Headlines: April 5, 2011
by Meg Larkin
Health care costs have not escaped the Capitol Hill furor over government spending. House Republicans have introduced a proposal to limit Medicare and Medicaid costs that would fundamentally reshape both programs. Although the proposals for reorganizing Medicare and Medicaid could save substantial amounts of money for the Federal government, it is unclear to what degree they would increase the share of costs borne by States and beneficiaries. The proposals would transform Medicaid, which currently operates as a Federal/State partnership into a type of block grant program that would give States more discretion in determining how to spend Medicaid funds. Medicare would be transformed by having the Federal government contribute a specified sum of money to the cost of purchasing private health coverage. Democrats in Congress are opposed to both proposals, and have raised concerns that the changes would significantly hurt the elderly and the poor, who are the main beneficiaries of both programs. It remains to be seen how the proposed reforms will impact the 2012 election cycle.
In regulatory news, concerns over cost and safety have fuelled a fight over the role of the FDA. The struggle is between pharmacists and the Federal Government concerning which group is better positioned to regulate the safety and availability of the nation’s pharmaceuticals. At the center of the controversy is the role of compound pharmacies – pharmacies that make medical concoctions not otherwise available to patients. The concoctions are typically things like liquid versions of a drug that is only available in pill form, and are theoretically supposed to be made for individual patients only, although compound pharmacies have been known to manufacture and sell large batches. The current issue centers on the availability of a drug to prevent premature births that has been on the market since 1956, but until recently was only available through compound pharmacies. The FDA approved the application of KV Pharmaceuticals for an exclusive license to distribute the drug pursuant to the Orphan Drug Law in February, and KV promptly announced that it would charge $1,500 per injection, or $30,000 for an entire course of the drug. This sparked an outcry among patients and physicians, who had previously been able to obtain the drug at much lower costs from the compound pharmacies, and induced KV to announce a lower price. The company justified the increased cost by pointing to the expense of clinical trials required by the FDA. While FDA approval is often seen as key to ensuring safety and efficacy, this case raises questions about how costs should be considered in seeking FDA approval for substances that are already commercially available.
In research news, a new study has found that patients may have more options for the treatment of coronary artery disease and heart failure. The Wall St. Journal reported that, “The study, called Stich, found benefits in treating people with medication only, and in treating people with a combination of bypass surgery and medication. Both approaches can be effective, with risks and benefits associated with each one.” By finding that both approaches provided distinct risks and benefits for patients, the study removes pressure from doctors to consistently choose one option over another, and encourages involving patients in treatment decisions and encouraging doctors and patients to pick the treatment option that best fits the patient’s needs. The study findings suggest that doctors and patients may have more time to make the decision about whether bypass surgery is necessary in any given case case.
Finally, in public health news, a recent study has found an increase in the number of CT scans given to children. According to the Boston Globe, “The number of ER visits nationwide in which children were given CT scans surged from about 330,000 in 1995 to 1.65 million in 2008 -- a five-fold increase. The number of kids' ER visits didn't increase measurably during the study, but the percentage of visits involving CT scans climbed from about 1 percent to almost 6 percent.” The findings have raised concerns about increased radiation exposure among children, and possible improper dosing in medical facilities that don’t specialize in pediatric care. Because children have longer life expectancies and are more sensitive to radiation, an increase in the number of CT scans raises concerns about long term cancer risks and other adverse effects. The researchers emphasized the need for proper oversight and attention to imaging practices involving pediatric patients.
Meg Larkin is a third year law student at Boston University School of Law. Please feel free to email her with any questions, comments, suggestions or concerns.