Tag Archives: clinical trials

Be Skeptical of Pharmaceutical Company Claims

Ben Goldacre’s TEDTalk describes the selective bias in research and publishing which strongly favors articles with positive outcomes. In my field of psychiatry, this bias is only the tip of the iceberg. In many cases, the articles are not even written by the scientists whose names appear on them. They are “ghostwritten” by drug company minions.

In my role as a medical expert in product liability lawsuits against drug companies, judges have empowered me to dig into the otherwise secret interiors of drug company data vaults. The following observations have been generated during my forensic investigations and have been documented in my books and scientific articles.

Beware the ghost(writer)s of medical research

How ghostwriting feeds Big Pharma profits – Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

Doctors’ Conflicting Interests Can Cost Money and Lives, and Hinder Medical Discoveries

The fact that doctors take money from pharmaceutical companies happens to be old news. But this time around, the docs in question come from Stanford University. Previous news stories reported that doctors receiving pharmaceutical funding hailed from Harvard, the University of Miami, the Medical College of Georgia and the University of Cincinnati College of Medicine.

More than a few of these doctors are psychiatrists who have received tax-supported, public National Institutes of Health and National Institute of Mental Health funding for clinical research, have participated in U.S. Food and Drug Administration advisory panels or have appeared on, or on behalf of, various not-for-profit psychiatric advocacy boards — some of which are heavily supported by the manufacturers of psychiatric medications.

False peace of mind – Antidepressant Placebos

Beginning in 1998, a series of studies have repeatedly questioned the difference in efficacies between antidepressant drugs and placebos. Pioneering analysis work done by University of Connecticut researchers Irving Kirsch and Guy Sapirstein confirmed the effectiveness of antidepressants – but also their inert counterparts. In 38 studies conducted with over 3,000 depressed patients, placebos improved symptoms 75 per cent as much as legitimate medications.

“We wondered, what’s going on?” said Kirsch in a 2010 interview with Newsweek. The medical community, skeptical of his analysis, asked him to instigate a more comprehensive study with the results of all clinical trials conducted by antidepressant manufacturers, including those unpublished – 47 studies in total.

Over half of the studies showed no significant difference in the depression-alleviating effects of a medicated versus non-medicated pill. With this more thorough analysis, which now included strategically unpublished studies from pharmaceutical companies, placebos were shown to improve symptoms 82 per cent as much as the real pill.

Psychiatrist on Payroll of Glaxo Pleads Guilty to Research Fraud

A psychiatrist on the payroll of GlaxoSmithKline has been sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company’s antidepressant Paxil on children. GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study. The case’s significance goes beyond simple research fraud, as Glaxo is now defending itself against charges that for 15 years it deliberately concealed evidence that Paxil increases the risk of suicide in children. Maria Carmen Palazzo is already serving a sentence of 87 months for defrauding Medicare and Medicaid.