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January 2, 2019 by David Healy, MD, FRCPsych

Making Medicines Safer for All of US

Editorial Note: Aberystwyth on the West Coast of Wales is one of the best places in the world to see starlings murmurate.  Clive King from the Computer Science Department there also organises TedX talks and  on November 24 convened a panel of speakers to talk about murmurating swallows, ambivalent motherhood and making medicines safer among other things. 

The full set of talks is HERE –  they were all fascinating. Ambivalent Motherhood was compelling.  My talk on making medicines safer – or healthcare climate change – is HERE.  The text is below.

The Greatest Failing in Healthcare

Two years ago, when Jeremy Hunt was Britain’s Minister of Health, he said that children’s Mental Health Services were the greatest failure of Britain’s National Health Service.

Back then and even more so now there was a range of articles and programs about university students committing suicide at unprecedented rates, distressed teenagers in schools given antidepressants because of difficulties accessing Mental Health Services, and this week a quarter of young women in Britain were reported to have a mental health problem.

This is not just happening in the UK. There are comparable articles and programs about the same issues from New Zealand to the United States.

The old media put forward the new social media as an explanation for what is going on.  This looks like a new plus new makes five answer – you must remember the old media hate the new media.

What I hear from non-media people most often is we have become a quick fix culture. I think there is something to this. But I’ve struggled with the idea of what a quick fix is.

A Quick Fix

President Trump came to my aid on this recently when he said after a school shooting ‘why not put a good guy with a gun into every school?’ For many people this sounds crazy but no-one had an answer to his follow-up challenge – “Well if a good guy with a gun isn’t going to solve the problem, why do we have good guys with guns in front of the White House?”

Guns work. They’re a fix but multiplying guns and putting them into too many situations – like schools – sounds like a recipe for disaster.

Medicines are like guns.  They are poisons that can fix some things but multiplied up too much and used too widely they can also do more harm than good.

Especially when the information about medicines is fake information….

Most of you have heard about ghost writers. Donald Trump’s book The Art of the Deal is very famously ghost written. We link ghostwriting to footballers and film stars, Tony Blair perhaps but Gordon Brown’s book seems less likely to have been ghosted.

We tend to think brainy people don’t need ghostwriters.  Think again.

The greatest concentration of ghost writing on earth centres on the drugs your doctor gives you. Since 1989, when Prozac came on the market, almost every article in the best medical journals that has anything to do with pharmaceuticals has been ghost written. The people whose names are on these articles aren’t the authors.

The ghosts are smart women with PhDs who are better writers than most doctors – so this might not be a problem if the ghosts and the rest of us had access to the underlying trial data.

But the ghosts don’t. And we don’t. No one has access to the data. FDA who approve drugs in the USA don’t have access. MHRA who approve them here don’t have access.

So what do the nice people who write the NICE guidelines which dictate which heart medicines, or gut medicines, or antidepressants your doctor gives you base their views on?

Well – they work from ghost written articles. They have no access to the data.

This is a tricky situation for all doctors. There used to be a gulf between the NHS, a notionally public health system, and US healthcare, which is notionally private, but there is less and less difference these days – both are run by managers whose number one task is ensure doctors keep to the guidelines.  This is not being done for your good – it’s being done in case you are killed or injured when if everyone keeps to the guidelines the organisation and the managers are fine.  No-one cares about you.

If any issue comes up in the public domain about some drug, the response from politicians is that everything would be fine if doctors just kept to the guidelines.

All these people are looking at a rotten apple in a barrel problem.  But you and I face a rotten barrel problem.

The greatest threat to you now comes from a doctor who keeps to the guidelines rather than one who doesn’t. And the “good” doctor who keeps to the guidelines is entirely in the pocket of the pharmaceutical companies – even though they haven’t paid him a cent.

The Berlin Wall and Prozac

Now let me bring you back to 1989 and the fall of the Berlin Wall.

Prozac came on the market that year – the first of a new generation of antidepressants that we call the SSRIs. These were hyped as the drugs that were going to make you better than well. Help you transition from the old you to a new and better you.

The contrast between these miracle drugs and say – the antihistamines – was extraordinary. No-one thinks antihistamines are miracle drugs. They do minor things and can cause more problems than they are worth. But Prozac and the other SSRIs are just antihistamines. The SSRIs were inferior to older antidepressants.

The hype about the miracles SSRIs produce and their freedom from harms was only possible because nobody could see the data from SSRI clinical trials. The data shows these drugs can make you suicidal, and homicidal.  80% of people get hooked to them. They can wipe out your sex life and it can remain wiped out decades after you stop if you were able to stop – these problems were all concealed.

SSRIs and Children

The drugs came on the market for adults but they began to be used for children on the back of reports from doctors claiming they worked wonders for children also.

We do clinical trials to curb the sometimes paid for enthusiasms doctors have. If the trial is negative we don’t use the drug. Well 30 trials have now been done in children – all negative.  There is a doubling or tripling of suicidal events in the children on treatment compared with the children not on treatment in these trials. This is the greatest volume of negative trials for any treatment of any condition in recorded history.

What’s happened the sales of SSRIs – well aside from oral contraceptives, these drugs are now the most commonly used drugs by teenage girls and their use is exploding. Up to 50% of university students in the US are on these or related drugs. The people who take the most are trainee doctors – the people you depend on not to turn to a quick fix for your problems.

How did this happen? Well while the trials are negative, the ghostwritten articles say the drugs work wonderfully well and are safe.

But one more thing – before the ghosting and lack of access to data accidentally came to light, Prozac had already been approved for use in young people in the US and here.  Now for a drug to be approved trials have to show it worked.  MHRA and FDA knew there were no trials showing Prozac worked – there are more negative trials for Prozac than for any other drug. But they approved it.

NICE Guidelines recommend the use of Prozac for teenagers and young people even though NICE know there are no positive trials for Prozac.

These approvals and the ghosted articles have led to the explosion of use of these drugs in young people.  Water flows down even a hint of a gradient – unless there is a bump in the way. What ghostwriters do is they smooth out the bumps so that your doctor has no hint there is anything there.

What I am saying about antidepressants applies to any drug you are on.

Poly-Fix

Through to about 1989 you were on only one drug and for a short time – an antibiotic for a few weeks.

Now 50% of people over the age of 45 are on 3 or more drugs every day of the year; 50% of people over the age of 65 are on 5 or more drugs. Guidelines mean that every year you live the number of drugs you are on will increase – many of us over 70 are on 10-15 drugs a day.

The companies who sell these drugs aren’t about making you better than well – they’re about making drug sales better than good – they want to transition their drugs from poisons into sacraments.

Sacraments are a quick fix.  Poisons are not. Poison may sound like a strong word – but a medicine is a chemical plus information. The chemicals are always risky.  The information is key to controlling those risks.

Donald Trump brought us Fake News. The old media imply only stupid people believe Fake News – but steer clear of the fact that doctors have been living on a diet of Fake News for 30 years.

It used to be said the magic of medicine is about bringing good out of the use of a poison. In order to bring good out of the use of poison, both you and I need to know all the risks that go with this poison, especially if you’re on 3, 4 or 5 drugs.

One of the creators of modern medicine was Philippe Pinel who was famous for saying that a Fix is great but its often more important to know when not to use that Fix.

Modern medicine began with Pinel 200 years ago, since when your life expectancy has increased year on year.

As of two years ago in the Western world it began to fall. We now expect you to die earlier than we expected two years ago.

Linked into this fall, there is a change in the climate of healthcare. Healthcare is now addicted to the idea our drugs work well and are free of harm and are a quicker and cheaper fix than have someone help tackle your problems in the least risky way.

When you hear talk about changing climates most of us think about global climate change. We can’t yet see the sea level rising but if you look online you can see you are more likely to die earlier now than we thought you would a few years ago.

Climate Change

It is very difficult for any of us to do much about global climate change – but each of us can do something about the climate in healthcare.  To borrow a phrase from the pharmaceutical industry, Ask your doctor… if it would be a good idea for you and her to have access to the data on any drug she wants to put you on.

This will be a scary moment for you and for her.  You will both sense the power of those interests who would prefer things stay as they are.  But if you stand your ground you will not only reverse changes in the healthcare climate you may do something about global climate change too which is being driven by the same forces.

Ask an older relative or friend in a care-home or wherever how many drugs they are on – a lot are on 10 or 15 quick fixes.  There is good evidence that reducing this to 5 or less adds years to their life, makes them less likely to be admitted to hospital and in many cases can bring about something close to a rebirth.

Faced with escalating healthcare costs, our politicians blame the elderly – we have no option but to throw more and more treatment at them.  They make it sound like Care. But it’s not.  They are throwing quick fixes at them that make the problem worse – just as we are doing with our children.

In this Simpson’s cartoon a downbeat Bart says: “This is the worst day of my life”. He looks like he needs a quick fix – an antidepressant.

Homer intervenes saying “No. This is the worst day of your life so far”.

This black humor points to something we have lost and need to regain.  Regaining it needs more than listening to a talk like this, some of you need to go out and Ask your Doctor if accessing the data is good for you, for her and for us….

 

Source: DavidHealy.org/making-medicines-safer-for-all-of-us/

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