Physician Participation in Direct-to-Consumer Genetic Testing: Pragmatism or Paternalism?
Schleckser, Kathryn, Harvard Journal of Law & Technology
TABLE OF CONTENTS I. INTRODUCTION II. WHAT IS DTC GENETIC TESTING, AND HOW DOES IT WORK? A. Select a Provider and Purchase a Kit B. Spit! C. Wait D. Explore the Results III. REGULATION OF THE DTC GENETICS INDUSTRY: LEGAL SOURCES FOR PHYSICIAN PARTICIPATION REQUIREMENTS A. Food and Drug Administration B. Centers for Medicare and Medicaid Services C. Federal Trade Commission D. State Regulation IV. PHYSICIAN PARTICIPATION REQUIREMENTS ARE UNNECESSARY AND ILL-ADVISED A. DTC Tests Are Not Misleading Products B. DTC Industry Leaders Disclose the Risks of Testing C. Research Shows That DTC Customers Understand Their Results D. Evidence Does Not Suggest That Consumers Take Drastic or Ill-Advised Action in Response to Results Without Consulting a Physician E. Early Evidence Suggests That DTC Genetic Testing Does Not Cause Psychological Harm F. Primary Care Physicians Are Ill-Prepared to Assist Patients with the Genetic Testing Process G. Mandatory Disclosure of Genetic Testing Results Creates Privacy Concerns H. Federal Trade Commission Enforcement Actions Could Enhance Consumer Understanding and Remove Disreputable Companies from the Marketplace V. CONCLUSION
DNA has gone mainstream. (1) In the sixty-plus years since Watson and Crick first opened the world's eyes to the double helix, (2) genetics --as a construct--has morphed into a cultural juggernaut. (3) From forensic crime dramas (4) to the ubiquitous soap opera paternity test, (5) DNA is everywhere, and not just in the literal sense. In our new "Genomic Era," (6) concepts once limited to the laboratory have made their way into men's (7) and women's (8) magazines, cartoon sitcoms, (9) and, ergo, daily conversation. This increasing public awareness of DNA science --intensified by completion of the thirteen-year-long (10) and nearly four billion dollar (11) Human Genome Project ("HGP") in 2003 (12)--has created a new market for personal genetic information. (13) "Americans want to know the details of their genetic codes." (14) As the cost of DNA technology has plummeted, (15) the direct-to-consumer ("DTC") genetics industry has emerged to meet this demand. (16) Today, people curious about the contents of their genomes can simply select a DTC provider, (17) order a test kit online, mail back a saliva sample, and wait. (18) Once a laboratory has analyzed their DNA for hundreds of genetically correlated traits, disease risks, carrier statuses, and drug responses, (19) customers simply log in to a secure, online portal to view their results. (20) No doctor required. (21)
While DTC providers, and many customers, promote the lack of physician involvement as a form of "patient empowerment," (22) critics of the process are concerned about the public's ability to understand the meaning and limits of genetic testing without a doctor's guidance. (23) Accordingly, some scholars have argued for increased regulation that would require physician participation--not only to help consumers interpret results, but also to help them decide whether to get tested in the first place. (24) This Note argues against such requirements and in favor of the true DTC model. Part II explains the details of the DTC process. Part III summarizes the regulatory landscape affecting the DTC industry, with an emphasis on federal and state authorities that currently mandate doctor involvement, or that might do so in the future. Part IV addresses the rationales for mandating physician participation--arguing that (1) fears of customer harm are exaggerated, (2) leading DTC providers adequately explain testing risks, (3) most doctors are ill-equipped to advise their patients about genetic testing, (4) physician involvement would implicate privacy concerns, and (5) advertising regulation via the Federal Trade Commission ("FTC") would better serve consumers. …