Chapter
FDA: public protector or corporate coach?
FDA approval and the failure of regulatory safeguards
The new antimiscarriage drug
The FDA approves DES for use in pregnancy
Prenatal use persists despite evidence of inefficacy
Plumper chickens, bulkier beef
The FDA - reluctant regulator
Another use for DES: from pregnancy enhancer to pregnancy terminator
The cancer link: local initiative, FDA inertia
Prenatal DES: the failure to inform
Getting DES out of meat: winning the battle and losing the war
The rise and fall of the DES morning-after pill
The history of the artificial heart
The NIH artificial heart program
The redirection of the NIH program
The breakaway of the Utah heart
The commercial ingredient
The Barney Clark experiment
5 The swine flu immunization program
More problems and mounting opposition
The impasse over liability
Immunization begins - finally
Guillain-Barre syndrome and the program's demise
6 Genetic engineering: science and social responsibility
The early years: scientists' fears
The controversy goes public
The breaking of consensus: the emergence of dissident scientists
Recombinant DNA goes to Congress
Taking it to the streets: recombinant DNA at the local level
Exit research controversy
NIH reform: form versus content
Biotechnology: R for the economy
Continuing controversies: hubris and humility
Part III Lessons, questions, and challenges
Varying perceptions of risks (or, The risk you see depends on where you sit)
The patient's right to informed consent
Informed consent and medical experimentation
Changing attitudes toward collective risks
Risk assessment: analysis and ideology
Beyond risks and benefits
8 Compensating the injuries of medical innovation
Injury compensation: goals and problems
DES lawsuits: who pays when drugs cause injuries?
A new view of medical risks
Breaking new legal ground
Liability for immunization injuries: lessons from the swine flu program
Injuries due to medical experimentation
New problems, new solutions
Broader manufacturer liability
Social insurance with liability funding
9 What is fair? Medical innovation and justice
What is "justice" in medical innovation?
Access to scarce resources: Are some more equal than others?
Access to the artificial heart
Resource allocation in an era of medical limits
Covert rationing, overt injustice
Private profit at public expense
10 The role of the public
The nature of public concerns
Reassessing risks and benefits
Soft issues and hard choices: broadening and humanizing biomedical policy
The impact of public efforts
Keys to public involvement and influence
Questions and arguments about public participation
11 What is possible? Toward medical progress in the public interest
Common pitfalls in decisionmaking
Present realities, future visions
Individual and collective risks
Compensation of injured victims
Allocation of health resources
The central dilemma: lack of public accountability
Making medicine more publicly accountable