Article: STAR*D Wars Study Failure on Antidepressants

Unmentioned by NIMH is an even larger group of depressed people who did not participate in STAR*D and whose exclusion likely inflated the STAR*D remission rates. STAR*D subjects were selected from a pool of depressed people who had enough faith in medical care to seek it, and the research shows that one of the most important variables predicting the effectiveness of antidepressants is faith in the treatment. In a 2004 Journal of Clinical Psychiatry study on an experimental antidepressant, depressed patients who expected the antidepressant to be "very effective" had approximately three times higher rate of positive responses than those patients expecting it to be only "somewhat effective." How large is that group of depressed Americans who STAR*D did not sample from because they do not have faith in medical treatment? According to the 1999 Surgeon General's Report on Mental Health, "Nearly two-thirds of all people with a diagnosable mental disorder do not seek treatment"; and a 2000 poll showed that only 28 percent of American adults were willing to take antidepressants for depression for an extended period of time when pollsters informed them that safety studies on long-term use had not been conducted. It is likely that STAR*D treatment would have resulted in lower remission rates had it included depressed people who had little or no faith in antidepressant treatment - no small group.

In summary (1) a placebo control, if it had been included, would have likely resulted in as good or better remission rates than the rate reported in either stage one or stage two of STAR*D; (2) in the time that it took to complete stage one and stage two of STAR*D, approximately 50 percent of depression patients had remission of their depression symptoms, which is the same percentage of depressed people who routinely have remission if they had received no treatment at all; and (3) the 50 percent remission rate trumpeted by NIMH is inflated because of the exclusion from STAR*D of depressed patients who would have been less likely to have had remissions with STAR*D treatment.

The lack of benefits for STAR*D beyond a placebo and spontaneous remission effect makes the risk-benefit analysis for antidepressant treatment fairly simple. Even the most enthusiastic antidepressant prescribers agree that these drugs can have serious adverse affects, including headaches, stomachaches, nausea, dizziness, agitation, diminished sex drive, and memory difficulties. By 2004 the U.S. Food and Drug Administration (FDA) had ordered that antidepressants carry a "black box" warning, the government's strongest warning, alerting consumers to increased suicidal thoughts and behavior among children and teens taking them; and in July 2005, the FDA issued a "Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications," which stated: "Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medication."

However, the risk-benefit analysis of financial bottom line for pharmaceutical companies is another matter. Annual antidepressant sales are approximately $12 billion in the U.S. and $22 billion worldwide.

Many Americans are unaware that drug studies reviewed by the FDA in their approval process are furnished to the FDA by the drug's manufacturer; and pharmaceutical companies, historically, have loaded the dice in these studies to make their new antidepressants appear more effective than the drugs actually are. In addition to subject exclusions (called "cherry picking"), the outcome measurement is biased to weigh more heavily those symptoms that are affected by drugs and neglects symptoms of depression that are less affected by drugs; also sugar-pill placebos are used rather than placebos that create body sensations, this allowing subjects and researchers to more easily guess who has in fact received treatment (called "penetrating the double blind"). And drug companies sometime move into outright fraud.

In 2004 New York State Attorney General Eliot Spitzer brought suit against GlaxoSmithKline alleging that it had engaged in repeated and persistent fraud with respect to Paxil. As part of the settlement, Glaxo agreed to pay a fine. Spitzer had evidence that Glaxo had suppressed the results of studies on children and adolescents which showed Paxil to be ineffective and to increase the risk of suicidal thinking and behavior.

While the FDA's trust of flawed and fraudulent pharmaceutical company data has long been a problem, NIMH's STAR*D study is a kind of "boot on the face" for Americans. In STAR*D, U.S. taxpayers paid for a methodologically substandard study done by drug-company connected researchers, who drew unjustifiably positive conclusions about antidepressants.

Why did NIMH allow itself to be used as, essentially, a promotional tool by the pharmaceutical industry (Big Pharma)? Similar to other powerful industries, Big Pharma has created a revolving door of employment with government agencies, and it is not unusual for higher-ups leaving NIMH to become affiliated with pharmaceutical companies. Examples of the NIMH-Big Pharma revolving door include Steven Paul, a scientific director of NIMH, leaving in 1993 to become vice president of Eli Lilly (manufacturer of Prozac, Zyprexa and other psychiatric drugs); and Lewis Judd, a former NIMH director, who in 2001 joined the scientific advisory board of Roche Pharmaceutical (manufacturer of Valium, Klonopin, and other psychiatric drugs).

It's difficult for Congress to confront the NIMH-Big Pharma revolving door when its members engage in this same process. In 2005 USA Today reported, "Billy Tauzin, a former Republican congressman from Louisiana who now heads the Pharmaceutical Research and Manufacturers of America (PhRMA) [Big Pharma's trade group] . . . helped shepherd the Medicare prescription drug law to passage as chairman of the House Energy and Commerce Committee before joining PhRMA for a reported $1 million a year or more."

NIMH's bastardization of science is a problem not simply for people who care about mental health. When word gets out that a major scientific institution is not doing science, then all scientific institutions become suspect, and this has many societal implications. The discrediting of scientific institutions, for example, helps fossil-fuel dependent industries obfuscate the fact that real science does show that global warming is a genuine phenomenon. And the loss of authority of scientific institutions aids the cause of the religious fundamentalists who deny evolution and demand that intelligent design be taught in public schools.

Historically, the loss of truth and reason is a good thing for autocracy and it is a bad thing for democracy.

Bruce Levine is a clinical psychologist and author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations, and a World Gone Crazy.

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