A recent study in the Journal of Clinical Epidemiology had some shocking figures about the effects of conflict of interest in drug research – or perhaps not that shocking to those who follow news of drug industry research scandals. The study evaluated 185 published meta-analyses, studies that compile the data from prior research to be able to draw more conclusions.

The researchers found that one-third of the meta-analyses analyzed had been authored by employees of the pharmaceutical industry, while 80 percent had been authored by people with other financial ties to the industry – either through funding of the study itself, or through receiving personal or professional gifts, speaking fees, grants or other boons from drug companies.

Unsurprisingly, studies authored by drug company employees were 22 times less likely to make negative statements about a drug than those authored by independent researchers.

Research fraud can kill

The recent scandal regarding concealed side effects of the antidepressant Paxil provide a clear example of the real-world consequences of this systemic research fraud.

In 2001, Paxil manufacturer SmithKline Beecham (now GlaxoSmithKline) published a trial concluding that the drug was effective in treating depression in children and adolescents, and that it was “generally well tolerated.” In the following year, two million youths were prescribed the drug.

In fact, a recent re-analysis of the data from this study – conducted by Australian researchers and published in the journal BMJ – reveals these conclusions to be an outright fraud. The data clearly show the drug to be no more effective than a placebo. In addition, 12 of the 93 children assigned to take the drug developed suicidal thoughts. The new study called this side effect rate “clinically significant.”

The researchers also found that the study had been typed up by a writer employed by the drug company, and that one of the senior researchers was under federal investigation for conflicts of interest.

In 2012, GlaxoSmithKline was fined $3 million for engaging in fraud for its marketing of Paxil (also known as paroxetine or Seroxat) between 1997 and 2004. The charges included paying doctors to attend recreational events – such as meals, spas and hunting trips – where the company promoted the drug.

Just the tip of the iceberg

Alarmingly, the proprietary nature of research means that GlaxoSmithKline’s data doctoring would never have been revealed if the company had not been forced to disclose its research documents as part of a lawsuit filed against it by the New York attorney general. And that lawsuit, in turn, would never have happened if not for a Scottish TV reporter who looked over the initial study and was puzzled by the term “emotional liability” – a label that the researchers had invented in order to conceal the more accurate term “suicidal thoughts.”

Experts warn that there is nothing particularly unique about Paxil; nearly every drug on the market got approved based on company-funded studies, the raw data of which are proprietary and concealed from public view.

This concealment has a very clear motive: According to a 2006 study, 78 percent of industry-sponsored drug trials found favorable results. In contrast, only 48 percent of independently funded trials found the drugs being studied to be safe and effective.

BMJ editor Fiona Godlee said that the Paxil case, “shows the extent to which drug regulation is failing us.” It is common practice, she said, for drug companies to exaggerate the benefits of their products and minimize the risks. She particularly singled out the cholesterol-lowering blockbuster drugs known as statins, noting that little independent research has been conducted into their side effects.

“This long running saga has within it all the seeds of our current discontent – industry malpractice, paid opinion leaders twisting the results of trials, hidden data allowing manufacturers, academics and clinicians to overstate the benefits and underplay the harms of treatment,” she said.

Sources for this article include:

ProjectCensored.org
DailyMail.co.uk
PostBulletin.com
Science.NaturalNews.com

Read More..