Shortage Was Predicted [NYT]
By DENISE GRADY
Published: October 7, 2004
Zeta, as long as we're ranting... Doc
America's dependence on just two companies for nearly all of its flu vaccine has left the nation in a vulnerable position, on the brink of the flu season with about half as much vaccine as officials had expected. As a result, health officials, who usually nag the public to get flu shots, now find themselves imploring healthy people to skip the shots to save vaccine for people who need it more like babies, the elderly and people with illnesses.
It is a problem that public health experts have been predicting for years, warning that too few companies were making vaccines and that the government, although aware of the problem, was not doing enough to encourage companies to stay in the field so that the United States would not be so dependent on a few manufacturers.
The shortfall, which federal officials announced on Tuesday, arose because of manufacturing problems at one of companies, Chiron, which the United States had been counting on for 46 million to 48 million of the 100 million doses planned for this year.
Chiron said it could not provide any vaccine, because of a manufacturing problem at its plant in Liverpool, England.
The problem is the latest in a series of shortages of vaccines in the last 10 years or longer, as the number of vaccine manufacturers has dwindled.
Drug companies left making vaccines because it was not profitable, public health experts say, and many use the word "fragile" to describe the vaccine supply.
Flu vaccine is difficult to make, and the market is uncertain, because outbreaks vary from year to year, and in mild seasons many people simply skip the shots. But most of the time the vaccine cannot be used the next year, and if manufacturers are left with excess, they have to throw it away.
In the United States, 36,000 people a year die from influenza and its complications, and more than 100,000 are hospitalized.
The shortage "was utterly predictable, one of those slow-motion train wrecks that the public health community has been expecting for years," Dr. Irwin E. Redlener, associate dean of the Mailman School of Public Health at Columbia University." You cannot have a vital function like vaccine production limited to the manufacturing capacity of two companies. It leaves no room for failure."
"It's a major public health fiasco," Dr. Redlener said, adding that the shortage might lead to an increase in flu deaths this year.
British health officials said Wednesday that their United States counterparts were aware of problems at the Liverpool plant long before the British government revoked its license to make flu vaccine.
Dr. William Schaffner, chairman of preventive medicine at the Vanderbilt University School of Medicine in Nashville and a member a government advisory panel on vaccination, said that shortages in a wealthy country like the United States were almost inconceivable.
"We have to realize that the era of dirt cheap vaccines is over," Dr. Schaffner said "We have to be willing to pay more for the wonderful protection we get from vaccines. When there is more profit, it will be an incentive for companies to enter the market."
Dr. Gregory A. Poland, director of vaccine research at the Mayo Clinic in Rochester, Minn., and also a member of the advisory panel, said that one by one, companies had dropped out of making flu vaccine "because it is expensive to build and sustain a manufacturing plant, and they cannot recoup their costs."
One possible solution, Dr. Poland said, is that "either the government will have to subsidize or give incentives to manufacturers to get into the flu vaccine manufacturing business or the government will have to own or operate, either themselves or through a contractor, a plant to produce vaccine."
At a news conference yesterday, Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, said that there were too few vaccine manufacturers and that the only way to avoid similar shortages would be to develop "a comprehensive national strategy with the government and the private sector to develop production capabilities that don't exist now."
House Speaker J. Dennis Hastert issued a statement acknowledging that the problem needs to be repaired.
"There are only a handful of vaccine manufacturers left in the world,'' Mr. Hastert said. "We know that our current production capabilities would not be able to handle a massive surge for vaccine products caused by a flu crisis. We need to take steps to address this situation before it becomes an even bigger problem.''
Many public health experts said the government had to work with manufacturers to find ways to make vaccine production attractive.
"Perhaps,'' Dr. Schaffner of Vanderbilt said, "this event will be like the drunk who has to bottom out before they seek therapy."
nytimes.com |
