Ch. 4— The Pharmaceutical Industry • 77 
The genes that are transferred from plant to 
bacteria must ob\ iously be ileterminecl on a 
case-bv-case basis. The case study on acetamino- 
phen (the acti\ e ingredient in analgesics such as 
Tylenol) demonstrates the steps in such a feasi- 
bility study. (Seeapp. l-.\.) 
'I'be first stej) in such a study is to detei'inine 
w hetber and w here enzymes e.xist to carry out 
the necessary transformation for a given prod- 
uct. .-\cetaminophen for instance, can be made 
from aniline, a relati\ely ine.\pensi\e starting 
material. The two necessary enzymes can be 
found in several fungi. Either the enzymes can 
be isolated and used directly in a two-step con- 
version or the genes for both enzymes can be 
transferred into an organism that can carry out 
the entire conversion by itself. 
(li\en the cost assumptions outlined in the 
case study and the assumptions on the efficien- 
cy of comerting aniline to acetaminophen, the 
cost of producing the drug by fermentation 
could be 20 percent lower than production by 
chemical synthesis. 
Impacts 
Genetic technologies can help pro\ ide a \ arie- 
ty of pharmaceutical products, many of which 
ha\ e been identified in this report. But the tech- 
nologies cannot guarantee how a product will 
he used or even whether it u ill he used at all. 
The pharmaceuticals discussed ha\e illustrated 
the kinds of major economic, technical, social, 
and legal constraints that u ill play a role in the 
application of genetic technologies. 
Clearly, the major direct impacts of genetic 
technologies will be felt primarily through the 
type of products they bring to market. Never- 
theless, each new pharmaceutical will offer its 
own spectrum and magnitude of impacts. Tech- 
nically, genetic engineering may lead to the pro- 
duction of growth hormone and interferon with 
equal likelihood; but if the patient population is 
a thousandfold higher for interferon, and if its 
therapeutic-effect is to alle\ iate pain and lower 
the cancer mortality rate, its impact will be sig- 
nificantly greater. 
Many hormones and human proteins cannot 
be extensively studied because they are still 
either unax ailable or too expensiv'e. Until the 
physiological properties of a hormone are 
understood, its therapeutic \ alues remain un- 
known. Recombinant DNA techniques are being 
used to overcome this circular problem. In one 
laboratory, somatostatin is being used as a re- 
search tool to study the regulation of the hor- 
monal milieu of burn patients. A single experi- 
ment may use as much as 25 mg of the hor- 
mone, which, as a product of solid state chem- 
ical synthesis, costs as much as $12,000. Re- 
ducing its cost would allow for more extensive 
research on its physiological and therapeutic 
qualities. 
By making a pharmaceutical available, genet- 
ic engineering can have two types of impacts. 
First, pharmaceuticals that already have med- 
ical promise will be available for testing. For ex- 
ample, interferon can be tested for its efficacy 
in cancer and viral therapy, and human growth 
hormone can be evaluated for its ability to heal 
wounds. For these medical conditions, the in- 
direct, societal impact of applied genetics could 
be widespread. 
Second, other pharmacologically active sub- 
stances that have no present use will be avail- 
able in sufficient quantities and at a low enough 
cost to enable researchers to explore their possi- 
bilities, thus creating the potential for totally 
new therapies. Genetic technologies can make 
available for example, cell regulatory proteins, a 
class of molecules that control gene activity and 
that is found in only minute quantities in the 
body. The cytokines and lymphokines typify the 
countless rare molecules involved in regulation, 
communication, and defense of the body to 
maintain health. Now, for the first time, genetic 
technologies make it possible to recognize, iso- 
late, characterize, and produce these proteins. 
The potential importance of this class of phar- 
maceuticals— the new cell regulatory mole- 
