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 • One’s right to reject treatment or die • One’s 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 • The pursuit of biological resilience is more than just about law and courts – it’s economic

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 family’s 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 patient’s 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 law’s 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 • “Assisted death by doctor” as an affirmative defense if charged with a crime related to a terminal patient’s 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 in Belgium for this law

7. Shouldn’t we also 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, the judicial forum for many federal agencies like the FDA • Ultimately an en banc 8-2 decision • SCOTUS certiorari denied

9. Abigail Burroughs • Suffered 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 access 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., cont’d. • The Abigail Alliance’s 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., cont’d. • To prove a fundamental right under the 5th Amendment’s substantive due process (SDP) clause: • 1. ”[D]eeplyrooted in this Nation's history and tradition • 2. “[I]mplicitin the concept of ordered liberty.” • If an SDP fundamental right is established, then strict scrutiny applies for the government to prove that both: • A compelling state interest • “Narrow tailoring” for the least intrusive means to serve the compelling interest

13. Fundamental rights to self-determine treatment in the U.S.A., cont’d. • 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., cont’d. • 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., cont’d. • 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. • In other words, statutes override common law doctrine

16. Fundamental rights to self-determine treatment in the U.S.A., cont’d. 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., cont’d. • Theresult 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 FDA’s administrative power to prevent the procuring a drugs that had not only been proven safe, but also effective (efficacy is evaluated in phase II clinical trials)

18. What should have been argued • Administrative Law “Chevron Doctrine” • Agencies perform their duties by way of “enabling acts” from Congress • The enabling act’s plain meaning controls agency decisions generally • But if no plain meaning is apparent, then an agency’s action must not be arbitrary, capricious, or directly contradict the enabling act • Strategy: make an argument that the FDA standing in the way of patients saving their own lives are • rooted in arbitrary, circular reasoning • contradicts the FDA’s 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 more “meta” argument than simply just 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. Real life application: • “I won’t be satisfied until I say/feel I’m satisfied, and [your burden and standard of proof] is subject to rise or fall at my [arbitrary & capricious] whim.”

20. The Precautionary Principle, cont.’d. • The American Enterprise Institute’s 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. There’s hope! • The 21st Century Cures Act (U.S.A.) • Approved by the U.S. House of Representatives by a 344-7 vote – awaiting the U.S. Senate’s vote • The Safety of Regenerative Medicine Act and the Pharmaceutical Affairs Act (Japan) • Early Commercialization & Early Reimbursement • http://replicel.com/recent_coverage/japans-take-on-regenerative-medicine-early-commercialization-early-reimbursement/

24. PDUFA V’s 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 • Upcoming hearings drawing “considerable public interest” in CBER’s “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products” hearing

25. U.S. President Barack Obama’s 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?