[NVIC] Doctors Behaving Badly

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

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" Protecting the health and informed consent rights of children since 1982. "

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BL Fisher Note:

It is no wonder M.D./Ph.D. researchers find themselves in a credibility

gap. We have put them on a pedestal for far too long, creating an elitist

class which considers themselves entitled to special entitlements and

protection from ethical constraints.

For far too long, the American public has been worshipping at the feet of

those who practice science and medicine, naively assuming men and women who

gravitate toward the healing arts are somehow exempt from human flaws that

tempt them to cut corners or exploit others for profit, career advancement

and fame. It has been a costly mistake to allow scientists and doctors to

police themselves because we have based our entire health care system on a

collective trust they are always telling the truth.

Transparency, accountability and justice are three values which will help

keep the scientific research process and those who operate it truthful. The

public should have full access to all scientific data and analysis used to

proclaim a medical intervention is safe and effective for human use. Those

who accept responsibility for proclaiming a medical intervention safe and

effective should be held accountable if they are not truthful. And those who

are harmed by a medical intervention which has been falsely proclaimed to be

safe and effective should be able to access the civil court system to seek

justice.

htp://www.nytimes.com/2006/05/02/health/02docs.html?ei=5088 & en=989fce7c62c8e

849 & ex=1304222400 & partner=rssnyt & emc=rss & pagewanted=all

The NY Times

May 2, 2006

The Doctor's World

For Science's Gatekeepers, a Credibility Gap

By LAWRENCE K. ALTMAN, M.D.

Recent disclosures of fraudulent or flawed studies in medical and

scientific journals have called into question as never before the merits of

their peer-review system.

The system is based on journals inviting independent experts to critique

submitted manuscripts. The stated aim is to weed out sloppy and bad

research, ensuring the integrity of the what it has published.

Because findings published in peer-reviewed journals affect patient care,

public policy and the authors' academic promotions, journal editors contend

that new scientific information should be published in a peer-reviewed

journal before it is presented to doctors and the public.

That message, however, has created a widespread misimpression that passing

peer review is the scientific equivalent of the Good Housekeeping seal of

approval.

Virtually every major scientific and medical journal has been humbled

recently by publishing findings that are later discredited. The flurry of

episodes has led many people to ask why authors, editors and independent

expert reviewers all failed to detect the problems before publication.

The publication process is complex. Many factors can allow error, even

fraud, to slip through. They include economic pressures for journals to

avoid investigating suspected errors; the desire to avoid displeasing the

authors and the experts who review manuscripts; and the fear that angry

scientists will withhold the manuscripts that are the lifeline of the

journals, putting them out of business.By promoting the sanctity of peer

review and using it to justify a number of their actions in recent years,

journals have added to their enormous power.

The release of news about scientific and medical findings is among the most

tightly managed in country. Journals control when the public learns about

findings from taxpayer-supported research by setting dates when the research

can be published. They also impose severe restrictions on what authors can

say publicly, even before they submit a manuscript, and they have penalized

authors for infractions by refusing to publish their papers. Exceptions are

made for scientific meetings and health emergencies.

But many authors have still withheld information for fear that journals

would pull their papers for an infraction. Increasingly, journals and

authors' institutions also send out news releases ahead of time about a

peer-reviewed discovery so that reports from news organizations coincide

with a journal's date of issue.

A barrage of news reports can follow. But often the news release is sent

without the full paper, so reports may be based only on the spin created by

a journal or an institution.

Journal editors say publicity about corrections and retractions distorts and

erodes confidence in science, which is an honorable business. Editors also

say they are gatekeepers, not detectives, and that even though peer review

is not intended to detect fraud, it catches flawed research and improves the

quality of the thousands of published papers.

However, even the system's most ardent supporters acknowledge that peer

review does not eliminate mediocre and inferior papers and has never passed

the very test for which it is used. Studies have found that journals publish

findings based on sloppy statistics. If peer review were a drug, it would

never be marketed, say critics, including journal editors.

None of the recent flawed studies have been as humiliating as an article in

1972 in the journal Pediatrics that labeled sudden infant death syndrome a

hereditary disorder, when, in the case examined, the real cause was murder.

Twenty-three years later, the mother was convicted of smothering her five

children. Scientific naïveté surely contributed to the false conclusion, but

a forensic pathologist was not one of the reviewers. The faulty research in

part prompted the National Institutes of Health to spend millions of dollars

on a wrong line of research.

Fraud, flawed articles and corrections have haunted general interest news

organizations. But such problems are far more embarrassing for scientific

journals because of their claims for the superiority of their system of

editing.

A widespread belief among nonscientists is that journal editors and their

reviewers check authors' research firsthand and even repeat the research. In

fact, journal editors do not routinely examine authors' scientific

notebooks. Instead, they rely on peer reviewers' criticisms, which are based

on the information submitted by the authors.

While editors and reviewers may ask authors for more information, journals

and their invited experts examine raw data only under the most unusual

circumstances.

In that respect, journal editors are like newspaper editors, who check the

content of reporters' copy for facts and internal inconsistencies but

generally not their notes. Still, journal editors have refused to call peer

review what many others say it is — a form of vetting or technical editing.

In spot checks, many scientists and nonscientists said they believed that

editors decided what to publish by counting reviewers' votes. But journal

editors say that they are not tally clerks and that decisions to publish are

theirs, not the reviewers'.

Editors say they have accepted a number of papers that reviewers have

harshly criticized as unworthy of publication and have rejected many that

received high plaudits.

Many nonscientists perceive reviewers to be impartial. But the reviewers,

called independent experts, in fact are often competitors of the authors of

the papers they scrutinize, raising potential conflicts of interest.

Except when gaffes are publicized, there is little scrutiny of the quality

of what journals publish.

Journals have rejected calls to make the process scientific by conducting

random audits like those used to monitor quality control in medicine. The

costs and the potential for creating distrust are the most commonly cited

reasons for not auditing.

In defending themselves, journal editors often shift blame to the authors

and excuse themselves and their peer reviewers.

Journals seldom investigate frauds that they have published, contending that

they are not investigative bodies and that they could not afford the costs.

Instead, the journals say that the investigations are up to the accused

authors' employers and agencies that financed the research.

Editors also insist that science corrects its errors. But corrections often

require whistle-blowers or prodding by lawyers. Editors at The New England

Journal of Medicine said they would not have learned about a problem that

led them to publish two letters of concern about omission of data concerning

the arthritis drug Vioxx unless lawyers for the drug's manufacturer, Merck,

had asked them questions in depositions. Fraud has also slipped through in

part because editors have long been loath to question the authors.

" A request from an editor for primary data to support the honesty of an

author's findings in a manuscript under review would probably poison the air

and make civil discourse between authors and editors even more difficult

than it is now, " Dr. Arnold S. Relman wrote in 1983. At the time, he was

editor of The New England Journal of Medicine, and it had published a

fraudulent paper.

Fraud is a substantial problem, and the attitude toward it has changed

little over the years, other editors say. Some journals fail to retract

known cases of fraud for fear of lawsuits.

Journals have no widely accepted way to retract papers, said Kennedy,

editor in chief of Science, after the it retracted two papers by the South

Korean researcher Dr. Hwang Woo Suk, who fabricated evidence that he had

cloned human cells.

In the April 18 issue of ls of Internal Medicine, its editor, Dr. Harold

C. Sox, wrote about lessons learned after the journal retracted an article

on menopause by Dr. Poehlman of the University of Vermont.

When an author is found to have fabricated data in one paper, scientists

rarely examine all of that author's publications, so the scientific

literature may be more polluted than believed, Dr. Sox said.

Dr. Sox and other scientists have documented that invalid work is not

effectively purged from the scientific literature because the authors of new

papers continue to cite retracted ones.

When journals try to retract discredited papers, Dr. Sox said, the process

is slow, and the system used to inform readers faulty. Authors often use

euphemisms instead of the words " fabrication " or " research misconduct, " and

finding published retractions can be costly because some affected journals

charge readers a fee to visit their Web sites to learn about them, Dr. Sox

said.

Despite its flaws, scientists favor the system in part because they need to

publish or perish. The institutions where the scientists work and the

private and government agencies that pay for their grants seek publicity in

their eagerness to show financial backers results for their efforts.

The public and many scientists tend to overlook the journals' economic

benefits that stem from linking their embargo policies to peer review. Some

journals are owned by private for-profit companies, while others are owned

by professional societies that rely on income from the journals. The costs

of running journals are low because authors and reviewers are generally not

paid.

A few journals that not long ago measured profits in the tens of thousands

of dollars a year now make millions, according to at least three editors who

agreed to discuss finances only if granted anonymity, because they were not

authorized to speak about finances.

Any influential system that profits from taxpayer-financed research should

be held publicly accountable for how the revenues are spent. Journals

generally decline to disclose such data.

Although editors of some journals say they demand statements from their

editing staff members that they have no financial conflicts of interest,

there is no way to be sure. At least one editor of a leading American

journal had to resign because of conflicts of interest with industry.

Journals have devolved into information-laundering operations for the

pharmaceutical industry, say Dr. , the former editor of BMJ,

the British medical journal, and Dr. Horton, the editor of The

Lancet, also based in Britain.

The journals rely on revenues from industry advertisements. But because

journals also profit handsomely by selling drug companies reprints of

articles reporting findings from large clinical trials involving their

products, editors may " face a frighteningly stark conflict of interest " in

deciding whether to publish such a study, Dr. said.

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