Wednesday, April 20, 2016

Pharma Corps and FDA Collude to Push Antidepressants on youth

 Analysis Shows Pharma Corps, FDA Collude to Push Dangerous Antidepressants on Youth

Elizabeth Montag
April 20, 2016

(ANTIMEDIA) Copenhagen, Denmark —Pharmaceutical companies systematically suppress pertinent data showing the increased risk of suicide and aggression in young patients taking antidepressants, a scientific analysis has demonstrated. Researchers analyzed 70 studies assessing the safety and efficacy of the drugs, concluding that “in children and adolescents the risk of suicidality and aggression doubled” — but information of this nature has often been misrepresented and buried in the appendices of studies.

Though the study was released in January and received a moderate degree of media attention, coverage of the findings tended to highlight the increase in aggression while glossing over the calculated role of pharmaceutical companies and the FDA in suppressing data and supporting faulty science. Some articles acknowledged the poor quality of tests the researchers examined. Others made a point to highlight widespread misreporting, but most stopped short of recognizing the duplicitous nature of the pharmaceutical giants and the FDA, whose willful complicity and consistent flouting of scientific research are central to the concerns raised in the January study.

The analysis, conducted by researchers at the Nordic Cochrane Center in Copenhagen and published in the British Medical Journal, examined 70 clinical study reports — the studies submitted to regulatory agencies like the FDA and EMA (European Medicines Agency) for approval of new drugs. The investigators examined double-blind, placebo-controlled trials conducted on selective serotonin reuptake inhibitors (SSRIs) and norepinephrine reuptake inhibitors (SNRIs). Common SSRIs include Paxil, Lexapro, Zoloft, and Prozac. SNRIs include Cymbalta and Effexor.

They concluded that while adults did not experience significant increases in suicidal and aggressive behavior, “despite using clinical study reports, the true risk for serious harms is still uncertain.” They noted “the low incidence of these rare events and the poor design and reporting of the trials makes it difficult to get accurate effect estimates.”

In addition to poor design and reporting, the Cochrane researchers found those conducting the pharmaceutical studies often mislabeled reactions in patients. Such practices ultimately downplayed the risks of antidepressants, including the links between suicide and violence.

Twenty-seven events were coded as emotional lability or worsening depression, although in patient narratives or individual patient listings they were clearly suicide attempts,” the researchers explained. In one instance, a suicide attempt was inexplicably deemed a case of “elevated liver enzymes” after a young patient intentionally overdosed on acetaminophen.

Scientific American detailed how the data was not only manipulated, but suppressed:
The investigators discovered that some of the most revealing information was buried in appendices where individual patient outcomes are listed. This information, however, was available for only 32 out of the 70 trials.”
They noted two pediatric studies they examined had fraudulent data. The body of research had other deficiencies, as well:
Details were unavailable for non-serious events, as they were either listed in adverse events tables or given in the appendix of individual patient listings without any narratives. These events were increased hostility, aggressiveness, rage, or anger.”

Further, they found instances of akathisia — restlessness, muscle quivering, and an inability to sit still associated with psychiatric drugs — were more common in those taking certain antidepressants than among those taking placebos. Akathisia is associated with a “jumping out of your skin” feeling and can increase the risk of suicide and aggression. The practices of the 70 studies’ authors, however, obfuscated these concerns. “[O]ur number of akathisia events is likely to be an underestimate, as the event appeared to be have been coded under many other activation terms, such as irritability, agitation, or nervousness,” the BMJ study explains.

The researchers’ conclusions are consistent with a small study published last year in the PLOS Medicine journal that found adolescents taking SSRIs were significantly more likely to commit violent crime.  Though those authors cautioned the results needed further validation, the BMJ study may bolster growing concerns the drugs are associated with aggressive behavior — but this has failed to attract concerns from regulatory agencies.

Tarang Sharma, a Ph.D. student at Cochrane and lead author of the study, discussed some of the problems revealed by her initial findings.“We found that a lot of the appendices were often only available on request to the authorities, and the authorities had never requested them,” she said, alluding to the role of regulatory agencies, which are demonstrably perpetuating bad science and, as a result, the pervasiveness of antidepressant use.

The researchers themselves struggled to obtain the data on the 70 clinical study reports, which, as the Scientific American notes, “are often withheld under the guise of commercial confidentiality.
Peter Gøtzche, a researcher at Cochrane and co-author of the study, argues “[a]ll this secrecy actually costs human lives.” Though the EMA eventually provided data after being publicly accused of mismanagement, the FDA has still not complied with researchers’ requests.

It’s deeply unethical when patients volunteer to benefit science, and then we let drug companies decide that we cannot get access to the raw data,” Gøtzsche said. “The testing of drugs should be a public enterprise.” This sentiment highlights the concerns raised by the study’s findings. Though misreporting and buried data were acknowledged in media reports, few linked these practices to what is, in many circles, commonly known: pharmaceutical companies pay researchers to “discover” outcomes favorable to them — and the FDA, plagued by a revolving door with industry, is evidently unconcerned with the validity of such studies. The agency is deserving of further skepticism and blame considering it refused to share its data with the Cochrane researchers.

Though the link between antidepressant use and suicidal tendencies in children and adolescents has long been known — the FDA began issuing black box warnings in 2004 — the Cochrane investigation found the increased incidences of aggression were not previously recognized. The FDA does not issue warnings regarding potential aggression as a result of taking antidepressants, and psychologists have criticized the agency for its weak approval process and low quality standard for scientific research on psychiatric drugs. Though the conclusions of researchers do not prove a definitive causal relationship between antidepressants and aggressive and suicidal behavior, they warrant further study and more data, as the authors caution.

Joanna Moncrieff, a researcher and psychiatrist at London College who was not involved in the BMJ study, said, “This is obviously important in the debate about school shootings in the [U.S.] and in other places where the perpetrators are frequently taking antidepressants.” Moncrieff has conducted her own research into the efficacy of antidepressants.

According to data from the Citizens Commission on Human Rights, “a non-profit, non-political, non-religious mental health watchdog,” over eight million children in the United States, alone, take psychiatric drugs. Over two million take antidepressants — and nearly 700,000 of them are between the ages of six and twelve. As of 2013, over 45,000 children between ages four and five, and over 46,000 children aged two to three are prescribed antidepressants. Over 26,000 babies younger than a year old are prescribed the pills, as well. This widespread use makes it even more concerning the FDA will not release the studies it uses to approve them.

Given the complicity of regulatory agencies with behemoth pharmaceutical companies, it is unsurprising that data showing adverse side effects has been suppressed. Considering the Cochrane study’s findings, however, it’s clear independent scientists — as opposed to those funded by pharmaceutical companies — are only beginning to discover the potential hazards of antidepressants.
My view is that we really don’t have good enough evidence that antidepressants are effective, and we have increasing evidence that they can be harmful,” Moncrieff said. “So we need to stop this increasing trend of prescribing them.

As Sharma, the study’s lead author, admitted, “I’m actually kind of scared about how bad the actual situation would be if we had the complete data.”

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