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Yes, you should be afraid, continued


By the numbers

20 million–80 million

number of people who died worldwide in 1918 as a result of an influenza outbreak better known as the Spanish- flu pandemic

500,000

number of deaths in the US in 1918 as a result of the Spanish flu

524,060

Number of deaths in the US (through 2003) as a result of AIDS since the genesis of the disease in this country

36,000

number of Americans who die each year from ordinary flu viruses

5

number of avian-flu varieties found in humans over the past decade

1997

year H5N1 first passed from birds to humans

6

number of people who died in Hong Kong as a result of the first H5N1-flu outbreak

23

number of people who died in Southeast Asia when H5N1 broke out in late 2003 and early 2004

100 million

number of birds in asia THAT died from the flu or were killed to prevent the spread of the virus between December and March

50 percent

mortality rate for reported cases of H5N1 in humans

1

number of people infected with bird flu in Virginia’s Shenandoah Valley in 2002 when a strain of the virus, H7N2, broke out among the area’s poultry

The Bush administration has also voiced its opposition to a plan, floated by UN secretary general Kofi Annan, to suspend patent rules in the event of an outbreak. Annan’s plan would allow more drug companies to manufacture their own versions of drugs like Tamiflu — the flu drug made by Roche Holding of Switzerland — or a future anti-flu drug. To the Bushies, intellectual-property protection is sacrosanct, so the US stands firmly with Roche, which announced a week ago that it would not relinquish its Tamiflu patent. By this Tuesday, Roche said they might be open to the idea, but there has been no such change of heart by the Bush administration.

But the big idea, the grand strategy for boosting flu-vaccine development and production, was rolled out in a new administration code word: "certainty." Certainty, Leavitt explained in the October 7 press conference, refers to assurance that drug companies will have a permanent, huge, profitable market for such products.

Leavitt’s idea is that the US can provide this "certainty" by "creating an ethic of vaccinations" — i.e., convincing tens of millions of Americans to regularly get flu shots they don’t particularly need.

More details on this plan will follow, but Leavitt has thus far been doing his part to whip up demand, by scaring the bejesus out of the general populace. For the past two weeks, Chicken Little Leavitt has called the global spread of H5N1 virtually inevitable, and he’s been quoted in major media outlets saying that "the world is woefully unprepared," "a pandemic is essentially nature’s terrorist," and "there will be a pandemic, and our preparation is not adequate." And sure enough: although Leavitt’s call for panic is not the only reason, demand for avian-flu drugs has leapt — Europe is now experiencing a run on Tamiflu, and there are reports that a run may be starting in the US. (Bids for a single course of treatment of Tamiflu on eBay were recently up to $175 dollars, roughly four times the normal prescription price, before the auction site pulled the plug due to its rules against selling prescription drugs.)

DANGER, DANGER

Much criticism has been leveled against the Bush administration for failing to stockpile Tamiflu. But stockpiling may prove to be a classic case of fighting a new war with the last war’s weapons.

Any drug useful for today’s virus will likely be useless against tomorrow’s. Viruses evolve through mutation, to survive against the immunity that humans build against earlier versions. Every year, pharmaceutical companies must create a new vaccine for regular, run-of-the-mill influenza, once they identify the new season’s version of the virus.

While Tamiflu, a retroviral drug, seems promising (though far from proven) against the current strain of avian-flu virus, by last weekend signs had emerged that the virus is already developing resistance to it.

Besides, Tamiflu is a treatment, not a preventive vaccine, and it must be administered within two days of contracting the disease. In fact, recent tests at the University of Minnesota suggest that it may need to be taken before exposure to the virus. As we’ve learned from Katrina (see "Will You Die?" sidebar), the US simply doesn’t have the emergency-response capacity to buy, store, secure, distribute, and administer enormous amounts of any needed item in that limited time frame. If anything, producing and stockpiling too much Tamiflu or other retroviral treatment drugs may actually prove counterproductive, because doing so will occupy what limited resources we have — resources we will need for making, storing, and distributing an actual vaccine when the time comes.

That’s why disaster-preparedness plans for virus pandemics, like the one Massachusetts drew up in 2001 and revised this July, assume a period of several months between the first identified case — and thus the first specimen for study — and the availability of a useful vaccine.

And therein lies the rub, particularly for a free-market economy like ours. To be ready to respond to an outbreak, we need to have, at the ready, an entire infrastructure in place for the creation, manufacture, and distribution of a drug that, until the time comes, does not and cannot exist.

Building and maintaining capacity for a theoretical future product is not something free markets do well. Companies do not invest millions in manufacturing facilities for non-existent products.

The Bush administration, which is full of former corporate executives, understands this problem perfectly well. "People are not inclined to produce product for which there is no market," Leavitt said on October 7.

For most other types of emergency threats to our population, the US government accepts this fact and takes on the job itself. We don’t rely on a for-profit Coast Guard to stand ready to save flooding victims from their houses, or on a for-profit military to stand ready to protect us against attack. We are, however, counting on the for-profit pharmaceutical industry to swoop in and save us from avian flu when the time comes.

But those companies have shown no inclination to do so out of the goodness of their hearts, and they are arguably even more resistant to government persuasion now than when Eisenhower and Johnson failed to spur them to action. Thanks to mergers and consolidations, there are now just five American vaccine-making companies, compared with 25 just 30 years ago — and only two of those five make an influenza vaccine.

The pharmaceutical industry, meanwhile, has become the single largest government-influence peddler, according to the Center for Public Integrity, spending well over $100 million a year on lobbying and campaign contributions. Most of that money comes via the industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA). Its current president is former US congressman Billy Tauzin who, just last year, was chairman of the House committee that regulates the pharmaceutical industry.

In short, judging by recent legislation and activity by agencies like the Food and Drug Administration, the US government is more likely to do big pharma’s bidding than vice versa.

Indeed, right after the October 7 top-level bird-flu meeting with the president, executives of two of the six companies, Wyeth and Merck, announced that they do not plan to start flu-vaccine programs.

The Bush administration’s only solution, then, is to continue upping the ante, guaranteeing more and more "certainty" in the form of enormous profits and minimal risk, until the drug companies deign to make a vaccine to save thousands, if not millions, of lives. In that vein, the US agreed this month to buy $100 million worth of a new bird-flu vaccine from French company Sanofi-Pasteur — regardless of whether it proves to be effective against any strain of virus that actually reaches the US, let alone whether it pass such trivial tests as FDA approval. Then last weekend, Leavitt announced that the US government is discussing the possibility of providing financial incentives or even direct aid to the six remaining gigantic pharmaceutical companies.

When the pharmaceutical and insurance industries demanded similar concessions during the 1976 swine-flu crisis, Congressman Henry Waxman asked, "Are you in effect saying that the insurance industry is using the possibility of a swine-flu pandemic as an excuse to blackmail the American people?" We sure could use more questions like that now.

David S. Bernstein can be reached at dbernstein[a]phx.com.

page 2 

Issue Date: October 21 - 27, 2005
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