When Clinical Trials Uncover New Problems
When you volunteer to participate in a medical-research study, you expect the unexpected; you even sign a consent form acknowledging that you do. But a new report finds that many participants get more than they bargain for when they sign up for these trials. In a sample of more than 1,400 participants involved in research using imaging techniques such as X-ray, CT scan and MRI, scientists found that 40% of the study volunteers learned of potential health problems that were unrelated to the original purpose of the study.
That figure may sound alarming, but only 6% of the surprise findings required additional clinical care, with 1% benefiting the volunteer--early cancer diagnoses, for example.
The results, say the scientists, should remind investigators to be better prepared for unanticipated consequences. Even as imaging technology that detects the smallest lesions continues to improve, most researchers and volunteers are still working with consent forms that neither adequately address these possibilities nor describe how they should be handled when they occur.
Increase Statin Use, Lower Health Care Costs?
Heart disease is the leading killer of Americans, and yet it is preventable, say experts. Which is why researchers decided to find out whether helping more healthy people avoid the disease--by prescribing cholesterol-lowering drugs known as statins more widely--could save not only lives but health care dollars as well. Current national guidelines suggest that only those at high risk of developing heart disease--defined as having a greater than 20% chance of experiencing a heart event in the next 10 years--should take a statin. But the new study has found that if the threshold for statin eligibility were lowered to include people with even 15% risk, overall costs for treating problems such as heart attack and chest pain would drop.
The authors stress, however, that the calculation represents a delicate balance between the health benefits and potential risks of the therapy. While statins are relatively safe, like any other drug they have side effects, like muscle weakness, which can become severe. If giving statins to more people without symptoms of heart disease causes an increase in serious side effects, it could result in higher health care costs in the long run.
Finding that balance is now up to a group of experts who are currently revising national heart-risk guidelines.
FROM THE LABS
Is It That Time of The Month?
Women's monthly periods can lead to moodiness, owing to fluctuations in estrogen, and now a rat study suggests that the hormone changes may leave the brain a bit fuzzier too. Rats with lower estrogen levels took longer to learn a new task than those with higher levels. Previous studies had found that ovulating women had trouble concentrating, but the animal work is the first to measure the hormone's effect on cognitive function.