Bioethics Commission Forms International Research Panel to Address Clinical Trials

The Bioethics Commission has finished its first meeting that focused (at least on the second day) on its latest Presidential task – a study of international clinical trials involving human subjects.  As part of the five-month study, an International Research Panel has been formed to address the issue.  Only four of the 14-member panel is from the U.S.  You can find more detailed biographical information at the Commission’s blog entry.  I also recommend reviewing all the liveblogging the Commission did during this meeting to get a fuller picture of what took place.  I’ll post about the first day of the meeting at another time.

John Arras (US) is the Porterfield Professor of Biomedical Ethics and Professor of Philosophy, Director of the Programs in Bioethics, and affiliated programs with the Center for Biomedical Ethics and Humanities in the School of Medicine at the University of Virginia.  He is a member of the Commission.

Julius Ecuru (Uganda) is the Assistant Executive Secretary at the Uganda National Council for Science and Technology (UNCST).

Christine Grady (US) is a member of the Presidential Commission for the Study of Bioethical Issues. She is the Deputy Chief of the Department of Bioethics at the National Institutes of Health Clinical Center.

Dirceu Greco (Brazil) is the Director of the Department of STD, AIDS and Viral Hepatitis of the Brazilian Ministry of Health.

Amy Gutmann (US) chairs the Presidential Commission for the Study of Bioethical Issues, and President of the University of Pennsylvania.

Unni Karunakara (India) was the deputy director of health for the Millennium Villages Project at the Earth Institute at Columbia University.

Nandini Kumar (India) is a member of the executive committee of the Forum for Ethics Review Committees in India (FERCI), a National Chapter of the Forum for Ethics Review Committees in Asia Pacific (FERCAP).

Sergio Litewka (Argentina) is the International Programs Director and research assistant professor for the University of Miami Ethics Programs.  He is the project director for the Pan American Bioethics Initiative.

Luis Lopez (Guatemala) sits on the Board of Directors for the Latin-American Forum of Committees for Ethical Research in Health and is a faculty member at the University of San Carlos (USAC).

Adel Mahmoud (Egypt) is the former President of Merck Vaccines and an expert on disease control in the developing world and vaccine development.

Nelson Michael (US) is a member of the Presidential Commission for the Study of Bioethical Issues. He is Director of the Division of Retrovirology at the Walter Reed Army Institute of Research and the Director, U.S. Military HIV Research program.

Peter Piot (Belgium) is Director of the London School of Hygiene and Tropical Medicine.

Huanming Yang (China) co-founded BGI (formerly Beijing Genomics Institute) in 1999 and is currently President and Professor of BGI.

Boris Yudin (Russia) is head of the Department of Comprehensive Problems of Human Studies at the Institute of Philosophy of the Russian Academy of Sciences.

This panel will meet three times, and at least one time outside of the United States, in preparing their report.  Additionally, Commission staff have already been poring through records in the National Archives to add some historical context to the Guatemalan study that prompted President Obama to have the Commission study international clinical trials.

While the President set no specific timeframe for either the international study or the review of the Guatemalan research, Commission staff anticipates having the review ready sometime this summer.  The panel anticipates having a report ready in the fall.

3 thoughts on “Bioethics Commission Forms International Research Panel to Address Clinical Trials

  1. February 25, 2011

    PUBLIC COMMENTARY

    TO: The Presidential Commission for the Study of Bioethical Issues
    1425 New York Ave. NW,
    Suite C-100
    Washington, DC 20005

    FROM: Deborah Rae Lamb
    and John Mecca

    Dear; Chairperson Ms Amy Gutmann, Ph.D., and Vice Chairperson Mr James W. Wagner, Ph.D.,

    This letter is in response to the request for comments regarding the “Day 2″ Tuesday March 1st Session 8, titled “Social Justice and Ethics Issues”.

    HERE ARE OUR COMMENTS,
    PLEASE MAKE THEM AVAILABLE FOR THE PUBLIC TO READ!

    The purpose of this letter is hoped by us to provide insight to you in your newly revamped Bioethics Committee, as to what changes to law and policy you might recommend to President Obama related to “Clinical Trials — Social Justice and Ethics Issues”.

    The Committee may well be familiar with reports of clinical trials abuses, where they have not heard of such complaints, we write you to tell you of these things and the attendant liabilities that follow such actions especially where they go on without correction.

    Deborah Rae Lamb and John Mecca are both being used in wavier of consent human experiments of an egregious kind involving egregious extreme torture level pain and potentially cancer and other disease inducing effects. Before going on and explaining further we have evidence of these experiments upon ourselves that our bodies have been implanted with devices causing the egregious effects by having been tested by an indisputable IEEE test that shows the devices as electromagnetic weapons are emitting near lethal levels of radio and electric energy in vivo inside of our bodies.

    We, as one would understand have been studying Federal and State law regarding our predicament and find there is a wide range of potential sources of government agencies that may be responsible.

    The new task of the newly reorganized President Obama Bioethics Committee would benefit from bringing about the cessation of the egregious experiments we describe being done to us and thousands of other people throughout the United States, many of whom we are in collaboration with to find ways to stop the waiver of consent daily continual physical criminally actionable assaults.

    That legal liability exists for the actions of federal/state government activities of the kind described by us is sufficient on its own for interest by the Committee, however there are many facets to the issue that ordinarily are not discussed, such as the egregious activities undermining faith and respect in government for one, where there are millions of mentions on the INTERNET of harmful experiments carried out or ongoing by government.

    The current levels of disenfranchisement of certain demographic of the news reading voting public will soon become more aware of these atrocities and it makes no sense not to make changes that will otherwise result in difficulties of a political and liability nature.

    After several years of reviewing the laws and indirect policies and known published policies we write to you to ask that you consider recommendations to the President Obama of the need for sweeping changes to halt abuses by enacting “presidential orders” to curb abuse. In consideration “Strengthened Protections for Human Subjects of Classified Research” has internal safeguards by research committee members reviewing classified research may appeal a project going forward to try to stop it, is little consolation for real world victims such as Deborah Lamb, John Mecca and the thousands of other victims of vendetta experiments across the country. The old saying goes if it is not broken don’t fix it, we are here to tell you the checks and balances of ethical conduct are broken and need to be fixed, a substantial number of fellow victims have died of the attacks by government sponsored experiments in the last two years.

    “Title 3–The President Memorandum of March 27, 1997; Strengthened Protections for Human Subjects of Classified Research—President Clinton”

    Many of the victims such as Deborah and John mention harassment attached to the electronic attacks as if it were being done to them as a result of false profiles enabling the project coordinators to have the field observer personnel feel justified to be carrying out activities they surely know fall outside the circle of legal sanctions permitted by law. Some victims believe as we do that the attacks are being used for political purposes. There is a certainty that the government reputation will suffer if it stands idly by during the egregious abuses of wavier of consent classified experimentation.

    What should be done is to have a reporting system that has the ability to investigate abuse beyond the available appeal process in Strengthened Protections for Human Subjects of Classified Research Members whom vote on projects to go or not go forward.

    Such an internal system is we feel impossible to depend upon, too often we have noted for example researchers caught carrying out unethical experiments seem to be rewarded and attain high positions. We know that diabolical minds in classified research require unwitting healthy subjects. Classified research needs to be understood for what it is, a sadistic activity. Change is needed to stop the abuses, the need now is for ethical leadership not valueless safeguards, real change is needed in the form of halting the egregious research in order to stop the United States from being compared to Nazi Germany experiment atrocities, as it is being compared to the Nazis today across the nation on internet websites and blogs.

    Real change where no comprehensive law is generated to stop the atrocities would require that a “public review board” be established to deal with the egregious actions of researchers. Where such as we describe is known across the country by millions of web page reports cannot be construed to be “classified” that such egregious activities are so well documented and known of is tragic that nothing has been done.

    Secret human experimentation is an unethical Bill of Attainder action, injuring and killing people for knowledge or any experiment is slavery. There should not be laws that allow for waiver of consent for human experimentation by agency heads or anyone. There should be mandatory consent from the person approached for experimentation and that they understand what they are consenting to.

    According to the Belmont Report a human subject should always be able to say no and to stop the experiment at any time. We have found out, that we are being brutally experimented on without our knowledge or consent by electromagnetic weaponry via covertly installed devices in our bodies, and we are saying “NO”, we want out and it has not stopped.
    * * *
    This is Deborah Rae Lamb’s statement; I have been put in a wavier of consent human experiment of implanted in the body torture devices program, my life has been destroyed by sick government program abuses that include physical torture that amount to terrorism of me. I have been constantly tortured by electronic torture devices implanted in my body causing extreme pain, dangerous blood pressure drops, induced sleep deprivation, illnesses, caused to be unable to work, financial devastation and severe emotional distress where I fear for my life. The electronic assaults are debilitating and painful and implanted devices can cause cancer, stroke, heart attack, tumors, cysts and other health threats.

    I have evidence by an IEEE test that there are transmissions going to and from the covertly implanted devices in my body, it stands to reason that tracking and monitoring my physiology is being done, studied just as a lab rat; these are the actions of immoral researchers. I suffer on a daily basis from this torturous activity from implanted devices, and I have lost the affection, support and interaction with my family due to this program of non-consensual human experimentation. I have been damaged physically, financially, socially, and emotionally that has put me in serious doubt as to my religious faith. I consider this a cruel and unusual punishment without due process sabotaging my life and I am at risk of death.

    * * *
    This is John Mecca’s statement; I have been put in a wavier of consent human experiment of implanted in the body torture devices program, my life has been destroyed by sick government program abuses that include physical torture that amount to terrorism of me. I have been constantly tortured by electronic torture devices implanted in my body causing extreme pain, dangerous blood pressure drops, induced sleep deprivation, illnesses, financial devastation and severe emotional distress where I fear for my life. The electronic assaults are debilitating and painful and implanted devices can cause cancer, stroke, heart attack, tumors, cysts and other health threats.

    I have evidence by an IEEE test that there are transmissions going to and from the covertly implanted devices in my body, it stands to reason that tracking and monitoring my physiology is being done, studied just as a lab rat; these are the actions of immoral researchers. I suffer on a daily basis from this torturous activity from implanted devices, and I have lost the affection, support and interaction with my family due to this program of non-consensual human experimentation. I have been damaged physically, financially, socially, and emotionally that has put me in serious doubt as to my religious faith. I consider this a cruel and unusual punishment without due process sabotaging my life and I am at risk of death.

    * * *

    http://WWW.SECRETANGEL.TV

    In closing our correspondence to you, we would want that you remember our letter in conjunction with the words of then Senator John Glenn, whom endeavoured to right the wrongs being engaged in by authorities unconscionable acts and that the efforts of Senator Glenn be resurrected and a BILL passed such as his BILL, that would by its merits of ethics benefit the country. We seek the dismantling of these Bill of Attainder laws and policy programs in federal, state and institutions jurisdictions. A federal law should be passed that carries criminal penalty for those whom carry out wavier of consent experiments upon anyone, especially those whom create false profiles in order to gain control of a person for purposes of wavier of consent experimentation.

    “Excerpt from Senator John Glen in the Senate ” Mr. GLENN. Madam President, if I approached any Senator here and I said, You did not know it, but the last time they went to the doctor or went to the hospital, your wife or your husband or your daughter or your son became the subject of a medical experiment that they were not even told about.” — Senator John Glenn
    Sen. John Glenn, Congressional Record, introducing BILL S. 193 to the 105th Congress. The Bill did not become law; such a law is still needed for the reasons Glenn describes here. (The text of the bill can be found and the Senators remarks were found under the 105th Congress for S. 193. )

    In accordance with 28 U.S.C. § 1746, I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge, belief and technical IEEE evidence.
    /s/ Deborah Rae Lamb
    Deborah Rae Lamb
    119 Whittier Drive,
    Kings Park, NY 11754
    Telephone# (631) 360-1557
    /s/ John Mecca John Mecca
    119 Whittier Drive,
    Kings Park, NY 11754
    Telephone# (631) 360-1557

  2. It should be noted that I am in no way affiliated with the Commission, and I have no indication that anyone affiliated with the Commission will read this post or any associated comments.

    The Commission has issued a request for public comment in the March 2nd edition of the Federal Register. Comments are due May 2. You can email comments to info@bioethics.gov

  3. Pingback: Exactly What Drugs Aren’t Running Shortages Right Now? « Pasco Phronesis

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s