Pharmaceutical and biotech firms are racing to find treatments and vaccines for severe acute respiratory syndrome (SARS), but they worry that by the time they come up with an actual product, the virus may not be the health crisis it appears to be today.
"To be competitive, you need to get into this fast and work fast," said Gordon Cameron, president and chief financial officer of Acambis Inc, the firm supplying small pox vaccine for a national stockpile. "We're certainly looking at SARS. But we're still trying to figure out what the market will be and what the technical hurdles might be. We have to decide shortly. In the next couple months, we either have a program or we don't."
Despite the urgency, much uncertainty remains. Scientists identified the virus causing SARS just a month ago. SARS has infected more than 5,400 people and killed more than 350 since it first appeared in China late last year. But no one knows how fast or how far the virus will spread.
Few infectious disease specialists believe SARS will disappear. But they can't predict whether SARS will turn into an epidemic, wax and wane with the seasons like the common cold, or remain a relatively rare illness. Even in a best-case scenario, a vaccine or treatment is years away and by the time it is available, many firms worry the sense of urgency may have faded and too few people will want to be vaccinated to justify the hundreds of millions of dollars it takes to develop a drug or a vaccine.
The drug industry is seeking assurances from various federal health agencies that they will streamline the testing process and buy large quantities if a SARS vaccine pans out. Drug companies say they are willing to take the risk for now because the early research into a drug or vaccine is the least expensive part of the process. But developing, testing and then gaining regulatory approval to get a drug to market can cost hundreds of millions of dollars.
"We're not looking for risk-free, nothing we do is risk-free," said Len Lavenda, a spokesman for Aventis Pasteur, the world's biggest vaccine maker, based in Lyon, France. "But we are looking for assurance the government is going to be there in five years."
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the agency is exploring various options for funding research and partnering with industry. But, he said, it is not yet clear that the government would promise to buy a successful vaccine.
The hurdles in developing vaccines are even more considerable than with other types of drugs. Since they are given to healthy people, they must be safer than most other medications. They are often tested in tens of thousands of patients to ferret out uncommon side effects before reaching the market.
Even then problems arise. A vaccine for rotavirus, a stomach illness that kills a million children worldwide each year, was tested in 10,000 infants in 27 clinical trials over 15 years before it was approved. After all that, a rare side effect only emerged later, causing the vaccine to be pulled off the market.
But the industry is plowing ahead. Pharmaceutical giant Merck and Co, based in Whitehouse Station, New Jersey, is screening its stable of drugs to see if any of them will help treat SARS. Merck asked the government for a copy of the virus and dozens of its researchers are beginning work to discover a vaccine.