Monday, August 28, 2006

Direct-to-consumer drug marketing

In the August 21 edition of the Christian Science Monitor, Jonathan Rowe Drug ads sell a problem, not a solution addresses the issue of direct-to-consumer pharmaceutical monitoring.

Rowe comments comments on the practice of "selling sickness and notes, "Medicine is supposed to be about science, not huckstering; about healing people, not persuading more of them that they are sick. There are far better ways to inform the public about health issues than to spend billions of dollars a year pushing pills."

Where might potential benefit lie? Some, including lobbying groups for the pharmaceutical industry, argue that the ads increase consumer knowledge of treatment options for their conditions and may lead individuals to be more active in medical decision-making. Potential harm? Others argue that these drugs lead to overdiagnosis and treatment of medical conditions, pursuit of inappropriate therapy by patients, and interference in the patient-doctor communication process.

The article mentions a statement released last fall, signed by 200+ medical school faculty members, calling for an end to direct-to-consumer drug marketing.

The American Medical Association has what might be considered a fairly lenient policy about direct-to-consumer marketing and is currently advocating more research into the positive and negative potential impact of these advertisements.

This topic was also the focus of a recent Institute of Medicine workshop (previous post here) and FDA scrutiny of the issue.

A quick PubMed search yields many articles reflecting these and other viewpoints.

Media coverage of scientific discoveries

Inside Higher Ed August 21, 2006: "The Embargo Should Go"

Interesting discussion of the relationship between journal embargo practices (i.e. making the article available to journalists before its publication and entry into the public eye) and popular media coverage of scientific discoveries:

"The embargo system also works against the public interest in the way that it misleads the public about science and medicine. The embargo creates a torrent of news that draws excessive public attention to most research. Put simply, journalists should ignore most of the journal articles that they now cover so energetically. Most journal articles are but single dots in the pointillist enterprise that is the scientific method — but the breathless coverage catalyzed by the embargo system often gives the impression that each week’s paper is a major breakthrough. Journalists pay much less attention to later studies that play down the findings."

The opinion piece also uses BiomedCentral as an illustrative example:
"When BioMed Central started in 2000, it did not offer advance embargoed access to journalists; journalists had to wait to read a journal article until it was publicly posted on BioMed Central’s Web site. But journalists ignored its journal articles.

Consequently, in 2003, BioMed Central tweaked its editorial processes so it could start offering journalists a brief period of embargoed access — a few days to at most a week. Since the change, BioMed Central has seen a marked increase in press coverage."

Medical applications of traffic cameras

A study currently in progress at SUNY Upstate will explore how emergency department physicians can use a highway camera monitoring system to better assess what has happened to incoming patients during an automobile crash, including extent of injury and response of paramedics.

Medical News Today story: Doctors To Use Real-Time Images Of Crash Scenes To Assess Injury

"As part of a new study, SUNY Upstate Medical University physicians will use traffic surveillance cameras to view motor vehicle crashes and rescue operations on Central New York highways. The real-time view of crash scenes through a camera lens may provide emergency room physicians with information that may help them provide better care to crash victims when they arrive in the emergency room.

The study-believed to be the first of its kind in the nation-is being funded by the noted U.S. economist Alfred Kahn, who survived a car crash in 2003 and spent weeks recovering from his injuries at SUNY Upstate's teaching hospital, University Hospital. "

Saturday, August 26, 2006

Cochrane, EBM, and fascism, continued

Related to the article I talked about in this post, "Deconstructing the evidence-based discourse in health sciences: truth, power and fascism", Ben Goldacre of the Guardian follows up on an earlier badscience post about the article with another entry, "Archie Cochrane: 'Fascist'."

Excerpt from Goldacre's commentary on the article and on Archie Cochrane:
"...the argument of this paper – bear in mind it’s not an easy read - seems to be that: evidence based medicine rejects anything that isnt a randomised control trial (which is untrue); the Cochrane Library, for some reason, is the chief architect of this project; and lastly, that this constitutes fascism, in some meaning of the word they enjoy (28 times)...

Now firstly, they are plain wrong about the Cochrane Library (which simply produces good reviews of published literature): it does not only use trial data, as they claim, and it is spectacularly ignorant of them to suggest otherwise.

But there is a more important general issue here. Evidence based medicine is widely perceived as being soul-less, and algorithmic: the last thing we’d want from doctors. This is a foolish misunderstanding. EBM is about using quantitative information, in concert with all other forms of knowledge, sensibly, in a clinical context. It does not denigrate other forms of knowledge, like clinical experience or patient preference. It is not about being an automaton. I believe you humanities graduates would call that a “straw man” argument.

Well that’s all a bit sensible: how about some more childish attacks, ideally involving fascism? Okay then. I will wear their label of “fascist” with a cheeky grin. But Archie Cochrane, on the other hand, pioneering epidemiologist, inspiration for the Cochrane Library, a prisoner of war for four years in Nazi Germany (“the main reason for my capture was my inability to swim to Egypt”) who has, from his abstracted position, probably saved more lives than any single doctor you know, might see it a little differently, since in 1936, he dropped out of medical school and travelled to Spain to join the International Brigade, where he fought genuinely violent totalitarian oppression, the fascists of General Franco, with his own two hands. Now. What did you do with your summer holidays?

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Friday, August 25, 2006

Peer review in the sciences

In the September issue of Wired magazine, Adam Rogers has an interesting (and amusing) piece about how peer review is evolving -- Get Wiki With It: Peer review – the unsung hero and convenient villain of science – gets an online makeover. Rogers notes:

"Almost every journal does it, from marquee pubs like Nature to highly specialized periodicals like International Journal of Chemical Reactor Engineering. (No offense to IJCRE – you guys are a helluva read.) When it works, it's genius – quality control that ensures the best papers get into the appropriate pages, lubricating communication and debate. It's the quiet soul of the scientific method: After forming hypotheses, collecting data, and crunching numbers, you report the results to learned colleagues and ask, "What do you folks think?"

But science is done by humans, and humans occasionally screw up. They plagiarize, fake data, take incorrect readings. And when they do? Oy! Somebody always blames peer review. The process is lousy at policing research. Bad papers get published, and work that's merely competent (boring) or wildly speculative (maverick) often gets rejected, enforcing a plodding conservatism. It seems silly to say this about a system that's been in development since the mid-1700s, but the whole thing seems kind of antiquated. "Peer review was brilliant when distribution was a problem and you had to be selective about what you could publish," says Chris Surridge, managing editor of the online interdisciplinary journal PLoS ONE."

The piece mentions new peer review processes being tested as part of Nature's new peer review debate and by the new journal from the Public Library of Science, PLoS ONE.

Related posts:
JAMA editorial: "The influence of money on medical science"
Recent media commentary on peer review
Image editing in the medical literature

Thursday, August 17, 2006

Variety post: faked data, virtual collaboration, transdisciplinary research, doctor-patient communication

A few interesting things I've read lately...

Wednesday, August 16, 2006

Evidence-based medicine as a form of fascism?

Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence-based discourse in health sciences: truth, power and fascism. Int J Evid Based Healthc 2006;4:180-6.
Very interesting article which attempts to deconstruct evidence-based medicine to expose it as a "fascist structure." The authors seem to provide a very limited representation of the EBM concept and how it is operationalized in the clinical arena, focusing on the Cochrane Collaboration and its practices as the embodiment of EBM.

In addition to its fairly inflammatory language and sweeping generalizations, the paper also seems to lack any true grounding in knowledge of clinical medicine or practice which might make it more convincing. The paper has a number of great phrases, referring to EBM as a process of "ossifying discourse" and a "regime of truth" and promoting a "vigilant resistance...from within the health disciplines themselves."

The links below provide further commentary on this piece and examples of other articles considering criticisms of EBM.

Commentary on the article:
- Nobel Intent blog: "Surely they're joking"

- badscience blog

- Salto sobrius blog: "Truth, power, fascism and silly buggers"

- "It's a trick, right?"

Related articles:
Barry CA. The role of evidence in alternative medicine: contrasting biomedical and anthropological approaches. Soc Sci Med. 2006 Jun;62(11):2646-57.
"The growth of alternative medicine and its insurgence into the realms of the biomedical system raises a number of questions about the nature of evidence. Calls for ‘gold standard’ randomised controlled trial evidence, by both biomedical and political establishments, to legitimise the integration of alternative medicine into healthcare systems, can be interpreted as deeply political. In this paper, the supposed objectivity of scientific, biomedical forms of evidence is questioned through an illumination of the multiple rhetorics embedded in the evidence-based medicine phenomenon, both within biomedicine itself and in calls for its use to evaluate alternative therapeutic systems."

Kagan AR, Burchette RJ, Iganej S. The case for case reports: avoiding statistical seduction. Am J Clin Oncol. 2006 Aug;29(4):325-7.
"...searching for the single best treatment, when no single treatment works for all patients, leads to a sort of intellectual tyranny that has numerous names: the gold standard, the community standard, best practice, and evidence-based medicine (EBM), with the implication that to take an alternative management route is substandard and unethical."

Gerber A, Lauterbach KW. Evidence-based medicine: why do opponents and proponents use the same arguments?Health Care Anal. 2005 Mar;13(1):59-71.
"...both opponents and proponents rely on different notions of autonomy and free judgment in their argument."

Brody H, Miller FG, Bogdan-Lovis E. Evidence-based medicine: watching out for its friends. Perspect Biol Med. 2005 Autumn;48(4):570-84.
"The activities of three categories of so-called friends might well give EBM an undesirable reputation. These "friends" are the practitioners of a crude version of EBM (uncritical acceptance of randomized controlled trials while rejecting all other forms of evidence), commercial sponsors of clinical trials whose biases distort the available evidentiary base, and bureaucrats who employ EBM practices in the service of inequitable rationing of health resources."

More commentary on the Holmes article and on EBM at Respectful Insolence - "Damn those microfascists demanding evidence-based medicine!"

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Monday, August 14, 2006

Laptop security during traveling

Information Week lists some good common-sense tips from Absolute Software for securing laptops before air travel. The tips for packing a laptop safely in luggage to be checked are good (their suggestion of soft foam or bubble wrap beats my strategy of wrapping the laptop in t-shirts).

Related links:

Technorati tags: ; ; ; airport security

Sunday, August 13, 2006

Increasing number of authors per article

The National Library of Medicine provides a brief analysis of trends in the number of individual and collective authors for each PubMed/Medline citation over the last 50+ years. Not surprisingly, considering the nature of some of the big trials, the process of large genetic analysis studies, and other changes in biomedical publishing, the number of authors per Medline record has been steadily increasing over time since 1950.

The highest author count per article in the 2000-2004 period? 743 authors. The average number of authors for that time period was just over 4.

How do researchers determine who has contributed "enough" to a manuscript to be listed as an official author of the work? The International Committee of Medical Journal Editors recommends standards for deciding who should be an author of a given article. Medical journals have operationalized these guidelines in a number of ways (e.g. see BMJ's instructions for determining authorship and providing this information with each submission of original research and the BMJ editorials "Authorship: time for a paradigm shift?" and "Authorship is dying; long live contributorship").

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MeSH terms: Authorship; Periodicals/standards; Periodicals/ethics

Friday, August 11, 2006

Generalizability of clinical research

A frequent criticism of published randomized, controlled trials (RCTs) is that interventions that are successful in the RCT setting, often with personnel who have time dedicated to the study and strictly defined patient inclusion/exclusion criteria, may not translate well to the real-world clinical setting. Generalizability is one facet of the CONSORT statement, which outlines quality standards for reporting of clinical trials.

A research methodology article in today's British Medical Journal, "Assessment of generalisability in trials of health interventions: suggested framework and systematic review" (Bonell C et al, 2006 Aug 12;333:346-9), addresses the issue of generalizability and makes recommendations for "systematic evaluation and reporting of applicability" for all studies of health interventions.

Using studies of HIV prevention as an example, the authors recommend that researchers include in their process explicit consideration of questions such as "Can the intervention be delivered elsewhere?" and "Does the intervention meet recipients' needs?"

The authors note potential tremendous contributions to clinical effectiveness if investigators elaborate "contextual determinants of success" for the health interventions they consider, and if systematic reviews address generalizability as one component of research assessment.

Thursday, August 10, 2006

Today's technology applied to yesterday's scientific research questions

"The scientific do-over" (registration required), an article by Jeffrey M. Perkel in yesterday's The Scientist, considers "What would you do if you could apply modern technologies to yesterday's scientific questions?"

Perkel discusses a few examples of previous scientific research and how much time would have been saved and perhaps freed up for additional investigations if today's technology had been available. He also notes "You either have the skills or you don't, and no amount of technological development can change that."

The article considers how increased technological capacity for research also increases expectations and demands on the individual researcher.

JAMA editorial: "The influence of money on medical science"

In response to recent media commentary on conflicts of interest revealed during post-publication editorial scrutiny of several articles in the Journal of the American Medical Assocation (JAMA), the journal's Editor in Chief, Catherine DeAngelis, MD, MPH, authored an editorial this week (JAMA 2006;296 early release) discussing "research irregularities" and undisclosed financial conflicts of interest in articles involving for-profit companies.

She notes that current JAMA editorial policy requires independent statistical analysis by an academician when a study is industry-sponsored, and reports anecdotal evidence that this policy has led to some companies asking that their sponsored studies not be submitted to the journal.

She poses several questions to prompt further scrutiny of this issue -- "..what is appropriate compensation?...How do editors preserve the integrity of their journals while ensuring that they serve as vehicles for dissemination of scientific information that could help clinciians provide better care for their patients?" DeAngelis concludes the editorial by discussing steps that JAMA has taken to pursue potential conflicts of interest and involvement of individual academic institutions in investigating and correcting undisclosed conflicts of interest.

Friday, August 04, 2006

Problems for clinicians and patients in interpreting diagnostic test results

A study published in today's British Medical Journal by Bramwell et al (BMJ 2006; 333:284), Health professionals' and service users' interpretation of screening test results: experimental study, examines accuracy of interpretation of the results of fetal testing for Down's syndrome in pregnant patients, obstetricians, and midwives.

Participants were provided with either frequencies (e.g. "Roughly 100 out of 10,000 babies have Down's syndrome...") or percentages ("Roughly 1% of babies have Down's syndrome...") to illustrate the risk of Down's syndrome actually being present when a test result is positive; 86% of responses were incorrect, though clinicians had a higher rate of correct answers (43%) than midwives (0%) or patients (9%). The groups did not differ significantly in overestimating or underestimating risk.

The data presented as frequencies were more often interpreted correctly than percentage data, though overall rates of correct answers remained low. Researchers also queried participants regarding their confidence in their answers; health professionals indicated that they were confident in their answers, though many turned out to be incorrect.

Boxes 1 and 2 of the article provide examples of the information provided to participants and an explanation of the calculations to accurately interpret risk based on a positive test result.

Given these difficulties in interpreting diagnostic testing information and the apparent misplaced confidence exhibited by clinicians in the study, the authors recommend increased awareness of difficulties in interpreting such information and consideration of different ways of displaying information for increased success.

Related link: A training case, "Screening for Antibody to the Human Immunodeficiency Virus," from the Centers for Disease Control and Prevention uses HIV testing examples to illustrate how population characteristics (pre-test probability) and diagnostic test properties (sensitivity and specificity) affect the interpretation of diagnostic test results.

Thursday, August 03, 2006

Consumer-marketed genetic testing

An entry in The Scientist blog yesterday, Consumer genetic tests on trial (requires registration), discusses a recent Government Accountability Office investigation into claims by companies marketing genetic tests to consumers, noting that "the results appear to hit a pretty rich vein of snake oil."

Brendan Maher comments, "They bought genetic test kits from four companies and sent in a dozen fictitious profiles from the same two people... The test’s first iteration, which submitted dog, cat, and blank samples were sent back because they couldn’t be processed, but the second test did not reflect well on the four companies exposing at best their proclivity toward ambiguous reports and recommendations, to at worst the disparate prediction of disease risk that verges on diagnosis and the soliciting of overpriced supplements or “DNA-repair” pills that presumably do nothing."

The full GAO report, "Nutrigenetic testing: tests purchased from four web sites mislead consumers," is available online, as well as recent related Senate committee hearing transcripts.

A previous Scientist blog entry, Genomes in the supermarket, noted that the academic community concluded that nutrigenomic tests being marketed directly to consumers "weren’t ready for prime time." The Scientist also includes a deeper discussion of the past evaluation of these products, Dieting for the genome generation: nutrigenomics has yet to prove its worth. So
why is it selling?

A recent commentary piece in the Journal of the American Medical Association, The incidentalome: a threat to genomic medicine by Kohane, Masys, and Altman, discusses the broader implications of screening tests that may scan up to the whole genome. These authors point out potential serious problems with interpretation of results in the absence of knowledge of mediating factors such as family history or test characteristics such as sensitivity and specificity, rate of false positives, etc.

Wednesday, August 02, 2006

MedlinePlus and the IOM report

Last week's Director's podcast from the National Library of Medicine (Rob Logan PhD subbing for Dr. Lindberg this week) discussed the new Institute of Medicine report about preventing medication errors (previous posting here).

The podcast transcript also describes the use of MedlinePlus to access information about prescription and over-the-counter drugs.