October 13, 2010
Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.
Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.
The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.
Pfizer maintains its drug is effective.
But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.
This is not the first time a large drug company has come under fire about its published drug trial data.
Trial informationPharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.
GSK rejected claims that it improperly withheld drug trial information.
But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.
Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.
Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.
They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.
Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.
Biased pictureThe researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.
“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.
They warn that the lack of all information means policy makers are unable to make informed decisions.
In the US, it is already a requirement that all data – both positive and negative – is published. The UK is also striving to achieve this.
The UK’s regulator, the MHRA, said: “There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in late 2011/early 2012.”
A spokeswoman for Pfizer said: “In the UK, Pfizer’s reboxetine is licensed for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.
“This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions.
“Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.
“Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review.”
Others lay at least some of the blame with the medical journals that publish drug trial data.
In response, the BMJ has promised to devote an entire issue to the topic next year.
BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: “It is time to demonstrate a shared commitment to set the record straight.”
August 19, 2009
Citizens Commission of Human Rights International
By Jim Marrs
Today, one of the biggest problem we have, and one of the things that shocks so many Americans, is the rise of teen suicides and the rise of school shootings. Yet all we hear from the corporate mass media on the shootings is “Well, we need to take the guns away.” Let me tell you something, I went to school in Texas. We took guns to school. Nobody shot anybody. So what’s changed? Drugs. Kids on psychiatric drugs. Nearly every school shooter in this country can be shown to have been involved with psychotropic drugs—either taking them at the time of the shootings, or what can be even worse, coming off of them. And teen suicides? Read the FDA black box warnings, these drugs can cause suicidal ideation. So logically, if kids are being drugged up with antidepressants, and if in fact teen suicides are rising, then it doesn’t take a rocket scientist to realize that we better stop drugging our kids to death.
Psychiatric drugs cause major changes in brain chemistry and in behavior. International drug regulators warn that the drugs we are doling out to kids can cause mania, psychosis, depersonalization, suicidal and even homicidal ideation. If we take a look at the school shooters that were under the influence of these drugs, you have to wonder why there hasn’t been a federal investigation into the correlation between drugs documented to cause violence and suicide and kids taking them who then became violent and suicidal. If even a handful of these school shooters were found to be taking PCP or smoking crack we would have headline news announcing a causal relationship between illicit drug use and acts of violence. But because these kids are taking legal drugs, prescribed by a psychiatrist for an alleged mental disorder, something we use to refer to as “childhood,” the powers that be don’t think it merits an investigation. Well we are all aware of how much Pharma spends on lobbying efforts. Regarding corporate media I would venture a guess that the reason they haven’t taken on the issue is simple: Big Pharma is now one of, if not the largest, advertisers in the United States, with $5 billion a year spent on direct to consumer advertising.
The rise of drug-induced acts of violence and suicide isn’t limited to our schools. In January 2009 it was reported that more of our military died of suicide than of combat deaths. Why is that? Could it be because our military are getting pumped full of psychiatric drugs? What Time Magazine referred to as “America’s Medicated Army?” Well if we are “medicating” our troops with antidepressants and antipsychotics, drugs documented to cause suicidal reactions, let’s put 2 and 2 together and state the obvious—these drugs are minimally a contributing factor.
Many people don’t realize that psychiatry’s love affair with the military dates back more than 90 years; During World War I the biggest problem the German military had was desertions—people leaving the front lines of the War. So the Germans turned to psychiatrists who came up with a solution: Electroshock. Psychiatrists theorized that if the shock soldiers experienced due to the brutalities of war made them desert the front lines, then another kind of shock—electroshock—could get them to be good little soldiers and willingly return to combat. Maybe because electroshock wiped out their memory, or maybe because soldiers chose to face the front lines rather than have another 450 volts of current tear through their brain, it worked. Psychiatry had come up with a winning strategy for the military to deal with reluctant soldiers and since that time the love affair between the two entities has never waned.
Today there are mobile psychiatric units that travel with the troops to ensure they’re drugged up as needed. And though they are not yet employing electroshock, as more Americans are made aware that these psychotropic drugs are killing our troops, don’t be surprised if sometime soon you pick up a newspaper and find psychiatrists promoting a new cure for Post Traumatic Stress Disorder; Electroshock.