Website Highlights Unpublished Drug Trials

John Lister's picture

An independent website is listing companies that have failed to publish clinical trials results, despite being legally required to do so. The site could help reduce the problem of drug companies keeping quiet about results that don't help their business.

Critics of the pharmaceutical industry say that although published trial results may be genuine, they can still be misleading. That's because a company might publish the results of a trial that suggests their drug is effective while not publishing trials that are less clear-cut. That's led to calls for all clinical trial results to be made public.

It's not yet a legal requirement, however, as of this month a section of a law passed in 2007 has finally taken effect. That law says companies must publicly register certain types of trials and then publish the results with one year of the trial being completed. These include any trials on already approved drugs that are carried out on US citizens.

Tardy Organizations Listed

Despite the Food and Drug Administration (FDA) having the legal authority to impose fines on companies that miss this deadline, it turns out some companies have not published the results as required.

Dr Ben Goldacre, a long-time campaigner for greater transparency in drug trials, believes it's too difficult and time-consuming for people to trawl through Food and Drug Administration records to figure out which trials are in this situation. He's started a 'TrialsTracker' website that automatically gathers together this data and lists the raw numbers and percentages of how many trial results each company has reported on time.

The site also tracks the total amount the government could have collected in fines for the missed deadlines, along with the actual amount of fines it has imposed - which is currently zero. (Source: trialstracker.net)

FDA Questions Rankings

Goldacre says the aim isn't so much to 'name and shame' offenders, but rather to pressure them to put more efforts into complying with the law. At least one organization has added the missing results after being listed on the site. (Source: bbc.co.uk)

The FDA says the data it makes public, which TrialsTracker uses for its rankings, isn't necessarily sufficient to say for certain if a company has missed the deadline.

What's Your Opinion?

Is the TrialsTracker a worthwhile exercise? Should the government be producing its own accountability tables of whether organizations comply with regulations? Is it dangerous for outside bodies to produce such rankings?

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Comments

ifpusr's picture

Incredible. Anyone who has read 'Bad Pharma' by Ben Goldacre will know how overdue and how critical is action on this issue. The amount of money at stake around the possible discrediting of numerous shonkily and prejudicially researched drugs is in billions as big pharma systematically bury research not supporting efficacy of their products, do their best to conceal the fact of pharma-funded research that supports their products, and any other egregious activity possible to maximise profits. There is total corruption involved with this. $ talks, truths balks.

I'll be fascinated to see whether public opinion will shift things after this site gets well-known.