CLINICAL TRIALS

BY MELINDA VOSS

 

Fetal cell implants improve parkinson's patients, doctors say. So ran the promising headline in the Los Angeles Times over Marlene Cimons's February 1 story on the results of a controversial experiment involving patients with Parkinson's disease. The piece, which was based on a study about to be published in the March issue of the New England Journal of Medicine, revealed that after receiving the cells, patients could hold a knife and fork, button their own clothes, and reduce their medication or eliminate it altogether. Reporting on that same NEJM study, Gina Kolata's page-one article in the March 8 New York Times told an entirely different story: parkinson's research is set back by failure of fetal cell implants.

Further: Cimons reported that the experiment was so successful that fourteen of the twenty people in the control group decided to have the actual surgery; Kolata wrote that the experiment was so dreadful that six people chose not to have it. Cimons said that only 15 percent of the people experienced bad side effects; Kolata said that because of the severity of those side effects some researchers had concluded that the experiment should not be done again on humans.

What gives? For one thing, there were sharp differences between the researchers involved in the study: Cimons focused on the lead author, the University of Colorado neurologist Curt Freed, who believed that the experiment offered hope of long-term benefits; Kolata buried that assessment deep in the story, giving prominent play instead to a researcher, Dr. Paul E. Greene, who described patients with disastrous side effects in graphic detail. In fact, the study had produced mixed results; although researchers had used various measures to assess patients, each newspaper highlighted the finding supporting its lead and downplayed or didn't mention the other outcomes.

Explaining her approach, Kolata says: "I'm the only person I know of who deliberately sought out doctors who had evaluated the patients. That made a huge difference in the kind of information I got. I didn't go into this thing thinking I would trash the study."

She also viewed Freed's assessment -- that the surgery offered hope -- skeptically. "Curt Freed sells that treatment and he's been selling it all along," she says. "There are a lot of ethical questions about the sale of a treatment being tested." As a result, Kolata described only a single positive finding -- the improvement of transplant recipients under age sixty -- as "one glimmer of hope."

By contrast, Cimons focused on the positive outcomes but did not mention measures that showed no benefit. Low in the story, she noted that 15 percent of the patients had developed excessive movements.

Cimons says she based her story on an interview with Freed and an abstract. She chose not to wait until the study was published because of the policy debate swirling around fetal cell and stem cell research. "I was trying to be competitive," she says. She had worked with Freed over the years, she says, and had no reason to doubt his interpretation of the findings. Moreover, Cimons says the clinical findings impressed her.

So, what can one conclude from this mishmash?

While the Los Angeles Times story may have been overly enthusiastic and The New York Times piece may have been overly negative, neither story noted important caveats that would have helped readers better understand the study's significance. Those caveats (some of which, according to Cimons, were deleted by editors from her original copy) apply as well to many other stories on medical research:

* Results from one trial, particularly the first controlled experiment, should not determine the fate of a treatment. (The New England Journal of Medicine made this point in an editorial released with the study. The Rocky Mountain News and Science magazine took note.)

* Initial experimental treatments often have disastrous results. (As The Times of London noted in its report on the study, "Every surgical operation is built on the broken bodies of those first in the queue to experience it. Well-established therapies, such as bone marrow transmission, started by killing every patient given them.")

* It usually takes years before experimental treatments become standard therapy. (National Public Radio quoted a researcher unconnected with the study as saying: "To expect success right off the bat is just absurd, and it will take a number of decades to take a therapy like this and turn it from a preliminary result into a successful and reproducible therapy.")

The London newspaper also observed that because today's medical research is conducted much more publicly than previously, pressures for recognition propel advances prematurely into the public consciousness. Wise journalists will take those pressures into account.
 
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Melinda Voss is executive director of the Association for Health Care Journalists and a journalism teacher at the University of Minnesota. She was a staff writer at The Des Moines Register for twenty-six years.