She (Joanna Moncrieff, from University College London) adds that clinical study reports “are likely to underestimate the extent of drug-related harms.”
If a friend or someone in your family is being recommended antidepressants, have them check out these first…
“If you want drugs, this is your guy.”
Psychiatrist kills 36 patients. Click the link above to see the news clip.
Study 329 was a clinical trial conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI antidepressant marketed as Paxil and Seroxat, in treating depressed teenagers.
It concluded that paroxetine is “generally well tolerated and effective for major depression in adolescents.” In 2001, the study was published in the Journal of the American Academy of Child and Adolescent Psychiatry.
Study 329 was funded by GlaxoSmithKline (GSK), the drug’s manufacturer.
In the years following that study’s publication, reports of suicidal thoughts and behaviors in teens taking the drug raised concerns about Paxil’s effectiveness and safety. In 2003, the U.S. Food and Drug Administration (FDA) advised doctors not to prescribe the drug to teenagers suffering from depression. The following year, the FDA voted to require manufacturers to add a black box warning to their product labels.
In 2012, GSK pleaded guilty to fraud charges and paid $3 billion in fines – the largest health care fraud settlement in U.S. history – which included a criminal fine of $1 billion. The fine also included an amount for “preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.”
A recent reanalysis of tens of Study 329 revealed that the antidepressant paroxetine is not only ineffective for teens with depression – the drug is not safe for adolescents. The reanalysis team found that the authors of the original paper “deliberately misrepresented the outcomes of the study” and changed the protocols of the study without following the proper procedures to do so.
Unfortunately, Study 329 is not an outlier: drug studies have long been known to be flawed, mainly because testing is conducted by the very entities that stand to profit from sales of the medications – the drug manufacturers.
Another recent study exposed just how pervasive and serious the problem is.
Because pharmaceutical industry influence is known to permeate research, people who review scientific papers as part of their jobs rely on meta-analyses, which are supposedly thorough reviews that summarize the evidence from multiple trials, rather than trust individual studies.
Meta-analyses are meant to be as comprehensive as possible and to serve as a shortcut to a lot of evidence for busy clinicians who don’t have time to do a full evaluation of each drug on their own.
But as Roni Jacobson of Scientific American explains, a recent analysis casts doubt on that practice as well:
…the vast majority of meta-analyses of antidepressants have some industry link, with a corresponding suppression of negative results.
The latest study, published in the Journal of Clinical Epidemiology, which evaluated 185 meta-analyses, found that one third of them were written by pharma industry employees. “We knew that the industry would fund studies to promote its products, but it’s very different to fund meta-analyses,” which “have traditionally been a bulwark of evidence-based medicine,” says John Ioannidis, an epidemiologist at Stanford University School of Medicine and co-author of the study. “It’s really amazing that there is such a massive influx of influence in this field.”
The researchers considered all meta-analyses of randomized controlled trials for all approved antidepressants including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, atypical antidepressants, monoamine oxidase inhibitors and others published between 2007 and March 2014.
Here’s a list of the findings of the analysis:
- Almost 80 percent of meta-analyses in the review had some sort of industry tie, either through sponsorship, which the authors defined as direct industry funding of the study, or conflicts of interest, defined as any situation in which one or more authors were either industry employees or independent researchers receiving any type of industry support (including speaking fees and research grants).
- About 7 percent of researchers had undisclosed conflicts of interest.
- A third of the papers were written by industry employees; of the majority of authors, 60 percent were independent, university-affiliated researchers with conflicts of interest.
- For the 53 meta-analyses where the author was not an industry employee and did not report any conflicts of interest, 25 percent had unreported conflicts of interest that the researchers identified in their search and included in their evaluation.
- Meta-analyses by industry employees were 22 times less likely to have negative statements about a drug than those run by unaffiliated researchers.
- The rate of bias is similar to what a 2006 study found: industry-sponsored trials reported favorable outcomes 78 percent of the time, compared with 48 percent in independently funded trials.
We knew that the industry would fund studies to promote its products, but it’s very different to fund meta-analyses which have traditionally been a bulwark of evidence-based medicine. It’s really amazing that there is such a massive influx of influence in this field.
Erick Turner, a professor of psychiatry at Oregon Health & Science University who was not associated with the research, told Scientific American he is “very concerned” about the results but is not surprised:
There’s a certain pecking order of papers. Meta-analyses are at the top of the evidence pyramid. Industry influence is just massive. What’s really new is the level of attention people are now paying to it.
Pharma Giant Funded their Own Study Claiming Drug Was Safe for Kids — It was Actually Deadly
By Jay Syrmopoulos on October 10, 2015
Under current U.S. law, pharmaceutical companies are required to only market and advertise their drugs for FDA approved conditions.
Big pharma heavy-hitter GlaxoSmithKline (GSK) illegally influenced doctors to prescribe the antidepressant drug paroxetine (sold under the brand name Paxil) to teenagers and kids for years even though it was not FDA approved for use in adolescents.
Not to be discouraged by pesky laws, GSK began a focused marketing blitz aimed at doctors, which was a huge success with over 2 million Paxil prescriptions being written for kids in 2002 alone.
So why did doctors write over 2 million Paxil prescriptions for children when the drug was not even approved by the FDA for use in kids?
GlaxoSmithKine actually funded a research study that was published in 2001, known as Study 329, which claimed to show that the drug was “well tolerated and effective” in children.
A subsequent study, not funded by the pharmaceutical company, had drastically different conclusions as to the effectiveness and safety of Paxil in adolescents.
According to a report by Vox:
A major new analysis of the raw data behind Study 329, published in BMJ, suggests that the original conclusions were wildly wrong. Not only is Paxil ineffective, working no better than placebo, but it can actually cause serious side effects, including self-injury and suicide.
The New York State Attorney General’s office eventually found out what was going on with Paxil (and fraudulent activities related to other GSK drugs), sued GSK, and the company pleaded guilty to the wrongdoing, paying out $3 billion in fines. Through legal discovery, it became clear that the company knew their data on Paxil for teens was problematic, even hiring a PR firm to ghostwrite Study 329. In 2004, the FDA added an explicit “black box warning,” recommending against Paxil’s use in adolescents.
The researchers also found that Study 329 was fundamentally flawed. Researchers drastically downplayed serious risks and harms in their analysis of the drug, while intentionally manipulating their data.
To put this entire episode in perspective, GlaxoSmithKline not only created intentionally misleading “scientific” research, but attempted to use this misleading study to get doctors to prescribe its anti-depressant – to kids – for “off-label” use. The entire time GSK knew that the drug had no more benefit to children than a placebo and could lead to suicide and self-harm.
While GSK was massively fined for marketing Paxil to adolescents, drug companies are attempting change the current law to allow them to promote their products for uses that have not been approved by the FDA.
Two companies have sued the FDA, claiming that the current law violates their First Amendment right to free speech.
In August, a federal court in New York ruled in favor of one of the companies, Amarin, which sought to market its prescription fish oil for off-label uses.
A second company filed a similar lawsuit arguing that it should be allowed to promote its post-surgery pain drug for uses that are much broader than those authorized by FDA, according to Vox.
Writing for the Boston Globe, Ed Silverman explained the reality being faced.
“Beyond matters of constitutional law and governmental oversight, the pharmaceutical industry is clearly angling to boost prescription sales. Of course, this would fatten bottom lines, a good thing if you happen to be a shareholder,” Silverman said.
If pharmaceutical companies are successful in changing the law, it could potentially have major implications for public health and safety. The ability of patients and doctors to discern the difference between slick marketing ploys and evidence-based science may become even more difficult than it is already if the drug companies get their way.
Please share this story to help wake people up to the big pharma rip off!
Jay Syrmopoulos is an investigative journalist, free thinker, researcher, and ardent opponent of authoritarianism. He is currently a graduate student at University of Denver pursuing a masters in Global Affairs. Jay’s work has been published on Ben Swann’s Truth in Media, Truth-Out, AlterNet, InfoWars, MintPressNews and maany other sites. You can follow him on Twitter @sirmetropolis, on Facebook at Sir Metropolis and now on tsu