BMJ: Discipline Researchers Who Withhold Research Results

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BMJ: Discipline Researchers Who Withhold Research Results

Post by rlstanley » Sat 7 Jan 2012 4:07 ... h-results/

BMJ: Discipline Researchers Who Withhold Research Results

Ethics Illustrated
Posted by Jennifer Miller, Bioethicist

January 5, 2012

[medpagetoday] Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing healthcare costs, according to a series of reports published by the British Medical Journal(BMJ).

“The current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine,” according to an editorial published with the reports.

A solution, according to Richard Lehman, MD, a consultant psychiatrist at the University of Oxford, and Elizabeth Loder, MD, MPH, a contributing editor at BMJ, would be to subject researchers who withhold data to “disciplinary action by professional organizations.”

An unexpected finding in the BMJ analysis was that serious lapses appear to have occurred in clinical trials funded by the National Institutes of Health.

According to the analysis, less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.

While industry-related profit motives may not be a factor in such cases, there are other possible explanations, said senior author Harlan Krumholz, MD, of Yale University.

Sometimes researchers may get an unexpected finding that contradicts a position they have staked out, he said.

“It is a conflict of their academic beliefs,” he said.

At the same time, medical journals may not want to publish negative findings, he said.

A second BMJ paper assessed clinical trials of drugs that already had received at least one Food and Drug Administration approval. In such cases a law requires the reporting within one year of the completion of the trial.

Despite the law, only 163 of 738 such trials, or 22%, had reported the results within a year, the paper found.

Lead author Andrew Prayle, PhD, a researcher with the University of Nottingham, in England, said he hoped the finding would spur more researchers to post summaries of the work at the NIH site,

The BMJ papers are just the latest salvos in an ongoing controversy over both industry support of research and control of raw data from trials.

“It is grossly unethical and an insult to the integrity of medicine when this is allowed to occur and go unpunished,” said orthopedic surgeon Chuck Rosen, MD, president of the Association for Medical Ethics.

From diabetes drugs to spine surgery products, scandals involving concealed data have mounted. Consider the cases of a trio of drugs that were the subject of Journal Sentinel/MedPage Today articles:

For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing the drug provided no benefit in improving artery health. During that time the drug was heavily marketed to consumers in TV ads. The situation came to light in 2008 after a congressional investigation was launched.

In 2003, a clinical trial of Multaq, a drug that treated irregular heart beat, was stopped because more patients who were getting the drug were dying than those who were getting a placebo. However, the study was not published until five years later.

In 2007, an independent analysis of the diabetes drug Avandia found that the drug increased heart attacks and cardiovascular deaths.

Steven Nissen, MD, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.

“Had the medical community known about this hazard, Avandia would likely never have become the world’s largest selling diabetes drug,” said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “Our ability to provide the best care for patients is dependent on access to all of the available clinical trial evidence, regardless of whether the study showed favorable results.”

While much of the criticism of suppressed medical research has been aimed at drug companies, research data from medical devices also has been delayed, especially when it reflects negatively on a product.

Critics pointed to Medtronic’s bone-growth stimulating back surgery product known as Infuse.

Last year, the Journal Sentinel/MedPage Today reported that the results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers. The paper was written by surgeons who have received millions of dollars in royalties from other Medtronic spine products.

What’s more, the authors of the belated paper downplayed the bone overgrowth, saying it did not harm patients, a claim that was flatly refuted by a doctor interviewed by the Journal Sentinel/MedPage Today.

The doctor, an Oklahoma orthopedic surgeon, said two of his patients who were in the trial had to undergo additional surgery because the bone overgrowth was painfully impinging on nerve roots. One of the patients, a man who was in his 50s at the time, needed three operations — one for the implant, a second to remove the unwanted bone formation, and a third when the additional bone grew back yet again.

Independent research and Journal Sentinel stories since have noted that unpublished data showed that Infuse was linked to a variety of serious complications, including sterility in men and cancer.

The failure of the medical literature to report such findings “has been a major failure in our field,” said Eugene Carragee, MD, a Stanford University orthopedic surgeon and editor-in-chief of the Spine Journal.

Carragee said the BMJ analysis and its call for disciplinary action against offending doctors is “an important departure from the historical laissez-faire attitude of the recent past.”

By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage

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Re: BMJ: Discipline Researchers Who Withhold Research Result

Post by rlstanley » Sat 7 Jan 2012 4:20

Scientists say unreported drug data a health hazard
Reuters, Tuesday January 3 2012

LONDON, Jan 4 (Reuters) ..."Missing data is a serious problem in clinical research," the scientists said about their findings. "It distorts the scientific record, so that clinical decisions cannot be based on the best evidence."

New rules set out in 2007 by the U.S. Food and Drug Administration, which regulates the world's largest market for drugs, made publication of a results summary on the website within 12 months mandatory for all eligible trials that were either started or ongoing as of September 2007.

As of 2008, the global drug industry body the International Federation of Pharmaceutical Manufacturers and Associations also required its members -- which include the world's major drugmakers -- to register all trials in patients and publish a summary of the results.

But in the BMJ studies, Richard Lehman from Britain's Oxford University and the BMJ's clinical epidemiology editor Elizabeth Loder described finding a "culture of haphazard publication and incomplete data disclosure". ...

Drug firms, for their part, have been publishing more data from trials they sponsor, but this is sometimes done on obscure websites rather than in high-profile peer-reviewed journals, and critics say the industry is still far from transparent....

"Most clinicians assume that the complex regulatory systems that govern human research ensure that this knowledge (from clinical trials) is relevant, reliable, and properly disseminated. It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case," Lehman and Loder wrote in a commentary on the findings.

"When the word 'mandatory' turns out to mandate so little, the need for stronger mechanisms ... becomes very clear."

A third study in the series found that when previously unpublished data are included in meta-analyses of drug trials -- studies which seek to collate all the available evidence to come to a more robust conclusion -- the results are often different.

The researchers said the results showed that "past failures to ensure proper regulation and registration of clinical trials, and a current culture of haphazard publication and incomplete data disclosure, make the proper analysis of the harms and benefits ... almost impossible."

Lehman and Loder warned that patients "will have to live with the consequences of these failures for many years to come" and called for more robust regulation and full access to raw trial data to allow better understanding in future of the benefits and harms of many kinds of medicines.

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Re: BMJ: Discipline Researchers Who Withhold Research Result

Post by rlstanley » Sun 8 Jan 2012 2:30

In the Age of Transparency, Who Should Control the Raw Data?

Media Page Today, By John Fauber, 25 June 2010

When asked about his lack of access to raw data, Page maintained that this was not a problem for him and did not negate his ability to draw clinically relevant conclusions. He vouched for the accuracy and completeness of the data though he did not actually see those raw data.

This process, researchers held at arm’s length from raw data, has become fairly standard over the last 30 years. Today drug companies such as sanofi-aventis, which paid for the study, routinely collect the data and perform analyses without an external audit for accuracy or completeness....

Page says it comes down to trusting the drug company....

But more and more critics say "trust" is not enough. They say there is something wrong with the way medical research is done in America. They point to a growing number of scandals in which drug companies allegedly have suppressed or manipulated research, skewing results to make drugs look better and safer.
full article: ... mias/20898

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