World Journal

of Microbiology

& Biotechnology

Biotechnology in the USA

12.439-443

education

for non-scientists

D.F. Betsch, The focus and funding for science education in the USA is to channel bright students into PhD programs and science research careers. While this goal is necessary to our country’s continued technical innovation, the contributions of non-scientist members of our society to the cycle of economic development through technical innovation are usually overlooked. Public support of scientific research, both financial and philosophical, and the commercialization of useful technologies by business people are critical components of the cycle which depend on increasing science education for non-scientists. For the industry’s continued success, it must adopt business strategies that maintain public confidence and defuse countermarketing efforts by several small but influential public opposition groups. Key words: biotechnology,

education, public awareness.

Within this article biotechnology will be defined narrowly as commercial products or services that depend on the deliberate manipulation of cells, DNA or proteins. Biotechnology in the USA was developed from numerous, seemingly unrelated discoveries by academic researchers between the 1960s and the 198Os, primarily in American universities but also in Europe. The first private companies were established in the latter half of the 1970s and offered their first stock to public investors after 1981 (Figure I). The first markets addressed were pharmaceutical; products became commercially available with the introduction of recombinant DNA-produced human insulin in 1984. Biotechnology products for agricultural markets lagged behind, partly because of intense public scrutiny, with the first food products (recombinant DNA-produced chymosin and bovine somatotropin, and transgenic tomatoes and squash) reaching the marketplace within the last few years. Presently, the USA has over 1300 privately or publicly funded biotechnology companies which employ about 100,000 people; losses total about US $2 billion annually against revenues of US $8 billion (Kreeger 1995). In addition, most major pharmaceutical and agricultural companies have substantial interests in developing biotechnology prodThe author is with Biotechnology Training Programs, Inc., Bryant 1150 Douglas Pike, Smithfield, RI 02917 USA; fax: 401-232-6319.

@ 1996 Rapid Science

College,

Figure 1. Founding companies

(Burrill

of public and private 8 Lee 1994).

American

biotechnology

ucts. There are more than 1000 pharmaceutical products and 400 agricultural products awaiting regulatory approval (Anon. 1995); typically this approval process requires 7 to 10 years and US $100 to 500 million. Approximately 24 pharmaceutical, 10 agricultural, and numerous diagnostic products are already commercialized. However, despite 20 years of economic activity and many billions of dollars of investment, the biotechnology industry remains one based on promises rather than performance.

Economic

Development

Cycle

During the last 50 years, economic development in the USA has followed a cycle of investment, innovation, and development (Figure 2). The centre of the model, the under-

Publishers World ]mmml of Microbiology 6 Biotechnology. Vol 12, 1996

439

D.F. Befsch

l-l

AND SERVICES

PUBLIC INTEREST

Figure (Dibner INVESTMENT

COMMERCIAL

2. The economic

development

cycle

in the USA

lying motivation for innovation and development, is the public interest, which broadly includes employment opportunities and those goods and services that contribute to a longer, healthier, or more comfortable life. Within our society, the biotechnology industry is expected to become the most significant new business area, in both economic and social terms, as we enter the 21st century. The critical component in this cycle is trust. Tax-payers must be confident that their hard-earned tax money will be invested in scientific research that will benefit them and support their values and lifestyles. Investors must feel confident that their biotechnology stocks will deliver profits at some future time. Consumers must believe in the integrity of government regulatory bodies to ensure the safety and effectiveness of drugs and health-care treatments and to protect the food supply and the environment. Unfortunately, several developments in the biotechnology industry are beginning to threaten this public trust: (i) increasing commercialization of university research; (ii) barriers to commercialization that undermine the success of new companies; (iii) modifications in government regulatory policies. Commercialization of Llniversify Research Public support for university research, though among the highest in the world, has not been keeping pace with increasing demands from research scientists. For example, the fraction of grants funded by the National Institute of Health (NIH), the primary source of government funds for life sciences research, has slipped from 90% to 10 to 15% during the last three decades (Finn 1995). Consequently, corporate funding of university research has increased to fill the gap. The public had traditionally believed that taxpayer investment in university research would certainly

440

World]ooumal of Microbmlogy 6 Biotechnology, Vol 12, 1996

of regional

biotechnology

centers

in the USA

&

REGUIATIDNS

Figure

3. Founding 1995).

lead to economic development but that the two should remain separate; this connection was seldom questioned even by people without formal training or experience in scientific research. However, the recently accelerated pace of commercializing university biotechnology research is beginning to create among the public a resentment, that tax monies and public universities intended for the good of society have been used instead to increase the wealth of individual professors or companies. In biotechnology, ideas for commercial development have come primarily from the strong base of university research. The connection between university discovery and commercial development has become quite intimate, leading to the establishment of regional biotechnology centers at or near universities throughout the USA, whose primary purpose is to assist in the commercialization of university research (Figure 3). Furthermore, it is quite common now for university professors to form biotechnology companies or to serve such companies as directors or consultants. This practice was nearly unknown even 20 years ago. The unfortunate result of this practice may be that university professors lose their position as the most trusted source of information about biotechnology due to the suspicion of profit motives. Barriers fhuf Undermine the Successof New Companies Biotechnology has been intensely capital-driven, given the enormous costs of product development, and intensely risky. Nonetheless, the industry has been able to raise US $60 billion during its 20 year lifespan to keep new companies and new products moving forward. There is perhaps no greater expression of trust than the placement of millions by private investors in a new biotechnology company. However, investor confidence has much deteriorated during the 1990s, given the number of products to fail regulatory approval and th e fates of the sponsoring companies (Table 1). Vertical integration is the emerging pattern in the industry as large pharmaceutical and chemical companies replace public and private investors to feed biotechnology’s immense appetite for capital. The effect of vertical integration is likely to be greater stability but lesser innovation.

Biotechnology education for non-scientists Table 1. Decrease in value of clinical trials fail (Egan et al. 1995). Company

Alpha Celtrix

Date

1 Biomedicals Pharmaceuticals

biotechnology

stocks

of bad news+

when

% Decrease (1 day)

April 28, 1994 October 31,1994

68% 63%

Centocor

January

18, 1993

63%

ProCyte Synergen U.S. Bioscience

October February

17,1994 22, 1993

December

13,1994

68% 67% 69%

l Bad news from clinical

usually trials.

means

publication

of

disappointing

data

Modifications in Government Regulafo y Policies Several federal government agencies regulate biotechnology products; the FDA (Food and Drug Administration), EPA (Environmental Protection Agency), and USDA (US Department of Agriculture) are most notable. Many biotechnology products faall under the regulatory oversight of all three bodies; for example, transgenic cotton developed to contain the Bt toxin (against the cotton boll weevil) is regulated as a pesticide (EPA), as a food product because of the seed oil (FDA), and as a crop (USDA). Responding to pressures from the industry, these agencies have been working to streamline their approval processes and, as a result, have been openly criticized by public interest groups for sacrificing the safety of the people and the environment for the economic profits of the corporations. Though not particularly logical, this argument resonates with the American public who believe that their government regulators should not be involved with the industries they are supposed to be regulating. These examples of erosion of the public trust in the institutions of economic development should be taken as warning signs that education and public relations are critical to the future success of the biotechnology industry.

Training

and education

To be meaningful, training programs must be targeted to the specific needs of the audience. For the purposes of this analysis, it is convenient to divide the biotechnology audience into three broad groups: practitioners, professionals, and public (Table 2). ‘Practitioners’ are the scientists, graduate students, and technicians who actually perform the experiments and develop the technology. Excellent opportunities for training are available within our university system and fellowships ensure that no qualified students are refused admission for lack of funding. Continuing education, conferences and workshops, easy access to scientific journals, and private training programs ensure that practitioners keep up with

the latest developments. For example, within 6 years of the commercial introduction of the polymerase chain reaction (PCR) in 1989, virtually every life science laboratory in the country has access to this technology. ‘Professionals’ are those whose occupations require some peripheral involvement with biotechnology but who are not directly involved with the research or technology. Examples include health-care professionals, who need to be aware of new medications or treatments, attorneys who must interpret DNA fingerprint evidence, insurance agents who are considering the relevance of genetic predispositions to disease, stock analysts who follow the public biotechnology companies for their clients, and high school life-science and agriculture teachers. Unfortunately, training opportunities for these professionals are extremely limited, except for a recent wave of federal funding for teacher enhancement programs in the name of producing more science students at the university level. Obviously, members of this group do not require the detailed laboratory training of the practitioners but do desire an awareness of the vocabulary, concepts, and new commercial developments. People not connected with either of these groups fall into the ‘public’ category, by default. Educational opportunities for members of the public are virtually non-existent, except for individuals who wish to enroll in university courses out of curiosity, with their own tuition support. Most Americans report that their primary source of science information is television, followed by news and entertainment magazines. Certainly we wish for greater educational opportunities for our people than the films ‘Jurassic Park and ‘Outbreak or the much-publicized televised trial of Mr. OJ. Simpson can offer. Yet, spending for public awareness programs is less than 2% of the biotechnology centres’ budgets (Figure 4) and even less than that of the federal government’s science budget. An additional barrier to public awareness programming, beyond the budgetary limitations, is a simple lack of curiosity among the audience. Perhaps it is too obvious to state that one’s interest in biotechnology training depends mostly on the relevance of that training to one’s employment or well-being. People become most interested when there is an economic stake to the information they will gain. Without the urgency of career relevance, biotechnology training must be somewhat entertaining to be effective. The challenge to biotechnology educators is to target the needs of particular audiences while producing prograrnmes that are entertaining, informative, economical, and strongly reinforce the linkage among scientific research, commercial development, and economic benefits to the society at large. For the sake of continued financial support for research, every scientist should devote some energy to public awareness programmes. Likewise, for the sake of

WorldJournal

of Microbiology 6 Biotechnology, Vol 12. 1996

441

Table

2. Groups

for targeted

-all

Public

Ability/Interest very

O.l-o.S%

2-5%

others

95-98%

-vocabulary -concepts -commercial -ethics

to high (depending on to employment and background)

low to moderate education level relevance)

(depending and economic

applications

-basic vocabulary -basic concepts -commercial applications -social impacts

on

(1993).

Countermarketing

‘Vermont Biotechnology 06601 USA.

Working

for Economic DC 20036.

Trends,

1 National Wildlife Federation, Washington, DC 20036.

World Journal

The

ofMicrobiology

Group,

Pure Gene

development Public

awareness

Admlnlstration

2

22%

science training and education 8%

Strategies

Kotler (1973) introduced the term ‘countennarketing’ to describe actions by non-commercial interests, usually motivated by concern for the health or welfare of society, to eliminate the demand for a particular product or service. Popular examples in America include the American Lung Society’s anti-smoking campaign or current efforts by AIDS activists to promote use of condoms to prevent the transmission of HIV. Several aspects of industry marketing and public interest group countermarketing strategies are presented in Table 3. Several non-profit groups, including the Vermont Biotechnology Working Group’, the Foundation for Economic Trends and Pure Food Campaign’, and the National Wildlife FederatioI?, have taken extremely strong public positions against biotechnology products, even before these products have become available in the marketplace, based primarily on a philosophical objection to the power to manipulate genetics that biotechnology implies. In one particular case, the commercialization of recombinant-bovine somatotropin by the Monsanto Corporation, the efforts of countermarketers frustrated the product approval process. Although the product was first developed in 1978, it did not pass FDA approval until November 1993 with a final development cost in excess of US $500 million. Included in the countermarketing tactics were

442

needs

-procedures

high

moderate relevance educational

society’s economic and ethical future, members of the public should seek to participate in educational programmes in biotechnology.

2 Foundation Washington,

Tralnlng -details

-health-care providers -attorneys -business people -science teachers

Professionals

programs. Population”

-scientists -students -technicians

Practitioners

Silvestri

training

Identity

Group

l

biotechnology

15 Barre

Food

St., Montpelier,

Campaign,

Exchange,

VT

Research

Facultylstudsnt support

34%

20%

Flgure (Dibner

4. Spending 1995).

profile

of US regional

biotechnology

centers

threats of boycotts, lawsuits against product approval at the federal and state levels, and an intensive media campaign questioning the safety of the product for humans and cattle and impugning the integrity of the university research and government agencies involved. FDA approval was considerably delayed by political pressure aroused by countermarketers but was finally granted on the strength of positive scientific data. In this case, the industry observed firsthand the susceptibility of public opinion to misinformation, emotional appeals, and questions of risk and food safety and industry’s helplessness to defuse the opposition based on scientific arguments. This experience will certainly temper the enthusiasm for introducing new biotechnology food products for some time into the future. Clearly, the best defense against irrational opposition is greater public awareness and sophistication about biotechnology through educational programs delivered by organisations, such as universities, that do not directly profit by the information they are disseminating.

A Model for Biotechnology Non-Scientists

Education

for

1130 17th St.,

1400 16th St., NW,

6 Biotechnology, Vol 12. 1996

In 1989, the author founded a private company, ogy Training Programs, Inc. (BTP), to provide

Biotechnoltraining for

Biotechnology education Table 3. Comparison of marketing in opposition to the biotechnology

strategies of the biotechnology industry (Bonnici 1995).

Category

Biotechnology

emphasis regulatory basis

benefits status

of appeals

motivation

(must

regulated government to consumers

industry

and countermarketing

industry risks state

and local

(need

virtually protected

unregulated by constitutional

emotion/fear misinterpretation/misuse

commercial

political/moral/ethical

Conclusion The promises of the biotechnology industry remain strong in the areas of improved health care and longevity, improved agricultural yields with fewer inputs, and a new avenue for economic growth and jobs. Unfortunately, the public is not equipped to fulfil its role in the economic development cycle, because of lack of education and under’ Iowa Biotechnology Education Program, 1210 Molecular ing, Iowa State University, Ames, IA 50011.

Biology

Build-

non-scientists

interest

groups

groups

not prove)

rational/logical scientific evidence

scientists, ‘practitioners’, in the latest biotechnology techniques. A unique opportunity was created, however, to use the equipment, instructors, and profits of the company to provide educational programs to non-scientists, that is, ordinary citizens whose lives would surely be affected by the new biotechnology developments. In 1990 BTP and the Iowa State University (ISU) Office of Biotechnology (a biotechnology center in the heart of America’s agricultural region) received funding from several regional commercial interests to support the Iowa Biotechnology Education Program, a series of 36 public awareness workshops reaching nearly 1000 individuals4. Three fundamental principles guided the workshops: (i) all participants should receive ‘hands-on’ experiences; (ii) participants would be encouraged to teach in future workshops; (iii) commercial applications for agriculture would be emphasized. To date, the program has trained well over 5000 individuals and continues on the enthusiasm and strength of former participants who act as teachers and organizers of programs in their communities. In the process of publicizing and producing the workshops, the school systems and public media of Iowa have become saturated with biotechnology information. Public awareness of biotechnology issues in Iowa is among the highest in the country and the risks and benefits of new biotechnology products and services are well understood by the average person. The Iowa program for public education in biotechnology has been an extremely successful example of the positive influence of education on the intellectual self-esteem and empowerment of the people.

of public

Opposition

prove)

at federal, levels

strategies

for

right

to free

of scientific

speech evidence

standing of the risks and benefits of this new technology. Already there are signs of eroding trust in the institutions of government and academia to manage these new toois. The power of biotechnology to change life arouses fear and suspicion, arming countermarketers with a strong message of alarm. The practitioners of biotechnology are in a poor position to determine its social or economic impacts due to their narrow focus on the technology itself. For its own comfort, the public should know something about the biotechnologists’ ‘world view’, that is how they view life and what values they place on it. The public should understand the cycle of innovation and commercialization of biotechnology and the new paradigms that arise from collaborations among government, university, and corporate agencies. It should feel confident enough to contribute to decisions about the impact of biotechnology products and services on life and whether it wants these products at all. We can achieve the goal of an enlightened public only by a commitment to lifelong learning, by strengthening our school science programs for all students and by providing opportunities for continuing education after formal schooling is finished.

References Anon. 19% Biotechnology medicines and vaccines approved and under development. Genetic Engineering News 15, L-16. Bonnici, J. 1995 personal communication. Burrill, G.S. & Lee, K.B. 1994 &tech ‘94, Ernst & Young Annual Report. San Francisco: Ernst & Young. Dibner, M.D. 1995 Biotech centers represent a major force in development and support of the industry. Genetic Engineering News 15,4-s. Egan, J.J.,Cronan,

R.T. & Johnson, J.L. 1995 Managing a crisis in clinical trials. Bio/TechnoLogy 13, 559-561. Finn, R. 19% NIH Study section members acknowledge major flaws in the reviewing system. The Scientist 9, 1, 7. Kotler, P. 1973 The major tasks of marketing management. Journal of Marketing

3 ‘7, 42-49.

Kreeger, K.Y. 1995 Looking back, biotech report outlines future survival strategies. i’%e Scientist 9, 1, 6. Silvestri, G.T. 1993 The American Work Force 1992-2005, Occupational Employment, DC: US Bureau of

Monthly

Labor

Labor Statistics.

Review

(Nov.).

Washington,

Biotechnology education for non-scientists in the USA.

The focus and funding for science education in the USA is to channel bright students into PhD programs and science research careers. While this goal i...
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