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Before receiving Food and Drug Administration approval, drug manufacturers must conduct clinical trials of their new drugs. Although all drug studies can be manipulated, antidepressant and antipsychotic drugs are particularly vulnerable to bias. The bias is not limited to the makers of these drugs. Most psychiatrists and their professional organizations strongly favor the use of neuropsychopharmacologic agents even when justifying data are lacking. This article relates an example of this bias involving antidepressants and suicide risk and then discusses 10 common research design strategies that are used to obtain the desired conclusion rather than find truth.
Keywords: clinical trials; drug studies; randomized placebo-controlled trial (RCT); antidepressants; American College of Neuropsychopharmacology (ACNP); FDA
In 2004, New York's activist attorney general, Eliot Spitzer, brought suit against the British pharmaceutical giant GlaxoSmithKline. The suit centered around five clinical trials of the company's antidepressant Paxil. Seeking to expand sales, the company conducted a series of clinical trials using children who seemed anxious. The attorney general charged the drug maker with fraud for releasing only one of the five trial resultsthe one showing mixed results-which was then spun to indicate that Paxil was the drug of choice for treating nervous children. The unreleased studies found that not only was there no mental health benefit, but each of the four studies found that suicide-related events rose for children on Paxil compared with a placebo.
Many Americans heard media stories concerning suicide risk for children on antidepressants. But behind the main story there are often many other "substories," some of which make for some interesting reading. The Paxil-suicide risk data had been in the hands of several British regulatory agencies long before the story entered the newspapers; however, the suicide risk found in these studies had been hidden by Glaxo. It was not hard to do. They simply called suicidal thoughts and behaviors emotional lability, a term that few people actually understood.
When American journalists later saw the term and made inquiries, it caused the British authorities to reexamine the data in their files. That is when they discovered the suicide risk and proceeded to issue a warning against use by children (Committee on Safety in Medicines [CSM] Working Group, 2005). That action prompted further response in America by journalists,...