William Aiken, Contributor
The intention of this letter is not to respond to the personal attacks by Dr Henry Lowe, but is designed to inform the public of the questions they should ask of any new bioactive product being brought to market, whether produced by a local or foreign scientist, with the intention of preventing, treating or ameliorating any disease - whether it is a pharmaceutical or neutra-ceutical agent.
The questions posed are especially important in this particular instance because the Jamaican moss ball or 'old man's beard' (Tillandsia Recurvata) from which Dr Lowe's product is derived does not enjoy a tradition of human consumption and, therefore, does not have a historical track record of safety in humans, unlike other neutraceutical products which, by definition, are derived from food sources and therefore require less regulatory oversight.
On hearing of the launch of Dr Lowe's formula, I sought the information listed below but could not find it anywhere. Instead, what I found was a patent application outlining the molecule's ability to kill cancer cells in the lab. While this is good, it is far from sufficient information in the scientific and public domain to guide one on the safety and efficacy of the product in question in humans, hence my deliberate use of the words "overstated and premature" which I continue to stand by. I could not, in good conscience, recommend or prescribe a product which I myself would not be willing to take because of a lack of the requisite safety information.
The minimum numbers of questions that every responsible and ethical doctor will ask, and that discerning members of the public should also ask before deciding on the safety of a new bioactive compound derived from a plant not traditionally ingested by humans, are as follows:
1. Do in-vitro and in-vivo toxicological studies unequivocally demonstrate that the compound is safe and in which medical/scientific journal are these results published?
2. What is the effect of the bioactive molecule on the liver and kidneys, the two organs primarily involved in the detoxification and excretion of most drugs, and where are the published data to be found?
3. What, if any, are the acute toxicological effects of the bioactive molecule on the cardiovascular system, central nervous system and gastrointestinal system and in what journal is this information to be found?
4. What is the effect on the skin and mucous membranes and where is this information to be found?
5. What is the effect of this compound on the function of the male reproductive system of the rat and its offspring? Where is the information to be found?
6. Is this compound secreted in semen and what is its effect on the reproductive function of the female partner?
7. What, if any, are its long-term genetic and oncogenic (potential to cause cancer) effects?
8. Where are the published reports of the preliminary studies carried out in a limited number of human volunteers to demonstrate the compound's safety and handling by the human body?
9. We know that there are thousands of molecules that are biologically active against cancer cells in the lab which do not translate into a net benefit when tried in humans. In which scientific journal can we find even limited evidence of the efficacy of this product?
Beyond the question of efficacy, the onus is on Dr Lowe to provide unequivocal and incontrovertible scientific evidence that this is first and foremost a safe product. Members of the medical fraternity in general, and the urological community in particular, eagerly await the answers to these questions by the provision of objective and validly obtained published evidence.
Dr William D. Aiken is head of urology, University Hospital of the West Indies.