It seems that hardly a month goes by without another shocking example of drug companies hiding, manipulating or lying about data in order to mislead consumers about the safety or effectiveness of their products.
The big cases that have garnered media coverage around the world recently were Vioxx and Avandia. But there’s constantly smaller, equally shocking stories of how pharma cherry-pick data to exaggerate how great their drugs are.
This week, the British Medical Journal (BMJ) published some amazing research showing that a reasonably common antidepressant — reboxetine (Edronax) — is actually completely ineffective and possibly harmful. And, what’s more, the only reason it appeared to be effective in earlier meta-analyses, was because Pfizer, the dug’s manufacturer, was hiding data that showed it was ineffective!
What’s more, the only reason we thought it was equally as safe as other common antidepressants (like Prozac) was that Pfizer were hiding the evidence that it was more harmful.
But, you might ask, how exaggerated were the claims of effectiveness?
Well, the German researchers calculated this by comparing what the published data said about the effectiveness of reboxetine, with what the pooled published and unpublished data said. The published data exaggerated the effectiveness by 115%. That is, it said it was more than twice as effective than it actually is, compared to placebo. (That means twice as likely to result in remission than it really was.)
It’s bad enough that Pfizer chose not to publish data that wasn’t positive about its shiny pill. But the real kicker to the story is that when the researchers initially approached Pfizer asking them for access to the data, they refused. Only after a report was published stating that there was no reliable evidence of the drug’s effectiveness, did Pfizer agree to hand over the data.
When they turned over all the raw data, the researchers uncovered biases in the published reports resulting from cherry-picking and biases between what trials were reported, and what were not.
As two editors of the BMJ said in an accompanying editorial, this kind of behaviour cannot be allowed. Compulsory preregistration of trials goes some way to solving the problem — it means that we know when trials are conducted, and not published. But to stop the biased analyses of the data, we need the raw data made publicly available.
I can’t help being surprised by the response pharmaceutical companies make when these revelations are made. Rather than saying “Yep, it looks like the drugs aren’t effective. We’ll withdraw them immediately,” or even, “Well, let’s wait a bit longer and see what the evidence says,” they almost always reply by saying that the drugs work fine.
GSK said it after it was revealed that they had fiddled with the evidence behind rosiglitazone (Avandia), Merck said it after Voixx and Pfizer are saying it now.
Until pharmaceutical policy is changed around the world, it really is going to be a matter of another day, another drug company cover-up. They’ll just keep getting away with it.
Godlee F, & Loder E (2010). Missing clinical trial data: setting the record straight. BMJ (Clinical research ed.), 341 PMID: 20940217
Eyding, D., Lelgemann, M., Grouven, U., Harter, M., Kromp, M., Kaiser, T., Kerekes, M., Gerken, M., & Wieseler, B. (2010). Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials BMJ, 341 (oct12 1) DOI: 10.1136/bmj.c4737
Given the potentially dangerous consequences of cherry picking and publication bias by these companies – that could result in patients going untreated, or even being harmed by their medication – should this not be considered a criminal issue; one akin to willful poisoning or knowingly withholding treatment?
It seems to me that the executives responsible for such decisions should be criminally prosecuted for conspiring to convince the public that unproven medicines are safe and effective. The final effectiveness should be irrelevant, since the intent was already to push the drugs as effective treatments irrespective of the unknown consequences.
And the thing that kills me is the damage that actions like this do to the credibility of scientific medicine in the public mind. When arguing for it as the only effective medical model, you always have to say, “Well, yes. The pharmaceutical companies are evil, but that doesn’t mean that all their drugs are fake.” Not very convincing to a great many people.
Alan, I agree. I think that there’s lots of cases where people responsible for great harm should not be able to hide behind corporations, as they currently can.
The other case that immediately springs to mind is environmental damage. Oil spills etc should result in individuals be considered criminal matters.
Without such a deterrent, the costs that result from fines or whatever are just taken into account by the companies in their expected utility calculations.
Scicurious has mentioned this post in the Scientific American Guest Blog. There she says that it’s not accurate to have reported that the researchers found that Reboxetine was “potentially harmful”. As I said in the comments there, I think it is accurate. In fact, it’s exactly what the researchers say themselves: