Thursday, October 27, 2011

Corporate ethics: the Xigris example

Howard Brody has a post up about Eli Lilly's pulling the sepsis drug Xigris from the market and, of particular interest, the story (if the reports are accurate) of how the corporation had maneuvered to get it used:
The part of the Xigris story that especially caught my attention was how some of my colleagues in bioethics were caught up in the company's PR campaign without apparently realizing it--or else taking the money and not caring. As one prong of the marketing strategy, Lilly decided that since Xigris cost so much, and since so few ICUs were purchasing it (since the studies had been so equivocal), then there must be rationing of life-saving treatment going on. Of course one solution would have been to lower the price, but perish the thought. So Lilly instead forked over $1.8M to fund an "ethical" study of rationing in the ICU, with the intent of bringing pressure to bear on recalcitrant units with the dreaded "R word."

The part of the story that I did not cover in HOOKED, as Williams reminds us, was actually addressed in a 2006 commentary in the New England Journal (subscription required) by Eichacker and colleagues. Having managed to get the FDA to approve Xigris despite iffy data of efficacy and safety, Lilly bankrolled a big PR firm to do three things--set up the rationing "ethics" inquiry, and get major medical societies to write guidelines for sepsis care that included the use of Xigris (by funding the guideline panels and making sure that numerous docs with Lilly money in their pockets served on the panels). The third thing however was what made Eichacker and company worried. It was Lilly's subsequent effort to lobby the organizations that create quality indicators for hospitals and insurers to include those guidelines in their quality measurements. That is, if an ICU did not use Xigris, because they deemed it insufficiently useful and overly dangerous (a reasonable evidence-based position at the time), the hospital might get a lower score for quality of care and then have problems with insurance reimbursement as well as the bad publicity. Eichacker et al. very reasonably said this was a blatant hijacking of these quality indicators for commercial purposes.

...Why bother sending drug reps into thousands of doctors' offices if you can buy off the people who write the guidelines and the people who ding the hospitals for bad quality of care?
To reiterate: They hired a PR firm to portray the non-use of their drug as rationing, lure ethicists - ! - and guidelines developers into going along with this framing, and work to get the quality-rating organizations to favor the use of their drug and penalize those hospitals that weren't using it. For a drug with little evidence of efficacy and which in the end was withdrawn for a lack of it.

Brody quotes David E. Williams' advice to the drug companies:
--Industry: Feel free to market your products and services aggressively, but don’t take things too far. If you do you’ll end up killing the goose that lays the golden eggs. No one will trust doctors, guidelines or journals anymore
First, the idea that it's morally acceptable for corporations making medications to put the interests of their shareholders above those of the people taking the medications is a huge problem. Of course, that's to be expected in a corporate-capitalist system. They've been getting away with it, and indeed escalating, for decades, and moreover have other means of attaining their goals. They're not going to worry about this alleged long-term risk to reputations. Nor are doctors and medical organizations - in a situation in which these corporations are free to pursue their interests aggressively - going to counter them. Regulations, if they were passed and enforced, would make some difference,* but the real meaningful solution is to separate corporations from medicine entirely. Or, at the very least, to take out the worst offenders by revoking their corporate charters or holding their executives personally criminally responsible.

* In this specific case, a report on the drug's withdrawal notes that the study showing a lack of effectiveness was "ordered by European regulators in 2008 as a condition of the product's continued approval there."

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