Diabetes Patients Flood FDA with Comments on Cybersecurity for Medical Devices, as reported by Mariam Baksh for NextGov.com, 8 July 2022.
The Food and Drug Administration received more than a thousand comments—mainly from diabetes patients and their family members—in response to draft cybersecurity guidance for staff to use when processing submissions from medical-device manufacturers seeking approval to market their products.
To clarify, over 1800 comments have been reviewed … BUT OVER 100,000 comments were received and overwhelmed the FDA! THANK YOU to everyone who spoke up and shared your concerns. YOUR VOICES are having an impact! I finally received an email yesterday as a result of my open letter to Dr. Robert Califf, Commissioner of the FDA … ready to set up a working meeting!
With a 90-day public comment period ending on 7/7/22, the FDA will now begin the process of finalizing cybersecurity guidance for its pre-market submissions, according to a notice in the Federal Register. The FDA is under pressure from Congress to improve the cybersecurity of medical devices through its premarket approval process, with some scholars saying what the agency does next could serve as a model for a sector-specific approach to regulating and enforcing reasonable measures to secure an increasingly connected world from malicious actors. Samples of comments:
- “Please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my OWN devices,” reads one entry from a sample of the comments the FDA posted to the docket on the guidance. The emphasis is from the commenter. The vast majority of the comments the FDA received followed a template, with individuals tailoring their entries to reflect personal circumstances surrounding their management of diabetes in themselves or others, but they all stressed its life-threatening nature and a need to have more control over their fates.
- “I live with insulin-requiring diabetes, an incurable chronic disease requiring continuous monitoring of blood glucose values and administration of insulin,” reads one comment using only boilerplate language. “It is imperative that access to my own devices remain possible. The ability to receive glucose values from my continuous glucose monitor and the ability to command my insulin pump to deliver insulin are already permitted and expected of me. In fact, if I don’t do [this], I will die. So please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my own devices.”
Prior authorization delays even reach congresswoman’s family was reported by Jennifer Lubell for AMA-Assn.org, 7 July 2022. That’s right … this comes from the American Medical Association, about the horrors of prior authorizations demanded way too often by insurance companies. Finally!
Rep. Suzan DelBene has heard too many disconcerting stories about prior authorization. A parent of one of her relatives had been scheduled for surgery as COVID-19 cases dropped and procedures started opening again, but had to cancel the surgery for lack of a timely prior authorization. In another scenario, a major insurer decided it needed prior authorization for cataract surgeries. “There are so many stories that we’ve heard. If you or your loved ones are frustrated by the health care system, it’s not just you. We know it’s folks across the country and so many families,” said Rep. DelBene, a member of the House Ways and Means Committee and chair of the moderate New Democrat Coalition.
DelBene, who represents Washington’s 1st congressional district, has co-sponsored a bipartisan bill—the “Improving Seniors’ Timely Access to Care Act”—that would ease prior-authorization challenges physicians face in caring for patients covered by Medicare Advantage plans.
More than one-third (34%) of physicians responding to an AMA survey (PDF) reported that prior authorization led to a serious adverse event in a patient. “The more that things are standardized, the more we can see prioritization streamlined, the more that providers are spending more time providing health care versus billing app forms,” DelBene said.
The legislation, also introduced in the Senate, cuts unnecessary delays in care by streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation, which has more than 330 bipartisan co-sponsors in the House and Senate, incorporates all the major elements of a 2018 consensus statement developed by leading physician, hospital, medical group, health plan, and pharmacy stakeholders.
Read more: Prior authorization delays even reach congresswoman’s family
Is Chocolate Good for You? was posted by Alice Callahan for NYTimes.com, 12 July 2022. Studies suggest that cocoa might benefit health, but it’s unclear how that may translate to a typical bar of chocolate.
Chocolate has a long and illustrious reputation. Made from cocoa, which is derived from the beans of the cacao tree (whose scientific name translates to “food of the gods”), it was used by some of the earliest Mesoamerican cultures as food, medicine, ritual offering, and perhaps even currency. It’s no less valuable in modern times; the global chocolate market grew by nearly 20 percent between 2016 and 2021, with an approximate revenue of $980 billion in 2021, according to the market research firm Statista.
Taste surely plays a role in chocolate’s popularity, but you may have also heard that this delectable treat is good for your health. How does this perception stack up against the science?
“Cocoa is clearly good for you,” said Dr. Dariush Mozaffarian, a cardiologist and professor of nutrition at the Tufts Friedman School of Nutrition Science and Policy. “Whether chocolate is good for you or not depends on how much cocoa is actually in it, and what else is in it.”
Cocoa beans are packed with fiber and “loads of phytonutrients,” Dr. Mozaffarian said, referring to the natural chemicals found in plants. Cocoa is thought to contain about 380 different chemicals, among them, a large class of compounds called flavanols that have attracted significant research interest for their potential health benefits. But it’s less clear how many flavanols and other phytonutrients you need to improve health, or whether your chocolate bar of choice contains enough of them to do so.
Estimates are based on observational studies, which have important limitations, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Boston. These studies can only identify correlations between eating chocolate and health; they can’t prove that chocolate causes benefits — people who eat more chocolate may be different in other ways that affect their health, Dr. Manson said.
Observational study findings have also been inconsistent. Some have found no benefit, and others have found that those who eat chocolate habitually or more frequently are more likely to gain weight, she pointed out. Such studies also don’t often account for the different types of chocolate, which can vary in their cocoa content. And the sugar, fat, and calorie count might negate any health benefits from the cocoa.
After following the participants for 3.6 years, the researchers found that while — when compared with the placebo group — the cocoa supplement group was not statistically less likely to have cardiovascular events including heart attacks and strokes, they did have a 27 percent reduction in cardiovascular deaths. Dr. Manson called these results “promising signals for heart protection,” though she emphasized that another trial is needed to confirm the findings before translating them into recommendations for cocoa flavanol intake.
Importantly, the COSMOS trial did not give participants chocolate, but rather concentrated capsules of cocoa extract produced by chocolate-maker Mars, which also partially funded the study. Chocolate is “a wonderful treat, but to perceive it as a health food, I think it has its limitations,” Dr. Manson said.
For his part, Dr. Mozaffarian is persuaded by the existing research that dark chocolate containing 70 percent or more cocoa is likely beneficial for heart health, even if it contains fewer flavanols than tested in the COSMOS trial. “Eating a small amount of dark chocolate every day is probably really good for us, and it will make you happy because it tastes good,” he said.
Dr. Mozaffarian said he does not receive any funding from the chocolate industry, but he did admit one conflict of interest when it comes to this particular food. “My conflict is that I do love dark chocolate,” he said.
Read more: Is Chocolate Good for You?
Eating chocolate is typically discouraged by nutritionists, as it is can be high in calories, fat, and sugar. Cocoa, however, chocolate’s primary ingredient derived from the seed of the cacao plant, has been found to have numerous that could be beneficial for both the body and mind.
Most notably, pure cocoa is highly nutritious and is a powerful source of antioxidants, substances that can prevent or slow down cell damage caused by free radicals. Free radicals are unstable and highly reactive molecules produced by the body when responding to environmental stresses, which are associated with aging and disease. In addition, cocoa has been found to help regulate blood pressure and prevent cognitive decline.
Despite these potentially beneficial properties, chocolate bars rarely contain cocoa alone, but also sugar, oils, butter, and other ingredients that are unhealthy for the body. The healthiest type of chocolate is thus likely to be dark chocolate comprised of high percentages of cocoa.
Elham Kalantarzedeh, Maryam Radahmadi, and Parham Reisi, three researchers at Isfahan University of Medical Science in Iran have recently carried out a study on rats investigating the impact of different dark chocolate dietary patterns on synapses in a specific region of the brain, known as the hippocampal CA1 area. Their findings, published in Nutritional Neuroscience, suggest that dark chocolate consumption could have beneficial effects on the brain of individuals exhibiting chronic isolation stress.
Read more: Study explores the effects of eating dark chocolate on the brain