Fratantoni of the FDA acknowledges that "the risk factors" of Optro and the other hemoglobin products in the pipeline have dropped in recent years, but the field is still fraught with uncertainties. "We're farther along than we were five years ago, but that wasn't very far," he says. "In 1990 we didn't know what was going on. We'd inject hemoglobin, and the patient's blood pressure wouCR>ld go up,CR> and we'd start to see these weird symptoms: pains here and there, chest pains, muscle pains."
Fratantoni remains wary of the blood substitutes on several counts. There are still questions about blood pressure fluctuations and the possible release of free radicals, an altered form of an oxygen molecule that's been linked to cancer and other diseases. Another area of concern is the short half-life the compounds have in the body; after a day or two, the transfused product is metabolized in the organs, which could result in a need for further transfusions. Somatogen has "solved some problems by engineering changes into the molecule," he says, but other problems persist.
"I'm still enthusiastic about seeing these products get developed," Fratantoni adds, "because I feel there may be uses for them we haven't even thought of." He suggests that a product like Optro might be particularly useful in countries "that may never be able to develop a safe blood supply," as a stop-gap measure until the patient can be transported to a safer environment.
But Somatogen has bigger plans for Optro than simply the occasional pick-me-up for well-heeled tourists in Bangkok or Kinshasa. Andre de Bruin doesn't consider himself to be a starry-eyed idealist, yet he expects Optro's commercial launch target to be 800,000 units a year (20 metric tons). The availability of a safe alternative to donor blood will "dramatically impact how a physician thinks about how and when to do a transfusion," he says, thereby minimizing the possibility that patients will suffer from not being transfused enough.
There's more. Somatogen's research department is currently at work on a second-generation molecule and related products that could be used to treat anemia (by stimulating the production of red blood cells in the bone marrow) or to scavenge nitric oxide, which appears to play a role in septic shock, cirrhosis of the liver, organ transplant rejections and other maladies. "We definitely see this as a platform technologCR>y, from whicCR>h several products can come," de Bruin says.
It all sounds wildly improbable and vaguely romantic, like an old "Better Living Through Chemistry" filmstrip. About what you'd expect from the kind of people willing to invest hundreds of millions of dollars and years of frustration on a batch of fermented bacteria that might never turn a profit.
Charles Scoggin understands the yearning too well. His new startup is a medical information services company, to be called Rodeer--which, he explains, means "a gathering of cowboys, usually in the fall, for the purposes of rounding up stock." The venture promises to be quite different from his last one.
"I'm in danger of having to learn a new word here," he says. "It's r-r-r-"
Rodeer?
"No," he says. "R-r-r-revenues.
