Headlines: February 17, 2011
by Meg Larkin
First, in policy news, four states have received waivers of some of their obligations under the health reform law. Florida, New Jersey, Ohio, and Tennessee have received temporary waivers that allow health insurance companies in those states to offer less generous benefit packages than the health reform law would otherwise require. The waivers are intended to be temporary measures that clear the way for a smoother implementation of the health reform law without creating gaps in coverage, and will allow insurance companies in those states time to change their offerings. According to the New York Times, “To qualify for a waiver, a state, an employer or an insurer must show that compliance with the federal requirement would cause ‘a significant increase in premiums or a decrease in access to benefits’.” The waivers affect less than 2 percent of all patients who currently receive health insurance through their employers. The waivers gave House republicans an opportunity to investigate the new office charged with overseeing the private insurance market in the United States in the wake of the health reform law.
In patient safety news, Johnson and Johnson has recalled 70,000 Invega syringes. The syringes contain an injectable formulation of the drug, which is used to treat schizophrenia. Johnson and Johnson expressed concern that the cracks in the syringes could result in contamination of the drug or infection at the injection site, or that users might receive a lower than therapeutic dose because of leakage. The company said that the cracks may have been caused by problems with the label application process. A company spokesman said the issue had been resolved and that the manufacturing line was up. In other safety news, Medtronic has advised doctors to use caution when refilling implantable drug delivery pumps. The Wall St. Journal reported that, “The issue involves the company's SynchroMed II and SynchroMed EL implantable pumps, which are placed in under skin in the abdomen to deliver medicine for treating pain or spasticity. In a so-called "pocket fill," drug refills are accidentally injected into the pocket around pumps rather than into the pumps themselves. This can put patients at risk for an overdose as drugs are absorbed into the body, or an underdose because their medical problems aren't being treated.” The FDA has forced the company to change package labeling related to the refill risk, and the company sent a letter to doctors advising them of the risks of missing the pump when refilling a patient’s medication.
In research news, a faster method of flu vaccine production has met with initial success. Preliminary studies have shown that the new vaccine is just as safe and effective as the older version, and it can be produced in a much shorter period of time. The new vaccine is grown in animal cells, rather than chicken eggs, which increases the speed of production and reduces the risk of contamination. Further testing is still required before the new vaccine production method will be able to be used in the United States, but the vaccine’s manufacturer is eager to conduct the necessary trials as soon as possible. A vaccine made using this method has been approved in Europe since 2007.
Finally, in public health news, new guidelines have been released to prevent heart disease in women. Heart disease is the number one killer of women in the United States, but there is little awareness among women of the risk factors and treatment options. The American Heart Association has issued new guidelines that aim to increase prevention efforts and improve awareness of the risk factors for heart disease. For the most part, the new AHA guidelines restate old treatment advice, but they also make some innovative suggestions, such as increased consumption of fish oil and omega-3 fatty acids for women with high cholesterol. It remains to be seen whether the guidelines will have an impact on public awareness or how physicians treat their female patients.
Meg Larkin is a third year law student at Boston University. Please feel free to email her with any comments, questions, suggestions or concerns.