|PCSK9 inhibitors (evolocumab and alirocumab) have been approved based primarily on studies showing they reduce LDL cholesterol (the “bad” cholesterol) and atherosclerotic plaque in patients with high LDLs and already taking statins. However, treaters and payors have been waiting for proof they reduce “hard” cardiovascular (CV) outcomes, such as heart attacks and strokes. On February 2, evolocumab became the first to provide that proof, when Amgen announced topline results from its FOURIER trial showing the drug significantly reduced the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization), and the key secondary composite endpoint (CV death, non-fatal MI, or non-fatal stroke).
|Read More: MedpageToday, CardioBrief, FirstWord Pharma
||Wave of the future in fighting Alzheimer’s?
||Many potential drug therapies for Alzheimer’s disease target amyloid-beta, a protein known to accumulate in the brains of AD patients. Recently, scientists reported in Nature a mouse study that used very novel approach: flickering lights that trigger certain brain waves which, in turn, reduced brain levels of amyloid-beta. Clinical trials may start soon.
|Read More: Science News, The Atlantic, LA Times
||President Trump on drugs
||Amidst the flurry of news coverage President Trump’s activities since he took office, numerous outlets reported that, at his (mostly closed-door) meeting January 31 with pharma executives, he said his administration would cut FDA regulations “at a level nobody’s ever seen before,” reduce “astronomical” drug prices through increased competition, bring more drug manufacturing to the United States, and that his nominee for FDA commissioner (still not disclosed as of this writing) will be “fantastic.” On reducing regulations: The day before the meeting, the President signed an executive order requiring federal agencies, including the FDA, to repeal at least two existing regulations for every new one they create.
|Read More about the POTUS-pharma meeting: The New York Times, The Washington Post, Bloomberg Politics, USA Today, STAT; about the “two-for-one” executive order: The Washington Post, The Atlantic, USA Today
||A fountain of youth – for mice
||While reprogramming ordinary cells to become more like stem cells reverses cellular age, no studies have directly shown age-altering effects in living organisms…until recently. A report published in Cell showed a form of cellular reprogramming reduced cell and physiological aging, and prolonged lifespan by 33% in mice genetically programmed to age prematurely. Normal mice also benefited from the reprogramming – their muscles and pancreas healed better.
|Read More: New York Times, STAT, Science News, ScienceDaily
||Hamming it up
||Perhaps in the not-too-distant future, we may solve the problem of organ shortages for transplantation by growing human organs in animals. In another report in Cell, scientists took a big step by showing the first successful implantation of human intermediate stem cells in a pig embryo, followed by growth of the resulting chimeric embryo. Some of the human stem cells turned into muscle cells and precursors of organs including the pancreas and liver.
||Read More: The Scientist, National Geographic, CNN
One-stop shopping for drug information
|With the ever-increasing number of drugs and fewer reps to educate physicians about them, many docs spend an onerous amount of time accessing multiple websites to get important drug information. As reported by FiercePharma, seven companies are working together to create a single, easily and quickly accessible digital system for physicians and other health care professionals to get the information they need. The “Align Biopharma” group includes Allergan, AstraZeneca, Biogen, GlaxoSmithKline, Novartis, Pfizer and the software company Veeva Systems.
|Read More: Align Biopharma, PharmaPhorum, Pharmaceutical Commerce
||Possible Pharma conflicts of interest (COI)?
||According to three reports published in JAMA Internal Medicine, the pharmaceutical industry may influence patient advocacy groups, guidelines by and submitted to federal agencies, and tweets from physicians. Some specifics:
· One report found that 67% of nonprofit patient advocacy groups received money from for-profit companies in the past year, and it constituted more than half the funding for 12%.
· A second report found that, in reviewing two Institute of Medicine (IOM) guidelines – one for cholesterol and the other for hepatitis C virus – IOM standards for COI limits among guideline committees were met by the former but not the latter, and neither met COI standards for committee chairs and cochairs.
· A third report focused on the CDC’s recent guidelines designed to curb use of opioid medications and found that, during the open comment period, comments opposing or less supportive of the guidelines were more common from organizations that received funding from opioid manufacturers.
· With a backdrop of physicians’ rapid uptake of Twitter, a fourth report found about 80% of 634 Twitter-using US hematologists/oncologists had some COI, raising the question – in the opinion of the investigators – of how such possible COIs should be disclosed given the realities and constraints of social media.
|Read More: NPR, The Scientist, MedpageToday, HealthNewsReview
||Eat, drink and be wary!
||When we eat, our body senses the incoming calories and proportionally ratchets down feelings of hunger. But despite its high calorie content, alcohol has long been known to have a paradoxical effect of triggering overeating, though precisely how was not known. Now, new studies in mice reported in Nature Communications provide insights to this mystery, showing – for the first time – that alcohol activates certain neurons in the hypothalamus associated with eating behavior. Now put away that beer and the chips!
|Read More: The Scientist, Scientific American, Fox News |