1 Boring Old Man

I think Deep Throat’s line, "Follow the money," was a bit of fiction from screenwriter William Goldman rather than historical fact, but it doesn’t matter. It captured a principle that may well outlive its origins. Here, Ginny Barbour uses it with finesse:

Follow the Money; or, Why it Took an Accounts Committee to Decide Why Access to Clinical Trial Data Matters

PLoS blogs

By Virginia Barbour

January 3, 2014

Ginny Barbour, Medicine Editorial Director at PLOS, discusses a recently-published UK Government spending report on access to clinical trial information and the stockpiling of Tamiflu.

Yesterday the UK Parliament’s Public Accounts Committee, which monitors UK Government spending – focusing on “value-for-money criteria which are based on economy, effectiveness and efficiency” – published a rather amazing report; not just because of the topic of its enquiry but in particular its conclusions, which have implications well beyond the UK. The topic was “Access to clinical trial information and the stockpiling of Tamiflu”: the conclusions were that the money spent on Tamiflu was likely misspent, and moreover the lack of access to clinical trial data more widely is unacceptable.

Richard Bacon MP, member of the Committee of Public Accounts, said in  quote which succinctly sums up how unacceptable the current position is :

“The full results of clinical trials are being routinely and legally withheld from doctors and researchers by the manufacturers of medicines. This has ramifications for the whole of medicine. The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined. Regulators and the industry have recently made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today.”

Or, as the report’s summary says

“This longstanding regulatory and cultural failure impacts on all of medicine, and undermines the ability of clinicians, researchers and patients to make informed decisions about which treatment is best.”

AllTrials, a coalition spearheaded by Ben Goldacre [doctor and author of Bad Pharma], the charity Sense About Science, the BMJ, PLOS [where I am the Medicine Editorial Director] and a group of independent academics, was born out of real anger that the many backroom discussions on trials were simply going nowhere and there was a need to bring the issue of hidden data into the public view. The campaign has been successful in mobilizing academics and patients groups, has lobbied UK and European Parliamentarians and overall has been a key reason in the movement toward more transparency of a number of pharmaceutical companies.

It’s ironic in the end though that it may take a Committee whose job it is to look at spending to point out what Health Departments seems to have been willing to ignore – that hiding clinical trial data is tremendously damaging to society, at an individual, professional and yes, even a financial level.

Ben Goldacre sums it up thus:

“We cannot make informed decisions about which treatment is best, when vitally important information is routinely and legally kept secret. Future generations will look back at this absurd situation in the same way that we look back on mediaeval bloodletting.”

It’s not really so ironic, it’s the way the world works. Allen Jones ran across a funny account working as an investigator for the Pennsylvania OIG. The trail he followed ended up busting a mega-scam called TMAP, still under-prosecuted. How could we be surprised that it was the money spent by the British government on Tamiflu that finally revealed that the efficacy of the drug rested on selected clinical trials, and there were a raft of unpublished trials sitting in Roche’s file drawers? Joel Grey and Liza Manelli told us that "Money makes the world go round" a long time ago. Thus, the Pharmaceutical industry and friends have tainted the integrity of the medical profession as a whole keeping it spinning…