Another day, another drug company cover up

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...

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by comparing what the published data said about the effectiveness of reboxetine, with what the pooled published and unpublished data said.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