Think the drugs your GP gives you are safe Well, don't be so sure
00:50 GMT, 24 April 2012
We are all swallowing an increasing number of pills, not just to treat disease but to cut the risk of getting a disease in the first place. Even in a time of austerity the NHS is spending nearly 12 billion on drugs and the total keeps rising.
People believe the drugs are effective and safe because they have all been properly tested in clinical trials. But this is a dangerous delusion.
Failures in our system for testing drugs mean not only are drugs often no better than a placebo, but, at worst, they end up damaging the health of tens of thousands of Britons every year. Pharmaceutical companies spend billions conducting trials to come up with evidence for the benefits of drugs, but they have a number of ways of making small benefits look impressive.
Risks: Failures in drug testing can end up damaging the health of tens of thousands of Britons every year
Then they play down or conceal damaging side-effects. There are a number of examples of drugs with serious side-effects that the pharmaceutical companies have actively hidden from drug watchdogs as well as patients. Recent well-publicised cases include the anti-inflammatory painkiller Vioxx that caused heart attacks, the diabetes drug Avandia that also caused heart attacks and anti-depressants known as SSRIs that raise the risk of suicide.
Patients have been paid billions of dollars in compensation in America and Vioxx and Avandia have been taken off the market — but the SSRIs are still widely used. And these are just the drugs we know about.
We are in this disastrous situation because clinical trials today are part of what might be called ‘results-based medicine’.
The original objective of clinical trials was simply to find out if the drug in question was effective and safe — but that ideal is at death’s door. What has taken over is a hard-nosed ‘whatever it takes’ commercial approach. For instance, despite repeated requests by researchers for the full results that were used to license the blockbuster anti-flu drug Tamiflu, the company has refused to make them available. Researchers wanted to see the data because of a strong suspicion the drug was far less effective than claimed.
Dangers: Some drugs can have serious side-effects. (Posed by model)
But it wasn’t supposed to be like this. More than 50 years ago, following the Thalidomide disaster, a scientific system of properly testing drugs was set up. Before any drug could be prescribed, trials should prove it was safe and more effective than an inert ‘sugar pill’, a placebo.
But drugs have been turned into just another commodity, supported by brilliant marketing of the benefits, while problems and dangerous side-effects are brushed under the carpet, turning what should be a huge benefit into an increasing problem.
Before a drug can be widely prescribed, it has to go through an intensive period of testing, first on animals, then on a small number of patients to see if it is more effective than a placebo. Finally, there are two larger trials, usually involving several hundred people treated for between three to six months. Information from these is then passed on to the drug regulators in each country — the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK — who then check it before issuing a licence.
So how have drug companies managed to get round this system designed to protect patients
The simplest way is just not to publish unfavourable results. Another way is to publish negative trials but to make them look good. There are plenty of cases on record of senior consultants being paid handsomely to present findings from trials in a favourable light. Meanwhile, doctors who speak out about drug dangers can be vilified and journals who try to publish their work can be threatened with litigation.
As a psychiatrist who has spent nearly 15 years uncovering concealed evidence of how SSRIs can cause patients to commit suicide, I’m very aware of the ability of drug companies and drug regulators to keep asserting there is no problem in the face of the most damning evidence.
In a system committed to patient safety, reports of side-effects would be carefully investigated. But when I uncovered evidence that the companies making the SSRI drugs for depression were hiding studies that showed a raised suicide risk, no one wanted to know. The UK drug watchdog — the MHRA — did nothing. Another technique to play down unfavourable results is ‘ghost writing’. In theory, the scientist heading a clinical trial analyses the findings and the results are published with his or her name on it. Not so in the distorted version of evidence-based medicine created by drug companies.
Payouts: Pharmaceutical companies have had to pay millions in compensation to patients who have had adverse reactions to drugs
We are talking here about the controlled trials, which doctors and regulators rely on to tell if a drug is more likely to work for you or to cause you harm. Worryingly, many that appear in top journals such as the New England Journal of Medicine have actually been written up by ‘ghosts’ employed by the pharmaceutical company that has a patent on the drug, and so are far more likely to provide the results they want.
However, the name that appears on the paper is often that of a senior consultant who is well paid for lending his name and authority to the work.
Sometimes, there can be a shocking gap between what the trial had found and how it was written up.
Then there is the reclassifying of patients. Every trial has patients who drop out — for personal reasons or because they couldn’t stand the side-effects. But they are all simply classified as being ‘non-compliant’, meaning they didn’t take their drugs.
There is a fundamental reason why doctors and patients can’t get reliable information about side-effects from supposedly ‘scientific’ clinical trials. It’s not just that they are downplayed or hidden — the trials aren’t designed to find the problems in the first place.
Trials run for only a few months with a few thousand people. That’s not enough time or numbers to detect rare but serious side-effects when millions of people take a drug for years.
Also, the side-effects are often the same as the ones caused by the disease. Depression raises the risk of suicide but so do SSRI anti-depressants. Cardiovascular conditions cause memory loss and diabetes — as do statins. The way to isolate the side-effects of the drugs is to test them on healthy volunteers, which companies have to do, but the results are rarely released to the public.
Just how much the system allows drug companies to accentuate the positive and eliminate the negative was shown in the way a tranquiliser called Zyprexa (olanzapine in the UK) was promoted. It was licensed on the basis of four clinical trials involving just over 2,000 patients.
Yet the company was able to carve up the results into separate articles that appeared in 234 medical publications all saying how effective this drug was. The evidence for its benefits appeared overwhelming when it was just the same data being repeated.
Sales soared. There was no mention of the potentially deadly side-effects, even though it was known to increase the risk of diabetes and heart disease — as well as being linked with suicide. The companies cut the risk up into small bits so that overall it looks safe.
But until trial data is freely available for independent researchers to examine, these abuses are likely to continue.
Professor David Healy’s book, Pharmageddon, is published by the University of California Press, 27.95.