Your Body, Your Cells? Direct-to-Consumer Marketing of Autologous Stem Cell Therapies in the United States, Japan, and Australia.

AuthorLaird, Kathleen C.

TABLE OF CONTENTS I. INTRODUCTION II. WHY ARE AUTOLOGOUS STEM CELL THERAPIES FOR SALE? A. The Rise of Autologous Stem Cell Therapies B. Aggressive DTC Marketing III. UNPROVEN ASCT MARKETING & REGULATORY RESPONSES A. Unique success of DTC marketing techniques of clinics offering unproven ASCT 1. ASCT marketing through an individual autonomy and patient choice lens 2. Use of "tokens of scientific legitimacy" to proliferate and evade regulatory scrutiny B. Recent efforts in the United States, Australia, and Japan to curtail unproven ASCT leave continued loopholes 1. United States 2. Japan 3. Australia 4. Political Tensions Between Innovation & Safety 5. Enforcement & Outsourcing Responsibility IV. STEM CELL SAFETY & EFFICACY DECLARATION & GUIDELINES A. WHO Involvement Is Key 1. Declaration for stem cell and regenerative medicine safety and efficacy 2. WHO Committee & Stem Cell Guidelines V. CONCLUSION I. INTRODUCTION

A seventy-seven-year-old music teacher, Doris, was left nearly blind after paying more than $8,000 for a stem cell treatment at a US clinic that claimed to cure macular degeneration. (1) A Romanian child died from having stem cells injected into his brain at a large German clinic. (2) And veteran James DeLittle went to Ukraine, paying $8,500 for a stem cell therapy that allegedly would help his Parkinson's. (3) Two years later, he is still deteriorating and feeling "conned." (4)

Thousands of private clinics in the United States and around the world successfully market "miracle" stem cell therapies directly to patients, primarily over the internet, claiming to treat anything from orthopedic conditions to Alzheimer's. (5) But there is a cost. Most of these companies engaged in direct-to-consumer (DTC) marketing (6) are unregulated clinics making claims about unproven stem cell procedures in return for a hefty profit. (7) Initially, the "stem cell tourism" phenomenon described clinics operating in countries without adequate medical product regulations, like China and India, that target patients from wealthier countries, like the United States. (8) However, businesses selling unproven stem cell treatments have greatly proliferated across the globe, including and particularly in highly regulated countries like the United States, Japan, and Australia. (9) Indeed, experts estimate that the United States is now home to more than seven hundred commercial stem cell clinics. (10)

A few stem cell therapies have been proven to effectively treat certain blood cancers and blood disorders. (11) But, to date, no clinically valid data supports stem cell interventions for the variety of diseases that these commercial clinics claim to treat. (12) Many leading academics, bioethicists, and international stem cell organizations have criticized these companies' actions and issued warnings to prospective patients. (13) Yet, clinics continue to flourish, claiming that blind patients, "thanks to stem cell therapy, c[an] see again," or that their therapies can "reverse autism symptoms," exploiting the hope, health, and pocketbooks of desperate patients with incurable diseases. (14)

This Note describes why, despite reports of adverse outcomes and international criticism from reputable scientific experts, companies peddling unproven stem cell therapies continue to enjoy extraordinary success around the world. (15) Specifically, this Note will argue that DTC stem cell marketing is successful due to the misconceptions surrounding autologous stem cell therapies (ASCT), which are cells derived from the patient's own tissue. (16) Commercial clinics primarily market autologous stem cell interventions and aggressively promote the idea that patients own their cells and so should--and do--have a greater degree of control and freedom in choosing to undergo this type of treatment. (17) This concept has proven highly persuasive in convincing patients that they are uniquely empowered and knowledgeable consumers when it comes to ASCT. (18) This prompts patients to accept more risk when undergoing unproven procedures, particularly when patients have no other validated, curative treatment for a serious disease. (19) Plus, commercial clinics fiercely advocate that access to ASCT is an issue of personal autonomy and patient control, which amplifies this marketing success. (20)

Investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials...The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use.") [hereinafter FDA Warns].

This analysis will also discuss how clinics exploit regulatory frameworks in developed countries like the United States, Japan, and Australia, to evade oversight. (21) Specifically, clinics use "tokens of scientific legitimacy," like displays of hyperbolic patient testimonials in lieu of scientific data, publications in journals without peer review standards, and registration of alleged clinical trials through government websites. (22) Finally, clinics make claims that their ASCTs fall within certain regulatory exceptions and threaten legal action in defense of such loopholes. (23)

The striking success of DTC marketing for ASCT has showcased the ineffectiveness of the regulatory and legal responses by individual countries. (24) Italian officials finally banned a controversial stem cell company from performing its procedure because of safety concerns, and its owner was convicted of fraud. (25) But, two years later, the owner was arrested again for allegedly offering the same therapy in the US state of Georgia. (26) Similarly, the U.S. Food and Drug Administration (FDA) won a notable legal victory in 2014 that affirmed its authority to regulate ASCT and prohibited a company from marketing its treatment in the United States. (27) Undeterred, this company currently offers this procedure in the Cayman Islands and continues to provide other therapies that fall into a regulatory gray area in the United States. (28)

This Note will evaluate transnational DTC marketing of unproven stem cell therapies and will propose that an equally aggressive and coordinated international response is required. (29) Part II will describe stem cell therapies, the rise of unproven ASCT in highly regulated countries, and provide an overview of stem cell regulations in the United States, Japan, and Australia. Part III will first discuss the DTC marketing tactics used by clinics, grounded in ideals of patient ownership and autonomy, and then will evaluate the regulatory responses by the United States, Japan, and Australia. Part IV will propose that an international solution is needed to meaningfully protect patients and to curb the continued success of rogue stem cell clinics. Specifically, this Note will propose that the World Health Organization (WHO) develop stem cell clinical safety and efficacy guidelines and issue a declaration calling on state leaders to adhere to such guidelines.

  1. WHY ARE AUTOLOGOUS STEM CELL THERAPIES FOR SALE?

    1. The Rise of Autologous Stem Cell Therapies

      Stem cell tourism has relocated; patients in search of stem cell therapies to treat nearly any disease or condition can find clinics selling miracle cures without traveling beyond their national borders. (30) Businesses marketing unproven stem cell therapies are now plentiful in highly regulated, wealthy countries, and are particularly prevalent in the United States, Japan, and Australia. (31) Despite regulatory oversight and support for science-based innovation in these countries, the internet and social media facilitate the rapid growth and success of a new industry selling unproven treatments through DTC advertising. (32)

      Stem cells--which are considered part of a broader category of regenerative medicine (33)--hold unique clinical promise because of their ability to duplicate, self-renew, and differentiate into other kinds of cells to repair damaged tissue or organs. (34) In 1998, scientist Dr. James Thomson of the University of Wisconsin was the first to derive (or extract) human embryonic stem cells, and in 2006, Dr. Shinya Yamanaka of Japan--in tandem with Dr. Thomson--isolated adult induced pluripotent stem cells. (35) The derivation of pluripotent stem cells was significant because pluripotent cells can be "reprogrammed" to hold characteristics of nearly any type of cell, including embryonic stem cells, but are derived from other parts of the body. (36)

      Stem cell therapies also carry unique safety risks. (37) Large quantities of human cells that are grown outside the body are susceptible to contamination or infection, which can produce severe adverse events like tumor growth. (38) Nonetheless, these early discoveries "triggered a wave of optimism" among the science community, prompting exaggerated media claims about the potential biomedical applications of stem cells. (39) Since these discoveries, however, few stem cell products have been proven effective, despite many clinical trials. (40) Therapies that regulators have approved are limited to treating some blood cancers and immune diseases. (41) Some posit that this early hype generated unreasonable patient expectations about the availability, safety, and efficacy of stem cell treatments, creating a gap between expectations and the scientific reality. (42) While the clinical potential of stem cells continues to puzzle scientists, a new, profitable industry has developed to fill this gap, selling unproven stem cell therapies--treatments that are not supported by clinical safety or efficacy data--to treat a seemingly endless menu of conditions. (43)

      The first US stem cell clinic opened in 2002 and, according to a database maintained by Dr. Leigh Turner, this has grown to about "432 distinct US businesses [selling stem cell therapies] provided at 716 clinics" as of early 20 1 7. (44) However, Dr. Turner believes there are likely more than one thousand clinics in the United...

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