In Robert Louis Stevenson's day, body snatchers dug up corpses in the dead of night. Modern body snatchers take tissue from the living, and they do it in daylight. This week in St. Louis, the Eighth Circuit heard an appeal in the case of William Catalona, a famous prostate-cancer surgeon and the man who developed the PSA test to screen for prostate cancer. Over the years Dr. Catalona collected thousands of tissue samples from his patients to help him research this dreaded disease. The tissues were all from individuals who had family histories of prostate cancer, indicating a genetic cause. When Dr. Catalona left Washington University for Northwestern, he wanted to take these tissues with him. Six thousand patients notified the university that they wished their tissues to go with him.
Ignoring the requests of patients, Washington University claimed the tissue collection as its own, and sued Dr. Catalona. In March of this year the district court ruled the collection belonged to the university. Judge Stephen Limbaugh found that the patients had given their tissues to WU as a gift, and therefore the university owned the tissues outright.
The decision surprised many. As a recipient of federal funds, Washington University was required to follow the federal regulations on informed consent for tissues received from patients. This included acknowledging in writing that the tissues would be used only for prostate research, that patients had the right to withdraw from the study at any time, and to have their tissue samples destroyed upon request.
However, Judge Limbaugh ruled that patients had no such rights. In his view, the right to withdraw merely meant the right not to contribute more tissues. The right to have the tissues destroyed meant only that the samples would be used anonymously. The guarantee that tissues would only be used for prostate research could be ignored, and WU was free to use the tissues for any purpose whatever.
This contradicted prior tissue cases in which courts have ruled that written documents do indeed afford patients ongoing rights to tissues after they had left their bodies. The fact that Judge Limbaugh's decision also abrogated federal guidelines left many observers uneasy. In addition there was the awkward legal matter that any donation with these restrictions could not be termed a gift. And the ethical issue was plain. Patients had donated their tissues with a written promise of control. Now that written promise was deemed worthless by a judge.
Research universities around the country greeted the ruling with unseemly enthusiasm, and hastily joined forces to prevent a successful legal appeal. Although the National Institutes of Health and other federal centers conduct research under the federal guidelines, universities now claim that these rules are impossibly onerous and impede research. Unless researchers are allowed to do whatever they want, they warn patients, the flow of life-saving miracles will dry up. This kind of high-handed attitude toward patients went out of style in the 1970s, after the first waves of malpractice litigation brought a bruising new reality to medicine.
Similarly harsh legal actions are likely to follow in the aftermath of the Catalona case. Patients have serious and legitimate interests -- practical, legal and religious -- in their tissues and how they are used in research. If the documents signed for WU are not sufficient to stand up in court, universities will soon face more restrictive language, this time drawn up by patients' rights groups. Major donors may be pressured to bypass universities that refuse to follow federal guidelines; alumni groups may be mobilized to protest university policies. Such tactics are known to be waiting in the wings, pending the Catalona appeal.
For universities, perhaps the most damaging outcome may be the loss of confidence that patients feel in major centers of research and healing. There was a time when physicians were ranked just below Supreme Court justices. Those days are long gone. Our university hospitals and major medical centers still command respect. But the perception that they are businesses like any other is growing stronger every day. Except, they're not -- they're non-profits, exempt from most of the rules and disclosures that are required of American businesses. In short, caveat patiens, keep copies of everything you sign, bring a lawyer to every medical appointment, and always, always watch your back.
This decision is very wrong and in the wrong run hurt biomedical research. If the patients do not have a right to withdraw consent and participation, then less will likely participate.
No comments:
Post a Comment