Irresponsible reporting of clinical trials by the news media

It is important for journalists to highlight any potential bias in medical research so that patients and physicians alike can judge how valid clinical trial findings are. Today the Journal of the American Medical Association published a study showing that almost half of news stories on clinical trials fail to report the funding source of the trial. In addition, two-thirds of news articles refer to study medications by their brand names instead of by their generic names.

The authors Hochman et al. reviewed papers published between 1st April 2004 and 30th April 2008 in the top five medical journals (New England Journal of Medicine, JAMA, the Lancet, Annals of Internal Medicine and Archives of Internal Medicine) to find pharmaceutical-company-funded studies that evaluated the efficacy or safety of medications. They then searched 45 major US newspapers (for example New York Times and USA Today) and 7 US-based primary news websites (including ABC News, CNN and MSNBC) for news stories that reported these clinical trials.

A total of 358 company-funded clinical trials were identified, and 117 of these yielded 306 distinct news stories. Of the 306 news stories, 42% did not report the funding source of the clinical study. A total of 277 of these news articles were about medications that had both brand names and generic names, but 67% of stories used brand names in at least half of the references to the medication and 38% used only brand names.

By using a brand name in news articles instead of a generic name, journalists are inadvertently favouring one pharmaceutical company over another. For example, the cholesterol lowering drug atorvastatin (generic name) is manufactured by several different pharmaceutical companies who all give it a different brand name - Pfizer call it Lipitor, whereas Merck until recently marketed a version called Zocor. Drugs are often referred to by their brand name because these titles tend to be better known - you've probably heard of paracetamol but not of acetaminophen; fair enough, maybe, but this practice still represents biased reporting.

Hochman et al. also surveyed 94 newspaper editors to find out whether these individuals thought that their publication accurately reported clinical trials. Interestingly, 88% of editors stated that their newspaper often or always reported reported company funding in articles about medical research, and 77% said that their publication often or always referred to medications by their generic names.

It seems that news outlets think they are reporting funding sources in medical articles when actually they're not. Academic journals have strict policies for disclosing funding and potential conflicts of interest, so why don't newspapers follow suit?

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M. Hochman, S. Hochman, D. Bor, D. McCormick (2008). News Media Coverage of Medication Research: Reporting Pharmaceutical Company Funding and Use of Generic Medication Names JAMA: The Journal of the American Medical Association, 300 (13), 1544-1550 DOI: 10.1001/jama.300.13.1544

Randomized control freakery

Nature Clinical Practice Cardiovascular Medicine has recently published an interesting review article on clinical trial design - 'From randomized trials to registry studies: translating data into clinical information'.

This isn't a guide on how to read a clinical paper - you should have a look at Prof Trisha Greenhalgh's book 'How to read a paper' or the extracts published in the BMJ way back in 1997 in you need tips on that front. Rather, the NCP Cardiovascular Medicine review examines different study designs, and interestingly puts forward a case for observational trials, as compared with randomized controlled trials.

Randomization - in which patients are allocated to treatment or no treatment (or placebo) in an entirely indiscriminate manner, thus distributing both known and unknown confounders between groups - and control or placebo groups - which comprise patients who do not receive the intervention - are the benchmarks of a good clinical study, allowing an investigator to isolate the effect of a treatment from various confounding factors.

However, the NCP review argues:

"The results of observational studies are often dismissed in favor of prospective randomized studies because of the widely recognized biases inherent in observational studies. Yet such studies form the basis of much of the medical knowledge we have today. Accordingly, rather than dismiss information gained from observational studies, it is more appropriate to recognize these biases and their effect on results, and to modify interpretation appropriately. Indeed, from a practical standpoint, all studies sustain some form of bias, either implicitly or explicitly."

In addition, the authors state:

"Strict inclusion and exclusion criteria mean that the results of randomized studies might not be as applicable to general populations as are findings from observational studies, including both clinical registries and retrospective reviews"

The take-home message of the article is that practicing clinicans should analyze the patient population of a trial carefully before applying the findings to a patients of theirs.

This paper also discusses statistical power and the use of surrogate and composite end points, the validity (or not) of post hoc analysis, and the utility of peer review for spotting trial-design pitfalls. But obviously I'm more interested in the iconoclastic view of randomized controlled trials...