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gathered in the research process presents a dichotomous management
situation. On the one hand, as Samuels pointed out in relation to the
pharmaceutical companies, "The industry values information and recog-
nizes the need for long-term access for scientific, regulatory, and manage-
ment purposes.'"*^ On the other hand, these records are sensitive, for
personal as well as corporate reasons, and close control of the documents
is critical. Because of this, some companies may have initiated records
retention policies that emphasize records destruction rather than records
retention.'*'^ Such policies are counter to archival practices and, as early as
the 1960s, led to a push among archivists for companies to retain com-
pany records chronicling the success and failures of a company's history. '^^

Largely as a result of this situation, the overall status of documenting
the health industries is unclear. John Swann noted that "few drug compa-
nies maintain archives (or admit they do)."'^^ An examination of the
standard archival directories and reference tools supports Swann's assess-



NOTES 201



ment of the state of archives in the pharmaceutical industry as well as the
other industries examined in this chapter. 5*^ The few entries that exist for
the pharmaceutical industry in the Research Libraries Information Net-
work (RLIN) are generally for the personal papers of researchers who
worked for a leading pharmaceutical company, or pharmaceutical com-
pany records from the late nineteenth and early twentieth centuries that
are now housed at a college or university. There are even fewer indica-
tions of records programs in the other health industries examined in this
chapter. One interesting exception is that the records of several Silicon
Valley medical equipment companies (predominantly "high tech" com-
panies in such areas as medical imaging) are held at the Silicon Valley
Information Center. These, too, however, are the "public records" of the
companies, typically including press releases, quarterly and annual re-
ports, and Securities and Exchange Commission (10-K) reports. ^^

On the positive side, a number of archivists or records managers in the
health industries are listed in the SAA Directory. This seeming discrepancy
only reaffirms the speculation that the industries examined here may
have documentation programs in place but do not report such activities to
the standard directories, largely for proprietary and business reasons.
Without a thorough survey of the industries in question, a task beyond the
scope of this study, it is difficult to assess the total nature of documenta-
tion. However, as with other components of the U.S. health care system, it
is very likely that an increased documentation effort among the health
industries is warranted.



NOTES

1. Stanley Wohl, The Medical Industrial Complex (New York: Harmony Books,
1984), 1.

2. "Corporate Scoreboard," Business Week, 16 March 1992, 65. The five
companies are Merck & Co., Bristol-Myers Squibb, Johnson & Johnson,
American Home Products, and Eli Lilly and Company.

3. Some types of health industries, notably health insurance providers such as
Blue Cross/Blue Shield, are nonprofit and will not be discussed in detail here.
On the other hand, portions of other institutions of the U.S. health care sys-
tem are for-profit, such as some hospitals and nursing homes (see Chapter 2).

4. Jonathan Liebenau, Medical Science and Medical Industry: The Formation of the
American Pharmaceutical Industry (Baltimore: Johns Hopkins University Press,
1987), vii.

5. D. J. De Rezno, ed., Pharmaceutical Manufacturers in the United States (Park
Ridge, N.J.: Noyes Data, 1987), iii; "Corporate Scoreboard," Business Week, 16
March 1992, 65, 74.



202 HEALTH INDUSTRIES



6. Helen W. Samuels, "Documenting Modern Chemistry: The Historical Task of
the Archivist," (manuscript), 13-14.

7. (Liebenau, Medical Science and Medical Industry, 1 37, n. 18). This definition of
ethical companies has changed in the 1990s as advertising aimed at the
consumer has increasingly been used by traditional ethical companies. Still,
the products are prescription drugs that are sold to pharmacies and not to the
consumer.

8. Gary D. Nelson, Pharmaceutical Company Histories, vol. 1 (Bismarck, ND:
Woodbine Publishing, 1983), 79.

9. Meir Statman, Competition in the Pharmaceutical Industry: The Declining
Profitability of Drug Innovation (Washington, D.C.: American Enterprise
Institute for Public Policy Research, 1983), 4-6.

10. Jerome E. Schnee, "Governmental Control of Therapeutic Drugs: Intent,
Impact, and Issues," in Cotton M. Lindsay, ed.. The Pharmaceutical Industry:
Economics, Performance, and Government Regulation (New York: John Wiley &
Sons, 1978), 9. For precedents to the 1906 act, see Mitchell Okun, Fair Play in
the Marketplace: The First Battle for Pure Food and Drugs (DeKalb, 111.: Northern
Illinois University Press, 1986) and John B. Blake, ed.. Safeguarding the Public:
Historical Aspects of Medicinal Drug Control (Baltimore: Johns Hopkins Press,
1970).

11. Schnee, "Therapeutic Drugs," 10.

12. Thalidomide was found to cause severe malformations in limbs of developing
fetuses. The impact of the thalidomide episode is chronicled by Henning
Sjostrom and Robert Nilsson, Thalidomide and the Power of the Drug Companies
(Baltimore: Penguin, 1972).

13. Schnee, "Therapeutic Drugs," II.

14. Mary Graham, "The Quiet Drug Revolution," Atlantic, January 1991, 34-40.

15. Walter J. Campbell, "The Emerging Health Care Environment: Seleaed
Issues," in Lindsay, Pharmaceutical Industry , 135-136.

16. Walter S. Measday, "The Pharmaceutical Industry," in Walter Adams, ed..
The Structure of American Industry, 5th ed. (New York: Macmillan Publishing
Co., 1977), 255.

17. David Schwartzman, Innovation in the Pharmaceutical Industry (Baltimore:
Johns Hopkins University Press, 1976), 103.

18. Lilly's gross sales in 1985 were $3.27 billion, with $1.78 billion of that being
pharmaceutical products. De Renzo, Pharmaceutical Manufacturers, 94. See also
David Tucker, The World Health Market: The Future of the Pharmaceutical Industry
(New York: Facts on File Publications, 1984), 24-25.

19. The categorization here is adopted from Califano, who characterizes the
primary activities of the pharmaceutical companies as "to invent, patent, and
market drugs," and Samuels, who lists the functions of the pharmaceutical
companies as "research and development, testing of drugs, toxicology tests,
clinical studies, regulatory submissions and approval, marketing and sales,
corporate management." Joseph A. Califano, Jr., America's Health Care
Revolution: Who Lives? Who Dies? Who Pays? (New York: Random House, 1986),
124; Samuels, "Documenting Modern Chemistry," 16-17.



NOTES 203



20. Jerome E. Schnee and Erol Caglarian, "The Changing Pharmaceutical
Research and Development Environment," in Lindsay, Pharmaceutical
Industry, 9 1 .

2 1 . For a general discussion of the distinaion between applied and basic research,
see Chapter 4.

22. Schwartzman, Pharmaecutical Industry, 29.

23. Schnee and Caglarian, "Pharmaecutical Environment," 93.

24. John P. Swann, Academic Scientists and the Pharmaceutical Industry: Cooperative
Research in Twentieth-Century America (Baltimore: Johns Hopkins University
Press, 1988), 4.

25. Gilbert D. Harrell, "Pharmaceutical Marketing," in Lindsay, Pharmaceutical
Industry, 69.

26. Constance Sommer, "Drug Firms Profits Exceed Other Industries, Report
Says," Boston Globe, 26 Feb. 1993, 18. This figure is about $2 billion more than
the industry spends annually to develop new drugs.

27. Harrell, "Pharmaceutical Marketing," 72.

28. See "Whittle and Drug Companies Team Up for Medical Books," Publishers
Weekly, 17 May 1991, 44.

29. See Elisabeth Rosenthal, "Drug Companies' Profits Finance More Promotion
Than Research," New York Times, 21 Feb. 1993, 1, 26.

30. David A. Siskind, "Contributions of the Pharmaceutical Industry to Improved
Health," in Lindsay, Pharmaceutical Industry, 41.

31. Measday, "Pharmaecutical Industry," 269.

32. Federal Policies and the Medical Device Industry (Washington, D.C.: U.S.
Congress, Office of Technology Assessment, OTA-H-230, October 1984), 4.

33. 1987 Census of Manufactures (Washington, D.C.: U.S. Department of
Commerce, Bureau of the Census, 1989), 1-2.

34. "Corporate Scoreboard," Business Week, 16 March 1992, 74, 65.

35. Mark Sexton, "AMPA and STM Discuss Medical Publishing Future,"
Publishers Weekly, 13 April 1990, 40; "First Electronic Medical Journal to
Debut in 1992," Library Journal 1 Nov. 1991: 32.

36. Califano, America's Health Care Revolution, 124.

37. "Corporate Scoreboard," Business Week, 16 March 1992, 79.

38. Source Book of Health Insurance Data, 1989 (Washington, D.C.: Health Insurance
Association of America, [1989]), 7.

39. Malpractice insurance, which has played an increasingly large role in the
economics of health care since World War 11, is not treated here as "health
insurance," but it is an important segment of the insurance industry and the
U.S. health care system.

40. Ronald L. Numbers, "The Third Party: Health Insurance in America," in
Judith Walzer Leavitt and Ronald L. Numbers, eds.. Sickness and Health in
America: Readings in the History of Medicine and Public Health (Madison:
University of Wisconsin Press, 1978), 139.

41. Numbers, "Third Party," 139-141. Also see his Almost Persuaded: American
Physicians and Compulsory Health Insurance. 19 12-1920 (Baltimore: Johns
Hopkins University Press, 1978).



204 HEALTH INDUSTRIES



42. Ibid., 142. Also see Odin W. Anderson, Blue Cross Since 1929: Accountability and
the Public Trust (Cambridge, Mass.: Ballinger, 1975), 18.

43. Numbers, "Third Party," 145.

44. Ibid., 147.

45. H. E. Freeh and Paul B. Ginsburg, "Competition Among Health Insurers,
Revisited," Journal of Health Politics, Policy and Law 13 (1988): 279-91. See also
Freeh and Ginsburg, "Competition Among Health Insurers," in Warren
Greenberg, ed.. Competition in the Health Sector: Past, Present, and Future
(Germantown, Md.: Aspen Systems, 1978), and Banks McDowell,
Deregulation and Competition in the Insurance Industry (New York: Quorum
Books, 1989).

46. Samuels, "Documenting Modern Chemistry," 18.

47. The case of E. I. du Pont de Nemours & Co., although not falling into the
health industries, provides an example of this type of practice. See David A.
Hounshell, "Interpreting the History of Industrial Research and
Development: The Case of E. I. du Pont de Nemours & Co.," Proceedings of the
American Philosophical Society 134 (1990): 387^07. Such a policy at DuPont,
according to Hounshell was "designed ostensibly to protect the company" but
"comes at an extraordinary high cost: corporate amnesia." [405]

48. See Helen L. Davidson, "The Indispensability of Business Archives," American
Archivist 30 (1967): 593-97, which is based on her experience at the Eli Lilly
and Company Archives, and Davidson, "Selling Management on Business
Archives," ARMA Quarterly 33 (1969): 15-19, which discusses the types of
records to preserve for a firm involved in functions comparable to those
discussed in this chapter. An even older report, also based on the Eli Lilly and
Company Archives, is Irene M. Strieby, "All the King's Horses . . . ," Special
Libraries 50 (1959): 425-34. Another argument in favor of businesses
maintaining their own archives is John Teresko, "Should You Keep An
Archives?" Industry Week 188, 15 March 1976, 36-39.

49. Swann, Scientists and Industry, 8.

50. The 1988 edition of the National Historical Publications and Records
Commission's Directory of Archives and Manuscript Repositories in the United States
includes only two pharmaceutical entries (Abbott Laboratories and E. R.
Squibb & Sons). The health insurance industry has only one entry, that for
Blue Cross of California.

5 1 . Some of the companies included are Adac Laboratories, Circadian, Cooper
Biomedical, Rasor Associates, and Sierra Scientific.



SELECT ANNOTATED BIBLIOGRAPHY

No single comprehensive study exists for the broad field of health industries, but
many examinations of heahh care in the late twentieth century include
discussions of this important segment of the U.S. health care system. One
useful source is Joseph A. Califano, Jr., America's Health Care Revolution: Who



SELECT ANNOTATED BIBLIOGRAPHY 205



Lives? Who Dies? Who Pays? (New York: Random House, 1986). Also of use are
Stanley Wohl, The Medical Industrial Complex (New York: Harmony Books,
1984) and Barbara Ehrenreich and John Ehrenreich, The American Health
Empire: Power, Profits, and Politics (New York: Random House, 1970).

A number of general studies of the pharmaceutical industry are of note. Jonathan
Liebenau in Medical Science and Medical Industry: The Formation of the American
Pharmaceutical Industry (Baltimore: Johns Hopkins University Press, 1987)
provides an overview of the development of the industry up to the 1 930s with
a focus on Philadelphia firms. A work edited by Cotton M. Lindsay, The
Pharmaceutical Industry: Economics, Performance, and Government Regulation
(New York: John Wiley & Sons, 1978), includes several essays on various
aspects of the industry. Another essay, "The Pharmaceutical Industry," by
Walter S. Measday, in Walter Adams, ed.. The Structure of American Industry,
ed. 5 (New York: Macmillan, 1977), is still of value. A general reference
source on the industry is D. J. De Rezno, Pharmaceutical Manufacturers in the
United States. For an international focus on the industry, see Robert Ballance,
Janos Pogany, and Helmut Forstner, The World's Pharmaceutical Industry: An
International Perspeaive On Innovation, Competition, and Policy (Brookfield, Vt.:
Edward Elgar, 1992).

The medical supplies and equipment industry is less well represented in published
works. R. D. Peterson and C. R. MacPhee, Economic Organization in Equipment
and Supply (Lexington, Mass.: Lexington Books, 1973), is an older treatment
of the broad area of this industry. Various government reports on this
industry are of more value, including Federal Policies and the Medical Device
Industry (Washington, D.C.: U.S. Congress, Office of Technology Assessment,
1984). Studies of specific products are available, such as Manuel Trajtenberg,
Economic Analysis of Product Innovation: The Case ofCT Scanners (Cambridge:
Harvard University Press, 1990).

For a general overview of the medical publishing industry, see Judith S. Duke, The
Technical, Scientific, and Medical Publishing Market (White Plains, N.Y.: Knowl-
edge Industry Publications, 1985).

The health insurance industry is perhaps the most widely written about health
care industry. Almost any daily newspaper or weekly magazine contains
some item on this industry. The standard reference book on health insurance
statistics is the annually published Source Book of Health Insurance Data (Wash-
ington, D.C.: Health Insurance Association of America). Economic aspeas of
the industry are discussed in Banks McDowell, Deregulation and Competition in
the Insurance Industry (New York: Quorum Books, 1989). Ronald L. Numbers,
Almost Persuaded: American Physicians and Compulsory Health Insurance, 1912-
1920 (Baltimore: Johns Hopkins University Press, 1978) provides historical
background to the issue of health insurance in the United States.

A work focusing on the archival aspeas of business records, including pharmaceu-
tical companies, is Bruce Bruemmer and Sheldon Hochheiser, The High-
Technology Company: A Historical Research and Archival Guide (Minneapolis:
Charles Babbage Institute, Center for the History of Information Processing,
University of Minnesota, 1989).



CHAPTER 8



Documentation Planning and
Case Study

JOAN D. KRIZACK



Documentation planning is strategic planning for archives. It is an active
process that defines, within an institution or organization, which func-
tions and programs or activities will be documented and to what extent. It
also defines the purpose or purposes for which records will be collected:
institutional operations,^ historical research, or, in the case of certain
health care institutions, biomedical research. Documentation planning
specifies the goals of documentation and outlines methods of attaining the
goals. The product of documentation planning is a plan that is more
specific than a traditional collecting policy. Grounded in institutional,
interinstitutional, and system analyses, the plan identifies specific record
series for preservation. Documentation plans are not static; they should be
revised regularly to reflect changes in the institution and the larger system
of which it is part.^

Documentation planning is accomplished in two stages: analysis and
selection. The first stage consists of three layers of analysis: ( 1 ) an institu-
tional analysis, (2) a comparison of the institution with others of the same
type (regionally and nationally),^ and (3) an analysis of the relationship of
the institution to its broader context, in this case the U.S. health care
system. The selection stage consists of making decisions at three levels: ( 1 )
the function/activity level,* (2) the department or subdivision level, and
(3) the record series level.

The order in which the first two levels are addressed depends on
whether the function is the administration function or a function of a
specific type of institution. For example, a hospital's administration func-
tion may be broken down into activities (i.e., governance, external rela-



207



208 DOCUMENTATION PLANNING AND CASE STUDY



tions, fiscal management, operations management, facilities manage-
ment, and human resources management). Then the archivist identifies
the departments and records series that document these activities. All of
the remaining functions (i.e., patient care, health promotion, education,
and research), however, are documented in each of the medical and
ancillary departments. For these functions, the first level of decision-
making is the department or subdivision level, the second level is the
function level, and the third level is the record series level.



STAGE ONE: ANALYSIS

INSTITUTIONAL ANALYSIS

The basis of documentation planning is an analysis of the institution, its
relation to other institutions or organizations of the same type, and its
place in the larger environment in which it operates. These internal and
external analyses require some time and effort, but they provide a strong
foundation for formulating effective documentation plans and performing
other archival activities, such as processing and reference.
Institutional analysis consists of five elements:

1. Understanding the institution's mission and defining its functions;

2. Determining whether the institution is freestanding or part of a
larger organization (i.e., determining who owns and controls the
institution);

3. Understanding how the institution interacts with other
institutions, both public and private;

4. Becoming familiar with the institution's history and culture; and

5. Understanding institutional constraints.

Understanding the institution's mission and defining its functions involve
identifying the institution's purpose and the broad categories of activities
in which it engages. Here it is important to compare the institution's
functions with the functions of the U.S. health care system as a whole (see
Table 1-1 ), to identify any functions of the institution that are not health
care system functions, and to understand each function's relative impor-
tance. A good sense of the institution's mission and functions should
emerge from reading its mission statement, bylaws, and recent annual
reports. It may also be necessary to peruse management literature related
to the type of institution you are documenting to define appropriate
functions. This functional analysis is vital to the documentation planning
process because it provides a broad overview of the institution and



STAGE ONE: ANALYSIS 209



because it is the first and most general level at which documentation
decisions are made.

The second element of the institutional analysis is determining
whether the institution is freestanding or part of a larger organization or
corporation. This is particularly important because it affects where rele-
vant records are likely to be found and who is responsible for their
preservation. If the institution is part of a larger body, the archivist must
understand its relation and the relation of other subordinate entities to the
parent body. This information is necessary if archivists are to have a more
complete picture of their own institutions and to determine where, out-
side of the home institution, significant documentation is likely to reside.
Some archivists responsible for institutional records will, of course, be
working for the larger organization or corporation. If this is the case, they
still need to be concerned about preserving selected records of the subor-
dinate institutions.

Identifying other institutions, public and private, with which your
institution interacts and understanding the nature of the interaction is the
third element of the institutional analysis. In today's complex society,
institutions and organizations are linked to one another through coopera-
tive agreements, funding arrangements, and governmental regulation.
These interconnections, which are becoming more frequent and complex
in the face of national health care reform, affect the types of record
produced, their uniqueness, and their location. By exploring these inter-
institutional relationships, archivists may find they need not preserve
certain record series because those series are being preserved by another
institution. Carrying this idea further, archivists may use the information
gleaned from the analysis to initiate cooperative collecting agreements.

The fourth element of the institutional analysis is becoming familiar
with the institution's history and culture. Understanding the institution's
history enables the archivist to determine whether its functions and their
relative importance have changed over time and provides a basis for
comparison with other institutions of the same type, which is the next step
in the analysis stage of documentation planning. This element of institu-
tional analysis is easily accomplished if a historical volume or a series of
historical essays has been written. Otherwise, basic information on the
institution's founding, its development, and significant events in its past
may be gathered from in-house publications such as annual reports and
newsletters, local histories, and other sources.

Institutional culture may be defined as the values, beliefs, and as-
sumptions of an institution. Institutional culture is not necessarily appar-
ent from the records that institutions generate, yet a grasp of the culture is
essential to a well-crafted documentation plan. Archivists can begin to



210 DOCUMENTATION PLANNING AND CASE STUDY



understand their institutions' values, beliefs, and assumptions by discuss-
ing with appropriate administrators both the formal and the informal
channels through which policy is formulated and information is commu-
nicated, by acquiring an understanding of how the institution perceives
itself and treats its employees, and by learning about the institution's
physical environment, employee activities (such as sports competitions
and Christmas parties), rituals (service awards), and symbols (logo or
seal). 5

Understanding institutional constraints is the final element of the
institutional analysis. Whether the institution is financially sound and has
adequate personnel and space is obviously important, because these
factors will directly affect the resources available for a records program
and therefore the program's scale. If a hospital, for example, is located in
the middle of a city where space is costly and there is little room for
expansion, the archives program will likely not be assigned adequate
on-site storage space. The financial soundness of an institution may be
determined by consulting recent annual profit/loss statements (often
published in institutional annual reports) or by talking with the institu-
tion's chief financial officer. The head of human resources and the institu-
tion's facilities planner will be able to provide the information on person-
nel and space resources.

COMPARISON WITH OTHER INSTITUTIONS OF THE SAME TYPE

The second step in the analysis stage of documentation planning applies
the institutional analysis to a broader level, using it to compare a specific


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