Was NIMH Trial Rigged To Favor A Forest Drug?
In 2002, the National Institutes of Mental Health finalized a contract with the University of Texas Southwest Medical Center to run a 4,000-patient study of antidepressants at a cost of $35 million. The principal investigator chosen to run the year-long study was John Rush, a controversial figure who, at the time, was the professor and vice chair in the Department of Clinical Services (pictured to the left).
However, a recently unsealed whistleblower lawsuit charges that Rush, who is now the vice dean for clinical services at Duke-NUS Graduate Medical School Singapore (see this), also had financial ties to Forest Laboratories, which sells the Celexa antidepressant (see here). And as a result, he allegedly designed the protocol to favor Forest and received kickbacks, according to the lawsuit, which was filed by psychologist H. Edmund Pigott.
Pigott has previously published papers claiming the comparative study, which was called STAR*D and cost an estimated $35 million, was biased (read this and this). And his lawsuit claims the conflict of interest was the reason that Celexa was chosen as the only antidepressant used in the first part of the study, which gave Forest a significant marketing advantage and led to increased sales.
Moreoever, he also alleges that the study was falsified and overstated the effectiveness of the Forest drug, which he maintains should prompt regulators and the medical community to conduct a reevaluation of the use of antidepressants for treating depression. The upshot is that the study results prompted state and federal healthcare programs to overpay for Celexa.
In his lawsuit, Pigott notes Celexa was supposedly chosen as the first antidepressant given to patients because the pill was prescribed less often than similar drugs, which meant patients would have had less exposure to the Forest pill. Another rationale was that Celexa caused fewer discontinuation symptoms, which meant switching to another drug later in the trial would not be as problematic. And Celexa presumably caused fewer interactions with other drugs.
However, Pigott argues that such logic used to justify the protocol was unfounded. In his view, if Celexa was scientifically superior, doctors would have prescribed the pill more often. But by choosing the Forest drug as the only antidepressant in the first part of the study, Forest would benefit as long as success rates were the same or better than previously documented trials, the lawsuit maintains.
Meanwhile, Pigott goes on to argue that published STAR*D results that were positive and supported the effectiveness of antidepresssants, only 108 of the 4,041 patients, or 2.7 percent, had an acute-care remission and neither relapsed nor dropped out during the 12 months of continuing care that followed. He also cites his own paper in which he maintains that STAR*D changed outcome measures and analyses, and inflated the Celexa remission rates by 44.9 percent.
Finally, Pigott notes that four years after STAR*D findings were published, along with more than 70 peer-reviewed articles about the results, none of the articles published by the STAR*D authors have reported outcomes of any of the 12 pre-specified measures of the study. Other STAR*D researchers, by the way, also had alleged ties to Forest, according to the lawsuit (which you can read here).
Forest, you may recall, pleaded guilty to obstruction of justice, distributing an unapproved drug and illegally promoting two other meds, including Celexa, in 2010. The drugmaker paid $313 million, which included $164 in criminal penalties (back story with the plea agreement can be read here). Forest was charged with promoting Celexa for pediatric use, when the drug was approved only for adults.
We have asked Forest Labs for a company and will update you accordingly.
As for Rush, he was sighted by US Senator Chuck Grassley during a probe of academics who received NIH grants to study medicines while simultaenously failing to properly disclose financial ties to the drugmakers that sold those same medications. One such relationship involved Eli Lilly (you can read more here). Shortly after the disclosure, Rush left for Singapore (see this).
Rush also once headed a controversial program called TMAP, or Texas Medication Algorithm Project, which was allegedly orchestrated by Johnson & Johnson to boost the use of its Risperdal antipsychotic in the public sector throughout the country. TMAP relied on various state officials and academics to develop and sell the program as a policy tool, according to a recently settled lawsuit (read here and here).
