Is Big Pharma Over-Selling Depression?

If you watch late-night television you’ve probably seen the ads  for a new antidepressant drug called “Rexulti.”  It’s billed as a break-through cure for people who’ve already been treated for depression but are still experiencing its symptoms.   The manufacturer, Otsuka, is heavily promoting Rexulti just as it did its earlier controversial anti-depressant known as “Abilify.”

It’s all part of a new push by Big Pharma to sell “treatment-resistant” depression as a major new public health threat.

But is it, in fact?  And does Rexulti actually help?

It turns out that Big Pharma has been sponsoring research on treatment-resistant depression for some time.  And despite only mixed supporting evidence from clinical trials, they’ve managed to foist new drugs on unsuspecting consumers that exhibit a host of side effects, some of them potentially dangerous.

Much of the current emphasis on treatment-resistant depression can be traced to a 2007 meta-review conducted by Sidney H Kennedy and Peter Giacobbe which noted that some depression patients were failing to achieve “remission” after “two adequate trials of anti-depression therapy” – a period of about 6 weeks.

What was missing?  A 2012 study by Dr. Khalid Saad Al-Harbi  found that some patients being treated for depression still suffered from “functional impairment, poor quality of life, suicide ideation and attempts, self-injurious behavior, and a high relapse rate.”

At the time of these early studies, estimates of those suffering from “treatment-resistant” were fairly low — in the 10% range, but with speculation that it might be as high as 30%.  That seemed vaguely reassuring – after all, antidepressants on the market wereworking for most people, it seemed.                                                                                                                               But it wasn’t long before physicians were reporting that as many as 70% of depression patients weren’t achieving “remission.”  Amazingly, despite a two decades push by Eli Lilly on Prozac, the new depression wonder drug wasn’t actually working for most people.

That might have – indeed, should have — given the medical establishment pause. They might have consulted a number of studies suggesting there were other non-pharmaceutical techniques — from talk therapy to brain massage to electro-shock — that might augment the depression meds.  Some studies suggested an even more obvious solution:  Simply increase the patient’s dosage

Instead, drug companies like the Japanese-based Otsuka seized upon the problems with Prozac and its competitors to start developing a new class of drugs.

From the beginning, this effort has been controversial.  For one thing, the new medications are considered “anti-psychotics,” not “antidepressants.  While drugs like Prozac work on the brain’s neuro-transmitters, specifically its ability to transfer serotonin, the science behind the anti-psychotics turns out to be as cloudy as the disease it seeks to treat.

Rexulti – and its predecessor, Abilify, also produced by Otsuka – is supposed to be designed to treat conditions as diverse as depression, schizophrenia and bipolar disorder, in other words close to the entire range of major mental disorders.

But how does it actually work?

 For example, does it address brain inflammation?  There is a growing body of research on this topic, suggesting that it might be another source of depression, which drugs like Prozac focused on serotonin fail to address.  In addition, resistance to Prozac and similar drugs could be because some depression sufferers have “co-occurring” mental illnesses, such as bipolar disorder, which features bouts of mania or hypomania – mood “highs” that alternate with the depression’s “low”.

For reasons that are still unknown, Otsuka managed to convince the FDA to approve Abilify on the assumption that it could treat patients with bipolar disorder.  In fact, there wasn’t much evidence that it could — not consistently.  But distribution and use of the new drug in the US market soon became widespread.  And the results proved disastrous.

In 2011, reports began surfacing that Abilify was displacing other more established and effective drug treatments for bipolar disorder.  Investigators also discovered that Otsuka had managed to begin selling Abilify commercially without having conducted the usual panoply of clinical trials typically required to secure FDA approval.

In fact, it appeared that only a single clinical trial, conducted without the usual protocols, and under Otsuka’s own private corporate auspices, had proven sufficient to secure FDA approval.

It should have been a major medical scandal, but it wasn’t.  To this day the FDA has never really explained how this might have occurred.  But it probably didn’t hurt that Otsuka had decided to partner with Bristol Meyer-Squibb, an American pharmaceutical giant with enormous lobbying influence, to promote its new product in the US market.

Still, there was a fall-out, mainly from physicians who refused to prescribe Abilify.  And that’s basically how Rexulti got on the market.  Otsuka, without accepting blame for the way it had foisted Abilify on consumers, set about creating a new and improved version of the drug, promising much the same results.

Is Rexulti working?  No one knows, not yet at least, but that hasn’t kept Otsuka from aggressively promoting the drug everywhere.  Those ads on late night TV run continuously, often 3-4 every hours, hammering home the message that there is fresh relief for depression sufferers

Amazingly, the ads for Rexalti are not shy about listing possible side effects.  There are relatively minor annoyances like nausea, constipation and a stuffy nose, but there are others, such as “weight gain,” “distress,” “agitation” and “seizures” that should be cause for concern, especially since they are openly described as “common.”  And there’s also the possibility of heart attacks and strokes, especially among the elderly or those with pre-existing conditions.

It’s a formidable list, and makes any sane person wonder:  Even if Rexulti works, is it really worth the risk?

Another issue is cost.  You can get a free sample of Rexulti, but advertisements don’t tell you that a monthly prescription could cost you anywhere from $600 to $1,000 dollars. Right now, there’s no generic, so Otsuka and its collaborators are poised to rake in big profits.  For a company with such a dubious track record, this hardly seems like consumer protection at its best.

Science has come a long way in its understanding of brain chemistry and depression, but the medical establishment is reluctant to admit that it’s still fumbling around in the dark, experimenting with new drugs, just hoping their drugs will prove effective, while limiting the harm.

Eli Lilly, of course, made billions off of Prozac during the early depression “boom” years of the 1990s.  The Indiana-based pharmaceutical giant promised to make a debilitating disease treatable in new and more effective ways, and in fact, some of the stigma surrounding the disease did begin to subside.

But it’s also helped make Americans more pill-dependent than ever.  You won’t find pharmaceutical companies asking the tough questions about why depression persists – and whether other lifestyle conditions, from diet and exercise to substance abuse, work addiction and a loss of intimacy and community, are partly to blame.   Addressing the issue this way might open up a brand new discussion about the quality of American life and about the deeper changes needed to make ourselves feel truly happy and healthy.

Americans, it seems, want a quick fix for everything.  And the Squibbs and Otsukas of the world, in search of big profits, are here to make sure they get it, regardless of who it may harm.

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