​Celexa / Lexapro Lawsuits – Consumer​ Fraud in Pediatric Use

Complaints filed by Wisner Baum against Forest in the multidistrict litigation MDL No. 2067, Master Docket No. 09-MD-2067-NMG before Judge Nathaniel M. Gorton for the District of Massachusetts include:

1. PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND, a third-party healthcare payor fund, on behalf of itself and all others similarly situated, Plaintiff, v. FOREST PHARMACEUTICALS, INC. and FOREST LABORATORIES, INC. Defendants.
2. MARLENE T. LOCONTE, et al., on behalf of themselves and all others similarly situated, Plaintiffs, v. FOREST PHARMACEUTICALS, INC. and FOREST LABORATORIES, INC. Defendants.

According to the lawsuits, Forest misrepresented the efficacy of Celexa and Lexapro for use in children and adolescents, pushed doctors to prescribe the drugs notwithstanding their lack of efficacy and lied to regulators about the conduct of at least one of the studies on which the FDA relied to approve Lexapro in adolescents.

Judge Certifies Class for consumers in Missouri, Forest Settles Claims

On January 10, 2014, Judge Nathaniel Gorton certified a class of Missouri consumers (parents who purchased Celexa or Lexapro for their children). On March 26, 2014, a settlement was reached in the case ranging from a minimum of $7,650,000 to a maximum of $10,350,000 depending on submitted claims.

Studies Testing Efficacy

Drug makers are required to test drugs for efficacy and safety and submit the results to the FDA before a 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. They are “double blind.”

If either the researchers or the patients are “unblinded” during the clinical trial, it invalidates the data since there is no way to determine whether the effects observed are caused by the drug as opposed to other factors. Blinding is intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of a clinical trial. If either the researcher or the patient knows that a drug is being administered, that knowledge will likely influence their assessment. Numerous studies have confirmed this fact. Blinding is a vital factor in medication research.

In trials of antidepressants, patients are interviewed about their symptoms 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 depression score. The higher the score, the worse the depression.

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 as those taking the drug. Generally, unless a drug company can provide the FDA with two clinical trials in which the patients receiving the drug achieve significantly more symptom improvement than those taking a placebo, the FDA will not approve the drug.

Forest Misrepresented a Pivotal Celexa Study

The primary focus of the government’s prosecution of Forest involved the off-label promotion and dissemination of Forest’s “positive” MD-18 study and the suppression of its negative Study 94404. MD-18 was a double-blind, placebo-controlled clinical trial in children and adolescents and Study 94404 was a double-blind, placebo-controlled clinical trial in adolescents. Forest’s representation during the government’s prosecution that MD-18 was a positive study was used to ameliorate Forest’s misconduct.

What the government did not know is that MD-18 achieved a positive result due to the improper inclusion of nine patients in the study for whom “the blind was unmistakenly [sic] violated” or, as Forest’s medical director put it, who were “automatically unblinded” due to a dispensing error.

When Forest discovered the dispensing error mishap, the company informed the FDA that the final analysis of MD-18 would exclude the unblinded patients. But once Forest realized that the unblinded patients would need to be included in the study to make MD-18 positive (i.e. show that Celexa outperformed a sugar pill), Forest decided to put the unblinded patients back into the final analysis and falsely told the FDA the patients were not actually unblinded.

In a draft letter sent to the FDA regarding the dispensing error, Amy Rubin, a Regulatory Affairs Manager for Forest, characterized the mishap as only having “the potential to cause patient bias.”

Dr. Charles Flicker, the Senior Medical Director overseeing MD-18, did not approve of this language. He told Rubin that, while the potential to cause patient bias is a “masterful stroke of euphemism,” he wanted the language to be more clear that the “integrity of the blind was unmistakenly [sic] violated.”

Rubin replied by thanking Dr. Flicker for the compliment and added, “[P]art of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing.”

“Not only was the disclosure to the FDA dishonest, according to a Forest Regulatory Affairs manager, it was her job to mislead the FDA and protect medical and marketing,” says attorney Brent Wisner. “The USAO and the DOJ did not know the full story when they sat down to settle civil and criminal charges against Forest in 2010. The evidence we collected in discovery strongly supports the reopening of the government’s investigation and prosecution. Forest should be held to account for the fraud perpetrated on the FDA, the USAO, physicians, parents, and most importantly, children.”

Antidepressants Celexa and Lexapro Ineffective for Childhood Depression Court Documents Show

Forest Laboratories Inc. and Forest Pharmaceuticals Inc. (now owned by Allergan) and the company’s hired “key opinion leaders” have promoted the use of Celexa and Lexapro for use in pediatric depression for nearly 20 years notwithstanding knowledge that all but one of the clinical trials of the drugs failed (on every efficacy measure used during the studies). The one “positive” study showed a small statistical advantage, but did not show a clinically meaningful effect. Thus, Forest/Allergan have exposed children and adolescents to the drugs’ risks including an increased risk of suicide without offering a benefit. Forest/Allergan have placed profits over the lives of children and adolescents.

See also: FDA Orders Black Box Suicide Warnings on Antidepressants for Children, Adolescents and Young Adults

Medical Literature Questioning Efficacy of Celexa and Lexapro

• The most comprehensive meta-analysis of antidepressant clinical trials in pediatric patients by Cipriani et al. finds antidepressants, and in particular Celexa and Lexapro, “do not seem to offer a clear advantage for children and adolescents.” Neither Celexa nor Lexapro statistically or clinically differentiated from placebo.
• In an invited commentary regarding the Cipriani meta-analysis, Jon Jureidini, Professor of Psychiatry at the University of Adelaide, Australia, stated that “antidepressants, including fluoxetine (Prozac), are likely to be more dangerous and less effective treatments than previously recognized, so there is little reason to think that any antidepressant is better than nothing for young people.” Read: Antidepressants fail but no cause for therapeutic gloom
• Canadian researchers analyzed the clinical trials of Celexa and Lexapro (even without knowing about the MD-18 unblinding issue) and concluded: “From these data, [Celexa and Lexapro] should not be considered for first-line treatment of adolescent depression” and “the US FDA approval of escitalopram was premature, given the available evidence.”
• Most Antidepressants Ineffective for Kids with Depression
  (Paxil pediatric Study 329. Quotes Dr. David Healy)
• New look at happy pill’s downside
  (Cipriani meta-analysis) “Only full disclosure of drug trial results will maintain trust.”
• SSRIs, a systematic efficacy review in adults
  Conclusion: “Our results show that the harmful effects of SSRIs versus placebo for major depressive disorder seem to outweigh any potentially small beneficial effects.”

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