Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a new conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
California Declares Secondhand Smoke a Toxic Pollutant
California officials voted Thursday to become the first state to declare secondhand smoke a toxic air pollutant, which puts it in the same category as arsenic, benzene and diesel exhaust.
The unanimous vote by the California Air Resources Board was based on a September report that concluded that young women exposed to secondhand smoke have a 68 percent to 120 percent increased risk of breast cancer, the Associated Press reported.
Secondhand smoke was also linked to other kinds of cancer, asthma, heart disease, premature births, and health problems in children. The report was based on the findings of 1,000 studies of the effects of secondhand smoke.
"If people are serious about breast cancer, they have to deal with secondhand smoke. That's what this is all about," Stanton Glantz, director of the Center for Tobacco Control, Research and Education at the University of California, San Francisco, told the AP.
He called the report, by scientists at California's Office of Environmental Health Hazard Assessment, "a seminal, international document. It's impossible to underestimate what a big deal this is."
EPA Not Collecting Full Data on Lead in Drinking Water: Report
The U.S. Environmental Agency has been dragging its feet in forcing states to collect and report required data on lead levels in drinking water, according to a Washington Post report.
The Government Accountability Office (GAO) study, being released Friday, also found that the EPA has little information on lead levels in drinking water in schools and childcare facilities.
The EPA database doesn't have data on recent test results on more than 30 percent of community water systems in the United States and is missing data on more than 70 percent of water systems, the Post reported.
The lack of proper data, "may be undermining the intended level of public health protection," the GAO noted.
Growing Number of Drug Treatment Patients Started Using at Young Age
A growing number of Americans in treatment for drug abuse began using at least one of their problem drugs before they were 13 years old, according to a report released Thursday by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
In 2003, 14 percent of people (162,708 people) admitted for treatment began using drugs prior to age 13, compared with 12 percent (114,462 people) in 1993, the report said.
The number of patients who started using marijuana before age 13 increased from 20 percent in 1993 to 23 percent in 2003. The number of patients who began using opiates before age 13 increased from 4 percent in 1993 to 5 percent in 2003. Opiates include heroin and prescription pain killers.
The percentage of patient who used cocaine before age 13 declined from 5 percent to 4 percent, and there was also a decline in those who used stimulants (such as methamphetamine) -- from 10 percent to 9 percent.
"Age at first use is an important predictor of the potential for serious substance abuse problems later in life. The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak with their children early and often about the dangers of drug use," Charles Curie, SAMHSA administrator, said in a prepared statement.
Hospitals Need Better Records to Prevent Drug Errors: Alert
U.S. hospitals need to improve their record-keeping and communication in order to prevent drug errors that often occur when patients are discharged or transferred, says an alert issued Wednesday by the Joint Commission on Accreditation of Healthcare Organizations.
Among the recommended improvements: medications and proper doses should be listed in a highly visible location on patient medical charts; that information should be communicated to doctors, nurses and patients during transfers between one hospital unit and another; discharged patients should be given an accurate list of their required medications and instructions for use, the Associated Press reported.
The alert was sent to more than 15,000 hospitals and healthcare organizations in the United States.
Poor record keeping means that patients being transferred or discharged are at risk of getting double doses of drugs, the wrong medication, or incompatible drugs, the commission noted.
It's estimated that medication errors result in the deaths of more than 7,000 hospitalized patients each year in the United States, the AP reported. According to the commission, breakdowns in communication were responsible for 63 percent of reported drug errors that caused death or serious injury.
Pregnancy Increases Snoring
Women are twice as likely than normal to snore during the late stages of pregnancy because their airways tend to be narrower, says an Edinburgh University study.
Researchers found that 41 of 100 pregnant women snored, compared with 17 of 100 non-pregnant women. The increased snoring among pregnant women may be linked with weight gain and pressure on the trachea and lungs caused by the distended abdomen, BBC News reported.
The study also found that women snorers had, on average, a one-centimeter greater neck circumference than non-snorers.
The researchers noted that as pregnant women's airways narrow, their blood pressure increases. High blood pressure is linked to pre-eclampsia. So this study supports previous data that pregnant women who snore have a greater risk of pre-eclampsia, the study authors said.
The findings appear in the European Respiratory Journal.
Food Fact: A touch of cinnamon.
For diabetes control, a dash of cinnamon may have a surprisingly sweet payoff. Researchers have found it may enhance insulin's ability to metabolize glucose. It's estimated that as little as 1/4 tsp. cinnamon may have a positive effect on blood sugar. Cinnamon is also rich in catechins, which are potentially health-protective, although the catechins in cinnamon are not as well studied as those found in tea. If your cinnamon has been sitting on the shelf for more than a year, toss it out. As with most spices, its flavor goes flat with time.
Fitness Tip of the day: Patience pays.
If you don't get results right away, don't quit -- buff takes time. When you start an exercise program, don't expect changes overnight. It may be a couple of weeks before you see improvements. Although changes may seem subtle at first, stick with it. Even small amounts of exercise will start you on the road to a better body.
FAQ of the day: Is tofu a good source of calcium?
Many kinds of tofu are excellent sources of calcium, but not all. If tofu is processed with calcium sulfate -- as most are -- it will have about 260mg of calcium per cup. This calcium is as absorbable by the body as the calcium in milk. But tofu processed with nigiri will have little calcium. Similarly, calcium-fortified soy milk contains 300mg of calcium, the same as a cup of milk, but not all soy milks are fortified. Read the label to be sure.