War against disease vs profit margins

Vaccine crises top
bioterror: docs



As frightened Americans scramble for scarce flu shots, medical experts warn that chronic shortages of vaccines and other lifesaving medicines pose a greater threat to the nation than biological terrorism.
"Since 9/11 there has been a lot of erratic focus on bioterrorism prevention," said Dr. Irwin Redlener, head of the National Center for Disaster Preparedness at Columbia University's Mailman School of Public Health. "This creates fragility in the rest of the public health system."

More dangerous than biological agents, Redlener said, is the chronic shortage of vaccines and a lack of new antibiotics to fight drug-resistant superbugs.

"Monkey pox, avian flu, SARS, anthrax. All this was a total surprise in the field of medicine," said Dr. John Bartlett, chief of infectious diseases at Johns Hopkins University. "The system must be ready to react, but it is not."

Experts have warned repeatedly of the dangers of widespread cutbacks in vaccine production and research.

Dr. Julie Gerberding, chief of the Centers for Disease Control and Prevention, conceded only three weeks ago that the country's "entire vaccine program is fragile."

The U.S. got a wakeup call in 1989, when a measles epidemic struck. In three years, it sickened 55,000 Americans, resulting in 11,000 hospitalizations and 123 deaths, mostly of children under 5.

Efforts were taken to bolster the system. But rigid federal rules slowed vaccine production and low government-negotiated vaccine prices battered pharmaceutical companies' profits.

For big pharmaceutical companies, the profits are in drugs like the popular cholesterol-lowering Lipitor, which costs a patient $100 a month for life.

Today, only five companies produce vaccines, down from 25 three decades ago. One company is the sole provider of 21 different vaccines. There are only three licensed sources for meningitis vaccine, and just one each for polio, measles, diphtheria and anthrax. Despite terror threats, the U.S. has no licensed manufacturers of anthrax vaccine.

This lack of backup can create public health nightmares, as the current flu scare shows. Discovery of contamination at Chiron Corp., one of only two flu vaccine producers, crippled supply.

This is nothing new.

From November 2000 to May 2003, unprecedented shortages of eight of the 11 major pediatric vaccines - including those for measles, mumps, chicken pox, tetanus, diphtheria and whooping cough - caught the public health system off guard. This summer there was not enough anti-meningitis vaccine, forcing doctors to ration inoculations.

Currently the only critical shortage of vaccine is for influenza, according to the CDC. But few experts dispute that this could change at any time.

"The most predictable part of the situation is that it is unpredictable," Bartlett said.

Meanwhile, the pipeline for development of new antibiotics also has dried up.

Like vaccines, antibiotics are expensive to produce - it costs $800 million to $1.7 billion to bring a new drug to market - and they don't measure up in sales potential.

Only five of the 506 new drugs in development are antibiotics, according to a report in the journal Clinical Infectious Diseases.

Many experts fear that while the federal government has earmarked $5.6 billion to counter potential bioterrorism, it continues to shortchange prevention of diseases that can be equally ruthless.

"Not one American has died from bioterrorism since President Bush first announced Bioshield I in February 2003," Bartlett told the Senate Health Committee this month, adding that drug-resistant diseases have killed tens of thousands of Americans.

Originally published on October 31, 2004