Risk, cost shrivel vaccine makers

Bush asks few players left to develop protection against avian flu


When President Bush met with vaccine makers at the White House Friday to prod them toward vaccines against the deadly avian flu, his pleas fell on few ears.

The vaccine industry in America has been in steady decline over the past four decades, to five companies last year from 26 in the late 1960s.

Experts say the recent shortages of vaccines against even seasonal flu are a result of the slide, precipitated by lawsuits and major changes in the pharmaceutical business.

"It's just too high-risk for a potentially low return on investment," said Christopher-Paul Milne, assistant director of the Tufts Center for the Study of Drug Development in Boston.

Businesses are less and less interested in vaccines because the process is expensive, the market is much smaller than for other drugs and the legal liability risks are great, various experts said.

Lawsuits filed against vaccine makers have cost hundreds of millions of dollars to fight.

"This is not a market any company wants to get into rationally," said John Clerici, a Washington attorney who has testified on the topic before Congress.

With so few players left in the industry, Friday's meeting with the president at the White House didn't last long - 45 minutes, according to Jean-Pierre Garnier, GlaxoSmithKline's chief executive officer. He attended along with representatives from Merck & Co., Sanofi-Aventis, Wyeth, Chiron Corp. and Gaithersburg-based MedImmune Inc.

Since 2000, shortages have cropped up in nine of the 12 required childhood vaccinations in the United States. During the past two years, shortages of seasonal flu vaccine have grabbed the attention of public health officials and politicians. The avian flu threat, with the potential to kill many thousands, heightens concern.

"You have this thing boiling, the virus is mutating and mutating and mutating, and we don't have an infrastructure to make a flu vaccine," said Paul A. Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia. "That's probably the most striking example of what's wrong with the system, of how the system has failed."

Vaccines, and those who make them, were once heralded as miracle workers, responsible for saving millions of lives. But the sector has lost some prestige and focus as the population has gotten more used to living without many infectious illnesses and drugmakers turned to more profitable ventures.

Pfizer Inc.'s cholesterol medication Lipitor, for example, generated sales of $11 billion last year. Worldwide vaccine sales, on the other hand, are estimated at less than $8 billion.

Lawmakers in recent years have introduced bills to lessen the burden on manufacturers and draw new companies to the sector, but they haven't succeeded. Industry analysts think the threat of a pandemic from avian flu and the recent interest in the topic from the president, who spent his last vacation reading up on the great influenza epidemic of 1918 that killed millions, may give a boost to legislative remedies.

"We should take advantage of this issue. Even if we do not have an epidemic strain, we should use it to strengthen the basic infrastructure," said Charles M. Helms, speaking personally and not in his role as chairman of the National Vaccine Advisory Committee.

The industry has been under stress for a long while, said Ian D. Spatz, vice president of public policy at Merck & Co. Merck has a long tradition in vaccine manufacturing - announcing last week a vaccine successful in preventing cervical cancer - and intends to continue in the field, Spatz said. But, he added, "we can't do it ourselves, we need the competition, we need many others to be involved."

He recalls similar excitement and discussions about vaccines during the seasonal flu shortages last year, but only temporarily. "We saw that attention and discussion fade away," Spatz said, "so we hope that this time it will be maintained."


For archived coverage of the avian flu threat, go to baltimoresun.com/avianflu.

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