April 1, 2020
Dr. Stephen H. Hahn
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dr Tedros Adhanom Ghebreyesus
World Health Organization
Avenue Appia 20
RE: L.E.A.F Pharmaceuticals Experiments on Rwandan Subjects with Covid-19
I am writing to alert you as a matter of urgency with regard to the Rwanda operations of L.E.A.F Pharmaceuticals, a U.S-based private company whose Founder, President and CEO is listed as Dr. Clet Niyikiza. L.E.A.F Pharmaceuticals has its official address as 216 West Cummings Park Woburn, MA 01801,United States. It has its sole foreign subsidiary, L.E.A.F Rwanda, officially in partnership with the Government of Rwanda.
Dr. Clet Niyikiza announced on March 29,2020, that his company is ready to start, within two weeks, of yet to be known drugs or vaccines on Rwandan patients who have Covid-19. A Rwanda Government official stated last week that talks with LEAF Pharmaceuticals are close to conclusion to enable the experimentation on Rwandan subjects to start as soon as possible.
This should ring alarm bells. Dr. Niyikiza has been a member of President Paul Kagame’s Presidential Advisory Council for many years. President Kagame was very much instrumental in the founding of L.E.A.F Pharmaceuticals, and the subsequent establishment of L.E.A.F Rwanda. In fact, to all intents and purposes, L.E.A.F Rwanda is effectively controlled by Rwanda’s military and intelligence services.
As Rwanda and the rest of the world grapple with the relentless onslaught by Covid-19, the Government of Rwanda must not be allowed to add more injustice to the already-abhorrent human rights record. You may be well aware that the U.S. Department of State 2019 Country Reports on Human Rights Practices: Rwanda (https://www.state.gov/reports/2019-country-reports-on-human-rights-practices/rwanda/) reports, among other things, that the government committed arbitrary or unlawful killings; disappearances by or on behalf of government authorities; abuse of detainees by police, military, National Intelligence and Security Services (NISS) officials; and, arbitrary arrest and detention of citizens without due process.
It is imperative that the U.S. and Food and Drug Administration, and the World Health Organization hold the Government of Rwanda and L.E.A.F Pharmaceuticals accountable to all the provisions of the World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/).
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. (Article 22)
In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. (Article 26)
Additionally, it is also very important to investigate whether L.E.A.F Pharmaceuticals breached any of the provisions of The Foreign Corrupt Practices Act of 1977 (FCPA) (15 U.S.C. § 78dd-1, et seq.). Furthermore, it is absolutely necessary to investigate President Kagame’s global money laundering operations for his personal gain, and in support of his criminal ventures against Rwandan citizens..
Rwanda’s ruling party (RPF), military(RDF) and intelligence (DMI), to which L.E.A.F. Pharmaceuticals is subservient, have lost public trust and are the best candidates to repeat the ugly lessons of Nazi Germany’s Dr. Josef Mengele’s experiments or the U.S. Tuskegee Experiment.
Under no circumstances, even in the deepest despair and death that the Covid-19 tragedy has imposed on humanity, should the world community compromise on the ethical principles of respect for autonomy, beneficence, non maleficence, and justice.
All Rwandans and the world at large are forewarned.
Dr. Theogene Rudasingwa
Ishakwe-Rwanda Freedom Movement
Hon. Tibor P. Nagy
Assistant Secretary of State for African Affairs
U.S. State Department
2201 C St NW
Washington, DC 20520
Director Christopher Wray
Federal Bureau of Investigation (FBI)
935 Pennsylvania Avenue, NW
Washington, D.C. 20535-0001
Chief, Fraud Section
Fraud Section, Criminal Division
U.S. Department of Justice
950 Constitution Ave., NW
Washington, DC 20530