Friday, June 12, 2009

Pfizer Deceives, While GSK Shines

Pfizer has apparently held back clinical trial data for its anti-depressant reboxetine (known in Germany as Edronax) from IQWiG, Germany's drug-benefit assessment agency, leading the agency to declare "no proof of benefit" in its preliminary report.

The report was commissioned by Germany's Federal Joint Committee, which uses such information to determine which drugs should be reimbursed.

In holding back data from at least 9 studies of reboxetine (Edronax), which has been tested in at least 16 trials, according to IQWiG, Pfizer's committing "deception through concealment," according to Peter Sawicki, the agency's director, which he describes as a "non-trivial offence."

A Pfizer spokesman was quoted in German daily Die Welt as saying "we made sufficient data available to IQWiG". Whatever the truth--and why else would Pfizer hold back various published and un-published data, we ask, unless it was un-flattering?--it's certainly ruffled IQWiG's feathers.

The Agency issued a separate press release about Pfizer's misdeeds, alongside its announcement of the preliminary report on anti-depressants. In it, it talks about "publication bias" being "one of the most important and dangerous sources of error in medicine." Quite right too. And why is Pfizer's behavior just asking for trouble in this particular case? Because "other researchers have already shown that the effect of several [anti-depressant] agents has always been exaggerated in the published literature--up to 70%."

IQWiG has concluded that a 2005 agreement with one of the country's pharma associations whereby manufacturers voluntarily disclose clinical trial information, published and unpublished, is no longer reliable. It' s calling on an EU-wide legal obligation to publish results--including retrospectively, as exists in the US.

Pfizer isn't the only perpetrator here. "Companies have repeatedly refused to provide the institute with study documents requirement for the benefit-assessment," the press release continues. In this latest preliminary report on anti-depressants, Essex Pharma was also pushed into the spotlight for possible trial concealment, with the result that its drug, mirtazapine, received a distinctly luke-warm assessment as well.

Only GlaxoSmithKline shone as an example of how things should be done. In the case of bupropion XL, the institute was given "access to the complete clinical study reports by the manufacturer." And, guess what, there was proof of benefit for this agent compared to placebo in acute therapy and no indications of harm. (It wasn't a good as venlaxafine XR, mind you.)

These aren't big drugs, they aren't new drugs. But Pfizer isn't doing itself or the sector's reputation any good in holding back data. It should probably at least pretend to take IQWiG a bit more seriously, given the agency's role as a health-technology assessor in Europe's largest market.

All the more so since Pfizer has been stung in Germany before--like when it refused to accept authorities' decision to group Lipitor (known there as Sortis) into a broader 'jumbo-group' pegged at a similar price to other statins. The drug's share fell to below 3%, prompting Pfizer to return with a rebate deal.

And on the subject of rebate deals: we'll have some more posts on those shortly. For now, let's just say that they've become widespread since German payors have been allowed to negotiate directly with pharmacos. And the signs are that some companies now realize they have no choice but to get even more creative in building relationships with payors. So buck up, Pfizer.

image by flikrer Aelle used under a creative commons license

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