Altman, Lawrence K. "Secrecy Is Hurting Medical Research, a U.S. Official Says," New York

 

Altman, Lawrence K. "Secrecy Is Hurting Medical Research, a U.S. Official Says," New York
Times, 10 February 1996, p. 11.

WASHINGTON, Feb. 9 - In recent rears, going against a long tradition if openness in science,
many researchers have accepted secrecy as a common working practice. This change, a leading
Government official said in a medical journal this week, is impairing progress in cancer research
and other fields.

The official, Dr. Steven A. Rosenberg, chief surgeon and a leading investigator at the National
Cancer Institute, said that some participants in clinical trials of experimental anti-cancer drugs
could be harmed by the secrecy.

The reason, Dr. Rosenberg said, is that implicit in the demand for secrecy is the desire of some
companies that competitors use the wrong amounts of a drug under study. If too little or too
much drug is used in experimental trials, the treatment may be ineffective or produce serious
adverse effects. In either case, a patient could suffer or die.

The secrecy surrounding the research arises from agreements that many scientists sign with drug
and biotechnology companies when they use products from the companies, of like drugs or
chemicals, in their experiments. The terms of the agreements vary, but they can require of
scientists to keep confidential for a decade details and findings of experiments, including those
that might be of immediate benefit to patients.

Dr. Rosenberg cited four examples in his paper in The New England Journal of Medicine and he
added others in an interview. But he declined to name any of the people or companies involved
because he said he was attacking a widespread practice, not individuals.

The trend toward secrecy began several years ago. It has grown, Dr. Rosenberg said, as
competition for Federal scientific grants has increased and more scientists have come to rely on
grants or contracts from private companies that are investing in biomedical research.

Dr. Rosenberg, who achieved prominence when he participated in President Ronald Reagan's
colon cancer operation in 1985, said in the interview that he was calling for more open
discussion of the problem in universities, hospitals and meetings. "A lot of people don't want to
discuss it because it is a source of embarrassment," he said.

Companies demand secrecy or confidentiality agreements in research involving their chemicals
or drugs, known as reagents, because control of information from the results provides a
competitive edge, Dr. Rosenberg said.

He wrote, "The complex legal arrangements that are often required prior to the sharing of
reagents significantly impede if not prevent scientists from acquiring the materials needed to
facilitate their work." The problems are occurring more often, he said.

In one case, he cited a meeting of cancer specialists and researchers to discuss experimental
human cancer vaccines at the National Instiutes of Health, the Federal agency in Bethesda, Md.
An organizer stipuated that all new information presented at the meeting be kept confilential to
encourage a free and open exchange of information.

Another example Dr. Rosenberg gave involved a scientist who reported data describing a new
molecule hat might be useful in cancer treatnent. But the scientist refused to dentify the molecule
because his paper had not been accepted for publication in a journal.

Another example involved a biotechnology company that had developed a promising new
anti-cancer Igent and had just completed studies to determine the safety of different mounts of
the experimental agent.

The company said it would supply he agent to Dr. Rosenberg's team or studies in humans at the
National Cancer Institute. But the company refused to disclose critical findings about the dosage
and adverse effects in the preliminary animal research unless Dr. Rosenberg's team kept he
information confidential.

Dr. Rosenberg said in the intervriew that he refused to sign but that he "eventually got the
information rom another researcher who was not willing to keep the secret."

In a fourth example Dr. Rosenberg said he refused to sign an agreement to keep confidential any
information about studies of a new retgent for least 10 years.

A similar problem arose at a meeting last week on the AIDS virus, which was partly sponsored
by the National Institutes of Health and the Federal Centers for Disease Control and Prevention.
A feature of most scientific meetings is the written reports about findings that scientists post on
wallboards.

Participants read the posters as they walk through the rooms. Most such posters are based on
research paid for by the Government. The participants' registration fee of tbout $350 was also
usually paid for by Government grants, or it was tax ieductible.

Meeting organizers prohibited hotographs of the posters, in part to limit dissemination of the
information. Yet participants were free to write as much information as they vanted from the
posters. The reasons given for this ranged from protecting copyrights to competition between
companies.