More Evidence That Aspirin Can Stave Off Death

Taking aspirin as infrequently as 1 to 3 times a month reduced the risk of all-cause and cancer-related mortality in older adults in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial compared to no aspirin use, a post-hoc analysis of 146,152 individuals in the trial indicated.

Moreover, more frequent, weekly use of aspirin significantly reduced the risk of mortality from both gastrointestinal and colorectal cancer and it reduced all mortality endpoints regardless of body mass index (BMI), Holli Loomans-Kropp, PhD, MPH, National Cancer Institute, Rockville, Maryland, and colleagues reported in JAMA Network Open.

The analysis was based on participants’ self-reports of aspirin use in the previous year, collected at enrollment.

At a median follow-up of 12.5 years (range 8.7-16.4 years), the risk of all-cause mortality was reduced by 16% (HR 0.84, 95% CI 0.80-0.88, P<0.001) among those who took aspirin 1 to 3 times a month versus none.

Taking aspirin once or twice weekly reduced the same endpoint (HR 0.86, 95% CI 0.81-0.90, P<0.001). Similar risk reduction for all-cause was also seen when aspirin was taken 3 or more times per week (HR 0.81, 95% CI 0.80-0.83, P<0.001).

Cancer mortality was also reduced with aspirin use 1 to 3 times per month (HR 0.87, 95% CI 0.81-0.94, P<0.001); more frequent use was also associated with reduced cancer mortality though the magnitude did not increase markedly (HR 0.85 for use 3 times or more per week, 95% CI 0.81-0.88, P<0.001).

Risk reductions were seen as well with frequent aspirin use for gastrointestinal cancer mortality (HR 0.75, 95% CI 0.66-0.84, P<0.001) and colorectal cancer mortality (HR 0.71, 95% CI 0.76-0.89, P<0.001).

When participants were stratified by baseline BMI, every mortality endpoint was also significantly reduced with aspirin use irrespective of weight status, and with no suggestion that the apparent protective effect was diminished for overweight/obese individuals.

“These findings suggest that prophylactic aspirin use may reduce risk of mortality among older individuals,” the authors concluded.

The PLCO Cancer Screening Trial randomized participants ages 55-74 to cancer screening or to a control arm at 10 centers in the U.S. This particular analysis included those participants who were 65 or older at baseline or survived to age 65 during follow-up. Mean participant age at baseline was 66.3 and slightly over half were women.

Loomans-Kropp and colleagues pointed out that evidence regarding the prophylactic benefit of aspirin in older adults has been mixed.

For example, the Aspirin in Reducing Events in the Elderly (ASPREE) study found that during 4.7 years of follow-up, adults from ages 65 to 70 years who took 100 mg of aspirin a day were at increased risk for all-cause mortality compared to placebo controls. However, this study contradicted many others that supported a survival benefit with aspirin. Loomans-Kropp and colleagues thus wanted to revisit the question and also to explore whether aspirin might be less protective among individuals who were overweight or obese.

The U.S. Preventive Services Task Force currently recommends low-dose aspirin for the prevention of both cardiovascular disease and colorectal cancer among individuals from ages 50 to 59 at average risk for cardiovascular disease, although they suggest treatment should be individualized for those from ages 60 to 69. The USPSTF made no recommendations for aspirin use in individuals 70 years of age and older, citing insufficient evidence.

Loomans-Kropp had no conflicts of interest to disclose.

• Primary Source

  JAMA Network Open

  Source Reference: Loomans-Kropp, H, et al “Association of aspirin use with mortality risk among older adult participants in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial” JAMA Network Open 2019; DOI: 10.1001/jamanetworkopen.2019.16729.

https://www.medpagetoday.com/primarycare/generalprimarycare/83689

Sight Diagnostics’ finger prick blood tester wins FDA clearance

The dream of a comfortable, tabletop blood testing device, one needing only a few drops taken from a finger and a handful of minutes, has now arrived in the U.S.—and this time carrying an official FDA clearance.

Sight Diagnostics received a 510(k) green light from the agency for its OLO analyzer, allowing it to provide lab-grade results for the common complete blood count test in hospitals, clinics and elsewhere.

The compact device uses digital microscopes to visually tally the number of red blood cells, white blood cells and platelets found in a sample to provide physicians with a quick overview of a patient’s general health. The panel is included in over 90% of baseline blood tests.

“The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” said Carlo Brugnara, director of the hematology lab at Boston’s Children’s Hospital, where U.S. clinical trials of the OLO device were conducted in part.

The OLO has been commercially available in Europe and other international markets since it obtained a CE mark in July 2018. Currently, it’s being evaluated by Oxford University Hospital Trust and will also form the base of a pilot blood testing program with the U.K. pharmacy chain Superdrug, according to Sight. The company also said it is working to establish partnerships in Africa, Asia and South America.

“In rarer cases––involving acute leukemia, for instance––a CBC can make the difference between life and death,” added Brugnara, who also serves as professor of pathology at Harvard Medical School.

Going forward, Sight plans to pursue an FDA waiver from CLIA laboratory regulations to certify OLO’s use in smaller U.S. practices and pharmacies.

“The years our R&D team spent solving complex engineering and design challenges have positioned us well to expand our offering in the future,” the Israeli startup’s chief technology officer, Sarah Levy, said in a statement.

“Our end-goal is to offer diagnostics for any disease with visible signatures in the bloodstream,” Levy said. “We are confident Sight can continue to improve patient outcomes through new, faster, less costly and more convenient testing.”

The OLO device and its artificial intelligence-based technology got its start screening tens of thousands of blood samples for signs of malaria using digital fluorescent microscopy. The company’s algorithms draw from nearly half a petabyte of blood image data collected over five years of clinical work.

https://www.fiercebiotech.com/medtech/sight-diagnostics-finger-prick-blood-tester-wins-fda-clearance

After Zantac scare, FDA targets generic metformin for carcinogen tests

After a global scare over carcinogen contamination in heartburn med Zantac, regulators are growing increasingly wary about other drugs that may have flown under the radar. Now, generic metformin, a Type 2 diabetes medication, could be next in the FDA’s firing line.

The FDA is testing samples of metformin for the probable carcinogen N-Nitrosodimethylamine (NDMA) that has already been tied to global recalls of generic and branded Zantac earlier this year and for “sartan”-based heart pressure drugs in 2018.

“The agency is in the beginning stages of testing metformin; however, the agency has not confirmed if NDMA in metformin is above the acceptable daily intake (ADI) limit of 96 nanograms in the U.S., FDA spokesman Jeremy Kahn said in an email. “These investigations take time. The FDA will communicate further information when we understand more of the situation and of what, if any, actions health care professionals and patients should take.”

Scrutiny over metformin, a generic drug produced globally, follows the global scare over NDMA contamination in Zantac this summer that led to industrywide recalls. In November, the FDA put out what amounted to a confidence-booster for the drug, saying that the agency’s testing found NDMA amounts comparable to that found in “grilled or smoked meats.”

But the ball could already be rolling on metformin after the Singaporean Health Sciences Authority announced Wednesday it had recalled three of 46 versions of the drug sold in the country after finding NDMA above the “internationally acceptable amount.”

The authority said the risk to patients taking those products was low because those products had been supplied locally for only a short time.

The European Medicines Agency has also said it is testing metformin samples for NDMA and has so far found no unsafe levels of the contaminant, Bloomberg reported.

Whether drugmakers follow their own example on metformin as they did with Zantac––including global distribution halts and recalls––has still yet to be seen. However, the ongoing scrutiny over that drug continues to play out among global regulators.

On Wednesday, the FDA said all producers of Zantac (ranitidine) and nizatidine should test lots of the drugs for NDMA before shipping to consumers. If unacceptable levels of NDMA are found, the results should be reported to the FDA and not put out on the market, the administration said.

“We continue to work with industry and regulatory agencies around the world to determine the reasons for NDMA in these drugs and have developed and posted multiple testing methods to identify NDMA in (Zantac),” the FDA said in a release.

Drugmakers and retailers began pulling lots of generic and brand Zantac off the shelves after online pharmacy Valisure alerted the FDA and the industry to the presence of NDMA in Zantac in September. Valisure also filed a Citizen Petition with the FDA seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA in them. NDMA is one of three impurities the FDA discovered last year in sartan blood pressure meds that led to a global recall.

In mid-October, drugmakers including GlaxoSmithKline––the original producer of branded Zantac––Sanofi, Teva, Dr. Reddy’s Laboratories and others opted to pull the drug off the market. Retailers including Wal-Mart, CVS, Walgreens and Rite Aid also decided to clear the drugs off their shelves.

https://www.fiercepharma.com/manufacturing/after-zantac-scare-regulators-turn-to-generic-metformin-for-carcinogen-tests

Hospital operators file suit against proposed price transparency rule

As expected, hospital groups filed a lawsuit yesterday in Washington, DC aimed at blocking a proposed Trump administration rule requiring them to disclose negotiated rates with payers. The industry turned to the courts after intensive lobbying efforts came up empty.

The legal route has already paid dividends to hospitals. About a year ago, they blocked the administration from cutting Medicare payments for certain drugs. In September, a judge ordered the administration to stop Medicare cuts to doctors who see certain patients in some hospital clinics (the cuts targeted higher prices paid to some hospital clinics for the same care delivered in non-hospital clinics).

The transparency rule is set to take effect in 2021 if upheld.

Related tickers: XLV, HUM, UHS, THC, HCA, CYH, UNH, WCG, MOH, CI, CNC, ANTM, CVS

https://seekingalpha.com/news/3524027-hospital-operators-file-suit-against-proposed-price-transparency-rule

Akers Strategic Review Explores Entering Hemp, Cannabinoid Processing Industry

Akers Biosciences, Inc. (the “Company” or “we”) (NASDAQ: AKER), a developer of rapid health information technologies, today announced that it will continue its strategic review and has identified the hemp and minor cannabinoid sectors as promising adjacent opportunities that could benefit from Akers’ core competencies. The company is exploring how to leverage its 30 years of operational history in its medical device business, where its current products have U.S. Food and Drug Administration (FDA) clearance, its current operations practice Good Manufacturing Processes (cGMP), its medical device facility is certified under ISO 13485 – 2016 and the facility carries an Analytical Lab Certification for Schedules 2, 3, 4 and 5 controlled substances issued by the U.S. Drug Enforcement Administration (DEA) and the State of New Jersey.

The Company has an extensive history in the development, production, and distribution of rapid screening and testing products designed to deliver medical information to healthcare providers. We believe that recent public statements by regulators, including the FDA, expressing concerns about the safety of certain cannabidol products on the market creates an opportunity for a company like Akers, with experience in manufacturing and developing safe diagnostic tools, to pursue this opportunity, and help develop new safe products derived from cannabinoids.

Akers has also formed an Advisory Board with expertise in the hemp and minor cannabinoid industry to assist the Board of Directors in its strategic review including, potentially, the extraction, testing, purification and formulation of safe cannabinoids within the hemp industry. The Advisory Board may also explore a pathway to consumer products with a focus on minor cannabinoids.

The Company intends to work closely with its new Advisory Board members Bob Hoban and Michael Patterson, as well as its own legal counsel. Hoban is the President and Founder of Hoban Law Group which is a full-service law firm specializing in ‘cannabusiness.’ Hoban won the landmark Cannamart case in 2010 which led to Colorado’s commercial cannabis regulatory system in 2011. Patterson is a Health Care executive with over 25 years of experience who is currently the Chief Executive Officer of U.S. Cannabis Pharmaceutical Research and Development LLC. Michael is a subject matter expert in the Global Cannabis Industry and a Board member of the American Journal of Endocannabinoid Medicine.

http://www.globenewswire.com/news-release/2019/12/05/1956801/0/en/Akers-Biosciences-Continues-Strategic-Review-Explores-Leveraging-its-30-years-of-Laboratory-Operations-to-Enter-into-the-Hemp-and-Minor-Cannabinoid-Processing-Industry.html

BioLineRx reports interim data on BL-8040 combo in pancreatic cancer

Preliminary data from a Phase 2a clinical trial, COMBAT/KEYNOTE-202, evaluating BioLineRx’s (NASDAQ:BLRX) lead oncology candidate BL-8040, combined with Merck’s Keytruda and chemo, in metastatic pancreatic cancer patients showed a positive effect (these patients are highly treatment-resistant).

The results are being discussed at its Investor & Analyst Event today in New York and will be presented at ESMO IO next week in Geneva.

In 15 evaluable patients, there were four partial responders and eight with stable cancer, implying a disease control rate of 80%.

Median progression-free survival and overall survival (OS) have not yet matured. OS data should be available in mid-2020.

No new safety signals were reported.

https://seekingalpha.com/news/3523985-biolinerx-reports-interim-data-on-blminus-8040-combo-in-pancreatic-cancer

Axsome and Marinus go opposite ways on SAGE-217 miss

Marinus Pharmaceuticals (NASDAQ:MRNS) is up 3% premarket while Axsome Therapeutics (NASDAQ:AXSM) is down 8% following Sage Therapeutics’ failed Phase 3 study of SAGE-217 in major depressive disorder (MDD).

SAGE is down 62% premarket.

SAGE-217 is a next-generation GABA modulator, specifically, a neuroactive steroid.

Marinus is developing ganaxolone, also a GABA modulator, for postpartum depression.

Axsome is developing AXS-05, an NMDA receptor agonist, for MDD.

https://seekingalpha.com/news/3524001-axsome-and-marinus-go-opposite-ways-on-sageminus-217-miss