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Tuesday 4 June 2013

Medications: Is Depression Still Profitable?

This spring, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, the DSM-5, has been released amongst a torrent of criticism. Much has been made of various changes to the diagnostic criteria for individual disorders.

But the louder cries have argued that the revision is driven as much – or more – by the wishes of large pharmaceutical firms than by science or public need. With each succeeding revision of the manual, a larger proportion of the population has been diagnosible as having a mental disorder deserving treatment – often a proprietary drug treatment. The range of human experience deemed “normal” has correspondingly shrunk.

Much of the fury in this most recent debate has centred on the diagnosis of depression – particularly Major Depressive Disorder. More on the issue can be found here. This is a familiar battleground, as the field has undergone years of controversy about the effectiveness of the antidepressant medications (see here, here, and here). In a few short decades, this drug class has climbed to the number two position in overall sales, second only to the cholesterol-lowering statin drugs.

These drugs have been immensely profitable for the pharmaceutical industry, and many have questioned whether the profit motive has driven their marketing more than the science underpinning their use. But is the party now winding down?

Medication Development and Patents

It costs a huge amount of money to develop a medication for market. It must go through a series of trials demonstrating its safety and its effectiveness (generally relative to placebo; it need not be shown to be more effective than preparations already on the market). Some drugs get partway through this process and prove to be duds, with the result that the development costs are lost. It’s a risky business.

For a private corporation to bother, there has to be some hope of recovering the development costs (for the successful drug, and for the drugs that never made it to the pharmacy) and making an eventual profit. So the drugs are patented, meaning that the developer has the sole right to produce and market that preparation, and they can pretty well set their own price for it. These patents expire, however, and then other companies can manufacture the same medication, driving the price down markedly through competition.

Once a drug is off patent (generally after 20 years in North America), the profitability is sharply reduced. The motivation to promote the product to physicians and public largely evaporates. (This is why drugs advertised for years as miracle cures suddenly vanish from the airwaves.) A company that has two medications in the same class (two antidepressants, for example), one on patent and the other off, will shift most of its promotional budget to the former.

Many pharmaceutical companies have only a few real “blockbuster” drugs, so the looming expiry of a patent on one of their main moneymakers is ominous. For example, a 2012 article in U.S. Pharmacist estimated that the sales of the antidepressant Lexapro amounted to 59% of the overall sales for Forest Laboratories. The major firms survive by having a pipeline of new drugs (which will have new patents) on the way.

You can see the problem. What if a new drug class is developed, the various companies all go out and make minor variations on these, they promote the medications (and public awareness of the disorders they treat), and then the pipeline dries up, with no new preparations arriving on the market? The high profits associated with the patented medications will vanish with the patent expirations and not be replaced.

What about antidepressants?

This is the situation in which the industry finds itself in the case of antidepressants. In the 1950s there were no antidepressant medications. Then the tricyclic antidepressants came out and rapidly gained a foothold in the market. In the 1980s the selective serotonin reuptake inhibitors (SSRIs: Prozac, Luvox, Paxil, Zoloft, Celexa) began to appear, then a variety of other variations (such as the serotonin and norepinephine reuptake inhibitors (SNRIs: Effexor, Pristiq) and others (Wellbutrin, Remeron). Just when one drug would go off patent, another would appear.

But the flurry of antidepressant development has passed, and most of the patents have now expired. Take a look at the most widely used antidepressants (most dates are USA expiries):

Prozac (fluoxetine) - patent expired 2001
Paxil (paroxetine) – patent expired 2003
Luvox (fluvoxamine) – patent expired 2000
Zoloft (sertraline) - patent expired 2006
Celexa (also Cipramil; citalopram) – patent expired 2003
Effexor (venlafaxine) – patent expired 2007
Remeron (mirtazapine) - patent expired 2010
Lexapro (also known as Cipralex; escitalopram) - patent expired 2012
Cymbalta (duloxetine) - patent expires June 2013
Wellbutrin (also Zyban; bupropion) – patent expires August 2013
Pristiq (desvenlafaxine, a modification of Effexor) - patent expires 2022

Antidepressants continue to be prescribed at rates that some find alarming and well beyond the range of conditions and severities for which there is adequate research support. But with the reduction in cost associated with patent expiry, the overall dollar value of sales has declined from a peak of $15billion in worldwide sales in 2003 – and shows signs of declining further in the years to come. Thomson Reuters Pharma predicts total sales under $6billion by 2016. This is all coming from price reductions associated with patent expiry, not from a decline in prescriptions for these medications.

For example, Cymbalta, the patent for which expires this month, is presently the #2 selling antidepressant in the United States, with overall worldwide sales of $2.7billion. This revenue will not all vanish, obviously, as the medication will go on being prescribed, but the price will most likely drop by 70% or more, eliminating most of the profits for Eli Lilly and most motivation to promote the drug to the public.

And what’s in the pipeline? Not much, apparently. AstraZenica’s TC-5214 crashed and burned in 2012, and development was halted on both agomelatine and aprepitant. Certainly there isn't anything that anyone is describing as a “game-changer” with markedly greater effectiveness than what we have now.

Will this be good for the depression treatment field? Hard to say. Your thoughts?

Online Course

Is there an alternative to a medication-based approach? If someone takes medication, is there more they can do in order to maximize the effect? Consider seeking the help of a qualified psychotherapist trained in cognitive behaviour therapy.

In addition, our clinic has developed a cognitive behavioral guide to self-care for depression. Though not a substitute for professional face-to-face care, UnDoing Depression may be a useful adjunct to your efforts.  The preview is below. For 50% off the regular fee of $140 USD, use coupon code “changeways70” when you visit our host site, here.

We also have courses for professionals and for the public entitled What Is Depression, What Causes Depression, Diagnosing Depression, Cognitive Behavioral Group Treatment of Depression, How to Buy Happiness, and Breathing Made Easy. For the full list with previews and substantial discounts, visit us at the Courses page of the Changeways Clinic website.

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