Destroying vaccine development

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President Bush is urging vaccine companies — those that are left — to find ways to jump-start production of vaccines to shield the world from the avian flu. However, there is little the president can do to quickly reverse a decade of policies and litigation that has killed the vaccine industry just as surely as the avian flu will kill millions of people, particularly children, worldwide. Price controls on pediatric vaccines, increased regulation of vaccine development and Vioxx-like litigation have caused continuing shortages of vaccines for influenza and childhood diseases. They have also have scared away the investment needed to produce huge quantities of shots to contain the avian flu and other outbreaks in a timely fashion.

Scientists are predicting that an avian flu outbreak could affect 25 percent to 35 percent of the U.S. population and kill more than 2 million people. Thirty million more around the world could die as well. The sickness and fear left in the wake of the epidemic will result in a massive global economic downturn. Think of September 11, Katrina, Rita, the AIDS crisis in Africa and the tsunami combined and then multiply it tenfold. That's the impact an avian flu outbreak would have on our way of life and well-being.

A vaccine against avian flu is under development. However, we lack the capacity to produce and distribute it to the millions most in need. The virus — H5N1 — is mutating into a form that could spread quickly from human to human. Therefore, the vaccine currently being developed might be useless. The expertise exists to reconfigure vaccines to thwart new strains quickly, but that requires production capacity we do not have.

Over the last decade, instead of promoting vaccine development, we virtually destroyed it. First, the Vaccines for Children program — Sen. Hillary Clinton's dry run for national health care — froze prices on childhood shots — and demanded bulk purchases. That one policy has contributed to the shuttering of state-of-the-art vaccine facilities and the exodus of several large drug companies from the business.

Then in the wake of the anthrax scare, politicians, including Sen. Charles Schumer and so-called consumer advocates, called for the government to seize the patents of drug companies and give them to generic firms who in turn would produce antibiotics like Cipro . Since then, companies have largely shied away from doing any business with the government out of concern that their products would be next. So, now Mr. Schumer wants the United States and other nations seize the patents of companies that make anti-flu medicines such as Tamiflu and Relenza. Not only will such measures dry up investment in flu-fighting medicines, but generic firms are unlikely to have the know-how to safely reproduce such complex products or have the margins to take on the legal liability of producing a medicine that if not properly formulated could be either ineffective or deadly.

Next, safety fears — ginned up by trial attorneys and demagogues like Sen. Charles Grassley — have led the FDA to demand longer and bigger clinical trials and tougher manufacturing standards. Hence, a rotavirus vaccine that will prevent 6 million childhood deaths a year from that disease was required to undergo a 60,000-patient study and nearly a decade to develop because of fears fostered by a rare side-effect found in 125 children immunized with another earlier vaccine for the disease.

Despite such delays and the threat of a pandemic that will kill millions, the staunch allies of the trial bar are still blocking any effort to limit liability for problems associated with an avian flu vaccine. They want to "protect" consumers, at least those that are still alive after a virus sweeps across the world without a vaccine to stop it.

As a result, many small biotech companies with excellent technologies that could be applied in creating vaccines tailored to different versions of the avian flu and other pathogens are simply limping along. They are mostly losing money in pursuit of better science thanks to threat of class-action lawsuits similar to those being brought against Merck, which also happens to be one of the few large vaccine makers left in the world. They are stalled at the FDA. And the threats of price controls and patent seizures are greater then ever. We have no vaccines to fight off bioterrorism more than four years after September 11 and we are ill-prepared to fight the avian flu .

It is said that by failing to learn from history we are condemned to relive it. By persisting in policies and lawsuits that punish the vaccine industry we are condemning millions to death. At a time when medical progress is entering a golden age, we are virtually defenseless against the dark clouds of disease that, once again, threaten to encircle the globe.

Robert Goldberg is the director of Manhattan Institute's Center for Medical Progress and the chairman of the institute's 21st Century FDA Task Force.