Dear Dr. Roach: I wondered what your reaction is to the recent study suggesting that taking an 81-mg aspirin daily has no/little benefit for anyone who has not already experienced heart disease or blood vessel issues (stroke) and might pose more risk in the form of stomach bleeding than benefit?
I have been taking the low-dose aspirin daily as a preventive measure for a number of years based on some bad family heart history (my dad鈥檚 two brothers and my brother all had quadruple bypass surgeries at age 50). Dad had bypass surgery at age 84, though he did not have any prior identified heart issues. He is doing pretty well at age 93 today.
I鈥檓 age 64 and do not having any stomach/bleeding issues (nor have any identified heart issues), but do not want to continue the aspirin if there is more risk than likely benefit.
D.R.B.
There have been many studies on aspirin, and although it is clear that people with known blockages in the blood vessels of the heart benefit from regular aspirin use, it remains unclear how much benefit (if any) exists for people without known heart disease. One large study decades ago showed such a large benefit that the study needed to be stopped, as it was considered unethical not to offer aspirin to everybody. Since then, there have been numerous studies that have been unable to confirm a benefit for people at lower risk. In the current study, the subjects (a person in a study is a 鈥渟ubject,鈥� not a 鈥減atient鈥�) had far fewer cardiac 鈥渆vents鈥� (such as heart attack or stroke) than expected, and even though the rate was slightly lower in the group taking aspirin, the results were neither statistically significant nor large enough to be clinically meaningful. The adverse-event rate related to treatment was about three per cent higher in the aspirin group.
The higher your risk of heart disease, the more likely you are to benefit from taking aspirin, but since there is always a risk, it should not be taken by people who are at low risk for heart disease. Family history is one risk, but blood pressure, cholesterol level, diet and exercise patterns, and smoking history also should be considered when balancing risks and benefits of aspirin. It鈥檚 still not a straightforward decision for many people, and the new study didn鈥檛 really help identify who benefits.
Dear Dr. Roach: Should we be concerned that some of our medicines are being manufactured in foreign countries?
S.H.
The U.S. Food and Drug Administration regulates all drugs sold in the United States, and all drugs are required to meet the same standards for purity, no matter where they are manufactured.
However, there have been several recent high-profile incidents of contaminated pharmaceuticals and raw materials used for manufacturing coming from several countries. The FDA cannot perfectly regulate products coming from other countries, some of which do not have strong consumer protection laws or product liability laws. A very large proportion of drugs sold in the U.S. are made in or have ingredients made in countries, some of whose factories may not follow good manufacturing practices. We need better inspection in the short term, and reconsideration about the outsourcing of materials to the lowest-cost manufacturer.
Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to [email protected].
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