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On November 30, 2016, the New England Journal of Medicine published a piece entitled “Clarifying Stem-Cell Therapy’s Benefits and Risks.”  The authors, which include Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, M.D., argue that, aside from a few indications, the clinical use of autologous stem cell therapies (stem cells that come from you and go into you) has not been proven effective and can even be dangerous.  The argument as presented has two obvious flaws: First is that the FDA has chosen to ignore years of clinical data from competent, certified practitioners that demonstrate efficacy, Second, their one cited example of the danger of autologous stem cells is actually an example of allogeneic stem cell use (stem cells from another person).  However, even these glaring criticisms belie a more critical flaw, one that is more legal in nature and that engages essential questions about our privacy right in our own bodies and its derivatives.  To better understand this, we can look to an unlikely example – abortion rights.

At first glance, pro-choice advocates and advocates for personal stem cells don’t seem to have much in common.  The former issue revolves around whether and under what circumstances a woman can terminate her pregnancy.  The latter issue concerns whether and under what circumstances a patient can use his or her own stem cells to heal themselves.  The former issue has been extensively litigated – in both the public and the courts – and, thus, the doctrinal and philosophical parameters of the debate have long been established.  Conversely, the issue of personal stem cells has little judicial precedent and has seen almost no public debate at all.  Despite these distinctions, the two issues have one crucial unifying element – our fundamental right to privacy under the U.S. Constitution and how it protects our bodies from undue government intrusion.  Indeed, the convergence of abortion rights and personal stem cell rights lies at the nexus of liberty, autonomy, and bodily integrity.

Personal Stem Cells: A Gift From You to You

At the outset, let me articulate my own conception of what I refer to as “personal” stem cells.   The concept of personal stem cells (technically referred to as autologous or homologous stem cells) is based upon three basic related propositions:

  1. The scientific fact that we all have primordial, undifferentiated cells in our own bodies called stem cells that can be harvested from bone marrow or adipose tissues and used to potentially heal ourselves.
  2. The legal fact that so long as they are “minimally manipulated,” those cells cannot reasonably be classified as “drugs” because they are derivations from one’s own body that are extracted from one person and administered to the same person
  3. The philosophical proposition that one has a qualified legally cognizable right to use those cells to heal oneself. 

A substantial amount of scientific studies has confirmed the safety and efficacy of personal stem cell therapy for a variety of indications such as lower extremity ulcers and degenerative arthritis of the knee, with the possibility of treating traumatic brain injury. However, due to the possibility of restrictive FDA regulations, the clinical availability of the therapy faces an uncertain future.  In the interest of introducing certainty and fairness in the regulation of such a novel medical technology, it is proposed that the right to privacy is the appropriate framework with which to define the currently undefined regulatory space personal stem cells occupy.

We Have Privacy Right in Our Own Bodies

So why should the right to privacy extend to personal stem cells?  Generally speaking, privacy in America law is founded upon the common law principle of personal autonomy, or the right to be left alone.  The jurisprudential foundation of modern formulations of privacy can be found in the case of Meyer v. Nebraska (1923), in which the Supreme Court found that the 14th Amendment

[…]Denotes not merely freedom from bodily restraint, but also the right of the individual to contract, to engage in the common occupations of life, … and generally to enjoy those privileges long recognized at common law as essential to the orderly pursuit of happiness by free men.

Cases adjudicated subsequent to Meyer tended to focus on safeguarding the personal autonomy inherent in intimate familial relations.  For example, in Skinner v. Oklahoma (1942), the Court struck down a law compelling sterilization of a certain class of felons.

Although the holding in Skinner turned generally on the right to procreate, it also underscored the right to bodily integrity in certain medical matters.  This logic was in many ways extended in Griswold v. Connecticut (1965) when the Court crystallized the constitutional underpinnings of the right to privacy by pronouncing that, “specific guarantees in the Bill of Rights have penumbras, formed by emanations from those guarantees that give them life and substance.”  Moreover, those guarantees create “zones of privacy” which protect certain intimate activities from “means which sweep unnecessarily broadly and thereby invade the area of protected freedoms.” Eisenstadt v. Baird (1972) extended privacy protections to individuals, in “matters so fundamentally affecting a person” as the decision to have children.  In the area of bodily integrity, specifically, the Court in Union Pacific Railway Co. v. Botsford (1891) opined that “[n]o right is held more sacred, or is more carefully guarded … than the right of every individual to the possession and control of his own person, free from all restraint or interference from others, unless by clear and unquestionable authority of law.”

A Woman’s Right to Choose Is a Woman’s Right to Her Own Body

When the Court applied the right to privacy to the abortion issue in Roe v. Wade (1973), it extended the privacy protections implied in the 14th Amendment’s concept of personal liberty to abortion rights.  The Court based its holding in large part on the myriad of detriments to the woman that the Texas abortion ban in question would impose: the prevention of specific and direct medically diagnosable harm, the imminence of psychological harm, the taxing of mental and physical health, and the distress of the woman’s entire family.  The Court concluded that these factors were to be considered by the woman and her physician in consultation.  Later, in Planned Parenthood v. Casey (1992), the Court reiterated that “[t]hese matters, involving the most intimate and personal choices a person may make in a lifetime, choices central to personal dignity and autonomy, are central to the liberty protected by the Fourteenth Amendment.”

Treating Personal Stem Cell Rights Like Abortion Rights Just Makes Sense

The fundamental similarity in the concerns over restricting access to abortions and personal stem cells warrants a similar application of the right to privacy.  Like a woman’s decision to abort or to give birth, decisions concerning infirmity and health are precisely those kinds of intimate activities that require constitutional protection under a “zone of privacy.”  Furthermore, the list of detriments to the woman seeking an abortion, as articulated by the Roe Court, eerily mirrors that of the potential personal stem cell patient.  Indeed, the physical illness itself, and the complex of psychological trauma and social stigma that often accompanies it, is inherently taxing to both the patient and the family members who care for them.  Personal stem cells offer the promise of freedom “to engage in the common occupations of life,” and few would argue that the prospect of freedom from disease and disability is “essential to the orderly pursuit of happiness by free men” as set forth in Meyer.

Abortion rights and personal stem cell are also comparable with regard to the preservation of bodily integrity.  It would be a gross understatement to say that the abortion procedure is an intrusive one, one in which a literal physical extension of a woman is extricated.  Likewise, the personal stem cell extraction procedure requires the literal removal of part of a person’s body.  While certainly not the same order of magnitude, it is nevertheless a decision over one’s bodily autonomy and exercise of personal liberty, one that could potentially be life or death.  Thus, although the Court has yet to explicitly recognize a fundamental right to access medical treatment, Botsford remains applicable – no right is more sacred than the right of every individual to the possession and control of his own person, free from all restraint or interference, unless by clear and unquestionable authority of law.

Crippling Federal Interference in the Exercise of Privacy Rights Cannot Stand

Finally, the right to personal stem cells should be regulated primarily at the state level, just as abortion rights are.  Current FDA stem cell regulations already prohibit the use of personal stem cells whose processing exceeds the “minimally manipulated” standard, classifying them as “drugs” which must be subjected to a glacially slow and obscenely expensive clinical trial process.  Future regulations are certain to whittle away the right even further.  For example, the FDA’s current “Draft Guidance on Homologous use of Stem Cells, and Cellular and Tissue-Based Products” sets forth a “same basic function” standard that could potentially limit access to personal stem cell therapy.  Given its history, the FDA’s stated intent of protecting patients is dubious, and its new regulations will likely have a chilling effect similar to its interpretation of the “minimally manipulated” standard, which limits one’s use of personal “strong” (mesenchymal) stem cells (a sub-set of stem cells that can turn into many different cell types).  These are the personal stem cells that do the most work in healing.

This intrusion by the federal government is exactly the kind of intrusion that pro-choice advocates have fought against for years, in the form of the Hyde Amendment, the Partial Birth Abortion Act, and the Unborn Victims of Violence Act.  Although clearly not without their own challenges, the federal government must recognize that the state legislatures, agencies, and courts, along with medical ethics boards and the doctor-patient relationship itself, is more than sufficient to balance the state’s interest in the health, safety, and welfare of its citizens with the patient’s right to privacy, personal autonomy, individual liberty, and bodily integrity.

Our Bodies Are Ours, Period

Undue infringement by the federal government upon so sacrosanct a right as the bodily integrity of private persons must be viewed as paternalistic, Victorian and an affront to the freedoms inherent in the Constitution itself.  At its core, the fight for abortion rights is about fundamental fairness in the form of gender inequality.  The fight for access to personal stem cells is also an issue of fairness, in the form of health inequality, an inequality that viciously affects our wounded warriors, our senior citizens and our moms and dads who often must turn to addictive opiates to alleviate their pain.  The expansion of the right to privacy to a person’s right to use his or her stem cells is simply a logical extension of American constitutional law, forward-thinking public policy, and basic common sense.  Federal restrictions on both abortion rights and the use of personal stem cells must be considered inhumane, anachronistic and contrary to evolved American standards of liberty.  Capricious constraints on choice are the corset that chokes the conscience of the constitution and the country.

 

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