Article
Author(s):
Top news of the day from across the health care landscape.
The Department of Health and Human Services (HHS) has issued new rules to ensure that valuable information from clinical trials is widely available to both participants and scientists, reported NPR. Although scientists have been required to post the results of experiments on ClincialTrials.gov since 2007, many top universities and drug companies have failed to do so. The new set of rules was published on Friday in the Federal Register, and were created to make it easier for scientists, universities, and corporations to understand which experiments should be included in the federal database. It also expands the list of studies that must be registered to include experimental behavioral interventions and phase 1 drug trials, if they have funding from the National Institute of Health (NIH). Furthermore, the rules require for the first time that companies post trial results for drugs that do not make it to marker, and not just the ones that do. Researchers will also be required to state in advance how they plan to analyze their results. These new rules will take effect in January 2017, and researchers will have 90 days to comply.
Although federal courts have ruled that compensation for bone marrow donors is permitted in most cases, they are now considering a regulatory change that would again criminalize payments, reported The Washington Post. This change could jeopardize a new Washington DC-based startup company called Hemeos, which looks to find matches for people who need bone marrow transplants, particularly in African American communities, where finding a match is more difficult. The Institute for Justice, as well as Hemeos, believe that compensating donors could increase the amount of potential donors, and allow for more transplants. According to an analysis by the institute, nearly 3000 individuals die each year waiting for a bone marrow transplant.
Immunotherapy has become one of the hottest areas of oncology and is transforming cancer care; however, there are still drawbacks with this form of treatment. According to NPR, a clinical trial of nivolumab (Opdivo) in patients with newly-diagnosed lung cancer unexpectedly failed as a first-line therapy, shaving $20 billion off Bristol-Myers in one day. Furthermore, although immunotherapy is generally more tolerable than radiation and chemotherapy, there are still side effects to take into consideration. Also, immunotherapies are not cheap, with some costing well over $100,000 a year. Although immunotherapy has shown great promise, there is still the question of why more people don’t respond to treatment.