TIME: Almanac 1993/TIME Almanac 1993.iso/time/020491/0204350.000

Text File | 1992-08-28 | 5.4 KB | 113 lines

                                                                                MEDICINE, Page 69

Delays That Can Cause Death


Debate grows over when to publicize lifesaving research findings

By ANASTASIA TOUFEXIS -- Reported by Dick Thompson/Washington


    Dr. Anne Willoughby had a dilemma. She is the director of
a study begun in 1988 to see if infusions of immunoglobulin
(IG) in children  infected with the AIDS virus could boost their
weak immune systems and help stave off illness. An independent
panel that had been monitoring the investigation informed
Willoughby early this month that children receiving monthly
doses of IG, a protein produced by the body's cells, were
faring significantly better than those given a placebo. The
youngsters had fewer bacterial infections and fewer
hospitalizations. News of the advance in treatment could have
enormous consequences for up to 20,000 children in the U.S. who
carry the virus and the 1,700 to 2,000 HIV-infected babies who
are born each year. But how and when should the information be
released?

    That question is at the heart of a growing debate among
scientists, 200 of whom gathered this month at the National
Institutes of Health in Bethesda, Md., to air the issue.
Traditionally, researchers have published their findings in
medical journals, like the New England Journal of Medicine or
the Journal of the American Medical Association. Supporters
insist that this approach helps ensure credibility by allowing
time to weed out sloppy science. Editors send submitted papers
to outside scientists for comment, a system known as peer
review. But the process can be lengthy. Between the time a paper
is first offered and its publication, months or even more than
a year can pass. Critics charge that such lapses can cause
critical delays in the application of new treatments and may
even cost patients their lives. They favor speedier release of
medical news, through mailed bulletins to physicians or general
press conferences.

    Defenders of the publish-first route maintain that the
peer-review system, introduced in England in 1665, is a crucial
quality-control mechanism. "It avoids mistakes," declares Dr.
Arnold Relman, editor of the N.E.J.M. "It minimizes the hype,
exaggeration and biases and prevents the dissemination of
premature and unwarranted conclusions. Short-circuiting that
process is not a good idea."

    Many doctors agree. They complain that patients sometimes
hear about developments through the press and come into medical
offices waving a news clipping and demanding the latest
treatment. Physicians say that without seeing a complete
scientific report, they have no way of assessing the
information or knowing whether it is appropriate for a
particular patient.

    Opponents, however, contend that major studies today receive
intense independent scrutiny while they are under way, and thus
the journal peer-review system may not be as necessary as
before. Embargoing medical news until publication, they say,
may actually put patients in greater jeopardy than allowing
information to be released quickly. Though journal editors
insist that the review process can be speeded up for urgent
papers, they concede that sometimes an important report has
gone unrecognized. For example, Yale University researchers sent
a paper to the N.E.J.M. in October 1989 noting that patients
with spinal-cord injuries who were treated with high doses of
steroids while in the emergency room had much better recoveries
than patients who did not receive the drugs. The impact of the
discovery is enormous: about 10,000 people a year suffer such
spinal-cord injuries. But the paper was not published until
seven months later.

    Moreover, some critics charge that medical editors' defense
of the status quo is aimed more at safeguarding journal profits
than at assuring the spread of accurate information. The
N.E.J.M. is notorious for refusing to publish papers if the
findings have already received publicity in the press. Editor
Relman defends the practice: "We share every publisher's desire
to be interesting and original. What's wrong with that?" What's
wrong is that the policy impedes the free flow of scientific
information by intimidating researchers into not talking about
their work before publication. Having a paper appear in the
N.E.J.M. can enhance chances of winning new grants or help push
a faculty member toward gaining tenure.

    Still, scientists increasingly appear to be finding it
difficult to justify withholding important information. Three
years ago, researchers from the National Cancer Institute
discovered that women with a certain type of breast cancer who
received aggressive drug therapy had less chance of having a
quick relapse than those who received standard treatment. Dr.
Vincent DeVita, then director of the NCI, decided not to wait
for publication. He issued a clinical alert. Says DeVita: "By
the time that article was published, 50,000 women could have
passed through that window of opportunity."

    For Willoughby too, the choice in the end proved simple.
After consultation with colleagues, officials at the NIH and
the Food and Drug Administration, a decision was made to
release the results of the study of immunoglobulin in children
-- at a press conference and in overnight letters sent to
physicians. Says Willoughby: "Once we were certain that the
results were sound, there really was no alternative."