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Concealment of medical-study data is a ‘serious ethical breach’ and harms patients, journal finds

Too much data from clinical trials is concealed or disappears, a situation that is threatening the integrity of evidence-based medicine and harming patients, according to a scathing series of articles published this week in the journal BMJ (formerly known as the British Medical Journal).

The articles confirm the concerns of many bioethicists and others that much of the evidence from human trials involving drugs, medical devices and other treatments is unreported — or reported inadequately.

Dr. Richard Lehman
cebm.net
Dr. Richard Lehman

“We are not dealing here with trial design, hidden bias, or problems of data analysis — we are talking simply about the absence of the data,” write Dr. Richard Lehman, a primary-care specialist at the University of Oxford, and Elizabeth Loder, a Boston neurologist and BMJ editor, in an editorial that accompanied the series. “And this is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems. Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants.”

One of the BMJ articles found that more than half of drug trials funded between 2005 and 2008 by the National Institutes of Health had not been published in a scientific journal within 30 months of completion. In fact, one-third of the trials examined remained unpublished at three years.

Another article found that only 22 percent of U.S. trials mandated under a 2007 law to report their results on ClinicalTrials.gov within 12 months had actually done so.

Dr. Elizabeth Loder
brighamandwomens.org
Dr. Elizabeth Loder

“When the word ‘mandatory’ turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear,” Lehman and Loder write.

Other papers published in this special BMJ issue point out how difficult it is for even the most dogged researchers to access data from many drug studies and how when previously unpublished data are finally retrieved and included in large meta-analyses, the results often differ from what was initially reported.

As a result, it’s “almost impossible,” note Lehman and Loder, for patients and doctors to assess the real risks and benefits of various drugs and treatments.

“Concealment of data should be regarded as a serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organizations,” Lehman and Loder conclude. “This may achieve quicker results than legislation in individual countries, although this is also desirable.”

Comments (4)

  1. Submitted by Bill Gleason on 01/05/2012 - 11:06 am.

    Excellent article.

  2. Submitted by Ray Schoch on 01/05/2012 - 01:42 pm.

    Thanks, Susan. This is a good piece, and worrisome – as it should be.

  3. Anonymous Submitted by Anonymous on 01/05/2012 - 04:41 pm.

    SSRI studies are the worst of the lot – most studies that showed no improvement for mild to moderate depression were suppressed by the drug makers. This is from a story in the NY Review of Books:

    Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor.

    This was a better data set than the one used in his previous study, not only because it included negative studies but because the FDA sets uniform quality standards for the trials it reviews and not all of the published research in Kirsch’s earlier study had been submitted to the FDA as part of a drug approval application.

    Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.

    http://www.nybooks.com/articles/archives/2011/jun/23/epidemic-mental-illness-why/?pagination=false

  4. Submitted by RODNEY COPELAND on 01/05/2012 - 09:12 pm.

    “Concealment of data should be regarded as a serious ethical breach…”

    No, it is fraud.

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