Laura Plumlee, the plaintiff (a person who is suing) said that during the three years she took Zoloft, it did not help her. Her lawyer, R. Brent Wisner, says the FDA (Food and Drug Administration) should not have approved Zoloft because Pfizer had not published some clinical trials which demonstrated that the medication was not significantly different to a placebo.
Baum Hedlund, Aristei & Goldman and Pendley Baudin & Baudin & Coffin filed the lawsuit on behalf of the Plaintiff and consumers throughout the USA and California.
A placebo is a dummy drug, a substance with no active ingredient taken by some participants in a clinical trial to determine whether the target drug, in this case Zoloft, is more effective.
Pfizer is accused of deceptively marketing Zoloft as a "highly effective treatment for depression", while knowing that the medication was virtually indistinguishable from a sugar pill at best.
The complaint alleges:
- Most of the Zoloft clinical trials that focused on its efficacy proved to be either negative or neutral. In most of the efficacy studies, Zoloft was not significantly better than a placebo in relieving the symptoms of depression. In some cases, the placebo produced better results than Zoloft.
- Pfizer knew about how effective or ineffective Zoloft was, "as documented in internal company documents discussed in the complaint."
- Even though Pfizer knew full well that Zoloft's effectiveness was "less than stellar", it continued falsely marketing the drug as if it were very beneficial for patients with depression.
- Zoloft's drug label was deliberately crafted by Pfizer to mislead consumers and doctors into believing that the medication is better at treating depression than it really is.
- By convincing consumers and doctors that Zoloft was highly effective in treating depression, Pfizer knew it could turn a profit. This was not achieved via its inaccurate and misleading drug label, but rather through a "a comprehensive scheme of selective publication of clinical trial data, ghostwriting positive manuscripts about the efficacy of Zoloft, paying prominent physicians (known as Key Opinion Leader or "KOLS") to tout the efficacy and safety of Zoloft, and misleading advertising on television and in magazines."
- Tens of billions of dollars were reaped in Zoloft sales profits, as a result of the company's extensive and deceptive marketing efforts.
- Zoloft was launched in 1991. Since then, sales have brought in over $30 billion in revenue for the company. Before Zoloft's patent expired in 2007, which was followed by a range of less expensive generic alternative to the brand named drug, Zoloft's annual sales exceeded $3 billion each year. Even today, after the patent expired, Zoloft still brings in more than $500 in sales annually. There are over 20 million prescriptions of Zoloft and generic sertraline filled annually.
"I was led to believe this medication was very effective at treating depression. What I got was three years of false hopes with side effects. I kept telling my doctor that I didn't think Zoloft was helping me, but he kept telling me I was wrong. I feel duped and betrayed by Pfizer. Through my lawsuit, I hope to make Pfizer pay back the money it took from me and others who bought Zoloft. I think that ought to give Pfizer and other drug companies some incentive to stop deceiving the public. Pfizer should not be allowed to keep money it made by dishonest means."
Attorney Michael L. Baum said:
"People think that, if a drug has been approved by the FDA, it must be okay. But, as the recent spate of FDA whistleblower cases have shown, that's not necessarily the case." For example, Dr. David B. Ross, a former FDA medical reviewer who blew the whistle on the antibiotic Ketek, explained in an interview that the drug industry "has become FDA's client. People at FDA know that they have to be careful about upsetting industry... even if a product doesn't work.. there is pressure on managers that gets transmitted down to reviewers to find some way of approving it.
Manufacturers like Pfizer know this and have taken advantage of it, despite the fact that their primary responsibility is to properly inform doctors and patients about the benefits and risks of the drugs they market. Millions of consumers in the United States spent billions of dollars for a drug whose benefits were likely clinically insignificant while exposing them to some very serious risks."
Dr. Irving Kirsch, director of the Placebo Studies Program at Harvard Medical School, mentioned in his book The Emperor's New Drugs "Drug companies knew how small the effect of their medications were compared to placebos, and so did the FDA and other regulatory agencies. The companies found various ways to make the data seem more favorable to their products.. My colleagues and I hadn't really discovered anything new. We had merely revealed their 'dirty little secret'."
Regarding the Zoloft efficacy class action just filed, Kirsch added "In the studies Pfizer conducted to test Zoloft's efficacy for treating depression, a majority showed no significant difference between Zoloft and placebo. What is also troubling is that in the two studies where Zoloft appeared to perform better than placebo, the difference was so small that it is unlikely to be of any meaningful clinical benefit to the patient. My analyses of the research conducted by Pfizer demonstrates that the perceived benefit patients feel they get from Zoloft is primarily due to the placebo effect - the belief or hope that they are taking an effective medication."
Pfizer says that clinical studies, as well as years of data on millions of patients over twenty years proves that Zoloft is an effective antidepressant.
In an interview with The Associated Press, Pfizer and four experts in psychiatry called the lawsuit "frivolous".
Written by Christian Nordqvist