Comments Re:13 year BMJ investigation of research misconduct

[Guest guest]

Comments Re:13 year BMJ investigation of research misconduct

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

www.ahrp.org

FYI

Responding to the AHRP Infomail--Medical Journal

Editor Finds Truth Hard to

Track Down (December 27) Eddie Vos,* expert

nutrition specialist offers

comments about the13-year ' " investigation " of

alleged research misconduct by

an Indian physician, as reported in the Wall

Street Journal (December 27).

Noting that the BMJ allowed 10 years to elapse

before ever confronting Dr.

Ram Singh with accusations about the integrity of

his research, Eddie Vos

puts the blame on the journal. Had the editor

given Dr. Singh a fair and

square opportunity to defend his work, he might

have been able to do so. At

that time, he might have been able to provide the

raw data. On the other

hand, iIf misconduct had been found, the journal

had a duty to inform its

readers about the false claims in the BMJ

article. But the journal editor's

" investigation " was conducted in secret.

Vos notes that " Relating that an Indian

researcher was remiss to have

records of a long-published study destroyed by

'termites' sounds exotic and

'fishy' but it makes no sense since the West uses

shredders, as per policy

and routinely so. " Indeed, he notes that Canadian

universities REQUIRE

scientists to destroy original research data.

There is another issue that AHRP finds troubling,

an issue not addressed by

the WSJ: that is, BMJ's extraordinary

endorsement, in 2003, of a highly

controversial recommendation that is sure to make

pharmaceutical companies

even richer. The BMJ breathlessly endorsed much

expanded use of statins to

reduce heart atacks--an endorsement contradicted

by Dr. Singh's findings

that nutrition and life-style changes are the

best means for reducing heart

attacks.

..

In an October, 2003 editorial, Dr.

(then) editor of the BMJ

rhapsodized about the " Pollypill " (which some

have called the " weapon of

mass salvation " ).

The Polypill solution was introduced as the lead

article in the BMJ June 28,

2003 issue as a magic bullet combination: " A

strategy to reduce heart

disease by more than 80% " .

The two British authors' contention was that 1 in

3 people over the age of

54 could look forward to an additional 11 or 12

years of life free from

cardiovascular disease by taking a daily

Polypill.

See: Wald NJ, Law MR. A strategy to reduce

cardiovascular disease by more

than 80%. BMJ 2003;326: 1419-24. (28

June.)[Abstract/Free Full Text]

Dr. 's October editorial has the ring of an

evangelist preacher:

" Light the blue touch paper and retreat 5

metres. That's what we did when

we published a series of papers suggesting that

if everybody started taking

a pill containing six ingredients at the age of

55 then deaths from heart

disease and stroke would be reduced by 80%. The

pill would contain aspirin,

a statin, folic acid, and three antihypertensives

at half dose. Versions of

all the drugs are now off patent, and the pill

could be produced for pence.

Wild with enthusiasm, I suggested that the issue

of the BMJ that published

the articles might be the most important for 50

years and become a

collector's item....It could be available for me

to take on my 55th birthday

on 11 March 2007 (no cards, please). "

http://bmj.bmjjournals.com/cgi/content/full/327/7418/0-g

See: Letters in response to Dr. 's

editorial:

http://bmj.bmjjournals.com/cgi/eletters/327/7418/0-g#37410

See also, " Converting Millions of Healthy People

Into Perpetual Patients " by

Roisch, MD, clinical professor of medicine

and psychiatry at New York

Medical College and is President of the American

Institute of Stress who

critiques those who led the Polypill stampede:

" A guest editorial by , co-director

of the Clinical Trials

Research Unit, University of Auckland was not

quite as gushy [as 's].

However, it also seemed to endorse the authors'

claim that the Polypill

would have " a greater impact on the prevention of

disease in the Western

world than any other known intervention " ! Not

surprisingly, the professors

filed a patent application for their formulation

and a trademark application

for the name Polypill over three years

ago....There is apparently little

concern about safety because of the relatively

low dosages of the various

drugs, which apparently does not reduce their

effectiveness... " See:

http://www.redflagsweekly.com/rosch/2003_jul21.html

* Most Recent Publications of Eddie Vos:

Vos E, Rose C. Risk Factors for Cardiovascular

Disease in Women. JAMA Dec.

14, 2005.

Vos E, Rose C. Questioning the benefits of

statins. Can Med Ass'n J. Nov.

8, 2005.

Vos E. Use of statins not supported by study.

Br Med J. 2005 (331):159.

Vos E. Modified Mediterranean diet and

survival. Key confounder was

missed. Br Med J. 2005 (330):1329.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Re: Medical Journal Editor Finds Truth

Hard to Track Down

Dear Vera, while it is undeniable that the

initial randomization of

patients was flawed in this now 13 year old

publication's, it is

inexcusable to wait that long with such

accusations, 10 years after the

initial publication was printed. Clearly the

Journal is at fault here.

Please realize that reputable Canadian

universities force their

researchers to destroy original research data

unless a compelling case is

made not to. Relating that an Indian researcher

was remiss to have

records of a long-published study destroyed by

'termites' sounds exotic

and 'fishy' but it makes no sense since the West

uses shredders, as per

policy and routinely so.

There was no indication of deliberate fraud and

unfortunately this

episode tarnishes the entire Indian research

world without adequate

analysis because of a Journal's delay in acting,

i.e. asking for the data

when they were clearly still available in 1992.

Dr. Singh, with eminent Israeli researcher Berry

and others, published

another study in 2002 Lancet that showed that an

increase in plant based

omega-3 fatty acid reduces second heart attacks

and deaths thereof. This

study is here: http://tinyurl.com/cp5px [Medline

12433513]. This study

doubled the intake of plant based omega-3 fatty

acid and reported an

about halving of second cardiovascular events.

As amazing as this may

seem, it is entirely in line with a similar

study, the Lyon Diet Heart

Study, that nobody questions, see here:

http://circ.ahajournals.org/cgi/content/full/99/6/733.

Let us not flush the baby with the bath water and

dismiss studies that

find amazing benefit with nutritional approaches

[no drugs] and most

importantly omega-3 increases that actually lower

cardiovascular deaths.

The Journal should have asked others to repeat

the study in question

rather than generating this Royal Mess that

benefits nobody but the

established drug and low cholesterol / low-fat

industries that have

proven not to be beneficial to people's health.

Please send this around in my name, signed, Eddie

Vos

http://www.health-heart.org

--------------------------------

> VERACARE wrote:

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting Openness, Full Disclosure, and

Accountability

> www.ahrp.org

>

> FYI

>

> A front page report in The Wall Street Journal

underscores the inherent

> flaw in the " peer review " vetting system used

by science journals.

>

> This case involves a 12- year investigation by

(then) editor of the

> BMJ, Dr. . The investigation was

sparked by two letters

> sounding an alarm about a 1992 article by Dr.

Ram Singh, a cardiologist

> practicing in India, published in the BMJ.

>

> Dr. Singh is the author of numerous articles in

prestigious journals,

> including The Lancet and the American Journal

of Cardiology.

>

> There are troubling aspects to the case to be

sure--such as missing

> data which may have been eaten by termites; the

lack of computerized

> data, due to primitive resources;

>

> and statistical errors which Dr. Singh readily

acknowledges.

>

> One has yet to evaluate whether Dr. Singh's

reports claiming

> astonishing reduction in heart attacks in

patients who changed their

> diets by increasing fruits and vegetables,

fibers and a glass of

> whiskey is entirely without merit--particularly

because such life-style

> changes have been shown by others to be

effective.

>

> But such medical advice collides with the

chemical solution that

> pharmaceutical stakeholders recommend for our

current ailments, many

> of which are linked to diet, and sedentary

life-styles.

>

> Although there are different contributing

factors in any one of the

> research related scandals that have been

recently uncovered--whether

> they occurred at prestigious US. or U.K, or

Canadian academic

> institutions, or in India, South Korea, or

China--there is an

> underlying flaw underscored in each and every

research publication

> scandal.

>

> The underlying flaw that seems to elude journal

editors and the

> scientific community is the need to

independently examine the actual

> data BEFORE publication.

>

> Journal editors must adopt a PUBLICATION

REQUIREMENT for all authors

> submitting clinical trial reports if they want

to protect the integrity

> of both the journals and the scientific

literature. Authors should be

> REQUIRED to submit ALL RAW DATA along with

their research report.

>

> Journal editors have it in their power to

refuse to publish any

> clinical trial report unless its data has been

independently analyzed.

>

> Only then, can the integrity of the journal

literature--and of

> medicine--be restored.

>

> Until such a publication rule is adopted,

science journal editors will

> repeatedly find themselves in the embarassing

situation of having to

> find a face-saving explanation of how one after

another of its

> published clinical trial reports is shown to be

unsupported by the

> data.

>

>

> Contact: Vera Hassner Sharav

> 212-595-8974

> veracare@...

>

> PAGE ONE

>

http://online.wsj.com/article_email/SB113565052512831921-

lMyQjAxMDE1MzI1NzYy

NTcwWj.html

>

> THE WALL STREET JOURNAL

> Playing DetectiveAt Medical Journal,

> Editor Finds Truth Hard to Track Down

>

> Termite-Eaten Data Plague Dr. 's 12-Year

Probe Of an Indian

> Researcher

> Pestering a Busy Statistician

>

> By ANNA WILDE MATHEWS in London and PETER

WONACOTT in Moradabad, India

>

> December 27, 2005; Page A1

>

> In 1992, the British Medical Association's

flagship journal published a

> study led by Indian doctor Ram B. Singh with a

striking finding:

> Heart-attack victims who ate more fiber, fruits

and vegetables for a

> year cut their risk of death during that period

by almost half.

>

> A year later, , the journal's

editor, received two letters

> questioning the findings. What followed was an

extraordinary inquiry

> stretching over a dozen years and 5,000 miles.

Along the way, Dr. Singh

> contended that termites had eaten crucial data

and Dr. spent four

> years begging a busy statistician to deliver a

report.

>

xxx cut xxx

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________

[Guest guest]

Comments Re:13 year BMJ investigation of research misconduct

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

www.ahrp.org

FYI

Responding to the AHRP Infomail--Medical Journal

Editor Finds Truth Hard to

Track Down (December 27) Eddie Vos,* expert

nutrition specialist offers

comments about the13-year ' " investigation " of

alleged research misconduct by

an Indian physician, as reported in the Wall

Street Journal (December 27).

Noting that the BMJ allowed 10 years to elapse

before ever confronting Dr.

Ram Singh with accusations about the integrity of

his research, Eddie Vos

puts the blame on the journal. Had the editor

given Dr. Singh a fair and

square opportunity to defend his work, he might

have been able to do so. At

that time, he might have been able to provide the

raw data. On the other

hand, iIf misconduct had been found, the journal

had a duty to inform its

readers about the false claims in the BMJ

article. But the journal editor's

" investigation " was conducted in secret.

Vos notes that " Relating that an Indian

researcher was remiss to have

records of a long-published study destroyed by

'termites' sounds exotic and

'fishy' but it makes no sense since the West uses

shredders, as per policy

and routinely so. " Indeed, he notes that Canadian

universities REQUIRE

scientists to destroy original research data.

There is another issue that AHRP finds troubling,

an issue not addressed by

the WSJ: that is, BMJ's extraordinary

endorsement, in 2003, of a highly

controversial recommendation that is sure to make

pharmaceutical companies

even richer. The BMJ breathlessly endorsed much

expanded use of statins to

reduce heart atacks--an endorsement contradicted

by Dr. Singh's findings

that nutrition and life-style changes are the

best means for reducing heart

attacks.

..

In an October, 2003 editorial, Dr.

(then) editor of the BMJ

rhapsodized about the " Pollypill " (which some

have called the " weapon of

mass salvation " ).

The Polypill solution was introduced as the lead

article in the BMJ June 28,

2003 issue as a magic bullet combination: " A

strategy to reduce heart

disease by more than 80% " .

The two British authors' contention was that 1 in

3 people over the age of

54 could look forward to an additional 11 or 12

years of life free from

cardiovascular disease by taking a daily

Polypill.

See: Wald NJ, Law MR. A strategy to reduce

cardiovascular disease by more

than 80%. BMJ 2003;326: 1419-24. (28

June.)[Abstract/Free Full Text]

Dr. 's October editorial has the ring of an

evangelist preacher:

" Light the blue touch paper and retreat 5

metres. That's what we did when

we published a series of papers suggesting that

if everybody started taking

a pill containing six ingredients at the age of

55 then deaths from heart

disease and stroke would be reduced by 80%. The

pill would contain aspirin,

a statin, folic acid, and three antihypertensives

at half dose. Versions of

all the drugs are now off patent, and the pill

could be produced for pence.

Wild with enthusiasm, I suggested that the issue

of the BMJ that published

the articles might be the most important for 50

years and become a

collector's item....It could be available for me

to take on my 55th birthday

on 11 March 2007 (no cards, please). "

http://bmj.bmjjournals.com/cgi/content/full/327/7418/0-g

See: Letters in response to Dr. 's

editorial:

http://bmj.bmjjournals.com/cgi/eletters/327/7418/0-g#37410

See also, " Converting Millions of Healthy People

Into Perpetual Patients " by

Roisch, MD, clinical professor of medicine

and psychiatry at New York

Medical College and is President of the American

Institute of Stress who

critiques those who led the Polypill stampede:

" A guest editorial by , co-director

of the Clinical Trials

Research Unit, University of Auckland was not

quite as gushy [as 's].

However, it also seemed to endorse the authors'

claim that the Polypill

would have " a greater impact on the prevention of

disease in the Western

world than any other known intervention " ! Not

surprisingly, the professors

filed a patent application for their formulation

and a trademark application

for the name Polypill over three years

ago....There is apparently little

concern about safety because of the relatively

low dosages of the various

drugs, which apparently does not reduce their

effectiveness... " See:

http://www.redflagsweekly.com/rosch/2003_jul21.html

* Most Recent Publications of Eddie Vos:

Vos E, Rose C. Risk Factors for Cardiovascular

Disease in Women. JAMA Dec.

14, 2005.

Vos E, Rose C. Questioning the benefits of

statins. Can Med Ass'n J. Nov.

8, 2005.

Vos E. Use of statins not supported by study.

Br Med J. 2005 (331):159.

Vos E. Modified Mediterranean diet and

survival. Key confounder was

missed. Br Med J. 2005 (330):1329.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Re: Medical Journal Editor Finds Truth

Hard to Track Down

Dear Vera, while it is undeniable that the

initial randomization of

patients was flawed in this now 13 year old

publication's, it is

inexcusable to wait that long with such

accusations, 10 years after the

initial publication was printed. Clearly the

Journal is at fault here.

Please realize that reputable Canadian

universities force their

researchers to destroy original research data

unless a compelling case is

made not to. Relating that an Indian researcher

was remiss to have

records of a long-published study destroyed by

'termites' sounds exotic

and 'fishy' but it makes no sense since the West

uses shredders, as per

policy and routinely so.

There was no indication of deliberate fraud and

unfortunately this

episode tarnishes the entire Indian research

world without adequate

analysis because of a Journal's delay in acting,

i.e. asking for the data

when they were clearly still available in 1992.

Dr. Singh, with eminent Israeli researcher Berry

and others, published

another study in 2002 Lancet that showed that an

increase in plant based

omega-3 fatty acid reduces second heart attacks

and deaths thereof. This

study is here: http://tinyurl.com/cp5px [Medline

12433513]. This study

doubled the intake of plant based omega-3 fatty

acid and reported an

about halving of second cardiovascular events.

As amazing as this may

seem, it is entirely in line with a similar

study, the Lyon Diet Heart

Study, that nobody questions, see here:

http://circ.ahajournals.org/cgi/content/full/99/6/733.

Let us not flush the baby with the bath water and

dismiss studies that

find amazing benefit with nutritional approaches

[no drugs] and most

importantly omega-3 increases that actually lower

cardiovascular deaths.

The Journal should have asked others to repeat

the study in question

rather than generating this Royal Mess that

benefits nobody but the

established drug and low cholesterol / low-fat

industries that have

proven not to be beneficial to people's health.

Please send this around in my name, signed, Eddie

Vos

http://www.health-heart.org

--------------------------------

> VERACARE wrote:

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting Openness, Full Disclosure, and

Accountability

> www.ahrp.org

>

> FYI

>

> A front page report in The Wall Street Journal

underscores the inherent

> flaw in the " peer review " vetting system used

by science journals.

>

> This case involves a 12- year investigation by

(then) editor of the

> BMJ, Dr. . The investigation was

sparked by two letters

> sounding an alarm about a 1992 article by Dr.

Ram Singh, a cardiologist

> practicing in India, published in the BMJ.

>

> Dr. Singh is the author of numerous articles in

prestigious journals,

> including The Lancet and the American Journal

of Cardiology.

>

> There are troubling aspects to the case to be

sure--such as missing

> data which may have been eaten by termites; the

lack of computerized

> data, due to primitive resources;

>

> and statistical errors which Dr. Singh readily

acknowledges.

>

> One has yet to evaluate whether Dr. Singh's

reports claiming

> astonishing reduction in heart attacks in

patients who changed their

> diets by increasing fruits and vegetables,

fibers and a glass of

> whiskey is entirely without merit--particularly

because such life-style

> changes have been shown by others to be

effective.

>

> But such medical advice collides with the

chemical solution that

> pharmaceutical stakeholders recommend for our

current ailments, many

> of which are linked to diet, and sedentary

life-styles.

>

> Although there are different contributing

factors in any one of the

> research related scandals that have been

recently uncovered--whether

> they occurred at prestigious US. or U.K, or

Canadian academic

> institutions, or in India, South Korea, or

China--there is an

> underlying flaw underscored in each and every

research publication

> scandal.

>

> The underlying flaw that seems to elude journal

editors and the

> scientific community is the need to

independently examine the actual

> data BEFORE publication.

>

> Journal editors must adopt a PUBLICATION

REQUIREMENT for all authors

> submitting clinical trial reports if they want

to protect the integrity

> of both the journals and the scientific

literature. Authors should be

> REQUIRED to submit ALL RAW DATA along with

their research report.

>

> Journal editors have it in their power to

refuse to publish any

> clinical trial report unless its data has been

independently analyzed.

>

> Only then, can the integrity of the journal

literature--and of

> medicine--be restored.

>

> Until such a publication rule is adopted,

science journal editors will

> repeatedly find themselves in the embarassing

situation of having to

> find a face-saving explanation of how one after

another of its

> published clinical trial reports is shown to be

unsupported by the

> data.

>

>

> Contact: Vera Hassner Sharav

> 212-595-8974

> veracare@...

>

> PAGE ONE

>

http://online.wsj.com/article_email/SB113565052512831921-

lMyQjAxMDE1MzI1NzYy

NTcwWj.html

>

> THE WALL STREET JOURNAL

> Playing DetectiveAt Medical Journal,

> Editor Finds Truth Hard to Track Down

>

> Termite-Eaten Data Plague Dr. 's 12-Year

Probe Of an Indian

> Researcher

> Pestering a Busy Statistician

>

> By ANNA WILDE MATHEWS in London and PETER

WONACOTT in Moradabad, India

>

> December 27, 2005; Page A1

>

> In 1992, the British Medical Association's

flagship journal published a

> study led by Indian doctor Ram B. Singh with a

striking finding:

> Heart-attack victims who ate more fiber, fruits

and vegetables for a

> year cut their risk of death during that period

by almost half.

>

> A year later, , the journal's

editor, received two letters

> questioning the findings. What followed was an

extraordinary inquiry

> stretching over a dozen years and 5,000 miles.

Along the way, Dr. Singh

> contended that termites had eaten crucial data

and Dr. spent four

> years begging a busy statistician to deliver a

report.

>

xxx cut xxx

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________