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Published online by Cambridge University Press: 29 April 2021
The struggle for control of this nation's life-giving blood resources was, up until five years ago, largely a private affair between representative organizations of the blood collectors. The system that emerged from that struggle was declared unhealthy by several experts who complained that blood was too often unsafe or unavailable. Then in 1972 the government, predominantly the federal government, responded to public pressure and joined the fray. This Comment examines some legal, political, and policy aspects of the battle over blood collection—a battle from which no stable guiding force has yet evolved.
1 U.S. Const, amend. X.
2 Blood Bank Act, Pa. Stat. Ann. tit. 35, § 6501 (Purdon) (Supp. 1975).
3 Public Health Service Act, 42 U.S.C. § 262 (1970).
4 Drug Amendments of 1962, P.L. 87-781 § 301, 76 Stat. 780 (codified in scattered sections of 21 U.S.C).
5 Id. § 40.
6 61 Am. Jur. 2d Physicians, Surgeons and Other Healers § 13 (1972)Google Scholar.
7 MacG, J.. Burns & Peltason, J., Government by the People 499 (8th ed. 1972)Google Scholar.
8 Titmuss, , The Gift Relationship: From Human Blood to Social Policy (1971)Google Scholar.
9 There is substantial conflict over what constitutes a “volunteer” blood donor. Titmuss, especially when speaking of British donors, takes the strictest interpretation of the term: someone with no prospect of “tangible immediate rewards in monetary or non-monetary forms.” Id. at 88-89. American authors tend to think of the volunteer donor more in terms of the definition offered by the American Association of Blood Banks (AABB): that is, as “a person who meets patient blood needs by donating blood as replacement or in advance of need for himself or others without payment.” Hemphill, , Blood Collection and Use by AABB Institutional Members, 14 Transfusion 527–29 (1974)CrossRefGoogle Scholar. Neither “volunteer” receives cash payment for his blood, but the latter stands to gain considerable reward.
Conflicts such as this over definitions must be settled promptly as a prerequisite to clear debate concerning the overriding issue of how to make safe, affordable blood available to those who need it.
In this Article, “voluntary” means “donated without monetary reward.” “Commercial” means “donated in return for monetary reward.“
10 Note, The Gift of Blood: A Comparison of Voluntary and Commercial Blood Programmes, The Medical Journal of Australia, July 8, 1972, at 61–63CrossRefGoogle Scholar.
11 Walsh, , Purcell, , Morrow, , Chanock, , and Schmidt, , Posttransfusion Hepatitis After Open-Heart Operations, 211 J.A.M.A. 261–65 (1975)CrossRefGoogle Scholar.
12 Surgenor, , Progress Toward a National Blood System, 291 New Eng. J. Med. 17, 21 (1974)CrossRefGoogle Scholar [hereinafter cited as Surgenor, Progress].
13 National Blood Policy, 39 Fed. Reg. 32,710 (1974)Google Scholar.
14 Anderson, , Anderson-Titmuss Debate over the Gift Relationship, 2 Int. J. Health Services 317-18(1972)Google Scholar.
15 Surgenor, Progress, supra note 12.
16 Surgenor, , Advantages of Volunteer Blood Donation, 291 New Eng. J. Med. 1365–66Google Scholar.
17 Michael Israel, M.D., the Blood Bank Director at Hershey Medical Center, agrees that the hepatitis problem had been overstated. He disagrees with some of Titmuss’ other conclusions, stating that—especially in recent years—paid donors are becoming less deserving of their bad name. Dr. Israel disputes the cost efficiency claims for volunteer blood, pointing out the expenses involved in administering existing programs that provide free blood to families of unpaid donors. He also suggests that while money may provide an incentive for a potential paid donor to lie about his health, there may well be a greater incentive to lie in order to gain blood coverage for one's family by donating without pay to organizations which arrange such coverage. Interview with Michael Israel, M.D. (February 2, 1976) [hereinafter cited as Israel Interview].
18 38 Fed Reg. 2966(1973).
19 Public Health Service Act, 42 U.S.C. § 262(c)-(d) (1970).
20 38 Fed. Reg. 2965 (1973).
21 Surgenor, Progress, supra note 12, at 17-22.
22 Its goal was to supply the country's needs with free blood obtained from unpaid volunteers. However, ARC philosophy dictates that blood be distributed back to communities in proportion to its collection. The usual result of such a practice is a full supply to suburban hospitals with a simultaneous deficient supply to city hospitals. Furthermore, occasional cases of ARC undersupply are particularly troublesome for hospitals that rely heavily on this source of supply since they tend to have no normalized relationships with other suppliers.
23 AABB services to members include training, setting of standards, inspection, and accreditation. The most significant achievement of the AABB, however, has been its establishment of a national clearing-house for blood. This project allows members to withdraw or deposit blood as needed, based on a credit system. Such a system provides greater security to hospitals afraid of a sudden blood surplus or deficit, but criticism has been directed at fees charged to lenders and borrowers that go to the AABB. Critics also note the lack of AABB unified donor recruiting programs, a policy that often leads to fierce competition among members for blood donors.
24 Surgenor, Progress, supra note 12, at 19.
25 Note, The Gift of Blood: A Comparison of Voluntary and Commercial Blood Programmes, The Medical Journal of Australia, July 8, 1972, at 62Google Scholar. The remainder of blood and much of collected plasma at that time was t he work of various profit-making enterprises, represented by organizations such as the American Blood Institute and the American Pharmaceutical Manufacturers Association. Surgenor, Progress, supra note 12, at 20.
26 Id. at 19.
27 Phillips, , Controls Constrict Sources, Hospitals, Dec. 16, 1972 at 42Google Scholar.
28 Blood Bank Act, Pa. Stat. Ann. tit. 35, §§ 6501-23 (Purdon) (Supp. 1975).
29 National Blood Policy, 39 Fed. Reg. 32,702 (1974)Google Scholar.
30 38 Fed. Reg. 2965 (1973)Google Scholar.
31 Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1) (1970).
32 Drug Amendments of 1962, P.L. 87-781 § 301, 76 Stat. 780 (1962) (codified in scattered sections of 21 U.S.C).
33 Letter from Robert D. Langdell to AABB Membership (October 11, 1972) [hereinafter cited as Langdell Letter].
34 38 Fed. Reg. 2965 (1973)Google Scholar.
35 Langdell Letter, supra note 33.
36 Note, FDA Requires Registration—ABB to Take Peer Review Responsibility, Am. Ass‘n Blood Banks News Briefs, April 1973, at 1.
37 38 Fed. Reg. 2965–67 (1973)Google Scholar.
38 Drug Listing Act of 1972, P.L. 92-387,86 Stat. 559 (amending 21 U.S.C. § 360 (1970)).
39 Note, FDA Requires Registration—AABB to Take Peer Review Responsibility, Am. Ass‘n Blood Banks News Briefs, April 1973, at 1.
40 21 C.F.R. § 1301 (1976).
41 38 Fed. Reg. 2966 (1973)Google Scholar.
42 21 U.S.C. § 331 (Supp. V 1975) (prohibited acts); 21 U.S.C. § 333 (1970) (penalties); 21 U.S.C. § 360 (Supp. V 1975) (registration requirement).
43 21 U.S.C. § 375(b) (1970).
44 40 Fed. Reg. 53,532 (1975)Google Scholar.
45 Surgenor, Progress, supra note 12, at 21.
46 Id. at 21-22.
47 Id. at 22.
48 Id.
49 Surgenor, , Progress Toward a National Blood System: The American Blood Commission, 294 New Eng. J. Med. 1367 (1976)CrossRefGoogle Scholar [hereinafter cited as Surgenor, Commission].
50 Allen, , Advantages of Volunteer Blood Donors, 291 New Eng. J. Med. 1365 (1974)Google Scholar.
51 Surgenor, , Advantages of Volunteer Blood Donors, 291 New Eng. J. Med. 1365–66 (1974)Google Scholar.
52 Israel Interview, supra note 17.
53 Phillips, supra note 27, at 41.
54 40 Fed. Reg. 53, 532-33 (1975)Google Scholar.
55 Israel Interview, supra note 17.
56 Lacerte, , Kane, , and Cohen, , U.S. Licensed Blood Banks: Evaluation of Whole Blood and Its Components, Transfusion, 339–43 (1972)CrossRefGoogle Scholar.
57 Surgenor, Commission, supra note 49.
58 See page 85 supra.
59 Id.
60 Id. at 1370.
61 Id. at 1369.
62 Id. at 1370-71.
63 Id. at 1369.
64 Id.
65 Id. at 1371.
66 Id. at 1369.
67 Note, Am. Ass'n Blood Banks News Briefs, December/January 1975/76, at 22, 25-26 (letter to HEW from AABB President Herbert F. Polesky, M.D.).
68 Surgenor, Commission, supra note 49, at 1368.
69 Id. at 1369.
70 Id. at 1370.
71 Id.
72 Hemphill, The President's Message, Am. Ass'n Blood Banks News Briefs, July/August/September 1976, at 4, 4-5.
73 Id. at 7.
