Regenerative medicine technology should be supported by regulatory agencies, and not treated with suspicion.

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
 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 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
 Doctors can use “assisted death” 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 exists in Belgium for this
law

7. But by the same
token,
shouldn’t 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., 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]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., 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.

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.
 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 FDA’s 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 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 people
like Abigail Burroughs saving their own life is
 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 “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 won’t be satisfied (with your evidence) until I
say/feel I’m satisfied (with your evidence), and I’ll
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 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 2015 American Cures Act
 Approved by the U.S. House of Representatives
by a 344-7 vote – awaiting the U.S. Senate’s vote

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

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
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