The Immortal Life of Henrietta Lacks (51 page)

I also relied on both published and unpublished reflections by those directly involved in the controversy. Published articles include W A. Nelson-Rees, “Responsibility for Truth in Research,”
Philosophical Transactions of the Royal Society
356, no. 1410 (June 29, 2001); S. J. O’Brien, “Cell Culture Forensics,”
Proceedings of the National Academy of Sciences
98, no. 14 (July 3, 2001); and R. Chatterjee, “Cell Biology: A Lonely Crusade,”
Science 16
, no. 315 (February 16, 2007).

PART THREE: IMMORTALITY

Chapter 23: “It’s Alive”

This chapter relied in part on letters housed at the AMCMA, on Deborah Lacks’s medical records, and on “Proceedings for the New Haven Conference (1973): First International Workshop on Human Gene Mapping,”
Cyto genetics and Cell Genetics
13 (1974): 1–216.

For information on Victor McKusick’s career, see the National Library of Medicine at nlm.nih.gov/news/victor_mckusick_profiles09.html. His genetic database, now called OMIM, can be found at ncbi.nlm.nih.gov/omim/.

For selected documentation of the relevant regulations protecting human subjects in research, see “The Institutional Guide to DHEW Policy on Protection of Human Subjects,” DHEW Publication No. (NIH) 72–102 (December 1, 1971); “NIH Guide for Grants and Contracts,” U.S. Department of Health, Education, and Welfare, no. 18 (April 14, 1972); “Policies for Protecting All Human Subjects in Research Announced,”
NIH Record
(October 9, 1973); and “Protection of Human Subjects,” Department of Health, Education, and Welfare,
Federal Register
39, no. 105, part 2 (May 30, 1974).

For more information on the history of oversight of research on human subjects, see
The Human Radiation Experiments: Final Report of the President’s Advisory Committee
(Oxford University Press, available at hss.energy.gov/HealthSafety/ohre/roadmap/index.html).

Chapter 24: “Least They Can Do”

What started as Microbiological Associates grew to become part of several other, larger companies, including Whittaker Corp, BioWhittaker, Invitrogen, Cambrex, BioReliance, and Avista Capital Partners; for the profiles of those companies and others that sell HeLa, see
OneSource CorpTech Company Profiles
or
Hoover.com
.

For HeLa pricing information, search the product catalogs of any number of biomedical supply companies, including
Invitrogen.com
.

For patent information, search for HeLa in Patft.uspto.gov.

For information on the ATCC as a nonprofit, including financial statements, search for American Type Culture Collection on
Guidestar.org
; for its HeLa catalog entry, visit
Atcc.org
and search for HeLa.

For information on HeLa-plant hybrids, see “People-Plants,”
News-week
, August 16, 1976; C. W Jones, I. A. Mastrangelo, H. H. Smith, H. Z. Liu, and R. A. Meck, “Interkingdom Fusion Between Human (HeLa) Cells and Tobacco Hybrid (GGLL) Protoplasts,”
Science
, July 30, 1976.

For an account of Dean Kraft’s attempts to kill HeLa cells using “psychic healing,” and thus cure cancer, see his book,
A Touch of Hope
, as well as related videos on
YouTube.com
(available by searching for Dean Kraft).

For the research done on the Lacks family’s blood samples, see S. H. Hsu, B. Z. Schacter, et al., “Genetic Characteristics of the HeLa Cell,”
Science
191, no. 4225 (January 30, 1976). That research was funded by NIH Grant number 5P01GM019489–020025.

Chapter 25: “Who Told You You Could Sell My Spleen?”

Much of the Moore story appears in court and government documents, particularly the “Statement of John L. Moore Before the Subcommittee on Investigations and Oversight,” House Committee on Science and Technology Hearings on the Use of Human Patient Materials in the Development of Commercial Biomedical Products, October 29, 1985;
John Moore v. The Regents of the University of California et al
. (249 Cal. Rptr. 494); and
John Moore v. The Regents of the University of California et al
. (51 Cal.3d 120, 793 P.2d 479, 271 Cal. Rptr. 146).

The Mo-cell patent is no. 4,438,032, available at Patft.uspto.gov.

The literature regarding the Moore trial and its implications is vast. Some useful sources include William J. Curran, “Scientific and Commercial Development of Human Cell Lines,”
New England Journal of Medicine
324, no. 14 (April 4, 1991); David W. Golde, “Correspondence: Commercial Development of Human Cell Lines,”
New England Journal of Medicine
, June 13, 1991; G. Annas, “Outrageous Fortune: Selling Other People’s Cells,”
The Hastings Center Report
(November-December 1990); B. J. Trout, “Patent Law—A Patient Seeks a Portion of the Biotechnological Patent Profits in Moore v. Regents of the University of California,
“ Journal of Corporation Law
(Winter 1992); and G. B. White and K. W O’Connor, “Rights, Duties and Commercial Interests: John Moore versus the Regents of the University of California,”
Cancer Investigation
8 (1990).

For a selection of media reports about the John Moore case, see Alan L. Otten, “Researchers’ Use of Blood, Bodily Tissues Raises Questions About Sharing Profits,”
Wall Street Journal
, January 29, 1996; “Court Rules Cells Are the Patient’s Property,”
Science
, August 1988; Judith Stone, “Cells for Sale,”
Discover
, August 1988; Joan O’C. Hamilton, “Who Told You You Could Sell My Spleen?”
BusinessWeek
, April 3, 1990; “When Science Outruns Law,”
Washington Post
, July 13, 1990; and M. Barinaga, “A Muted Victory for the Biotech Industry,”
Science
249, no. 4966 (July 20, 1990).

For the regulatory response to the Moore case, see “U.S. Congressional Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells—Special Report,” Government Printing Office (March 1987); “Report on the Biotechnology Industry in the United States: Prepared for the U.S. Congressional Office of Technology Assessment,” National Technical Information Service, U.S. Department of Commerce (May 1, 1987); and “Science, Technology and the Constitution,” U.S. Congressional Office of Technology Assessment (September 1987). See also the never-passed “Life Patenting Moratorium Act of 1993,” (103rd Congress, S.387) introduced February 18, 1993.

Details of the oil-consuming bacteria involved in Chakrabarty’s lawsuit can be found in patent no. 4,259,444, available at Patft.uspto.gov. For more information on the lawsuit, see
Diamond v. Chakrabarty
(447 U.S. 303).

For further reading on other cell ownership cases mentioned in this chapter, see “Hayflick-NIH Settlement,”
Science
, January 15, 1982; L. Hayflick, “A Novel Technique for Transforming the Theft of Mortal Human Cells into Praiseworthy Federal Policy,”
Experimental Gerontology
33, nos. 1–2 (January-March 1998); Marjorie Sun, “Scientists Settle Cell Line Dispute,”
Science
, April 22, 1983; and Ivor Royston, “Cell Lines from Human Patients: Who Owns Them?” presented at the AFCR Public Policy Symposium, 42nd Annual Meeting, Washington, D.C., May 6, 1985; and
Miles Inc v. Scripps Clinic and Research Foundation et al
. (89–56302).

Chapter 26: Breach of Privacy

Whether the publication of a person’s medical records would violate HIPAA today depends on many factors; most important, who released the records. HIPAA protects “all ‘individually identifiable health information’… in any form or media, whether electronic, paper, or oral,” but it only applies to “covered entities,” which are health-care providers and health insurers that “furnish, bill or receive payment for” health care, and who transmit any covered health information electronically. This means any noncovered entity can release or publish a person’s medical records without violating HIPAA.

According to Robert Gellman, a health-privacy expert who chaired a U.S. government subcommittee on privacy and confidentiality, any Hopkins faculty member releasing Henrietta’s medical information today would most likely violate HIPAA, because Hopkins is a covered entity.

However, in October 2009, as this book went to press, portions of Henrietta’s medical records were again published without her family’s permission, this time in a paper coauthored by Brendan Lucey, of Michael O’Callaghan Federal Hospital at Nellis Air Force Base; Walter A. Nelson-Rees, the HeLa contamination crusader who died two years before the article’s publication; and Grover Hutchins, the director of autopsy services at Johns Hopkins. See B. P. Lucey, W. A. Nelson-Rees, and G. M. Hutchins, “Henrietta Lacks, HeLa Cells, and Culture Contamination,”
Archives of Pathology and Laboratory Medicine
133, no. 9 (September 2009).

Some of the information they published had previously appeared in Michael Gold’s
Conspiracy of Cells
. They also published new information, including, for the first time, photos of her cervical biopsies.

According to Gellman, “It seems quite likely that HIPAA was violated in this case. But the only way to know for sure is an investigation that would go into complicated factors, including how they got the medical records in the first place.” When I called Lucey, the paper’s primary author, and asked how he’d gotten her records, and whether anyone had sought the family’s permission to publish them, he told me the records had come from his coauthor, Hutchins, at Hopkins. “Ideally, you’d like to get family approval,” he said. “I believe Dr. Hutchins tried to track down a family member without success.” The authors had obtained IRB approval to publish a series of articles using autopsy reports; in the other articles, they’d used initials to conceal patients’ identities. Lucey pointed out that some of the information from Henrietta’s medical records had been previously published, as had her name. “In this case protecting her identity with initials wouldn’t have worked,” he said. “Anyone can figure out who she is, since her name has already been connected with the cells.”

When it comes to the dead and privacy: For the most part, the dead do not have the same right to privacy enjoyed by the living. One exception to that rule is HIPAA: “Even Thomas Jefferson’s records, if they exist, are protected by HIPAA if they’re held by a covered entity,” Gellman said. “A hospital can’t give away the records, regardless of whether the patient is dead or alive. Your right to privacy under HIPAA continues to exist until the sun runs out of hydrogen.”

One other point to consider: though Henrietta was dead and therefore without the privacy rights of the living, many legal and privacy experts I talked with pointed out that the Lacks family could have argued that the release of Henrietta’s medical records violated
their
privacy. There was no precedent for such a case at that time, but there have been such cases since.

For more information on the laws regarding confidentiality of medical records, and the debate surrounding them, see Lori Andrews’s “Medical Genetics: A Legal Frontier;”
Confidentiality of Health Records
by Herman Schuchman, Leila Foster, Sandra Nye, et al.; M. Siegler, “Confidentiality in Medicine: A Decrepit Concept,”
New England Journal of Medicine
307, no. 24 (December 9, 1982): 1518–1521; R. M. Gellman, “Prescribing Privacy,”
North Carolina Law Review
62, no. 255 (January 1984); “Report of Ad Hoc Committee on Privacy and Confidentiality,”
American Statistician
31, no. 2 (May 1977); C. Holden, “Health Records and Privacy: What Would Hippocrates Say?”
Science
198, no. 4315 (October 28, 1977); and C. Levine, “Sharing Secrets: Health Records and Health Hazards,”
The Hastings Center Report
7, no. 6 (December 1977).

For related cases, see
Simonsen v. Swensen
(104 Neb. 224,117N.W. 831, 832,1920);
Hague v. Williams
(37 N.J. 328, 181 A.2d 345. 1962);
Hammonds v. Aetna Casualty and Surety Co
. (243 F Supp. 793 N.D. Ohio, 1965);
MacDonald v. Clinger
(84 A.D.2d 482, 446 N.Y.S.2d 801, 806);
Griffen v. Medical Society of State of New York
(11 N.Y.S.2d 109, 7 Misc. 2d 549. 1939);
Feeney v. Young
(191, A.D. 501, 181 N.Y.S. 481. 1920);
Doe v. Roe
(93 Misc. 2d 201,400 N.Y.S.2d 668,
677. 1977); Banks v. King Features Syndicate, Inc
. (30 F Supp. 352. S.D.N.Y 1939);
Bazemore v. Savannah Hospital
(171 Ga. 257, 155 S.E. 194. 1930); and
Barber v. Time
(348 Mo. 1199, 159 S.W.2d 291. 1942).

Chapter 27: The Secret of Immortality

For more on Jeremy Rifkin’s lawsuits, see
Foundation on Economic Trends et al. v. Otis R. Bowen et al
. (No. 87–3393) and
Foundation on Economic Trends et al. v. Margaret M. Heckler, Secretary of the Department of Health & Human Services et al. (756 F.2d
143). For media reports on the case, see Susan Okie, “Suit Filed Against Tests Using AIDS Virus Genes; Environmental Impact Studies Requested,”
Washington Post
, December 16, 1987; and William Booth, “Of Mice, Oncogenes and Rifkin,”
Science
239, no. 4838 (January 22, 1988).

For the HeLa species debate, see L. Van Valen, “HeLa, a New Microbial Species,”
Evolutionary Theory
10, no. 2 (1991).

For more on cell immortality, see L. Hayflick and P. S. Moorhead, “The Serial Cultivation of Human Diploid Cell Strains,”
Experimental Cell Research
, 25 (1961); L. Hayflick, “The Limited in Vitro Lifetime of Human Diploid Cell Strains,”
Experimental Cell Research
37 (1965); G. B. Morin, “The Human Telomere Terminal Transferase Enzyme Is a Ribonucleoprotein That Synthesizes TTAGGG Repeats,”
Cell
59 (1989); C. B. Harley, A. B. Futcher, and C. W Greider, “Telomeres Shorten During Ageing of Human Fibroblasts,”
Nature
345 (May 31, 1990); C. W Greider and E. H. Blackburn, “Identification of Specific Telomere Terminal Transferase Activity in Tetrahymena Extracts,”
Cell
43 (December 1985).