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Why are we obsessed with Herbal compounds at USPlabs?
Herbs to drugs
A huge reason USPlabs PRIME is extremely potent and one of a kind!
Many consumers may believe there is always a distinct line between herbs and prescription drugs; some believe drugs represent something of undeniable potency and safety, while herbs or plant supplements represent something weaker or lacking in some way to a comparable drug product. However, many may not be aware that over 50% of all drugs used clinically are either natural products (i.e. obtained from plants, microorganisms and some animal sources) or are derivatives thereof (1,2). In the United States alone, plant-derived compounds account for nearly 25% of all drugs on the market (3).
Some consumers may question, why then, aren’t more of these natural products used as drugs? In some cases, derivatives of the naturally occurring compounds are necessary to address issues such as toxicity, potency and bioavailability. This is by no means a new process, however. In fact, the first synthetic commercial drug, aspirin (acetylsalicylic acid), was derived or synthesized from salicylic acid, a compound naturally occurring in plants, back in 1897 (3,4); those which have taken undergraduate organic chemistry courses will undoubtedly be familiar with this. The salicylic acid derivative was made to reduce the gastrointestinal irritation and potential toxicity found with ingestion of free salicyclic acid and is but one example of the aforementioned reasons as to why these derivatives of natural products are developed. However, there are also cases where the improvement upon the lead compound is not quite as significant as one would like to think. In these particular cases, it is naïve to assume anything other than the fact that some derivatives are necessary for patent purposes. Considering the costs involved with drug development and protection afforded by these patents, it is ideal to seek out a compound which can be sold exclusively be a company for a given period of time, often up to 20 years (5). But, to put it simply, naturally occurring compounds can not be patented as an invention itself, as they are merely discoveries; though processes involved with isolation/purification and novel, unobvious uses are patentable, however (5). Consequently, it is often vital for pharmaceutical companies to develop a derivative of these compounds, or at the very least, use them for inspiration in the development of new drugs, which can be patented.
One other potential solution to the issue involving the patentability of natural products may be seen with the designation of botanical drugs. The FDA has created a new regulatory category which allows for the production of botanical drugs. In essence, these are highly characterized natural products which have been clinically evaluated for safety and efficacy in a similar manner to conventional drugs; though the normal process to approval may be shortened compared to conventional counterparts, if a history of safe human use can be demonstrated (3). The first prescription botanical drug approved by the FDA was Veregen ™, a defined composition of catechins and other isolated components from green tea leaves, used topically for the treatment of external genital and perianal warts (6). Senna and psyllium are two examples of over-the-counter (OTC) botanical drugs (3).
When reviewing the potential for these natural products to continue to play an important role in finding drug-like molecules, it is necessary to note that much of the potential resources have remained untapped. For example, it has been estimated that between 250,000 and 500,000 plant species exist in nature, yet, less than 5% of known plants have been investigated for one or more biological activities (2,7). This leaves open the possibility of finding many more drug-like compounds. Some naturally derived compounds which weight lifters and bodybuilders will be familiar with include the drugs metformin, exemestane, formestane and fulvestrant (8).
Remember the next time you ingest a natural product or supplement; these aren’t necessarily any weaker than their drug counterparts, nor may they be completely innocuous as well. Yet, also be cognizant that although a nutraceutical may not have drug status, it does not mean it is worthless or ineffective; in some instances it may only mean it can’t be patented or that the pharmaceutical industry hasn’t yet found an effective derivative to market.
References
1. Fabricant DS, Farnsworth NR. The value of plants used in traditional medicine for drug discovery. Environ Health Perspect. 2001 Mar;109 Suppl 1:69-75.
2. Vuorelaa P, Leinonenb M, Saikkuc P, et al. Natural products in the process of finding new drug candidates. Curr Med Chem. 2004 Jun;11(11):1375-89.
3. Schmidt B, Ribnicky DM, Poulev A, et al. A natural history of botanical therapeutics. Metabolism. 2008 Jul;57(7 Suppl 1):S3-9.
Herbs to drugs
A huge reason USPlabs PRIME is extremely potent and one of a kind!
Many consumers may believe there is always a distinct line between herbs and prescription drugs; some believe drugs represent something of undeniable potency and safety, while herbs or plant supplements represent something weaker or lacking in some way to a comparable drug product. However, many may not be aware that over 50% of all drugs used clinically are either natural products (i.e. obtained from plants, microorganisms and some animal sources) or are derivatives thereof (1,2). In the United States alone, plant-derived compounds account for nearly 25% of all drugs on the market (3).
Some consumers may question, why then, aren’t more of these natural products used as drugs? In some cases, derivatives of the naturally occurring compounds are necessary to address issues such as toxicity, potency and bioavailability. This is by no means a new process, however. In fact, the first synthetic commercial drug, aspirin (acetylsalicylic acid), was derived or synthesized from salicylic acid, a compound naturally occurring in plants, back in 1897 (3,4); those which have taken undergraduate organic chemistry courses will undoubtedly be familiar with this. The salicylic acid derivative was made to reduce the gastrointestinal irritation and potential toxicity found with ingestion of free salicyclic acid and is but one example of the aforementioned reasons as to why these derivatives of natural products are developed. However, there are also cases where the improvement upon the lead compound is not quite as significant as one would like to think. In these particular cases, it is naïve to assume anything other than the fact that some derivatives are necessary for patent purposes. Considering the costs involved with drug development and protection afforded by these patents, it is ideal to seek out a compound which can be sold exclusively be a company for a given period of time, often up to 20 years (5). But, to put it simply, naturally occurring compounds can not be patented as an invention itself, as they are merely discoveries; though processes involved with isolation/purification and novel, unobvious uses are patentable, however (5). Consequently, it is often vital for pharmaceutical companies to develop a derivative of these compounds, or at the very least, use them for inspiration in the development of new drugs, which can be patented.
One other potential solution to the issue involving the patentability of natural products may be seen with the designation of botanical drugs. The FDA has created a new regulatory category which allows for the production of botanical drugs. In essence, these are highly characterized natural products which have been clinically evaluated for safety and efficacy in a similar manner to conventional drugs; though the normal process to approval may be shortened compared to conventional counterparts, if a history of safe human use can be demonstrated (3). The first prescription botanical drug approved by the FDA was Veregen ™, a defined composition of catechins and other isolated components from green tea leaves, used topically for the treatment of external genital and perianal warts (6). Senna and psyllium are two examples of over-the-counter (OTC) botanical drugs (3).
When reviewing the potential for these natural products to continue to play an important role in finding drug-like molecules, it is necessary to note that much of the potential resources have remained untapped. For example, it has been estimated that between 250,000 and 500,000 plant species exist in nature, yet, less than 5% of known plants have been investigated for one or more biological activities (2,7). This leaves open the possibility of finding many more drug-like compounds. Some naturally derived compounds which weight lifters and bodybuilders will be familiar with include the drugs metformin, exemestane, formestane and fulvestrant (8).
Remember the next time you ingest a natural product or supplement; these aren’t necessarily any weaker than their drug counterparts, nor may they be completely innocuous as well. Yet, also be cognizant that although a nutraceutical may not have drug status, it does not mean it is worthless or ineffective; in some instances it may only mean it can’t be patented or that the pharmaceutical industry hasn’t yet found an effective derivative to market.
References
1. Fabricant DS, Farnsworth NR. The value of plants used in traditional medicine for drug discovery. Environ Health Perspect. 2001 Mar;109 Suppl 1:69-75.
2. Vuorelaa P, Leinonenb M, Saikkuc P, et al. Natural products in the process of finding new drug candidates. Curr Med Chem. 2004 Jun;11(11):1375-89.
3. Schmidt B, Ribnicky DM, Poulev A, et al. A natural history of botanical therapeutics. Metabolism. 2008 Jul;57(7 Suppl 1):S3-9.
