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Thursday 19 February 2015

Over the Falls Without a Barrel: The Patent Cliff and Prescriber Impartiality

The sound is deafening.
Imagine calling up your old college friend Science and asking her advice. She speaks softly, hesitantly, and with frequent caveats. You strain to hear what she says, but there’s a problem.

It’s a party line.

While you try to hear Science speak, two boisterous rowdies named Marketing are shouting at you, all but drowning her out. They butt in, answering your questions before she gets a chance, claiming to speak on her behalf. It’s tempting to give up and listen to them instead.

This is the situation for any prescriber. “Science” is out there, murmuring in the distance, while the boys from Marketing giggle, whoop, and exclaim in an attempt to attract attention. They sound like 15-year-old boys, and their understanding of Science is about as deep. There is a light at the end of the tunnel, however. At 16, they get bounced off the line.

Umm, what? A Primer on Drug Development.

When a pharmaceutical company discovers a potential new drug, they undertake a mammoth project designed to assess a) whether it really works, and b) whether the risks and side effects outweigh the benefits. The aim is to amass sufficient evidence that the Food and Drug Administration (in the USA) or other national organizations (such as Health Canada in, you know, Canada) will approve the sale of the drug and the type of disorders for which it can be openly prescribed – the so-called “on-label” uses.

The process of gaining approval generally takes 5 to 8 years and can cost from several hundred million to more than a billion dollars. The figures vary widely, in part depending on whether one includes the cost of researching drugs that don’t ever make it to market. For every drug eventually approved, there are four to ten that start human trials and don’t wind up on the pharmacy shelf. So the true cost of development is not just the enormous cost of the trials for successful Drug A, but also the costs of failures B, C, D, E, and F. During the development period, the company is bleeding money and can only get it back once the drug is available in the marketplace.

In order to encourage companies to undertake this risk, governments place a pot of gold at the end of the rainbow. This is patent protection. The company that develops the drug has the exclusive right to produce and market it – in effect, achieving a monopoly on that medication. They can set the price to reflect not only the cost of producing the drug, but also to repay the cost of drug development and testing. If they have a “blockbuster drug” – one that becomes a major seller – they can also make huge profits.

The problem with this system is that patients and governments wind up paying enormous prices for the drug. The solution is to impose limits on patent protection – after which rival companies can produce generic versions of the same drug. Generics companies don’t have the same development costs, and so they price their versions much lower, which the original developers are forced to come close to matching. So when a drug goes off patent, the price drops sharply (often by over 80%) and the advantage to the original developer vanishes.

The period of patent protection is typically 20 years from the date of initial filing of the request. Given the delays in the approval process, the actual period during which a company can market the drug exclusively varies, but is usually around 15 years.

The result is that FDA approval essentially fires the starting gun on a race to recoup development costs and turn a profit. The finish line is the end of patent – often called the patent cliff.

The Expensive Elephant in the Room

There’s one bit of accounting that’s often left off these sketched reviews of the process, and that’s the cost of marketing the drug once it has been approved. Most accounts indicate that pharmaceutical companies spend at least as much on marketing as they do on drug development research. One account (below) suggests the figure is almost twice as high for marketing.

Well, fine. What’s the point of developing a new treatment if no one finds out about it and patients go untreated?

The marketing costs do not include the means by which prescribers are alleged to receive their knowledge about practice: reading journal articles. Here’s an estimate of total costs from Gagnon & Lexchin (2008) – all figures in billions of US dollars:

  • Samples (the provision of free packages of medication to prescribers, who can offer them to patients in the office to get them started, after which they will continue on paid prescription): $15.9 b.
  • Detailing (essentially, visits by sales representatives to physician offices, plus the provision of pamphlets, swag, and related products): $20.4 b
  • Direct to consumer advertising (advertisements in newspapers, magazine, television, and internet that is directed to the general public rather than to healthcare providers, often with the advice to “ask your doctor”): $4 b
  • Sponsorships, displays, and the provision of speakers to professional meetings: $2 b.
  • E-promotion & mailings (generally to prescribers), promotion-related post-approval clinical trials: $0.3 b
  • Journal advertising (advertisements in publications aimed at professionals): $0.5 b
  • Unmonitored promotion (estimated; includes amounts that do not appear in other categories including promotion to unmonitored physicians or in unmonitored journals and miscellaneous other marketing strategies): $14.4 b 

Of particular note here for the nonprescriber is the contrast between the amount for direct to consumer advertising (the seemingly ubiquitous and presumably expensive “ask your doctor” ads) at $4 billion, and the marketing to physicians, a much smaller group of people, at a cost 5 times as great at $20.4 billion.

One might be tempted to wonder how the firms can possibly spend so much money marketing to prescribers. Imagine that instead of producing television ads they sent the salesperson directly to your home to act out the advert in person – while making you lunch and providing golfing fees.

But all this ends?

Once a medication “goes off the patent cliff,” profits decline precipitously and the motivation to promote the med to physicians and the public decline as a consequence. The drop can have a major impact on a pharmaceutical firm – just search using the terms “antidepressant patent cliff” to turn up a variety of business analyses like this one:

Let’s take a look at the names and patent expiration dates of some of the most well-known antidepressants.

  • Prozac (fluoxetine), 2001
  • Paxil (paroxetine), 2003
  • Zoloft (sertraline), 2006
  • Remeron (mirtazapine), 2010
  • Effexor XR (venlafaxine), 2011
  • Lexapro, Cipralex (escitalopram), 2012
  • Cymbalta (duloxetine), 2013
  • Wellbutrin (bupropion), 2013
  • Pristiq (desvenlafaxine), 2022 – of note, desvenlafaxine is marginally different from Effexor and is often regarded as little more than a patent extender on Effexor.
  • Viibryd (vilazodone), 2022

Overall dollar sales figures for antidepressants have tended to fall as the medications have gone over the patent cliff. Revenue for antidepressants peaked at about $15 billion per year in 2003, and is projected to decline to $6 billion in 2016. Depression, once a major money-maker for pharmaceutical corporations, is fading as a revenue opportunity.

Why is this important?

Remember our party line? The marketing rowdies drowning out our friend Science get laid off when their drugs go off patent. The drugs are still around, but the distorting influence of their promotional activities (disguised as science) largely end. The air clears, and our prescriber is left undisturbed to examine the literature once more.

Of course, this doesn’t solve all the problems. Prescribers are likely still to have received most of their psychopharmacology education from the marketing team. And having been subjected to endless lectures about the wonders of various drugs, they may feel that they already understand the scientific backing and neglect to look again. As well, most of the articles in the scientific journals are funded and written by (guess who!) the pharmaceutical companies themselves, and there has been a marked publication bias favoring positive studies over negative ones.

Nevertheless, the end of patent means fewer free samples, fewer visits from pharmaceutical reps, fewer paid lunches, fewer “opinion leaders” making the rounds showing the companies’ own slides, fewer conference symposia lavishly funded by patent owners, and less general noise distorting the environment. Medical decision-making is likely to be based at least somewhat more on science than on enthusiasm and hoopla.

What about newer antidepressants?

There are still a few preparations on patent, and in the past there have always been new medications coming online. Once Prozac went off patent, everyone finally shut up about it and more profitable medications picked up the baton and continued the charade. Won’t that continue?

Well, that’s the thing.

The pipeline is just about empty. Some firms have given up on depression, and in the past few years a variety of preparations have bitten the dust before reaching the approval stage. There is a noticeable lack of enthusiasm about upcoming products, though the few that remain on patent will doubtless be promoted to death. So there will still be some rowdies on the line trying to drown out science, but there will be fewer of them and they seem to have become somewhat muted. Not even the pharmaceutical reps seem able to muster much enthusiasm for the newer products, and the usual claims of “revolutionary advances” are not being heard.

So, Science. It’s been a while. At last we’re (almost) alone. Whisper your ambivalence. We can finally hear you.


Gagnon M-A, Lexchin J (2008) The cost of pushing pills: A new estimate of pharmaceutical promotion expenditures in the United States. PLoS Med 5(1): e1. doi:10.1371/journal.pmed.0050001

York University. "Big Pharma Spends More On Advertising Than Research And Development, Study Finds." ScienceDaily. ScienceDaily, 7 January 2008. <>.

Thursday 5 February 2015

In Praise of the Nervous Breakdown

Perhaps not beyond repair.
Even the most level-headed individual can be rendered insufferable by taking an introductory psychology class. Suddenly the neophyte student will become an arrogant expert, deriding the ignorance of friends, family, and dinner companions.

The use of the term “nervous breakdown” is a case in point. Uttering the words is a bit like blowing a dog whistle: Intro Psychology graduates will converge from miles around to clarify that there is no such thing.

In this case, however, the phenomenon is not restricted to sophomores. Mental health professionals of every stripe will nod in agreement. Nerves don’t spontaneously break or, if they do, they don’t cause the most common forms of mental distress. The term does not appear in the DSM-5 nor, for that matter, in DSMs I through IV. Doesn’t exist; never did.

Pay attention to the people so corrected, however. They respond with bemused tolerance or finger-tapping impatience, but seldom with gratitude or thanks at being better informed. In discussing their (or their family member’s) nervous breakdown, they were not asserting an etiology of distress, nor providing a psychiatric diagnosis.

Instead, they were describing a period of time during which the sufferer became less capable of managing the vicissitudes of life and instead withdrew inward while experiencing some form of psychological pain. The emotional tone may have been characterized more by anxiety, or depression, or embitterment. They may or may not have exhibited transient psychotic symptoms. Perhaps they were hospitalized; perhaps not.

From Nervous Breakdown to the 21st Century

“Nervous breakdown” became an informal way of describing transient psychological difficulty early in the 20th century (Barke, Fribush, & Stearns, 2000), and persisted (with peaks and valleys) to its end. It was the preferred term in familial gossip about others, and it was often the way that people would describe their own mental blips – when they weren’t calling them “crack-ups” (as F. Scott Fitzgerald did in his 1936 essay about his own experience).

Today there have been enough students of psychology (and public education by experts) that the term has faded somewhat, though we continue to hear of celebrities being hospitalized for mysterious “nervous exhaustion” (or the abbreviated “exhaustion”) – likewise a term never to be found in any diagnostic manual. Try going up to triage nurses in a busy emergency ward and saying "I'm exhausted." Watch their expression.

Instead, we hear about depression – often, about how it is a chronic and relapsing illness caused by mysterious and never-named (or, umm, found) biochemical imbalances. We understand that mental distress is “an illness like any other illness,” though the people who say this would be hard pressed to define the essential characteristics of an “illness,” so this becomes a bit meaningless. We subdivide anxiety into half a dozen primary “anxiety disorders” to be distinguished from depression, anger, disillusionment, grief, and other difficult emotions by ... by ... well, by a belief system that is impolite to describe as more theological than scientific.

In the process we have created a bogus corpus of common knowledge that exceeds that known by those who have actually read the literature or examined the data. We have also learned to characterize someone who has had episodes of difficulty as being forever defined by their least functional period. Thus, a person who has once experienced a major depressive episode qualifies, from that moment until death, as having Major Depressive Disorder. People are defined by their pathologies more than by their recoveries.

Recent controversies over the development of the DSM-5, as well as the failure of some etiologic theories of disorder (like the monoamine hypothesis for depression), have tarnished the image of formal diagnosis somewhat. Many of us in the field wonder if our diagnostic attempts have been more pathologizing than enlightening or helpful.

In this atmosphere, maybe it’s time we dusted some older ideas off the shelf for a second look. We could do worse than to start with “nervous breakdown.”

What’s so good about nervous breakdowns?

Consider the similarities between nervous breakdown and skin breakdown.

When I was younger I spent some time working in a rehabilitation hospital for people who had suffered spinal injuries. The nerve damage would often prevent clients from perceiving the normal discomfort that might formerly have prompted them to shift positions. As a result, unless they were mindful they would sit in the same position for hours and develop pressure sores – essentially the breakdown of skin and subcutaneous tissue. These would have to be carefully managed but would eventually heal.

So the characteristics of skin breakdown are:

  1. A reduction of functioning in a certain system (in this case, skin), 
  2. Caused by external stimuli (like a poorly padded wheelchair), plus 
  3. Inattention to self-care (like timed posture adjustments whether one feels uncomfortable or not), which is
  4. Expectable in normal individuals (they do not reveal that one was born with defective skin), and are
  5. Manageable or treatable, and 
  6. Once resolved is no longer called a skin breakdown (because the skin has healed), and 
  7. Serves as a reminder that one may be at risk of this problem (having had it before) and may need to engage in closer self-care in future.

All of these are useful ideas in the case of most psychological conditions. If we transfer the concepts to, let’s say, depressive episodes, we have:

  1. A reduction in behavioral or emotional coping or functioning,
  2. Typically brought on in part by external events (losses, work stresses, role conflicts, relationship issues), plus
  3. A disruption or deficit in self-care (exercise, diet, sleep factors, the role of social contact, making personally meaningful activity a priority). These are
  4. Expectable in normal individuals (meaning that they do not require evidence of a biological defect in advance of the development of the disorder and do not provide evidence that one is a defective human being), and are
  5. Manageable and treatable (most depressive episodes are self-resolving and most can be resolved more quickly with coaching to enhance self-care and life balance using behavioral activation – and sometimes medication), and
  6. Once resolved should no longer be called depression (any more that a person recovered from a bout with flu should be defined as a “flu sufferer”), and
  7. Can serve as a reminder that one may be at risk of a recurrence (having once had the problem may indicate or produce a higher susceptibility of the problem in future, therefore mandating closer attention to self-care in the future).

Although one could easily quibble with a few points, this perspective is considerably more useful and in accord with the data (at least for most people in depression) than the disease model that the mental health system attempts to impose instead.

The Key Distinctions

For me, the most important differences between the current model of disorder and the “nervous breakdown" idea are (at the risk of some repetition of the above):

Episodic nature. One says “I had a nervous breakdown” rather than “I am a nervous breakdown” or “I have nervous breakdown disorder, even though right now I feel fine.” It was an event, not a characteristic of the person. It does not define them.

Symptomatic Vagueness. The term allows the user to disclose a period of psychological distress without necessarily revealing all of the intimate details. Critics may complain that this lacks the specificity of formal diagnosis, but formal diagnosis is often useful only insofar as it guides treatment selection – which current diagnostic methods do remarkably poorly. In any case, no one is suggesting that the entire diagnostic system be replaced by a pamphlet with the words “nervous breakdown” on it.

Trigger-Based. When people talk about nervous breakdowns they tend to focus on the factors that brought them about. “I was under enormous pressures at work, I had a health scare, and my spouse left me.” This is in accord with the data on most psychiatric conditions – they tend not to appear out of the blue. By contrast, the dominant model most clients are presented with is defect-based and noncontextual. “It’s just a biochemical imbalance, it could have happened at any time and had little to do with your life.”

Nonsensical. The strained smiles of those who are informed that “nerves don’t break” tells the tale. Most people understand that the words in the term “nervous breakdown” are the product of heritage, not science, and are not intended to be taken literally, any more than the terms “radical conservative” or “viral meme.” At best, all of these are metaphorical or allusive in nature. The disorder-based terms we currently use, on the other hand, bring with them unhelpful and often inaccurate baggage.

Recoverable. Once diagnosed with depression, people are defined as suffering from Major Depressive Disorder and are frequently informed that they must be in some form of treatment henceforward, even if they appear to be symptom-free. The evidence for the benefit of ongoing post-episode treatment is poor. Nervous breakdowns are typically viewed, by their episodic nature, as events that are resolvable – perhaps with rest, a reduction in stress, or a systematic reworking of one’s life circumstances.

Recurrence-Aware. The nervous breakdown idea acknowledges that most episodes of mental distress can be expected to resolve quite well with good inter-episode recovery. (The evidence appears to be accumulating that depression became a more-frequently chronic disorder with the onset of chronic treatment.) But it also allows that a person may be more vulnerable to such episodes than others, therefore meriting greater vigilance for stress, lifestyle imbalance, and early warning signs of destabilization.

The Capacity/Stress Model

Perhaps best of all, the nervous breakdown idea hints at the notion of a “breaking point” and at the interaction between the person and the environment in a way that seems to fit with evolving conceptions of distress episodes.

Put simply, people appear to have a capacity for processing demands, stresses, and losses imposed on them by their environment. If they challenge themselves gently and allocate sufficient resources to self-management (getting adequate sleep, leisure, exercise, a proper diet, and so on – the need for which may vary based on individual factors), then they are generally able to cope with these demands. Further, their capacity may gradually increase over time – just as exercising with increasing weights may result in greater muscle capacity, within limits.

When circumstances overload a person or crowd out self-care, the processing capacity appears to shrink. What once was a manageable level of demand now exceeds the person’s ability to cope, driving coping abilities lower still. Thoughts and behavior may become disorganized and chaotic as the person thrashes away at their circumstances or retreats inward from a sense of defeat.

The “breaking of nerve” is not a literal event, but a decline in the person’s ability to manage things at their former level. Recovery typically involves rest, a rethinking of the circumstances that led to the collapse, and the gradual reintroduction of elements of the person’s life (perhaps with pharmacological assistance along the way).


I am not arguing for the wholesale abandonment of diagnostic specificity, nor the blending of all distress episodes into a single term. Clearly there is some usefulness (at least to the care team) in knowing whether a person’s contact with reality has been lost, or whether anxiety or despair predominate, or whether suicidality is present. But these important aspects are typically found in the case description rather than in the diagnostic label in any case.

Certainly there are people in whom a biological predisposition to episodes of distress or decompensation is a major factor. Certainly there are people for whom a purely medical approach is necessary or more helpful than a nonmedical one. And certainly there are individuals whose illnesses will prove chronic rather than episodic.

But to suggest that the idea of nervous (or “mental”) breakdown is necessarily a more primitive concept than the inaccurate or faux-precise diagnostic categories with which we currently diagnose people seems false. If we look at the utility to the sufferer, I suspect that the older and less formalized perspective may be superior.

If only we could get psychology students to agree.


Barke, M, Fribush, R, & Stearns, PN (2000). Nervous breakdown in 20th-century American culture. Journal of Social History, 33, 565-584.

Carey, B (2010). On the verge of “vital exhaustion”? New York Times, June 1.

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