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CHAPTER 14: Management in the 21st Century
VIDEO TITLE:
“Raven Biotechnologies: If It Isn’t Ethical, It Isn’t
Right”
RUNNING TIME: 11:00
RELEVANT CONCEPTS:
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Ethical dilemmas
Codes of ethics
Life saving drugs – risk of side effects
Responsibility of companies to society
Role of profit in drug development
Acceptable versus unacceptable risks when testing drugs
OVERVIEW:
Discussions of changing approaches to drug research and the ethics involved in those
changes are highlighted in this video. Works on multiple levels with the content for this chapter.
The pharmaceutical industry is experiencing a resurgence, fueled by advances in biotechnology.
Drugs can now be tailored to target specific diseases with significantly reduced side effects. This
boom began with the genetic engineering pioneered at Genentech in the late 1970s.
Yet, despite these advances, the success rate for new drugs is less than 10%. Drugs that
show promise in initial tests may prove to be unsafe, ineffective, or uneconomical. Drug company
research divisions walk a fine line—building upon discoveries and developments in the field
while not violating the rights of patent holders. The stakes are extremely high. A successful drug
can earn hundreds of millions of dollars. With this much at stake, companies must be constantly
aware of the potential for unethical behavior in pursuit of profit.
DISCUSSION QUESTIONS:
1.
Once a drug passes preliminary and toxicology testing, it must eventually be tested on
non-terminal human subjects. A standard industry practice is to pay physicians to conduct
trials and to pay test subjects for their participation. Do you believe research trials paid
for by the drug company can be objective? Why or why not?
2.
A drug company discovers that a drug it is testing is ineffective on the targeted disease.
However, in testing the researchers find that will treat a common disease in a developing
country. The profit potential is very low. What should the company do? Why?
3.
Could large pharmaceutical companies, such as Abbot Labs, Pfizer, or Merck, adopt
Raven’s ethical framework? Why or why not?
SUGGESTED ANSWERS TO DISCUSSION QUESTIONS:
1.
Once a drug passes preliminary and toxicology testing, it must eventually be tested on
non-terminal human subjects. A standard industry practice is to pay physicians to
conduct trials and to pay test subjects for their participation. Do you believe research
trials paid for by the drug company can be objective? Why or why not?
This is an ongoing area of debate. If physicians are paid by the company to test a product,
there can be a bias for positive results. In an ideal world, drug testing would be conducted
by an impartial entity. In the real world, however, new drugs would never come to market
without paid testing. The Food and Drug Administration relies on research presented by
the drug developer. While there may be a potential conflict of interest, only the
pharmaceutical company itself has the deep pockets and the incentive to conduct such
testing.
2.
A drug company discovers that a drug it is testing is ineffective on the targeted disease.
However, in testing the researchers find that will treat a common disease in a developing
country. The profit potential is very low. What should the company do? Why?
This scenario is based on the classic case of Merck Pharmaceutical and ivermectin, its
break-through treatment for river blindness. Merck’s research in veterinary drugs led to a
treatment for the primary cause of blindness in sub-Saharan Africa. But even at heavily
discounted prices, no government could afford the treatment. Merck eventually decided
to provide the drug at no cost to those affected. The company reaped an enormous public
relations bonanza that helped establish its reputation for social responsibility.
In 2003, however, the same company was forced with withdraw its blockbuster pain
reliever Vioxx when patients began developing life-threatening cardiac problems.
(BONUS CASE 14-2: “Merck and Ethics” on pages 14.43-14.44 of the Instructor’s
Resource Manual also deals with Merck and ethics.) Interesting discussion topic.
3.
Could large pharmaceutical companies, such as Abbot Labs, Pfizer, or Merck, adopt
Raven’s ethical framework? Why or why not?
Raven’s ethical foundation is just that, its foundation. Jennie Mather created Raven
Laboratories with a specific mission, to develop biotechnological drugs without
compromising ethics, “to serve a greater good by breaking the old rules.” Every decision
the company made was built upon that framework. Large pharmaceutical corporations
can operate ethically, and do. Is it easier for a small company to operate ethically?
Maybe. Small companies have fewer stockholders and face less intense scrutiny, but
small doesn’t equal ethical, and large doesn’t equal greedy.