----- Original Message -----

From: <Nathaniel.Lim@n...>
To: <cancercure@y...>
Sent: Friday, April 27, 2001 8:21 AM
Subject: [cancercure] Key Breast Cancer Study Was a Fraud


> Key Breast Cancer Study Was a Fraud
>
>
> By THOMAS H. MAUGH II and ROSIE MESTEL, LA Times Medical Writers
> April 27,2001
>
>
> A key study pointing to the effectiveness of high-dose
> chemotherapy and bone marrow transplants in treating metastatic
> breast cancer was based on faked data, cancer experts said Thursday.
>
> The American Society of Clinical Oncology announced that an
> unscrupulous South African researcher, Dr. Werner Bezwoda, has led
> thousands of women with breast cancer to undergo expensive,
> debilitating and often fatal bone marrow transplants. His data were
> fraudulent, suggesting the controversial procedure was more
effective
> than it actually is, the society concluded.
>
> "Bezwoda . . . duped us all," Dr. Larry Norton, the
> organization's president-elect, said at a news conference.
>
> The new revelations do not mean that bone marrow transplants
are
> worthless, the oncology society said, only that they have not yet
> been proven effective. Several large clinical trials are underway to
> determine precisely how beneficial they are, and the society
> reiterated its position that women should undergo the procedure only
> if they are enrolled in a clinical trial.
>
> The oncology society also urged insurance companies to help pay
> for ongoing clinical trials, but concluded that the companies had no
> responsibility to pay for bone marrow transplants performed outside
> those trials.
>
> Bezwoda was fired from his post at the University of
> Witwatersrand in Johannesburg in 1999 after revelations that he had
> faked data in a preliminary report of another study on the use of
> high-dose chemotherapy and bone marrow transplants in patients where
> the malignancy had spread to lymph nodes.
>
> On Thursday, the oncology society said that an audit of a 1995
> paper by Bezwoda showed that it also was fraudulent and took the
> unprecedented step of withdrawing it.
>
> A specially convened team of experts sent to Johannesburg to
> audit his 1995 research concluded that there was no scientific basis
> for Bezwoda's very positive findings.
>
> The 1995 study had concluded that women with metastatic breast
> cancer who received high-dose chemotherapy followed by a bone marrow
> transplant had a 95% response rate, compared to only 53% among women
> who received conventional treatment. That finding was a linchpin in
> the ensuing wave of support for the treatment, Norton said, and
> helped entice many women into undergoing the treatment.
>
> "This is a stunning betrayal of public trust," said Dr.
Lawrence
> H. Einhorn, the oncology society's president.
>
> At least 30,000 American women have undergone the procedure at
> an average cost of about $100,000. In the initial studies, at least,
> 10% to 20% of the women died as a direct result of the treatment. It
> has been used less commonly, however, since the initial reports of
> the fraud that led to Bezwoda's firing.
>
> Insurance companies' responsibility to pay for bone marrow
> transplants has been a great source of controversy and litigation.
> Several women have received large jury awards because their insurers
> would not pay. And as many as 10 states have mandated that companies
> pay for the procedure.
>
> The companies, in turn, have said that the procedure is
> experimental and that its reputed benefits have not been proved. The
> oncology society's statement seemingly validates that position.
>
> The American Cancer Society agrees. "There is no clear proof
> that high-dose chemotherapy followed by a bone marrow transplant
> gives a sufficiently improved outcome to warrant insurance
companies'
> reimbursing for it," said Dr. Harmon Eyre, the cancer society's
> medical director.
>
> Interest in high-dose chemotherapy was already strong when
> Bezwoda published his 1995 paper. The idea was to use very high
doses
> of anti-cancer drugs to kill breast cancer cells. These doses also
> kill bone marrow, however, so the patient's immune system must be
> rescued with a bone marrow transplant.
>
> Bezwoda's report, however, was purportedly the first randomized
> trial to test the effectiveness of the therapy and find a benefit.
>
> "Although it was a trial of only 90 patients, its influence was
> greatly magnified by the intense debate ongoing in the United States
> about the value of high-dose chemotherapy for breast cancer," the
> oncology society's report said.
>
> After the scandal about Bezwoda's 1999 report, the University
of
> Witwatersrand invited a team led by Dr. Raymond B. Weiss of
> Georgetown University to examine Bezwoda's records. It
> uncovered "substantial evidence" of scientific misconduct.
>
> Among its findings:
>
> * The study protocol--or plan--was written nine years after the
> study actually began.
>
> * There were at least three treatment-related deaths among
those
> receiving high-dose chemotherapy, although the 1995 report said
there
> were none.
>
> * There were no records at all for 29 of the 90 patients.
>
> * There were insufficient records for many other patients, and
> some women were treated with drugs and regimens not consistent with
> the published information.
>
> * There were untrue statements in eight other publications by
> Bezwoda.
>
> "It's really a terrible story," said Dr. Stephen Forman, of the
> City of Hope National Medical Center in Duarte. "You trust
physicians
> to do the right thing, and this was obviously an example where--for
> reasons only he knows--he not only misled other physicians but, more
> importantly, misled a lot of women."
>
> Forman and Dr. John Glaspy of UCLA's Jonsson Comprehensive
> Cancer Center agree that the appropriate place for women getting
high-
> dose chemotherapy for their breast cancer is, for now, in clinical
> trials. But what do you do, asks Glaspy, when a patient with a
cancer
> that is likely to kill her wants treatment--but does not want to
take
> part in a clinical trial?
>
> That question haunts physicians on the front lines. "It's
always
> a little easier for the generals behind the battlefield with the map
> to say 'go left,' or 'go right,' " he said. "It's a different issue
> for the guys with the rifles in the trenches."
>
>
> --- -------------------------------------------------
> The report and associated material are available at the
oncology
> society's Web site: www.asco.org.
>
>