Lies and Stats
Posted on March 27, 2007
Filed Under For Argument's Sake |
GSK have just been fined for making false claims about the Vitamin C content of their Ribena product in ads in New Zealand. Here is a very interesting case. And it reminds me of the BBC and Blue Peter. It’s a bit about health and a bit about journalism
First GSK is one of the world’s largest pharmaceutical companies. As a group pharmas are generally critical of those who make health claims for foods and supplements. Lo, now they are owning consumer brands like Ribena they are converted to the health benefits of Vitamin C - trials underway in the USA show it can also be of value in fighting cancer but to date most pharmas have opposed that idea. Vitamin C is cheap and unpatentable, whereas chemo drugs are wildly expensive and patent protected.
So what hapepned in NZ? Two schoolgirls found that GSK’s Ribena had virtually no Vitamin C in it. GSK claimed it had four times the Vitamin C of oranges.
What was GSK’s explanation? Faulty testing methods.
Now I am rubbing my chin. Here is a company that goes through what we understand are some of the most rigorous regulatory testing in the world when it launches drug products. But it can’t test Ribena as well as two schoolgirls can. Leave aside your skepticism of drug licensing.
What reminds me of the BBC and Blue Peter is this - when they were found faking a competition result THE BBC’s explanation was - it was a mistake. Surely it was a deceit and corrupt?? And can a journalistic organisation like the BBC, one of the most rigorous in the world, not choose the right or accurate words?
Back to pharmas - can they manage the ethics of owning drug companies and consumer brands? GSK failed the NZ test and I hope I have time to follow more of their adventures in the retail trade.
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2 Responses to “Lies and Stats”
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Hi Haydn,
I spent three years working in the pharma research industry as an auditor, so I’ve seen quite a lot of what you’re talking about. You’re right - Home Office and FDA regulations are among the most rigorous of any industry worldwide. One drug from every hundred thousand discovered is chosen for progression, and it has to pass a battery of toxicological, safety, efficacy, and pharmacokinetic preclinical testing before it is even considered for clinical trials. Clinical trials must pass through four phases successfully, and even then, the drug can still be rejected for human use.
However, one thing I’ve learned is that all the regulation in the world is not worth a damn if the staff carrying out the work will not adhere to the standards in place.
Time and again I used to have to reiterate to staff that compliance with the regulations (and the procedures based on the regs) was the most critical part of what they did. I would never suggest that they falsified records (they didn’t), but I have certainly seen bad science, which in itself is enough to (unintentionally) skew results.
One of the main problems as I saw it (and the reason I got out of the industry) is that for all the billions of pounds the pharma industry makes, as little as possible is invested in the staff who carry out these studies. Spend millions discovering a drug? Sure. When it comes to the testing though, pay is unbelievably poor in light of the criticality of the work being carried out. Not only that, the education of staff - how what they’re doing affects Joe Public - leaves a lot to be desired. The bigger picture is never discussed. Can you imagine how much more likely a person would be to care about what they’re doing if it’s been drilled home to them that people’s lives depend on what they do? When they spend all day in the lab shaking test tubes, it’s no wonder a lot of them don’t even consider this. Apathy and complacency were par for the course among us.
That said, one of the things that often amused me was the horrendous quality of the data produced by doctors during clinical trials. Doctors, whose sworn purpose is to protect human life. You’d imagine that work on humans would be even more stringently controlled than pre-clinical work, but judging by the quality of data I used to see coming through, doctors themselves needed to be educated on the importance of producing quality output. The critical distinction between medical knowledge and the knowledge of how to conduct quality scientific research never seemed to be considered an issue.
Sorry, I tend to start ranting about this whenever I get into it.
[…] Science-ology* March 28, 2007 at 1:16 pm | In remember remember remember remember, people will see me and cry, I feel it coming together, I’m gonna learn how to fly HIGH, fame - I’m gonna live forever | This morning I posted a bit of a rant in journalist Haydn Shaughnessy’s blog. He was commenting about GlaxoSmithKline’s apparently lax controls over the quality of their work after a recent discovery (by schoolgirls!) that showed GSK’s claims about Ribena’s Vitamin C content were, at best, dubious. Having worked in the industry for a few years, I have experience of some of the things he was referring to, and so I chipped in rather a rant of a comment. I went back to his blog a while ago and was chuffed to find that Haydn had quoted some of my comment in a new post. Wahey, I’m famous. Cheers Haydn. […]