Archive for the ‘Pharmaceuticals’ Category

Has Psychiatry just become a marketing tool for pills?

March 2, 2014

I have always been uncomfortable with the readiness to “medicalise” all behavioural issues. Where parents or teachers or social workers and others charged with teaching behavioural skills can easily find an excuse for their failures. Because a behavioural problem has been classified as a medical problem. Nearly always leading to the use of medication.  There seems to be an unholy alliance between the psychiatry industry and the pharmaceutical industry.

The Psychiatry Bible (DSM 5) has seemed to me to be nothing but a Marketing Brochure for the pharmaceutical companies where

The drug companies pay eminent professors, university officials and teaching hospital chairmen millions ‘in personal income’ to concoct more and more abnormalities so that more and more pills can be dished out by GPs and specialists. 

They pocket consultancy fees to attend conferences, give marketing lectures and endorse useless tablets. They are bribed, in essence, not to openly criticise the pharmaceutical industry.

.. people are led to believe they have ‘a problem in their brain’ if they drink too much coffee (‘caffeine-related disorders’), stutter or swear (‘language disorders’), are shy or reserved (‘social phobias’), suffer period pains, are too fat or too thin, feel irritable, sexy, unsexy, sleepless, tired, or experience grief for more than two weeks after the death of a loved one. By these means, 26.2  per cent of all American adults suffer from a disorder of some sort, requiring that it be ‘pharmacologically treated’. Though psychiatric research is by all accounts ‘a hodgepodge, scattered, inconsistent and ambiguous’, one thing has definitely emerged – that anti-depressants don’t work. Extensive trials have shown that placebos induce as much of a degree of uplift as Prozac, Seroxet or any of the other wonder drugs, which simply make patients feel numb, glassy and emotionally disengaged.

Now it seems Dyslexia does not really exist

Now comes The Dyslexia Debate, published yesterday, a rigorous study of this alleged ailment by two distinguished academics – Professor Julian  Elliott of Durham University, and Professor Elena Grigorenko of Yale University.

Their book makes several points. There is no clear definition of what ‘dyslexia’ is. There is no objective diagnosis of it. Nobody can agree on how many people suffer from it. The widespread belief that it is linked with high intelligence does not stand up to analysis.

And, as Parliament’s Select Committee on Science and Technology said in 2009: ‘There is no convincing evidence  that if a child with dyslexia is not labelled as dyslexic, but receives full support for his or her reading difficulty, that the child will do any worse than a child who is labelled dyslexic and then receives special help.’

 This is because both are given exactly the same treatment. But as the book’s authors say: ‘Being labelled dyslexic can be perceived as desirable for many reasons.’ These include extra resources and extra time in exams. And then there’s the hope that it will ‘reduce the shame and embarrassment that are often the consequence of literacy difficulties. It may help exculpate the child, parents and teachers from any perceived sense of responsibility’.

I think that last point is the decisive one and the reason for the beetroot-faced fury that greets any critic of ‘dyslexia’ (and will probably greet this book and article). If it’s really a disease, it’s nobody’s fault. But it is somebody’s fault. For the book also describes the furious resistance, among teachers,  to proven methods of teaching children to read. Such methods have been advocated by  experts since Rudolf Flesch wrote his devastating book Why Johnny Can’t Read almost 60 years ago.

It was not so long ago that James Davies addressed the ills of Psychiatry in his book “Cracked: Why Psychiatry is Doing More Harm Than Good” and Richard Saul published his book “ADHD Does Not Exist” criticising the over-diagnosis of ADHD. Richard Saul writes in the New Republic:

The stimulants most often prescribed for ADHD represent several different types of agents that help control attention and behavior. These include methylphenidate (like Ritalin and Concerta) and mixed salt amphetamines (like Adderall and Vyvanse). Each of these has a specific effect on the body’s neurotransmitters, or the chemical compounds that help transmit signals within the nervous system. The exact mechanisms by which these chemicals interact are very complex, but essentially, if levels of these chemicals are too low or their activity is blocked, the transmission of messages within the nervous system decreases, corresponding to a state of inattention or impulsivity. Specific medications aimed at targeting attention-deficit and hyperactivity symptoms help increase levels of neurotransmitters and their activity. For example, methylphenidate-based medications like Ritalin increase the activity of the neurotransmitters dopamine and noradrenaline in the parts of the brain that help to control attention and behavior. Adderall also increases dopamine’s effects, but in a more gradual way than Ritalin and similar agents do.

So let’s back up a moment. If stimulants can increase one’s attention span and reduce impulsivity, why shouldn’t we use them? Furthermore, even if we’re masking another underlying condition, aren’t we at least solving the problems of inattention and impulsivity in the patient? The answer to both of these questions is a resounding NO. While stimulants can help people with a variety of symptoms in the short term, they have multiple damaging effects in the short- and long-term. The most common short-term side effects associated with stimulants involve overstimulation, such as loss of appetite and sleep disturbance, but perhaps more troubling are the longer-term effects of stimulant use, which include unhealthy weight loss, poor concentration and memory, and even reduced life expectancy in some cases. Long-term, patients also face the development of tolerance, which exacerbates these side-effects. After a while, the body adjusts its natural production of these same chemicals in the brain, and the temporary improvements in attention and behavior begin to disappear. This is why we see doctors prescribing higher and higher doses of the stimulant to achieve the same effect in the patient as time wears on—a dangerous pattern.

Medicalising behavioural issues or blaming genetic causes for behavioural lapses is a cop-out. Both for the offending individual and for those who ought to be helping the individual to modify his behaviour.

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Pfizer writes off $725 million – were they a victim of scientific fraud?

January 20, 2014

Whether it is just error or bad judgement or fraud we will never know. Perhaps all three.

NewsObserver: In 2008, Pfizer paid $725 million for the rights to a Russian cold medicine called Dimebon. The pharmaceutical giant thought the drug could help ameliorate the symptoms of Alzheimer’s. Several clinical trials showed the medicine had no more impact than a placebo. Pfizer has largely abandoned the project.

Earlier this week came the news that Pfizer have now written off the entire $725 million.

The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation.

It is not only Pfizer which has been forced to make costly write-offs. Not long ago  GlaxoSmithKline was forced to shut down Sirtris Pharmaceuticals which it had acquired in 2008 for $720 million:

Xconomy:

Glaxo paid $720 million to acquire Sirtris in April 2008, to get ahold of technology that generated lots of breathless media coverage as a modern-day fountain of youth. The company sought to make drugs that act on sirtuins, a class of proteins that scientists believe play a role in aging, programmed cell death, and other key cell processes.

Even though the company is closing the Sirtris site, Stubbee says Glaxo remains confident in the drug candidates it got from that acquisition. ….

…. Sirtuins are known to be active when the body is in a calorie-restricted state, which scientists have shown contributes to longer lifespan. The idea at Sirtris was to make small-molecule chemical compounds that activated sirtuins as a way of fighting diseases that develop as people age—including Type 2 diabetes and cancer. ….. The research into the biological role of sirtuins, from Sirtris co-founder David Sinclair, has attracted its share of skeptics. Just last week, Sinclair, a researcher at Harvard Medical School, sought to buttress his early work with a new article in Science that says resveratrol and related compounds can activate sirtuins. One critic, quoted by the Boston Globe last week, said the role of one sirtuin called SIRT1 in aging, “is still as clear as mud.”

GSK is putting a brave face on all of this.

But for many medical and biotech researchers, the path to fame and fortune is by starting a start-up with some new compound or technique and by “leveraging the promise”. For pharma and biotechnology start-ups the objective is to be bought up by one of the majors for as exorbitant an amount as can be managed. And it seems that one way to inflate the value is by making preliminary data and trials show very optimistic results. Negative results never see the light of day and the positive aspects are exaggerated and at worst manipulated.

The ten-fold growth of retractions in medicine related fields since 1975 is mainly due to misconduct according to this report in Nature where “fraud or suspected fraud was responsible for 43% of the retractions”.

For Big Pharma this is simply a consequence of having “outsourced” part of their research. They can afford a few failures it could be thought. Of course the final cost is eventually borne by the consumers but some start-ups make a killing along the way.

When “science” becomes a marketing tool for pharmaceuticals

December 3, 2012

There are many industries which play the “science as marketing game” but perhaps the most blatant are the pharmaceutical and medical industries. Sometimes researchers are just unwitting pawns in the marketing game but in a sense they are also at fault in being susceptible to becoming pawns. This cautionary tale about the diabetes drug Avandia reported in the Washington Post only enforces my view that since society invests the scientist with an aura of objective truth-seeking, then society must also demand a measure of responsibility and accountability from the scientist. And that can only happen if scientists have a measure of liability for the “product” they produce.

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