Anthony Cox writes:
Even accepting Ben Goldacre’s points about poor media reporting tagged on the end of his excellent post about the pharmaceutical industry’s failures to give the whole story about their products, prompted by the PLOS study on anti-depressants, it has to be accepted that the Independent’s front page lead screaming Drug giants warned: Tell the truth on medicines is in the main correct. The pharmaceutical industry have continually let the public, and themselves, down over the years, even if on balance their products provide a public good. While the days of being able to market medication with zero evidence of safety and efficacy are long gone, even with the regulation that has developed over the past 50 years, the pharmaceutical industry still manages to shoot itself in the foot. Over and Over. And Over. Again.
With an increasingly sceptical public, especially on vaccines, the pharmaceutical industry must maintain the highest standards of scientific openness. Every time they place a banana skin on the floor, and then run at it, public faith in medicines is undermined. It is unacceptable that organisations like NICE cannot see all the studies conducted by drug companies. While the homeopathy industry avoids performing studies that may show their products won’t work, the pharmaceutical industry conduct studies and then cherry pick those that do show an effect. On Radio 4’s today programme I even heard a newsreader say that industry were contesting the PLOS study on the basis that it was not in line “with patient experience”. Yep, that’s the same anecdotalism argument you hear from homeopaths and other cranks.
Get the data out in the open. Let it be scrutinised and live with the results.
It is increasingly clear that the pharmaceutical industry prefer to be dragged along to what is an inevitable conclusion and in the process further damage their reputation.
Which leads me onto another point. Ben pointed to a blog post on the excellent Science-based Medicine blog about the use of unlicensed medicines with his Miniblog. His comment was “Quacks often make a shrill fuss about drugs being used off license, because they don’t understand that licenses don’t have a huge amount to do with the evidence for and against.” He is, as always, quite right. Without the unlicensed use of drugs many patients would not receive effective treatment. An obvious example is paediatrics. Despite attempts to encourage companies to obtain licences for indications in children, which hopefully may improve the situation, many treatments in children are unlicenced. Currently, drug companies are not allowed to push or market unlicensed indications.
In an ideal world the FDA’’s proposal to loosen up the rules, so that companies could inform prescribers of unlicensed use, would be fine.
The U.S. Food and Drug Administration (FDA) today issued draft guidance on “Good Reprint Practices” for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
“Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” said Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”
But as the PLOS study shows, it is not an ideal world. This is the thin end of a wedge. Opening a door to this activity could undermine the effects of regulation to ensure claims about efficacy are backed up with evidence. In another PLOS study it was shown that 38% of drug representative visits concerning gabapentin included at least one unlicensed use. Given the state of pharmaceutical industry at present, and what we know about their marketing methods, the FDA proposal seems naive and potentially dangerous.
http://www.blacktriangle.org/blog/
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