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The Right to Live, the Right to Thrive

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Mallory McLaren
Mallory McLaren

The document discusses fundamental rights regarding medical treatment and experimentation. It summarizes key court cases that established the right to refuse treatment or die, but not a right to assisted suicide. It also discusses the Abigail Alliance case, where terminally ill patients argued for access to experimental drugs, but courts affirmed the FDA's role in determining drug safety and efficacy. The document advocates that individuals should have more autonomy over their medical treatment and the right to try to save their own lives through experimental means when facing terminal illness.

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The Right to Live, The Right to Thrive Mallory E. McLaren, J.D.
Agenda Fundamental rights to determine what happens to your body Ones right to reject treatment or die Ones right to self-determine medical treatment and experimentation The state of law and governance today Dissonance between the governmental interest to preserve life and how it meets that goal Pursuing biological resilience is more than just about law and courts
About me: J.D. Seton Hall University B.A. - The Evergreen State College Resiliency and regenerative biotechnology sector entrepreneur Long-time advocate for trans* & intersex persons / gender identity inclusion and equality Veganism & Vegetarian life choices / Animal welfare and liberation
Fundamental rights to end medical treatment in the U.S.A. 1976: Removal of respirator could be removed at the familys behest In re Quinlan NJ Supreme Court SCOTUS certiorari denied then a legal gray area period concerning who by, and how, extraordinary measures are decided 1990: Clear and convincing evidence of patients wishes are required for removal of life support Cruzan v. Director, Missouri Department of Health U.S. Supreme Court 1997: Right to assistance in suicide is not a fundamental right Washington v. Glucksberg U.S. Supreme Court
Turning a new leaf: Assisted termination-of-life in the U.S.A. Death with Dignity legislation Oregon 1997 (date of the laws last challenge) Washington 2008 Vermont 2013 Oregon and Wash. require self administration of life- ending drugs Montana decriminalized assisted suicide in 2009 by state judicial precedent Doctors can use assisted death as an affirmative defense if charged with a crime related to a terminal patients death
Turning a new leaf, globally Euthanasia in Belgium Legislation in effect since 2002 Patients with psychiatric conditions and even children can request voluntary euthanasia. Patients must have a constant and unbearable suffering which is incurable Doctors administer the final treatment A national board requires doctors to account for every euthanasia event administered Overwhelming public support exists in Belgium for this law
But by the same token, shouldnt we have the right to live?
Fundamental rights to self- determine treatment in the U.S.A. 2007: [The] Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach The D.C. Federal Circuit, which rules on decisions and rulemaking of independent federal agencies like the FDA Ultimately an en banc 8-2 decision SCOTUS certiorari denied
Abigail Burroughs Suffered from aggressive head and neck cancer Died in 2001
Human Clinical Trials Phase 1: Safety (including dosage and side effects) The Abigail Alliance attempted to get drugs/therapies at this stage Phase 2: Efficacy + Safety Phase 3: Large-scale drug trial monitoring: side effects comparison to existing treatments gathering information on how to use the drug/treatment in the safest manner
Fundamental rights to self-determine treatment in the U.S.A., contd. The Abigail Alliances argument: The common law [criminal & tort] concepts of self-defense, necessity, and interference with rescue are broad enough to demonstrate the existence of the fundamental right for persons in mortal peril to try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks. In other words, activity that is self-defense + necessity + attempt to rescue oneself = protection as a fundamental right A right to medicines
Fundamental rights to self-determine treatment in the U.S.A., contd. To prove a fundamental right under the 5th Amendments substantive due process (SDP) clause: 1. [D]eeply rooted in this Nation's history and tradition 2. [I]mplicit in the concept of ordered liberty. If an SDP fundament al right is established, then strict scrutiny applies for the government to prove that both: A compelling state interest exists Narrow tailoring for the least intrusive means to serve the compelling interest
Fundamental rights to self-determine treatment in the U.S.A., contd. A brief history of decisional privacy as a 5th Amendment fundamental right: 1965: A specific right to use contraception from general right to be free from intrusion into sacred precincts of marital bedrooms Griswold v. Connecticut U.S. Supreme Court 1973: A specific right to terminate a pregnancy from broader right to privacy Roe v. Wade U.S. Supreme Court 1976: A right to determine extended family living arrangements from broader constitutional protection for the sanctity of the family Moore v. City of East Cleveland - U.S. Supreme Court D.C. Circuit in Abigail Alliance: In any event, the Alliance's liberty claims are not grounded in the abstract notion of personal autonomy but rather in the specific right to act to save one's own life.
Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law self-defense: Unlike the cases in which the doctrine of self-defense might properly be invoked, this case involves risk from drugs. Because terminally ill patients cannot fairly be characterized as using reasonable force to defend themselves when they take unproven and possibly unsafe drugs ... [the Abigail Alliance] cannot draw support from the doctrine of self-defense. Taking a drug is not self-defense in the classic sense because [in part] the tool Alliance patients want to use to save themselves may not actually save them
Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law necessity: The U.S. Supreme Court [has spoken]: under any conception of legal necessity ... The defense cannot succeed when the legislature itself has made a determination of values ... and that is precisely what the FDCA has done ... Congress has prohibited general access to experimental drugs ... and has prescribed in detail how experimental drugs may be studied and used by the scientific and medical communities.
Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law interference with rescue: It is difficult to see how a tort addressing interference with providing necessary aid would guarantee a constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA's clinical testing process
Fundamental rights to self-determine treatment in the U.S.A., contd. The result of the Abigail Alliance case: Affirmed the right of doctors and patients to make decisions about pre-approval [post phase II] drugs and therapies under narrow exemptions ...But also Affirmed the FDAs administrative power to prevent the procuring a drugs that had not only been proven safe, but also effective
What should have been argued Administrative Law Chevron Doctrine Agencies perform their duties by way of enabling acts from Congress The enabling acts plain meaning controls agency decisions generally But if no plain meaning is apparent, then an agencys action must not be arbitrary, capricious, or directly contradict the enabling act Strategy: make an argument that the FDA standing in the way of people like Abigail Burroughs saving their own life is rooted in arbitrary, circular reasoning contradicts the FDAs goal of promoting well-being because it leaves terminally ill patients no meaningful options to assent to risk when attempting to self-preserve Bodily autonomy Individual right to avoid physical frailty and premature death A meta argument more meta than a right to medicines
The Precautionary Principle The proponent of an activity, rather than the public or government, should/must bear the burden of proof. Or, in other words... I wont be satisfied (with your evidence) until I say/feel Im satisfied (with your evidence), and Ill tell you when that is, and [your burden and standard of proof] is subject to increase at my whim.
The Precautionary Principle, cont.d. The American Enterprise Institutes view: A blanket better safe than sorry policy is wholly arbitrary or incoherent, and leads to absurd outcomes Becomes a Trojan horse pretext for other ideological crusades When selectively applied to politically disfavored technologies and conduct it serves as a barrier to both technological progress and economic growth See https://www.aei.org/publication/the-problems- with-precaution-a-principle-without-principle/
The Right to Live, the Right to Thrive
This is not just about me. This is about so many others. -Abigail Burroughs
Theres hope! The 2015 American Cures Act Approved by the U.S. House of Representatives by a 344-7 vote awaiting the U.S. Senates vote
PDUFA Vs Patient Centered Drug Development Factors Analysis of condition Current treatment options Benefits to patient, society, and science Risks to patient, society, and science Our ability to manage peril or risk
U.S. President Barack Obamas 2015 State of the Union call for a Precision Medicine Initiative
The Right to Live, the Right to Thrive
The Right to Live The Right to Thrive mallory@eternabiocapital.com https://www.linkedin.com/in/malloryemclaren QUESTIONS? COMMENTS?

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The Right to Live, the Right to Thrive

  • 1. The Right to Live, The Right to Thrive Mallory E. McLaren, J.D.
  • 2. Agenda Fundamental rights to determine what happens to your body Ones right to reject treatment or die Ones right to self-determine medical treatment and experimentation The state of law and governance today Dissonance between the governmental interest to preserve life and how it meets that goal Pursuing biological resilience is more than just about law and courts
  • 3. About me: J.D. Seton Hall University B.A. - The Evergreen State College Resiliency and regenerative biotechnology sector entrepreneur Long-time advocate for trans* & intersex persons / gender identity inclusion and equality Veganism & Vegetarian life choices / Animal welfare and liberation
  • 4. Fundamental rights to end medical treatment in the U.S.A. 1976: Removal of respirator could be removed at the familys behest In re Quinlan NJ Supreme Court SCOTUS certiorari denied then a legal gray area period concerning who by, and how, extraordinary measures are decided 1990: Clear and convincing evidence of patients wishes are required for removal of life support Cruzan v. Director, Missouri Department of Health U.S. Supreme Court 1997: Right to assistance in suicide is not a fundamental right Washington v. Glucksberg U.S. Supreme Court
  • 5. Turning a new leaf: Assisted termination-of-life in the U.S.A. Death with Dignity legislation Oregon 1997 (date of the laws last challenge) Washington 2008 Vermont 2013 Oregon and Wash. require self administration of life- ending drugs Montana decriminalized assisted suicide in 2009 by state judicial precedent Doctors can use assisted death as an affirmative defense if charged with a crime related to a terminal patients death
  • 6. Turning a new leaf, globally Euthanasia in Belgium Legislation in effect since 2002 Patients with psychiatric conditions and even children can request voluntary euthanasia. Patients must have a constant and unbearable suffering which is incurable Doctors administer the final treatment A national board requires doctors to account for every euthanasia event administered Overwhelming public support exists in Belgium for this law
  • 7. But by the same token, shouldnt we have the right to live?
  • 8. Fundamental rights to self- determine treatment in the U.S.A. 2007: [The] Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach The D.C. Federal Circuit, which rules on decisions and rulemaking of independent federal agencies like the FDA Ultimately an en banc 8-2 decision SCOTUS certiorari denied
  • 9. Abigail Burroughs Suffered from aggressive head and neck cancer Died in 2001
  • 10. Human Clinical Trials Phase 1: Safety (including dosage and side effects) The Abigail Alliance attempted to get drugs/therapies at this stage Phase 2: Efficacy + Safety Phase 3: Large-scale drug trial monitoring: side effects comparison to existing treatments gathering information on how to use the drug/treatment in the safest manner
  • 11. Fundamental rights to self-determine treatment in the U.S.A., contd. The Abigail Alliances argument: The common law [criminal & tort] concepts of self-defense, necessity, and interference with rescue are broad enough to demonstrate the existence of the fundamental right for persons in mortal peril to try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks. In other words, activity that is self-defense + necessity + attempt to rescue oneself = protection as a fundamental right A right to medicines
  • 12. Fundamental rights to self-determine treatment in the U.S.A., contd. To prove a fundamental right under the 5th Amendments substantive due process (SDP) clause: 1. [D]eeply rooted in this Nation's history and tradition 2. [I]mplicit in the concept of ordered liberty. If an SDP fundament al right is established, then strict scrutiny applies for the government to prove that both: A compelling state interest exists Narrow tailoring for the least intrusive means to serve the compelling interest
  • 13. Fundamental rights to self-determine treatment in the U.S.A., contd. A brief history of decisional privacy as a 5th Amendment fundamental right: 1965: A specific right to use contraception from general right to be free from intrusion into sacred precincts of marital bedrooms Griswold v. Connecticut U.S. Supreme Court 1973: A specific right to terminate a pregnancy from broader right to privacy Roe v. Wade U.S. Supreme Court 1976: A right to determine extended family living arrangements from broader constitutional protection for the sanctity of the family Moore v. City of East Cleveland - U.S. Supreme Court D.C. Circuit in Abigail Alliance: In any event, the Alliance's liberty claims are not grounded in the abstract notion of personal autonomy but rather in the specific right to act to save one's own life.
  • 14. Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law self-defense: Unlike the cases in which the doctrine of self-defense might properly be invoked, this case involves risk from drugs. Because terminally ill patients cannot fairly be characterized as using reasonable force to defend themselves when they take unproven and possibly unsafe drugs ... [the Abigail Alliance] cannot draw support from the doctrine of self-defense. Taking a drug is not self-defense in the classic sense because [in part] the tool Alliance patients want to use to save themselves may not actually save them
  • 15. Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law necessity: The U.S. Supreme Court [has spoken]: under any conception of legal necessity ... The defense cannot succeed when the legislature itself has made a determination of values ... and that is precisely what the FDCA has done ... Congress has prohibited general access to experimental drugs ... and has prescribed in detail how experimental drugs may be studied and used by the scientific and medical communities.
  • 16. Fundamental rights to self-determine treatment in the U.S.A., contd. Re common law interference with rescue: It is difficult to see how a tort addressing interference with providing necessary aid would guarantee a constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA's clinical testing process
  • 17. Fundamental rights to self-determine treatment in the U.S.A., contd. The result of the Abigail Alliance case: Affirmed the right of doctors and patients to make decisions about pre-approval [post phase II] drugs and therapies under narrow exemptions ...But also Affirmed the FDAs administrative power to prevent the procuring a drugs that had not only been proven safe, but also effective
  • 18. What should have been argued Administrative Law Chevron Doctrine Agencies perform their duties by way of enabling acts from Congress The enabling acts plain meaning controls agency decisions generally But if no plain meaning is apparent, then an agencys action must not be arbitrary, capricious, or directly contradict the enabling act Strategy: make an argument that the FDA standing in the way of people like Abigail Burroughs saving their own life is rooted in arbitrary, circular reasoning contradicts the FDAs goal of promoting well-being because it leaves terminally ill patients no meaningful options to assent to risk when attempting to self-preserve Bodily autonomy Individual right to avoid physical frailty and premature death A meta argument more meta than a right to medicines
  • 19. The Precautionary Principle The proponent of an activity, rather than the public or government, should/must bear the burden of proof. Or, in other words... I wont be satisfied (with your evidence) until I say/feel Im satisfied (with your evidence), and Ill tell you when that is, and [your burden and standard of proof] is subject to increase at my whim.
  • 20. The Precautionary Principle, cont.d. The American Enterprise Institutes view: A blanket better safe than sorry policy is wholly arbitrary or incoherent, and leads to absurd outcomes Becomes a Trojan horse pretext for other ideological crusades When selectively applied to politically disfavored technologies and conduct it serves as a barrier to both technological progress and economic growth See https://www.aei.org/publication/the-problems- with-precaution-a-principle-without-principle/
  • 22. This is not just about me. This is about so many others. -Abigail Burroughs
  • 23. Theres hope! The 2015 American Cures Act Approved by the U.S. House of Representatives by a 344-7 vote awaiting the U.S. Senates vote
  • 24. PDUFA Vs Patient Centered Drug Development Factors Analysis of condition Current treatment options Benefits to patient, society, and science Risks to patient, society, and science Our ability to manage peril or risk
  • 25. U.S. President Barack Obamas 2015 State of the Union call for a Precision Medicine Initiative
  • 27. The Right to Live The Right to Thrive mallory@eternabiocapital.com https://www.linkedin.com/in/malloryemclaren QUESTIONS? COMMENTS?