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As part of the fallout from a recent $2.2 billion Risperdal settlement between Johnson & Johnson and the federal government, documents have come out suggesting that the company’s Janssen subsidiary may have intentionally withheld clinical trial data that cast the antipsychotic drug in a negative light.
The Department of Justice (DOJ) has released internal documents of researchers expressing concern and dismay over the company sitting on clinical trial data that showed poor outcomes regarding Risperdal, while appearing to cherry pick the data that presented the drug more positively.
The documents include emails regarding a clinical trial identified within them as RIS 232, which appears to deal with the effectiveness and safety of Risperdal, which the government says Johnson & Johnson marketed illegally for uses not approved by the FDA.
One of the e-mails (PDF) from 2003, partially redacted, states “Janssen has been sitting on the trial results for a long time. Yet it has a moral and ethical responsibility to publish results quickly and in a way that can be understood and makes clinical sense. It has an obligation to publish not just the clinical efficacy data which should very well be informative and supportive of the use of risperidone if considered properly, but also the safety data, including events that have been labeled in the past as ‘cerbrovascular adverse events’ and death.”
Risperdone is the active ingredient in the antipsychotic Risperdal.
Another email (PDF), also written by a concerned researcher, this one heavily redacted, appears to indicate that the company had four pooled studies, one of which showed poor results and decided to keep that study under wraps.
“At this point, we must be concerned that this gives the strong appearance that Janssen is purposely witholding (sic) the findings from RIS 232,” the writer warns. “I really do have to speak out and urge that Janssen avoids embarrassment and accusations about suppressing information that is relevant to providers and consumers.”
The study was eventually published in 2006. Risperdal has been on the market since 1994.
Increasing Concerns Over Corporate Clinical Trial Data
The revelations come after the Justice Department got Johnson & Johnson to plead guilty to accusations that it marketed Risperdal for unapproved uses, including its use as a chemical restraint for elderly patients in nursing homes with dementia. The illegal marketing came despite FDA warnings that antipsychotics could increase the risk of death in dementia patients. The company was also accused of paying kickbacks to doctors that pushed Risperdal and other Janssen drugs.
However, it also comes at a time when regulators and independent health experts are raising alarms about a disturbing trend in the pharmaceutical industry regarding the withholding of clinical trial data.
Earlier this month AstraZeneca announced that the DOJ had launched an investigation over its conduct regarding Brilinta clinical trials. While no details of the nature of the investigation were revealed by the company, the investigation comes after accusations that it downplayed or covered up data on heart problems linked to the blood thinner.
An August study in the International Journal of Cardiology suggested that AstraZeneca may have manipulated data during a clinical trial to make the drug appear safe when data suggested otherwise. Among the irregularities was the fact that an independent review of the data found that 46% of all primary endpoint events favoring Brilinta came from just two countries, Poland and Hungary, despite the participation of subjects from numerous other countries. The review also found that heart attacks linked to Brilinta were under-reported in the clinical trial findings.
Last month, health experts from the European Medicines Agency (EMA) wrote an editorial in the New England Journal of Medicine promoting a draft policy that would require drug makers in Europe to make patient-level data from clinical trials available to the public without revealing the identities of the patients.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on complications linked to its Infuse bone growth product in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.
Risperdal Health Concerns
In addition to concerns that the antipsychotic could increase the risk of death among elderly dementia patients, the DOJ’s investigation revealed that it was also given to children and the mentally ill in nursing homes for off-label purposes.
Risperdal has been linked to serious side effects among children, including a risk of male breast growth in young boys and a possible increased risk of childhood diabetes.
Johnson & Johnson currently faces a growing number of Risperdal breast growth lawsuits that allege inadequate warnings were provided for consumer or the medical community about the risk that young boys may experience the development of breasts, a condition called gynecomastia. In some cases, plaintiffs have alleged that boys developed breasts measuring as large as a 38D cup size after using the medication, with many cases resulting in the need for breast removal surgery. The psychological effects of Risperdal breast growth can have a devastating impact on the boys, greatly impacting their overall quality of life.