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Most people associate the name Frankenstein with the classic movie monster first made famous by Boris Karloff. Ultimately inspiring some 82 feature films, 11 made for television movies and four television series, Mary Shelly’s gothic tale created one of the most enduring images in literature. But her book “Frankenstein, or the Modern Prometheus” was far more than a mere horror story. It was intended as a cautionary tale, warning about the dangers of technology and the temptation to lose sight of our humanity in its pursuit Indeed, in her last revision of the book, published in 1831, Shelly wrote

“ … for supremely frightful would be the effect of any human endeavour to mock the stupendous mechanism of the Creator of the world.”

It is ironic that the central character of the book Shelly wrote to convey her warning was a research physician – Dr. Victor Frankenstein – because contemporary medical research seems to have fallen victim to the same sort of tunnel vision and arrogance that caused her protagonist’s downfall. More and more, the well being of patients is being ignored by medical researchers in a mindless pursuit of power, prestige and profits. The result is, as Mary Shelly suggested, frightful. Worse, to a large degree, the excesses of medical research are being financed by the taxpayers who sometimes become its casualties.

Indeed, today there are over 4,000 federally funded research institutions in the United States. They are conducting an estimated 80,000 clinical trials with some 20 million participants! Federal funding for medical research in 2002 will total almost $23.9 billion. Next year it is slated to increase to $27.3 billion! While the outlays for research are enormous, the funding of oversight to assure that human research subjects are not endangered or abused is minimal.

Until last year, the federal Office for Human Research Protections (OHRP) had just two full-time investigators. Although its funding was been tripled this year, even with the increase, the OHRP budget is only $5 million. As a result, the agency only has about 40 employees to review all 80,000 ongoing clinical trials. The FDA, which shares some of the responsibility for overseeing clinical trials does a little better, but still only manages to make site visits to about 10% of the Institutional Review Boards (IRBs) that approve medical research projects at federally funded institutions.

Even this scant oversight, however, has turned up serious problems.

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