Saturday, October 22, 2005

THE ATTACK ON OUR GUARDIANS AGAINST DISEASE

In the wake of the management snafus of Katrina, President Bush was asked about the avian flu threat at his October 4 press conference; he offered a thoughtful answer which shows, at least, that no hapless Michael Browns will be in charge of a Viral Big One.

Yet once again, we don't know the future; we don't know whether the US government's response will be equal to the challenge. But some distant early warning indicators are not so promising; one of Uncle Sam's scenarios envisions shortages of food, medicine and electricity, followed by mass riots and the ultimate death of 1.9 million Americans. In other words, as we stare into the tiny grains of the flu virus, we could be looking at Katrina multiplied by a thousand. This is the best we can do? The richest country in the world? Clearly, what we have seen over the past few decades hasn't been management, but rather malpractice.

But even before we get to the management blame game, we should be looking toward the manufacture of a cure. Unfortunately a cure doesn't exist -- a future action item if there ever was one, which we will come back to later. For now, we do have an anti-viral medicine, called Tamiflu, but we don't have enough. Indeed, at present, so parlous is our condition that even if we wanted to start manufacturing more right away, it would still take years to build up an adequate stockpile.

What's more, as Waldemar Ingdahl has noted here at TCS, since 1970, the number of companies producing vaccines has fallen by 80 percent. Which is to say, while the need has been going north, the supply has been going south. What explains this wrong-way trend? One reason is that the government has practiced a kind of malign neglect toward vaccines and toward the innovative side of the pharmaceutical industry.

Consider the fate of Merck. The New Jersey-based company is currently being clobbered by costly Vioxx lawsuits, based on junk science, as the federal government watches passively. Yet even so, Merck has persevered on a vaccine for the human papilloma virus, which accounts for perhaps 70 percent of the world's cervical cancers. It would be a tragic shame if Merck were knocked out of the innovation box by big lawsuits, before its vaccine, Gardasil, ever reaches the women who need it. What national interest would that serve?

We need to rethink our approach to manufacturing, because at present, US government mismanagement -- tolerance for predatory lawsuits -- is undercutting the productive and lifesaving fundaments of the pharmaceutical industry. Indeed, motivated by a strange mix of desperation and calculation, many governments around the world are considering compounding past mismanagement with still more mismanagement. Here's how: Hans Hogerzeil, acting director of the department of essential drugs and medicines policy at the World Health Organization, demanded recently that Roche, the maker of Tamiflu, cut its price and waive its patent rights, so that anybody, anywhere, could make the drug.

Hogerzeil's comments stand in sharp contrast to those of his boss, Lee Jong-wook, who, mindful of the enormous investment needed to make medicines, has said that it is bad policy to weaken drug patents, since they are the cornerstone of production. But of course, it's Hogerzeil's flamboyantly anti-corporate populism that grabs the attention of the controversy-crazed world media.

If any of this legal-medical jousting sounds familiar, it should. Because the same Hogerzeil and the same WHO had the same bright idea about AIDS drugs. Working closely with NGO activists, the world's public health-ocracy cooked up a scheme to "pre-qualify" copycat AIDS drugs, manufactured in India, onto the market. But "pre-qualification" proved to be a synonym of "non-quality." So great was the danger of these pseudo-drugs that they had to be withdrawn from the marketplace. It was a humiliating for the neo-Naderite "H Team" of genericists, but evidently not so humiliating that the H-ers aren't up to the same trick again.....

If it costs close to a billion dollars to make a drug, and if future profits are non-existent -- well, it doesn't take much management expertise to see that future discovering and manufacturing will be non-existent, too.

More here




Bravo! Less money for drug research and more money for lawyers: Just what the world needs: "Swiss drugmaker Serono SA has agreed to pay $704 million to settle criminal and civil charges that it illegally promoted its AIDS drug, prosecutors said yesterday, in one of the biggest sums collected in the government's growing scrutiny of pharmaceutical firms. The company's Serono Labs unit of Rockland agreed to plead guilty to charges it conspired to market Serostim by supplying doctors diagnostic software that was not fully approved by the Food and Drug Administration. The software, prosecutors said, led to an increase in demand for the drug prescribed to treat wasting in AIDS patients. The company also agreed to plead guilty to offering doctors all-expense-paid trips to a medical conference in Cannes, France, in return for writing prescriptions of Serostim, an arrangement that US Attorney General Alberto R. Gonzales blasted as 'The 'Cannes Kickback' campaign.'"

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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