Investigation Finds Serious Flaws in Study That Served as Basis for Guideline Suspected of Killing Nearly a Million Europeans
Dr. Mercola
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 study1, 2 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 guideline3 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 force4).
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,5 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:7
"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 investigations8 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,9 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.
Understanding the Potential Risks and Benefits of Beta-Blockers
Beta-blockers are drugs commonly used in the treatment of high blood pressure and congestive heart failure. They dilate your blood vessels, which reduces your heart rate and blood pressure.
Until recently, the European Society of Cardiology (ESC) recommended using beta-blockers in patients undergoing non-cardiac surgery as well, regardless of whether the patient had a heart condition.
The medical literature and media articles reflect ongoing concern and confusion about whether or not to use beta-blockers in non-cardiac surgeries. What the media are missing is that there are two different classes of patients, and the studies typically involve either one or the other—but rarely do they compare both.
When viewed in total, the research suggests that giving beta-blockers to non-cardiac surgery patients can have lethal consequences in people who do not have a pre-existing, serious, life-threatening heart condition.
In one study,10 perioperative use of beta-blockers showed that people who had the highest risk of dying from them were the ones with the lowest cardiac risk. In effect, they found that perioperative beta blockers may have helped those with the most serious pre-existing heart conditions, while harming those with little or no prior heart risks.11
Anytime drugs are involved, it's important to understand and weigh the risks and benefits. In this case, in order for non-cardiac perioperative beta blockers to be of potential benefit, the risks associated with heart disease must outweigh the heavy risk and side effects of the drug itself, which covers a very limited target population. The moral of this story is that patients should push back to ensure the physician sees a definite need before prescribing this, or any other, drug. In this case, it appears that nearly a million Europeans with little or no need were given the drug as part of a routine guideline, and paid with their lives.
How Many Americans May Have Been Harmed by Similar Guidelines?
If the claim that beta-blockers may be killing some surgical patients — those who don't already have serious risks for cardiac conditions, and who are not already on beta-blockers – what is the potential number of deaths in the US? Fortunately, according to a previous Forbes article12 published in July 2013, US guidelines are less aggressive in their support of perioperative beta blockers. Researchers say more than 30 million non-cardiac surgeries occur in the US each year,13 so if you divide 30 million by the 25 percent that European researchers claim may be harmed by this one-size-fits-all practice, you end up with a number of 7.5 million American surgery patients POTENTIALLY harmed by beta blockers each year. The numbers could be higher, or lower.
According to the CDC,14 the total number of surgical procedures performed in the US is 51.4 million, of which 4.7 million are cardiac-related. Using this statistic, the number of Americans potentially affected by dangerous beta-blockers is 46.7 million, giving us a potential number of more than 11.6 million who could die from this drug every year in the US. On the other hand, we don’t know how many already had a life-threatening heart condition prior to going in for non-cardiac surgery and might have benefited from the drug, opposed to patients whose risk of death is increased by the absence of prior heart disease...
Tragic Fact: Most Research Claims Cannot Be Trusted
In 2005, Dr. John Ioannidis, an epidemiologist at Ioannina School of Medicine in Greece, showed that there is less than a 50 percent chance that the results of any randomly chosen scientific paper will be true.15 So just think about this for a moment. You have a far better chance of tossing a coin and guessing correctly than you do for any random "scientific" paper is valid. This is extraordinary, especially since skeptics who regularly ridicule natural medicine use these studies as a justification for the vilifications.
Additionally, a large number of investigations have revealed that when industry funds the research, it's virtually guaranteed to be favorable to their product. Other conflicts of interest play a significant role in the outcome as well. Did the fact that Dr. Poldermans was the chairman of the committee that drafted the beta-blocker guideline influence his research conduct? We don't know, but there's always a risk that hidden incentives can come into play with this kind of conflict of interest.
In recent years, a number of individuals have taken it upon themselves to prove just how easily the system can be fooled by fake science. A previous article in Slate Magazine16 headlined: "How Gobbledygook Ended Up in Respected Scientific Journals," reveals how a group of MIT graduate students created a program that randomly generates computer-written research papers. Shockingly, these fake papers have been routinely published in various scientific journals over the past several years.17
No one knows exactly how many have been published as the creators of the program, called SCIgen, made it available for free download. An unknown number of people have used it18 besides its creators. Cyril Labbé, a French computer scientist developed a way to detect SCIgen generated manuscripts,19 and have alerted publishers about 205 of them so far. Confounding the problem further, highly paid PR firms disguised as scientific organizations have been created for the specific purpose of controlling how the media reports new science and portrays industry. Two examples are Science Media Centre (SMC) and the American Council on Science and Health (ACSH), both of which are heavily funded by the industries they represent.
Exercising Good Judgment in an Era of Conflicting Interests
Ultimately, the take-home message here is that even if a drug or treatment is "backed by science," this does not guarantee that it's safe or effective. Likewise, if an alternative treatment has not been published in a medical journal, it does not mean it is unsafe or ineffective. This is why it's crucial to have a philosophical framework to assist you in evaluating all these studies. First, always consider the source of the information... Who funded the study and where it was published? Also, do not accept the findings of any single paper, as scientific results are only reliable after replication and the building of consensus through time. Look for corroboration.
Anytime you're trying to address a health issue, make full use of all the resources available to you, including your own common sense and reason. Since it is well established that most drugs do absolutely nothing to treat the cause of disease, it would be prudent to exercise the precautionary principle when evaluating a new drug claim, as it will more than likely be seriously flawed, biased, or worse.
If you value your health and life, remember that prescription drugs kill more people than illegal drugs or motor vehicle accidents. Hypertension is dangerous if uncontrolled, increasing your risk for heart attack and stroke. But using drugs like beta-blockers to lower your blood pressure may shorten your lifespan instead of extending it. For recommendations on lowering your blood pressure without the use of drugs, please see my previous article, "Foundational Lifestyle Strategies to Maintain Healthy Blood Pressure."
If you're facing a health challenge, it is best to identify a qualified natural health consultant—someone who really understands health at a foundational level and has had extensive experience in helping others resolve their health care challenges. Just make sure to see a competent regular physician to make certain any serious conditions like cancer are ruled out as well.