Healthcare Solutions Mgmt. Group Inc. (HSMD)

[sunspotter]

"This is considered ALTERNATIVE medicine so those protocols are not necessary in Kenya."

Not true.

By both Kenyan law and by US law (which applies to AQLV as a US company even if they operate in Kenya) the claims made by Hoffman for NatuRx make it a medicine by definition. And that means they must do all the things that I listed they haven't done so far. It also means they're deliberately flouting the law.

"How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]."

http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm

Since AQLV claim that NatuRx can treat AIDS/HIV - and indeed have conducted an unauthorised, uncontrolled study in that very indication in Kenya - NatuRx is by definition a drug.


The relevant Kenyan policy can be found here:

https://webapps.sph.harvard.edu/live/gremap/files/ke_NCST_guidelines.pdf

"Scientifically unsound research on human subjects is unethical in that it may expose subjects to risks or inconvenience to no purpose."

"Research that uses biased samples, questions, or statistical evaluations, that is underpowered, that neglects critical end points, or that could not possibly enrol sufficient subjects cannot generate valid scientific knowledge and is thus unethical."

"In the final step, risks and potential benefits of the clinical research interventions to individual subjects are compared. In general, the more likely and/or severe the potential risks the greater is likelihood and/or magnitude of the prospective benefits must be; conversely, research entailing potential risks that are less likely and/or of lower severity can have more uncertain and/or circumscribed potential benefits."

"In Kenya evaluation of scientific research is done through scientific and ethical review committees in the relevant local institutions charged with the responsibility of conducting research in human subjects."

"Individuals must continue to be treated with respect from the time they are approached—even if they refuse enrolment—throughout their participation and even after their participation ends......Fourth, the welfare of subjects should be carefully monitored throughout their research participation. If subjects experience adverse reactions, untoward events, or changes in clinical status, they should be provided with appropriate treatment and, when necessary, removed from the study."

Guidelines
1) Biomedical research involving human subjects must conform to generally accepted scientific principles and must be based on laboratory and animal experimentation and a thorough knowledge of the scientific literature in the area of the research.

2) The design and performance of each experimental procedure involving human subject must be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to the ethics clearance committee, which is independent of the investigator and the sponsor of the research. For public institutions with standing ethical clearance, standing ethical committees are to be found in their institutions.

Private institutions, e.g., NGOs, individuals and groups of individuals who wish to engage in biomedical research involving humans, should affiliate themselves to public institutions mandated to do medical research in Kenya—Kenya Medical Research Institute (KEMRI), Kenyatta National Hospital, Eldoret Referral Hospital, or they can send their research proposals to the National Council for Science and Technology for evaluation and advice as to with which institution they should affiliate.

3) All biomedical research involving human subjects conducted in Kenya should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subjects will rest with the medically qualified person and never on the subject of the research despite the subject having given his/her consent.

4) Every biomedical research involving human subjects must be preceded by a careful assessment of predictable risks in comparison with the anticipated benefits to the subjects or others. The protection of the subject or subjects must always prevail over the interests of science and society.

"5) The investigator or the investigating team should terminate any research involving humans if in his/her or their judgement it may if continued be harmful to the individual or individuals involved in the research."

"The investigator must ensure that:
- Persons in underdeveloped communities be ordinarily involved in research that could be carried out reasonably well in developed communities. For example, it would not be ethical for an investigator to conduct research into cardiovascular diseases in slum dwellers rather than in the well-to-do members of communities from up-market estates."

"Externally Sponsored Research:


Externally sponsored research entails two ethical obligations.

- An external sponsoring agency should submit the research protocol to ethical and scientific review according to the standards of the country of the sponsoring agency, and the ethical standards applied should be no less exacting than they would be in the case of research carried out in that country.

- After scientific and ethical approval in the country of the sponsoring agency, the appropriate ethical clearance committee of the institution in Kenya where the research is to be conducted must satisfy themselves also that the proposed research meets the established scientific and ethical requirements.

- Externally sponsored research designed to develop a therapeutic, diagnostic or preventive product must be responsive to the health needs of Kenya. That means the research to be conducted must address health problems that are important in Kenya.

- The sponsoring agency should agree in advance of the research that any product developed through this research will be made reasonably available to the inhabitants of the community in which research has been conducted or to the whole country at the completion of successful testing.

- Consideration should be given to the sponsoring agency agreeing to maintain health services and faculties established for purposes of the study in Kenya after the research has been completed.

- Such collaborative research should help to develop capacity for similar research in Kenya."


And for good measure, here's why Mutisya broke the law by even taking NatuRx into Kenya:

" What are the legal requirements for exporting unapproved products under sections 801(e) and 802 of the Act?


Sections 801(e) and 802 of the Act contain numerous legal requirements for exporting unapproved products and other products that do not comply with the relevant requirements of the Act for distribution and sale in the United States. For sections 801(e) and 802 of the Act, refer to the following internet address: www.fda.gov/opacom/laws/fdcact/fdcact8.htm.

http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm#x