Drug problems: what plays in America stays in America

Over the years I have found the ability of the Atlantic to have dulling effect on the sensibilities of doctors and the media remarkable. It’s a  phenomenon that only affects prescription drugs.While we in the UK eagerly follow every twist and turn in American cultural life, illegal pharmaceutical activities that may have serious implications for our health and which have been detected and even punished over there, cause barely a ripple over here.

Concealing dangerous side effects, illegally promoting drugs for a condition that they are not licensed for and generally being  economical with the actualite are rarely reported, except in the financial pages when they affect the share price. Now this strange blindness has afflicted us again in connection with a fairly new anti-stroke drug called Pradaxa- see it here. My investigation into the latest developments with Pradaxa (dabigratan) – 2.300 court cases, incriminating company emails and improperly hidden or lost documents, appears in the Daily Mail today.

Other example of this mysterious force in action includes ignoring for years research showing that anti-depressant SSRIs were linked with a higher risk of suicide in children and the heavyweight tranquilizers (antipsychotics) being widely prescribed for use on elderly people with dementia even though they were not licensed for this use and in fact the evidence clearly showed that they didn’t improve behaviour and that they raised the risk of cardiovascular problems. Or what about the heart attack risk linked with the diabetes drug Avandia that had been known about for years but was also kept quiet.

In all those cases the bulk of the information came from the States, often from court cases or other forms of investigation which were easily available on the web. The remarkable thing was the barrier that the Atlantic apparently posed to any UK paper investigating this, let alone doctors or the regulators taking any notice, at least not until it became impossible to ignore.

Ethical climate in the UK

A related observation is that where drugs are concerned there is another extraordinary difference in ethical  standards between the two sides of the Atlantic. Here in the UK we seem blessed with a far more upright moral climate that somehow infuses American pharmaceutical firms with higher standards so that those which had been doing illegal things over there, such as promoting a drug to doctors to treat a disorder that it that didn’t have a licence for, suddenly stopped doing anything like that as soon as they arrived over here.

When I once asked the MHRA (the UK drug watchdog) if they knew of any cases of illegal off label promotion they said that they hadn’t been told about any but if I heard of any could I let them know. When it comes  to some of the problems that afflict drugs in American, the motto seems to be the old one of not seeing or hearing evil.

So when I came across details of the court cases and the hidden emails I thought that blind spot can’t still be functioning. Even though we kind of look down on the American habit of suing over everything, it is pretty well established that when American court cases that involve a new drug start appearing that’s a pretty good sign that something is going on. Since our own Yellow Card system for reporting side effects is pretty hopeless ( best estimate is that it picks up less than 10 percent) – surely someone whose job it was to track side effects and take action might use court cases as an early warning system.

Worrying things cross the Atlantic

But apparently not. A quick check of the newspaper coverage revealed that the main thrust of Pradaxa stories was the demand that more people should be put on it now that NICE had declared it cost-effective. Not a hint of anything slightly worrying happening across the Atlantic.

Pradaxa is licenced to treat a condition called atrial fibrillation, which is what happens when the electrical rhythms of the heart get out of synch. One effect is a much greater risk of strokes and blood thining drugs like Pradaxa cut the risk. Strokes in the brain are often deadly and if not your life can be horribly limited, so the drug obviously has the potential to do a lot of good. But what’s happend with Pradaxa shows yet again that relying on drug companises to give a full and frank account of the plusses and minuses of their products is a risky business.

This is particularly relevant at the moment with regards to statins and recent claims by a senior researcher that the risk of side effects are very low so there is no problem prescribing them to practically everyone over 50.  What none of the reports make clear is that the data this claim is based solely on trials run by drug companies and that given their record they are not to be trusted. I will soon be posting about this on HealthInsightUK.org.

 

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Comments

  1. L.H. Olavius says:

    Most treatments suffers from lack of evidence.

    http://clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.html

    Often when I discuss above figure one of the arguments is, that 80 to 90% of all conventional medicine prescriptions are from the 11% group, but I have never seen actual evidence for that figure.

    Does such data exist?

  2. elainelewis says:

    Hi Jerome, interesting article! Here in the united states, Rx drugs are advertized on TV. The Pradaxa ad is well known to me. The ad says it can cause fatal bleeding and that if you stop taking Pradaxa, it can increase your risk for a stroke (and the whole point of this drug is to decrease your risk for a stroke, ironically)! I can just imagine what all the lawsuits must be about! As you’ve pointed out before, drugs are probably not the appropriate response to diseases caused by lifestyle.

    • Not sure what lifestyle changes work for stroke ; does look as if drug is effective iin cutting stroke, issue seems to be found issue around monitoring and deba

    • Went off too soon; main disputed issue is value of monitoring

    • ChristyRedd says:

      elainelewis……Like millions of other Americans I’ve seen that ad too. I remember the cautions at the end of the ad vividly. Why would anyone want to take a drug that could cause fatal bleeding or increase your risk of having a stroke? Fiona Godlee, Editor, BMJ, also noted “In the balance between benefits and risks it is an uncomfortable truth that most drugs do not work in most patients.”
      http://www.bmj.com/content/346/bmj.f3666
      Here are a few statistics about conventional drugs in general:
      Adverse drug reactions are believed to cause over 100,000 deaths per year in the U.S. making drugs the third leading cause of death.
      Adverse drug reactions caused over 2 million hospitalizations in 1994 alone.
      Drug-related mortality/morbidity is estimated to cost the U.S. health care system more than $150 BILLION every year.
      19 drugs have been withdrawn from the market since 1998.
      26% of drugs introduced between 1980 and 2006 carry black box warnings (meaning “use at your own risk”).
      That’s good medicine? Not in my book!
      Source: FDA/CDER/PhRMA/AASLD Meeting “Detecting and Investigating Drug Induced Adverse Events, The International Serious Adverse Event Consortium’s Experience to Date”, March 27, 2008,
      Arthur Holden, Chairman, SAEC Ltd.

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