October 17, 2007 at 9:18 pm #17342marionsModerator
One of the problems lays with the clinical studies required by the FDA. It is difficult not only for the patients meeting the criteria, but also for the exhuberant amount of money it requires to conduct these studies.
There is plenty of research in academia. However, the amount of money required to then follow up the research with these clinical studies, in most instances, is simply not available. Mainly, pharmaceutical companies are the ones conducting studies however, in order to recoup their investments, a drug will have to be produced and patented in order to allow for a financial return.
There are some interesting things happening with drugs. In many instances, a drug may have lost it’s right to a patent. Therefore, one or more compounds may be added to the very same drug – more clinical studies follow – and voila, you now have a brand new drug with another right to a patent.
Certainly, if the FDA could amend their restrictions by allowing alternative medicine to be bound by less rigorous requirements in order to gain approval for their application, then of course, we could possibly see physicians treating more patients with herbs and – or recommending alternative treatment protocols.
Hoping for changes to come about.
MarionsOctober 17, 2007 at 12:22 pm #17341peterMember
An encouraging read, thank you for posting.
I was particularly struck by the quote from the FDA expressing their interest juxtaposed with the earlier reference to scientists needing to isolate one data variable for their research. (and perhaps also so the drug companies can synthesize it?)
I believe we need a paradigm shift for research into herbal therapies to take the place it deserves in our fight against this disease.
contains papers on a number of herbal/immunotherapy/etc trials conducted in other countries that show encouraging results. These are often rejected in the US as they do not isolate one data point to measure for the success of the trial. Other cultures are able to focus on what will help the patient and in my opinion it is time for us in this country (US) to broaden our focus.
Pure science has a key role in both our learning as well as our development of treatments. My point is not to discount this but rather to compliment it by pursuing other avenues as well with the enormous resources available in this country.
My two cents.
-PeterOctober 16, 2007 at 4:04 pm #785saraMember
This article was posted online today:
The Chinese herb Ban Zhi Lian may not be in everyone’s lexicon, but to the 80 women with stage IV metastatic breast cancer, who are participating in the second phase of the BZL101 clinical trials, it represents hope and life.
For Bionovo, the drug discovery and development company in Emeryville, Calif., that’s behind BZL101, there’s hope too. The trial is the first FDA-validated clinical study of a potential cancer drug derived from a Chinese medicinal herb, says Dr. Mary Tagliaferri, a co-founder of the company, former practicing acupuncturist and a breast-cancer survivor. “Sixty-two percent of chemotherapy drugs come from natural products, and plants have been the basis of almost every new class of medication,” she says. “It makes sense that these plants can act as anticancer agents.”
Tagliaferri’s interest in Ban Zhi Lian, which has traditionally been used to treat swellings, sores and fever, was sparked in 1996 by a fellow acupuncturist, Isaac Cohen, who would later become a co-founder of Bionovo. At that time, Cohen had been treating, for a decade, women who were battling breast cancer with conventional medicines and had run out of treatment options. “In their exhaustion and desperation, they were trying to find an alternative treatment that was not so harsh,” says Cohen, who often prescribed herbs to be prepared as teas to ease the side effects of chemo and hormone therapy. But the patients’ oncologists, says Cohen, discouraged them from trying anything new. “They’d say Chinese medicine was quackery and that there was no evidence it worked,” he says. Still, Cohen observed that many of the women to whom he gave Chinese herbs, including Ban Zhi Lian, responded well to the herbs and even experienced a relatively good quality of life. “At first I chucked it to luck,” he says. “But then you see it’s not just luck. And then you ponder why.”
Cohen’s early observations about Ban Zhi Lian may have started out as a hunch, but they may hold up. In 1996, Cohen and Tagliaferri, along with Dr. Debu Tripathy, then a breast cancer specialist at the University of California, San Francisco, co-founded the Complementary and Alternative Medicine program at the university’s Carol Franc Buck Breast Care Center. Over the next several years, the trio amassed enough evidence about the herb’s anticancer properties
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