U.S. Creates Drug and Medical Device Surveillance System
The U.S. government will establish a surveillance system to help monitor the safety of drugs and other medical products on the market.
The system will analyze Medicare claims data for signs of problems with medicines and medical devices. On Thursday, the U.S. Health and Human Services Department introduced a plan to allow federal agencies, states, and academic researchers to examine Medicare claims data. That access will be subject to protections for privacy and trade secrets.
The system would enable the U.S. Food and Drug Administration to analyze significantly more information than it can today by tapping into databases of health information to detect early signs of emerging safety problems.
This kind of surveillance system was recommended in 2006 by the Institute of Medicine, and the FDA has been under pressure to implement such a system, the Associated Press reported.
"This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market," HHS Secretary Mike Leavitt said in a prepared statement.
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More States Have Anti-Smoking Laws
Between 2004 and 2007, the number of states with laws prohibiting smoking in workplaces, restaurants and bars tripled from eight to 25, and the number of states with no kind of anti-smoking law decreased from 16 to eight, says a study in the new Morbidity and Mortality Weekly Report, from the U.S. Centers for Disease Control and Prevention.
In every case where there was a change to an existing law, the smoking restrictions became more stringent.
If the trend continues, the United States may achieve the national objective of making indoor public places and worksites smoke-free in all states by the year 2010, the study authors said.
There is no safe level of secondhand smoke, which contains more than 50 carcinogens and causes heart disease and lung cancer in nonsmoking adults, the researchers noted. Eliminating smoking in indoor spaces is the only way to fully protect nonsmokers. It's also been shown that smoking restrictions help smokers kick the habit.
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Girls More Likely to Suffer Severe Knee Injuries
Boys suffer more sports-related knee injuries than girls, but girls are more likely to suffer more severe injuries, says a U.S. study that looked at 1,383 knee injuries at 100 high schools during the 2005-06 and 2006-07 school years.
Of those injuries, 1,023 occurred in boys and 380 occurred in girls. Boys spent an average of less than one week recovering and 12 percent of their injuries required surgery. Girls spent an average of more than three weeks recovering and 25 percent of their injuries required surgery, CBC News reported.
Girls were twice as likely to suffer knee injuries caused by bad landings, jumping and pivoting, rather than through contact with other players, said the study, which will appear in the June issue of the American Journal of Sports Medicine.
The researchers said girls' increased risk of these types of knee injuries may be due to "a number of risk factors, including neuromuscular, hormonal, and mechanical differences," CBC News reported.
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Pilots, Air Traffic Controllers Can't Use Smoking-Cessation Drug
Pilots and air traffic controllers will no longer be permitted to use the smoking cessation drug Chantix because it may cause side effects that could threaten aircraft safety, the U.S. Federal Aviation Administration said Wednesday.
The decision was based on emerging data about the drug, said FAA spokeswoman Laura Brown. For example, a report from the Institute for Safe Medication Practices said Chantix was linked to a number of health and safety problems, including accidents and falls, potentially lethal heart rhythm disturbances, heart attacks, seizures, diabetes and various psychiatric troubles, The New York Times reported.
In February, the U.S. Food and Drug Administration issued a public health advisory warning that some people taking Chantix had developed serious psychiatric symptoms and some had committed suicide.
The FAA will inform the 150 pilots and 30 air traffic controllers known to be using Chantix that the drug is no longer acceptable and they should stop using it, the Times reported. The agency will also notify associations representing commercial and private pilots that the drug is no longer permitted.
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Merck Halts Cholesterol Drug Study
A study of the experimental cholesterol drug MK-0524A has been halted by Merck & Co., three weeks after the U.S. Food and Drug Administration refused to approve the drug.
Merck, which hasn't revealed why the FDA rejected the drug, said the agency's decision didn't influence the cancellation of the ACHIEVE study, the Associated Press reported.
The study was stopped on the basis of data from previous studies of various cholesterol drugs that suggested ACHIEVE wouldn't be able to determine if the new drug would do much to prevent plaque build-up in the arteries of patients who have high cholesterol levels due to genetic factors, according to Dr. Yale Mitchel, vice president of cardiovascular disease at Merck Research Labs.
Some experts criticized the drug maker's actions.
Merck's explanation isn't satisfactory and it's not appropriate to halt medical experiments on human volunteers "without proper cause," Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told the AP.
"I am concerned whether the reasons for terminating this trial are commercial or scientific," Nissen said.
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Brain Protein Linked to Addiction
A brain protein called DARPP-32 appears to play a role in addiction, according to a French study in the journal Nature.
Cocaine and other addictive drugs work by increasing levels of a messenger chemical called dopamine, which stimulates the brain's "reward" center. The French team found that DARPP-32, which helps the dopamine signaling process, built up in the part of the brain called the striatum when normal mice were given cocaine, amphetamine or morphine, Agence France-Presse reported.
The researchers then created genetically modified mice that produced a slightly altered form of DARPP-32 and found that the drugs had much less effect on these mice than normal mice in terms of impaired movement and drug cravings.
The results suggest that developing a drug that blocks DARPP-32 accumulation in the brain may prove useful in treating addiction and certain kinds of mental illness in which dopamine may play a role, AFP reported.
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