A reanalysis of data from a controversial study reveals that a widely prescribed antidepressant, Paxil, may be ineffective and even harmful.
A controversial study published in 2001 allegedly showed that Paxil, a popular antidepressant, was safe and effective in adolescents with depression, opening the door for doctors to write millions of prescriptions for children and teens. But now, reanalysis of the data reveals a number of problems with the original research, highlighting potential foul play by a consultant on the drug maker’s payroll - who also happened to be the study’s lead author.
Paxil is manufactured by GlaxoSmithKline, the second largest pharmaceutical company in the world, and the drug haven is no stranger to controversy. In the past decade, the company has been accused of intimidating research doctors, participating in animal rights violations, and committing fraud. GlaxoSmithKline has spent billions to resolve lawsuits over illegally marketing drugs, including Paxil.
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Despite the fact that there are dozens of medications to treat depression, only one is approved by the FDA: Prozac. There are speculations that Study 329, the controversial Paxil study, contributed to the eruption of new antidepressants claiming to be effective and safe for the general public. Study 329 was led by Martin Keller, a psychiatry professor at Brown University, and in 1999, a Boston Globe investigation revealed that he had financial ties to drug companies.
The new study reanalysed the raw data from Study 329, finding disturbingly different results than those published in the original paper. Led by Jon Jureidini, a professor at the University of Adelaide in Australia, the new study revealed that Paxil was no more effective than a placebo. In fact, it found that the drug increased harmful symptoms like suicidal thoughts and behaviors.
These dangerous side effects were blatantly understated by the study authors — the most flagrant example was how the researchers referred to a suicide attempt as an “emotional liability.” There were also a number of transcription errors, and Jureidini told the Washington Post that it looked like there were “deliberate attempts to play down the adverse event profile.”
In response to the new study, GSK released a statement on the same day it was published. The company said that by providing the researchers with the raw data, it shows GSK’s commitment to data transparency. The company claims it publishes the results of all studies whether they’re positive or negative, and also says the link between between Paxil and a higher risk of suicidal tendencies among adolescents is widely known — warning labels have been on the product for more than a decade, the company says.
But people are inclined to trust a doctor’s recommended route of treatment, and despite the warning labels, Paxil has been taken by over 100 million people. “This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” Jureidini said in a statement.
The study researchers hope that by bringing this issue to light, raw research data will become more accessible. It’s extremely rare for researchers to reanalyze the findings of studies that have already been published, but the credibility of published research has been taking some heat lately: another study that tried to reproduce the findings of 100 major psychology studies found that less than half could be reproduced.
The notion that this could potentially be a trend in a number of major research studies is wildly discomforting, especially concerning the studies like Study 329 that have huge implications on public health and drug regulations.
As reported by TIME, Jureidini clarified, “It’s not the point of this paper to humiliate GSK or accuse anyone of fraud. It’s an attempt to honestly present the data. This is what the original paper should have looked like. If the original paper had reported things this way, there never would have been a problem.”
