It’s a mission, however, that will never get off the ground if the pharmaceutical industry has anything to say about it. Big pharmaceutical companies have also expressed concern about vaccine supplies but claim that they are already working on a solution. Though the industry’s strategy has not been spelled out in detail, executives at Merck and other companies know what they don’t want: the investment of tax dollars in a big federal project. That, they argue, would be a disaster.In the weeks just after the October anthrax mail attacks, when concern about shortages was greatest, the drug companies issued reassurances that they were taking the supply problem seriously. The Washington, DC, lobby that represents drug firms-the Pharmaceutical Research and Manufacturers of America-recruited Michael Friedman, a former acting commissioner of the FDA, to manage an emergency working group made up of representatives from a score of drug companies. Friedman argues it would be a mistake to build a taxpayer-owned facility. The assumption that government must take charge because vaccines are inherently unprofitable is inaccurate, he says, contending that it was not just a lack of profits but national complacency about infectious diseases that led to a dearth of vaccines. All that has changed, Friedman says: “Now that we are facing a real bioterrorist threatpublic and private resources will be mobilized.”
Pharmaceutical executives are wary of anything that smacks of increased federal involvement in their business. Adel Mahmoud, president of Merck Vaccines, the world’s second-largest maker of vaccines, says the National Vaccine Authority plan is far too ambitious and would surely fail to meet its goals. He thinks many people underestimate just how difficult it is to produce vaccines on a mass scale. Moreover, he points to an eight-year-old federal vaccine purchase program that helps states immunize children-a program he says is already doing economic harm. Federal officials bargain hard to get a low price in these massive purchase deals, Mahmoud says. They “twist my arm to the point where [they create] a price cap.” And price caps discourage production. “In an open-market society, let the field develop according to the forces that will shape it,” Mahmoud says. “The more you regulate it, the more you undermine it.”
Large firms like Merck are the main players in vaccine manufacturing today, but biotech companies are making innovations that will be important for the future. And among the smaller companies, attitudes about the proposed vaccine authority vary widely. Some executives are strongly opposed-like William Haseltine, CEO of Human Genome Sciences of Rockville, MD. Haseltine says, “You don’t ask DOD to build fighter planes; why should it make vaccines?” He believes the government should invest not in production facilities but in the basic science of infectious diseases and coax academics into long-term partnerships with industry. “We need to rebuild and provide funding; the new scientists will come,” Haseltine says.
Industry skeptics like Haseltine are easy to find, but Thomas Monath, vice president for research at Cambridge, MA-based Acambis, says, “I am one of the rare people in industry who thinks it would be a good idea” to build a federal vaccine production facility. Monath, who began his vaccine development career on the army’s staff at Ft. Detrick, continues to advise military and civilian officials.
Another supporter of the idea is Franklin Top, executive vice president of MedImmune, a biotechnology firm in Gaithersburg, MD. Top thinks contracting out to a smattering of private firms might cost more money-and take longer-than concentrating the work in a facility owned by the government and directed by outside experts. “Once the big contracts are in place, you’re stuck with them,” he says. “These behemoths have a life of their own.”
The arguments for and against a National Vaccine Authority have been refined during a decade of debate over the issue. In many ways, however, the shock of the terrorist attacks changed the climate surrounding the vaccine debate in Washington, as well as in industry. As General Russell said right before he was recruited into the Bush administration, “People began to behave more in a manner of How do we solve a national problem?’ rather than How do I defend my bureaucratic ass?’”
But so far, neither the administration nor Congress has shown much enthusiasm for a National Vaccine Authority. Congress did decide to pour hundreds of millions of biodefense research dollars into the National Institutes of Health this year. But it did not draw up a master plan for translating research into vaccines-and it did nothing to address the shortages of vaccines for childhood and other common diseases. For now, the government is relying on the standard approach: giving out research grants and contracts and hoping that industry will rise to the challenge.
During the November 27 Senate hearing on vaccine shortages, Rhode Island senator Reed was obviously disturbed by the landscape of troubles that the experts described. This, Reed said, is “an amazing situation.” It is-one that will require an amazing solution. Perhaps that solution lies in a National Vaccine Authority, and perhaps not; it’s hard to see how those feuding over the question will reach a truce. If they can’t, and if the status quo is preserved, no less than the health of the nation will be the casualty.
|Diphtheria and tetanus||Nationwide shortage causing delays of routine booster shots for adolescents and adults||One of two manufacturers left market|
|Diphtheria, tetanus and pertussis||Nationwide shortage causing fourth and fifth boosters to be deferred||Two of four manufacturers left market; removal of chemical preservative forces change from multidose to single-dose vials, which cuts yield|
|Influenza||Only 50 million doses available in October 2001, as compared to 75 million in October 1999||One of four manufacturers left market; one manufacturer not in compliance with U.S. Food and Drug Administration’s manufacturing procedures|
|Measles, mumps, rubella||Delays of six weeks in delivery||One manufacturer, production problems|
|Pneumococcal||34 states face shortages, causing vaccination in children older than two to be deferred||Single manufacturer of new product|
|Varicella||Delays of six weeks in delivery||One manufacturer, production problems|
|Anthrax||U.S. Department of Defense suspends mandatory military vaccination; none routinely available for civilians||One manufacturer, FDA violations|
|Smallpox||U.S. stockpile only enough to vaccinate five percent of population||Original vaccine out of production; manufacturers of new vaccine yet to deliver product|