Headlines: June 14, 2010
by Meg Larkin
In government news, the FDA is taking steps to regulate direct to consumer genetic testing. This week, the FDA sent letters to five companies that make the tests, saying that the tests are medical devices, and that the tests must be approved by the FDA before marketing. The letters did not say that the tests must be taken off the market until they are approved. Much of the debate centers around whether the tests are a medical tool, or whether they are simply providing consumers information about themselves. Some doctors and regulators believe that the tests should be monitored as devices because they provide detailed information that could inform medical decision-making. The House Energy and Commerce Committee is also investigating the issue.
In other regulatory news, the FDA is considering a new type of morning after pill. The drug, ella, is made by a French pharmaceutical company and can prevent a pregnancy up to 5 days after unprotected sex. Plan B, the morning after pill available in the United States rapidly loses efficacy as time passes, and is ineffective after 72 hours. Ella has sparked a controversy because of its chemical similarity to RU-486, also known as the abortion pill. Critics of the pill are concerned that women might use the drug when they are already pregnant, and unknowingly give themselves an abortion. Ella has only been tested for use as a contraceptive. The Washington Post reported that the manufacturer has no plans to test Ella as an abortion drug.
In research news, ten years after the first map of the human genome, health care still hasn’t seen any major changes. When the human genome project was embarked upon, researchers thought it might help to identify the common causes of diseases like cancer and Alzheimer’s, but ten years later those hopes have not been realized. After years of studying human DNA, researchers are starting to think that diseases may be caused more by rare variants that are harder to detect through DNA testing. According to the New York Times, “The only way to find rare genetic variations is to sequence a person’s whole genome, or at least all of its gene-coding regions. That approach is now becoming feasible because the cost of sequencing has plummeted, from about $500 million for the first human genome completed in 2003 to costs of $5,000 to $10,000 that are expected next year.” While the human genome’s health care potential seems to have fallen short, it has led to major advances in the field of biology.
In international health care news, the United States and Vietnam are still in conflict about the lingering effects of Agent Orange. Most Vietnamese people believe that the United States should be doing more to help them cope with the after-effects of the herbicide used during the Vietnam War. According to the Boston Globe, “while the United States has provided assistance to Vietnamese with disabilities regardless of their cause, it maintains that there is no clear link between Agent Orange and health problems.” Vietnamese officials are asking for a larger financial commitment from the United States to help people who, it claims, were disabled by the herbicide. Agent Orange can leach into sediment and soil causing effects years after its initial use.
Meg Larkin is a law student at Boston University. Please feel free to email her with any questions, comments, suggestions, or concerns.