Table of Contents:

Foreword

Introduction

I. Storm Gathering

1. 1918

2. Master of Metamorphosis

3. H5N1

4. Playing Chicken

5. Worse Than 1918?

6. When, Not If

II. When Animal Viruses Attack

1. The Third Age

2. Man Made

3. Livestock Revolution

4. Tracing the Flight Path

5. One Flu Over the Chicken's Nest

6. Coming Home to Roost

7. Guarding the Henhouse

III. Pandemic Preparedness

1. Cooping Up Bird Flu

2. Race Against Time

3. Tamiflu

IV. Surviving the Pandemic

1. Don't Wing It

2. Our Health in Our Hands

3. Be Prepared

V. Preventing Future Pandemics

1. Tinderbox

2. Reining in the Pale Horse

Topics

References 1-3,199

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Big business is not waiting for the government to get its act together. Multinational corporations have been stockpiling what Fortune described as “now the most sought-after drug in the world.”2499 Corporations from Microsoft to Shell2500 to General Electric have been advised to stock up on the dwindling global supplies of antivirals.2501 Virgin Atlantic chair Richard Branson snapped up 100,000 pills of Tamiflu for his employees.2502 One commentator poked fun at leaked corporate continuity plans, which have tended to concentrate on maintaining profitability through the pandemic. A column in the London Observer, titled, “Bird Flu: You’ll Die, but Your I.T. Will Survive,” spoofed lines like “Assess your business continuity preparedness for this type of workforce outage scenario and try to improve it (if necessary),” by adding suggestions such as “Bulk buy flowers and coffins as part of your business continuity preparedness for a permanent workforce outage scenario.” And “Set up email autoresponders to communicate: ‘Sorry, I’m out of the office due to death.’”2503

UN flu czar David Nabarro testified before a U.K. House of Lords inquiry into pandemic flu. He finds the pandemic plans of the large multinational companies “very, very scary” and is concerned that their “lockdown” attitude will interfere with potential coordination efforts. “They are closing down, retrenching, lockdown of personnel, staying in their homes, one or two months’ survival rations, their own Tamiflu stocks in some cases and other medications. That kind of reaction will make the necessary joined-up early response work very, very difficult.”2504

No law bars corporate hoarding of scarce lifeline medications in the United States.2505 The practice was apparently so pervasive among U.S. corporations that Roche decided to temporarily2506 suspend all shipments to private sector recipients in the United States.2507 Similar moves to stem corporate accumulations have been made within other countries.2508 Many doctors have also been quietly siphoning personal Tamiflu stockpiles for their friends and families.2509

It seems that unless we want to beg our politicians, doctors, or CEOs for a dip in their respective urinals, Joe Blow and Jane Q. Public are going to be left hanging out to dry without any medical protection. Should we all be buying a private stash? Nobel Prize winner Peter Doherty says yes, everyone should consider asking their doctors for prescriptions for Tamiflu to be filled and stored for safe keeping. Professor Doherty never leaves home without his pack of Tamiflu—what he calls his $56 “insurance policy.”2510

Others agree. Graeme Laver, the molecular biologist whose discoveries led to the invention of the antiviral drugs, said: “They should be available for people to get quickly. Imagine if one of your children develops fever and aches and pains, and you know the bird flu is around. You will want that drug now. But if it is all locked up….”2511 Laver has his own supply.2512 Laver’s colleague, the director of the WHO collaborating center on influenza in Australia, has a supply for his family. “Most people I know in the field have their own supply,” he said. “People need to give some thought to whether they want to take some responsibility for their own protection.”2513

A World Health Organization spokesperson was criticized for “risking panic” by recommending that everyone try to get Tamiflu for their families if they can. “We do recommend that in the average household you do have Tamiflu if you can afford it,” he said on Hong Kong’s public radio station, “and if you can find it in the present circumstances.”2514 In light of the drug’s scarcity, the president of the Hong Kong Medical Association thought it better that people didn’t know. “In view of the shortage of Tamiflu on the market, this particular expression may stir up people to go out and stockpile Tamiflu,” he said. “This will create even more stress.”

The American Medical Association opposes having a personal reserve of Tamiflu for two reasons. Although the AMA “understands the concern people have for their health and the health of their families,” it recommends against having a pack of Tamiflu “just in case” because people may accidentally initiate treatment for an unrelated illness, contending that “[n]eedlessly taking an antiviral may contribute to the problem of resistance to that antiviral drug, which would then make the drug less useful in the event of an actual avian flu outbreak.” The AMA also argues that the Tamiflu is needed now to treat seasonal cases of the regular flu, which can be dangerous in high-risk and elderly individuals.2515

Antiviral resistance is different from antibacterial resistance. The reason the medical profession’s overprescription of antibiotics is a bad idea is that when you take an antibiotic for a typical cough or cold, not only is it ineffective (because upper respiratory tract infections are overwhelmingly caused by viruses, not bacteria),2516 but you can generate antibiotic resistance among unrelated bacteria you harbor in your body.

The nostrils of between 25% and 30% of us are colonized, for example, by a bacteria called Staphylococcus aureas. In our noses, the bacteria does no harm; but if it gets into an open wound, “staph” bacteria can cause a serious infection.2517 Taking unnecessary antibiotics could turn this harmless nasal traveler into a “flesh-eating” superbug by selecting for antibiotic resistance.2518 Further, the bug could swap genes with other bacteria and spread the antibiotic resistance around.2519 Influenza viral drug resistance, however, cannot be generated in the same way.

People do not chronically harbor influenza virus. If, as the AMA fears, some people accidentally take their Tamiflu for the wrong illness, then it may be wasted, but it’s not possible to promote resistance because, by definition, they do not have the flu. In other words, there is no flu virus for the drug to affect. If, on the other hand, they took it correctly—when they started showing symptoms of a deadly pandemic virus—they might significantly improve their chances of survival, exactly what the personal stash was designed to do.

The AMA evidently wants to conserve the remaining U.S. supply of Tamiflu for the elderly and other high-risk individuals during the regular flu season. However, because it’s so difficult to accurately diagnose the flu outside of a known epidemic, a 2006 systematic review published in the Lancet concluded that Tamiflu “should not be used in seasonal influenza control and should only be used in a serious epidemic or pandemic….”2520 Additionally, the seasonal flu is so mild that even in high-risk populations the mortality rates of seasonal influenza—even untreated—is about 0.1%.2521 H5N1 currently kills about 50% of those affected.2522,2523

During this precarious time when Tamiflu is so scarce, might it not make more sense to safeguard the drug for the inevitable pandemic rather than use it against the regular flu—the opposite of the AMA’s recommendations?3171 Unfortunately, the AMA can’t have it both ways. At least, perhaps, the AMA should stop criticizing those with the foresight to obtain the drug to protect their families. U.S. Health Secretary Leavitt was asked if he personally had any Tamiflu at home in his medicine cabinet. He replied, “I have a blister pack of 10 with me.”2524

Some bioethicists are concerned about affordability.2525 It isn’t fair that only those who can cough up $50 to $100 in advance be allowed access to the drug, but do they really imagine poor people getting any once the pandemic strikes? Asked if he was concerned that only people who could afford the drug were likely to have their own supply, the president of the Royal New Zealand College of General Practitioners replied, “I’m afraid that’s how life works.”2526

As a public health practitioner and associate director within the Department of Homeland Security, Osterholm thinks it’s best to leave it up to the government to decide how to distribute the existing national stores.2527 After witnessing the bureaucratic bungling during Katrina, others are skeptical that the pills would be dispensed efficiently and equitably during a true national pandemic emergency. Might it not be better to get it into people’s hands now for safekeeping? Although Osterholm retains faith in the system, “[A]s a husband, a father and a friend,” Osterholm said, “do I think the idea of personally stockpiling is something you should be considering? Absolutely.”2528

Right or wrong, people are buying it up. Before Roche suspended shipments to North America in October 2005, it disclosed that more Tamiflu was being sold in a single day in Canada than was sold in all of 2004. In the United States, prescriptions were up more than 700%.2529 “Sales,” remarked one internet pharmacy spokesperson, “are definitely off the chart.”2530

If the early events in Europe’s experience with outbreaks among birds are any indication, the scant U.S. supply will dwindle even further. “Following four ducks in Romania carrying avian flu, Europe has gone mad,” the head of pharmaceuticals at Roche said. “I don’t think it is possible to find a single packet of Tamiflu in Paris anymore.”2531 After Turkey’s infected turkeys were announced, Belgrade sold out in a day.2532 The Turkish people snatched up their country’s one million pills within two weeks.2533

In the United States, scattered stocks of Tamiflu remain strewn among pharmacies across the country. After obtaining the necessary prescription from one’s doctor, those interested in stocking up may have to run through the yellow pages, calling around to pharmacies in order to find any Tamiflu locally. Internet pharmacies are another option, but may carry higher risk of counterfeit product.2534 U.S. customs agents have already intercepted shipments of counterfeit Tamiflu.2535 Even during the regular flu season, criminal cases of phony flu vaccines have emerged.2536 To reduce the risk of ordering fraudulent, misbranded, or adulterated drugs, one can stick to websites accredited by the www.nabp.net/vipps/consumer/listall.asp, the , or the www.ciparx.ca/cipa_pharmacies.html.

Roche marks boxes with a three-2537 to five-year2538 expiration date, but the drug is expected to last at least ten years without losing its activity if kept under proper conditions.2539 The drug should be stored at room temperature away from humidity—not in the medicine cabinet in a bathroom that can get steamy, under the kitchen sink, or in the refrigerator. Stuffing it in a sock drawer is fine, but the WHO cautions that “because antivirals will become valuable commodities during a pandemic, they should be stored in a secure place.”2540

Since Chinese poultry farmers may have rendered the entire amantadine class of antiviral drugs useless, Relenza is the only other option if Tamiflu is unavailable. Relenza was invented in the 1980s and remains the only other licensed drug within the chemical class of Tamiflu.2541 Relenza lacks oral bioavailability, though, meaning that it has to be directly inhaled into the lungs of flu patients with a special powder inhaler device. When the Tamiflu pill was invented in 1996, Relenza use declined, but it’s making a comeback, thanks to the Tamiflu shortage.2542

Governments favor Tamiflu.2543 The mode of inhaled delivery not only makes Relenza more difficult to self-administer, but may also preclude use by small children (who may not be able to follow a caregiver’s instruction) and those with asthma (because of potential respiratory side effects).2544 Relenza’s greatest drawback, though, may be its lack of systemic circulation. Although Tamiflu and Relenza are considered similarly potent against the virus,2545 very little of the inhaled Relenza is absorbed into the bloodstream from the lungs. This quality may make it safer for pregnant women to use,2546 but it may also make it a poor choice against viruses like H5N1. Relenza’s localized application may be fine for the seasonal flu or for milder pandemics in which the virus concentrates within the lungs, but H5N1 could hide from Relenza, storming its way through other organ systems of the body.2547

Relenza proponents do point out one important potential advantage to the drug: the seeming decreased likelihood—compared to Tamiflu—of generating viral resistance.2548 H5N1 is a “real fast learner,”2549 as one British expert pointed out, and already a few, rare, partially Tamiflu-resistant H5N1 strains have been identified.2550 If a pandemic strain were to emerge Tamiflu-resistant, Relenza would at least provide some protection. But, according to a spokesperson for GlaxoSmithKline, the drug giant that makes Relenza, the entire company’s supply for 2005 and 2006 has already been committed to health authorities. “This is not something you can just turn on the faucet and something comes out,” he said.2551

Tamiflu needs to be taken properly to diminish the risk of promoting resistance. Just as it’s important to complete a full course of antibacterial antibiotics, even after one starts to feel better, it’s important to complete at least the full five days of Tamiflu treatment. This would argue against making Tamiflu available over the counter, as Roche2552 and others2553 have advocated. Keeping it a prescription-only drug allows the doctors to impress upon their patients the need to take the full course. Another option would be to allow pharmacists to dispense it without prescription, but with proper guidance, ideally in conjunction with a rapid diagnostic flu test.2554 Flooding countries with cheap generic Tamiflu without clear instruction does raise a legitimate risk of fostering global resistance.2555 “Be careful of what you wish for,” warned one expert.2556

A more serious scenario is if the global poultry industry finds generic Tamiflu cost-effective enough to start feeding it to their chickens. Assuring that a generic version of Tamiflu is not and will not be used on poultry is “going to be very hard,” according to Osterholm. “There’s no evidence it is being used in China right now,” he said, “but we could have said the same six months ago [about amantadine].”2557