[News item] Why Big Pharma is not addressing the failure of antidepressants

Why Big Pharma is not addressing the failure of antidepressants.

From the 14 May 2015 post at The Conversation

Around a quarter of people experience depression at some point in their lives, two-thirds of whom are women. Each year more than 11m working days are lost in the UK to stress, depression or anxiety and there are more than 6,000 suicides. The impact of depression on individuals, families, society and the economy is enormous.

Front-line therapies usually include medication. All the commonly prescribed antidepressants are based on “the monoamine hypothesis”. This holds that depression is caused by a shortage of serotonin and noradrenaline in the brain. Existing antidepressants are designed to increase the levels of these chemicals.

The first generation of antidepressants were developed in the 1950s and a second generation came in the 1980s. Products such as Prozac and Seroxat were hailed as “wonder drugs” when they first came onto the market.

In the roughly 30 years since, these kinds of drugs have come to look tired and jaded. Patents have expired and there are doubts about their efficacy. Some scientists even argue the drugs do more harm than good.

Broken model

There has been no third generation of antidepressants. This is despite there having been moon-landing levels of investment in research. The antidepressant discovery process that gave rise to the earlier drugs is clearly broken. It is also apparent that this process had never worked that well, since the only real improvements over the previous 60 years were a reduction of side-effects.

By the mid-2000s the major pharmaceutical companies started disinvesting in this area. Government funding for basic research into depression and charitable funding followed a similar pattern. In 2010 GSK, AstraZeneca, Pfizer, Merck and Sanofi all announced that they had stopped looking for new antidepressants altogether. Professor David Nutt, the former government drug advisor, declared this to be the “annus horribilis” for psychiatric drug research. The likelihood now is that there will be no new antidepressants for decades.

However, there continues to be an urgent and pressing need for more effective treatments. The question the drug companies now need to ask themselves is, did they fail because the task was impossible, or did they fail simply because they got things wrong? Our view is that there was a systems failure.

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[News release] Publication bias and ‘spin’ raise questions about drugs for anxiety disorders

From the 30 March 2015 Oregon State University news release

A new analysis reported in JAMA Psychiatry raises serious questions about the increasingly common use of second-generation antidepressant drugs to treat anxiety disorders.

It concludes that studies supporting the value of these medications for that purpose have been distorted by publication bias, outcome reporting bias and “spin.” Even though they may still play a role in treating these disorders, the effectiveness of the drugs has been overestimated.

In some cases the medications, which are among the most widely prescribed drugs in the world, are not significantly more useful than a placebo.

The findings were made by researchers from Oregon State University, Oregon Health & Science University, and the University of Groningen in The Netherlands. The work was supported by a grant from the Dutch Brain Foundation.

Publication bias was one of the most serious problems, the researchers concluded, as it related to double-blind, placebo-controlled clinical trials that had been reviewed by the U.S. Food and Drug Administration. If the FDA determined the study was positive, it was five times more likely to be published than if it was not determined to be positive.

Bias in “outcome reporting” was also observed, in which the positive outcomes from drug use were emphasized over those found to be negative. And simple spin was also reported. Some investigators concluded that treatments were beneficial, when their own published results for primary outcomes were actually insignificant.

“These findings mirror what we found previously with the same drugs when used to treat major depression, and with antipsychotics,” said Erick Turner, M.D., associate professor of psychiatry in the OHSU School of Medicine, and the study’s senior author. “When their studies don’t turn out well, you usually won’t know it from the peer-reviewed literature.”

This points to a flaw in the way doctors learn about the drugs they prescribe, the researchers said.

“The peer review process of publication allows, perhaps even encourages, this kind of thing to happen,” Turner said. “And this isn’t restricted to psychiatry – reporting bias has been found throughout the medical and scientific literature.”

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More Being Prescribed Psychiatric Medications With No Diagnosis

From the 4 August Medical News Today article

59.5% of antidepressant prescriptions were made with no diagnosis in 1996, in 2007 the figure rose to 72.7%, researchers reported in Health Affairs. Antidepressant drugs are today the third most commonly prescribed class of drugs in the USA.

Nearly 8.9% of the American population had at least one antidepressant prescription during any given month during the period 2005-2008.

A good proportion of this growth in antidepressant prescription has been by non-specialist providers whose patients were not diagnosed by a psychiatrist.

Read the entire article

Related articles

• Prescriptions for antidepressants increasing among individuals with no psychiatric diagnosis (medicalxpress.com)
• More Antidepressants Prescribed by Non-Psychiatrists (psychcentral.com)
• Antidepressants Overprescribed in Primary Care (psychcentral.com)