[Ip-health] The drug industry's long and ignoble history of secrecy

[Ira Glazer]

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By Jeremy Laurance, Health Editor/
2/27/08
/

Discovering, testing and bringing a new drug to market can take more
than a decade and cost as much as =A3500m. Over the past 30 years, as the
costs have mounted, so have the pressures to protect new chemical agents
which could become potential blockbusters.

Secrecy became the pharmaceutical industry's watchword as it sought to
control publication of trials and even manipulate results. Cancer drugs
introduced in the 1990s claimed to offer major benefits which later
turned out to be more apparent than real. Evidence published in The
Journal of the American Medical Association showed that 38 per cent of
independent studies of the drugs reached unfavourable conclusions about
them, compared with just 5 per cent of studies funded by the
pharmaceutical industry.

In 2004, UK researchers commissioned by Nice to develop guidelines for
prescribing antidepressant drugs to children tried to obtain unpublished
trials from the drug companies. They were refused. They then contacted
the individual researchers who had worked on the trials. Only then did a
picture emerge of increased risk of attempted suicide, and a lack of
efficacy. Nice concluded by banning the drugs for under-18s with the
exception of Prozac.

Yesterday's report suggesting that modern antidepressants offer no
significant clinical benefit over placebo has been dismissed by the drug
industry as "just one study" which should not be allowed to undermine
the wealth of research showing that the selective serotonin reuptake
inhibitor (SSRI) antidepressants are effective.

But that is to miss the point. The Hull University researchers have
demonstrated how partial access to research can give a distorted view of
a drug. The non-disclosure of data on the SSRIs has raised doubts about
the trustworthiness of all research on antidepressants.

We should be relieved that the licensing authorities have an absolute
right to see all trial data, positive and negative, before approving a
drug. But, bizarrely, Nice, with the responsibility for deciding which
drugs should be used by the NHS, only gets what the drug companies agree
to give it. The Health Select Committee has called for action to remedy
this omission. Ministers must respond.