Research repeatedly shows that antidepressants give little benefit – but have many side effects

So, slowly, slowly the mainstream media seems to be catching up with what we’ve known for quite a while – the drugs don’t work, we’ve just been told they do.

If you follow this argument to source, then you have to question the drug companies about the way they run their drug trials and the way the way they market their (all too often) sub-standard and dangerous drugs – Glaxo, amongst many others, has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.

This from today’s Independent:

What if the drugs don’t work?

Research repeatedly shows that antidepressants give little benefit – but serious side effects. Yet millions who take them regard them as lifesavers. Markie Robson-Scott reports on the controversy that is dividing psychiatrists.

When my American friend Bill, who’d been on SSRI antidepressants for 22 years (Prozac, followed by Paxil, Lexapro, then Celexa), read a two-part article by Dr Marcia Angell in The New York Review of Books recently about the crisis in psychiatry and the inefficacy of antidepressants, he stopped taking his meds (tapering off gradually, monitored by his doctor). “The article brought on enough doubt to push me over,” he said. Since then, his moods have become more volatile – more anger, more emotion, such as crying at the end of the last Harry Potter film (he’s in his 50s). But he’s got his libido back after years of “muffled response” and that seems a worthwhile trade-off.

Instead of listening to Prozac, have we been listening to placebo all along? Research repeatedly appears to show that: antidepressants are little more than placebos, with very little therapeutic benefit but serious side-effects (70 per cent of people on Celexa and Paxil report sexual dysfunction, and in some, it carries on even when they stop taking the pills). The theory of chemical imbalance as a cause of depression is an unproven hypothesis; and doctors are prescribing the drugs mainly because of the “juggernaut of pharmaceutical promotion”, as the US psychiatrist Dr Daniel Carlat calls it.

It’s not surprising there’s a US media furore – about 10 per cent of Americans over the age of six take antidepressants. In the UK, prescriptions for the drugs went up 43 per cent in the last four years to 23 million a year.

Professor Irving Kirsch, associate director of the programme in placebo studies at Harvard Medical School and author of The Emperor’s New Drugs: Exploding the Antidepressant Myth, says the theory of chemical imbalance – that there is not enough serotonin, norepinephrine and/or dopamine in the brain synapses of depressed people – doesn’t fit the data (lowering serotonin levels in healthy patients has no impact on their moods). Chemical imbalance is a myth, he says. It follows that the idea that “antidepressants can cure depression chemically is simply wrong”. His meta-analysis of 38 clinical studies – 40 per cent of which had been withheld from publication because drug companies didn’t like the results – involving more than 3,000 depressed patients on SSRIs shows that only 25 per cent of the benefit of antidepressant treatment was due to the drugs and that 50 per cent was a placebo effect. “In other words, the placebo effect was twice as large as the drug effect,” though the placebo response was lower in the severely depressed.

This is not quite as damning as it sounds: placebos are extraordinarily powerful and can be “as strong as potent medications”. Placebo response is specific: placebo morphine eases pain, placebo antidepressants relieve depression. It’s a question of expectancy and conditioning: if you expect to feel better, you will, even if you’re getting negative side effects, because side effects, Kirsch says, convince people that they’ve been given a potent drug.

Psychotherapy boosts the placebo effect and is “significantly more effective than medication” for all levels of depression, he says. Antidepressants should only be used “as a last resort and only for the most severely depressed”.

Of course, not everyone agrees. Ian Anderson, Professor at psychiatry at the University of Manchester, who is to debate whether “antidepressants are useful in the treatment of depression” with Kirsch at a conference in Turkey next month, thinks we’re in danger of throwing the baby out with the bathwater when we say antidepressants are rubbish. Antidepressants are part of a doctor’s toolbox, though probably most useful for the most depressed; some people don’t take to talking therapies; it’s not an either/or situation, he says.

Professor Allan Young, chair of psychiatry at Imperial College London, agrees. “Depression is such a huge category of illness – there are multiple types, and each type responds differently.” Of course, the brain and the body are inextricably linked, he says, and placebo effects are greater in the less-severely ill.

To make things more complicated, there’s the nocebo effect. If you expect to feel bad when you come off antidepressants, you will, because “we tend to notice random small negative changes and interpret them as evidence that we are in fact getting worse”, Kirsch says.

Lucy, who was suicidal, took Cipramil (Celexa in the US) on and off for 10 years. She says the drug “gave me back myself, it was like a ray of light shining through fog”, but the side effects – nausea and lost libido among others – forced her off it. Then “it was like a clock ticking, a twitch in the back of my mind. I lived in fear of the depression coming back. The only thing that kept me alive was knowing the pills were there. But was it because I believed I was a depressive so when I had the negative feelings I panicked?”

For Judy, lofepramine, a tricyclic, worked well. “First I was given Prozac, which gave me huge anxiety, like a bad trip, and made me horribly aware of all my nerve-endings. But lofepramine worked from the first day. When I took it in the morning I’d get a chemical lift, like a switch being turned on: it was a fabulous rush of joy.”

She stopped taking it after six months. Several months later, she felt low, though not depressed – “I feel depression like a stone in my solar plexus, and it wasn’t like that. But still I thought it would be nice to have that short-cut to happiness, so I took a lofepramine and it had no effect whatsoever – because I wasn’t really depressed. So to me the placebo theory makes no sense.” Neither does it to Hannah, who took Prozac for 10 years and says “it was absolutely fantastic and saved my life”.

Daniel Carlat, a psychiatrist in Boston and author of Unhinged: The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis says that prescribing is a hit-and-miss affair. “Unfortunately we know a good bit less about what we are doing than you might think,” he writes. “When I find myself using phrases like ‘chemical imbalance’ and ‘serotonin deficiency’, it is usually because I’m trying to convince a reluctant patient to take a medication. Using these words makes their illness seem more biological, taking some of the stigma away.”

Most lay people, he says, don’t realise how little shrinks know about the underpinning of mental illness, though he’s not as convinced as Kirsch about the placebo effect and makes the point that the patients who turn up at his office are different from those recruited into clinical trials because drug companies, desperate to get their product to outperform a placebo, are picky about who they choose.

You have to have “pure” depression, unblemished by alcohol use, anxiety problems, bipolar disorder, suicidal thoughts, mild or long-term depression – which, says Carlat, would exclude most of his patients. Yet, as Marcia Angell, author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, says: “It’s true… but they are the best we have.”

If there’s one thing that’s clear among the contradictions, it’s that the brain remains mysterious. As Carlat says: “Undoubtedly, there are neurobiological and genetic causes for all mental disorders, but they are still beyond our understanding.” All we really know is that depression exists and that sometimes the drugs seem to work – even if it’s a placebo effect.

Antidepressants: the guidelines

* Never stop taking antidepressants without discussing it with your doctor, because abrupt cessation of SSRIs can cause withdrawal symptoms that can be both physical and mental.

* If you do decide to stop, you’ll need to reduce the dose gradually rather than stopping abruptly.

* If you’re happy with your antidepressant and you feel it works for you, then keep on taking it. Regular use is what works: if it ain’t broke, don’t fix it, says Professor Irving Kirsch.

We need to talk about antidepressants

It’s not often that I find myself agreeing with Peter Hitchins (he writes for the Daily Mail in the UK and I imagine we’re poles apart politically). However, the one thing we agree on is the potential danger of antidepressants – SSRIs.

Mr Hitchens has written about SSRIs and their attendant problems in the past and he returns to the subject in his review (hat tip to the Truthman for this) of the upcoming film ‘We need to talk about Kevin’. The movie is about the perpetrator of a High School massacre in a fictional American town.

In the movie it transpires that Kevin had been taking prescribed antidepressants and uses the fact as part of his defence. However, it seems to be to be a great shame that the film lightly dismisses Kevin’s acknowledged use of SSRI drugs as no more than a cheap defence attorney’s get-out.

Hitchins writes: “I’ve mentioned here before (see index) the extraordinary correlation between such killings and SSRI ‘antidepressants’. (Yes, I know correlation isn’t causation. That is precisely why I call repeatedly for a proper investigation into the apparent link). I’ve also mentioned the growing doubts (see index, under ‘antidepressants’)  among doctors about the nature and real effect of these drugs, notably the powerful articles by Dr Marcia Angell, of the Harvard Medical School, recently published in the New York Review of Books.”

I agree – and I believe that antidepressants can cause extreme violence.

All too often in the past, it seemed that the only other people in the world who would ever begin to entertain the possibility were people such as Michael Moore and Dr Peter Breggin in the USA – and in England David Healy, Andrew Herxheimer and David B. Menkes, who co-authored a paper on the subject in 2006 – Antidepressants and Violence: Problems at the Interface of Medicine and Law.

If you want more information, then you can read follow up with these links (or just type ‘Violence’ in the search box on the left of your screen:

What made Raoul Moat do it

Nebraska shooting – antidepressant connection yet again?

Lost in translation – were Anti-Depressants Involved In Finland School Massacre?

A brief history of school shootings

The Finland Massacre

SSRI stories

Antidepressants and violence

There simply has to be a proper investigation into this issue – and I believe that the drug companies (such as Glaxo) know the problem exists, but have done nothing about it as it would have affected their profits.

‘More effective’ antidepressant costs the NHS millions of pounds – Lundbeck accused of rigging ‘independent’ drug trial

A drug company involved in shady dealings? – lying and cheating? – rigging drug trials?

While this won’t come as a surprise to regular readers of Seroxat Secrets, I continue to be amazed by the way that drug companies are still getting away with this kind of lying and cheating – what can we do to make it stop?

Here is the story from today’s Independent

NHS pays millions of pounds more than it needs to for drugs. Many alternatives available for a small fraction of the price

By Melanie Newman and Oliver Wright

The National Health Service is spending almost £25m a year on supplies of an antidepressant drug despite evidence that it has little clinical advantage over an almost identical medication which costs a fraction of the price.

An investigation by the Bureau of Investigative Journalism (BIJ) for The Independent has raised questions about the only independent study to find evidence that the drug, Cipralex, is clinically more effective than its out-of-patent predecessor, Cipramil. Both have a similar main ingredient but Cipralex costs £14.91, while the older Cipramil is available for just £1.31.

Cipralex, or Lexapro, as it is known in the US, is one of the most widely prescribed antidepressants in the world, but has been criticised for being little different from Cipramil, whose patent expired in 2002.

There has only ever been one independent, direct comparative study which suggests that Cipralex is clinically more effective. But the BIJ’s investigation has now established connections between employees of Lundbeck, the Danish company which makes both Cipralex and Cipramil, and Arbacom, a Russian company that sponsored the independent trial which indicated that the new drug worked better than the old one.

That trial helped to make the case for the new drug to clinicians, costing the NHS millions of pounds more in prescription costs. Last year, the health service spent about £3.3m more on Cipralex than on Cipramil, although the older drug was prescribed nine times as often. A paper based on the Arbacom trial, which was published in November 2007 in the medical journal Clinical Therapeutics, acknowledged “Alexander N Postnov and Markus Kornfeld at Arbacom for their help in revising the manuscript”. It appears that Mr Kornfeld may have assisted at the same time that he and his wife, Asa, were working for Lundbeck.

The BIJ has seen an email from Mr Kornfeld, dated August 2005, in which he sent a protocol for the trial to a Russian woman, copied to someone called “Alex”, with a message listing errors in the protocol. In August 2005, Mr Kornfeld was a Lundbeck consultant and his wife was a senior employee.

Mr Kornfeld’s email also forwarded a case-report form. The document’s properties appear to show this was created only two days previously, and had been modified by a different Lundbeck employee. Mr and Mrs Kornfeld no longer work at Lundbeck and neither responded to requests for comment. Anders Gersel Pedersen, Lundbeck’s executive vice-president for drug development, agreed that Mr Kornfeld was a consultant at the time but said nobody at Lundbeck, to the best of the company’s knowledge, had known about the Russian Arbacom trial.

The BIJ was unable to contact anyone from Arbacom, which does not appear to have been named as a sponsor of any published research before or since. The bureau uncovered further connections between Lundbeck and Arbacom. While the Arbacom trial was under way, Lundbeck entered into a research contract for an epilepsy drug with another Russian company.

In 2006 and 2007, when the Cipralex trial was being carried out, Lundbeck negotiated a research contract for an epilepsy treatment, VLB01, with the Russian firm Valexpharm. Documents seen by the bureau attach a value of $2m to the deal. Mr Kornfeld and Alexander Postnov, who were acknowledged in the Clinical Therapeutics paper about the Cipralex trial, were sent the contract. It is not clear who Mr Kornfeld was working for at this time, but Mr Postnov was using his Arbacom email address. Valexpharm appears in some listings at the same address as Arbacom, and Valexpharm appears to have registered Arbacom’s telephone numbers. Another employee apart from Mr Postnov appears to have worked for both firms.

A spokeswoman for Sistema, Valexpharm’s parent company at the time of the trial, denied that Arbacom was related to Sistema in any way.

However, Valexpharm’s current chief executive Alexander Bakhutashvili, a former president of Valexpharm’s immediate parent company Binnopharm, described Arbacom as a “partner generic company”.

Mr Pedersen insisted that there was “absolutely no linkage” between the epilepsy drug contract and Arbacom’s Cipralex trial. He said Arbacom had been trying to prove that Cipralex and Cipramil were identical, with the aim of producing a cheaper version of the former. When the results came out proving the clear superiority of Cipralex, he said, Arbacom offered to sell the data to Lundbeck. “We told them to publish,” Mr Pedersen said. The company ended up paying for Arbacom’s data, he added, but this was its only involvement in the trial. “Regulators prefer studies done by pharmaceutical companies because they are rigorous,” Mr Pedersen said. “There was no reason at all for us to be involved with the Arbacom trial.”

But questions remain over whether Cipralex represents good value for money to the NHS. The drug has been cited as an example of “evergreening” – a strategy manufacturers use to extend the life of a drug patent. When a drug is about to go off-patent, which would allow it to be copied and sold in a cheaper generic form, the company slightly alters the chemical make-up of its drug and files a new patent. This version is then protected and sold as a new drug, although it often contains similar ingredients to the old one.

Cipramil’s patent expired in 2002, at a time when it accounted for 80 per cent of Lundbeck’s revenues. Just before this, Lundbeck released Cipralex on to the market. In an article in the British Medical Journal, a senior cardiologist argued: “When resources are limited, giving one patient an expensive drug with no added value when cheaper alternatives exist stops other patients getting treatments they need.”

Lundbeck rejected suggestions of “evergreening” in the case of Cipramil and Cipralex. “That is simply not the case,” said Mr Pedersen.

A spokeswoman from the Department of Health said: “We are modernising the NHS so we can give patients better access to the medicines they need. That is why we are changing the way drugs are priced to ensure they offer value for money.

“Doctors should be able to focus on what matters most – achieving the best health outcomes for their patient. Value-based pricing will ensure that the price the NHS pays for medicines is based on an assessment of their value, looking at the benefits for the patient, unmet need, therapeutic innovation and benefit to society as a whole.”

www.thebureauinvestigates.com

By way of a postscript here are some stories about GlaxoSmithKline doing similar things with Seroxat trials.

Glaxo has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.

Read more about Seroxat here: More on Paxil and suicide – “Glaxo was aware of this risk, and hid it” and here: Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

And what happens in the UK when the MHRA  undertakes a criminal investigation into Glaxo and the withholding of clinical trial data?… and finds Glaxo guilty…? The answer is nothing happened to Glaxo – nothing at all.

Six and a half years on… and what has the MHRA done to clean up its act?

Nothing is the short answer.

Below are extracts from The House of Commons Select Committee Report of March 2005 on the The Influence of the Pharmaceutical Industry… March 2005 – that’s a long time ago and the UK drugs regulator, the MHRA, has still made none of the changes recommended.

The Select Committee summed up:

“The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements…. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest.”

Download the full report here, in the meantime here are a few choice extracts:

Page 4: The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism.

Page 8: The industry is hugely influential ….Its influence in Parliament is extensive. The Annex lists the All-Party Groups the pharmaceutical industry supports.

Page 4: The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence application business.

Page 5: The Government, like the MHRA, has tended to assume that all is for the best… In view of the failings of the MHRA, we recommend a fundamental review of the organisation

Page 30: The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry

Page 31: The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed.

Page 49: The consent forms do not inform patients that the raw data may be maintained by the industry, not made available to the general public or even reviewed by the regulatory authorities.Much of the criticism was essentially of the lack of transparency and the difficulties for doctors and others in assessing the research which is undertaken.

Page 52: The major impetus for greater transparency with medicines came from a lawsuit brought in August 2004 by the New York State Attorney General against GSK, alleging the company had concealed negative clinical trial results. As part of the settlement, GSK agreed to set up a public register of all clinical trials on all of its drugs.This breached a longstanding
convention, vigorously upheld by the regulators, whereby clinical trial results
were regarded as company property and commercially confidential.

Page 52: Too many problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials.

Page 78: The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it.

Page 79: Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process.239 The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

Page 79: Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; …The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. …Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

Page 79: Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem:

Page 82: In setting up the review of SSRI antidepressants, the MHRA/CSM responded to another long-standing concern about regulatory activity: the possible conflicts of interest of regulators.

Page 83: user reports of often serious problems had been systematically discounted or ignored.

Page 85: In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action: …every time we made difficult decisions there was always this issue of: ‘We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes’; and it was very clear that the MRHA officials were very mindful the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public.

Page 87: Further concerns, relating to the MHRA’s reliance on company summaries of data, rather than raw data are discussed elsewhere.

Page 96: A statement to the effect that heart problems were associated with Celebrex was issued by the MHRA in December 2004. In the statement, the Agency made it clear that it had not seen the actual data from the drug company but that its advice was based on information from Pfizer’s website.

Page 98: The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.

Page 102: Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned.

Page 103: The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI’s report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately.

Page 106: The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.

Page 106: The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements….During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite
competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

Page 117: The MHRA should put in place systematic procedures to randomly audit raw data.

Branding disease – how drug marketing works

This from CNN by Dr. Carl Elliott, an M.D. and Ph.D., who is is the author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine” (Beacon Press, 2010).

If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, “Propaganda,” by Edward Bernays, the father of public relations in America.

For Bernays, the public relations business was less about selling things than about creating the conditions for things to sell themselves. When Bernays was working as a salesman for Mozart pianos, for example, he did not simply place advertisements for pianos in newspapers. That would have been too obvious.

Instead, Bernays persuaded reporters to write about a new trend: Sophisticated people were putting aside a special room in the home for playing music. Once a person had a music room, Bernays believed, he would naturally think of buying a piano. As Bernays wrote, “It will come to him as his own idea.”

Just as Bernays sold pianos by selling the music room, pharmaceutical marketers now sell drugs by selling the diseases that they treat. The buzzword is “disease branding.”

To brand a disease is to shape its public perception in order to make it more palatable to potential patients. Panic disorder, reflux disease, erectile dysfunction, restless legs syndrome, bipolar disorder, overactive bladder, ADHD, premenstrual dysphoric disorder, even clinical depression: All these conditions were once regarded as rare until a marketing campaign transformed the brand.
Once a branded disease has achieved a degree of cultural legitimacy, there is no need to convince anyone that a drug to treat it is necessary. It will come to him as his own idea.

Disease branding works especially well for two kinds of conditions. The first is the shameful condition that can be destigmatized. For instance, when Pharmacia launched Detrol in the late 1990s, the condition the drug treated was known to doctors as “urge incontinence.” Patients called it “accidentally peeing in my pants” and were embarrassed to bring it up with their physicians.
Pharmacia fixed the problem by rebranding the condition as “overactive bladder.” Whereas “incontinence” suggested weakness and was associated mainly with elderly women, the phrase “overactive bladder” evoked a supercharged organ frantically working overtime.

To qualify for a diagnosis of “overactive bladder,” patients did not actually have to lose bladder control.” They simply needed to go to the bathroom a lot.

The vice president of Pharmacia, Neil Wolf, explained the branding strategy in a 2002 presentation called “Positioning Detrol: Creating a Disease.” By creating the disease of “overactive bladder,” Wolf claimed, Pharmacia created a market of 21 million potential patients.

Another good candidate for branding is a condition that can be plausibly portrayed as under-diagnosed. Branding such a condition assures potential patients that they are part of a large and credible community of sufferers. For example, in 1999, the FDA approved the antidepressant Paxil for the treatment of “social anxiety disorder,” a condition previously known as “shyness.”
See more CNN.com opinion articles

In order to convince shy people they had social anxiety disorder, GlaxoSmithKline, the maker of Paxil, hired a PR firm called Cohn and Wolfe. Cohn and Wolfe put together a public awareness campaign called “Imagine being allergic to people,” which was allegedly sponsored by a group called the “Social Anxiety Disorders Coalition.”

GlaxoSmithKline also recruited celebrities like Ricky Williams, the NFL running back, and paid them to give interviews to the press about their own social anxiety disorder. Finally, they hired academic psychiatrists working on social anxiety disorder and sent them out on the lecture circuit in the top 25 media markets.

The results were remarkable. In the two years before Paxil was approved for social anxiety, there were only about 50 references to social anxiety disorder in the press. But in 1999, during the PR campaign, there were over a billion references.

Within two years Paxil had become the seventh most profitable drug in America, and Cohn and Wolfe had picked up an award for the best PR campaign of 1999. Today, social anxiety disorder, far from being rare, is often described as the third most common mental illness in the world.

It is hard to brand a disease without the help of physicians, of course. So drug companies typically recruit academic “thought leaders” to write and speak about any new conditions they are trying to introduce. It also helps if the physicians believe the branded condition is dangerous.

When AstraZeneca introduced Prilosec (and later Nexium) for heartburn, for example, it famously repositioned heartburn as “gastroesophageal reflux disease,” or GERD. But it also commissioned research to demonstrate the devastating consequences of failing to treat it.

If all drugs were harmless, disease branding would be relatively harmless, too. But no drug is completely benign.

Paxil is associated with sexual dysfunction and dependence. It also carries a black-box warning for suicide in children and adolescents.

Side effects like these are a part of the drug that is Paxil. But they are never part of the brand.