January 2

Medical Journal Editor Finds Truth Hard to Track Down

This case involves a 12- year investigation by (then) editor of the BMJ, Dr. Richard Smith. 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
 PAGE ONE      

Playing DetectiveAt Medical Journal,
Editor Finds Truth Hard to Track Down

Termite-Eaten Data Plague Dr. Smith’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, Richard Smith, 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. Smith spent four years begging a busy statistician to deliver a report.

Finally this July, the journal, called BMJ, lowered the boom. Editors said they had "reasonable grounds to doubt the validity of the 1992 paper" and published an article calling the data in another paper submitted in 1994 "either fabricated or falsified."

Dr. Singh, while acknowledging some missteps, says he is the victim of scientists who don’t understand what it’s like to work without steady electricity or research grants. "The British people all over the world are the same," he says. "If some Indian questions them, they get annoyed."

The long investigation points to a problem in medical research: While prestigious journals act as gatekeepers, awarding legitimacy to some papers and withholding it from others, they have little power to detect or investigate questionable findings. The outside experts who review articles before publication often fail to catch faked results.

Even Dr. Smith, who stepped down from BMJ last year to take a position at UnitedHealth Group Inc., now says that journals "are not really set up to administer justice in these kinds of cases."

The issue becomes more complicated when American and European journal editors are working with authors in unfamiliar nations. The U.S. journal Science this year published claims that South Korean scientists had created stem-cell lines matched to 11 specific people using cloned human cells, while the U.K. journal Nature published work by the same team about an alleged cloned dog. Last week, the lead Korean author, Hwang Woo Suk, resigned from his university after an expert panel at the university said at least nine of the stem-cell lines were fabricated. Nature is investigating the dog paper.
"It’s more difficult in cultures that are different from yours, with languages that are different from yours, with institutions not precisely analogous to the ones that you’re used to dealing with," says Donald Kennedy, editor in chief of Science.

Since its publication in 1992, Dr. Singh’s study has been cited more than 200 times in other scientific articles and guidelines for doctors. Even as the BMJ quietly investigated him, Dr. Singh had dozens of articles published in other journals including The Lancet and the Journal of the American College of Nutrition.
Some of the articles offered eye-popping evidence about the cardiac-health benefits of a good diet. Various studies by Dr. Singh found that fish oil, mustard oil, zinc, magnesium, fruits and vegetables could all be tied to a lower risk of heart disease.

Dr. Singh, a balding 62-year-old with a formal manner, was born in a small town in India, one of four children of a local landlord. He earned his medical degree at Banaras Hindu University, a hotbed of anticolonial sentiment during British rule. He has long operated a three-story hospital in the northern Indian city of Moradabad and conducted his research there.

Patients entering the hospital are given a card with instructions written in Hindi, titled "Superfoods: How to avoid heart attack, high blood pressure and diabetes." The card recommends eating papaya, walnuts, lentils and reducing the vegetable oil that saturates the region’s cuisine. It also advises a glass of whiskey every other day and about 15 minutes of yoga daily.

Ambitious Study

In his 1992 BMJ article, Dr. Singh described an ambitious study in which 406 patients were told to follow a specific diet within two days of being diagnosed with a likely heart attack. In an interview, Dr. Singh says he recruited the patients by running newspaper advertisements and blaring through a loudspeaker in Moradabad’s chaotic streets. He says a half-dozen volunteers helped him, including a chemist who kept statistics, a far smaller team than such a trial in the U.S. would involve.

According to the article, Dr. Singh randomly assigned half the patients to a low-fat diet and the other half to a low-fat diet with extra helpings of fruit, vegetables and other fiber-rich foods. After one year, only 10% of the patients on the high-fiber diet had died, compared with 19% in the control group. It wasn’t surprising that the two groups would differ, but the size of the difference was dramatic.

A year after the article’s publication, two letters arrived on the desk of Dr. Smith at the massive brick headquarters of the British Medical Association. The editor, now 53, is also a whiskey lover and the brother of a well-known British comedian, Arthur Smith. He has his own comic streak: He once wrote a mock obituary of himself, calling BMJ "one of the world’s dullest medical journals" and describing his accent as " ‘gorblimey,’ an embarrassingly thin educated veneer over straight, guttural cockney."

In the first letter, Paul McKeigue, a senior lecturer at the London School of Hygiene and Tropical Medicine, and a colleague described "serious concern" about Dr. Singh’s research. Among other issues, they wondered how a single doctor could publish articles on five trials within 18 months in 1992-93, including three with more than 400 patients.
The second letter, from a researcher at a hospital affiliated with the University of Manchester, raised suspicions that Dr. Singh had tried multiple treatments simultaneously on patients and then written articles as if only one treatment was being used at a time.

Dr. Singh says the burst of 1992-93 articles came after a decade of research by himself and a dozen other health workers. He acknowledges making a "mistake" by using some of the same data in multiple articles. He admits he used some of the same patients in more than one study, which he says "ideally shouldn’t be done." Both practices are generally considered unacceptable by major medical journals.

Dr. Smith asked Stephen Evans, a statistical expert at the London Hospital Medical College, to review the BMJ article. Mr. Evans said that for a full analysis he would need raw data behind the numbers in the article. Dr. Smith, however, feared that Dr. Singh would refuse to cooperate with a demand for the raw data.

In the meantime, Dr. Singh had submitted several new articles to the BMJ and was waiting for an answer. Dr. Smith figured out a way to get a peek at Dr. Singh’s data-collection techniques without arousing suspicion. In August 1994, Dr. Smith wrote to Dr. Singh to "apologize profoundly" for not giving a quicker answer about the new articles. Would Dr. Singh send the raw data for those articles?

Eight months later, Dr. Singh shipped a box to London full of papers scrawled with handwritten data on one of the studies, a paper submitted in 1994 about an antioxidant diet. Dr. Smith promptly forwarded the sheaf to Mr. Evans. But the statistician, who was about to take a job with the British drug regulator, had little time to type the data into his computer and the project was "put on a back burner," he says.

In 1995, the original critic, Dr. McKeigue, filed a more substantial report to BMJ at Dr. Smith’s request. The report, based on a detailed recalculation of numbers in Dr. Singh’s studies, said his work was full of "inconsistencies and errors" and should be retracted.

Still, Dr. Smith had no smoking guns or eyewitness accounts suggesting real skullduggery, as opposed to a few technical slips. Eager to resolve the issue, he sent a series of nagging letters to Mr. Evans asking for a full report. "I know that I’m endlessly pressing you," he pleaded in May 1997, "but might you be able to let me have some data to respond to Singh very soon."

For his part, Dr. Singh grew testy at the BMJ’s foot-dragging on his submitted articles. In August 1997, he wrote Dr. Smith that if he didn’t get an answer on all of his articles by the end of September, "it would be difficult for us to wait any more." A week after Dr. Singh’s deadline, Dr. Smith told Dr. Singh that BMJ "will certainly not be publishing any of your papers." He said the journal had "severe doubts about the validity of these papers and of papers that you have previously published" and for the first time told Dr. Singh that the journal was investigating his work.

That investigation dragged on two more years until Mr. Evans finally turned in some results. The submitted 1994 paper on the antioxidant diet, he said, was full of basic statistical errors and contradictions. More worrisome, the pattern of the patients’ ages wasn’t the same between the two groups, as it should have been if they were randomly selected. Dr. Smith sent a letter to Dr. Singh in November 1999 detailing the problems and demanding an explanation.

When the letter arrived, "it was very shocking," Dr. Singh recalls. He wrote back and admitted "without any hesitation that the statistical analysis conducted by my colleague…may not be correct" but denied that the data were fabricated. He also expressed anger that Dr. Smith had waited so long to describe the concerns about his research, adding that he is a "short tempered person with type A behavior."

In his letter, Dr. Singh declined to respond to the specific allegations. He now says he did use a randomization process in the 1994 submitted paper.
Dr. Singh’s letter also disclosed that he could no longer supply the raw data for much of his published work because, he said, it had been eaten by termites.
In a recent interview at his hospital, Dr. Singh elaborated on the problem, waving a flashlight in a dark closet to show the trail the termites had followed. He says he funded most of his studies out of his own pocket and didn’t get any government research grants. When termites devoured a wooden bookshelf and the handwritten records it held, he says he threw almost everything out. The closet now has metal bookshelves.

Shanti S. Rastogi, a co-author of the 1992 paper, says frequent power outages in Moradabad long precluded the use of computers. "Any charge that this research is fraudulent doesn’t hold water," says Dr. Rastogi, a semiretired endocrinologist in New Delhi.

After the 1999 exchange of letters, Dr. Smith was determined to have some action taken against Dr. Singh, but he wasn’t sure what it should be. He persuaded the Indian Council of Medical Research to look into the matter, and it eventually sent Dr. Smith a two-page document citing "inconsistencies" and suspicious-looking numbers in Dr. Singh’s results. But the council said it had no power to discipline Dr. Singh.

A Duty to Publish

Dr. Smith decided the BMJ had a duty to publish its concerns and the journal’s ethics committee agreed in October 2002. Dr. Smith emailed Dr. Singh, informing him that the journal’s editors felt "the only way forward is to try and tell the entire story in the BMJ." Dr. Singh responded that he wanted a chance to defend himself. He sent a copy of one of his articles with a serrated edge that he said had been gnawed by termites. BMJ then spent more than two years preparing a package of articles. The journal’s ethics committee rejected one draft as too "sensational" and asked the writer to express more "dolefulness." Finally, on July 30, 2005, the BMJ carried a headline: "Suspicions of fraud in medical research — Who should investigate?" along with a photo of a list of Dr. Singh’s publications.

Inside, Mr. Evans, with a graduate student’s help, presented a statistical analysis concluding that the data from Dr. Singh’s 1994 submission "were either fabricated or falsified." Still, the BMJ wasn’t ready to retract the 1992 article after all those years. A carefully worded statement said only that the journal "wished to express concern about the validity" of the article, "based on investigations" it conducted.

On the same day, The Lancet — alerted by Dr. Smith to the BMJ’s investigation — published a similar expression of concern about a 2002 article in that journal in which a team led by Dr. Singh found that a diet rich in fruit, vegetables and whole grains cut heart problems nearly in half.
The Lancet also published a report by a doctor at an Israeli university who co-authored the 2002 article. That doctor, Elliot Berry, visited Moradabad and said he met with 93 patients who confirmed they took part in the study. Some of the patients, however, spoke in Hindi with Dr. Singh acting as interpreter. Dr. Berry was unable to view the study’s data forms, which Dr. Singh said hadn’t been kept, and the Israeli doctor noted that he was shown some papers that had been gnawed by termites.

Today, Dr. Singh’s international reputation is in shreds. William Roberts, the editor of the American Journal of Cardiology, says he plans to retract studies on diet and cardiac health led by Dr. Singh that appeared in his journal. Dr. Singh says his invitations to international conferences have dried up and he isn’t doing as much research these days.

Dr. Smith has his own regrets. He admits he should have told Dr. Singh earlier that the BMJ was scrutinizing his work. He thinks the journal should have gone sooner to an outside authority to ask for an investigation. But he doesn’t regret pursuing Dr. Singh for as long as it took. "There was no way we could just walk away from this," says Dr. Smith.

In Moradabad, Dr. Singh has his share of ardent supporters, who credit him for helping Indians reduce their risk of heart attacks. "What he advocated was a lifestyle change," said a local cardiologist, S.K. Raj, one recent evening, as he held a tall glass of Chivas Regal that Dr. Singh had poured for him. "He really changed the scenario." As friends gathered at a hospital meeting room nodded in sympathy, Dr. Singh railed against what he described as Dr. Smith’s lumbering attempt to be a "global policeman" of medical scholarship. "What can I do?" said Dr. Singh, sipping his Scotch whisky. "Let the dog bark."

Write to Anna Wilde Mathews at anna.mathews@wsj.com and Peter Wonacott at peter.wonacott@wsj.com


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