Regulated vs unregulated

Regulated vs unregulated

health products

Dr Derrick Aarons

Sunday, September 21, 2014

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SOME Jamaicans are not aware of the differences between regulated and unregulated health products. With regulation, it means the health product or drug is required by law to meet specific standards of purity, safety and dose-related effectiveness for whatever it claims to do. Most drugs prescribed by medical doctors must satisfy this standard, as doctors often rely on them to cure or effectively control specific illnesses, diseases or health conditions.


By law, these products or medication must have successfully undergone three phases of clinical trials: phase 1- tests first done in animals; phase 2- then tests done in a small group of healthy humans; and phase three- tests done in a large number of people with the illness or disease under study, in order to determine if the health product is effective, the dosages at which it is effective, and whether it has a positive balance of side effects and so on. If passed for general consumption, which is phase 4, a doctor's prescription is usually needed to purchase these medication, and their safety is continually monitored in the marketplace to determine if any adverse effects occur after permission is granted for sale. This is why the public will hear of some drugs, for example Vioxx, Propulsid, Fen-Phen, Phenformin, and Melleril, that were withdrawn from the market when they were found, subsequently, to be producing adverse effects hitherto undetected.


Unregulated products, however, are not required to meet any of these standards and are not subjected by law to any evaluation or follow-up in the marketplace. As long as they do not claim to cure any particular disease or ailment, they are not subjected to the rigorous clinical processes described. In order to prove that they cure, they would have had to undergo the clinical trial process to prove their effectiveness and safety. Hence their labels will not make any specific claim of benefit, but instead use general terms like 'may be helpful in', health aid, or 'has been used in', and may list a number of general health conditions.

So, if the undiscerning reader does not carefully identify that no strong claim of help or treatment is being made by the product, then they would have been deceived into spending a lot of money on products whose purity as well as effects have not been extensively studied to the highest scientific level.

While hoping to obtain some benefit, many Jamaican athletes in recent years have been embarrassed after using some of these unregulated, over-the-counter products whose purity did not meet the standards described. We all should realise that a market economy exists in most places in the Western world, and so any person or company can produce a health product and market it effectively for a profit. We should be discerning enough to realise that their main aim is to make money, and not presume that in all situations the marketer wishes to simultaneously provide us with some benefit.

While the large pharmaceutical companies also aim to make money, the law requires them to meet the standards outlined under clinical trials, proving benefit while identifying and minimising possible harms.


Many people are also sometimes deceived by products using the word 'natural'. They believe that once the product is natural and not built in a laboratory, then it cannot or will not harm the body. This is a big mistake. Many plants grow naturally in many countries around the world that are poisonous or harmful to the human body, and some people may react to some substances while others do not. Water is natural but has affected some people who drink it or bathe with it. Why then should they vouch for a product which is labelled natural without critiquing it further?


Consequently, when in doubt regarding advertised health products, always consult people with specialised knowledge in these areas, while still being critical that some of these people may have a conflict of interest if they make money from selling or trading in these substances or products. In the final analysis, it is 'caveat emptor' — let the buyer beware. You must use your critical-thinking skills in making your decisions.

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is a member of the Executive Council of RedBioetica UNESCO.

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