After Dorothea Lange’s photo Migrant Mother appeared in the San Francisco News in 1936, the US government allocated $200,000 to establish a migrant camp for homeless workers. After Upton Sinclair’s The Jungle, a novel about conditions in the meat-packing industry, was published in 1906, Congress passed the Pure Food and Drug Act and the Meat Inspection Act the same year. Today, Michael Crichton’s latest blockbuster, Next, off ers up a fictional look at the life sciences industry, complete with a seven-page appendix of policy recommendations.

Crichton, a Harvard-trained doctor, may set scientists’ teeth on edge with his mixture of insider detail and outlandish scenarios, but his market penetration - best-selling novels (often made into very big movies such as Jurassic Park) - is surely a force to be reckoned with. Can public perception, fueled by such commercial fantasies, spur policy changes that will affect the biotech industry? Reviewing Next in the Wall Street Journal, Matt Ridley, author of The Red Queen and Genome, expressed support for Crichton’s advice to policymakers to ban gene patents and to establish clear guidelines for patients’ control over research on their tissues samples, but to avoid bans on research (such as embryonic stem cell research). “These suggestions are good ones,” wrote Ridley. “They may chafe some biotech companies, but they are essentially pro-market and pro-research.” And members of Congress seemed to agree. In February of this year, two congressmen, Xavier Becerra, a Democrat from California, and Dave Weldon, a Republican from Florida, introduced the Genomic Research and Accessibility Act to ban the practice of patenting genes found in nature.

Whether or not pop fiction can lead to policy change, the real stories underlying the fiction - the kinds of stories being widely covered by journalists - have led the public to eye researchers with some suspicion. In the actual incident that provided the inspiration for Next, a university-based doctor led his patient to believe he was still ill. He had the patient returning for follow-up visits over a period of years, while the doctor harvested blood, sperm, and bone marrow and sold a cell line made from the patient’s tissue. The doctor received money and stock options. When the patient sued him, the California Supreme Court held that the patient could not have a property interest in his own tissue, but the doctor could. However, the court did protect the patient in another way: Concerned about the divided loyalties of doctors who have ties to biotech companies, the court ruled that patients have a right of informed consent to know whether their physicians have a personal interest - financial or purely intellectual - that might affect their judgment. “A physician who adds his own research interest to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient,” the court said.

This issue is now being revisited by the Eighth Circuit Court of Appeals, in Washington University v. Catalona. Two decades ago, William Catalona, an internationally known cancer surgeon in St. Louis, Missouri, began asking his patients if they were willing to let him use for research purposes the tissue he removed from them. Over the years, he amassed more than 30,000 tissue samples and a wealth of data. In 1986, Catalona developed a simple blood test to screen for prostate cancer, the PSA, or prostate specific antigen test, and he undertook the research necessary to obtain approval by the US Food and Drug Administration. About 75 percent of American men over age 50 have had a PSA test for prostate cancer. Catalona’s current work focuses on genetic markers for prostate cancer.

Catalona’s employer, Washington University, had other ideas about the best use of the tissue samples. The university began to see the samples not solely as the means by which human subjects participated in prostate cancer research, but as a capital resource for the university. Many other medical centers had begun to enhance their bottom line by selling the raw material of patients’ pathology samples and blood tests to biotech companies for use in the companies’ research.

The issue came to a head when Catalona was asked to give a lecture at the annual meeting of the American Urological Association. He decided to compare all the predictive tests for prostate cancer through a blind study in which tissue samples from patients known to have prostate cancer and from men without prostate cancer were assayed using each of the existing tests. As part of the study, he planned to send samples to Beckman Coulter, which had acquired Hybritech, a life sciences and diagnostic company that had created a new assay.

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