April 23, 2014

Shocking Dangers of Plavix Revealed in 2nd Comparison Study

By Dr. Mercola

Americans are a pill-popping population, taking an average of 13 different prescription drugs per capita as of last year’s statistics.1 Children in the US are the most medicated in the world, averaging out at four prescriptions per child. Among seniors, drug use is beyond epidemic, averaging out at a staggering 28 prescriptions per person.

The biggest issue is what all of these drugs are really doing to your health.

The facts simply do not support the idea that massive drug use equates to improved health. On the contrary, we’re seeing massive increases in chronic illnesses. As drug use continues to increase, Americans’ health continues todecline, and this is no coincidence… Many drugs actually increase your risk of illness and premature death, and Plavix is just one of many examples.

Plavix and Aspirin – A Most Dangerous Heart Disease Prevention Plan

Plavix, manufactured by Bristol-Myers Squibb, is an anti-platelet drug that works by thinning your blood and making it less likely to clot. It is promoted for the prevention of strokes and heart attacks. It’s what is commonly known as a “blockbuster” drug, currently ranking second on the list of top selling drugs of 2011.

Sadly, Plavix also has serious side effects you may not be aware of. Six years ago, I warned my readers that when combined with aspirin, the drug nearlydoubled the death rate from heart disease among patients who had not had a previous heart attack but were at risk, compared to those taking aspirin alone.

prescribed drug Shocking Dangers of Plavix Revealed in 2nd Comparison Study

Plavix Health Risks Confirmed Again

Now, research2 investigating the effects of Plavix in combination with aspirin versus using aspirin alone for the prevention of stroke and cognitive decline has confirmed these disturbing results.

In fact, the anti-platelet arm of the study was terminated3 and patients were told to stop taking Plavix and take aspirin only, as it became apparent the Plavix-aspirin regimen significantly increased the risk of death. The combination also doubled the risk of gastrointestinal bleeding, and more than doubled fatal hemorrhaging. Previous studies have also demonstrated that Plavix patients have a higher rate of stomach ulcers. Numerous lawsuits have been filed by patients alleging they were injured by this common drug.

Here’s something to consider: An aspirin regimen will cost you around $6 per month (or even less than $1 per month if you split regular generic aspirin into quarters), compared to Plavix, which will set you back around $200 per month (or one-tenth of that price if you get generic Clopidogrel).

How in the world can anyone justify the use of a drug that increases your risk of death, and costs 33 to 200 times more than the most common alternative, and to top it all off, call it prevention? It’s really amazing how Bristol-Meyers has managed to pull the wool over everyone’s eyes on this one. Even if you take Plavix alone, without aspirin, you’re still likely wasting huge amounts of money, and, as the new evidence suggests, taking a higher health risk than you would with low-dose aspirin.

A 1996 Lancet study4 comparing Plavix versus aspirin for the prevention of ischaemic events, involving more than 19,000 people followed from one to three years, found that:

“…an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin.”

Note the words “intention-to-treat analysis.” Statistically, when a study uses intention-to-treat analysis, chances are exceptionally great that it has been inadequately applied, “potentially leading to a biased treatment effect,” according to a study5 assessing the methodological quality of intention-to-treat analysis as reported in randomized controlled trials in large medical journals.

What this means in plain English, is that whenever a study resorts to using intention-to-treat analysis, the data has likely been “massaged” in order to achieve a desired result – in this particular case, showing that Plavix was slightly better than aspirin for reducing your risk of stroke, myocardial infarction and vascular death. According to the authors of the above mentioned investigation into the proper methodology of such analysis:

“The intention to treat approach is often inadequately described and inadequately applied. …Readers should critically assess the validity of reported intention-to-treat analyses.”

Chronicle of an Unforetold Death

In 2000, one of the best articles I’ve ever read documenting the tragedy of the traditional medical paradigm was published in theJournal of the American Medical Association (JAMA). The author was Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health. Based on her article, I created a headline that has reverberated through the web ever since: Doctors Are The Third Leading Cause of Death in the US. Dr. Starfield’s research documented how a staggering 225,000 Americans die from iatrogenic causes, i.e. their death is caused by a physician’s activity, manner, or therapy. Her statistics included the following details:

  • 12,000 die annually from unnecessary surgery
  • 7,000 die annually from medication errors in hospitals
  • 20,000 die annually from other errors in hospitals
  • 80,000 die from infections in hospitals, and
  • 106,000 die from non-error, negative side effects of drugs each year

Her work opened our eyes to the true state of affairs within our medical system, so it is a truly sad irony that she recently became another statistic of Death by Medicine… In the August issue of Archives for Internal Medicine,8 her husband, Dr. Neil A. Holtzman, MD, MPH writes, in part:

“Writing in sorrow and anger, I express up front my potential conflict of interest in interpreting the facts surrounding the death of my wife, Barbara Starfield, MD, MPH. Within hours after her sudden and unexpected death, I notified the dean of the Johns Hopkins Bloomberg School of Public Health, on whose faculty she served, that Barbara had apparently died of a coronary occlusion… Because she died while swimming alone, an autopsy was required. The immediate cause of death was ‘pool drowning,’ but the underlying condition, ‘cerebral hemorrhage,’ stunned me…

Barbara started taking low-dose aspirin after coronary insufficiency had been diagnosed 3 years before her death, and clopidogrel bisulfate (Plavix) after her right main coronary artery had been stented 6 months after the diagnosis. She reported to the cardiologist that she bruised more easily while taking clopidogrel and bled longer following minor cuts. She had no personal or family history of bleeding tendency or hypertension.

The autopsy findings and the official lack of feedback prompted me to call attention to deficiencies in medical care and clinical research in the United States reified by Barbara’s death and how the deficiencies can be rectified. Ironically, Barbara had written about all of them.”

Drug Safety Must Become a Priority, Not an Afterthought

Dr. Holzman goes on to explain that when a patient dies suddenly (and not while in a health care facility), there’s no routine procedure to notify their physician, even if the patient is autopsied. Therefore, sudden deaths are only in very rare cases ever linked to adverse effects of medical treatment (most common of which is drugs). In this case, Dr. Starfield’s husband personally brought the findings of the autopsy to her doctor’s attention, who subsequently submitted an adverse event report to the FDA, stating that she was receiving Plavix, which may have contributed to her cerebral hemorrhage and subsequent death.

“The report may be the critical action that prompts a modification in use or design of the product, improves the understanding of the safety profile of the drug or device and leads to increased patient safety,” Dr. Holzman writes.

One of Dr. Starfield’s points of contention with the current medical system was the lack of systematic recording and studying of adverse events, and her death highlights this situation, as it is quite possible that it was the Plavix-aspirin combination that killed her, yet if it hadn’t been for an autopsy and her husband insisting on an adverse event report, no one would ever have been the wiser about such a connection.

Dr. Starfield herself pointed out that her statistics were likely far lower than the real count, as they only included people who died in the hospital. They did not include (as there’s no data) people who suddenly die outside a hospital setting, due to a drug side effect.

What if a sufficient number of adverse event reports had been filed prior to her taking a combination therapy of Plavix and aspirin – would her life have been spared? It’s impossible to speculate of course, but what is clear is that someone’s life would eventually be spared if adverse event reporting is taken seriously. Plavix sales brought in $4.6 billion in sales during 2010 alone;9meanwhile, there’s no telling how many Dr. Starfield’s there are out there, who suddenly collapse and die, and no one is ever made the wiser about their true cause of death…

As our population ages and morbidities accumulate, the United States needs policies that redirect American medicine to primary care physicians,” Dr. Holzman writes. “By providing continuing care over time, primary care physicians can practice person-focused as opposed to disease-centered care. They can get to know their patients as persons and become aware of their multiple morbidities, alert to the presence or possibility of disease and/or drug interactions.”

…When a specific adverse event is expected (eg, bleeding with clopidogrel), adverse event reporting to FDA should be mandatory, and the manufacturer should be obliged to conduct postmarket surveillance. When a harmful effect is confirmed, the FDA should issue a warning to physicians and require a warning in the package insert. Risks should be weighed against benefits to decide whether the drug should be removed from the market.”

How to Report Adverse Drug Reactions

Only a tiny fraction of all adverse drug reactions are ever reported to the FDA – according to some estimates as little as one percent. In order to truly alert the FDA to a problem with a product they’ve approved, they must be notified – by as many people as possible who believe they have experienced a side effect. This means you can take action against the manufacturers of drugs that continue to put your optimal health at risk, if you feel you have had a bad reaction.

I urge you, if you believe you have experienced side effects from a drug, let the FDA know about it! Please go to the FDA Consumer Complaint Coordinator page, find the phone number listed for your state, and report your adverse reaction.

What to Do if You’re at Risk of Heart Disease

Drugs like Plavix are prescribed as “preventive medicine,” but you can be sure that these drugs will not optimize your health. If you’re at risk for heart disease, I urge you to get your vitamin D levels checked, and if you are deficient, take steps to increase your levels to the therapeutic range of 50-70 ng/ml.

Then simply go through and systematically apply the lifestyle changes described in my Optimal Health Plan. I recently updated it with all the latest guidelines and recommendations, so it’s a really comprehensive health plan, covering everything from diet to stress reduction, exercise and supplements, in a systematic, step-by-step way. Making the proper lifestyle changes will virtually eliminate your risk – sometimes quite rapidly – because it helps to significantly reduce inflammation in your body. And, keeping your inflammation levels low is key if you want to reduce your risk of heart disease. An added boon of applying this program is that it will automatically also help you to prevent and treat type 2 diabetes.

Read the full article and comment here: http://articles.mercola.com/sites/articles/archive/2012/10/10/plavix-health-risks.aspx


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