By Dr. Mercola
Most people assume that scientific integrity is somehow assured; that there are safeguards along the way, preventing fraudulent research from harming patients.
Unfortunately, scientific misconduct has become a very serious and widespread problem that threatens the entire paradigm of science-based medicine—unless changes are made.
Again and again, papers assessing the prevalence of scientific fraud and/or the impact this is having shows that the situation is dire and getting worse. In short, we have lost scientific integrity, and without it, "science-based medicine" is just a term without substance.
Conflict of interest is another pervasive problem within the research field, and the featured article highlights a case that contains both.
Beta-blockers are drugs commonly used in the treatment of high blood pressure and congestive heart failure. They work primarily by blocking the neurotransmitters norepinephrine and epinephrine (adrenaline) from binding to beta receptors, thereby dilating blood vessels, which reduces your heart rate and blood pressure.
Until recently, the European Society of Cardiology (ESC) also recommended using beta-blockers in patients undergoing non-cardiac surgery.
A recent article in Forbes Magazine1 highlights how medical guidelines based on questionable science may have resulted in the death of hundreds of thousands of patients in just a few years:
"Last summer, British researchers provoked concern when they published a paper raising the possibility that by following an established guideline UK doctors may have caused as many as 10,000 deaths each year,2" Larry Husten, editorial director of WebMD professional news, writes.
"Now, they have gone a step further and published an estimate that the same guideline may have led to the deaths of as many as 800,000 people in Europe over the last five years3...
The 800,000 deaths are comparable in size to the worst cases of genocide and mass murder in recent history."
Guideline Based on Discredited Research May Have Caused 800,000 Deaths
The paper, originally published in the online version of the European Heart Journal,4 is a testament to the dangers of modern medicine, and why scientific rigor needs to be reestablished as the norm. As I've discussed before, scientific misconduct by medical researchers affects real people, living real lives. It could affect you.
When flawed research is used as the basis for medical guidelines, people that shouldn't die do... All in the name of increasing profits to the drug company with reckless abandon and little to no concern for the casualties.
The issue goes back to research done by Don Poldermans,5 a cardiovascular researcher in the Netherlands, who was fired for scientific misconduct in 2011. Some of the strongest evidence for the European Society of Cardiology's (ESC) guidelines on beta-blocker use in patients undergoing non-cardiac surgery came from Poldermans' DECREASE trial.
It's well worth noting that Poldermans was also the chairman of the committee that drafted the guideline (he has since resigned from his position with the task force6). While his DECREASE trial has not as of yet been retracted, the Erasmus Medical Center in Rotterdam stated7 he was fired because he was:
"…careless in collecting the data for his research. In one study, it was found that he used patient data without written permission, used fictitious data and that two reports were submitted to conferences which included knowingly unreliable data."
You would think that once this was known, immediate action would result. However, it took two years before the ESC withdrew the beta-blocker recommendation once the Poldermans scandal had unraveled. This is absolutely scandalous as nearly a half of a million people died unnecessarily due to the delay.
In that two-year span, many European clinicians may have felt that their hands were tied, as failing to follow guidelines can lead to being penalized—even if the doctor knows the guidelines are likely to do more harm than good. As reported by Forbes:8
"They note that more than half of the lives lost—potentially more than 400,000—may 'have occurred after the research was discredited,' though some of the damage may have been mitigated if doctors changed their practice after reading about the controversy...
Cole and Francis argue that much needs to be changed in the application of medical research: 'The aviation profession has led the way in systems to prevent, recognize, study, and learn from professional failures. Clinical medicine is now following the same path. We must develop similar systems for research.'"
Understanding and Weighing the Potential Risks and Benefits...
While some studies show perioperative beta blockers save lives, the featured report found that they're killing people. So which is it? It turns out that both may be true--the BIG DIFFERENCE is that it all depends on whether you have a pre-existing, serious, life-threatening heart condition or not.
If you DO have a pre-existing, life-threatening condition, beta blockers appear to be helpful when you go into surgery. But if you DON'T, they appear to harm or even kill you. o, it’s important to realize that various studies address two very different scenarios:
- People already taking beta blockers for serious heart conditions
- People who are given beta blockers prior to surgery, even though their risk is negligible
One study9 opposing perioperative use of beta blockers showed that people who had the highest risk of dying from beta blockers were NOT the ones with the highest cardiac risk, meaning: Beta blockers may have helped those with the most serious conditions, while harming those with little or no prior heart risks.10
The first indication that beta blockers should not be routinely given prior to non-cardiac surgery due to the increased risk of death came out in 2008,11 but it appears that even though cardiology guidelines were eventually changed in both the UK and the US to reflect this concern, physicians continued to prescribe the perioperative use of beta blockers anyway.
Now, the reason for the controversy is that Poldermans has been called out for corrupt research practices; thus, now researchers are speculating that hundreds of thousands of people have been killed by the mass use of beta blockers before surgery.
However, as early as 2009 Poldermans claimed12 that the adverse events are caused by individual physicians using too high of a dosage of beta blockers, and not because of problems relating to his research.
The medical literature and media articles reflect ongoing concern and confusion about whether or not to give beta blockers with non-cardiac surgeries. What the media are missing is that the studies are talking about two different classes of patients.
It’s really all about weighing the risk/benefit ratio. In order to be of potential benefit, the risks associated with heart disease must outweigh the heavy risk and side effects of the drug itself, which is a very limited target population.
The moral of the 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 people—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 article13 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,14 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, 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 deaths each year. 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...
Some validation for the concern that beta blockers is not a great idea for everyone may be found in an October 2013 study15 done in New York, which hasn’t been given much attention. It found that beta blocker use increased the odds of having an acute coronary event. In fact, researchers at SUNY were so concerned by what they found that they commented:
“The results from this study become especially important in view of the fact that beta-blockers are currently recommended by the American College of Cardiology/American Heart Association (ACC/AHA) 2011 guidelines regarding cardiac risk and management before, during and after surgery,"
Paper Removed for Peer Review
Interestingly, the paper that summarized the action taken to stop using the drug that was killing hundreds of thousands was quickly removed from the European Heart Journal's website, without explanation. Husten followed up with the journal, and was told that, due to an oversight, the paper had not been peer-reviewed prior to publication.
This is standard procedure for any article containing "scientific statements." The question is whether the paper actually contained statements in need of peer-review in the first place. Based on the reply from the paper's authors, this could be a matter of debate. Husten writes:
"The authors of the 'disappeared' article, Graham Cole and Darrel Francis, sent the following statement: 'Our article is a narrative of events with a timeline figure and a context figure. We had not considered it to contain scientific statements, but we admit that it does multiply together three published numbers...
The first of our two EHJ articles merely says that our community, which races to take credit when research-led therapy improves survival, must be equally attentive to the possibility of harm. The leverage of leadership means the magnitude of either may be far from trivial. Where our article relayed numbers, we made clear that alternative values were possible. The focus for readers was on how serious the consequences can be when clinical research goes wrong...
We admire Prof Lüscher's diligence in sending for peer review what we thought was merely multiplication. We await the review of the pair of articles. The first narrated one instance of a pervasive problem. The second suggests what each of us can do to reduce recurrences.'"
Research Claims an Apple a Day Is Comparable to Daily Statin Use
In related news, a recent study published in the British Medical Journal (BMJ)16 found that simply eating an apple a day might help prevent cardiovascular-related deaths in those over 50 to a similar degree as using a daily statin. This reminds me of the recent analysis17 that found exercise is just as potent as medications for pre-diabetes and heart disease. In fact, the evidence was so strong, the researchers suggested that drug companies ought to be required to include exercise for comparison when conducting clinical trials for new drugs. Perhaps diet ought to be a standard comparator as well?
As reported by Medical News Today,18 there's plenty of research suggesting that statins will reduce your risk of a vascular event like heart attack and stroke, even if you don't have an underlying risk of cardiovascular problems. Such questionable research is being used to push for more widespread use of the drugs. But just how valuable is such research, once you compare it to something as simple as adding an apple to your diet?
"...[T]he investigators decided to see how widespread use of statins would impact the rate of vascular mortality in the over-50 UK population, and they compared this with the effects of apple consumption... From their calculations, they found that if 17.6 million people in the UK took a statin a day, this would reduce the number of vascular deaths by 9,400. If the whole over-50 UK population (22 million) ate an apple a day, this could reduce the annual number of vascular deaths by 8,500.
But the researchers took into account the side effects of statin use, stating that prescribing a statin to everyone over the age of 50 could lead to over 1,000 extra cases of muscle disease (myopathy) and more than 10,000 additional cases of diabetes..."
Beware of New Cholesterol Guidelines
One in four Americans over the age of 45 currently take a statin drug, despite the fact that there are over 900 studies proving their adverse effects, and recently updated treatment guidelines for high cholesterol will likely DOUBLE the number of Americans being prescribed these dangerous drugs.
While they're trying to sell these new cholesterol guidelines as being focused on prevention through lifestyle modifications along with statin therapy, this is a gross misapplication of the word "prevention," as these drugs cannot possibly address the underlying conditions of heart or cardiovascular disease. (Even more egregious, it completely ignores recent research showing that statins can effectively nullify the benefits of exercise, which is one of the primary heart disease prevention strategies.)
It's also important to know that the cardiovascular risk calculator used to determine whether you are a candidate for statin drug treatment under these new guidelines (which ignores your cholesterol level), is seriously flawed. Until or unless the calculator is revised, it may overestimate your cardiovascular health risk by anywhere from 75 to 150 percent! Basically, it is currently calibrated in such a way that virtually everyone will qualify for statin treatment, no matter how healthy you are.
How to Get Solid Information in an Era of Confusion and Corruption
Ultimately, the take-home message here is that even if a drug or treatment is "backed by science," this in absolutely no way guarantees it is 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. Exercising and eating more fresh fruits and vegetables may be just as effective as a drug treatment, as some studies have shown. That is why it is so crucial to have a philosophical framework to assist you in evaluating all these studies that can fire off your alarm signals if it violates those guidelines.
You've got to use all the resources available to you, including your own common sense and reason, true experts' advice, and other's experiences, to determine what medical treatment or advice will be best for you in any given situation. I advise you to remain skeptical but open -- even if it is something I'm saying, you need to realize that YOU are responsible for your and your family's health, not me, and certainly not drug companies trying to sell their wares and convince you to take dangerous "symptom-cover-ups" disguised as science-based solutions.
Since it is very well established that most prescribed drugs do absolutely nothing to treat the cause of disease, it would be prudent to exercise the precautionary principle when evaluating ANY new drug claim, as it will more than likely be seriously flawed, biased, or worse.
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 serious disorders like cancer are ruled out as well.
Basic Tenets of Optimal Health
I have provided some general conclusions I have reached after seeing 25,000 patients and actively seeking to achieve a high level of wellness myself. Hopefully, you can use these as a starting point to develop your own personalized philosophical framework that can help you sort through any existing or new health recommendations as an additional filter, to help you determine if they are valid or not. We clearly want to learn from others' mistakes. No need to blindly follow medical advice that has killed hundreds of thousands.
- Eat a healthy diet focused on fresh, whole foods (ideally organic and/or locally grown). Try to eat a large portion of your food raw. You want to pay careful attention to keeping your insulin levels down, which means avoiding sugars and grains of all kinds, and replacing the lost carbs with healthful fats. Also, be mindful of your protein sources, making sure they're of high quality (ideally organically-raised and pasture-fed). A high-fat, moderate-protein, low-carb diet is likely to improve the health of most people. My optimized Nutritional Plan can guide you, whether you're at a beginner or advanced level.
- Consume healthy fat. The science is loud and clear on this point: omega-3 fats are essential for optimal health. Unfortunately, most fish commercially available today are polluted with mercury, PCBs, and other toxic substances, which is why I recommend you take a supplement like krill oil instead of getting it from your food. Other healthy fats include coconut oil, avocados, olives, olive oil, butter and macadamia nuts. All these fats are low in protein and carbs and will not impair insulin, leptin or mTOR.
- Make clean, pure water your primary beverage, and steer clear of all sweetened and/or flavored beverages, including those that contain artificial sweeteners
- Manage your stress. There are many effective stress-relieving tools out there, but I have found energy psychology approaches like the Emotional Freedom Technique (EFT) to be very helpful.
- Exercise regularly. Ideally, you want a comprehensive fitness regimen that includes stretching, high intensity interval training, core strengthening exercises, and strength training
- Get plenty of appropriate sun exposure to optimize your vitamin D levels naturally. UV exposure also has additional health benefits beyond vitamin D production. A robust and growing body of research clearly shows that vitamin D is absolutely critical for your health. The D*Action project has been initiated by GrassrootsHealth along with 42 leading vitamin D researchers to demonstrate how health can be achieved right now with what's known about vitamin D with a combination of vitamin D measurement and health outcome tracking. To learn more, please see this recent article.
- Limit your exposure to toxins of all kinds. The number of toxic chemicals and their sources is so large, addressing them all could easily require an entire library, but I believe you can help you keep your toxic load as low as possible by becoming an informed and vigilant consumer. This includes tossing out your toxic household cleaners, soaps, personal hygiene products, air fresheners, bug sprays, lawn pesticides, and insecticides, just to name a few, and replacing them with non-toxic alternatives
- Get plenty of quality sleep. Scientists have discovered that your circadian rhythms regulate the energy levels in your cells. In addition, the proteins involved with your circadian rhythm and metabolism are intrinsically linked and dependent upon each other. Therefore, when your circadian rhythm is disrupted, it can have a profound influence on your physical health. For example, research has also linked disrupted sleep cycles to serious health problems like depression, coronary heart diseases, and even cancer. If you have any kind of sleep problem, whether you're having trouble falling asleep or staying asleep, my article "33 Secrets to a Good Night's Sleep" is packed with great tips to help you finally get some good rest.