Bird Flu Blues

Last week, we learned that deadly avian flu has spread from Asia to Europe, poised to become the next human influenza pandemic--perhaps even more deadly than the 1918 flu, which killed 20-50 million people worldwide.

Leaks from a U.S. government report revealed that our country is utterly unprepared for such a calamity. And a new scientific study proved that the 1918 flu jumped directly to humans from birds--as might today's encroaching avian flu strain, known as H5N1.

In other words, of all the natural and manmade disasters that have plagued humankind in the past year, something worse may be just around the corner: a global epidemic of lethal influenza long feared by public health experts and infectious diseases specialists.

If that happens, the Bush team will be on the line as never before. If the administration handles this challenge correctly, it could lead the world in preventing unnecessary deaths and actually saving lives. If it fails, millions here and abroad could perish; the wrenching accounts from the 9/11 Commission could pale before the heartbreaking tales from the Pandemic Influenza Commission.

Today, according to the World Health Organization, a flu pandemic could kill 150 million worldwide--including, in a worst case scenario, 2 million Americans. Simply put, such an outbreak is today's number one worry among public health officials, especially because the H5N1 bird flu strain is extraordinarily virulent, both in birds and mammals. Human flu pandemics, sown in nature by viruses found in migrating aquatic birds, cannot be prevented. Over the past century, they have occurred about every 30 years. The last one took place in 1968--which means we're overdue for the next. No matter where on earth a pandemic takes root, high speed transportation would guarantee its transcontinental spread within weeks. High speed communications would guarantee global panic within hours. Whatever the course of today's H5N1, flu pandemics are inevitable.

To understand how federal officials could best handle this impending disaster, I consulted Dr. David Fedson. Fedson, an American, is former director of medical affairs for the French pharmaceutical company Aventis Pasteur MSD (now Sanofi Pasteur). Since retiring from his corporate post in 2002, he has been the most persistent and articulate gadfly of government and industry on their failure to prepare for the next monster wave of flu. Both as a scientist and a scholar, he has thought more deeply and written more prolifically than anyone else on the topic.

Earlier this year, in an interview about pandemic flu for the journal , he had told me: "We have a toxic mixture in America of a corporate culture that is inappropriate for producing vaccines for national security, and a political culture that is unwilling to accept government responsibility for ensuring it is achieved."

American leaders, Fedson explained to me, should learn from the lessons of history, back the best science with meaningful money, and at last adopt an attitude of collective responsibility for the planet.

Specifically, that means:

• Washington must offer financial incentives to American drug companies, so they wouldn't go broke making an emergency vaccine. • In case of a pandemic, drug companies must agree to suspend patent rights. • The federal government must accept all liability costs for pandemic vaccines. • The Bush administration must lead an international campaign to prepare for, and defend against, the next flu pandemic.

Let's look at these one by one. First, our country must be able to produce pandemic flu vaccines in a hurry. That requires immediate public funding for clinical trials of the most promising vaccine candidates. But right now, no American-owned pharmaceutical company produces pandemic flu vaccine.

Indeed, over the last decade or so, many American drug firms got out of the vaccine business altogether, because these commodity medicines are expensive to develop, cheaply sold and fraught with the risks of harming previously healthy people. If no American drug company can churn out a pandemic vaccine, we'll be left high and dry when the next globe-girdling outbreak begins. Other vaccine-producing countries will want to inoculate their populations, and will horde their pharmaceutical cache. We won't get any.

Our only hope is the French firm Sanofi Pasteur, which is the sole manufacturer of pandemic vaccine on U.S. soil. But because of technical and bureaucratic obstacles, it would be impossible to make a vaccine that could be produced rapidly and inexpensively for all the Americans who need it. Meanwhile, our supply of antiviral medications, which could be prescribed once a pandemic is underway, is also extremely thin.

To encourage more American drug companies to shoulder their pandemic responsibility, Fedson believes the federal government should guarantee that it will buy large quantities of the drug at an agreed-upon price.

Second, should a pandemic emerge, companies that hold the patent rights to vaccines and antivirals must allow generic production of their products, so rich and poor alike can benefit from the drugs. This month, UN Secretary-General Kofi Annan suggested just that, noting that the agency would encourage pharmaceutical companies "to be helpful, making sure that we do not allow intellectual property to get in the way of access of the poor to medication, allowing for emergency production of vaccine in the developing countries."

Patent rights are especially pertinent. A key laboratory technique for making pandemic-quantity vaccines, known as reverse genetics, is covered by patents owned by a U.S. company and a U.S. academic institution. Questions about intellectual property rights have delayed the roll-out of this highly promising approach. According to Fedson, now is the time--before a pandemic has exploded--to sort out these issues.

Fedson's third point--that Washington must agree to accept the costs associated with vaccine liability--stems from lessons learned back in 1976. That year, a flu strain appeared that was similar in make-up to the horrifying 1918 virus. Fearing a new pandemic, public health officials ordered emergency vaccine production under government contract, followed by a mass vaccination campaign. But everything went wrong. Liability worries stalled vaccine makers. Among the 45 million Americans who were eventually immunized, some suffered Guillain-Barré syndrome, a painful neurological disorder. That December, beset by controversy from the start, the vaccine program got the ax. Adding insult to injury, the predicted swine flu pandemic never happened.

Today, we have safeguards against the kind of debacle that occurred in 1976. Though there are never guarantees that a new vaccine is perfectly benign, careful clinical trials should expose most problems early on. And because of better surveillance and lab technology, we would know when a real pandemic was afoot.

Which brings us to Fedson's fourth point: the U.S. should help organize a broad-scale international effort to prepare for that inevitability. One model may be the Global Fund to Fight AIDS, Tuberculosis and Malaria. This public-private partnership commands both political respect and the power to write contracts, buy drugs, deliver it to the right places, and bolster local health facilities. A similar group dedicated to pandemic flu preparedness would spearhead vaccine development, production, and distribution; fund clinical trials; and design logistics for distributing vaccines equitably across the globe. 

Yet while looking abroad, we must also take care of matters at home. Tragically, our local public health departments--the true front lines in the battle against infectious and all other diseases--have been weakened in recent years by budget cuts. A pandemic surge could overwhelm hospitals with up to 10 million patients. Nor does it bode well that President Bush in 2004 appointed Stewart Simonson--a crony of former Secretary of Health and Human Services Tommy Thompson, and lawyer with no hands-on public health experience--as Assistant Secretary for Public Health Emergency Preparedness, a job that includes coordinating the nation's flu pandemic response. 

How did the role of public health--one of the towering moral and scientific achievements of the 19th century--shrink in recent years? For one thing, many of our political leaders consider disease prevention a cost, not an investment. Our corporate culture demands a 15-25 percent annual net return on sales, which life-saving commodity products such as vaccines never attain. Republican political ideology holds that market forces can solve all problems, and that less government is more--demonstrably untrue when it comes to preventing disease across populations. 

Yet when necessary, political calculation can trump political ideology. After the 9/11 attacks and subsequent anthrax outbreak, U.S. officials figured out a way to quickly stockpile and produce enough smallpox vaccine for every American--and spent billions of dollars to do so. They didn't feel the same urgency about pandemic flu, which is far more likely and far more deadly. 

Reading the headlines this past week, which were bristling with grim presentiments, I wondered if it was already too late to rein in the next flu pandemic. I put the question to David Fedson. "It's always too late, and it's never too soon," he said brightly. "But we've got to start somewhere."

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