Headlines: February 10, 2011
by Meg Larkin
First, in health reform news, certain provisions of the Patient Protection and Affordable Care Act are raising antitrust concerns. The Act encourages doctors and hospitals to work together to improve coordination of patient care and reduce costs through the creation of “Accountable Care Organizations.” Some in government are worried, however, that the creation of ACOs could lead providers to run afoul of antitrust laws and harm consumers. J.Thomas Rosch, a republican member of the Federal Trade Commission expressed concern over the antitrust risks posed by these new provider relationships in a series of private letters to the Obama administration and CMS. The letters reveal an internal fracture among the different enforcement agencies as to the legality of the new “Affordable Care Organizations” and uncover a disagreement between the FTC and the Justice Department regarding which agency should take the lead in antitrust enforcement related to health care providers. According to the New York Times, “Officials of the two agencies, which normally share responsibility for enforcing antitrust laws, are trying to devise a joint statement explaining how they will evaluate proposed collaborations by doctors and hospitals. The agencies said, in response to questions, that their goal was to have one consistent policy, but they refused to give details of their talks.”
In regulatory news, the Food and Drug Administration has criticized drug makers for failing to conduct the follow up studies required for continued FDA approval of their products. At a meeting on Tuesday, the FDA criticized six pharmaceutical companies whose cancer drugs were granted early approval through the fast-track process, with the understanding that the companies would then complete the research required to ensure that the medications met the FDA’s standards for safety and efficacy. The issue reflects the delicate balance that the FDA is required to strike between speeding potentially lifesaving drugs to the market and making sure that those drugs are actually safe and effective. The Wall St. Journal reports that, “In a compromise dating from the early 1990s, the FDA has granted accelerated approval several dozen times to cancer drugs based on preliminary evidence. Companies then promise to confirm the evidence in follow-up studies.” Once a drug is given preliminary approval, it becomes more difficult to recruit patients for the studies needed to confirm safety and efficacy. If companies don’t provide the required evidence, or if it fails to confirm the drug’s safety and efficacy, the FDA can issue large fines or revoke approval, but none of these measures has yet been considered with the six companies present at Tuesday’s meeting. Earlier this year, the FDA revoked Avastin’s early approval to treat breast cancer patients after follow up studies failed to confirm the promising pre-approval evidence.
In public health news, the Washington Post reports that the incidence of strokes is increasing among younger Americans. Studies presented at the American Stroke Association conference on Monday compared hospitalizations in 1994 and 1995 to hospitalizations in 2006 and 2007. During that time period, there was a 51% increase in the number of strokes occurring in men ages 15 to 34. Strokes rose 17 percent in women of the same age, and 47 percent in men from 35 to 44. The findings raise concerns about increased risk factors for stroke, including obesity and high blood pressure. By contrast, stroke risk in older people decreased during the same time period, which doctors at the conference attributed to better prevention and risk management.
Finally, in research news, a new study has shown that a painful yet routine breast cancer treatment is unnecessary in many cases. The study, paid for by the National Cancer Institute and published in the Journal of the American Medical Association, found that removal of the lymph nodes, which has long been routine in the treatment of breast cancer, may be not be beneficial in a large number of cases. According to the New York Times, “researchers report that for women who meet certain criteria — about 20 percent of patients, or 40,000 women a year in the United States — taking out cancerous nodes has no advantage. It does not change the treatment plan, improve survival or make the cancer less likely to recur. And it can cause complications like infection and lymphedema, a chronic swelling in the arm that ranges from mild to disabling.” A key barrier to the implementation of the study’s findings may be doctors’ resistance to changing a practice that has been a pillar of cancer care for over 100 years. At the same time, the new recommendations regarding lymph node surgery are in line with the general trend in breast cancer treatment towards less radical surgery and more treatment with radiation and chemotherapy. The new results are not applicable to all breast cancer patients, but only to those types of cancer examined in the study. However, they are an important factor that should be taken into account in determining a patient’s best course of treatment.
Meg Larkin is a third year law student at Boston University. Please feel free to email her with any questions, comments, suggestions or concerns.