Henry I. Miller attempts a Heimlich maneuver. Biotechnology-derived vaccines and therapeutics have featured prominently in the news during the past year. One such product is VaxGen s AIDS vaccine, which has entered an advanced phase of clinical testing. Others include the antiangiogenesis factors endostatin and angiostatin, which interrupt the blood supply to tumors and cure all manner of cancers in mice. But such behavior by journalists and investors ignores the realities of drug testing and regulation generally and the recent track record of biotech products in particular.
Drug development is lengthy and hugely expensive.
Following animal testing, the company then requests permission from the FDA to begin testing in humans. Assuming that the drug shows the desired effects and that there are no serious safety problems, clinical testing advances through three progressively larger and more complex phases in which data are accumulated on the product s safety and efficacy. During the 1980s, when the badly needed, second-generation, genetically engineered hepatitis B vaccine was developed, the FDA s decision about testing its efficacy was vexing. Large amounts of time and money were at stake. In the end, the FDA opted for the full clinical trials, rejecting even a middle course whereby seroconversion would be the primary measure of efficacy but a pilot study in Asia would confirm hepatitis prevention.