A recent reanalysis of a 2001 Paxil (paroxetine) study has put into serious doubt the whole field of psychiatry and how it conducts clinical trials (Le Noury et al., 2015; Keller et al., 2001).
The reanalysis showed that Paxil (paroxetine) is not effective for adolescents with depression and also found that there was an increase in harm on Paxil compared to a placebo, including suicidal ideations and behaviors and other serious side effects (Le Noury et al., 2015).
These findings are in stark contrast to the original 2001 Paxil study 329, which published its findings in the leading journal for child and adolescent psychiatrists, that Paxil was both safe and effective for adolescent depression (Keller et al., 2001).
How did psychiatry come to embrace a drug that is not effective and can cause serious harm in a vulnerable population? Obviously, the checks and balances to ensure the validity and safety of the drugs under study should be examined further.
The people and institutions involved in study validity and safety include the study investigators, data safety monitoring boards (DSMB), institutional review boards (IRB), the sponsoring hospitals or research institutes, the medical journals which publish the studies and ultimately the U.S. Food and Drug Administration (FDA) that approves these drugs for new indications.
However, I opine that the study investigators are the ones who are bestowed the responsibility of ensuring validity of their study results and safety of study participants as regulatory agencies are not able to oversee the day-to-day operations of a clinical trial.
So how do study investigators become swayed to do otherwise?
Big Pharma Buy Outs?
The major conflict of interest here is that psychiatry has been bought out by Big Pharma, with most of psychiatry’s thought leaders on the payrolls of these hugely profitable drug companies.
How do I know all of this? I used to be on the payroll of numerous drug companies for joining their speakers’ bureaus and their advisory boards. The drug companies would pay me $1,000 to $2,000 per talk to educate other doctors on the drug being promoted.
But before we were pranced around by the legions of drug reps that would set-up these educational talks at fancy restaurants to entice doctors to prescribe their drug, speakers like myself were flown and wined and dined to resort locations and given training on what to say to promote their drug and the drug companies even gave us slides that they made so that we could use these in our own presentations to other doctors.
And yes, we were paid thousands of dollars to attend these lavish training sessions and no expense was spared.
And if you are invited to participate as an investigator on a drug-company sponsored clinical trial, then you can’t possibly be objective as an investigator as your bias is to show that the drug works because you want to continue with the generous grant money provided by the drug companies so that you can continue with your research that is not being funded adequately by government sources.
So what is a struggling psychiatric researcher to do with less grant funding for his/her research? They join as investigators on these drug company-sponsored trials that pay quite well for each study patient recruited into the study.
But you will not be invited as an investigator unless you have a track record of positive results for previous drug trials. As a result, your grant- and money-fueled bias is to show that the drug works, and there are minimal side effects.