Modern Medicine Needs To Abandon Many Ineffective Therapies; Example – $25 Billion of Heart Drugs Don't Prevent Cardiovascular Death!
by Bill Sardi
Recently by Bill Sardi: Oh-No-bamacare
Saying many medical subspecialties in American Medicine exist largely upon treatments that are ineffective but never abandon them, a Northwestern University researcher is calling attention to the many scientific reports that do not support the scientific underpinnings for many therapies such as implantation of stents in coronary arteries and use of cholesterol-lowering drugs.
Vinay Prasad, MD and Andrae Vandross MD, of the Department of Medicine at Northwestern University in Chicago, are calling physicians to "abandon the cholesterol pill ship"; $25 billion of cardiac drugs don't prevent cardiovascular death among millions of high risk but otherwise healthy adults. So says a special report published in the April 23, 2012 issue of The Archives of Internal Medicine, a report that has received no news media coverage.
In an era when Obamacare is going to be ushered in to reduce needless healthcare spending, the public should begin to wonder if so-called miracle drugs like Lipitor, which have arrogantly been marketed as "science-based" and "FDA-approved," actually reduce the risk for deadly heart attacks? The practice of prescribing cholesterol-lowering drugs started with Mavacor in the early 1980s. The problem was then, as now, is that what is called a "surrogate marker" of heart and blood vessel disease was used in place of conclusive evidence that it prevents mortal heart attacks – the gold standard of all cardiac drugs. Does it save lives or does it just give false hope that a mortal heart attack won't occur at some time in the future?
In a recent analysis of 11 controlled published studies involving 65,229 healthy patients that covered a period of 1970-2009, reviewers said they "did not find evidence for the benefit of statin drug therapy on all-cause mortality in a high-risk primary prevention group." Statin drugs lower cholesterol production in the liver and are the most commonly-prescribed class of cholesterol-lowering drugs.
These were otherwise healthy adults who had a family history of heart disease or had other factors like high blood pressure or health habits like smoking that placed them in a higher risk grouping for mortal heart attacks.
Given that cardiac drugs are not totally without side effects, if the only benefit is the reduction of a number that measures circulating levels of blood fats (cholesterol), and otherwise healthy patients are just being put at risk to develop side effects (statin drugs are toxic to the liver), just exactly why do cardiologists continue to prescribe them? Many patients recount encounters with their cardiologist where they were sternly warned if they do not take this pill they could die suddenly of a heart attack. But the data says statin drugs only prevent non-mortal heart attacks in relatively healthy patients who take statins for prevention.
It's obvious, the fear of a mortal consequence from not following the doctor's advice is likely what prompts patients to comply and habitually take cholesterol-lowering drugs, and return to the doctor's office for a renewal of their prescription. Many a patient recounts to me that their cholesterol umber is low, 160, and they feel good about that. But they are no less at risk for a sudden-death heart attack than others who don't take a statin drug.
Cholesterol reduction: a moving target
In 2006 a US Air Force physician, Brian K Crownover MD, asked when the "end of the statin drug gold rush" would occur? Dr. Crownover took the cholesterol-lowering drug companies to task and asked just when were they going to stop moving the target so their drugs could be put to the test. First the effectiveness of cholesterol drugs was measured by total cholesterol in the blood. Then the target moved to reduction of LDL "bad" cholesterol (low-density lipoproteins). Then more recently the objective was to raise HDL "good" cholesterol (high density lipoproteins). Only this year (2012) has it been revealed that elevation of HDL "good" cholesterol does not reduce cardiac mortality.
Dr. Crownover said, at the time, that just when the patents expired on one cholesterol-lowering drug and lower cost generic versions were going to have an opportunity to reduce drug costs, "there was a shift to manage new targets," he lamented. He said, at that time, that physicians "eagerly await outcomes data (number of deaths) in the hopes of establishing the cost effectiveness of these new drugs prior to their expected dominance in the marketplace." Those words were spoken in 2006 and billions of statin drugs are still being prescribed.
Set the bar high
Vinay Prasad, MD and Andrae Vandross MD, of the Department of Medicine at Northwestern University in Chicago, authors of the landmark report published in the Archives of Internal Medicine mentioned at the top of this report, advocate "setting the bar high" for future approval of cardiac drugs. That is to say, stop using blood markers of disease that are assumed to correlate with cardiac death and conduct a more intensive study to see if these drugs do or do not save lives.
With scientific storm clouds gathering around the entire idea of employing cholesterol-lowering drugs, the question the authors ask is just how does modern medicine prepare to "abandon ship?" Cholesterol-phobia drives millions of patients to doctors' offices. It is a cash-cow.
And it's not just statin drugs that come under scrutiny, but ANY agent that lowers cholesterol, such as Zetia (ezetimibe), the drug that attempts to reduce cholesterol absorption from the diet, Tricor (fenofibrate), a drug that raises statin concentration in the blood, or even the oft-beloved niacin, which is touted to be a natural way to raise HDL cholesterol.
Drs. Prasad and VanDross say: "Recent trials in cardiovascular medicine have contradicted current medical practice." They state: "even long-established preventive practices may be erroneous."
They go on to say: "What is at stake in cardiovascular prevention is no small matter. Statins cost Americans over $19 billion in 2005 and two other cholesterol-lowering drugs another $5 billion."
Dropping a bombshell
Dr. Prasad and Vandross then unload another bombshell. Not only are millions of people screened for elevated cholesterol unnecessarily, they say: "regarding campaigns to screen for breast, prostate, and colon cancer to decrease cancer-specific death, none have shown an overall mortality benefit in prospective trials." Good God, how much of modern medicine is nothing more than a costly and deadly charade?
Trading disease prevention for death
Then Drs. Prasad and Vandross point to yet another sad fact. In their words: "At a minimum, however, it is reasonable to ask that lives saved from cancer are not traded for increased deaths from non-cancer causes or overwhelming morbidity. For instance, a recent study indicates the very announcement of a diagnosis of prostate cancer dramatically increases the risk for a heart attack or suicide.
They were referring to a review conducted in Sweden where more than 4 million men were screened for prostate cancer and found, during the first week after detection of prostate cancer, the risk for a heart attack rose 2.8 to 11.0-times and the risk for suicide rose by 8.4-fold. The sad fact is that many of these diagnoses were false positives (they didn't have prostate cancer at all) and for most of the rest, prostate cancer wasn't a death sentence, it was something they were going to die with, not of.
Does modern medicine ever abandon outmoded practices?
The answer to the above question is yes, but rarely and often begrudgingly, and having friends in government helps. For example, for years physicians believed that excessive stomach acid caused gastric ulcers. Antacids were prescribed and patients were advised to reduce stress. But then Australian doctors Barry J. Marshall and J. Robin Warren, who won a Nobel Prize for this in 2005, discovered that a bacterium (H pylori) caused stomach ulcers. But the antacid drug that was prescribed for this condition continued to be sold and prescribed until its patent wore off and only then did the FDA prod doctors to abandon the antacid drug. Profits are creating false realities in medicine.
Dr. Prasad, in a report entitled "Reversals of Established Medical Practices; Evidence to Abandon Ship," published in a January 2012 issue of The Journal of the American Medical Association, says:
"Ideally, good medical practices are replaced by better ones, based on robust comparative trials in which new interventions outperform older ones and establish new standards of care. Often, however, established standards must be abandoned not because a better replacement has been identified but simply because what was thought to be beneficial was not. In these cases, it becomes apparent that clinicians, encouraged by professional societies and guidelines, have been using medications, procedures, or preventive measures in vain."
Whole medical subspecialties may be a charade
Dr. Prasad goes on to ask: "How many established standards of medical care are wrong?" He says: "It is possible that some entire medical subspecialties are based on little evidence. Their disappearance probably would not harm patients and might help salvage derailed health budgets."
I suspect Dr Prasad is correct. And the most deadly diseases, cancer and heart disease, where physicians can more easily manipulate patients over the fear of dying, are the most likely medical specialties to lack strong scientific evidence for many of the treatments offered.
Dr. Prasad points to stents used to prop open coronary arteries, for which there is no evidence these arterial implants lower mortality, but they do reduce chest pain (angina). So Dr. Prasad says stents have ended up being "an expensive placebo for pain control."
Regarding stenting of coronary arteries, Dr. Prasad speaks boldly when he says: "Despite the evidence, many specialists will not abandon the procedure."
Medical progress questioned
He says the first generation of patients who undergo these unproven treatments "receive all the risk of treatment and no real benefits." Second, "contrary studies do not immediately force a change in practice." And third, "the contradicted practice continues for years." Imagine if the insurance billing code was withdrawn, just how many doctors would continue to prescribe these ineffective treatments.
Finally, says Dr. Prasad, the disproven practice "undermines trust in the healthcare delivery system." Yes, maybe, but so many Americans have been misled to believe American medicine is the best in the world. Patients aren't ready to believe anything contrary to that.
Who or what will ever disengage doctors from these disproven therapies? State medical boards don't. The American Medical Association won't. Medicare and private insurance keep paying for these services. The band keeps playing. Naïve patients blindly desire more treatment that they feel they paid for with their insurance premiums and Medicare payments.
Ethical science will disclose which therapies are ineffective, but belatedly. Dr. Prasad warns: "Asking corporate sponsors to conduct pivotal trials on their own products is like asking a painter to judge his or her own painting so as to receive an award. If a manufacturer can be allowed to manipulate the system to create a blockbuster product from an ineffective drug, the temptation is hard to resist."
