Heart Disease
Fibromyalgia
High Cholesterol Danger?
Toxic Metals
Free Radicals -- Primer
IV Chelation Therapy

Wrong Diet Causes Diabetes

Vibrant Life Home Web
Family Of Three Oral Chelation Formulas
The Wednesday Letter
The Hubbard Human Detoxification Program
Hopeless Diseases -- Invented to Sell Drugs
Wrong Relationship Cause of Disease

Brain Chemical Imbalance
Dr. Garry F. Gordon
Ultimate Resource On Chelation Therapy Home Page

Shopping Cart

Separate Search Page
or search below


Prevent Cancer

Oral Chelation Therapy
Other

Karl Loren's Policy On Psychiatric Drugs
Destruction Of American Education
Write To Karl Loren Table Of Contents

Journal Retracts Fraudulent South African Breast Cancer Study

Write To Karl Loren About This Page

Doctor
A study that influenced the use of a controversial treatment for women with advanced breast cancer has been retracted because it included bogus data. (PhotoDisc)
Retraction
Breast Cancer Study Based on Bogus Research


By Sarah Adler
ABCNEWS.com

 

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. Raymond Weiss, clinical professor of medicine at Georgetown 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. Timothy Johnson and 20/20 producer Callie Crossley contributed to this report.


 

 

Ethical, and Racial, Questions


The University of Wittswatersrand, where Bezwoda worked during his study, has decided not to contact his patients, many of them black South African women, with the new findings.

University officials would not say why when e-mailed by ABCNEWS.

Dr. Allen Herman, one of South Africa’s most prominent black doctors, disagrees with the decision.

“The university does have an ethical responsibility to contact Bezwoda’s former patients and/or family members. … Bezwoda [who is white] used mostly an inarticulate black patient population, from a black hospital in his research and assumed that their fingerprints served as informed consent and was appropriate enough — when in fact it was not,” Herman said.

Herman, a member of the board of the Medical Research Council of South Africa and dean of the National School of Public Health at the Medical University of Southern Africa, wants a revision of the ethical guidelines for clinical research in post-apartheid South Africa.

Bezwoda conducted his study in the final years of South Africa’s apartheid system of racial segregation.

“There is an inherent danger in researchers not adhering to basic ethical requirements in South Africa when the scientists do not come from the community in which they are serving,” Herman said.

 


Source

 

text onlyskip navigation
National Cancer Institute Cancer.gov  

Journal Retracts Fraudulent South African Breast Cancer Study
 

Posted: 04/26/2001

Related Pages:

Digest Page: High-Dose Chemotherapy for Breast Cancer
A collection of material about high dose chemotherapy with bone marrow transplant as a treatment for breast cancer.
Digest Page: Protecting Participants in Clinical Trials
A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.
Breast Cancer Home Page
NCI's gateway for information about breast cancer.
 
 
 

The Journal of Clinical Oncology (JCO) formally retracted a study it had published in 1995, after results of a full audit found unequivocal evidence of scientific misconduct and falsified data. The study, conducted by Werner Bezwoda, M.D., Ph.D. at the University of Witwatersrand in South Africa, claimed that women with metastatic breast cancer lived longer after being treated with high-dose chemotherapy and bone marrow transplant, as compared with women who received standard doses of chemotherapy.

These results, now shown to be "fake and completely inadmissable," according to an editorial in the June 1, 2001, issue of JCO, had led to the start of similar clinical trials around the world.

The retraction comes in the wake of controversy surrounding a presentation at the American Society of Clinical Oncology meeting in May 1999. At that conference, findings were presented from four separate clinical trials studying the use of high-dose chemotherapy followed by bone marrow cell transplants in women who had a type of breast cancer with a high risk of recurrence. Three studies found no evidence that the high-dose chemotherapy worked better. One study -- Bezwoda's -- showed that women did live longer when they received the intensive treatment.

However, a subsequent review of the 1999 data showed significant inconsistencies in the records and, at the request of the South African Medical Research Council and the University of Witwatersrand, a formal audit of the 1995 study was launched.

The formal audit, led by Raymond B. Weiss, M.D., a medical oncologist at Georgetown University in Washington, D.C, was released on the American Society of Clinical Oncology Web site on April 26, 2001. The report found problems not only with the 1995 study but with other research work conducted by Bezwoda. The auditors concluded that the Bezwoda's study does "not report verificable data, and nine other publications co-authored by [Bezwoda] contain at least one major untrue statement."

Larry Norton, M.D., of Memorial Sloan-Kettering Cancer Center in New York, who authored the JCO editorial, wrote that "auditing is a crucial addition to the scientific method in medicine, since attempts to replicate misreported regimens may result in patient harm." Such danger "raises the stakes as we consider how we can improve the process to make sure that this never happens again."

While "no procedure can totally protect against fraudulent statements and omissions," wrote Norton, the American Society of Clinical Oncology, which publishes JCO, "is committed to making the process as fail-safe as possible." The audit, "already a standard procedure in [National Cancer Institute]-sponsored cooperative group activities, should assume its proper, most-respected role in clinical trials everywhere....It is not a matter of medical methodology but one of medical ethics, which remains at the core of our being as clinical oncologists."

 
     

 


Special Pages On The Various of 19 Web Sites Authored by Karl Loren
OC History Oral Chelation Testimonials
Family Of Three Oral Chelation Formulas Life Glow Basic Life Glow Basic Ingredient List
Life Glow Plus Life Glow Plus
Ingredient List
American Heart Association -- Lies
Super Life Glow Super Life Glow
 Ingredient List
FAQ
All Products Shopping Cart Order Section Research
Taheebo Life Tea Witch Doctors Versus Harvard MSM Sulfur
Calcium How Bones Grow Colloidal Minerals
Jean Ross Philosophy The Wednesday Letter
Arthritis & James Coburn's Use Of MSM Karl Loren Viewpoints News And Announcements
Dr. Flanagan's Microhydrin 500 Page Book On Heart Disease Colostrum & Transfer Factor
Germanium Ultrasound Technology Bulk MSM
Cancer & Biopsy Diabetes Heart Disease & Bypass Surgery
Karl Loren's Diet Guarantee High Cholesterol Risk?
The Links Below Jump To Pages On Whatever Web You Are In
Table Of Contents Search This Web Navigation Help Page
Write To Karl Loren -- He Pledges To Answer EVERY Personal Message, Personally.  Click here or on his name in the box below.
The Links Below Are To Various Web Sites Published By Karl Loren
Karl Loren Web Vibrant Life Web Karl Loren's Book
Super Colostrum Bulk MSM Heart Disease
Emmessar Happiness Arthritis
Instead Of Chelation Therapy Super Colostrum (2)
Immune Egg Central Page For All 19 Webs!
 

I promise to answer your message -- click here to send me a personal message

Dear Karl,                                        

 

 

 

 

SUBSCRIBE:  The Wednesday Letter is a free electronic monthly newsletter written and published by Karl Loren.  You can view more than 50 back issues of this publication by clicking here.  The Wednesday Letter subscription list is maintained on a secure server, no name is ever given or sold to anyone, and it is never used except for this Newsletter.  It is automatically published on the Tuesday night just before the first Wednesday of every month.  You can subscribe to this free monthly electronic letter by entering your eMail address and name below.  You will then automatically receive a request for confirmation, sent to whatever address you have entered.  If you do NOT receive this confirmation request, then you will not be subscribed.  There may have been an error with your address and you should resubmit.  The letter is never sent twice to the same address -- so you do not have to worry about a duplicate subscription.  When you receive this confirmation request you must reply to it, or your subscription will not become active.  No one can subscribe your name, and address, without you being notified, and if you get an unwanted notice of subscription you only need to DO NOTHING and the subscription will NOT be active.

E-Mail Address:
First Name:
Last Name:

REMOVAL:  You can remove yourself from the subscription list in several different ways.  Click here to read about this entire newsletter system.  Every edition of The Wednesday Letter is delivered to your address with YOUR name and address in view on the letter, with a link that allows you to remove THAT name from the subscription list.  If you try to send this removal message from an address different from the one you used to send in your original confirmation, then you will get a warning notice first, sent to the subscription address, asking you to confirm that you want to be removed from the list -- by replying to THAT request for confirmation, you will then be automatically removed.  Thus, no one else can unsubscribe you, from some other computer, without your knowledge.  But, if you send in the unsubscribe notice from the same machine used to receive the Letter, then the removal from the subscription list is automatic.

E-Mail Address:

Personal Message:  When you send a personal message to Karl Loren, you will receive a personal reply as per his instructions.  Karl pledges that every personal message will get a personal answer. When you provide your mail address, we will send you free information including our free catalog and a cassette tape lecture by Karl Loren about heart disease, no charge, by mail, even if outside the US.  You can select particular information you would like to receive, along with the free cassette tape and catalog.

You can reach Vibrant Life in many ways, including by mail to Vibrant Life, 2808 N. Naomi St., Burbank, CA 91504.  Within the US and Canada, use the toll free number:  (800) 523-4521, the local number:  (818) 558-1799, the FAX:  (818) 558-7299, eMail to kimberly@oralchelation.com or any one of the hundreds of message forms throughout the 50 web sites.  Vibrant Life normally ships the same day we get an order.  There are message forms on each of the 100,000+ pages on this and other sites where you can communicate with Vibrant Life.  Check out our companion site, at:  http://www.oralchelation.net where Karl's 2000 page book is published.  Karl Loren is the author and webmaster for this BOOK, as well as for another web site about ORAL CHELATION.  His personal philosophical articles are at PHILOSOPHY

Copyright © May 20, 2008 6:24 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED.  Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions:  One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site.  This permission does not extend to materials on this site which are copyrighted by others.