Magazine article Science News

Breast Cancer Research on Trial; Congress Hears a Tale of False Data, Delays, and Doubts

Magazine article Science News

Breast Cancer Research on Trial; Congress Hears a Tale of False Data, Delays, and Doubts

Article excerpt

Congress hears a tale of false data, delays, and doubts

An uncharacteristic hush fell over the hearing room as 32-year-old Jill Lea Sigal described her fight with breast cancer: "The fear that arises from facing one's own mortality at my age can at times be paralyzing," she told members of Congress at a recent hearing.

Now, Sigal's dread of a deadly return of cancer is compounded by fear that she chose the wrong treatment for the disease.

Sigal told the House Subcommittee on Oversight and Investigations that she had received a diagnosis of breast cancer 6 months ago. At that time, her doctor told her about a landmark 1985 study that compared lumpectomy (excision of the tissue and a small amount of tissue surrounding it) to mastectomy (a more extensive procedure in which surgeons remove the entire breast and some of the lymph nodes). The study revealed that women in the early stages of breast cancer who opted for the breast-conservating lumpectomy plus radiation treatments lived just as long as those who underwent the more disfiguring procedure.

After consulting with her doctor, Sigal decided to undergo a lumpectomy. Last month, Sigal learned that the 1985 study contained fraudulent data.

"I thought I had made an informed decision," she told the panel. "Now I must wonder every day if I really have done everything to maximize my chances of survival."

At the hearing, designed to explore the federal government's response to this case of fraudulent breast cancer data, representatives of women's groups and government officials also testified in front of the standing-room-only crowds of lobbyists, scientists, and journalists. Rep. John D. Dingell (D-Mich.), chairman of the subcommittee, contends that key researchers and federal officials knew about the bad data for years yet failed to inform the public in a timely manner.

"The case before us is a vivid reminder of how poor the response of the scientific community can be and how serious the consequences may be when the scientific community and the federal government fall down on the job," Dingell says.

At stake: the public's trust not just in the lumpectomy study, but in several other important breast cancer trails as well (see sidebar). For example, this case has raised questions about the Breast Cancer Prevention Trial, a controversial study in which healthy women at high risk of developing breast cancer take the drug tamoxifen in hopes of staving off the disease (SN: 4/16/94, p.247).

The imbroglio began with Roger Poisson, a surgeon at St. Luc's Hospital in Montreal and one of the investigators in the National Surgical Adjuvant Breast and Bowell Project (NSABP). Poisson was one of about 5,000 physicians contributing data to NSABP, a multicenter U.S. and Canadian research group working on nearly two dozen cancer studies supported by funds from the National Institutes of Health.

In June 1990, staffers at the NSABP central office, located at the University of Pittsburgh, noticed in a routine review of data that Poisson's group had submitted two breast cancer reports that appeared identical except for the date of surgery. This oddity led NSABP to order a more extensive, on-site audit of the records at St. Luc's. The review, conducted in September 1990, revealed additional discrepancies in at least 20 cases.

NSABP Director Bernard Fisher and his chief statistician, Carol Redmond, traveled to Montreal in December 1990 to meet with Poisson and coinvestigator Sandra Legault-Poisson. Fisher and Redmond told the pair that the irregularities in recruiting patients must stop. They also informed Poisson that NSABP would conduct a more extensive audit of the St. Luc records.

But it wasn't until Feb. 12, 1991, 8 months after the initial finding of suspicious data, that Fisher alerted the National Cancer Institute (NCI) to the "irregularities" discovered at St. Luc's. …

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