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Gonzalez says he's hopeful the FDA ultimately will approve his method, and that, even though the treatments are natural, they can be patented. "The drug companies aren't dumb," Gonzalez says. "They'll use moon dust if you can prove it works."
Over the years, Gonzalez' treatments have come under attack from the medical mainstream. He has persevered through two lawsuits, as well as criticism from the New York state medical board. Gonzalez attributes his problems to "hostility" from the establishment.
Part of that hostility, counters Charles Staley, MD, is that alternative therapies are seldom studied in a scientific way. And this is a problem here. "If alternative medicine wants to show its benefits, it needs to do so using the same standards everything else is assessed by," says Staley, who is an assistant professor of surgery and a specialist in pancreatic cancer at Emory University School of Medicine in Atlanta.
Staley says for doctors to be able to compare this treatment with standard care, the study needs to be designed so patients are randomly assigned to each group. "I've never seen a trial that says the study will allow the patients to choose their treatment," he says. Without a scientific set up, he says, the study lets bias creep in and the results come into question.
The findings may seem interesting, but researchers can't make strong enough conclusions in order to advise how patients should be treated. At some point, he says, the researcher will have to have enough confidence in this treatment to compare it with standard therapy in a scientific study. Until then, the findings can't be helpful.
Earlier, Sen. Tom Harkin, (D-Iowa), a strong congressional booster of alternative treatments, told those attending the three-day meeting that federal support for the National Center for Complementary and Alternative Medicine has grown dramatically, from $2 million in the early '90s to the current budget request of $100 million. Still, he says, that's just a fraction of total budget for the center's parent agency, the National Institutes of Health.
"To me, it's just the height of stupidity for our conventional [physicians] to say, 'Well, they shouldn't do this', when we know how many Americans are involved in taking herbal remedies," Harkin tells WebMD. Harkin also says a White House commission to study policy issues related to dietary supplements will be launched next month, with a $1 million budget.
Staley adds that he doesn't discourage his patients from trying herbal treatments along with their traditional therapy. "I just tell them not to spend their life savings on them."