Did you register the huge 3 billion dollar fine recently slapped on GlaxoSmithKline, Britain’s biggest drug company and manufacturer of Lucozade ? And if so, did you briefly wonder whether it was enough? After all, hiding data that your product can kill people and making unsupported claims about safety would normally be enough to put most manufacturers in prison. According to one expert their diabetes drug Avandia was responsible for about 1000 extra deaths from heart disease in the UK alone.
Top executives admitted mistakes had been made, assuring us that those who had “engaged in misconduct” had been removed. Then they went on to stress that those crimes had been committed nearly a decade ago and that the company and its culture was quite different now. It was time to move on and rebuild trust.
But this is where Lucozade comes in. As last week’s Panorama showed, when it comes to exaggerated claims and a distinct lack of scientific evidence for benefit, GSK’s marketing of the “performance enhancing” sports drink Lucozade suggests that this particular leopard still has a fine set of spots. This is why the latest initiative by my co-author Patrick Holford to start a campaign for sensible regulation of the drug industry seems absolutely right and also long overdue.
You can sign up to it here. Entitled dramatically “Stop Drug companies Killing for Profit” it calls for changes such as appointing a genuinely independent watchdog (our currently regulator is largely paid for by the companies themselves) who will be able to take action over the kind of illegal marketing of unlicensed drugs that led to those huge fines, although only in the States.
Paying proper attention to side effects
It also calls for a careful risk/benefit assement before a drug is released on the market. Despite worries about the heart risk with Avandia right from the beginning, the trial set up to test this didn’t report for ten years by which time the drug had been taken by millions.
Other improved safety demands include paying proper attention to reports of side effects and investigating them properly as well as preventing companies from hiding unfavourable results. “Let’s join together in a gigantic outcry for the UK’s MHRA and the EU’s EMA to put safety first,” Holford writes.
This push is supported, among others by Dr David Healy, author of Pharmageddon, a powerful indictment of how drug benefits are over-egged and risks are underplayed. Healy and a few other have been calling for such changes for years and even though this is an uber Goliath vs. a micro David, pressure for action against rampant self-interest in other industries could well now spread to pharmaceuticals
No basis for benefit claims
So what exactly is the link between drugs for diabetes or depression (GSK hid data showing Seroxat raised the risk of suicide) and the marketing of a fizzy sugary drink? A lot more than you might think. The big sell on Lucozade is not that it is another “refreshing” fizzy drink like Coke or Fanta but that it’s benefits for sportsmen in rehydrating them and proving energy is “scientifically” based. However the Panorama investigation, backed up by the British Medical Journal found was that there was no basis for the claims at all.
You might think that is hardly news. Surely claims that Lucozade would push your athletic envelope were never really credible. On the other hand it is the official drink for the marathon and a major sponsor for the Olympics so the claim is working at some level.
But what is so fascinating and alarming is just how many parallels there were between the way the company tried to make a claim for the drink and the way they gather evidence for their drugs. And that does matter. This year GSK is planning to launch four new drugs in the UK. By 2015 the plan is that a total of 12 new GSK drugs will be available on prescription, backed by top sales teams. How many will be backed by the kind of soggy evidence used to promote Lucozade?
A major Lucozade marketing tool are the top sportsmen who are paid to endorse it. Exactly the same technique that’s used to promote drugs. Millions of dollars are regularly poured into the pockets of academics considered “key opinion leaders” who then lecture on the benefits.
Wrong group tested
The bulk trials quoted to support the benefits of Lucozade and another GSK sports product Maximuscle involved serious athletes. Experts interviewed by the BMJ agreed that the products might give a slight edge if you were very fit but none to the average weekend jogger. Precisely Lucozade’s target market. Drug trials frequently do the same in reverse. Studies are done on patients and then prescribed to many more healthy people for prevention.
At first sight Lucozade seemed impressively evidence based with over 100 trials said to demonstrate benefits. On closer examination only one involved more than a hundred people – the minimum needed for a reliable result – while the average number in a trial was just 9 and few were placebo controlled. Drug trials have to have much larger numbers but in the past close examination has often revealed statistical fudges.
If you are offered a GSK drug, remember this company has form and Lucozade suggests it hasn’t reformed