Prostate Drug Development and Clinical Trials

Caveat Emptor. If you have been following this blog you will not be surprised by the following development. Educate yourself and dont allow yourself to become a victim because of lack of information, in the information age.

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Cancer drug now ready for clinical stage

BY ALICIA DUNKLEY Observer senior reporter dunkleya@jamaicaobserver.com

Wednesday, December 15, 2010





JAMAICAN scientist Dr Henry Lowe says financing will be his next hurdle with another two to three years left in his work to break through with a formula to reduce and eliminate prostate cancer.

Lowe last week said he and his research partners were on the last leg of work to develop the drug which will take millions of US dollars.

In the meantime, however, he said the formula will be locally produced, first as a nutraceutical.

Speaking at the Observer weekly Monday Exchange at the newspaper's Beechwood Avenue offices in Kingston on Monday, Dr Lowe, who for the most part has funded his work, said the clinical tests which are to follow will be the most expensive part of the quest but said the signs so far are positive.

"I don't think financing will be an issue; I left a meeting where a major broker sat down with us this morning (Monday) for nearly two hours and they are going to be working with us to raise local and international financing because they have done all the research and they are satisfied that it is doable and should be supported," he told Observer editors and reporters.

Dr Lowe said when his first announcement about the potential of his research with the Jamaican ball moss was made some three years ago when the then People's National Party government had committed to putting up some US$3 million towards his research at that point. However, the administration changed in 2007 without this being carried out. The present government he said has not given any similar commitments.

Monday, Dr Lowe, who last week also launched the Bio-Tech Research and Development Institute — a linkage of the University of the West Indies, University of Technology, Northern Caribbean University and the Scientific Research Council — to further develop pharmaceuticals and nutraceuticals from indigenous Jamaican plants said this collaborative approach was the private sector mode of his endeavour.

"It was always something I felt was necessary. I submitted recommendations when Dr Carlton Davis was in the Office of the Prime Minister but you get nothing out of government, you make recommendations and nothing happens, this is why the institute is the private sector mode of making it happen," he said.

In the meantime, head of Public Health and Health Technology at the University of Technology and scientific pioneer in his own right, Professor Winston Davidson, said there was no question of abandoning Jamaica and taking the research abroad where the interest and funding was far more. He said the product will have to be seen as a global product, with a marriage of both the local and the global, noting that Jamaica would be wise to invest in developing the less traditional sectors given declines in areas it is heavily dependent, such as bauxite.



Read more: http://www.jamaicaobserver.com/news/Cancer-drug-now-ready-for-clinical-stage_8232258#ixzz18EF2TWOF

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Questions for Dr Henry Lowe
Published: Tuesday | December 14, 2010 9 Comments and 0 Reactions

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.

Insufficient information

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.


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