Archive for the ‘Featured’ Category

Omicron Variant of SARS-CoV-2: Dec. 1, 2021 update

Moving Simulation of SARS-CoV-2 Delta Variant

Image:  Computer Simulation of SARS-CoV-2. Reprinted with kind permission of Janet Iwasa of http://animationlab.utah.edu/cova From Dec. 1, 2021 The CDC confirmed today the first case of the Omicron variant, which is officially known as B1.1.529,  in the United States.  The most concerning aspect of this new variant is the number of mutations associated with it.  Viruses […]

The State of Cancer Research

And we already know how small a role the cancer gene plays in the onset of cancer: there has been an 8-fold to 17-fold increase in the incidence of cancer in the last hundred years, but not even one-millionth of 1 percent of that increase can be related to genes.

Genes evolve over hundreds of thousands (if not millions) of years, which means that the so-called cancer gene has had no impact on the huge increase we’ve seen since 1900. Virtually 90 percent of the cancer that we see today cannot possibly have anything to do with genes.

Clinical Evaluation Report (CER) Medical Writer

Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)  in compliance with the European Union (EU) Medical Device Regulation (MDR).  Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical […]

Combining Research, Safety, and Epidemiology

Risk Management Consulting (RMC), a health services research firm, offers Research, Safety, and Epidemiology services with experience in the healthcare consulting and biopharmaceutical industries. RMC provides the health care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. RMC’s projects range from retrospective to […]

CMS Shared Savings Program

Background The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients […]

Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.

“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type […]