Category: Peter Gotzsche

The Guardian (Peter Gøtzsche) : ‘Psychiatric Drugs Are Doing Us More Harm Than Good’


http://www.theguardian.com/commentisfree/2014/apr/30/psychiatric-drugs-harm-than-good-ssri-antidepressants-benzodiazepines

Psychiatric drugs are doing us more harm than good

As with benzodiazepines in the 1980s, the UK is prescribing SSRI antidepressants at a staggering rate – and to no good effect
'More than 53m prescriptions for antidepressants were issued in 2013 in England alone.'

‘More than 53m prescriptions for antidepressants were issued in 2013 in England alone.’ Photograph: travel-and-more/Alamy

We appear to be in the midst of a psychiatric drug epidemic, just as we were when benzodiazepines (tranquilisers) were at their height in the late 1980s. The decline in their use after warnings about addiction led to a big increase in the use of the newer antidepressants, the SSRIs (selective serotonin re-uptake inhibitors).

Figures released by the Council for Evidence-based Psychiatry, which was set up to challenge many of the assumptions commonly made about modern psychiatry, show that more than 53m prescriptions for antidepressants were issued in 2013 in England alone. This is almost the equivalent of one for every man, woman and child and constitutes a 92% increase since 2003.

Sales of antidepressants have skyrocketed everywhere and are now so high in my own country, Denmark, that – if the prescriptions were equally distributed – every citizen could be in treatment for six years of their life. The situation is even worse in the US, where direct advertising of prescription drugs to the public is permitted and where more psychiatrists were “educated” with industry hospitality than any other medical discipline.

I began to realise the scale of the problem when I was persuaded seven years ago to become a tutor for a PhD thesis on whether history was repeating itself, by comparing benzodiazepines (“mother’s little helper”) with SSRIs. This research has established that people get as hooked on SSRIs as they did on benzodiazepines, and 37 of 42 withdrawal symptoms were the same for SSRIs as for benzodiazepines.

It is hard to believe that so many people have become mentally disturbed and that these prescription increases reflect a genuine need, so we need to look for other explanations. There seem to be three main reasons for the huge growth.

First, the definitions of psychiatric disorders are so vague that many healthy people can be diagnosed inappropriately. Second, some of the psychiatrists who wrote the diagnostic manuals were on the industry’s payroll, and this may have also led to significant diagnostic inflation. Third, the companies’ behaviour has been worse in psychiatry than in any other area of medicine, with billion-dollar fines paid for the illegal marketing of psychiatric drugs for non-approved uses. The rise in sales reflects patient dependency on these SSRIs: they may have great difficulty stopping even when they taper off the drugs slowly. Withdrawal symptoms are often misdiagnosed as a return of the disease or the start of a new one, for which drugs are then prescribed. Over time, this leads to an increase in the number of drug-dependent, long-term users.

Another major problem with psychiatric drugs is that they can cause the symptoms they are supposed to alleviate. Unfortunately, psychiatrists tend to increase the dose or add another drug when a patient reports negative effects.

The problem is that many of these drugs simply do not work as people suppose. The main effect of antidepressants is not the reduction of depressive symptoms. They are no better than placebo for mild depression, only slightly better for moderate depression, and benefit only one out of 10 with severe depression. In around half of all patients, they cause sexual disturbances. The symptoms include decreased libido, delayed orgasm or ejaculation, no orgasm or ejaculation and erectile dysfunction. Studies in both humans and animals suggest that these effects may persist long after the drug has been discontinued.

The US Food and Drug Administration has shown that antidepressants increase suicidal behaviour up to the age of 40, and many suicides have been reported even in healthy people who took the drugs for other reasons (for example, for stress or pain). Another report also said that, among people over 65, antidepressants are believed to kill one out of every 28 people treated for one year, because they lead to falls and hip fractures. Indeed, it is not clear whether antidepressants are safe at any age.

My studies of the research literature in this whole area lead me to a very uncomfortable conclusion: the way we currently use psychiatric drugs is causing more harm than good. We should therefore use them much less, for shorter periods of time, and always with a plan for tapering off, to prevent people from being medicated for the rest of their lives.

Pharmafioso’s like GSK : ” Deadly Medicines, Organized Crime”, by Peter Gotzsche


http://www.dcscience.net/?p=6567

Deadly Medicines and Organised Crime: a review

April 16th, 2014 · No Comments

This is a web version of a review of Peter Gotzsche’s book. It appeared in the April 2014 Healthwatch Newsletter. Read the whole newsletter. It has lots of good stuff. Their newsletters are here. Healthwatch has been exposing quackery since 1989. Their very first newsletter is still relevant.

Most new drugs and vaccines are developed by the pharmaceutical industry. The industry has produced huge benefits for mankind. But since the Thatcherite era it has come to be dominated by marketing people who appear to lack any conscience. That’s what gave rise to the Alltrials movement. It was founded in January 2013 with the aim of ensuring that all past and present clinical trials are registered before they start and that and their results are published The industry has been dragged, kicking and screaming, towards a new era of transparency, with two of the worst offenders, GSK and Roche, now promising to release all data. Let’s hope this is the beginning of real open science.

cover

This version is not quite identical with the published version in which several changes were enforced by Healthwatch’s legal adviser. They weren’t very big changes, but here is the original.


Deadly Medicines and Organised Crime

By Peter Gøtzsche, reviewed by David Colquhoun
Published by Radcliffe Publishing Ltd on 1 August 2013. RRP £24.99 (320 pages, paperback)
ISBN-10: 1846198844 ISBN-13: 978-1846198847

As someone who has spent a lifetime teaching pharmacology, this book is a bitter pill to swallow.  It makes Goldacre’s Bad Pharma seem quite mild.

In fairness, the bits of pharmacology that I’ve taught concern mostly drugs that do work quite well.  Things like neuromuscular blocking agents, local anaesthetics, general anaesthetics, anticoagulants, cardiac glycosides and thyroid drugs all do pretty much what is says on the label.

Peter Gøtzsche is nothing if not evidence man.  He directs the Nordic Cochrane group, and he talks straight.  His book is about drugs that don’t work as advertised.  There is no doubt whatsoever that the pharmaceutical industry has behaved very badly indeed in the last couple of decades.  You don’t have to take my word for it, nor Peter Gotzche’s, nor Ben Goldacre’s.  They have told us about it themselves.  Not voluntarily of course, but in internal emails that have been revealed during court proceedings, and from whistleblowers.

Peter Rost was vice president marketing for the huge pharmaceutical company, Pfizer, until he was fired after the company failed to listen to his complaints about illegal marketing of human growth hormone as an anti-ageing drug.  After this he said:

“It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry … “

The pharmaceutical industry is the biggest defrauder of the US federal government under the False Claims Act.  Roche led a cartel that, according to the US Justice Department’s antitrust division, was the most pervasive and harmful criminal antitrust conspiracy ever uncovered.  Multibillion dollar fines have been levied on all of the big companies (almost all in the USA, other countries have been supine), though the company’s profits are so huge they are regarded as marketing expenses.

It’s estimated that adverse effects of drugs kill more people than anything but cancer and heart disease, roughly half as many as cigarettes.  This horrifying statistic is announced at the beginning of the book, though you have to wait until Chapter 21 to find the data.  I’d have liked to see a more critical discussion of the problems of causality in deciding why someone died, which are just as big as those in deciding why somebody recovered.  Nevertheless, nobody seems to deny that the numbers who are killed by their treatments are alarmingly high.

Gøtzsche’s book deals with a wide range of drugs that don’t do what it says on the label, but which have made fortunes because of corruption of the scientific process. These include non-steroidal anti-inflammatory drugs (NSAIDs), an area described as “a horror story filled with extravagant claims, bending of the rules, regulatory inaction, . . .”.  Other areas where there has been major misbehaviour include diabetes (Avandia), and the great Tamiflu scandal. and the great Tamiflu scandal. It took five years of pressure before Roche released the hidden data about Tamiflu trials. It barely works. Goldacre commented “government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic”

But the worst single area is psychiatry.

Two of the chapters in the book deal with psychiatry.  Nobody has the slightest idea how the brain works (don’t believe the neuroscience hype) or what causes depression or psychosis.  Treatments are no more than guesses and none of them seems to work very well.

The problems with the SSRI antidepressant, paroxetine (Seroxat in UK, Paxil in USA) were brought to public attention, not by a regulator, but by a BBC Panorama television programme.  The programme revealed that a PR company, which worked for GSK, had written

“Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.  Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.”

This referred to the now-notorious study 329. It was intended to show that paroxetine should be recommended for adolescent depression.  The paper that eventually appeared in 2001 grossly misrepresented the results.  The conclusions stated “Paroxetine is generally well tolerated and effective for major depression in adolescents”, despite the fact that GSK already knew this wasn’t true. The first author of this paper was Martin Keller, chair of psychiatry at Brown University, RI, with 21 others.

But the paper wasn’t written by them, but by ghost authors working for GSK. Keller admitted that he hadn’t checked the results properly.

That’s not all. Gøtzsche comments thus.

“Keller is some character. He double- billed his travel expenses, which were reimbursed both by his university and the drug sponsor. Further, the Massachusetts Department of Mental Health had paid Brown’s psychiatry department, which Keller chaired, hundreds of thousands of dollars to fund research that wasn’t being conducted. Keller himself received hundreds of thousands of dollars from drug companies every year that he didn’t disclose.”

His department received $50 million in research funding. Brown University has never admitted that there was a problem.  It still boasts about this infamous paper

The extent of corruption at Brown University rivals the mob.

The infamous case of Richard Eastell at Sheffield university is no better.  He admitted in print to lying about who’d seen the data.  The university did nothing but fire the whistleblower.

Another trial, study 377, also showed that paroxetine didn’t work.  GSK suppressed it.

“There are no plans to publish data from Study 377” (Seroxat/Paxil Adolescent Depression. Position piece on the phase III clinical studies. GlaxoSmithKline document. 1998 Oct.)

Where were the regulatory agencies during all this?  The MHRA did ban use of paroxetine in adolescents in 2003, but their full investigation didn’t report until 2008.  It came to much the same conclusions as the TV programme six years earlier about the deceit. But despite that, no prosecution was brought.  GSK got away with a deferential rap on the knuckles.

Fiona Godlee (editor of the BMJ, which had turned down the paper) commented

“We shouldn’t have to rely on investigative journalists to ask the difficult questions”

Now we can add bloggers to that list of people who ask difficult questions.  The scam operated by the University of Wales, in ‘validating’ external degrees was revealed by my blog and by BBC TV Wales.  The Quality Assurance Agency came in only at the last moment.  Regulators regularly fail to regulate.

Despite all this, the current MHRA learning module on SSRIs contains little hint that SSRIs simply don’t work for mild or moderate depression.  Neither does the current NICE guidance.   Some psychiatrists still think they do work, despite there being so many negative trials.

ssri box

The psychiatrists’ narrative goes like this. You don’t expect to see improvements for many weeks (despite the fact that serotonin uptake is stopped immediately).  You may get worse before you get better. And if the first sort of pill doesn’t work, try another one.  That’s pretty much identical with what a homeopath will tell you.  The odds are that its meaning is, wait a while and you’ll get better eventually, regardless of treatment.

It’s common to be told that they must work because when you stop taking them, you get worse.  But, perhaps more likely, when you stop taking them you get withdrawal symptoms, because the treatment itself caused a chemical imbalance.   Gøtzsche makes a strong case that most psychiatric drugs do more harm than good, if taken for any length of time.  Marcia Angell makes a similar case in The Illusions of Psychiatry.

Gøtzsche will inevitably be accused of exaggerating.  Chapter 14 ends thus.

“Merck stated only 6 months before it withdrew Vioxx that ‘MSD is fully committed to the highest standards of scientific integrity, ethics, and protection of patient’s wellbeing in our research. We have a tradition of partnership with leaders in the academic research community. Great. Let’s have some more of such ethical partnerships. They often kill our patients while everyone else prospers.

Perhaps Hells Angels should consider something similar in their PR: We are fully committed to the highest standards of integrity, ethics and protection of citizens’ well- being when we push narcotic drugs. We have a tradition of partnership with leaders in the police force”.

But the evidence is there.  The book has over 900 references.  Much of the wrongdoing has been laid bare by legal actions. I grieve for the state of my subject.

The wrongdoing by pharma is a disgrace.

The corruption of universities and academics is even worse, because they are meant to be our defence against commercial corruption.

All one can do is to take consolation from the fact that academics, like Gøtzsche and Goldacre, and a host of bloggers, are the people who are revealing what’s wrong.  As a writer for the business magazine, Fortune, said

“For better or worse, the drug industry is going to have to get used to Dr. Peter Rost – and others like him.”

At a recent meeting I said that it was tragic that medicine, the caring profession, was also the most corrupt (though I’m happy to admit that other jobs might be as bad if offered as much money).

At present there is little transparency.  There is no way that I can tell whether my doctor is taking money from pharma, data are still hidden from public scrutiny by regulatory agencies (which are stuffed with people who take pharma money) as well as by companies.  Governments regard business as more important than patients. In the UK, the Government continued promotion of the fake bomb detector for many years after they’d been told it was fake.  Their attitude to fake medicines is not much different.  Business is business, right?

One side effect of the horrific corruption is that it’s used as a stick by the alternative medicine industry. That’s silly of them, because their business is more or less 100% mendacious marketing of ineffective treatments.  At least half of pharma products really do work.

Fines are useless. Nothing will change until a few CEOs, a few professors and a few vice-chancellors spend time in jail for corruption.

Read this book. Get angry. Do something.