The Roles and Responsibilities of Physicians in Patients' Decisions about Unproven Stem Cell Therapies

Lau D. Ogbogu U. , “Stem Cell Clinics Online: The Direct-to-Consumer Portrayal of Stem Cell Medicine,” Cell Stem Cell 3, no. 6 (2008): 591–594; Regenberg A. C. Hutchinson L. A. , “Medicine on the Fringe: Stem Cell-Based Interventions in Advance of Evidence,” Stem Cells 27, no. 9 (2009): 2312–2319.

Enserink M. Article News , “Selling the Stem Cell Dream,” Science 313, no. 5784 (2006): 160–163.

See Lau , supra note 1; Regenberg , supra note 1.

Nature, Editorial, “Order from Chaos,” Nature 466, no. 7302 (2010): 7–8.

See Lau , supra note 1.

See Regenberg , supra note 1.

Ryan K. A. Sanders A. N. , “Tracking the Rise of Stem Cell Tourism,” Regenerative Medicine 5, no. 1 (2010): 27–33.

See, e.g., Zarembo A. , “A Desperate Injection of Stem Cells and Hope,” Los Angeles Times, February 20, 2005. See also Ledford H. , “Stem-Cell Scientists Grapple with Clinics,” Nature 474, no. 7353 (2011): 550 for a discussion of an important exception, stem cell clinics which claim their treatment methodologies are not subject to FDA oversight.

See Regenberg , supra note 1.

See Lau , supra note 1; Regenberg , supra note 1.

Sipp D. , “Stem Cell Stratagems in Alternative Medicine,” Regenerative Medicine 6, no. 3 (2011): 407–414.

See Regenberg , supra note 1; see Ryan , supra note 7.

Id. ( Ryan ).

See Ryan , supra note 7.

Hyun I. Lindvall O. , “New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research,” Cell Stem Cell 3, no. 6 (2008): 607–609; Nelson B. , “Stem Cell Researchers Face Down Stem Cell Tourism,” Nature Reports Stem Cells (2008), available at <http://www.nature.com/stemcells/2008/0806/080605/full/stemcells.2008.89.html> (last visited January 23, 2012).

Amariglio N. Hirshberg A. , “Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia telangiectasia Patient,” PLoS Medicine 6, no. 2 (2009): E1000029.

Thirabanjasak D. Tantiwongse K. , “Angiomyeloproliferative Lesions Following Autologous Stem Cell Therapy,” Journal of the American Society of Nephrology 21, no. 7 (2010): 1218–1222.

Scott C. T. , “What Stem Cell Therapy Can Learn from Gene Therapy,” Nature Reports Stem Cells (2008), available at <http://www.nature.com/stemcells/2008/0809/080904/full/stemcells.2008.123.html> (last visited January 23, 2012).

American Medical Association, 2009 Annual Report, at 26, available at <http://www.ama-assn.org/ama1/pub/upload/mm/37/2009-annual-report.pdf> (last visited January 23, 2012).

American Medical Association, “New AMA Guidelines on Medical Tourism,” available at <http://www.ama-assn.org/ama1/pub/upload/mm/31/medicaltourism.pdf> (last visited January 23, 2012).

Caffarini K , “AMA Meeting: Guidelines Target Safety of Medical Tourists,” Amednews.com, July 7, 2008, available at <http://www.ama-assn.org/amednews/2008/07/07/prse0707.htm> (last visited January 23, 2012).

See Lau , supra note 1; Regenberg et al., supra note 1.

Lindvall O. Hyun I. , “Medical Innovation Versus Stem Cell Tourism,” Science 324, no. 5935 (2009): 1664–1665.

See International Society for Stem Cell Research, “Mission Statement,” available at <http://www.isscr.org/Mission_Statement/2810.htm> (last visited January 23, 2012).

Daley G. Q. Hyun I. Lindvall O. , “Mapping the Road to the Clinical Translation of Stem Cells,” Cell Stem Cell 2, no. 2 (2008): 139–140.

International Society for Stem Cell Research, “Guidelines for the Clinical Translation of Stem Cells,” available at <http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf> (last visited January 23, 2012).

Id., at 4–5.

See Lindvall Hyun , supra note 23.

International Society for Stem Cell Research, “Patient Handbook on Stem Cell Therapies,” available at <http://www.isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf> (last visited January 23, 2012).

Furrow B. Greaney T. , Health Law (St. Paul, MN: West Publishing Co., 1995): At § 6–1.

See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

Schloendorf v. Society of New York Hospital, 211, N.Y. 125, 105 N.E. 92 (1914).

See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

See Furrow , supra note 30, at § 6–9.

92 Cal. App. 4th 692 (2001).

92 Cal. App. 4th at 697. Several of the legal charges were resolved in the physician's favor, but only after the Schiff's daughter had been treated. Id., at 698–699. The father also acknowledged that he was aware that the American Medical Association and the American Cancer Society were critical of the Texas physician, who was considered a “fraud” by many, and his experimental treatment. Id., at 697–699.

Schiff v. Prados, 92 Cal.App. 4th at 700.

Schiff v. Prados, 92 Cal.App. 4th at 702, citing Cobbs v. Grant, 8 Cal. 3d 229, 245 (1972).

Schiff v. Prados, 92 Cal. App. 4th at 701, citing Vandi v. Permanente Medical Group Inc., 7 Cal.App.4th 1064, 1071 (1992).

Schiff v. Prados, 92 Cal. App. 4th at 707, citing Spencer By and Through Spencer v. Seikel, 742 P.2d 1126 (1987).

Vincler L. A. Nicol M. F. , “When Ignorance Isn't Bliss: What Healthcare Practitioners and Facilities Should Know about Complementary and Alternative Medicine,” Journal of Health and Hospital Law 30, no. 3 (1997): 160–178, discussing physician obligations with respect to patient inquiries regarding complementary and alternative medicine (CAM). They suggest that physicians in an ongoing relationship have an obligation to inquire regarding CAM usage and provide information about the risks and benefits of the particular CAM in use. They suggest physicians have a minimum obligation to obtain and share information regarding basic efficacy and safety of the CAM in use, although they also indicate that obligation may be limited to the “reasonable efforts of a similarly trained practitioner.”

See, e.g., Stem Cell Information, “FAQs,” available at <http://stemcells.nih.gov/info/faqs.asp> (last visited January 23, 2012).

Lantos J. Matlock A. M. Wendler D. , “Clinician Integrity and Limits to Patient Autonomy,” JAMA 305, no. 5 (2011): 495–499, at 497–498.

Martin A. W. , “Legal Malpractice: Negligent Referral as a Cause of Action,” Cumberland Law Review 29, no. 3 (1999): 679–703, at 682–684 (discussing the negligent referral cause of action and emphasizing the “duty of the referring physician to use reasonable care in making the recommendation”).

See Vincler Nicol , supra note 42; Lantos , supra note 44.

See Lantos , supra note 44.

Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) cert. denied 552 U.S. 1159 (2008).

See Lantos , supra note 44.

See Vincler Nicol , supra note 42.

Wolf L. E. Lo B. , “When Parents Reject Interventions to Reduce Postnatal Human Immunodeficiency Virus Transmission,” Archives of Pediatric and Adolescent Medicine 155, no. 8 (2001): 927–933, at 928; Zarzeczny A. Caulfield T. , “Stem Cell Tourism and Doctors Duties to Minors – A View from Canada,” American Journal of Bioethics 10, no. 5 (2010): 3–15, at 6.

See Wolf Lo , supra note 51 and Zarzeczny , supra note 51.

Id. (Wolf and Lo).

See Zarzeczny Caulfield , supra note 51.

N. Kellogg and American Academy of Pediatrics Committee on Abuse and Neglect, “The Evaluation of Sexual Abuse in Children,” Pediatrics 116, no. 2 (2005): 506–512, at 511.

See, e.g., NY Penal §265.25. See id. (Kellogg and American Academy of Pediatrics Committee on Abuse and Neglect), supra note 57.

See, e.g., Fla. Stat. Ann. §39.201.

See Zarzeczny Caulfield , supra note 51 (reaching similar conclusions under Canadian law).

See Ryan , supra note 7.

Murdoch C. E. Scott C. T. , “Stem Cell Tourism and the Power of Hope,” American Journal of Bioethics 10, no. 5 (2010): 16–23.

See, for instance, H-480.964 Alternative Medicine, which outlines the AMA policy on alternative medicine highlighting the lack of safety of efficacy information on most alternative therapies and calling for such studies and for physicians to routinely inquire into their patients' use of such alternative therapies and educate both themselves and their patients about the state of scientific knowledge on these options. In addition, see D-480.981 Increasing Awareness of the Benefits and Risks Associated with Complementary and Alternative Medicine, calling on the AMA the “promote awareness among medical students and physicians of the wide use of complementary or alternative medicine, including its benefits, risks, and evidence of efficacy or lack thereof.”