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Bezwoda: Evidence of Fabrication in Original Article

Memorial Sloan-Kettering Cancer Center New York, NY
Memorial Sloan-Kettering Cancer Center New York, NY

To the Editor:The recent publication of the clinical trial by Stadtmauer et al¹ showing no benefit to high-dose chemotherapy in metastatic breast cancer led us to re-examine the earlier positive report of Bezwoda et al,² which, notoriously, has now been withdrawn.^3,4

It is apparent that although Bezwoda claims merely that he "misrepresented" his results, he undertook detailed fabrication. He clearly describes the treatment regimen/schedule for both the experimental and comparison groups in Table 1, and in Table 2 he gives precise figures for the amount of various agents said to have been received by patients correct to 1100 milligrams per square meter per week. Yet his audited reports revealed a completely different treatment regimen for the comparison group.

Furthermore, there may be evidence in the original publication that Bezwoda’s data were falsified, or at the very least, suspicious. The number of complete responses (CR) in control patients with soft tissue metastases is given as four in Table 6, whereas the total number of CRs in controls is given in Table 5 as only two. The number of CRs in experimental subjects with soft tissue metastases is similarly greater than the total number of CRs in this group.

Bezwoda et al² state that 49 patients had "two or more [metastatic] sites" and 41 patients had "more than two sites" (p 2485, column 1). Given that there are a total of 90 patients in the trial, all patients must have had at least two metastatic sites. Yet Table 4 gives the average number of metastatic sites per patient by group as 1.8 and 1.6.

Bezwoda et al also report the P value from the ² comparing the number of complete responses as "P < .01." Its correct value is P = 8 x 10^-7, which is implausibly small for a trial of this size.

REFERENCES

1. Stadtmauer EA, O’Neill A, Goldstein LJ, et al: Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. N Engl J Med 342:1069-1076, 2000[Abstract/Free Full Text]

2. Bezwoda WR, Seymour L, Dansey RD: High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: A randomized trial. J Clin Oncol 13:2483-2489, 1995[Abstract]

3. Grady D: Breast cancer researcher admits falsifying data. New York Times, February 5, 2000, p 9

4. Wits fires cancer researcher: Press release of the University of the Witwatersrand Medical School, Johannesburg, South Africa, March 10, 2000. Http://www.wits.ac.za/depts/wcs/media

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