Tuesday, August 21, 2007

Pharma Loses Crucial Court Battle in UK

It's fascinating to contrast two different postings on PharmaLive.com. The first, from Datamonitor, an industry data management firm, crows about the hoped-for victory in which "patient power" wins in a British court, and the mean old National Health Service and its National Institute for Health and Clinical Excellence (NICE) lose. At stake is whether NHS patients with mild Alzheimer's disease are allowed to obtain drugs to slow the progression of their condition.

The second post reports that the court threw out 5 of the 6 charges against NICE, leaving NICE "guilty" only on a small technicality that it can easily address.

The reason the court found in favor of NICE, in hindsight, is simple. All the scientific evidence goes to show that these drugs, which have precious little effect on Alzheimer's at any stage, are especially ineffective when given early in the course of the disease. The Datamonitor article notes that Alzheimer's is a terrible disease; and that it is becoming more common with the aging of the population. Both true. But neither means that the drugs work, as much as we might wish they did.

This victory is a very important one because my colleagues who study "evidence-based medicine" view NICE as the single most important body in the world for trying to bring rational cost control to medicine. The agency basically looks at the scientific evidence about both the benefits and the costs of treatment and then issues a ruling about whether the benefits are great enough to be worth it. (Many people think if we are ever going to have meaningful control of medical costs in the U.S., it will only be because we manage to invent NICE's U.S. equivalent.) The reason why no court challenges like this (or at least few) have occurred till now is that NICE has been very nice to the drug industry. Most treatments, even some thought to be questionable, have previously been approved. The mild Alzheimer's case is one of the relatively rare instances of NICE digging in its heels. (Which means that had the court overruled it here, it would have been especially unfortunate.)

Datamonitor made a big deal of "patient power" in the form of the Alzheimer's Society, which joined the two drug makers, Eisai and Pfizer, in the court suit. The Society's presence proved that this was all about patients getting the drugs that they have a right to, and not about greedy companies making more money. It was considered unimportant that the Alzheimer's Society receives generous funding from the two drug companies. The Society primly pointed out that it used funds from other sources to pay its court costs. (See HOOKED for a more extensive discussion of "astroturf," or how the industry creates supposedly "grass roots" action that happen to favor its products by laundering its money through PR middleman firms and through these patient advocacy groups.)


No comments: