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 December 2003


A baby aspirin a day keeps a heart attack away. This widely accepted health practice was seriously undermined at an advisory committee meeting of the Food and Drug Administration (FDA, held in December 2003.) The FDA advisory committee voted overwhelmingly to reject a petition from the Bayer Corp. to approve aspirin for reducing the risk of a first heart attack.

Though an estimated 20 million Americans already take low-dose aspirin daily to prevent a heart attack, this is an off-label use—that is, the aspirin manufacturers have not received FDA approval for this particular indication. FDA approval is required, however, once an aspirin manufacturer plans to advertise the drug for this use. And once approval is granted, the drug's packet insert must be rewritten to inform consumers of the new indication.

Bayer's petition made the FDA Cardiovascular and Renal Drugs Advisory Committee take a critical look at the five trials (One trial compared aspirin with vitamin E) in which people without heart disease took either aspirin or a placebo (a dummy pill). Altogether there were more than 55,000 participants at anywhere from low to high risk for a heart attack. Here is what the cardiologists and other experts on the committee found in the way of benefit: Aspirin produced about a 32% reduction in non-fatal heart attacks. [Translation: An estimated 3% of all moderate-risk people will have a heart attack in the next five years. Daily low-dose aspirin therapy will reduce their odds to about 2%.] The benefit is given in terms of a five-year period because the trials lasted four to seven years.

Several things troubled the FDA committee members about the results of these trials: Aspirin did not have any mortality reduction benefit; nor did it reduce the odds of having an ischemic stroke, which is, arguably, the most feared consequence of heart disease. Yet aspirin has the potential for causing another, less common type of stroke called hemorrhagic stroke, which is a rupture of a blood vessel in the brain.

One committee member who voted to reject Bayer's petition is Steven Nissen, MD, Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center. In a telephone interview, Dr. Nissen explained, “The data [from the five trials] were terribly weak.” You always have to weigh the trade- offs , he said, referring to hemorrhagic stroke as the major concern.

But the aforementioned 32% reduction in non-fatal heart attacks applies to the combined total of all the study participants, most of whom were men with differing levels of risk. The committee hit a snag once it came to individuals. Dr. Nissen said that he and other committee members were concerned that daily aspirin, if taken by people at a low enough risk, could cause more harm than good. Asked to define “low enough risk,” he explained that there was too much uncertainty to answer the question. “No one in the world can answer the question of who benefits and who doesn't, and if there is no answer, then how could I vote to approve?” he asked.

The fact that women were underrepresented in the five trials (only 20% of all participants) also troubled Dr. Nissen. “It may be that the risks exceed the benefit for women,” he said, “but we simply don't know—there is not enough data.” Still, Dr. Nissen was careful to stress that he was not against aspirin therapy for everyone, suggesting that people talk over the decision with their physicians. The FDA advisory committee “took a lot of heat,” said Dr. Nissen, referring to its decision to turn down Bayer's petition and thus reject the prevailing medical view that aspirin therapy is good for just about everyone. “We were called flat earthers ,” he said.

The FDA is not obligated to follow the decisions made by its advisory committees, but the agency usually does. The committee's decision, though entirely appropriate, illustrates how the current system works against consumers who want to become fully informed before they go on lifelong drug therapy. Approval would have meant a rewrite of the drug's packet insert to include the new indication. And this, in turn, would have compelled the advisory committee to identify  

the appropriate group of people for whom the benefit of aspirin therapy clearly outweighs the risks. The evidence from the five trials did not provide the answer; therefore, 20 million people will continue to take daily aspirin without knowing anything about the uncertainties of the supporting research.

The advisory committee's concerns can be contrasted with the practice guidelines aimed at physicians and published in 2002 by the U.S. Preventive Services Task Force. The Task Force concluded that the number of “cardiac events” prevented by aspirin therapy far exceeded the number of hemorrhagic strokes caused by aspirin therapy. This, too, is based on the combined results of the same five trials. When the Task Force tried to break things down for individuals, it came up with this estimation for moderate-risk men and women: “For 1,000 patients with a 3% risk of having a heart attack in the next five years, aspirin would prevent eight heart attacks but would cause one hemorrhagic stroke and three major gastrointestinal bleeding events.”

Where it concerns low-risk people, the Task Force is in agreement with the FDA advisory committee: MMMM
“…patients at low risk for coronary heart disease probably do not benefit from and may even be harmed by aspirin because the risk for adverse events may exceed the benefits…” (Annals of Internal Medicine, 1/15/02).


For More Information:

-Go to to see one method used by the Task Force to identify different levels of risk for a heart attack. The Task Force used an additional assessment tool based on the risk information from the Framingham Heart Study, which has since become outdated.

-The transcript of the December 8-9, 2003 meeting of the Cardiovascular and Renal Drugs Advisory Committee is likely to be posted on the Internet in February or March. Go to and click into “Advisory Committees.” Then go to this specific committee and its meeting date.

Maryann Napoli, January 2004 (1)

Danger: Regular Aspirin or Tylenol Can Hurt Your Kidneys as Evidenced By Professional Athletes

Since Alonzo Mourning, the Miami Heat's All-Star center, was found to have a kidney disorder more than a year ago - the same disease that caused the San Antonio swingman Sean Elliott to undergo a kidney transplant and eventually forced him to retire - many players in the National Basketball Association have grown acutely concerned about the use of anti-inflammatory drugs.

Medical experts say that use of the medication does not cause the kidney disease, which is called focal segmental sclerosis. But many doctors say that prolonged use at excessive levels of anti-inflammatory drugs, from over-the-counter medicine like ibuprofen and aspirin to prescription drugs like Vioxx and Indocin, may lead to other kinds of kidney problems.
By Mike Wise
New York Times January 29, 2002

Avoid Long Term Use of Tylenol and Aspirin or Advil

bulletAbout 15% of the people on dialysis today are there as a result of the damage that Tylenol and/or aspirin did to their kidneys. (2)
bulletTwenty percent of those with heart failure are due to them taking NSAIDs.(2)
bulletThese drugs may also be associated with diverticular disease of the colon.(2)
bulletA questionnaire of over 35,615 male health professionals showed that after adjustment for age, physical activity, and energy-adjusted dietary fiber and total fat intake, regular and consistent use of NSAIDs such as aspirin, advil and the host of prescription anti-inflammatory drugs and acetaminophen was associated with diverticular disease(3)
bulletMen who took painkillers six to seven days a week had a substantially higher risk of developing hypertension than those who did not. Those who took acetaminophen had a 34 percent higher risk, those who took non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen had a 38 percent higher risk, and those who took aspirin had a 26 percent higher risk. (3)
bulletMen who took 15 or more pills of any painkiller per week had a 40 percent higher risk of developing high blood pressure (3)

Do a search on the internet, type in 'aspirin a day'. You will get over a million hits and most of them will be extolling the benefits of an aspirin a day. You will also find get links like these:

bullet - Dr. Sanjay Gupta: An aspirin a day to keep Alzheimer's
bullet FDA article for general audiences discusses how this medication works, its uses, its potential role in prevention of heart attacks
bullet Diabetes - An Aspirin A Day - Diabetes Mellitus, Type 2, Type 1 ...
bullet ScienceDaily: An Aspirin A Day May Keep Colon Cancer Away
bullet Can an aspirin a day keep atherosclerosis at bay?
bullet Can an Aspirin a Day Keep Diabetic Retinopathy Away?

Maybe an aspirin a day prevents heart attacks, maybe is doesn't but it would be good to get an objective and unbiased opinion rather than fatten Bayer's bottomline. And does aspirin really work on all those diseases?

Regardless of whether it is effective or not, getting everyone in the world to take one aspirin a day is a heck of a profitable move for the Bayer Drug Company. I would like to have the confidence that all those people telling me to take an aspirin a day are doing so because it really is effective and not because they have some interest in the Bayer Corporation or operating under misinformation.

Pain is Nature's Way of Telling You Something is Wrong

Let me add this. Pain is your body's way of telling you something is wrong. Taking a pill to cover up the pain is not unlike putting a piece of tape over the red trouble light flashing on the dash of your car. Taking pain pills like these especially over a long period of time does not fix whatever the issue is, it covers up the symptoms and may cause side effects. We have a bad habit in this society of treating or covering up the symptoms rather than treating the actual disease or aliment.

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Daily aspirin therapy
Is an aspirin a day the right thing for you? It's not as easy a decision as it sounds. Know the benefits and risks first - Mayo Clinic
, click here to read  this article


bullet(2) Dr. Joseph Mercola
bullet(3) David Gutierrez - Newstarget


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These statements have not been evaluated by the Food and Drug Administration. This web page or any products found here are not intended to diagnose, treat, cure, or prevent any disease. If you find information here that is of interest to you, take it to your medical doctor for conversation and evaluation. Do not stop taking any prescription drugs without consulting with your medical doctor.

© 2007 - All Rights Reserved  Last updated on Monday, November 19, 2007