Five Minutes to Midnight

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In 2016 life expectancy in the United States fell for a second year in a row. This was the first time anything like this had happened apart from a brief flatlining for men around 1962 we now know was linked to tobacco use.

In 1962 the Food and Drugs Administration (FDA) put in place a set of regulations that are the single greatest influence on healthcare today in every country on earth, regulations that introduced a requirement for efficacy aimed at enhancing the safety profile of drugs.

(The legal requirement was effectiveness, but this is honoured in the breach rather than the observance).

British researchers have since noted that life expectancy is falling in the over 65s in the UK and has stalled in France and Germany as well.  This, they said, is the greatest slowdown in improvements in life expectancy since the 1890s. See HERE

Drug Wrecks

No-one looking at this issue so far has fingered Drug Wrecks, drug-treatment-related adverse events, as the likely source of the slowdown.  But these are now the leading cause of death and disability on the planet. The data on treatment related deaths in hospital settings show them to be the third leading cause of death, even though the contribution of drugs is written out of the script in for instance cancer or cardiovascular deaths, when in many instances it will have been treatment that killed. While tobacco is not now a medical treatment, its role in contributing to cancers and heart attacks adds to the point that the substances we consume, especially if we add in alcohol, can cause problems.

Almost by definition drug effects have to be an even commoner cause of death in community settings where the conditions treated are less severe than in hospital settings. But no-one has ever looked at deaths in our homes or places of work.

In the case of one group of drugs, the antidepressants, the data show over 10% of the population take them, of whom more than 80% take them indefinitely, almost certainly because they can’t stop. The sex life of everyone who takes the most common antidepressants is significantly compromised, often obliterated, while on treatment. Many remain permanently dysfunctional after stopping. Every drug has a hundred effects; sexual dysfunction in this case is just one of the 99 disabilities antidepressants cause.

If this one drug group is taken by over 10% of the population, and if 50% of us of all ages are on at least one drug and 50% of those over 45 are on at least 3 drugs, and 40% of over 65s are on 5 drugs or more, there are almost certainly more people disabled by medication than not. This trade-off might make sense if our treatments offered a clear benefit but few of the best-selling treatments in medicine – statins for cholesterol, drugs for osteoporosis, psychotropics for everything – offer anything like a clear enough benefit to warrant the disabilities we endure on treatment.  But there is a silence about this.

Zoning Out

Here’s the rub.  No-one likes to hear about or talk about drug wrecks.

For 5 years David Healy has been going around inviting people to embrace the idea that drugs inevitably cause harms.  The best way for anyone taking a drug to keep safe is to remember they are taking something that can do them harm.

At a time when an increasing number of nurses and pharmacists can prescribe, the best way for doctors to hang onto their jobs is to use the harms that drugs can cause to justify their existence (and high rates of pay) – it needs expertise to bring good out of the use of these inevitably risky chemicals.

But this message falls on deaf ears. The average person and average doctor just doesn’t want to hear about it.  They close to hiss.

There is something called a Zone of Proximal Development (ZPD) that every mother knows about.  If you are trying to get children and men somewhere, you may not be able to get them straight there.  You have to take them to where they can get and then take them in further manageable steps to where you need to get them.

The trouble with talking about the harms of drugs, even when dressed up as safety, is it takes most people wildly beyond their ZPD.  Few people if any, other than those already horrifically harmed by a drug, can contemplate the idea that medicine is about bringing good out of the use of a poison.  Some can cope with this idea in the abstract, but almost all of these become very uncomfortable with the idea you might be talking about my statin, or osteoporosis drug or antidepressant.

Zoning In

We prefer to hear about effectiveness rather than safety.

The 1962 amendments forced companies to demonstrate their drugs were effective. The idea was that eliminating ineffective drugs would contribute to safety.

A great idea – except for the fact that effectiveness is impossible to demonstrate in the brief clinical trials companies are prepared to run to get their drug on the market.  Effectiveness means saving lives or getting people back to work or something like that. It can’t be demonstrated in 6 week trials.

We have instead settled for efficacy.  The drugs on the market lower cholesterol or thicken bones unnaturally, or lower scores on rating scales.  This may not be legal but it is what it is.

So sometime back, even among those not inclined to wonder if making bones like marble was a bad thing to do, or drastically interfering with the metabolism of the most common constituent of our brains (cholesterol) might be risky, a data driven consensus emerged that having people on 5 or more efficacious drugs increases the risks of hospitalization and premature death. There is convincing evidence that reducing medication burden from 10 or 15 efficacious drugs to 5 or less increases life expectancy and reduces hospitalizations – see HERE.

It’s a bit like the nuclear bomb.  Too much efficacy can become a problem.  Too much efficacy is no longer effective – we just can’t use it.

Unless someone comes up pretty soon with evidence of a bizarre new and lethal virus liberated from the thawing glaciers of the Antarctic and circulating widely, you’d have to worry that the present drop in life expectancy of unknown origin is linked to the fact that 50% of us over 45 are on at least 3 drugs, and 40% of over 65s are on 5 drugs or more, and close to 90% of people on antidepressants for instance, drugs initially designed for 3-6 month use and tested in 4 week trials, are on them for over a year..

This may be healthcare’s nuclear moment.

While rifles and guns and smart bombs may be efficacious – if not actually effective – when we get to nuclear weapons there is too much efficacy to be effective. The equipment just can’t be used.

Similarly having people on 5 or more drugs chronically is just not effective.

This is not bad news.  There is win win here.  We who take drugs and those who give them to us can still have our cake and eat most of it.  Just we have to work within a limit.  This is a Zone that more people are happy to occupy than the traditional medical every-drug-is-a-poison zone whose traditional practitioners used to try balance the harms of a treatment against the harms of a condition.

If we are trying to ensure people don’t end up on 5 or more drugs, all of which are efficacious, Dee Mangin realised years ago we are forced to introduce safety into the equation and the values of the person being treated.  What do you want from treatment and what kind of problems do you particularly want to avoid?  Perhaps you would opt to live a good quality life but maybe die a few days earlier rather than live hooked up to machines barely able to recognize anyone around you for a few days longer?

This is the thinking that has given rise to Taper MD.

Revolution

Taper MD is RxISK’s ZPD.

In this zone, everyone still gets efficacy, lots of it. Much more than anyone used to get. Just as with food, there is now enough drugs to go around. But just as with food most of us know and more to the point accept that endlessly stuffing our mouth is not effective particularly if our values include staying alive or looking good.

For anyone who likes the hard-core, dark stuff, who likes a frisson from homicides or the obliteration of the ability to make love, the twentieth century medicine stuff Healy peddles can still be accessed on the RxISK site. Who knows it may come back into fashion after the Revolution.

Taper MD though is where the Revolution starts.

Its also a way for doctors, pharmacists and others to get onto the RxISK map of doctors and other healthcare professionals who listen. Anyone signing up for Taper will end up on the MAP.