by Jeff Clemetson, Editor
On New Year’s Eve, the Food and Drug Administration finally admitted what many holistic health practitioners have known for literally thousands of years – that herbal supplements work and are a tried and true method for curing various ailments. For the only the second time in its history for any herbal drug and the first for an oral herbal, the FDA voted to approve the botanical supplement crofelemer.
Crofelemer (Croton lechleri), also known as dragon’s blood, is native to South America and will be used to treat severe cases of diarrhea in HIV patients who are on antiretroviral medication. According to the FDA, the drug blocks water and electrolytes from the digestive tract, thus reducing the frequency of diarrhea. The oral pills will be sold under the name Fulyzaq and marketed by Salix Pharmaceuticals. “Currently, there are no FDA-approved therapies for HIV-associated diarrhea,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.”
Fulyzaq is only the second botanical drug approved by the FDA. The first was a topical green tea extract called Veregen which is available by prescription to treat, among other things, genital warts.
It stands to reason that herbalists would feel vindicated after so many years of being snubbed by the FDA and looked down upon by a medical establishment that reveres pharmaceuticals as a superior treatment for patients. However, FDA approval of drugs like Fulyzaq and Veregen could spell more trouble for an industry which is already under attack by regulators.
In the last decade, herbal supplements have been the target of a series of bans, regulations and restrictions in the United States and across the European Union. Claiming that herbal remedies are not proven, are unsafe, untested and are likely often hoaxes, government regulators have passed laws like the Dietary Supplement Health and Education Act and other outright bans on herbal supplements, even vitamins.
Despite thousands of years of practice in every culture on earth, herbalists find themselves accused of selling unsafe products. Why? Perhaps a look at the projected profits of the now-available-by-prescription-only herbal drug Fulyzaq can give us the answer. Salix Pharmaceuticals expects Fulyzaq to be available early this year and an initial analysis by Bloomberg estimates the company will see $18 million in sales for 2013 and as much as $26 million in sales in 2014.
Compare that to the herbalist who makes his/her own extract of dragon’s blood who will not make a dime off of a natural plant anymore because Salix has a patent and patients will need a prescription and you begin to see the bigger picture of why the FDA has been going after the herbal supplement community for the last decade – to insure that pharmaceutical conglomerates and not private healers will reap the rewards of our ancestral natural medicine arts.
The patentization of herbal remedies is a classic example of how the corporate-controlled government makes decisions on our “safety.” Placing bans or issuing patents on substances they would naturally have no control over – like food or plants – makes it illegal or expensive for an individual to grow or sell, making it the sole territory of large corporate businesses who have extensive lobbying ties with the regulators who oversee the laws that the corporations likely wrote themselves.
Unfortunately when it comes to herbal supplements, not much can be done because the laws are already in place. However, repeals and new laws are occasionally introduced to Congress that could end the bans and ease the regulations. Also, voter-backed initiatives in individual states are a proven method for keeping herbal medicine legal – the growing number of states that have passed laws allowing for the use of medical marijuana is proof that people can still overcome the lobbying efforts of even the biggest corporations and the oppression of even the strictest laws.