Another Case of Research Falsification Published by The LANCET/+2 articles from

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Another Case of Research Falsification Published by The

LANCET/+2 articles from LA Times

Mon, 23 Jan 2006 15:36:25 -0000

 

 

 

 

 

http://education.guardian.co.uk/higher/worldwide/story/0,9959,1687477,00.html

 

Guardian Unlimited [uK]

January 16, 2006

 

Respected Norwegian scientist faked study on oral cancer

Gwladys Fouché in Oslo

 

A Norwegian cancer scientist has been exposed as a fake after

falsifying a study on oral cancer published in the renowned medical

journal The Lancet.

 

Jon Sudboe, 44, invented more than 900 individuals as the basis for

his research on the correlation between taking anti-inflammatory

drugs, such as paracetamol, and oral cancer. The article, published in

October, concluded individuals who took anti-inflammatory drugs were

less likely to develop the disease.

 

" He faked everything: names, diagnosis, gender, weight, age, drug

use, " Stein Vaaler, director of strategy at Oslo's Radium hospital,

said. " There is no real data whatsoever, just figures he made up

himself. Every patient in this paper is a fake.

 

" He was an outstanding scientist in our hospital. I feel shocked and

depressed. We could not believe what happened or why he did it. "

 

The Radium hospital is now investigating all research involving Dr

Sudboe. An external commission, led by Anders Ekbom from Stockholm's

Karolinska Institute, is to start work later this week. It will also

examine 38 articles Dr Sudboe has published since 1997. The articles

had turned Dr Sudboe into an internationally esteemed scientist.

 

Several people who have co-authored research with Dr Sudboe said they

were stunned by the revelations. " This is as big a shock for me as for

everyone else, " colleague Dr Jon Mork told Norwegian newspaper VG. " I

don't think any of the other co-writers were aware of this. "

 

The Norwegian daily Dagbladet said Dr Sudboe's wife and twin brother

were among scientists who have collaborated with him, and said his

brother had co-written the Lancet article. There are no indications

anyone else knew of the fraud. Dagbladet said 250 of Dr Sudboe's

sample of 908 people had the same birthday.

 

The scandal came to light when the Norwegian prime minister's sister

read the article at Christmas. Camilla Stoltenberg, who works at the

Norwegian Institute of Public Health, noticed claims that Dr Sudboe

had gathered information from a national database. But the database in

question had not been open until now.

 

Dr Sudboe is currently on sick leave. He could not be reached for

comment and has not commented so far.

The scandal comes just days after an inquiry in South Korea found stem

cell pioneer Hwang Woo-suk had faked almost all his research. On

Friday, Dr Hwang asked for forgiveness, but said members of the

research team at Mizmedi hospital, Seoul, had lied to him about

growing stem cells from human embryos he had cloned.

 

***************************************

 

http://today.reuters.co.uk/news/newsArticle.aspx?type=scienceNews & storyID=2006-0\

1-16T170149Z_01_L15671814_RTRIDST_0_SCIENCE-NORWAY-CANCER-DC.XML & archived=False

 

Reuters

January 16, 2006

 

Oslo promises crackdown after cancer cheat scandal

By Alister Doyle

 

OSLO (Reuters) - Norway promised on Monday to speed up a new law that

may bring jail terms for medical cheats after a hospital accused one

of its cancer researchers of falsifying data published in a leading

journal.

 

" There must be no doubt about the quality of our research, " Health

Minister Sylvia Brustad told Norway's NTB news agency. " So we are

speeding up our draft law. "

 

The government would present the law to parliament later this year,

earlier than planned, after experts have worked on a review since 2003.

 

The law would propose stricter rules for overseeing research and might

make cheats liable to criminal charges that could bring jail terms.

Under existing rules, cheats can in the worst case be sacked and

banned from practicing medicine.

 

Officials said at the weekend that 44-year-old Jon Sudbo, a researcher

at Oslo's Radium Hospital, made up patients' case histories for a

study about oral cancer published by the British journal The Lancet in

October.

 

The hospital said an independent commission would probe all his

research. Sudbo is on a sick leave and has not been available for comment.

 

" They will start the work mid-week. Hopefully they will give us

answers in one to two months, " said Stein Vaaler, a hospital director.

 

Among improbabilities in Sudbo's research, 250 of about 900 supposed

patients were listed with the same date of birth.

Last year, South Korean scientist Hwang Woo-suk was exposed for

fabricating two studies claming he had cloned human embryos to provide

stem cells.

 

NOT RETROACTIVE

Any new Norwegian law making it a criminal offence to falsify data

could not apply to Sudbo. " A law would not have retroactive effect, "

Deputy Health Minister Wegard Harsvik told Reuters.

 

Richard Horton, editor of The Lancet, said the report published in

October would be retracted if Oslo supplied confirmation that it had

been falsified.

 

The hospital's Vaaler said a retraction would be made quickly if the

researcher admitted in writing to inventing the data. " So far he has

admitted falsifying data verbally, " he said.

 

" There are huge implications for the entire scientific community to

make sure that it has the best safety checks in place to prevent

fabrication and falsification of data, " Horton told Reuters.

 

The panel investigating Sudbo's research would look at why errors were

not spotted by a peer review.

Horton defended the current system of peer review but said the

competitive nature of scientific research probably contributed in both

the Norwegian and South Korean cases.

 

(additional reporting by Patricia Reaney in London)

 

 

THE NEW YORK TIMES

January 15, 2006

 

Idea Lab

 

Trial and Error

By DAVID DOBBS

 

Many of us consider science the most reliable, accountable way of

explaining how the world works. We trust it. Should we? John

Ioannidis, an epidemiologist, recently concluded that most articles

published by biomedical journals are flat-out wrong. The sources of

error, he found, are numerous: the small size of many studies, for

instance, often leads to mistakes, as does the fact that emerging

disciplines, which lately abound, may employ standards and methods

that are still evolving. Finally, there is bias, which Ioannidis says

he believes to be ubiquitous. Bias can take the form of a broadly held

but dubious assumption, a partisan position in a longstanding debate

(e.g., whether depression is mostly biological or environmental) or

(especially slippery) a belief in a hypothesis that can blind a

scientist to evidence contradicting it. These factors, Ioannidis

argues, weigh especially heavily these days and together make it less

than likely that any given published finding is true.

 

Ioannidis's argument induces skepticism about science. . .and a

certain awe. Even getting half its findings wrong, science in the long

run gets most things right - or, as Paul Grobstein, a biologist, puts

it, " progressively less wrong. " Falsities pose no great problem.

Science will out them and move on.

 

Yet not all falsities are equal. This shows plainly in the current

outrage over the revelation that the South Korean researcher Hwang Woo

Suk faked the existence of the stem-cell colonies he claimed to have

cloned. When Hwang published his results last June in Science, they

promised to open the way to revolutionary therapies - and perhaps

fetch Hwang a Nobel Prize. The news that he had cooked the whole thing

dismayed scientists everywhere and refueled an angst-filled debate:

how can the scientific community prevent fraud and serious error from

entering journals and thereby becoming part of the scientific record?

 

Journal editors say they can't prevent fraud. In an absolute sense,

they're right. But they could make fraud harder to commit. Some

critics, including some journal editors, argue that it would help to

open up the typically closed peer-review system, in which anonymous

scientists review a submitted paper and suggest revisions. Developed

after World War II, closed peer review was meant to ensure candid

evaluations and elevate merit over personal connections. But its

anonymity allows reviewers to do sloppy work, steal ideas or delay

competitors' publication by asking for elaborate revisions (it

happens) without fearing exposure. And it catches error and fraud no

better than good editors do. " The evidence against peer review keeps

getting stronger, " says Richard Smith, former editor of the British

Medical Journal, " while the evidence on the upside is weak. " Yet peer

review has become a sacred cow, largely because passing peer review

confers great prestige - and often tenure.

 

Lately a couple of alternatives have emerged. In open peer review,

reviewers are known and thus accountable to both author and public;

the journal might also publish the reviewers' critiques as well as

reader comments. A more radical alternative amounts to open-source

reviewing. Here the journal posts a submitted paper online and allows

not just assigned reviewers but anyone to critique it. After a few

weeks, the author revises, the editors accept or reject and the

journal posts all, including the editors' rationale.

 

Some worry that such changes will invite a cacophony of contentious

discussion. Yet the few journals using these methods find them an

orderly way to produce good papers. The prestigious British Medical

Journal switched to nonanonymous reviewing in 1999 and publishes

reader responses at each paper's end. " We do get a few bores " among

the reader responses, says Tony Delamothe, the deputy editor, but no

chaos, and the journal, he says, is richer for the exchange: " Dialogue

is much better than monologue. " Atmospheric Chemistry and Physics goes

a step further, using an open-source model in which any scientist who

registers at the Web site can critique the submitted paper. The

papers' review-and-response sections make fascinating reading -

science being made - and the papers more informative.

 

The public, meanwhile, has its own, even more radical open-source

review experiment under way at the online encyclopedia Wikipedia,

where anyone can edit any entry. Wikipedia has lately suffered some

embarrassing errors and a taste of fraud. But last month Nature found

Wikipedia's science entries to be almost as accurate as the

Encyclopaedia Brittanica's.

 

Open, collaborative review may seem a scary departure. But scientists

might find it salutary. It stands to maintain rigor, turn review

processes into productive forums and make publication less a

proprietary claim to knowledge than the spark of a fruitful exchange.

And if collaborative review can't prevent fraud, it seems certain to

discourage it, since shady scientists would have to tell their

stretchers in public. Hwang's fabrications, as it happens, were first

uncovered in Web exchanges among scientists who found his data

suspicious. Might that have happened faster if such examination were

built into the publishing process? " Never underestimate competitors, "

Delamothe says, for they are motivated. Science - and science - might

have dodged quite a headache by opening Hwang's work to wider

prepublication scrutiny.

 

In any case, collaborative review, by forcing scientists to read their

reviews every time they publish, would surely encourage humility - a

tonic, you have to suspect, for a venture that gets things right only

half the time.

 

David Dobbs is the author of " Reef Madness: Charles Darwin, Alexander

Agassiz and the Meaning of Coral. "

 

* Copyright 2006The New York Times Company

 

____________

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

 

================================================================================\

==========

BL Fisher Note:

 

Norway has got it right. Doctors and scientists who manipulate

scientific data, whether inside or outside of government, industry or

academia, should be thrown in jail. The judiciary, created by our

founding fathers to hold those accountable who lie and cheat the

public, is an important branch of government. It should be used to

insure that the science buttressing public health policy can be

trusted. This is especially true with regard to vaccines which healthy

people are mandated to take.

 

The New York Times op-ed piece below also has got it right.

Transparency in science and open public discourse about the

credibility of scientific data is essential to keeping everyone honest.

 

Accountability, transparency and justice is essential when it comes to

insuring the integrity of the science which drives public policy and

profoundly affects the life and health of every American.

 

________

See: PLoS Med 2(8): e124 Why Most Published Research Findings Are

False August 30, 2005 John P. A. Ioannidis

http://medicine.plosjournals.org/perlserv/?request=get-document & doi=10.1371/jour\

nal.pmed.0020124

 

______

 

Emacs!

 

Drug profits infect medical studies

January 7, 2006

 

LA Times

By John Abramson

 

SEVERAL OF OUR most venerated scientific journals have recently been

besmirched by allegations of scientific misconduct. Shocking? We

should be just as shocked as Inspector Renault when he discovered

gambling at Rick's Cafe in Casablanca.

 

First, the New England Journal of Medicine made public its concerns

about crucial data having been withheld from its 2000 report on a

study sponsored by Merck exaggerating the safety of its blockbuster

drug Vioxx, now withdrawn. Then the lead author of a seminal article

published in the journal Science reporting the creation of viable stem

cells from cloned human embryos admitted he falsified results and

resigned his academic post in disgrace.

 

This week brings the news that a Johnson & Johnson subsidiary failed

to include the deaths of two patients in a clinical trial of its new

drug for heart failure, Natrecor, in an article published in the

Journal of Emergency Medicine.

 

Why shouldn't we be surprised? Because over the last 25 years,

clinical research has been largely privatized. Three-quarters of the

clinical studies published in the three most respected medical

journals (the New England Journal of Medicine, the Journal of the

American Medical Assn. and the Lancet) are now commercially funded. As

a result, our medical knowledge grows not in the direction that best

improves our health but toward corporate profits, the way that plants

grow toward sunlight.

 

This wasn't always so. Before 1980, most medical studies were publicly

funded, and most academic researchers scorned industry support. Now,

however, the vast majority of clinical trials are commercially funded,

and with the financial stakes so high, there is mounting evidence of

individual scientists and corporations manipulating their findings.

 

Even our most trusted journals are dependent on drug-company money.

Drug makers don't just buy advertising in their pages. According to

Richard Horton, editor of the Lancet, they also pay up to $1.75

million for reprints of articles favorable to their drugs, which sales

reps then hand out to doctors.

 

And many journal articles are biased in favor of their sponsors'

products. A 2003 report in the Journal of the American Medical Assn.

found that clinical studies funded by drug companies are three times

more likely to conclude that the sponsor's drug is the treatment of

choice, compared to studies of the same drug that were not

commercially funded. (This study of the effects of commercial bias, by

the way, was funded by Danish research institutions.) The disturbing

conclusion is that most of the evidence in what doctors believe to be

" evidence-based medicine " is more infomercial than dispassionate science.

 

It's vital to protect the integrity of our medical knowledge. But the

current peer review system alone can't do the job. The journals, and

the peer reviewers they rely on, are in the untenable position of

having to trust that corporate sponsors have accurately and completely

reported their findings. At present, journal editors and peer

reviewers typically are not allowed unrestricted access to the data

from commercially sponsored research. Amazingly, many drug

company-funded researchers who write the articles are also not allowed

access to all of the data the company has collected.

 

There is no better cautionary tale than the unwarranted success of

Vioxx. Greater safety was the only reason for doctors to have

prescribed Vioxx, given that it provided no better relief of arthritis

symptoms or pain and cost up to 10 times more than the older

anti-inflammatory drug, naproxen (sold without a prescription as

Aleve). But Merck's own study clearly showed that Vioxx was more

dangerous than naproxen overall and caused significantly more heart

attacks, blood clots and strokes ­ whether or not the patient had a

previous history of cardiovascular disease.

 

SO WHY DID American doctors prescribe $7 billion worth of Vioxx after

Merck and the Food and Drug Administration knew all this?

 

Because the New England Journal article that ostensibly reported the

results of Merck's study didn't even mention either the cardiovascular

or the overall dangers of Vioxx. Instead, it reported only selective

data on heart attacks and strokes, allowing Merck to claim that Vioxx

wasn't a risk to people without a history of these problems.

 

The Journal's editors are now accusing Merck of withholding critical

data. Shame on Merck. But shame on the Journal too for not insisting

that the article include a discussion of the most important

complications. Doctors were left with the impression that Vioxx was

safer than naproxen when exactly the opposite was true.

 

The Journal again misled its readers in 2001, when one of its

influential review articles dismissed the dangers of Vioxx as perhaps

reflecting " the play of chance. " This article was published seven

months after FDA reviewers' concerns and Merck's own research data,

which documented the dangers, had been posted on the FDA's website.

Worse, the Journal violated its own policy prohibiting scientists with

conflicts of interest from writing review articles. (Both authors had

financial ties to Merck.) That the Journal disclosed those ties

mitigates neither its ethical breach nor the consequences of its

repeated understatement of the risks of Vioxx.

 

This is hardly an academic argument. According to an article in the

Lancet, based on Merck's own data Vioxx probably caused between 88,000

and 144,000 cases of serious heart disease.

 

The stem cell and Natrecor debacles offer further evidence that the

problem is not just individual bad actors or occasional lapses of

scientific integrity by drug makers. It's that even the most

prestigious journals are unable to perform the quality control that

doctors take for granted.

 

Sadly, the evidence shows that it's time for the journals to change

their policies from trust to " trust, but verify. " They should

introduce a new standard requiring an independent audit of the

accuracy and completeness of research reports before they are sent out

for peer review. These scientific auditors should be statisticians and

medical experts who are completely free of conflicts of interest and

are given unfettered access to the data.

 

The journals will rightfully claim they cannot afford to pay for such

scientific oversight. But the lack of oversight is even more costly.

Americans waste billions each year on drugs of dubious value. Until we

find a way to fund quality controls on published research, the cost of

our medical care will continue to soar and our health will suffer.

 

 

JOHN ABRAMSON, a clinical instructor at Harvard Medical School, is

author of " Overdosed America " (HarperCollins, 2004). He is a

consultant to attorneys of patients who took Vioxx and are suing Merck.

 

From the Los Angeles Times