Exposing patients with chronic, stable, exertional angina to placebo periods in drug trials

Article Abstract:

Controlled clinical trials, especially those that use a placebo (inert substance or ''sugar pill'') against which to compare the action of a drug, are thought to offer the most efficient and clear-cut evidence for usefulness of new drugs. However, this method cannot ethically be used if an effective therapy already exists, especially if it affects survival or illness. In the case of angina, therapy relieves the chest pain, but does not change the chances of survival or the course of related disease. There is increasing reluctance to approve research designs using a placebo for the study of angina, although there is no evidence of undue risk. Trials of 12 antianginal drugs using a placebo for comparison were evaluated for the frequency and type of adverse heart problems. A total of 3,161 patients were included. Heart-related problems leading to dropout were uncommon, and the placebo was not associated with increased risk when compared with the active drugs. Assignment to the group receiving the active drugs did not reduce the frequency of heart problems. There was a significant increased risk with the use of calcium antagonists, so in this case assignment to the placebo group would have been preferable. The Food and Drug Administration guidelines for the study of antianginal drugs specify symptom-limited exercise testing to measure effectiveness, and short-term placebo-controlled trials of one to four weeks, using patients who are not receiving any type of antianginal therapy. Long-term placebo-controlled trials of patients receiving background therapy are also recommended because they would provide useful information for labeling. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Drug therapy, Science and technology policy, Ethical aspects, United States. Food and Drug Administration, Placebos, Calcium channel blockers, Angina pectoris

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Minors' access to tobacco - Missouri and Texas

Article Abstract:

Minors are still able to buy cigarettes despite laws banning their sale and the presence of warning signs in stores. In Missouri, a law banning the sale of tobacco products to minors went into effect on Aug 28, 1992. In the three days prior to that, teams of two minors, aged 13 or 14, tried to buy cigarettes at 89 different stores in five different communities; almost half were successful. Stores were more likely to sell to girls than boys. Following the same procedure, minors tried to buy cigarettes in Texas, where the sale of tobacco products to minors has been prohibited since Sep, 1989. Of 94 attempts to buy cigarettes, 59 were successful, and 42 of 71 attempts to buy smokeless tobacco products were successful. Some measures that could reduce the use of tobacco products among minors include requiring tobacco-selling stores to obtain licenses that will be revoked if tobacco products are sold to minors, and requiring that purchasers show proof of age before products are sold.

Research, Laws, regulations and rules, Texas, Smoking and youth, Youth smoking, Missouri

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Factors Associated With Tobacco Sales to Minors: Lessons Learned From the FDA Compliance Checks

Article Abstract:

Many stores still sell cigarettes to minors, according to data from more than 150,000 FDA compliance checks between 1997 and 1999. Many sales clerks did not request proof of age and many teens asked older friends to purchase cigarettes for them.

Teenagers, Youth, Smokers

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