Investigation Finds Serious Flaws in Study That Served as Basis for Guideline Suspected of Killing Nearly a Million Europeans

Mercola.com
Take Control of Your Health

By: Dr. Mercola
Date: 13 August 2014

---

Investigation Finds Serious Flaws in Study That Served as Basis for Guideline Suspected of Killing Nearly a Million Europeans

This post contains exrtacts from the above article. To view the full article, click on the article title above.

Investigations assessing the prevalence of scientific fraud and/or its impact show that the problem is widespread and serious—to the point of making most of "science-based" medicine a genuine joke.

Conflict of interest is another pervasive problem that threatens the integrity and believability of most studies. We've been repeatedly faced with study findings that are clearly tainted with industry bias.

The soda industry's study finding that drinking diet soda makes you lose more weight than drinking no soda at all is just one of the most recent examples. It blatantly contradicts a massive body of research demonstrating that artificial sweeteners disrupt your body's metabolism and lead to greater weight gain than regular sugar.

Earlier this year, I reviewed findings that a flawed research paper may have led to the death of as many as 800,000 Europeans. The discredited paper served as the basis for a guideline that helped establish the "standard of care" to use beta-blockers in non-cardiac surgery patients.

The study's author, Dr. Poldermans, was also the chairman of the committee that drafted the guideline (he has since resigned from his position with the task force).

Physicians who failed to follow this guideline were at risk of medical reprimands. This case is a sobering example demonstrating the need for maintaining strict scientific integrity, and why the issue of conflicts of interest really needs to be more widely understood and addressed.

Scientific misconduct can have a very real impact on your health, or someone you love, as doctors routinely use published research to implement or alter treatment protocols.

Investigation Finds Serious Flaws in Prestigious NEJM Study

An investigation into Dr. Poldermans beta-blocker study has now been concluded, and as reported by Forbes, the full extent of the misconduct is almost impossible to ascertain, although it appears to be extensive:

"Erasmus Medical Center says it has wrapped up its investigation of Don Poldermans, the disgraced cardiology researcher who was fired for research misconduct...

One major finding... is that the most prestigious and influential publication from the Poldermans' group, the 1999 publication of the DECREASE 1 study in the New England Journal of Medicine⁶– appears to be riddled with serious problems...

The Dutch investigators found a number of important discrepancies between the trial conduct and the written protocol found in the archive of the Medical Ethics Committee. Poldermans told the investigators that there was an updated version of the protocol but this document has not been found."

Another major problem is that while Dr. Poldermans claimed adverse events were evaluated by two cardiologists who allegedly made up the trial's safety committee – both of them deny having any involvement in the study.

Only one of them could remember having been asked to participate, but claims he never actually did any evaluations. According to Dr. Poldermans, the two cardiologists had reviewed all patient data. He also claims that it was this two-man safety committee's decision to end the trial early. According to the featured article:

"One member said that he had given some advice to Poldermans by telephone about 'stopping rules.' Poldermans told the investigators that, contrary to the published report, the decision to stop the trial had been made by 'the steering committee.'

Perhaps surprisingly, the report does not conclude that the trial is invalid. Instead, it concludes that doubts about the scientific integrity can neither be confirmed nor denied."

The investigators also reviewed Dr. Poldermans extensive body of work, some 495 studies in all, trying to ascertain whether the studies actually took place. Lack of documentation and missing records hampered the investigation, suggesting Dr. Poldermans contribution to the field of medicine may indeed have been based on large-scale misconduct.

Most Misconduct Occurs in Drug Research

Previous investigations have revealed that the vast majority of scientific misconduct occurs in the drug literature, compared to the biomedical literature. Three guesses as to why that might be, and the first two don't count... Of course the answer is massive drug company conflict of interest and manipulation.

Two years ago, researchers at the University of Illinois at Chicago's Center for Pharmacoeconomic Research found that nearly 75 percent of retracted drug studies were attributed to scientific misconduct, which includes data falsification, data fabrication, questionable veracity, and plagiarism.

Tragically, since these are the types of studies that many health care professionals rely on to make treatment recommendations, large numbers of patients can be affected when false findings are published.
This certainly appears to be the case here—nearly one million surgical patients losing their lives over a five-year span as a result of a hazardous drug guideline is pretty significant.

Vioxx is another example of what canhappen when a drug is manufactured and marketed under false pretenses. It killed more than 60,000 people in just a few years' time, before it was removed from the market.

To this day there are lingering questions about the soundness of the research backing Vioxx. In 2008, Dr. Joseph S. Ross of New York's Mount Sinai School of Medicine came across ghostwritten research concocted by the company's marketing department, while reviewing documents related to lawsuits filed against Merck...

It's important to understand that our current medical system has been masterfully orchestrated by the drug companies to create a system that gives the perception of science while in fact being a heavily manipulated process designed to sell expensive and potentially toxic drugs. The drug companies that make them benefit, while your health suffers.