Fw: Retraction ... Breast Cancer Study Based on Bogus Research ~ 2 versions

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From: " Ilena Rose " <ilena@...>

Sent: Friday, April 27, 2001 2:13 AM

Subject: Retraction ... Breast Cancer Study Based on Bogus Research ~ 2

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http://abcnews.go.com/sections/living/DailyNews/breastcancer010426.html

Retraction

Breast Cancer Study Based on Bogus Research

By Adler

April 26 Fraudulent data have forced the largest U.S. organization of

cancer experts to retract a breast cancer study that influenced cancer

treatment throughout the world, and led to a stream of other research

trying to duplicate or add to the findings.

" This study made an enormous financial impact on the practice of treating

breast cancer in this country, said Dr. Weiss, clinical professor

of medicine at town University in Washington. He performed an audit

of the original study that is being published along with the retraction.

" Insurance companies were significantly influenced by this paper and began

paying for [this treatment] whereas they had been denying coverage for

this procedure previously, Weiss said.

Published in 1995 by the Journal of Clinical Oncology, the official

journal of the American Society of Clinical Oncology, the study supported

the use of high-dose chemotherapy followed by a bone marrow transplant for

advanced breast cancer.

The medical journal retracted the study today, the first such move in its

18-year history.

In the original study, Dr. Werner Bezwoda, the top chemotherapy expert in

Johannesburg, South Africa, reported that he had found that high-dose

chemotherapy and the subsequent bone marrow treatment prolonged survival,

compared to conventional chemotherapy and bone marrow treatment, for

metastatic breast cancer or advanced cancer that has spread from the

breast to other parts of the body.

But an official audit of the study, commissioned by the University of

Wittswatersrand, where Bezwoda was on staff until his firing last year,

and the Medical Research Council of South Africa, revealed phony data

regarding the safety and efficacy of such treatment.

Records Not Found

A search of more than 15,000 sets of medical records available from two

Johannesburg hospitals was performed to locate records for the reported 90

patients in the study. Records for only 61 of the 90 patients, many of

them black South African women, could be found.

Of these 61, only 27 had sufficient records to verify eligibility, and of

those 27, 18 did not meet one or more eligibility criteria. Only 25

patients appeared to have received their assigned therapy associated with

their enrollment date.

" Women, both in the United States and elsewhere, have a right to be

furious, said Dr. Barron H. Lerner, associate professor of medicine and

public health at Columbia University in New York and the author of The

Breast Cancer Wars: Hope, Fear, and the Pursuit of a Cure in

Twentieth-Century America.

Deaths Blamed on Treatment

There were at least three possible treatment-related deaths among patients

receiving high-dose therapy. Only seven of the 61 patients survived and

some of them may not have received the much-heralded therapy at all. In

addition, two statisticians identified errors in both the data and

analysis in the original article itself.

No patient signed a consent form, and there is little evidence of

randomization of the patients.Randomization is a process to prevent bias

in research so healthier patients, for example, don't get the new

treatment and thus give it a better result.

Bezwoda admitted at a university hearing last year that he wrote the

protocol for this 1995 study nine years after the study was completed. His

admission apparently was made only after it was clear he was to be

audited.

At the time, Bezwoda's published results were the first trial ever to

compare high-dose chemotherapy to some form of less intensive

chemotherapy.

Scientists had hoped to test this therapy in larger, randomized controlled

trials before endorsing it, but they were thwarted by desperate breast

cancer patients who demanded the therapy. Breast cancer patients feared

entering trials because they could not be guaranteed the high-dose

therapy.

Work Was Heavily Quoted

Prior to this revelation, Bezwoda's work had been quoted extensively in

both scientific and lay publications, and as late as 1999, continually

used by physicians in the decision-making process. A 2001 search found

this paper referenced 354 times in other scientific publications.

With the data from these two South African trials now being discredited,

and the results from 11 previous randomized studies showing little

benefit, it is unclear whether there is a role for high-dose chemotherapy

in the treatment of breast cancer patients.

Currently, there are now eight remaining studies, yet only two have

randomized more than 200 patients and show a relapse-free survival after

high-dose chemotherapy.

The retraction of the 1995 study follows an investigation of another study

high dose chemotherapy by Bezwoda, which too was found to be fraudulent.

ABCNEWS Medical Editor Dr. and 20/20 producer Callie

Crossley contributed to this report.

~~~~~~

http://dailynews./h/nm/20010426/sc/health_cancer_fraud_dc_3.html

Journal Retracts Breast Cancer Study

By Beech

WASHINGTON (Reuters) - A prestigious U.S. medical journal said on Thursday

it had taken the unprecedented step of retracting a study on breast cancer

after an investigation found the South African researcher had falsified

results.

The Journal of Clinical Oncology said it retracted the once-promising 1995

study on women with advanced breast cancer after an audit found that South

African researcher Dr. Werner Bezwoda faked much of the data.

``Bezwoda ... duped us all,'' Dr. Larry Norton, president-elect of the

American Society of Clinical Oncology (news - web sites), said in a

telephone news conference. The group publishes the Journal of Clinical

Oncology.

The journal said it was retracting the article to make sure it was no

longer referenced or cited as legitimate research in future medical

literature.

It was the first time in the journal's 18-year history it had retracted an

article, the group said.

The discredited study found that women whose cancer had spread beyond

their breasts benefited significantly from having high doses of

chemotherapy followed by bone marrow transplants.

``Many oncologists accepted the results as valid,'' the audit said, and it

``caused the number of patients treated with high-dose chemotherapy to

increase.''

ASCO said in a statement women should only receive high-dose chemotherapy

followed by a bone marrow transplant for metastatic breast cancer while in

a high-quality clinical trial. The doctor's group initiated the

investigation after a similar study by Bezwoda in 1999 was discredited.

Bezwoda admitted scientific fraud in the 1999 study and was dismissed by

Johannesburg's University of the Witwatersrand and is now in private

practice, said Dr. Weiss, a professor at town University who

headed the investigation team.

The 1995 study reported that women who received high-dose chemotherapy had

a response rate of 95 percent, compared to 53 percent of women who

received conventional dose treatment.

The auditors were able to locate records on only 61 of the 90 patients in

the clinical trial and many of those did not receive the treatment

described in the published study, Weiss said. The Bezwoda study said no

patients died as a result of their treatment during the study, but

auditors said they found at least three possible treatment-related deaths.

Bezwoda also erroneously said he received approval from his university's

review board and he failed to obtain signed consent forms from patients,

Weiss said.

He said the audit also uncovered false statements in eight other

publications written by Bezwoda.

In May 2000 ASCO established a task force to oversee clinical research,

but Norton said that ``fraud cannot be totally eliminated.''