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Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1

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CRPD - Mental Health Rights

In 2009 the USA signed but still has not ratified the Convention on the Rights of People with Disabilities (the “CRPD”). One of the purposes of the CRPD is “to promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity.” (CRPD, Art. 1.) Among the many rights of people with disabilities protected by the CRPD are the rights to equal recognition under the law (Art. 12), access to justice (Art. 13), and to live in the community, with choices equal to others. (Art. 19.)   Under the Vienna Convention on the Law of Treaties, once a nation signs a Convention, it is “obliged to refrain from acts which would defeat the object and purpose” of that Convention. (Vienna Convention on the Law of Treaties art. 18, May 23, 1969, 1155 U.N.T.S. 331.13)  Although the United States has not yet ratified the CRPD, the U.S. Supreme Court has made it clear that “the opinion of the world community, while not controlling [the Court’s] outcome, does provide respected and significant confirmation for [its] own conclusions.” Roper v. Simmons, 543 U.S. 551, 578 (2005).http://www.un.org/disabilities/documents/convention/convoptprot-e.pdf

UPR 53rd CAT Testimony by Medical Whistleblower Advocacy Network 10-14-14

Medical Whistleblower Advocacy Network 


Written Testimony 
 


Universal Periodic Review –53rd Session 


Convention against Torture and 


Other Cruel, Inhuman or Degrading Treatment or 
Punishment (CAT) 


 


Civil Society Consultation 


U.S. Department of State 
 


October 14, 2014 

 


Voiceless Victims: Wards of the Court 


 


 

I. Drafted 10/7/14 


 


II. Reporting Organization(s): Medical Whistleblower Advocacy Network 


Contact Information: Dr. Janet Parker DVM, Executive Director 


Email: MedicalWhistleblower@gmail.com 


http://medicalwhistleblowernetwork.jigsy.com/ 


 


Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for disabled persons and other individuals within the U.S.A. and abroad. MWAN human rights cases often involve issues with medical implications, such as protection of mandated reporters, medical abuse, medical fraud, psychiatric abuse, prisoner mistreatment, sexual assault, domestic violence and stalking. 
MWAN provides information, referrals, and also direct human rights defender advocacy services. MWAN has allowed victims of human rights violations to directly tell their own stories, assisting them when necessary with their time lines, helping them access documents, and doing research and analysis of their situations. 


III. Summary of Issues · 

  • Right to Informed Consent  
  • Abuse and Neglect by Guardians  
  • Protection of Human Subjects 
  • Use of “off-label” Psychiatric Drugs 

IV. Concluding Observations 

 

 

The United States as a nation has clearly agreed that torture, cruel inhuman, degrading treatment or punishment or punishment is prohibited in U.S. Jurisdiction. The United States of America agreed with the CAT Committee that … “the intentional infliction of mental pain or suffering was appropriately included in the definition of torture to reflect the increasing and deplorable use by certain States of various psychological forms of torture and ill-treatment, such as mock executions, sensory  deprivations, use of drugs, and confinement to mental hospitals.” However, for the vulnerable wards of the court within the U.S.A., there are few protections to prevent abuse and to allow transparency and 
accountability for the treatment of psychiatric patients. Wards of the court have surrogate decision makers for both legal and medical decisions. The U.S.A. mental health guardianship system offers few procedural protections, and has spawned a profit -driven professional guardianship industry that often enriches itself at the expense of society’s most vulnerable members the mentally ill. Yet despite 
numerous calls for reform, most states have done little to monitor professional guardians and prevent abuse and neglect. Secrecy, lack of transparency and lack of accountability makes a perfect environment for human rights violations of the mentally disabled. 


Research can be disguised as “treatment,” but instead actually be a harmful or deadly experiment done without the patient’s 
knowledge or informed consent to treatment. Forcing wards of the court to take medications that are “off-label” (not approved for that use by the Food and Drug Administration), is tantamount to human experimentation on the vulnerable wards of the court. Such violations of human subject provisions are routine with many patients in locked state and federal institutions given psychiatric drugs for “off-label uses.” Problems of patient abuse occur including: excessive dosing for purposes of chemical restraint, poly-pharmacy with multiple medications, lack of informed consent and the use of medication with little or no direct doctor/patient contact. In addition the use of medication with no real oversight of the process of diagnosis, means that patients can often not question the use of these medications because surrogate decision makers have been assigned by the court to make all medical decisions. Wards in mental health care have often been stripped of their legal rights and thus cannot assert their objections to treatment decisions. Unbiased independent review of medical charts is almost non-existent. 
Deceptive and coercive marketing practices by the pharmaceutical industry are common place. The practice of marketing drugs for purposes not backed by science is called “off-label promotion.” These drugs do not live up to their marketing promises but instead have been known to cause serious, even fatal side-effects, particularly in children and the elderly. Lives of some our most vulnerable citizens have been irreparably damaged and many have been lost to fatal adverse effects and even to suicide. 


The Committee for the Prevention of Torture (CPT) has stated: "Patients should, as a matter of principle, be placed in a position to give their free and informed consent to treatment. The admission of a person to a psychiatric establishment on an involuntary basis should not be construed as authorizing treatment without his consent. 


It follows that every competent patient, whether voluntary or involuntary, should be given the opportunity to refuse treatment or any other medical intervention. Any derogation from this fundamental principle should be based upon law and only relate to clearly and 
strictly defined exceptional circumstances." The principle of Free, Prior and Informed Consent is an important human right which has been addressed in many international and domestic laws and practices. The human rights of patients are also delineated in the Universal Declaration on Bioethics and Human Rights. The standards of the European Committee for the Prevention of Torture states that 
"consent to treatment can only be qualified as free and informed if it is based on full, accurate and comprehensible information about the patient's condition and the treatment proposed.” Consequently, all patients should be provided systematically with relevant information about their condition and the treatment which it is proposed to prescribe for them.” The United States is under constraints in the government’s power to use individuals in non-consensual experimentation, including non-consensual medical treatment and experimentation. Control of pharmaceutical and device products is vested by statute in the Food and Drug Administration (FDA) within HHS. Yet in spite of these regulations, wholesale use of “extra-label” psychiatric medications occurs daily in psychiatric hospital, mental health clinics and prison settings. 


V. So we respectfully ask: 
 


. What measures will the U.S.A. take to ensure the human rights protections for wards of the court? 


. Why has the U.S. government not taken steps to curtail the wholesale use of “off-label” use of psychiatric medications in violation of the Common Rule? 


. What will the federal government do to supervise the state courts guardianship system? 


 


VI. Suggested Recommendations for the U.S. government 


. Ratify the CRPD, CRC and ICESCR without any reservations, understandings or declarations, and without further delay in order to be 
in compliance of international recognized standards 
regarding the human right of informed consent. 

. Establish a federal database tracking system to facilitate tacking of complaints received by HHS, FDA or the DOJ regarding complaints of psychiatric abuse in psychiatric facilities, psychiatric nursing homes and in outpatient treatment. 


. Establish a separate database used to record and process allegations of misconduct which have been lodged by the wards against their court assigned guardian or medical treatment team. 


. Include persons with disabilities in the review policies at both the federal and state levels, to abolish all laws and mechanisms that restrict the legal capacity of any person (especially those with disabilities) and to create supportive measures for the exercise of legal capacity that 
respect the will and preferences of the person. 


. Evaluate all guardianship cases in the State Court system to see if they are in compliance with U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research and consistent with the ethical code of conduct established by the American 
Psychological Association, published in 1973. 


 

You Were Born An Original

Justice is not blind, she is merely blindfolded. Source Unknown

International Mental Health Rights

The United States under international treaty obligations has direct responsibility for human rights violations when committed by state agents or officials. Even when human rights violations are committed by non-state actors, primary responsibility, and accountability, in international law rests with the government of the national government in whose jurisdiction the violation occurs. The US government must do more than refrain from violating human rights and this includes the rights of persons with mental health disabilities. It must put effective measures in place so that violations committed by private individuals are prevented insofar as possible, and victims protected. Where violations occur, it must ensure that perpetrators are brought to justice with effective sanctions imposed, and reparation provided to the victim. This is called the Duty of Due Diligence.

 

The right to mental health is not just a right to mental health services, but it is also closely related to and dependent upon other rights. This includes the rights to food, housing, work, education, human dignity, life, non-discrimination, equality, the prohibition against torture, privacy, access to information, and the freedoms of association, assembly and movement. In addition, mental health care must be available, accessible, acceptable and of appropriate quality. [The Committee on Economic, Social and Cultural Rights(in its General Comment 14)]The U.S.A. has signed and ratified the International Covenant on Civil and Political Rights (CCPR), and thus is bound under international law to abide by its’ principles . The CCPR seeks guarantee a broad range of universal human rights across a wide range of human endeavor. The preamble to the CCPR recognizes that the rights derive from the inherent dignity of the human person. The CCPR sets out certain "civil and political" rights. Among these are many human rights relevant to the issue of least restrictive mental health treatment.Persons with mental health disabilities have under the CCPR, the Right of self-determination. This is the right of all peoples of self-determination,including a right to determine freely political status and dispose of natural wealth and resources (CCPR Article 1). Under the CCPR, those with mental health disabilities have the Right to life.The right to life, including restrictions on the circumstances in which capital punishment may be imposed (CCPR Article 6).

 

The Universal Declaration of Human Rights, adopted by the United Nations General Assembly declared in  Article 3 states: “Everyone has the right to life, liberty and security of person.”

Convention on the Rights of Persons with Disabilities Article 10 Right to life -states: “States Parties reaffirm that every human being has the inherent right to life and shall take all necessary measures to ensure its effective enjoyment by persons with disabilities on an equal basis with others,”

There is under numerous human rights treaties and instruments a prohibition against torture, cruel and degrading treatment. This is clearly stated in the Convention Against Torture (CAT) which the U.S.A. has both signed and ratified. The Prohibition of torture is also stated in the CCPR: “The right not to be subjected to torture or cruel, inhuman or degrading treatment or punishment, including the right not to be subjected to non-consensual medical or scientific experimentation (CCPR Article 7).”

Many in the field of human rights believe that hospital confinement and forced psychiatric treatment can be humiliating and degrading and leaves life long stigma and emotional trauma to the patient and can impact the patients’ life in a negative way permanently. Little is more degrading than for patients to be treated as warehoused commodities for the growing industry of for-profit mental facilities.

 

Disabled persons are viewed as chattel, as a “cash cow” for private for profit facilities and for profit guardians (surrogate decision makers). The use of a disabled person as a means to maximize profit and to extract taxpayer money in the form of expensive medical treatment under Medicaid and Medicare is demeaning to their humanity and dignity as human beings. These warehouse facilities utilize loopholes in the welfare laws to chemically restrain and control disabled and elderly people and thus force them to be compliant with medical fraud. This coupled with the removal of the patient’s legal rights to file complaints with the local, state or federal authority means that medical facilities and providers who are human rights violators have no oversight or monitoring of their behavior.

 

Thus when making medical decisions for the physical and mental health of patients who are entirely incapable of making decisions for themselves, there still is an obligation under Convention Against Torture (CAT) - for freedom from torture, inhuman or degrading treatment or punishment.The CCPR also states a Prohibition of slavery or servitude - The right not to be held in slavery or servitude, or (subject to certain express exceptions) to be required to perform forced or compulsory labour (CCPR Article 8).

Federal Election Commission - Pharmaceutical Dark Pac Money 1-8-15

Medical Whistleblower Advocacy Network

 

Written Comments for the Record


to the


Federal Election Commission


1/8/15

by


Dr. Janet Parker DVM

 

 


REG 2014-01 Earmarking, Affiliation, Joint Fundraising, Disclosure, and Other Issues (McCutcheon)
Our democracy is dependent on the ability of the will of the people to affect the actions of our elected
officials. Only when we know to whom elected officials are beholden, can we hold our elected
officials accountable. We have an obligation to ensure that our legislation, administrative policies and
practices are consistent with protections for Constitutional Rights and also Human Rights under
International Human Rights Treaties. Because of Supreme Court decisions like Citizens United, many
political spenders, such as the pharmaceutical industry are effectively allowed to hide their true
identities and to greatly influence legislation and administrative policies. When we as a nation do not
have transparency or accountability regarding political lobbying efforts of huge corporate interests, we
can not draft legislation that protects the human rights of patients to safe and effective health care. We
can also not protect vulnerable patients from being human subjects of research without their informed
consent, as medicine is a profit driven business and patients are very vulnerable and trusting of their
medical providers.


Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for
disabled persons and other individuals. MWAN provides information, referrals, and also direct human
rights defender advocacy services. I am a participating human rights advocate to the 2nd cycle of the
United Nations UPR Process reviewing the record of the United States of America.


Medical Whistleblower Advocacy Network is extremely concerned that the political power of the
pharmaceutical industry has furthered a profit making agenda which has overshadowed the rights of
patients and has led to the loss of human rights protections for vulnerable populations. The pursuit of
the almighty dollar often overshadows corporate responsibility to the public. We ask you to please
update and strengthen the FEC’s disclosure rules to protect our democracy.


The Pharmaceutical Industry lobby has mounted a sophisticated grassroots campaign to provide
political support for its position on key issues that affect its profit making enterprise – including
expanded Medicare/Medicaid funding for off-label drugs. The industry has funded various groups to
champion its positions, sponsored studies tilted to industry goals and hired public relations firms to
spearhead campaigns to soften up public opinion and government policies.


The Pharmaceutical Research and Manufacturers of America spent $12,650,000 on lobbying in 2014
according to OpenSecrets.org. Pfizer Inc. spent $6,910,000, Amgen Inc. spent $6,590,00, Eli Lilly &
Co. spent $5,776,000 and Novartis AG spent $5,435,000 and this is only what they actually disclosed,
not what they funneled through other 501 C 4 non-profit organizations. No health professional activity
is safe from the $200 billion pharmaceutical industry financial and political influence. The largest
growing portion of that market is now psychiatric medications which are highly profitable products but
of dubious benefit. Pharmaceutical companies spend a majority of their funds in marketing rather than
research and development. Financial and political power allows the pharmaceutical industry to push
their legislative agenda through Congress, influence regulatory actions of the FDA, and to control
research at academic medical centers. Public research institutions funded by tax dollars are doing the
basic research for the drugs, but the actual clinical trials are funded privately by the drug companies.
Off-label drug use clinical data is used to expand FDA approval to additional diagnoses. In order to
make patented drugs look better than they really are, clinical research trials are rigged. Government
granted exclusive marketing rights are extended for years by protective and aggressive industry
lawyers. The pharmaceutical industry has found that clinical safety trials are costly to perform. Instead
they have sifted their emphasis to political pressure on targeted government officials to sway public
policy decision making and thus be able to use federal tax dollars to pay for “off-label” use of welfare
recipients as their human subjects. Controlling the decisions of the medical proxy decision makers is
therefore their focus rather than making sure that medications are approved by the FDA as safe and
effective. Annually, the pharmaceuticals industry spends nearly twice as much on marketing as it
spends on research and development. According to the Center for Public Integrity the pharmaceutical
and health products industry has spent more than $800 million in federal lobbying and campaign
donations at both federal and state levels in the past seven years. (PublicIntegrity.org) The Supreme
Court Decision, Citizens United v. Federal Election Commission has now even further extended the
pharmaceutical companies influence over policy makers through unbridled secret contributions to 501 c
4 organizations which then can lobby legislators on behalf of the pharmaceutical industry. Individual
citizens of the U.S.A., especially persons with mental disabilities, cannot compete with equal lobbying
actions to the pharmaceutical industry. Indeed, many with mental health diagnosis are actually stripped
of their right to vote and even their right to petition their elected representatives for issues crucial to
their human rights. Surrogate decision makers often controlled by the medical proxies make voting
decisions for the wards and thus vote pro-pharmaceutical interventions. The human rights of wards of
the court are lost in this political exercise of power.


The pharmaceutical industry gives millions to public advocacy non-profit organizations with a variety
of missions, many of which then support the political agenda of the pharmaceutical firms. These nonprofit
organizations are under no legal obligation to reveal their donors, and thus provide an avenue for
support for positions favorable to the industry. Some of the groups that receive the industry funds are
independent, but many are just a front for the pharmaceutical lobby such as The Institute for Policy
Innovation (IPI). IPI does not disclose its funders, but according to the Foundation Center – Eli Lilly
and Company Foundation is among the group's supporters. The Eli Lilly Foundation is funded by Eli
Lilly and has the mission of providing financial support for non-profit organizations. With the support
of Eli Lilly funding the IPI has published reports opposing drug re-importation and price controls and
defending the industry's lavish spending on advertising, especially the direct-to-consumer advertising.
Other known pharmaceutical industry grassroots political lobbying groups are Seniors Coalition and
The United Seniors Association. The lobbying efforts by these so-called grassroots organizations can
be very deceptive, such as the Consumer Alliance 2002 campaign against legislation that would have
capped prices for prescription drugs. The Consumer Alliance faxed petitions to community leaders that
warned the poor and disabled were in danger of losing access to affordable prescription drugs. It was
revealed later by the Baltimore Sun, that Consumer Alliance was a front group used by Bonner and
Associates on behalf of PhRMA. PhRMA spent more than $60 million on television and newspaper
ads through a group called Citizens for Better Medicare. Citizens for Better Medicare claimed to be a
grassroots organization consisting of numerous organizations and more than 300,000 individual
members and had a mission to get passage of the Medicare prescription drug benefit in 2003. This
legislation has dramatically increased the amount of federal funding through Medicare to pay for off-label
psychiatric prescription drugs.


Off-label use is using a drug for a use that it has not been scientifically proven to be safe or effective –
in other words the drug has not met the requirements to be approved by the federal regulatory agency
the Food and Drug Administration. The pharmaceutical industry politically pushed for legislation
which would permit them to sell their patented drugs off-label (drugs without Food and Drug
Administration approval for that use). There is no need for the pharmaceutical industry to pay for
costly pharmaceutical clinical research trials when they can sell the drug off-label and get the US tax
payer to pay for it even if it is not even FDA proven to be safe or effective. The drug companies
promote these patented off-label drugs by deceptive direct-to-consumer and direct-to-doctor marketing
efforts. The practice of marketing drugs for purposes not backed by science is called “off-label
promotion.” Off-label drug promotion undercuts expectations that drug safety and efficacy have been
fully evaluated. The National Alliance for the Mentally Ill (NAMI) is a 501 C 3 which is funded by
pharmaceutical companies such as Eli Lilly to provide educational materials to both doctors and
patients touting the great benefits of the newly patented medications. Off-label promotion is illegal,
but the pharmaceutical industry pays their attorneys well to fight the FDA in court and when they are
finally criminally convicted the criminal penalties are not high enough to really prevent re-occurrence.
The pharmaceutical industry's political agenda is profit making – not provision of affordable, safe,
health care for all. When the government becomes a third party payer for off-label drug use and the
Medicare/Medicaid legislation mandates payment of any cost of psychiatric drugs then administrators
can not place reasonable cost-saving measures in place. When newer, more expensive drugs are used
off-label, it increases health care costs. The pharmaceutical industry has effectively turned welfare
recipients into human subjects for the testing of their patented drugs off-label and lobbied for the
federal government Medicare program to pay for this off-label use. Deceptive marketing through
contract with prescribing doctors and other medical professionals has expanded the off-label drug use
in this country and has increased health care costs. Highly profitable and expensive patented
medications are over-used and our population is over-medicated. Off-label drugs such as gabapentin
for chronic pain and olanzapine (Zyprexa) for dementia have shown that off-label use has potentially
very negative consequences. The highest rates of off-label use were for anticonvulsants (74%),
antipsychotics (60%), and antibiotics (41%). In an examination of off-label prescribing of 160
common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label
drug uses (73%) were shown to have little or no scientific support. Atypical antipsychotics and
antidepressants were particularly likely to be used off-label without strong evidence. ( Radley DC,
Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med
2006;166: 1021-6.)


Getting informed consent from a patient is a process, not just a formality, and engaging in that process
is of the essence of good medical care. But informed consent can not happen when research data is
suppressed and safety information is with held from prescribing doctors and patients. Informed
consent to use a medication is consent obtained freely, without threats or improper inducements, and
after appropriate disclosure to the patient of adequate and understandable information in a form and
language understood by the patient. Engaging in an informed-consent process between a clinical
doctor and a patient is an essential part of the standard of care in medicine. The involvement of human
beings in such research is prohibited unless the subject or the subject’s legally authorized representative
has provided prior informed consent, with only very limited exceptions. A waiver of informed consent
by the Institutional Review Board is supposed to be granted only in circumstances where the research
presents no more than minimal risk to subjects, and the waiver will not adversely affect subjects’ rights
and welfare. Wards of the court have surrogate decision makers for both legal and medical decisions,
thus wards are prevented even from effective appeal to the Judge or even to their US
Congressmen/Congresswomen. Thus the pharmaceutical industry's influence on surrogate decision
makers such as doctors can effectively control what medical care is given. In the U.S.A. the
guardianship system offers few procedural protections, and has spawned a profit-driven professional
guardianship industry that often enriches itself at the expense of society’s most vulnerable members—
the mentally ill.


We must support the right of federal regulatory agencies to do their job in researching what is safe and
what is not. The Food and Drug Administration's restrictions on off-label promotion serve two
substantial interests: ensuring that both doctors and consumers receive accurate, scientifically based
information, and assuring that drugs have been proven safe and effective. Right now Jazz
Pharmaceuticals is off-label marketing Xyrem which is the sodium salt of GHB – a well known date
rape drug. Xyrem is a Schedule III drug, but when diverted to illegal use it is a Schedule I DEA
Controlled Substance. In the December 2012 case US v Caronia, the company appealed its conviction
for off-label promotion claiming constitutional free speech. The ruling US v Caronia removes the
liability for drug sales representatives which are left unsupervised 99 % of the time, yet control much
of the industry's communication with physicians.


We need to hold elected officials accountable for the public health and safety and therefore we need to
know who is giving them campaign contributions in order to influence their decisions. The
pharmaceutical industry is currently influencing our elected officials so effectively that we are actually
force drugging wards of the court with off-label psychiatric drugs that have no proven efficacy or
safety. Pharmaceutical lobbying is hidden within so many countless NGO's that we have no idea which
elected official is being influenced. This money from secret sources has lead to wide spread corruption
within the health care industry and has undermined the protections for human subjects, patients and has
forced the US taxpayer to pay for expensive off-label drugs which are not only ineffective but in many
cases dangerous.


Please update and strengthen the FEC’s disclosure rules to protect our democracy.
Today the pharmaceutical industry has unprecedented ability to spread money to influence thinking,
mental health practice, and policy making. We need to impose reasonable restrictions on those who
can exercise such immense financial and political power.


For additional information please see my written statement for the record, The State of Civil and
Human Rights in the United States, Senate Judiciary Subcommittee on the Constitution, Civil Rights
and Human Rights, December 9, 2014 or visit my website:
http://MedicalWhistleblowerNetwork.Jigsy.com

From Vulnerability to Strength

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”
 
― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

P.O. 42700 

Washington, DC 20015

MedicalWhistleblowers (at) gmail.com

CONTACT

"Never impose on others what you would not choose for yourself."  Confucius

"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910