The mother of all drug battles

Furious Seasons reports that the US state of Arkansas is suing drug company Johnson and Johnson over claims that they misrepresented the facts over their popular antipsychotic drug risperidone.

This, in itself, is not a new occurrence, as it joins a long list of US state lawsuits against drug companies. With rumours that a similar 26 state joint lawsuit is about to begin, this is an indication that the corporate drug world is about to be shaken up on a grand scale.

Most of the lawsuits are over allegations that drug companies hid or massaged evidence to show that their new generation (‘atypical‘) antipsychotic drugs were more effective or less harmful than is now thought, or that they illegally promoted their drugs for conditions for which they weren’t licensed.

Most of the most popular atypical antipsychotics were introduced in the 1990s and were marketed as having less side-effects than the older generation drugs.

One of the most unpleasant are extrapyramidal side-effects. Caused by changes the dopamine system they can include involuntary movements and muscle stiffness that can resemble Parkinson’s disease in some respects.

However, recent reviews have challenged the idea that the newer drugs have less of these side-effects and other evidence has suggested that they have a higher risk of inducing problems with weight-gain and diabetes.

The marketing was remarkably successful though and the idea that the newer drugs ’cause less side-effects’ still persists. Only this week, a letter published in New Scientist stated that the newer drugs benefited patients because they have fewer side-effects.

Later, marketing shifted to suggesting atypicals were better for the ‘negative symptoms’ of schizophrenia (impaired emotion and motivation), and later still to suggest that they improved cognitive function, largely based on industry funded clinical trials.

Two ongoing independent studies have been key in challenging some of these ideas. The UK’s CUtLASS project and the US’s CATIE project are not funded by drug companies and have found, contrary to industry research, that, for example, newer antipsychotics are no better than the older drugs in improving cognitive function and that they have no advantage in improving quality of life.

Antipsychotics are genuinely useful and probably one of the most significant medical advances of the 20th century. Before then, no effective treatment for psychosis existed.

However, when side-effects appear (which is not always the case), they can range from the unpleasant to the medically serious, so doctors and patients need to be fully informed about the risks.

The most recent lawsuit from the state of Arkansas [pdf] alleges that, among other things, the drug company deliberately rigged their clinical trials to show less side-effects, failed to warn clinicians about the dangers and promoted their drug illegally.

While people like psychiatrist David Healy have been making these allegations for years, the fact that a large number of US states are willing to take the allegations to court signals that we are about to see a huge battle, and hopefully a period of significant reform, in how drug companies develop, test and market their products.

Reform is sorely needed. As well as scientific manipulation, personal drug marketing to psychiatrists is largely based on ensuring a regular supply of lavish gifts and selective information – as detailed by an article in today’s New York Times.

As an aside, if you’re in London this Tuesday, a debate is being held at the Institute of Psychiatry and the Maudsley Hospital on exactly this topic.

It’s entitled “Swallowing it Whole: This house believes that psychiatrists are unable to resist the seductive messages on the pharmaceutical industry” and is likely to be a lively event.

Link to Furious Seasons on the Arkansas law suit.
Link to NYT article ‘Dr Pharma Rep’.
Link to details of the Maudsley debate.

Encephalon 35 and 36 catch up

The psychology and neuroscience writing carnival Encephalon published both its 35th edition and its 36th edition in recent weeks, and I seemed to have slept through these momentous occasions, so hopefully this post will make amends.

Encephalon 35 was hosted at The Primate Diaries and includes articles on, among other things, the neuropsychology of creative thinking and the link between education and Alzheimer’s disease.

Brain in a Vat was the place to be for Encephalon 36 which had many fantastic pieces, including one on embodied cognition and another on the growth of the brain in people diagnosed with ADHD.

That’s just a sample of the large selection of articles submitted to the carnivals, so have a browse through both editions to get a flavour of what’s been hot in the online mind and brain world.

Link to Encephalon 35.
Link to Encephalon 36.

The joy of sexology

The Charlie Rose Show had a recent discussion on the science of sex, and the video of the programme is available to view online. It’s a fascinating discussion, largely focusing on biology and neuroscience, but as Dr Petra Boyton notes it’s quite a narrow consideration in some respects.

For me, simply seeing a discussion of sex research in the still remarkably prudish American media is a huge step.

I suspect their achingly academic approach to the subject reflects the need to be seen to be serious, but it’s also interesting that the Charlie Rose show is sponsored by Pfizer, the makers of Viagra, which may also account for the almost unrelenting focus on biology.

Petra Boynton suggests areas which weren’t tackled by the programme, and highlights that there’s much more to sex research than measuring the mechanisms of our bodies.

It’s well worth watching, but definitely with some of the context in mind.

One of the best programmes on sexuality I have seen on TV was The Truth About Female Desire, which was a collaboration with the Kinsey Institute and involved several women taking part in a number of scientific experiments on female sexuality.

Unfortunately, it doesn’t seem to be available on public servers, but I’ll post on Mind Hacks if ever I find a reliable torrent.

Link to Charlie Rose discussion on Human Sexuality.
Link to Petra Boynton on the programme.

Brave old world: the future of cognitive enhancement

The British Medical Association has just released a report on the ethics of using medical technology to increase cognitive function and optimise the brain. Although the report looks to possible futures, many of them are already upon us.

The report is an interesting sign that cognitive enhancement, using largely physical interventions such as drugs and implants, is now a topic important enough to trouble the UK’s professional medical association.

Many of the ethical concerns centre around a potential future where brain enhancing interventions are largely available to the wealthy, leading to a ‘brain gap’ where the less well off will have relatively poorer mental functioning because they can’t access the same cognitive benefits.

However, this is exactly the situation we already have.

Probably the single best cognitive enhancer available to the human race at the moment is a balanced diet and healthy lifestyle.

Poor health goes hand in hand with poverty, meaning those who have less money are likely to have brains that don’t function at their optimum because of increased stress, poor nutrition and increased susceptibility to damage and disease.

Martha Farah’s research group has been specifically researching the links between the neuropsychological development of children and poverty, and have found that children from poorer social groups have markedly poorer mental and neurological functioning.

It is possible that a drug or implant will be discovered in the future that will extend our abilities by an order of magnitude, but more likely the improvement will be much more modest. For example, an improvement of 10% would be considered to be clinically important.

So while it’s essential to consider the ethical implications of how specific cognitive technologies will affect us, the inequality-driven ‘brain gap’ is already here.

One ethical issue less commonly debated is whether we are justified in spending billions developing high-tech cognitive enhancers for a relatively small section of the population rather than support the widespread improvement in nutrition and lifestyle which we know has a strong, reliable and life-long effect.

Link to BMA report ‘Boosting your brainpower: Ethical aspects of cognitive enhancements’.

2007-11-23 Spike activity

Quick links from the past week in mind and brain news:

Glamour model Daisy Thompson-Lake has a forthcoming paper on synaesthesia in the British Journal of Psychology.

Cognitive Daily looks at whether selfishness or competition is the strongest influence on behaviour.

How does physical stress and illness affect mental states and psychopathology? ABC All in the Mind investigates.

PsyBlog examines recent research on achieving sustainable happiness.

Hollywood actor Forest Whittaker hails the pioneering brain surgeon that saved his mother’s life.

ABC Radio National’s Ockham’s Razor looks at the infamous case of Sir Roy Meadow and the debates over the existence of ‘Munchhausen’s syndrome by proxy’.

The New York Times has an article on South Korean boot camps to cure children of non-existent internet addiction.

Denial and public belief. ABC News covers research showing that highlighting false reports may actually make them more widely believed.

The BPS Research Digest looks at research on why sexism towards females in the workplace has a negative effect on males too.

Interesting post on Action Potential shock! The under-performing Nature blog has two great articles on the genetic control of intelligence and innate social evaluation in children.

The last of the neuromercials?

One of the most interesting things about the recent election brain scan nonsense is not that it got to the front page of The New York Times, as that’s happened several times before, but that the slap down from the scientific community has been remarkably strong and public.

The media is obsessed by neuroscience but in a very odd way. This means that sometimes complete nonsense gets published, like on this occasion, or the focus is on the least important thing.

For example, there have been many reports during the last few days about a study on people with migraines.

Almost all the headlines are variants of the ‘Migraine Sufferers Have Different Brains’ line. This just isn’t news. We know migraine sufferers have different brains because they have migraines and its a brain difference. It’s like reporting that ‘taller people have different heights’.

What the study actually found was that the somatosensory cortex, an area of the brain that is involved with representing body sensation, is thicker in people with migraines. Most interestingly, this was most pronounced in the section of this brain area that maps to the head and neck.

It was a correlational study, so it’s impossible to say whether these differences cause, or are caused by, migraine, but it’s a fascinating finding. Isn’t this so this much more interesting than repeating the obvious?

The media love stories about the brain because they often sound like explanations even when they’re nothing more than descriptions.

This is why nonsense like the ‘election brain scans’ gets media attention. In this case, it wasn’t even as if the ideas were distorted in the retelling, it was clearly nonsense from beginning to end. But because it had all the trappings of science, it made headlines.

This time, however, the size of the backlash from the scientific has been unprecedented.

It got plenty of negative attention in the blogs, but it also inspired a list of leading neuroscientists to write to the NYT to criticise it, it got featured in The Guardian’s ‘Bad Science’ column and has just been roundly condemned in the editorial from this week’s Nature.

If brain scans could really predict how people will react when they encounter advertising, you’d think that FKF Research would use it on their own material.

Ironically, for a company that supposedly specialises in neuromarketing, they just got themselves some incredibly bad press.

Link to Nature editorial.

Sad, mad or dangerous to diagnose?

The New York Review of Books has a wonderful article that ostensibly reviews three books about mental illness but is also a powerful summary of some of the most important criticisms of modern psychiatry.

One of the key points of debate is the extent to which distressing yet common mental states such as shyness or feeling low are being classified as mental illnesses such as social phobia or depression.

This is currently a hot topic. The British Medical Journal hosted a recent debate on whether depression is overdiagnosed with Ian Hickie arguing that it needs to be recognised more widely to stop people missing out on lifesaving treatment and Gordon Parker arguing that normal sadness is being excessively labelled as a medical disorder.

Drug companies have an obvious interest in getting more people diagnosed, but less obviously, although equally as pervasive, is their interest in pushing for new diagnoses.

On the level of the individual patient, medicalising a problem often shifts people’s thinking so they feel less empowered to make a difference to their lives – it becomes an illness to be dealt with by medical experts.

In the US, however, where insurance payments are often only guaranteed when a medical diagnosis is made, people might only be able to get relief from their mental distress if their problem is medicalised.

Unlike in socialised health systems, insurance-based healthcare can pressure professionals not to help people with non-specific or difficult to diagnose problems, meaning the existing categories are often stretched to allow such people to be treated.

Treatment has traditionally been medication, which means drug companies have a strong financial incentive to push for the changes to the classification of mental illness and promote theories which best support their treatments.

In contrast, cognitive behavioural therapy, a type of psychological therapy, is known to be as effective as drugs (the most effective treatment is both medication and therapy), and is better at preventing relapse.

However, because it isn’t a ‘product’, there is no corporate marketing machine behind it, meaning it is typically under-recognised and under-used.

The ‘promotion’ of psychological therapies is left to mental health charities (such as the recent We Need to Talk campaign) which pales in comparison to the billions spent by drug companies.

So, the extent to which mental and emotional distress should be treated as a medical disorder effects everything from the personal to the political.

The New York Review of Books article does a fantastic job of covering how these processes work, both at the medical and corporate level, and how they impact on our individual health care.

Link to article ‘Talking Back to Prozac’ (via MeFi).