Zoloft Class Action Claims Drug Company Misled Consumers about Zoloft’s Ability to Treat Depression

Drug makers are required to test drugs for efficacy and safety and submit the results to the FDA before the drug is approved. During these clinical trials, up to hundreds of patients are given either the drug being tested or a placebo (a sugar pill that has no medicinal benefit). Neither the patients nor the researchers testing the drug are supposed to be aware of which patients are receiving the actual medication.

In trials of antidepressants, patients are interviewed about their symptoms (usually using the 17-question Hamilton Rating Scale for Depression, or “HAM-D”) before, during, and at the end of the trial period, which usually lasts six to eight weeks, to determine how much their symptoms have diminished. Their answers are assigned a numerical value and summed to give an overall HAM-D depression score. The higher the score, the worse the depression.

However, many people experience significant symptom relief simply as a result of a belief that they are taking an active medication, even when the pill they are taking is a placebo. This is known as the placebo effect and it can be very powerful – so powerful in fact that, in many trials, those taking the sugar pill achieve as much symptom relief, according to HAM-D scores, as those taking the drug. Unless a drug company can provide to the FDA at least two clinical trials in which the patients receiving the drug achieve significantly more symptom improvement as measured by the HAM-D than those taking a placebo, the agency will not approve the drug.

Zoloft Side Effects

Antidepressants can have serious side effects and, without significant symptom improvement, the risk of injury from taking the drug far outweighs the benefit.

All SSRI (selective serotonin reuptake inhibitor) antidepressants, such as Zoloft, carry black box warnings (the FDA’s most serious warning) stating that “antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short term studies of major depressive disorder (MDD) and other psychiatric disorders.”

Antidepressants such as Zoloft have also been linked to a number of serious birth defects in children born to mothers who have taken the drugs. Zoloft birth defects include:

Manipulating the System, Deceiving Consumers

Pfizer conducted six efficacy trials that were carefully designed by the company to show that Zoloft was better than a sugar pill at treating depression. However, in only two of these trials was Zoloft able to “beat” the placebo in terms of lowered scores on the Hamilton Rating Scale.

Four out of six Zoloft trials demonstrated no benefit over placebo when taking the drug and the benefits measured in the two “successful” trials were minimal at best. This occurred despite the fact that these studies were specifically designed to maximize the superiority of the drug over placebo. In fact, the average difference in HAM-D scores between the drug group and the placebo group at the end of these trials was so small that a number of members of the FDA committee that reviewed the data questioned whether the small difference was significant enough to warrant Zoloft approval.

According to the complaint filed by Baum Hedlund, Zoloft’s product insert and label never provided doctors with sufficient information to allow them to conduct the necessary benefit/risk assessment for their patients, nor did it allow patients to make informed decisions about whether to take the drug.

Publication Bias

According to the complaint, Pfizer engaged in a practice known as publication bias, in which only clinical trials that achieve positive results (i.e., the drug outperforms the placebo) are published in medical journals. This practice makes it virtually impossible for physicians and consumers to reach an informed decision about a drug’s actual effectiveness, and exposes them to side effects and risks associated with these medications.

Dr. David Healy, a psychopharmacologist and professor at the University of Wales College of Medicine, and a colleague conducted an analysis of Zoloft articles that were “coordinated” by a medical communications company called Current Medical Direction (“CMD”). Pfizer had hired CMD to promote Zoloft in the 1990’s. David Healy & Dinah Cattell, Interface Between Authorship, Industry and Science in the Domain of Therapeutics, 183 British J. of Psych. 22-27 (2003). According to the study, CMD coordinated over 85 medical journal articles about Zoloft during a three-year period. By early 2001, 55 of these articles had been published in journals such as the New England Journal of Medicine, Journal of the American Medical Association (JAMA), Archives of General Psychiatry and the American Journal of Psychiatry. Of course, all of the clinical trial results were favorable to Zoloft. The analysis found that “the CMD-linked articles report[ed] universally positive results” and that there were “significant discrepancies between published data and the raw data from the actual clinical trials.” Most of the 85 articles appeared to have been authored by CMD and, in a number of instances, the authors were listed in Pfizer internal memos as “TBD” (i.e., “to be determined”). The study concluded that:

The combination of distinguished journal, distinguished author, an efficient distribution system and sponsored platforms appears to have led to an impact on the therapeutics domain greatly in excess of 50% of the impact of the rest of the literature on sertraline. The impact of this literature on third-party payers and other interested parties is at present unquantifiable. The question of literature impact would seem to be tied closely to the nature of ghostwriting. Authorship lines from perceived opinion-leaders with minimal company representation and non-declaration of other non-academic authorship inputs increase the likelihood that these articles will be influential with prescribers and purchasers.