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Merck is setting a good example by evaluating the drug in steps, carefully assessing its effect on patients, and not proceeding toward approval before testing the effect of the drug on patient outcomes in a large study.
FORBES: Merck Does The Right Thing
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But he calls for Bristol-Myers to do a large study to examine the drug's long-term effect on the heart.
FORBES: Bristol, Merck Drug May Double Heart Risk
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This study is another reminder that the effect of a drug on cholesterol levels may not predict what happens to patients.
FORBES: AstraZeneca Study is Good News for the Public, Bad News for AstraZeneca
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This time the agency asked for a new study to test the effect of a high dose of the drug on heart rhythm.
WSJ: FDA Approves Amylin's Bydureon Diabetes Drug After Delays
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Also, the safe and effective levels of drugs such as sibrafiban are not yet known, and the patients included in the study may not have been high risk, so the drug's effect would be small, they added.
BBC: Aspirin 'as good as heart drug'
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The study was based on data contributed by 596 patients with the disease, formally called amyotrophic lateral sclerosis or ALS. By showing that the drug didn't have any effect on progression of the condition, it contradicted a small study three years ago that suggested such a benefit was possible.
WSJ: ALS Study Falls Short, But Use of Social Media Holds Promise