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Though a natural remedy and thus far not causing
side effects associated with statin drugs, those skeptical about policosinol quickly point out that it is not an FDA approved drug. As such, it has not been subjected to
rigorous testing that comes with approving a new drug, including supervised preclinical trials and standardized testing in successively larger population of people. The fact that
FDA approves 1 out of 5000, or .0002 of
applications that it receives for new drug approval, is an indication of how highly valued – and rare – this approval is.
However, this instigates another debate – whether
FDA approval process is
most appropriate way to accept drugs into drug plans, and whether doctors should be permitted to prescribe non-FDA-approved drugs without undue concerns for malpractice lawsuits. Indeed, an MD may have personally benefited from a natural remedy like policosinol, but to prescribe that to a patient requires more support than personal preference, or even personal testimony.
And it is
intersection of these two separate debates -- whether policosinol works or not, and whether
FDA approval process is fair or not – that
situation, and verdict on policosinol, currently lies. This debate is frustrating to all sides; including patients themselves, who simply want a real solution.
However, despite these frustrations,
fact that efforts are being undertaken to develop – or verify – a remedy that is safe, complete, and free of side-effects – is a step in
right direction. Additional research on policosinol will further clarify whether that step should be towards FDA approval, or towards a warning label.
ABOUT PROTICA
Founded in 2001, Protica, Inc. is a nutritional research firm with offices in Lafayette Hill and Conshohocken, Pennsylvania. Protica manufactures capsulized foods, including Profect, a compact, hypoallergenic, ready-to-drink protein beverage containing zero carbohydrates and zero fat. Information on Protica is available at http://www.protica.com
You can also learn about Profect at http://www.profect.com
Copyright - Protica Research - http://www.protica.com
REFERENCES
[i] Source: “Heart Mender”. CNN.Com. http://www.cnn.com/SPECIALS/2001/americasbest/science.medicine/pro.pridker.html
[ii] Source: “Cholesterol”. American Heart Association. http://www.americanheart.org/presenter.jhtml?identifier=4488
[iii] Source: “Statin Medications: What are
Side Effects?”. Mayoclinic.com http://www.mayoclinic.com/invoke.cfm?id=AN00587
[iv] Source: “Policosinol ”. Wholehealthmd.com. http://www.wholehealthmd.com/refshelf/substances_view/1,1525,10127,00.html
[v] Source: “Policosinol : clinical pharmacology and therapeutic significance of a new lipid-lowering agent”. Gouni-Berthold I, Berthold HK. Am Heart J. 2002 Feb;143(2):356-65.

ABOUT PROTICA
Founded in 2001, Protica, Inc. is a nutritional research firm with offices in Lafayette Hill and Conshohocken, Pennsylvania. Protica manufactures capsulized foods, including Profect, a compact, hypoallergenic, ready-to-drink protein beverage containing zero carbohydrates and zero fat. Information on Protica is available at http://www.protica.com
You can also learn about Profect at http://www.profect.com