Linhardt hopes to be able to make a gram of synthetic heparin within a year, which would be enough to administer 100 doses in mice and allow the researchers to at least move forward with animal trials. He believes that one kilogram of synthetic heparin would provide the 10,000 doses needed to get through clinical testing on as many as 1,000 patients, although he says he is not able to give a timeline for when he would be able to make that much heparin. Success would mean that U.S. pharmaceutical companies could make the heparin they use in their blood-thinner products rather than importing it from China.
The heparin scare may prompt the U.S. National Institutes of Health to approve Linhardt's recent request for a $5-million federal grant over five years to complete his research. "Dr. Linhardt has a proof of concept," says Jawed Fareed, director the Special Coagulation Laboratory and the Hemostasis and Thrombosis Research Program at Loyola University Medical Center in Maywood, Ill. Fareed and Linhardt consulted during efforts to unravel the contamination mystery. Fareed became involved in the probe in March when doctors at the Medical Center's dialysis unit sought his advice on the FDA's heparin recall. "They wanted to know what they should do and asked if there was an alternative drug," he says. Fareed requested that the doctors send him all of the heparin in stock so he could determine whether they were contaminated in some way. Most of it was. "We were surprised by the results," he recalls, "and we were concerned about our patients."
A key factor in the success of synthetic heparin, at least initially: whether hospitals, clinics and insurance providers would be willing to pay a premium for it if it costs more than heparin coming from swine (which is about 20 cents per dose). Given how difficult it has been to produce small amounts today, it would take years and a "staggering" investment to make synthetic heparin a feasible business, says Erin Gardiner, a Baxter spokesperson, who adds that her company is not planning to get into the synthetic heparin business.
Still, Linhardt hopes that someone will take an interest in mass-producing the work he has begun. "The future is one that will be short continuously of heparin," he says. "Which means any adulterations of the heparin [imported by the U.S.], we're going to have to live with—or catch."