Science March (in April)
This last Saturday tens of thousands of physicians, scientists and policymakers raised signs and voices at Marches for Science in Washington DC, New York City, Los Angeles, San Diego, Chicago and other cities among some 610 marches around the world. Some concerns marchers raised included:
…Some felt a little reassured however, because just before the marches the White House announced that President Trump will continue what Barack Obama started in 2010, holding an annual science fair at the WH. Insiders say Trump is already selecting judges for the event who favor research on hair growth and hand enlargement.
Blockbusters to watch
Clarivate Analytics listed the 9 blockbuster drugs their analysts expect FDA to approve this year. The list, in order of sales projected in 2021 (totaling $16B), includes:
On your mark, get set….APPROVE! FDA vs. EMA
Speaking of upcoming drug approvals, according to a study in NEJM, from 2011 to 2015, FDA approved 170 new drugs compared to the EMA’s 144, with a median review time of 306 days vs. 383 days, respectively. An author of the study noted that, with PDUFA due for reauthorization in October 2017 and Congress pressuring the FDA to review drugs more quickly, the agency “…is already making decisions quickly and increasing its regulatory speed shouldn’t be our number-one priority.”
At the recent Congressional confirmation hearing for President Trump’s nomination for FDA Commissioner, nominee Scott Gottlieb, MD, touted the benefits of “adaptive trial design” (ATD) in which researchers build in options permitting adjustments as data is collected, for example changing the size of the trial, adding or removing study arms, etc. If adopted, ATD could have major implications in the approaches to and costs of clinical trials. However, as noted in Science, some experts are concerned ATD could weaken the validity of statistical analyses and confidence in study results. Related: Perspective articles for and against Dr. Gottlieb as Commissioner were published in NEJM.
Diet sodas: a stroke of bad luck?
An observational study in more than 4,000 people followed for 10 years linked consumption of one or more artificially sweetened beverages (ASBs)/day to about triple the risk for ischemic stroke and Alzheimer’s disease compared to non-consumers. The study, based on data from the Framingham Heart Study Offspring cohort, was published in the journal Stroke. The study authors as well as those of an accompanying Editorial noted that, because the study was observational, it cannot prove ASBs caused these negative outcomes; indeed, “reverse causation” may have been at play, with people at greater risk for stroke (e.g., those with diabetes) choosing to drink more ASBs.
What’s in YOUR…genes?
The FDA recently agreed to allow the genetic testing company, 23andMe, to market its tests directly to consumers to determine their genetic predisposition for 10 diseases, including Parkinson’s, Alzheimer’s and celiac disease. The agency, reversing its 2013 shutdown of the company’s previous, similar promotion, noted that while the tests provide information about genetic risk, they cannot determine overall risk, which can be affected by many factors such as environment and lifestyle.
More pedaling peddling
You may recall a couple months ago, Med-Sci Matters covered a Danish study in Circulation showing biking was linked with a reduced risk for heart attack. Now a new study in BMJ involving more than 260,000 people shows that, compared to non-active commuting (e.g., by car or mass transit), biking to work was associated with significantly reduced risks for cancer/cancer death by 45%/40%, CV disease/CV death by 46%/52%, and all-cause death by 41%. The researchers acknowledged that while the study is very suggestive and encouraging, it cannot prove cause and effect as it was observational. (PS – Weather permitting, yours truly bikes to CCA; the picture is me at a recent Bike MS event!)