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The
Columbia University 'Miracle' Story
A Story of Possible Fraud in the Medical Literature and a Medical Journal and Medical School Responding Poorly
Dr.
Bruce Flamm (clinical professor of OB/Gyn at Univ. of California) has been of
key importance in making this story known and analyzing the potential lessons to
be learned. (click
here for
lessons learned)
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The
bizarre story of this study is as follows:
***A
good rule of thumb for a medical journal is that anyone who uses the names of
dead children in order to fraudulently obtain bank loans, jobs, and passports,
is not a reliable source of data.***
A
study was published in the Journal of Reproductive Medicine in 2001, which if
true, was a landmark study. The study reported that women undergoing in vitro fertilization in Korea who were prayed for by
individuals in Australia, Canada, and the United States conceived at twice the rate as those patients that did not receive prayer.
The prayer groups were reportedly organized predominantly by one of the authors, presumably
by the currently imprisoned lawyer, Daniel Wirth. None of the patients who were prayed for were told they were in a study or
that they were being prayed for by other people. No informed consent was
obtained.
The
prayer group was said to have a remarkable increase in the rate of achieving a
successful pregnancy- 50% in the prayer group (44/88) vs. 26% in the no prayer
group (21/81, P=.0013). If
legitimate, this would
have been an historic publication. In reality, history will record this
publication as a classic example of flawed and possibly fraudulent medical
research.
The lead author,
whose name was eventually withdrawn from the study, was Dr. Rogerio Lobo. Dr. Lobo was the chairman of the
Obstetrics and Gynecology Department at Columbia University in New York at the time. He was also on the editorial board of the Journal of Reproductive Medicine, the same medical journal that published this study.
The other two authors were Daniel Wirth, a lawyer, and Dr.
Kwang Cha.
Dr. Cha was director of the
Cha
Columbia
Infertility
Center
at the time of the 'miracle' study but appears to have ended his
relationship with
Columbia University shortly after the study was published.
Daniel Wirth is a lawyer without a medical degree but with a degree in
parapsychology (a field dealing with ESP and other unproven phenomena). Mr. Wirth had
previously written a number of articles published in parapsychology journals
claiming to document paranormal phenomena and faith healing. (Only later would Daniel
Wirth be imprisoned after being convicted of unrelated fraud charges which included the use of the
names of dead people for illegal financial gain.)
Dr. Bruce Flamm, who is a clinical professor of
OB/Gyn at University of California at Irvine, wrote several letters to the Journal of Reproductive Medicine. He questioned the complex design of the trial. He also asked for the name to be released of the supposed independent statistician who was said to have been an outside source helping to guarantee the integrity of the data. Dr. Flamm, in
addition, suggested the possibility of fabrication. Dr. Flamm’s subsequent phone calls to the journal were not answered nor were his letters published in the Journal of Reproductive Medicine.
Other individuals also wrote letters to the journal questioning the study's
methodology and results. None of these letters were
published, as would have been appropriate near the time of publication of this presumably landmark trial.
Dr.
Flamm went on to write a critique of the study in the Scientific Review of
Alternative Medicine in 2002. Other authors subsequently contacted Dr. Flamm
about multiple independent inquiries into other questionable work by Daniel
Wirth, the lawyer without a medical degree.
In the meantime, the lack of informed consent resulted in an investigation of Columbia University (Dr. Lobo’s institution) by the United States Department of Health and Human Services
(DHSS). Dr. Lobo was listed as the lead author on the paper, as well as being identified by a Columbia University press release as having led the study. However,
Thomas Morris, Columbia University Vice President, responded to the DHSS investigation that
Dr. Lobo had first learned of the study from Dr. Cha six to twelve months after the study had been completed and had primarily provided editorial review and assistance with publication. Dr. Lobo would
later withdraw his name from the study
ostensibly because of this limited relationship to the study.
When
the scandal surrounding the 'miracle' study became public in mid 2004, Columbia
University, which is a highly respected institution, began an investigation. However, the investigation was
apparently halted when Dr. Lobo formally removed his name from the study.
Details of this investigation were not made public. The lack of public reporting of the details of their investigation of this study could be viewed as shirking of responsibility by Columbia University. This trial would not have received the same credence without the association of the study with Dr. Lobo and Columbia University. Columbia University
had even initially issued a press release claiming that the study had several safeguards in place to eliminate bias and that the study was carefully designed to eliminate bias.
Both physicians listed as authors at
the time of publication of this study were Columbia University physicians. Without these two physicians associated with Columbia University,
the only author remaining was a lawyer without a medical degree with a history
of prior publications on mysterious phenomena and faith healing. Any journal even considering publication would have demanded more documentation of the integrity and factual nature of the data presented. Columbia University’s response
after problems with this study have become apparent has been clearly insufficient.
In
addition, the actions of the Journal of Reproductive Medicine (JRM) have been
indefensible for a medical journal. Prior to publication, their peer-review
system failed to detect a flawed study. After publication, the journal had to be aware of the
considerable controversy that this article provoked. The journal did not publish
any letter to the editor or viewpoint criticizing this study even when they
temporarily withdrew the paper from their website. (The journal withdrew the
paper following the May 2004 publication in the London Observer of “Exposed:
Conman’s Role in Prayer-power IVF “Miracle”.)
In November 2004, they put the study back on their web site, reportedly
telling the press that they stood by the report. The Journal of Reproductive
Medicine at the same time published a defense of the article by the sole
remaining unincarcerated author of the study, Dr. Cha.
Dr. Cha noted that his defense of the article was written as a “reply… to
correspondence we received.” Almost
unbelievably for a medical journal, the rebuttal by Cha was printed by the
Journal of Reproductive Medicine without that journal ever previously or
concurrently publishing any letters or commentary they received regarding
criticism and limitations of this study.
After continued criticism in the national news media, the Journal of
Reproductive Medicine belatedly published a letter from Dr. Flamm in their
January 2005 issue. This was more than 3 years after the initial publication of
the 'miracle' study.
The Journal of Reproductive Medicine still refused to retract study. The
study was still being cited despite its highly suspect nature.
Kwang
Cha was the only remaining un-incarcerated author of the 2001 study. However, more recently, Dr. Cha has been charged with plagiarism of a study
he published in 2005.
The study was initially published in Korea. Dr.Cha
published it in the United States. Dr. Cha apparently perjured himself by
signing papers that this research had not been published previously. In
addition, the lead author of the paper when it was originally published in Korea
was not credited in the United States journal publication as even having
participated in the research.
http://www.the-scientist.com/news/home/52859/ )
After
months of investigation the editor of Fertility and Sterility (the United
States journal) concluded
that Cha's 2005 paper was essentially a word-for-word copy of a paper that had previously
been published by a different lead author in a Korean medical journal.
All three
authors of the "miracle" study have now been discredited. Only
one question remains. Will the Journal of Reproductive Medicine finally
retract the absurd Cha/Wirth/Lobo publication?
What should
now be done?
Columbia University should reopen an inquiry into the publication of this article and make public the information gathered from their previous inquiry. Without the Columbia University connection, this paper would not have been published in a similar fashion or received the undeserved credence that connection conferred. The paper is now back in the public domain on the Journal of Reproductive Medicine’s
internet site and would never have been there in the first place without the Columbia University connection. Columbia University shares responsibility for this
flawed and possibly fraudulent study being in the public domain.
The Journal of Reproductive Medicine also has a major responsibility in rectifying this situation.
The article should be retracted from the Journal of Reproductive Medicine. The Journal of Reproductive Medicine
would be well served by establishing an independent panel to review their own journal’s handling of this
matter by impartial and respected medical experts.
In the meantime, this study, whose data analysis and
data collection involved an imprisoned felon, should be withdrawn from the
medical literature. A good rule
of thumb for a medical journal is that anyone who uses the names of dead
children in order to fraudulently obtain bank loans, jobs, and passports is not
a reliable source of data.
What
follows the above synopsis of the Columbia 'Miracle Study are comments by Dr.
Bruce Flamm on the multiple valuable lessons to be learned from this unusual
sequence of events.
Eric
Roehm Columbia 'Miracle' Study
----------------------------------------------------------------------------------------------------------------
The Columbia "Miracle" Study
A plethora of lessons about medical research,
evidence-based medicine, and the peer-review system.
by
Bruce L. Flamm, MD, Clinical Professor
Obstetrics & Gynecology
University of California, Irvine
Lessons
from Columbia "Miracle" Study
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A
study led by Columbia University Medical School faculty appeared to
demonstrate miraculous results. In reality, this seemingly impeccable
study demonstrates a wide variety of research flaws and peer-review
errors. One of the three authors is now serving five years in Federal
prison for criminal fraud, another has formally removed his name from the
study, and the final author refuses to respond to questions about the
scandal.
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The
Cha/Wirth/Lobo study claimed to demonstrate, using meticulous scientific
methodology, that supernatural or paranormal phenomena actually exist. (1) These
mysterious phenomena apparently caused a 100% increase in the success rate of
complex infertility treatments. How did a bizarre study claiming extraordinarily
unlikely and apparently supernatural results end up in a peer-reviewed medical
journal?
The
following are some of the many important lessons that can be learned from this
incredible research saga:
1.
Always be suspicious of outrageous
claims. The Columbia 'miracle' study is an
excellent example of what Dr. C.N. Reckens, chairman of the Dutch Union Against
Quackery calls a, “seemingly impeccable paper proving absurd claims.” (2) A
related phrase cherished by most scientists is,
“extraordinary claims demand extraordinary evidence.” Thus, the first lesson
this paper teaches us is that we should be highly suspicious of studies that
appear to show astonishing results. Of course, every once in a while someone
will discover something that is truly astonishing! Nevertheless, such results
wave a red flag indicating extreme caution should be taken as the study is
reviewed.
2.
One red flag should prompt a search
for others. The extraordinary claims of
the Cha/Wirth/Lobo study should have prompted reviewers to look for other red
flags. In this case the peer review system completely failed. For example, an
obvious red flag was that one of the authors, Daniel Wirth, had no medical
degree but rather a degree in para-psychology, a dubious field that deals with
ghosts and supposed psychic phenomena. A five-minute Google search of this
author yields dozens of red flags that researchers at Columbia University as
well as the peer-reviewers and editors at the Journal of Reproductive Medicine
obviously missed. (3) If anyone had taken a moment to look, they would have
found that Mr. Wirth had already published many papers claiming bizarre healing
phenomena in paranormal magazines and alternative medicine journals.
3.
An overly complex study design is a
red flag. The Cha/Wirth/Lobo study involved a complex and convoluted study design involving various groups, levels, and tiers of overlapping and intertwining intervention groups. Multiple glaring red flags in the Cha/Wirth/Lobo manuscript should have caused reviewers to at least glance at prior publications by Daniel Wirth, the author with no medical credentials. This would have revealed a long pattern of similarly unusual study designs and bizarre healing methods. For example, one prior Wirth study involved only 15 patients yet evaluated some eight different interventions in various groups and combinations.
(4) The strange study included LeShan “elevated state of consciousness” healers, Reiki “life force transferring” healers, Intercessory Prayer healers, Non-contact therapeutic touch “energy field altering” healers, Guided imagery, biofeedback, visualization and relaxation techniques. There were almost as many study interventions as study participants! For comparison, imagine a study with only 15 study patients that claimed to evaluate the safety and efficacy of eight different investigational drugs!
4.
Lack of informed consent is a red
flag. The Cha/Wirth/Lobo study clearly
states that patients undergoing treatment were not aware of the fact that they
were being used as study subjects. This was a shocking revelation, particularly
in light of current governmental laws governing research and strict HIPAA
regulations. One would think that this would give reviewers a good reason to
look very carefully at the study design and methodology. However, reviewers at
Columbia University along with peer-reviewers and editors of the Journal of
Reproductive Medicine were apparently not alarmed by this information.
5.
Investigation of
a study by the Federal Government is a red flag.
The Columbia University press release announcing the publication of this study
mentioned the fact that study patients did not know they were taking part in a
study. This fact was subsequently mentioned in the New York Times in an article
that caught the attention of the U.S. DHHS Office of Human Subjects Protection.
This prompted a Federal investigation of Columbia University. Limited
information about this investigation has been made public and can be viewed at
the DHHS Internet site given below. During the investigation Columbia department
chairman Dr. Rogerio Lobo, who had been listed in the Columbia University press
release and the New York Times as the study's lead author, claimed to have not
been involved with the study until 6 to 12 months after its completion.
Three years later Dr. Lobo formally removed his name from the study. Concerns
about a study that are sufficient to spark a Federal investigation should
clearly have been sufficient to concern peer reviewers and editors. However this
red flag that was ignored.
6.
If the claimed results
are not only astonishing but also defy the know laws of physics then we are
faced with the reddest of all red flags. Before such a study is accepted for
publication it would be wise to await replication by an independent research
group. A fundamental rule of scientific research is that a valid study can
always be replicated by other researchers. Conversely, if other research groups
are not able to replicate a study then it is almost certain that the original
results were not valid.
7. Letters to the Editor serve an
important peer-review role. In some cases
even the most cautious peer-reviewers and editors may miss important errors in a
manuscript. Letters to the editor often correct such problems. In this case
peer-reviewers and editors at the Journal of Reproductive Medicine missed an
entire array of red flags. Worse yet, they undermined evidence-based medicine's
system of checks and balances by refusing to publish even a single letter
critical of the study. For three years letters from concerned physicians and
scientists were completely ignored by the Journal of Reproductive Medicine. The
JRM editors' stonewalling serves as an excellent example of exactly how editors
of medical journals should never behave. At the other end of the spectrum, the
British Medical Journal publishes rapid responses from readers on their Internet
site within 24 hours of their submission. Selected letters are then published in
the paper version of the British Medical Journal. This open and public peer
review system serves as an excellent example of how editors of medical journals
should behave.
8. Studies claiming supernatural
results may defeat peer-review systems. The
Cha/Wirth/Lobo study involved spectacular outcomes apparently related to distant
Christian prayers. Religion is a very sensitive subject and may create a serious
'blind spot' in evidence-based peer-review systems. Some journal peer-reviewers
may be unable to function objectively when faced with religious claims. If
psychic healers or fortune tellers had claimed to have doubled the success rate
of infertility treatments by utilizing Taro cards or Ouija boards their
manuscript would have been immediately rejected as utter nonsense by any
legitimate medical journal. Yet, the apparently supernatural results of the
Cha/Wirth/Lobo study were accepted and published by a supposedly evidence-based
peer-reviewed medical journal. Why?
9. Once a flawed medical study is
published in a peer-reviewed medical journal, the damage has already been done. In
the winter of 2001, newspapers and magazines around the world announced the
astounding results of the Columbia 'miracle' study. By June of 2004, a Google
search for the terms, “Wirth, Columbia, prayer” revealed more than 600
links, many to sites touting the supposedly miraculous results. For almost three
years the public had no knowledge of the study's serious flaws. During those
years the study was cited many times, even in peer-reviewed medical journals, as
strong scientific evidence for the power of faith healing.
10.
The peer-review system can continue
to fail even when serious flaws and problems are made public.
As of January, 2005, in spite of all the flaws and problems delineated above,
Columbia University apparently stands by the 'miracle' study and has concluded
its investigation of the matter. The publication was briefly removed from the
Journal of Reproductive Medicine Internet site but has now been reinstated and
can be viewed at the JRM Internet site at the link given below. Amazingly, after
ignoring readers concerns about the study for three years, the JRM published a
letter in the October 2004 issue in which co-author Kwang Cha was allowed to
defend the bizarre study. However, as of January 2005, the editors of the JRM
have refused to publish even a single letter critical of the Cha/Wirth/Lobo
study.
Internet
Links for more information about the Columbia 'Miracle” study
Skeptical
Inquirer
The
Columbia University Miracle Study:Flawed and Fraud:
http://www.csicop.org.Columbia
Miracle-Study
The
Federal Indictment of Daniel Wirth:
http://www.quackwatch.org/11Ind/wirthindictment.html
References
1.
Cha KY, Wirth
DP, Lobo RA. Does Prayer Influence the
Success of in Vitro
Fertilization-Embryo Transfer: Report of a Masked, Randomized Trial. Journal of
Reproductive Medicine. 2001;46:781–787
2.
Renckens CN. Alternative treatments in
reproductive medicine: Much ado about nothing. Human reproduction
2002;17:528-533
3.
Flamm BL. Faith healing by prayer:
Review of Cha, KY, Wirth, DP, Lobo, RA. Does prayer influence the success of in
vitro fertilization-embryo transfer? The Scientific Review of Alternative
Medicine. 2002; 6(1):47-50 Available on-line at the site listed above.
4.
Complementary Healing Therapies. Wirth DP, Barrett, MA. International Journal of Psychosomatics. 1994:41;1-67.
5.
Flamm BL. Faith Healing Confronts
Modern Medicine. The Scientific Review of Alternative Medicine. 2004; 8(1):9-14.
Available on-line at the site listed above.
Update
Feb 2007: Authors of Columbia "miracle" study shock the
world again:
***A
good rule of thumb for a medical journal is that anyone who uses the names of
dead children in order to fraudulently obtain bank loans, jobs, and passports,
is not a reliable source of data.***
Physicians
and scientists who have been following the saga of the Columbia University
"miracle" study may find this difficult to believe but one of the
strangest stories in the history of medical research has just become even
more bizarre. Daniel
Wirth, Kwang Cha, M.D., and Rogerio Lobo, M.D. were the authors of what appears
to be a fraudulent study of a randomized trial of the effects of prayer on
fertility rates which was published in the Journal of Reproductive Medicine. Since
that publication, one author has been imprisoned for fraud of another type,
the second author has been found guilty of plagiarism by another medical
journal, and Dr. Lobo has withdrawn his name from the study. The Journal of
Reproductive Medicine has refused to date to retract this study and this
fraudulent study is still being cited. This web page describes this unbelievable
and unfortunate situation.
Co-author Daniel Wirth was sentenced to five years in
federal prison for criminal fraud. Although Wirth was the man
who designed and allegedly conducted the "miracle" study, the
Journal of Reproductive Medicine refused to retract the Cha/Wirth/Lobo article. Then,
co-author Rogerio Lobo admitted that he learned of the study only after it
was completed and thus could not even verify that the
research had ever been conducted. In 2004 Lobo removed his name
from the publication.
Mysteriously,
the Journal of Reproductive Medicine still refused to retract it. Kwang
Cha, the only remaining un-incarcerated author of the 2001 study stood by
the miraculous results and claimed that the research was legitimate. However, in February 2007, Dr. Cha was charged with plagiarism of a study
he published in 2005.
(http://www.the-scientist.com
/news/home/52859/ )
After
months of investigation the editor of Fertility and sterility concluded
that Cha's 2005 paper was a word-for-word copy of a paper that had previously
been published by another author in a Korean medical journal. All three
authors of the "miracle" study have now been discredited. Only
one question remains. Will the Journal of Reproductive Medicine finally
retract the absurd Cha/Wirth/Lobo publication?
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