Industry takes the gloves off
But last February the industry upped its game and began a hardball fight back. Two pharmaceutical companies – AbbVie and InterMune – got an injunction to prevent the EMA from releasing any details about their drugs, bringing to a grinding halt the new transparency program as well.
What particularly shocked observers was that AbbVie were trying to keep hidden details of one of their drugs called Humira, which comes with a large range of nasty side effects – including skin cancer, lymphoma, leukaemia and acute liver failure. Used to treat, among other things, plaque psoriasis and rheumatoid arthritis it is precisely the sort of drug that patients should have full details on what they are letting themselves in for.
Last month, however, the European Court decided that EMA could keep releasing clinical trial data, while AbbVie was instructed to provide evidence for their claim that releasing information on their drugs would cause “serious and irreparable harm”. About the same time Roche agreed to give the Cochrane Collaboration access to all the 77 trials it sponsored on Tamiflu.
What was most surprising about the companies’ attempt to keep data hidden was their remarkable openness about why it was justified. Packaged up and rephrased in a variety of ways it all comes down to what they would call ‘commercial interests’ and what anyone else would call profit. John J Castellani from the ‘Pharma Research and Manufacturers of America’ has said by disclosing data ‘you’re essentially giving to competitors what we invested billions of dollars in’.
Side effects are commercially sensitive
The EFPIA, Europe’s pharmaceutical trade body, went even further. Together with AbbVie they argued that ‘adverse events’ in clinical data was classified as ‘commercially sensitive’. Translation: We’d like to keep quiet about the cancer and the liver failure in case it affects sales.
To buttress their case they argued that revealing what exactly had happened to individual patients (anonymised) taking the drug during trials ‘did not meaningfully contribute to the scientific review or evaluation of our products’. Imagine the response if a car manufacturer used a similar line to explain why it hadn’t told anyone about the tendency of a petrol tank to burst into flames.
The drug companies’ tough line galvanised campaigners for greater transparency to fight back. An organisation called AllTrials formed in the UK to push for publication of all data from clinical trials, collected 50,000 signatories. Supporters included high profile scientists and doctors as well as medical journals notably the British Medical Journal (BMJ).
However their most surprising and controversial signatory was Sir Andrew Witty, CEO of GlaxoSmithKline (GSK), a drug company whose record on concealing data had been a major impetus for transparency campaigners in the first place.
One of the most notorious of these was a clinical trial of GSK’s anti-depressant ‘Paroxetine’ known as ‘Study 329’ published in 2001. It found that the drug was safe and effective in treating adolescents. Last year GSK had to pay a £2 billion fine for hiding data showing that the drug was no more effective than a placebo and actually increased risk of suicide in children.
Repeated criminal activity
In fact it was just one of many fines levied on GSK over the last two decades for fraudulent drug pricing, illegal off label promotion and paying kick-backs to doctors. Writing in the BMJ, Drug company penalties are failing to curb illegal activities) a couple of months ago Dr Sidney Wolfe of the American campaigning body Public Citizen, pointed out that GSK topped the repeat offenders list having been fined a total of $7.56 billion over 20 years. During that period pharmaceutical companies had been fined $30 billion. Fines, Dr Wolfe claimed, had clearly failed to deter drug companies from “repeatedly engaging in criminal activity.”
All the same Dr Ben Goldacre, whose recent book Bad Pharma provided extensive ammunition for the transparency campaign, hailed GSK’s apparent conversion to the cause as an historic moment. Others were less impressed pointing out that although GSK have ‘pledged’ to make all their clinical trial data public dating back to the beginning of the company in 2000, we have yet to see any actual data being published.
Perhaps more revealing about the company’s true intentions is that, like AbbVie, GSK has set out conditions that will limit access to the data by allowing the company to decide who gets access and who doesn’t. If you wanted to have a look at their data, you’d have to come up with a ‘structured analytic proposal’, which GSK would have to approve. So not only can plans for research be rejected, but any plans that are approved will only be able to look at data that answers their pre-approved question, preventing any embarrassing chance discoveries.
What GSK’s apparent conversion reveals is how cynical and how apparently unaccountable the drug companies are under the current system. The saga of Study 239 is packed with examples of deliberate and consistent deception. Yet it has taken a decade to untangle it. Some of that job was done by researchers at the University of Adelaide; GSK refused to show them any data. True GSK were fined, but the amount was less than half of the profits of the company in that year – £4.7 billion. The penalty for harming and possibly even killing young people and then attempting to bury the evidence is no more than an exercise in naming and shaming, plus a relatively small fine.
Melayna Lamb
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Anybody who is concerned about this should sign up to and support the All Trials initiative. There’s a good writeup of this at Wikipedia: https://en.wikipedia.org/wiki/AllTrials