drugs approved in 2010 than in recent memory? Isn't this a sign that the FDA is being too obstructionist in approving new drugs?
Dr. Nissen, bless him, is having none of this. Better to have fewer, better, and safer drugs, he says. He offers as two reasons for the dwindling drug pipeline--first, the low hanging fruit theory that I favor in HOOKED--that with so many useful drugs having already been discovered, it is harder and harder to find new ones that are equally good and also safe. (He could have said it a bit more starkly--what the heck ever persuaded anyone that real scientific breakthroughs could be timed to occur precisely in accord with the drug companies' budget and patent cycles?) Second, he points out that increasingly the industry does not invest in real innovation, but instead "me too" drugs that can most quickly be marketed. If you don't invest in innovation, don't be surprised if you don't have any, says Dr. Nissen.
Then he goes on as a bonus to say a few choice things about critics of health reform. But that's not what this blog is about.
http://www.washingtonpost.com/wp-dyn/content/video/2011/01/06/VI2011010603537.html
The reporter for Bloomberg asks Dr. Nissen--isn't it bad for medicine that drug firms are in jeopardy of losing profits in coming years due to a shrinking dug pipeline and fewer new drugs approved in 2010 than in recent memory? Isn't this a sign that the FDA is being too obstructionist in approving new drugs?
Dr. Nissen, bless him, is having none of this. Better to have fewer, better, and safer drugs, he says. He offers as two reasons for the dwindling drug pipeline--first, the low hanging fruit theory that I favor in HOOKED--that with so many useful drugs having already been discovered, it is harder and harder to find new ones that are equally good and also safe. (He could have said it a bit more starkly--what the heck ever persuaded anyone that real scientific breakthroughs could be timed to occur precisely in accord with the drug companies' budget and patent cycles?) Second, he points out that increasingly the industry does not invest in real innovation, but instead "me too" drugs that can most quickly be marketed. If you don't invest in innovation, don't be surprised if you don't have any, says Dr. Nissen.
Then he goes on as a bonus to say a few choice things about critics of health reform. But that's not what this blog is about.
'Tis a French Custom--Libel Suits?
Q: How does a smart drug company discourage a non-commercial evidence-based information source from saying true but unfavorable things about one of their products?
A: Sue them for libel.
At least if you're in France.
http://www.ahrp.org/cms/content/view/748/9/ explains how Astellas Pharma, a Japanese-based multinational, is suing the noted French periodical Prescrire for libel over the publication's discouraging review of their drug, Protopic, an anti-eczema ointment which according to an FDA warning carries a cancer risk due to its immune suppression.
Dubois and Braillon, writing in the UK's HealthWatch, explain how France has become a sort of haven for these libel suits, with French institutions often being slow to defend a scientist who's attacked in this way: http://href.fr/healthwatch_oct10.pdf
In HOOKED I described suits of this sort as a variation on what's called SLAPP (strategic lawsuit against public participation). The basic idea behind SLAPP is that the plaintiff has very little if any chance of winning the suit; but the plan is both to impoverish the relatively impecunious defendent by running up a big legal bill to defend themselves against a deep-pockets company that has stables of lawyers on retainer, and indirectly to intimidate others from speaking out against the company for fear of similar treatment.
And here I thought that the US was the world capital for excessive litigation...
A: Sue them for libel.
At least if you're in France.
http://www.ahrp.org/cms/content/view/748/9/ explains how Astellas Pharma, a Japanese-based multinational, is suing the noted French periodical Prescrire for libel over the publication's discouraging review of their drug, Protopic, an anti-eczema ointment which according to an FDA warning carries a cancer risk due to its immune suppression.
Dubois and Braillon, writing in the UK's HealthWatch, explain how France has become a sort of haven for these libel suits, with French institutions often being slow to defend a scientist who's attacked in this way: http://href.fr/healthwatch_oct10.pdf
In HOOKED I described suits of this sort as a variation on what's called SLAPP (strategic lawsuit against public participation). The basic idea behind SLAPP is that the plaintiff has very little if any chance of winning the suit; but the plan is both to impoverish the relatively impecunious defendent by running up a big legal bill to defend themselves against a deep-pockets company that has stables of lawyers on retainer, and indirectly to intimidate others from speaking out against the company for fear of similar treatment.
And here I thought that the US was the world capital for excessive litigation...
Wednesday, January 5, 2011
What Do Pharma Execs Think?
Sorry to bore you with yet another tip of the hat to my esteemed colleague Roy Poses over at the Health Care Renewal blog, but I owe it to him that I am aware of this web page:
http://blog.pharmexec.com/2011/01/05/new-year-night-stalkers-what-will-keep-the-c-suiters-awake-in-2011/
So-- how does PharmExec.com see the world today? One thing I find intriguing is that we pharmascold types think of the drug industry as this huge, powerful juggernaut--as pointed out by Marcia Angell, if we go back to the olden days of 2002, even though major drug firms made up only 2% of the Fortune 500 companies, their total profits were more than half of the total profits of all 500 firms. Yet whenever we get to look through the keyhole at what Pharma execs think is going on, they see themselves as being beleaguered by all sorts of forces out to get them, and the survival of their companies from one year to the next has to be regarded as near-miraculous.
Here's how the post starts: "The consensus is that 2011 will be a bad year for Big Pharma. It must confront a breaking wave of patent expirations, while fiscal retrenchment has created an innovation cycle in reverse as payers find new ways to curb the drugs bill. Risk-averse regulators are transforming old tools like the FDA “complete response letter” into a registration parking lot, with no exit ramp to connect companies to a distracted — and increasingly impatient — community of clinicians and consumers."
Let's make a short list.
Yet it would be terribly short-sighted to dismiss this inside view as mere victimhood wailing. Here and there the post gives a little bit of evidence that even the suits now realize that all is not right with how they do business.
http://blog.pharmexec.com/2011/01/05/new-year-night-stalkers-what-will-keep-the-c-suiters-awake-in-2011/
So-- how does PharmExec.com see the world today? One thing I find intriguing is that we pharmascold types think of the drug industry as this huge, powerful juggernaut--as pointed out by Marcia Angell, if we go back to the olden days of 2002, even though major drug firms made up only 2% of the Fortune 500 companies, their total profits were more than half of the total profits of all 500 firms. Yet whenever we get to look through the keyhole at what Pharma execs think is going on, they see themselves as being beleaguered by all sorts of forces out to get them, and the survival of their companies from one year to the next has to be regarded as near-miraculous.
Here's how the post starts: "The consensus is that 2011 will be a bad year for Big Pharma. It must confront a breaking wave of patent expirations, while fiscal retrenchment has created an innovation cycle in reverse as payers find new ways to curb the drugs bill. Risk-averse regulators are transforming old tools like the FDA “complete response letter” into a registration parking lot, with no exit ramp to connect companies to a distracted — and increasingly impatient — community of clinicians and consumers."
Let's make a short list.
- We say: Even in European countries with price controls, that pay only about two-thirds of what the US pays for drugs, companies make plenty of profit to support R&D; and there's no serious drug cost containment on the horizon in the US. They say: Today, no country feels that it ought to have to pay for drug R&D, so the industry will soon find its research funds drying up.
- We say: It's a great step forward when resource-poor countries can negotiate a deal with a multinational drug firm for manufacturing of the drug to occur in a local factory, assuring both a more affordable drug for the local population plus jobs for the local economy. They say: That emerging-nation firm that they've been forced to work with is a potential future competitor, and they've been forced to grant that competitor substantial inside know-how in drug manufacturing--what amounts to the theft of intellectual property.
Yet it would be terribly short-sighted to dismiss this inside view as mere victimhood wailing. Here and there the post gives a little bit of evidence that even the suits now realize that all is not right with how they do business.
- On the incredible amount ($10-14B, depending on who you ask) that Pharma has paid out recently in criminal settlements: "Despite this, pharma has failed to address the problem from an industry-wide reputational, as opposed to a legal, standpoint. ”Tops in Fraud” is a ruinous moniker for a business so dependent on basic issues of trust like integrity, quality and safety – when will the industry, as part of a collective action, replace the gamey politicking with good policing?"
- On the relentless outsourcing of research to cut costs and avoid ethical scrutiny: "The traditional business model of Big Pharma — with its heavy investment in in-house innovation – is being reconsidered through new approaches that emphasize the outsourcing of R&D: from research to “search,” with the latter linked to external licensing and partnering. Taken to its logical extent, the new model could transform companies from innovators to distribution platforms that rely on marketing heft, size and scale to compete rather than science. Coupled with the ruthless drive for efficiencies that have led to large-scale layoffs of once cosseted professional staff, the trend raises an important reputational question: if the industry is no longer viewed as a wellspring of science and innovation, what strategy is in play to respond to a world that perceives industry as the WalMart of pills?"
- On take-no-prisoners marketing battles: "Stiff competition within therapeutic classes has created unheard of rivalries among companies that once were happy to share the same watering hole. Some marketers are investing millions in brand-bashing “anti-launch” strategies to limit the uptake of newer alternative products. The question is whether everyone loses when this logic is applied against the larger patient-first perspective that regulators and the public expect from the industry."
New Proposals for CME Reforms
Health law scholar Marc A. Rodwin of Suffolk U. Law School provides a very useful historical overview of drug industry involvement in continuing medical education and then offers some novel ideas for reform (subscription required).
In HOOKED I harp on the lack of historical perspective that infects most recent work on the pharmaceutical industry, and often portrays all the serious problems at the medicine-Pharma interface as if they first cropped up yesterday. Hence any thoughtful historical reflection is welcome, and Rodwin provides a comprehensive review of how drug advertising and CME evolved hand in glove through the 20th century.
Rodwin conducted interviews with CME managers, allowing him to make statements that put the lie to the comforting mantra that industry-sponsored CME is really education and not marketing. Perhaps the single most telling quote of this type is: "Moreover, CME providers traditionally sought funds from one firm per program because, as a manager of a CME provider explained to me, drug firms believed a provider supported by two or more firms with competing drugs would have a conflict of interest." Notice the obvious: if a conference were truly about education and not about pushing product, then having multiple industry sponsors would seem completely benign and indeed desirable. Also, as a secondary issue, notice that the naysayers who deny that "conflict of interest" exists or is a truly meaningful term of professional ethics, are apparently not joined by those within Pharma itself!
Rodwin joins those who criticized the 2004 ACCME guidelines as too wimpy--he notes that the rules say that a CME provider "cannot be required" by a sponsor to accept advice or direction regarding speakers or program content, meaning, "That language does not prohibit commercial supporters from offering advice, CME providers from soliciting suggestions from them, or CME providers voluntarily following suggestions of commercial supporters. My interviews with CME providers indicated that these were common practices."
So--what to do? Rodwin starts with a novel proposal. How about CME folks actually having to decide upon a curriculum? A medical school or a residency program that did not teach in accord with a standard curriculum decided upon by consensus within the relevant community of experts would speedily lose accreditation. Why, then, allow CME programs to be driven by the whims of who wants to speak on which topic, or which company wants to pay the freight? Merely having an agreed-upon curriculum based on science and real practice issues would go a long way toward correcting the tilt toward talking only about drugs, devices, and stuff that makes money for industry.
Past that, Rodwin would ban all direct and most indirect industry funding of CME, and ask Congress to impose a CME tax on all those who currently make profits off medical care (docs included). (Rodwin treats the idea that merely disclosing industry sponsorship of a CME program solves anything at all as hardly worth discussing.) If the anti-tax people start to howl about this, Rodwin reminds us that commercial firms that now pay for CME pass the resulting costs through to the end-purchaser anyway, so we all end up paying. If we did it via the tax, and allocated the tax proceeds to a federal agency who distributed them to non-profit CME entities, we'd have a greater likelihood that the same money would actually go toward improving our health.
Rodwin MA. Drug advertising, continuing medical education, and physician prescribing: a historical review and reform proposal. Journal of Law, Medicine and Ethics 38:807-815, Winter 2010.
In HOOKED I harp on the lack of historical perspective that infects most recent work on the pharmaceutical industry, and often portrays all the serious problems at the medicine-Pharma interface as if they first cropped up yesterday. Hence any thoughtful historical reflection is welcome, and Rodwin provides a comprehensive review of how drug advertising and CME evolved hand in glove through the 20th century.
Rodwin conducted interviews with CME managers, allowing him to make statements that put the lie to the comforting mantra that industry-sponsored CME is really education and not marketing. Perhaps the single most telling quote of this type is: "Moreover, CME providers traditionally sought funds from one firm per program because, as a manager of a CME provider explained to me, drug firms believed a provider supported by two or more firms with competing drugs would have a conflict of interest." Notice the obvious: if a conference were truly about education and not about pushing product, then having multiple industry sponsors would seem completely benign and indeed desirable. Also, as a secondary issue, notice that the naysayers who deny that "conflict of interest" exists or is a truly meaningful term of professional ethics, are apparently not joined by those within Pharma itself!
Rodwin joins those who criticized the 2004 ACCME guidelines as too wimpy--he notes that the rules say that a CME provider "cannot be required" by a sponsor to accept advice or direction regarding speakers or program content, meaning, "That language does not prohibit commercial supporters from offering advice, CME providers from soliciting suggestions from them, or CME providers voluntarily following suggestions of commercial supporters. My interviews with CME providers indicated that these were common practices."
So--what to do? Rodwin starts with a novel proposal. How about CME folks actually having to decide upon a curriculum? A medical school or a residency program that did not teach in accord with a standard curriculum decided upon by consensus within the relevant community of experts would speedily lose accreditation. Why, then, allow CME programs to be driven by the whims of who wants to speak on which topic, or which company wants to pay the freight? Merely having an agreed-upon curriculum based on science and real practice issues would go a long way toward correcting the tilt toward talking only about drugs, devices, and stuff that makes money for industry.
Past that, Rodwin would ban all direct and most indirect industry funding of CME, and ask Congress to impose a CME tax on all those who currently make profits off medical care (docs included). (Rodwin treats the idea that merely disclosing industry sponsorship of a CME program solves anything at all as hardly worth discussing.) If the anti-tax people start to howl about this, Rodwin reminds us that commercial firms that now pay for CME pass the resulting costs through to the end-purchaser anyway, so we all end up paying. If we did it via the tax, and allocated the tax proceeds to a federal agency who distributed them to non-profit CME entities, we'd have a greater likelihood that the same money would actually go toward improving our health.
Rodwin MA. Drug advertising, continuing medical education, and physician prescribing: a historical review and reform proposal. Journal of Law, Medicine and Ethics 38:807-815, Winter 2010.
Monday, January 3, 2011
Nurse Practitioners: The Next Frontier?
Elissa Ladd and colleagues from Harvard have published a study:
http://www.ajmc.com/issue/managed-care/2010/2010-12-vol16-n12/AJMC_10decLadd_WebX_e358to62
--on attitudes among a national sample of nurse practitioners regarding interactions with the drug industry. We have seen reason to believe that in recent years, physicians have become at least slightly more skeptical regarding industry marketing overtures (http://brodyhooked.blogspot.com/2010/11/are-physicians-taking-fewer-bribesgifts.html). We have also seen some evidence that the industry has increasingly targeted nurse practitioners, who have prescribing privileges (http://brodyhooked.blogspot.com/2008/02/nurses-soft-targets-for-pharma.html and http://brodyhooked.blogspot.com/2007/10/if-you-dont-feed-them-they-wont-come.html). Ladd's group did the first extensive national survey, which was marred by a very low response rate of 9%, though not that atypical of online surveys. If we can assume their sample was somewhat representative, a number of worrisome conclusions emerge:
Finally, it is worrisome, as Ladd and colleagues point out, that while the new sunshine provisions of the health reform law (PPACA) require as of 2013 that all payments to physicians be reported, payments to NPs are not included under its provisions.
http://www.ajmc.com/issue/managed-care/2010/2010-12-vol16-n12/AJMC_10decLadd_WebX_e358to62
--on attitudes among a national sample of nurse practitioners regarding interactions with the drug industry. We have seen reason to believe that in recent years, physicians have become at least slightly more skeptical regarding industry marketing overtures (http://brodyhooked.blogspot.com/2010/11/are-physicians-taking-fewer-bribesgifts.html). We have also seen some evidence that the industry has increasingly targeted nurse practitioners, who have prescribing privileges (http://brodyhooked.blogspot.com/2008/02/nurses-soft-targets-for-pharma.html and http://brodyhooked.blogspot.com/2007/10/if-you-dont-feed-them-they-wont-come.html). Ladd's group did the first extensive national survey, which was marred by a very low response rate of 9%, though not that atypical of online surveys. If we can assume their sample was somewhat representative, a number of worrisome conclusions emerge:
- 96% have regular contact with sales reps
- 83% think information provided by reps is reliable
- 93% believe themselves uninfluenced by reps' free gifts
- 78% think free meals provided by industry are a good/excellent way to learn about new drugs
- 83% think industry-sponsored continuing education is a good/excellent way to provide reliable education at affordable cost
- 90% think it ethically acceptable to attend industry sponsored meal events
- 75% think it ethically acceptable for speakers to be paid by drug companies
- 61% think taking small gifts and meals is ethically acceptable
Finally, it is worrisome, as Ladd and colleagues point out, that while the new sunshine provisions of the health reform law (PPACA) require as of 2013 that all payments to physicians be reported, payments to NPs are not included under its provisions.
Saturday, January 1, 2011
The Anatomy of Spin
An article (subscription required) that was published some months ago provides some useful information about spin in medical research publications, raises some important qustions, and poses a mystery of its own.
A group out of Oxford and Paris set out to describe exactly how spin appears in medical research publications. They searched databases for articles published between December 2006 and March 2007 reporting the results of randomized controlled trials. They were on the lookout for articles that reported trials in which the difference in the primary outcomes was statistically insignificant--figuring that this was the sort of paper where the temptation to introduce spin was greatest, and hence these papers would be most useful to decide what forms the spin took. They started with 1735 potentially applicable titles but ended up with only 72 papers that met all their criteria. They then proceeded to develop an assessment of the presence, degree, and categories of spin, which of necessity was a subjective enterprise. They also noted that in only 44 of the 72 papers were the primary research outomes clearly identified.
They found that among the 72 papers, 33% were funded wholly or in part by for-profit entities, and in another 37.5% the source of funding was not reported.
They found that spin was common--40% of the papers had spin in at least two separate sections of the main text, and 58% had spin in the Conclusion section of the abstract. The forms that the spin took included focusing on other results (such as within-group comparisons) that were statistically significant while downplaying the lack of significance in the primary outcomes; interpreting the lack of statistical significance as showing equivalence ("at least our treatment was shown to be no worse than...") which is a huge methodological no-no; and simply ignoring the lack of significance and playing up the supposed benefits and/or safety of the experimental treatment anyway.
So now we come to the mystery: the authors never reported how the level of spin correlated with for-profit funding. At one point they state, "Our results are consistent with those of other related studies showing a positive relation between financial ties and favorable conclusions stated in trial reports." But they give no numbers anywhere. My only hunch as to why they report no data on this apparently key variable is that with only 72 studies in their final sample, the numbers would have been too small to be of much reliability, and they did not want to be charged with committing themselves the very spin they were criticizing. But one would have expected an explanation of some sort.
OK, so what else can we glean from this study? Mainly one thing. Where the heck are the journal editors and reviewers? How can a study be published in a supposedly respectable journal, within the past few years, that fails to specify any source of funding for a major clinical trial, or that fails to make clear what are the primary outcomes? Plus, these authors were able to detect spin in a substantial percentage of these papers, based solely on the contents of the paper--they sought no access to any other data. If these authors could, the journal editors and reviewers presumably could too--yet they let these blatant misstatements pass. In short, if industry sponsors of research are seeking to add spin to their publications to goose the marketing of their products, it seems that today's journal editing apparatus is putty in their hands.
This might seem to be unfair criticism because the authors focused on only one specific type of research report--an RCT where the result is insignificant, but that is published anyway. (The problem of journals refusing to publish papers that produce non-statistically-significant findings, thereby skewing the publication record, is another issue beyond our scope here.) It may be that a lot of spin appears in such reports, but very little spin appears in reports of RCTs where the results reach statistical significance--no suprise if so, as there's then much less need to add spin. OK, fair enough. But if these authors focused especially on that sort of trial report because they expected that setting to create a strong temptation to add spin, then journal editors and reviewers should have been equally forewarned and should have been especially vigilant. So the fact that so much spin and nonreporting still made it through the review process is very worrisome.
Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 303:2058-64, May 26, 2010.
A group out of Oxford and Paris set out to describe exactly how spin appears in medical research publications. They searched databases for articles published between December 2006 and March 2007 reporting the results of randomized controlled trials. They were on the lookout for articles that reported trials in which the difference in the primary outcomes was statistically insignificant--figuring that this was the sort of paper where the temptation to introduce spin was greatest, and hence these papers would be most useful to decide what forms the spin took. They started with 1735 potentially applicable titles but ended up with only 72 papers that met all their criteria. They then proceeded to develop an assessment of the presence, degree, and categories of spin, which of necessity was a subjective enterprise. They also noted that in only 44 of the 72 papers were the primary research outomes clearly identified.
They found that among the 72 papers, 33% were funded wholly or in part by for-profit entities, and in another 37.5% the source of funding was not reported.
They found that spin was common--40% of the papers had spin in at least two separate sections of the main text, and 58% had spin in the Conclusion section of the abstract. The forms that the spin took included focusing on other results (such as within-group comparisons) that were statistically significant while downplaying the lack of significance in the primary outcomes; interpreting the lack of statistical significance as showing equivalence ("at least our treatment was shown to be no worse than...") which is a huge methodological no-no; and simply ignoring the lack of significance and playing up the supposed benefits and/or safety of the experimental treatment anyway.
So now we come to the mystery: the authors never reported how the level of spin correlated with for-profit funding. At one point they state, "Our results are consistent with those of other related studies showing a positive relation between financial ties and favorable conclusions stated in trial reports." But they give no numbers anywhere. My only hunch as to why they report no data on this apparently key variable is that with only 72 studies in their final sample, the numbers would have been too small to be of much reliability, and they did not want to be charged with committing themselves the very spin they were criticizing. But one would have expected an explanation of some sort.
OK, so what else can we glean from this study? Mainly one thing. Where the heck are the journal editors and reviewers? How can a study be published in a supposedly respectable journal, within the past few years, that fails to specify any source of funding for a major clinical trial, or that fails to make clear what are the primary outcomes? Plus, these authors were able to detect spin in a substantial percentage of these papers, based solely on the contents of the paper--they sought no access to any other data. If these authors could, the journal editors and reviewers presumably could too--yet they let these blatant misstatements pass. In short, if industry sponsors of research are seeking to add spin to their publications to goose the marketing of their products, it seems that today's journal editing apparatus is putty in their hands.
This might seem to be unfair criticism because the authors focused on only one specific type of research report--an RCT where the result is insignificant, but that is published anyway. (The problem of journals refusing to publish papers that produce non-statistically-significant findings, thereby skewing the publication record, is another issue beyond our scope here.) It may be that a lot of spin appears in such reports, but very little spin appears in reports of RCTs where the results reach statistical significance--no suprise if so, as there's then much less need to add spin. OK, fair enough. But if these authors focused especially on that sort of trial report because they expected that setting to create a strong temptation to add spin, then journal editors and reviewers should have been equally forewarned and should have been especially vigilant. So the fact that so much spin and nonreporting still made it through the review process is very worrisome.
Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 303:2058-64, May 26, 2010.
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