April 26, 2008
Vioxx “Ghost Writer” Disclosure Emphasizes Need For Fundamental Changes In FDA Approvals
Big Pharma’s ethics also need a major overhaul or the industry will go the way of the dinosaur.
The Journal of the American Medical Association (JAMA) reported this week that Merck and Co. faked reports on Vioxx. In other words, Merck employees wrote the reports, then attributed the articles to academic investigators hired and paid by the company to use their names.
Now that the JAMA report has made national news, all sorts of industry insiders are coming out of the woodwork and saying it’s common knowledge that Big Pharma hires ghost-writers — pays for the use of academic names — for research and development reports.
For example, in the In The Pipeline blog this week, Derek Lowe says there’s little doubt that the practice goes on. “I’ve never been in a position to see it happen, but it’s been reported for years,” he says.
Lowe points out that no one is suggesting the articles contain bad science or that conclusions drawn in them are faked, even if they written by Merck people.
“I haven’t seen anyone suggesting that the Merck studies themselves are bogus – they had damn well better not be – but by playing games with the external author list, the company invites suspicion,” Lowe says. The practice is driven by what he suggests is a need to bolster a drug’s image because of the money involved. Developing a new drug and shepherding it to market is enormously expensive.
Lowe gets close to the truth when he concludes that the only way to win back public trust, which he says “we’ve lost, in case anyone hasn’t noticed”, is to cut out the shortcuts and double-talk and “act as if what we’re doing — drug discovery — is something to be proud of.”
Calling for ethical changes in Big Pharma’s approach to its business is right on the money. But Lowe shows a lot of altruistic optimism when he says if such practices aren’t curtailed, the industry could face serious price controls, lots and lots of marketing restrictions, the FDA raising the bar for approvals to never-before-seen levels, and “flocks of lawyers beating their wings, circling around our every move” — as if Big Pharma can, on its own, accomplish the fundamental changes it needs to make.
Seeing as Big Pharma’s shady practices are so ingrained and so widespread, it seems to me that one of the measures Lowe warns of — the FDA revamping its approvals process and raising the bar – will almost certainly not be enough incentive to get Big Pharma’s ethics levels demonstrably high enough to warrant a return of public trust.
And while we’re talking about public trust, let’s face the flip side. The FDA itself has a long way to go in that department, too. The public wouldn’t be forced to resort to lawyers and the legal system if the FDA was really on the job.
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