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Economic Considerations in Animal Use for Research and Testing, Schemes and Mind Maps of Toxicology

The economic aspects of using animals in research, testing, and education. It discusses the costs and benefits of animal use, focusing on biomedical research and toxicological testing. insights into the costs of animal acquisition and maintenance, the role of animals in research and testing, and the economic implications of using animals. It also touches upon the development of alternatives to animal testing and the impact of regulations on animal use.

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Chapter 11
Economic Considerations
It would not be reasonable to make decisions on alternatives to animal use without having
some idea of the consequences to the health and welfare of the public.
Kennerly H. Digges
National Highway Traffic Safety Administration
U.S. Department of Transportation
March 20, 1985
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Chapter 11

Economic Considerations

It would not be reasonable to make decisions on alternatives to animal use without having some idea of the consequences to the health and welfare of the public.

Kennerly H. Digges National Highway Traffic Safety Administration U.S. Department of Transportation March 20, 1985

CONTENTS

P a g e

H o w Much Does Animal Use Cost?..................... .................

Costs and Benefits in Research.......................................... Biomedical Research......................................... ........ Supporting Patent Claims ,.......................... ..................

Costs and Benefits in Testing........................................ , .. Testing pesticides for Toxicity...................... .................... Testing and Product Liability....................... ................... Testing Costs of Animals and the Alternatives...... ,........ .,..........

National Expenditures for Research and Testing... ,....................... Toxicological Testing Services... .,....... .“......................... , ,. Government Toxicological Research and Testing.................... .. ...

Protecting Proprietary Interests ,....................... ................. Cooperative Research and Testing............................ ......... Toxicity Testing Data................................... .............

Summary and Conclusions........................................ .. ...

Chapter 11 References..... , ,................ ,........ ,............. ..

List of Tables

Table No.. Page 11-1. Total Savings Attributable to Biomedical Research......... ............ 11-z. Estimated Biomedical Research Outlays, Selected Years, 1900-75”...... ,.. 11-3. Selected Federal Expenditures Related to Toxicological Testing and Research, 1984-86...................... ,.....................

List ofFigures

Figure No, Page 11-1. Relation Between Number of Animals Used and Cost of Animal Use...... 11-2. Development of a Typical Pesticide for Agriculture ,. ,. ,...............

244 l Alternatives to Animal Use in Research, Testing, and Education

Figure 11-1 .—Relation Between Number of Animals Used and Cost of Animal Use Acquisition Maintenance Total i (^). .h II

  • (^) ‘x

I

The total cost of animal acquisition and maintenance equals the sum of the acquisition cost and the maintenance cost. maintenance cost depends-on the animal’s length of stay in the animal facility.)

Acquisition Maintenance

I (^) Number of animals used

x

I

+

Number of animals used

x

Total

I

(The

Using fewer animals will yield a decrease in the total cost of animal acquisition and maintenance, but the proportionate sav- ings ‘will be less than the decrease in the number of animals used. Both the price of each animal and the cost of maintenance per animal can be expected to increase to support the operating costs of breeding facilities and animal facilities. SOURCE: Office of Technology Assessment.

and the total cost of animal use. Although the

numbers and species of animals used (see ch. 3)

and the price per animal can be estimated, it is

currently impossible to estimate with any ac-

curacy the laboratory lifetime-and hence the to-

tal maintenance costs-of animals used in the

United States. Therefore no actual dollar figure

can be affixed to the cost of animal acquisition

and maintenance in research and testing. Begin-

ning in 1986, the Public Health Service (PHS) will

require reports on the average daily census of all

species housed in PHS-funded facilities (see app.

C). These data may permit an estimate of the to-

tal cost of animal use in a sizable portion of ani-

mal research—namely, that conducted in PHS-

funded facilities.

The relationship shown in figure 11-1 empha-

sizes several aspects of the economics of animal

use. If the number of animals used is reduced,

the total cost of animal acquisition and mainte-

nance will decline. But the proportional decrease

in total cost will not match the proportional de-

crease in the number of animals used. Reducing

animal use by 15 percent, for example, will not

effect a cost savings of 15 percent; the savings

will be somewhat less, for two reasons, First, if

the number of animals used decreases, the cost

of acquiring each animal can be expected to in-

crease somewhat. (A temporary drop in price for

some species that are in immediate oversupply

may occur, but this would last only through the

laboratory-useful lifespan of animals already on

Ch.11 -Economic Considerations Ž 245

hand and ready for sale.) With reduced demand, would have to spread the cost of operation over vendors would have to raise prices to cover their fewer animals. In both breeding and laboratory overhead. Second, if the number of animals used maintenance of animals, there are economies of decreases, the expense of maintaining each re- scale such that breeding and maintenance of mar- maining animal in a laboratory facility can be ex- ginally fewer animals does not yield a correspond- pected to increase. Laboratory-animal facilities ing decrease in costs.

COSTS AND BENEFITS IN RESEARCH

The many important economic contributions of research with animals are difficult to character- ize. First, research does not lend itself to such analysis. Normally, one experiment will draw from many others and contribute to future re- search, making allocation of costs and benefits to a particular activity virtually impossible. Second, the outcome of each experiment is uncertain, and the experiences in one program would not nec- essarily apply to others. Third, the delay between research and commercialization is long, reaching a decade or more, with payoff taking even longer. Thus, it is not possible to evaluate with any rea- sonable confidence the costs and benefits of cur- rent or even recent animal and nonanimal re- search practices,

Biomedical Research

This section discusses biomedical research in general, which unavoidably averages many di- verse research experiences. Biomedical research is of interest because it is a major user of animals, because it affects human health, and because it affects an important sector of the economy—the health care industry. As with most areas of re- search, many of the contributions are indirect and many are not easily quantified in economic terms (see ch. 5). Most benefits are realized in the health care industry, which in 1983 accounted for $355. billion (10.8 percent) of the gross national prod- uct (9). Drugs, which require both biomedical re- search and toxicological testing in their develop- ment, have annual sales of about $30 billion and contribute about 20,000 jobs to the economy (29).

The first medical discovery that was largely a result of research with animals was diphtheria antitoxin at the end of the 19th century. Its use reduced the likelihood of death for those contract-

ing diphtheria from 40 to 10 percent (28). Ani-

mals eventually came to be used in all phases of

biomedical research and in the development of

medical products such as drugs and devices and

of services such as surgery and diagnostic tech-

niques.

Research with animals that leads to practical

applications can last from a few days to many

years. It may involve inexpensive equipment or

hundreds of thousands of dollars’ worth of in-

strumentation, may be performed by a laboratory

technician with little supervision or by a team of

highly educated scientists, and may be done with

fruit flies or with primates. The costs will vary

accordingly.

The benefits and rates of return on a given ex-

periment vary widely. The rate of return for a

given research program can only be determined

reliably many years after commercialization. In

the case of products with high research and test-

ing costs and long lead times to commercializa-

tion, which applies to many of the products of bio-

medical research, the lag can be several decades.

A 1972 study on the rates of return for six large

pharmaceutical companies for research they con-

ducted in 1954 through 1961, when animals were

widely used, estimated the pretax private rate of

return to be 25 to 30 percent (2). The social rate

of return—the benefits to the public, was esti-

mated to be at least twice as high (20).

Another approach to gauging costs and bene-

fits involves looking at expenditures from 1900

to 1975 and comparing them with the benefits

of medical advances in preventing sickness and

death in the work force over the same period (4).

All data were adjusted to 1975 conditions. Anal-

ogous comparisons were made for 1930 to 1975.

Ch. 11-Economic Considerations. 247

Table 11-2.—Estimated Biomedical Research Outlays, Selected Years, 1900-75 (in millions)

Disease category 1900 1930 1963 1975 Total a........................................................... - - - - - -^ - - - - - - -^ -.^ - - -^ -^ - - -^ - - - Infective and parasitic diseases.................................... Neoplasms...................................................... Endocrine, nutritional, and metabolic diseases....................... Diseases of the blood and blood-forming organs..................... Mental disorders................................................. Diseases of the nervous system and sense organs.................... Diseases of the circulatory system.................................. Diseases of the respiratory system................................. Diseases of the digestive system, oral cavity, salivary glands, and jaws. Diseases of the genitourinary system............................... Complications of pregnancy, childbirth, and postpartum............... Diseases of the skin and subcutaneous tissue....................... Diseases of the musculoskeletal system and connective tissue........ Congenital anomalies............................................. Certain causes of perinatal morbidity and mortality................... Symptoms and ill-defined conditions................................ Accidents, poisonings, and violence................................ aTOtalS may not add due to rounding.

**$l0.

0.**

0,

**$1,561.

18.**

$4,640.

2,464.

SOURCEDatafrom S.J. Mushkin, Biomedica/ F?esearch:CosM and Benefits (Cambridge, MA’ Ballinger Publishing Cov 1979)

pound animals are much cheaper than purpose- bred ones and that it would be wasteful to de- stroy them when they could be used. The differ- ence in price between a purpose-bred and a pound dog ranges from $200 to $500 per animal. Estimates of the impact on research of a ban on using pound animals range from a tenfold in- crease in costs to effectively`stopping research in Los Angeles County (25). Others have argued that pound animals are poorly suited to most lab- oratory work because they are often in poor health and their genetic background is usually un- certain (25). It may seem ethically desirable to make use of animals that would be killed anyway, but an ani- mal that had been a pet may find laboratory con- ditions more stressful than a purpose-bred ani- mal would. Other nonpecuniary considerations are that people may hesitate to bring their ani- mals to a pound if they oppose laboratory use of pound animals and that those using pound ani- mals will see them as cheap, disposable experi- mental tools that need not be conserved (22).

Supporting Patent Claims

Data derived from animal research have pro- prietary value and are often used to support pat- ent applications for drugs or devices for humans.

Patents give the inventor an exclusive right to make and sell the patented invention, thus pro- viding an incentive to invent, which in turn fuels a growing economy. Thus, animal use can have important economic consequences in addition to improvement in health.

To obtain a patent, an inventor must show that the invention is novel and useful and must dis- close how to make it and use it. Data from studies with humans are normally obtained to support a patent on an invention to be used by humans, but data on animals can provide evidence of util- ity as well (12,15). And because they are normally obtained before research is done on humans, such data sometimes play a crucial role in determin- ing the date of an invention, which could deter- mine who gets the patent in the case of two com- peting inventors. Utility can be demonstrated with animal studies, but only if the data would convince someone of ordinary skill in the art that the same effect would be observed in humans (14). The character and quantity of evidence needed to show utility de- pend, in part, on whether the results agree with established beliefs (13). Courts recognize that an animal may respond differently than a human would (16), and in demonstrating the utility of an invention it is not necessary to demonstrate safety (11)17).

248 l Alternatives to Animal Use in Research, Testing, and Education

In vitro experiments are sometimes sufficient to demonstrate utility for patent purposes. In one recent case (7), in vitro tests showed that the chemical to be patented, an imidazole derivative, inhibited thromboxane synthetase in blood plate- lets. The activity of thromboxane synthetase was thought to be related to hypertension, pulmonary vasoconstriction, and other cardiovascular dis- eases, and the demonstration of the chemical’s ability to inhibit it was sufficient to show utility. Data showing therapeutic use were not required in showing that an invention had taken place. In another case, the fact that the inventor had given

a detailed description of how the substance to be

patented would behave was enough to support

a showing of utility, thus fixing the date of inven-

tion (24).

Although the use of alternatives to support pat-

ents is interesting, it does not have much practi-

cal effect on the use of animals in developing med-

ical products because safety and efficacy must be

demonstrated to satisfy regulatory requirements

(see ch. 7). These patent cases might have some

application, however, in demonstrating the suffi-

ciency of alternatives in other areas.

COSTS AND BENEFITS IN TESTING

There are several major economic benefits to using animals in toxicological testing. Drugs, food additives, pesticides, and many consumer prod- ucts are tested for toxicity or other kinds of haz- ards before they can be marketed and begin to generate income for the manufacturer. This is often done to meet regulatory requirements, but the tests are also done to avoid marketing unsafe products. In addition, testing is done to confirm that a product does in fact confer a benefit.

Testing Pesticides for Toxicity

Over a billion pounds of pesticides are used in

the United States annually, corresponding to over

$4 billion in sales. About 130 firms produce the

active ingredients in pesticides. Thirty of these

produce common products in high volume; the

others tend to produce specialty pesticides. Most

of the pesticides are used in the agricultural sec-

tor. About 7 percent are purchased by consumers

for home and garden use, while industrial and

institutional use account for about 20 percent (31).

Because pesticides are designed to be biologi-

cal poisons, they are among the most toxic sub-

stances commercially available. Most of the haz-

ards result from chronic, low-level exposure.

Exposure and the risk of it are widespread. About

2 million commercial farms in the United States

use pesticides, some of which remain in or on the

food and are eventually consumed. About 40,

commercial applicators use pesticides to treat

structures and facilities. The Environmental Pro- tection Agency (EPA) estimates that 90 percent of all households regularly use or have used pes- ticides in the home, garden, or yard (31). The re- sults of tests on animals are used by EPA to iden- tify hazards and to develop acceptable exposure levels and safe handling and disposal practices (see ch. 7). Thus, animal testing plays an important role in the protection of virtually the entire U.S. population. Acute poisonings have been estimated to cost over $15 million annually (1980 dollars), exclud- ing the value of saving lives or avoiding suffer- ing. The estimated cost of each death due to pes- ticide poisoning is $112,000, whereas the average cost of a nonfatal poisoning is $200 (23,31). The costs of cancer, the most important chronic ef- fect, is over $34 billion in 1980 dollars, with each cancer costing $52,000 (31). One research goal is to find new pesticides that are less toxic and more effective than those now in use, a search that en- tails animal testing. There are over 48,000 registered pesticide for- mulations, with an estimated 1,400 to 1,500 ac- tive ingredients (5). There are between 5 and 20 new registrations for active ingredients issued an- nually, each requiring a complete toxicological evaluation based on animal testing and other data. Another 1,500 to 2,000 new formulations or uses are also registered annually (5,31). These require little additional testing, as a rule, and often rely on data in EPA’s files.

250 l Alternatives to Animal Use in Research, Testing, and Education

der $1,000. An LD 5O test can be performed for

less than $2,000. Subchronic toxicity tests can cost

under $100,000, and those for long-term toxic-

ity or carcinogenicity for two species can be done

for less than $1 million, and perhaps for under

$500,000 (10,31). As a rule, the cheaper tests re-

quire fewer animals, but more importantly they

take far less time at each of three stages—plan-

ning, execution, and analysis. Another reason for

large variations in testing costs is the species used,

with maintenance costs approximating $0.05 per

day for a mouse, $4 for a dog, and $11 for a chim-

panzee. Most of the cost of maintaining animals

is attributable to labor expenses.

Various short-term in vitro tests for mutagenic-

ity have been developed over the past 15 years

in an effort to replace the more costly and time-

consuming carcinogenicity test (see ch. 8). The

most popular mutagenicity test, and one of the

first to be introduced, is the Salmonella typhimu-

rium/microsome plate mutation assay (the Ames

test), costing $1,000 to $2,000 (10). This assay has

the most extensive database thus far (1). Used

alone, it does not appear to be as predictive of

human carcinogenicity as are animal tests.

If the Ames test, some yet-to-be developed test,

or a battery of tests proves to be more predic-

tive of carcinogenicity than testing with animals,

the savings could be enormous. A battery of tests

that might indicate carcinogenicity has been sug-

gested by the National Toxicology Program (30)

and has shown some promise in preliminary

evaluations (see ch. 8). Most testing laboratories

could conduct this particular battery of tests for

under $50,000, and costs would probably decline

as the tests become more commonplace (10).

NATIONAL EXPENDITURES FOR RESEARCH AND TESTING

Research and testing in the United States are

financed and conducted in a variety of ways. The

sources of research funding are Government and

industry. Some Government research funds sup-

port Government laboratories, but a larger share

support research in academia. Industry research

is done primarily at in-house industry labora-

tories, with some funds contracted to other lab-

oratories and to academia.

Most testing is conducted by industry. The

chemical industry is the sector most directly af-

fected by regulatory policies concerning toxico-

logical testing. In 1982, this industry (Standard

Industrial Classification Code 28) had shipments

worth over $170 billion and employed 866,

people, which represented 8.7 percent of all in-

dustry shipments in the United States and 4.5 per-

cent of the employees.

Drugs, soaps and toilet goods, and agricultural

chemicals account for the greatest use of animals

in testing, and constitute almost a third of their

use by the chemical industry. The rest of the chem-

ical industry, in order to satisfy transportation,

disposal, and occupational health requirements,

does simple tests such as the LD 5O for substances

for which the potential exposure is high (see ch. 7).

Corporate research and development (R&D) in the chemical industry is large and concentrated in the industrial chemicals and drug sectors. Ex- penditures by the industry totaled $7.6 billion in 1984 (8), a figure that includes in-house toxico- logical testing, research involving the use of ani- mals, and many other activities. It has been esti- mated that the toxicological testing industry accounts for just under 10 percent of the R&D expenditures in the chemical industry (27), mak- ing testing an estimated $700 million expenditure in 1984. An unknown percentage is spent on re- search involving animals.

In the past 10 years, industry’s R&D expendi-

tures have grown at about 13 percent per year,

following a slight decline in the early 1970s. R&D

expenditures for drugs, as a percentage of sales,

are twice as high as the industry average, and

have grown at a slightly higher rate (8). Animal

use could be growing at a similar rate, although

survey estimates (see ch. 3) and other factors (see

ch. 8) do not support this notion.

The Federal Government also plays a major role

in animal research and testing, with almost $6 bil-

lion obligated for research in life sciences for

1985. University research in the life sciences,

which is funded largely by Government and some-

Ch. n-Economic Considerations l 2 5 1

what by industry, will cost an estimated $2.9 bil- lion (8). Projections of future expenditures depend on a number of factors, including the growth of the chemical industry and of R&D within it; the areas of R&D (e.g., new substances, new uses for old substances, new processes for making old sub- stances); regulatory policies, both domestic and foreign; the growth of the overall economy; tax policy; and further developments in nonanimal tests. International developments can have economic repercussions. For example, Swiss voters defeated in 1985a referendum virtually banning all animal testing (see ch. 16). A number of companies have facilities in Switzerland, and such a change could have shifted testing to another country. whether U.S. labs could compete for that business depends on the strength of the dollar.

Toxicological Testing Services

In 1984, the toxicity testing industry in the United States was estimated to be worth about $650 million per year (27). Sixty-five percent of the testing is done by corporations in-house. The remaining 35 percent (about $225 million annu- ally) is conducted by commercial laboratories, universities, and other organizations. Although there are over 110 U.S. laboratories that sell test- ing services, most specialize in a small number of assays and are not ‘(full service. ” Hazelton is the largest of the full-service labs, with domestic sales of $36 million in 1983. Except for Hazelton and several other large commercial labs, the in- dustry is a dispersed one, with the many small commercial firms accounting for approximately two-thirds of the value of domestic sales (10). The industry expanded its facilities in the 1970s in response to Federal regulatory changes and the passage of the Toxic Substances Control Act. Test- ing did not increase as much as expected, how- ever, and in the early and mid-1980s the indus- try was operating at 60 to 70 percent capacity (27). This has led to fairly level prices over the past few years and, in some cases, price cutting to maintain market position. Because of this com- petition, current prices reflect the actual costs of testing. Testing laboratories often do not quote set prices for some testing procedures or for par-

ticular batteries of tests, preferring to negotiate

on a case-by-case basis.

Government Toxicological

Research and Testing

The U.S. Government programs with strong ties

to toxicological testing are EPA, the National Cen-

ter for Toxicological Research in the Food and

Drug Administration, the Centers for Disease Con-

trol, and the National Institutes of Health (see table

11-3). other programs are not identified with sep-

arate budget line items and are dispersed among

various agencies and departments.

Table n-3.-Selected Federal Expenditures Reiated to Toxicoiogicai Testing and Research, 1984- (in thousands)

1984 1985a 1986a Environmental Protection Agency: Program expenses....... (^) $327,145 $380,341$376, Toxic substances...... (^) 34,484 39,341 38, Pesticides............. 32,772 (^) 37,805 36, Research and development......... 144,903 195,449 212, Toxic substances...... 12,327 14,450 26, Pesticides............. 1,738 5,121 (^) 6, Interdisciplinary........ 18,522 22,423 14, Food and Drug Administration: National Center for Toxicological Research. (^) 21,132 21,575 22, Drug program .,.......... 138,248 153,112 152, Food program........... 115,541 (^) 109,538 113, Devices and radiologic products.............. 62,568 67,081 68, Centers for Disease Control: Occupational safety and health research........ 54,740 54,863 57, Research on chronic and environmental disease.. 25,953 28,568 23, National Institutes of Health: National Cancer Institute: Cause and prevention... 276,075 (^) 301,655 285, Detection and diagnosis........... 63,182 70,524 66, Treatment............. 340,041 367,940 351, National Institute of Environmental and Health Sciences: Characterization of environmental hazards............. 19,152 21,136 21, Applied toxicological research and testing.. 57,781 57,303 56, Intramural research....... 48.643 55.051 52. aEstimates. SOURCE: U.S. Executive Office of the President, Office of Management and Budg- et, Budget of the United States Government, Fiscal Year IQ% (Washing- ton, DC: U.S. Government Printing Office, 1985),

Ch. 11-Economic Considerations l 2 5 3

requires that data be shared as long as compen- sation is offered. The terms of the compensation are subject to arbitration if the parties cannot agree. The other protection only applies to new pesticides (new active ingredients), not to new for- mulations of old ingredients. It gives exclusive use of the data to the data owner for 10 years unless the data owner explicitly agrees to sell the right to use the data. The Supreme Court recently decided in Ruck- elshaus v. Monsanto (26) that these provisions of FIFRA are constitutional. For data submitted be- fore 1972 or after 1978, there is no expectation of a proprietary interest, thus nothing is taken; for data submitted between those years, the com- pensation and arbitration provision, in combina- tion with the Tucker Act, provides adequate com- pensation. (See also the Environmental Protection Agency’s regulations at 40 CFR 1984 ed. 152; 40 FR 30884.)

Congress has recognized the important business interest in keeping information from competitors, but it also supports the public’s ‘(right to know” and the Federal Government’s need to know. An important barrier to the sharing of confidential business information among agencies is the differ- ing standards and procedures for handling it. The ad hoc interagency Toxic Substances Strategy Committee, coordinated by the Council on Envi- ronmental Quality, thought it would be necessary to pass legislation permitting the sharing of con- fidential data between health and environmental agencies (32). Such legislation would establish a need-to-know standard, require uniform security procedures for the data to be shared, impose uni- form penalties for disclosure, and provide for notification of the data submitted by the data holder at least 10 days prior to transfer.

SUMMARY AND CONCLUSIONS

The total dollar cost of animal acquisition and

maintenance is directly related to the length of

time animals stay in the laboratory. With no ac-

curate source of data on various species’ length

of stay, it is impossible to calculate the total cost

of animal use. Analysis of the factors involved in

the costs of animal acquisition and maintenance

indicates that a reduction in animal use will be

accompanied by a reduction in cost—although the proportionate savings will be less than the propor- tionate decrease in the number of animals used. Many of the issues involved with using animals in research and testing have economic implica- tions, although they do not lend themselves well to rigorous quantitative economic analysis be- cause many considerations are nonmonetary. A highly contested concern, for example, is the propriety of using unclaimed pound animals in laboratory studies. An area of animal use that is of major economic importance is biomedical research, which contrib- utes to health care through the development of drugs, medical devices, diagnostic techniques, and surgical procedures. Health care accounts for

over 10 percent of the Nation’s gross national

product, or $355 billion in 1983. The results of

research with animals might also reach the pub-

lic through patented products. Although data on

humans may also be required, and although

nonanimal or in vitro methods are sometimes

sufficient, many such patent applications use ani-

mals to show that the invention is useful.

Another use of animals with economic impor-

tance is toxicological testing, used to ensure that

new products are sufficiently safe. One type of

product for which such testing is of major con-

sequence to public health is in the development

of pesticides, which affect virtually all Americans

through the production and contamination of

food. The Environmental Protection Agency has

estimated that 90 percent of all households use

some pesticide product.

Whole-animal tests can be far more costly than

in vitro and nonanimal alternatives, largely be-

cause they are labor-intensive. The incentives to

find alternatives to the LD 5O and Draize tests are

primarily nonmonetary, however, as these tests

can be performed for $1,000 to $2,000. This is

254. Alternatives to Animal Use in Research, Testing, and Education

in the price range of the cheaper, currently avail-

able in vitro and nonanimal replacements.

Most research and testing in the United States

is financed by Government or industry. The

chemical industry, including the production of

drugs, has annual sales of over $170 billion and

spends over $7 billion on research and develop-

ment. An unknown fraction is spent on research

involving animals and about $700 million is spent

on toxicity testing.

The Federal Government sponsors much bio-

medical research and testing involving animals

(see ch. 12). An unknown amount leads to the de-

velopment or use of alternatives. The Government

also has many programs related to testing, includ-

ing the evaluation of testing data generated in

other sectors. Agencies with significant budgets

for such activities include the Environmental Pro-

tection Agency, the Food and Drug Administra-

tion, the Centers for Disease Control, and the Na-

tional Institutes of Health.

The Federal Government also has a special role

in the sharing of data derived from animal use,

as the data have proprietary value. First, antitrust

laws and policies affect industry’s ability to share

data and the costs of generating it. Such sharing

is facilitated by the passage of the National Co-

operative Research Act of 1984. It is also facili-

tated under the Federal Insecticide, Fungicide,

and Rodenticide Act and the Toxic Substances

Control Act.

CHAPTER 11 REFERENCES

  1. Auletta, A., Genetic Toxicologist, U.S. Environ- mental Protection Agency, Washington, DC, per- sonal communication, 1984.
  2. Baily, M. N., “Research and Development Costs and Returns, the U.S. Pharmaceutical Industry, ’’.l. Po]it. Econ. (Jan. -Feb. ):7O-85, 1972.
  3. Baxter, W .F., “Antitrust Law and Technological In- novation,” 1ss. Sci. Tech. 1(2):80-91, 1985. 4. Berk, A., and Paringer, L.C., Economic Costs of W- ness, 1930-1975 (Washington, DC: Public Services Laboratory, Georgetown University, May 1977).
  4. Bishop, F., Chief, Registration Support and Emer- gency Response Branch, Office of Pesticide Pro- grams, U.S. Environmental Protection Agency, Washington, DC, personal communication, 1985.
  5. Brusick, D.J., Director, Molecular Sciences Direc- torate, Litton Bionetics, Kensington, MD, personal communication, 1984.
  6. Cross v. Izuka, 224 USPQ 745, 1985.
  7. Chem. Engin. News, “Facts and Figures for Chemi- cal R&D,” 53(29):28, 1985.
  8. Gibson, R. M., Levit, K. R.,Lazenby, H., et al., “Na- tional Health Expenditures, 1983,” Health Care Fi- nan. Rev. 6(2):1-29, 1984.
  9. Hertzfeld, H. R., and Myers, T.D., “Economic and Policy Considerations,” contract report prepared for the Office of Technology Assessment, U.S. Con- gress, 1985.

11, In re Anthony, 56 CCPA 1443,414 F.2d 1383, 162 USPQ 594 (1969).

  1. In reBergeZ, 48CCPA 1102, 292F.2d 955, 130USPQ **_206 (1961).
  2. ~n re Chihnvsky, 43_** CCPA 775, 229 F.2d 457, 108 USPQ 321 (1956).
  3. In re Irons, 52 CCPA 938, 340 F.2d 974, 144 USPQ 351 (1965).
  4. In re Jo]]es, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980).
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  7. McGrath, J. P., Remarks at the 18th Annual New Eng- land Antitrust Conference, Boston, MA, Nov. 2,
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  9. Natural Resources Defense Council v. EPA, 595 F. Supp. 1255 (S.D.N.Y., 1984).
  10. Payton, N., Massachusetts Society for the Preven- tion of Cruelty to Animals, Testimony in Support of H1245, Boston, MA, February 1981.