Preprint: 'Greater Long-Term Weight Loss Linked to Increased ASCVD Risk'

 The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer reviewed.

Key Takeaway

• Adults aged 60-79 years who lost more than 5% of weight over 10 years had a significantly increased predicted 10-year risk of atherosclerotic cardiovascular disease (ASCVD) in an analysis based on National Health and Nutrition Examination Survey (NHANES) data.

Why This Matters

• This study supports the benefits of stable weight in promoting cardiovascular health in the elderly.

Study Design

• Data covering 1999-2018 were obtained from NHANES, a database intended to represent the noninstitutionalized, US civilian population.

• Demographic, socioeconomic, and health-related data, including weight history, were collected at home interviews and separate examinations and laboratory screenings.

• The analysis over the long-term interval of 10 years included 2322 persons; the short-term analysis over 1 year included 2543 persons. Their age range was 60-79 and all were self-reported to be free of ASCVD at baseline.

• The primary outcome of 10-year ASCVD risk was defined as a first nonfatal myocardial infarction (MI), death from coronary heart disease (CHD), or fatal or nonfatal stroke over a 10-year period.

Key Results

• The mean predicted 10-year ASCVD risk across the entire population (mean age 68, mean BMI 30.2 kg/m², 42% female) was 23.6%.

• Prevalences of 10-year weight change by degree of weight change was 28% for stable weight (±5.0%), 14.2% for moderate-to-large weight loss (≥10%), 9.9% for small weight loss (-5.1% to -9.9%), 14.4% for small weight gain (5.1% to 9.9%) and 33.5% for moderate-to-large weight gain (≥10%).

• Compared with stable weight, both moderate-to-large and small weight loss were associated with significantly increased 10-year ASCVD risk in unadjusted models and models adjusted for age, sex, and race/ethnicity, BMI, income-poverty ratio, physical activity, education level, and marital status.

• No significant association was observed between the weight gain categories and 10-year ASCVD risk in adjusted models, but moderate-to-large weight gain was associated with reduced ASCVD risk in the nonadjusted model.

• There was a dose-response relationship between continuous 10-year weight change ±10% and 10-year ASCVD risk, with greater weight loss tracking with increased risk. No such relationship was seen for weight change over 1 year.

 Limitations

• Weights were self-reported, which may have led to misclassification of weight change status.

• Fluctuations in body weight over the 10-year intervals were not considered.

• Weight measurements do not provide information on percentage body fat or lean mass.

Disclosures

• This study was funded by the National Center of China for Clinical Medical Research on Cardiovascular Diseases.

• The authors declare no competing interests.

This is a summary of a preprint research study, "Association between weight change and 10-Year Atherosclerotic Cardiovascular Disease Risk among U.S. older adults: data from National Health and Nutrition Examination Survey (NHANES) 1999–2018" written by Yuxuan Peng from the Beijing University of Chinese Medicine and colleagues on ResearchSquare.com, provided to you by Medscape. This study has not yet been peer reviewed. The full text of the study can be found on ResearchSquare.com.

https://www.medscape.com/viewarticle/985355

New Ransom Payment Schemes Target Executives, Telemedicine

 Ransomware groups are constantly devising new methods for infecting victims and convincing them to pay up, but a couple of strategies tested recently seem especially devious. The first centers on targeting healthcare organizations that offer consultations over the Internet and sending them booby-trapped medical records for the “patient.” The other involves carefully editing email inboxes of public company executives to make it appear that some were involved in insider trading.

Alex Holden is founder of Hold Security, a Milwaukee-based cybersecurity firm. Holden’s team gained visibility into discussions among members of two different ransom groups: CLOP (a.k.a. “Cl0p” a.k.a. “TA505“), and a newer ransom group known as Venus.

Last month, the U.S. Department of Health and Human Services (HHS) warned that Venus ransomware attacks were targeting a number of U.S. healthcare organizations. First spotted in mid-August 2022, Venus is known for hacking into victims’ publicly-exposed Remote Desktop services to encrypt Windows devices.

Holden said the internal discussions among the Venus group members indicate this gang has no problem gaining access to victim organizations.

“The Venus group has problems getting paid,” Holden said. “They are targeting a lot of U.S. companies, but nobody wants to pay them.”

Which might explain why their latest scheme centers on trying to frame executives at public companies for insider trading charges. Venus indicated it recently had success with a method that involves carefully editing one or more email inbox files at a victim firm — to insert messages discussing plans to trade large volumes of the company’s stock based on non-public information.

“We imitate correspondence of the [CEO] with a certain insider who shares financial reports of his companies through which your victim allegedly trades in the stock market, which naturally is a criminal offense and — according to US federal laws [includes the possibility of up to] 20 years in prison,” one Venus member wrote to an underling.

“You need to create this file and inject into the machine(s) like this so that metadata would say that they were created on his computer,” they continued. “One of my clients did it, I don’t know how. In addition to pst, you need to decompose several files into different places, so that metadata says the files are native from a certain date and time rather than created yesterday on an unknown machine.”

Holden said it’s not easy to plant emails into an inbox, but it can be done with Microsoft Outlook .pst files, which the attackers may also have access to if they’d already compromised a victim network.

“It’s not going to be forensically solid, but that’s not what they care about,” he said. “It still has the potential to be a huge scandal — at least for a while — when a victim is being threatened with the publication or release of these records.”

The Venus ransom group’s extortion note. Image: Tripwire.com

Holden said the CLOP ransomware gang has a different problem of late: Not enough victims. The intercepted CLOP communication seen by KrebsOnSecurity shows the group bragged about twice having success infiltrating new victims in the healthcare industry by sending them infected files disguised as ultrasound images or other medical documents for a patient seeking a remote consultation.

The CLOP members said one tried-and-true method of infecting healthcare providers involved gathering healthcare insurance and payment data to use in submitting requests for a remote consultation on a patient who has cirrhosis of the liver.

“Basically, they’re counting on doctors or nurses reviewing the patient’s chart and scans just before the appointment,” Holden said. “They initially discussed going in with cardiovascular issues, but decided cirrhosis or fibrosis of the liver would be more likely to be diagnosable remotely from existing test results and scans.”

While CLOP as a money making collective is a fairly young organization, security experts say CLOP members hail from a group of Threat Actors (TA) known as “TA505,” which MITRE’s ATT&CK database says is a financially motivated cybercrime group that has been active since at least 2014. “This group is known for frequently changing malware and driving global trends in criminal malware distribution,” MITRE assessed.

In April, 2021, KrebsOnSecurity detailed how CLOP helped pioneer another innovation aimed at pushing more victims into paying an extortion demand: Emailing the ransomware victim’s customers and partners directly and warning that their data would be leaked to the dark web unless they can convince the victim firm to pay up.

Security firm Tripwire points out that the HHS advisory on Venus says multiple threat actor groups are likely distributing the Venus ransomware. Tripwire’s tips for all organizations on avoiding ransomware attacks include:

• Making secure offsite backups.
• Running up-to-date security solutions and ensuring that your computers are protected with the latest security patches against vulnerabilities.
• Using hard-to-crack unique passwords to protect sensitive data and accounts, as well as enabling multi-factor authentication.
• Encrypting sensitive data wherever possible.
• Continuously educating and informing staff about the risks and methods used by cybercriminals to launch attacks and steal data.

While the above tips are important and useful, one critical area of ransomware preparedness overlooked by too many organizations is the need to develop — and then periodically rehearse — a plan for how everyone in the organization should respond in the event of a ransomware or data ransom incident. Drilling this breach response plan is key because it helps expose weaknesses in those plans that could be exploited by the intruders.

As noted in last year’s story Don’t Wanna Pay Ransom Gangs? Test Your Backups, experts say the biggest reason ransomware targets and/or their insurance providers still pay when they already have reliable backups of their systems and data is that nobody at the victim organization bothered to test in advance how long this data restoration process might take.

“Suddenly the victim notices they have a couple of petabytes of data to restore over the Internet, and they realize that even with their fast connections it’s going to take three months to download all these backup files,” said Fabian Wosar, chief technology officer at Emsisoft. “A lot of IT teams never actually make even a back-of-the-napkin calculation of how long it would take them to restore from a data rate perspective.”

https://krebsonsecurity.com/2022/12/new-ransom-payment-schemes-target-executives-telemedicine/

Medtronic left behind by the new class of glucose monitors

 Yesterday’s FDA clearance of Dexcom’s G7 leaves Medtronic alone as one of the big three continuous glucose monitor makers without a next-generation approval this year to its name. Medtronic’s 780G – not strictly a CGM but a hybrid closed-loop system incorporating a CGM as well as an insulin pump – was filed with the FDA in early 2021 but clearance is still likely a way away. The filing suffered a delay a year ago on quality control issues at Medtronic’s diabetes plant; last month the company said it had resolved the issues and was ready for reinspection. Even so, the lag between EU and US approval of the device could be as long as three years. And until clearance eventually arrives, Medtronic is being outplayed in the world’s largest diabetes market not just by Dexcom but by Abbott, whose Freestyle Libre 3 hit the US in late May. As for Dexcom, the next step will be securing reimbursement for the G7, though it will launch next year as a self-pay product. After that work will start on getting approval for combinations with insulin pumps, another important means of securing share of the global CGM market, which Stifel analysts say is worth $3bn.

Selected current and forthcoming diabetes devices - in-house
Company	Technology	Type	Status
Abbott	Freestyle Libre 3	CGM	CE marked Sep 2020; FDA approved May 2022
Dexcom	G7	CGM	CE marked Mar 2022; FDA approved Dec 2022
Insulet	Omnipod 5*	Insulin pump	FDA approved Jan 2022; CE marked Sep 2022
Tandem	t:slim X2	Insulin pump	FDA approved Aug 2017; CE marked Apr 2018
Tandem	t:slim X3	Insulin pump	In development
Tandem	Mobi	Insulin pump	Awaiting FDA approval
Ypsomed	Mylife YpsoPump	Insulin pump	CE marked Jun 2016; FDA filing planned for H2 2023
Medtronic	Minimed 770G	Closed-loop	FDA approved Aug 2020; CE marked
Medtronic	Minimed 780G	Closed-loop	CE marked Jun 2020; awaiting FDA approval
CGM = continuous glucose monitor. *Formerly called Omnipod Horizon. Source: company communications, analyst notes.

 

Selected current and forthcoming diabetes devices - collaborations
Companies	Technology	Status
Insulet/Dexcom	Omnipod 5* with G6	Approved US Jan 2022
Insulet/Dexcom	Omnipod 5 with G7	Expected 2022 or 2023
Insulet/Abbott	Omnipod 5 with Freestyle Libre 2	Expected 2023
Insulet/Abbott	Omnipod 5 with Freestyle Libre 3	Expected 2023
Ypsomed/Abbott	Mylife YpsoPump with FreeStyle Libre 3	Expected 2023
Tandem/Dexcom	t:slim X2 with G6	FDA approved and CE marked Dec 2019
Tandem/Dexcom	t:slim X2 with G7	Expected 2022 or 2023
Tandem/Abbott	t:slim X2 with Freestyle Libre 2	Expected 2022
Tandem/Abbott	t:slim X2 with Freestyle Libre 3	Expected 2022 or 2023
*Formerly called Omnipod Horizon. Source: company communications, analyst notes. https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/medtronic-left-behind-new-class-glucose

White House dismisses report that bank CEO could replace Yellen as Treasury secretary

 White House press secretary Karine Jean-Pierre on Friday played down a Fox Business report that said Bank of America CEO Brian Moynihan is on the Biden administration's short list to replace Treasury Secretary Janet Yellen if Yellen decides to leave her post. Jean-Pierre said that report "seems to be pure speculation" and pointed to Yellen's recent statement that she has no plans to leave. The report said Commerce Secretary Gina Raimondo is also a frontrunner for the Treasury job.

https://www.morningstar.com/news/marketwatch/20221209491/white-house-dismisses-report-that-bank-ceo-could-replace-yellen-as-treasury-secretary

Musk Confirms Political Candidates Were Shadow Banned By Twitter’s Censors

 by Tom Ozimek via The Epoch Times (emphasis ours),

Elon Musk has confirmed that political candidates were shadow banned by Twitter while running for office, in the latest revelation on the social media giant’s meddling in conversations of public interest, including by putting disfavored users on blacklists and suppressing distribution of their tweets.

Following the release of the second part of the “Twitter Files,” which revealed the social media giant put users on secret blacklists and used other shadow banning tools, Musk was asked by political commentator Ian Miles Cheong if political candidates were also subject to such censorship.

“So here’s a question for @elonmusk and @bariweiss: were any political candidates — either in the US or elsewhere — subject to shadowbanning while they were running for office or seeking re-election?'” Cheong asked in a tweet, tagging both Musk and journalist Bari Weiss.

“Yes,” Musk replied, confirming that Twitter has, as many have alleged, put its finger on the scale of conversations that were of importance to public interest, including in the context of elections.

The Epoch Times has reached out to Twitter for comment.

Twitter ‘Has Interfered in Elections’

Musk did not go into further detail but he has previously said that Twitter had “failed” to be impartial in content moderation and “interfered in elections.”

“The obvious reality, as long-time users know, is that Twitter has failed in trust & safety for a very long time and has interfered in elections,” Musk said in a Nov. 30 post on Twitter.

In that message, Musk was responding to criticism from Twitter’s former head of site integrity Yoel Roth, who said during a recent interview at the Knight Foundation conference that he didn’t believe safety had improved on Twitter after Musk’s takeover.

Roth also said that he thinks Twitter blocking the explosive Hunter Biden laptop story ahead of the 2020 presidential election was a mistake.

In the run-up to the 2020 election, the New York Post published a story about a laptop abandoned at a computer repair shop that purportedly belonged to Hunter Biden and contained emails suggesting that then-candidate Joe Biden had knowledge of, and was allegedly involved in, his son’s foreign business dealings.

President Joe Biden has repeatedly insisted he had no knowledge of or involvement in his son’s business operations.

U.S. President Joe Biden (L) waves alongside his son Hunter Biden after attending mass at Holy Spirit Catholic Church in Johns Island, South Carolina on Aug. 13, 2022. (Nicholas Kamm/AFP via Getty Images)

‘Secret Blacklists’

Weiss, founder and editor of The Free Press, released the second volume of the so-called “Twitter Files” on Dec. 8, revealing the social media platform’s “secret blacklists.”

Weiss has been working with Musk and independent journalist Matt Taibbi to disclose internal Twitter information regarding censorship.

Twitter’s censorship methods, according to Weiss, included placing specific users on a “Trends Blacklist” or a “Search Blacklist.”

The popular Libs of TikTok account, as well as Dr. Jay Bhattacharya, professor of medicine at Stanford University School of Medicine, are among the users who were secretly added to the “Trends Blacklist” by the company.

Bhattacharya was put on the list because he stated that children would be harmed by COVID-19 lockdowns. This action stopped his tweets from trending, Weiss said.

Conservative talk show presenter Dan Bongino was also put on a so-called “Search Blacklist,” Weiss disclosed.

Weiss also noted that conservative activist Charlie Kirk, founder of Turning Point USA, was put on a “Do Not Amplify” list.

The second installment comes just a week after Taibbi published, with Musk’s endorsement, details about the social media platform’s decision to suppress the New York Post’s report on the contents of a laptop tied to Hunter Biden.

Republicans had long accused Twitter—and some media outlets—of suppressing the Hunter Biden laptop story, which included reporting that bolstered claims that the president lied when he said he had no involvement in his son’s overseas business dealings.

In order to suppress the Hunter Biden report, Twitter executives marked it as “unsafe,” limiting its spread, and even blocking it from being directly shared via the platform’s direct message function, Taibbi said in comments on the first installment of the disclosures. He also noted that such extreme restrictions were normally reserved for content such as child pornography.

‘Shadow Banning’

Weiss, in comments on the latest Twitter Files release, detailed various ways that Twitter employees acted to suppress speech on the platform.

“A new #TwitterFiles investigation reveals that teams of Twitter employees build blacklists, prevent disfavored tweets from trending, and actively limit the visibility of entire accounts or even trending topics—all in secret, without informing users,” Weiss said on Twitter. 

“Twitter once had a mission ‘to give everyone the power to create and share ideas and information instantly, without barriers.’ Along the way, barriers nevertheless were erected,” she added.

https://www.zerohedge.com/political/musk-confirms-political-candidates-were-shadow-banned-twitters-censors

FDA Is Letting Harmful Lab-Developed Tests Fall Through the Cracks

 Imagine nearly ending a pregnancy because a lab test was wrong. In January 2022, a story in the New York Times recounted one pregnant woman's experience with an inaccurate genetic non-invasive prenatal screening (NIPS) test. These blood tests analyze small pieces of fetal DNA that cross the placenta into the mother's circulation to assess the risk for genetic abnormalities in the fetus. Though NIPS tests for more common conditions like Down syndrome are very useful clinically, tests for serious but rare conditions like Prader-Willi syndrome -- a condition associated with distinctive facial features, poor muscle tone, weight gain, and behavioral disturbances -- are prone to false-positives. Because Prader-Willi is so rare, it is actually more likely that a positive test is false than true.

And that is exactly what happened in this case. After her test came back positive for fetal Prader-Willi syndrome, the woman contemplated terminating her pregnancy. Luckily, she underwent a follow-up invasive procedure and learned that the initial result was indeed a false-positive. She went through with the pregnancy and delivered a baby with no indication of Prader-Willi syndrome. But it was a close call and the psychological toll was immense.

NIPS tests are a type of medical device called laboratory-developed tests (LDTs). Unlike conventionally manufactured medical devices, LDTs are developed and used in one laboratory and providers send their tests to that facility. At first, LDTs were largely confined to isolated academic laboratories, but with time the number and complexity of such tests has burgeoned as companies are increasingly offering them for more common conditions.

The FDA has the uncontested authority to review all medical devices -- including LDTs -- for safety and efficacy under the Federal Food, Drug, and Cosmetic Act. However, the agency has chosen not to use its authority to regulate LDTs to date. As a result, the FDA does not know how many of these tests are on the market, let alone whether they are safe or effective.

Defenders of the status quo love to point out that regulation of LDTs currently falls under the CMS Clinical Laboratory Improvement Amendments, thus rendering FDA regulation unnecessary in their view. But CMS regulates labs themselves rather than the safety and effectiveness of tests. CMS also only requires labs to have documentation of their tests' "analytical validity" but does not require "clinical validity" data. This means that, for example, CMS would only assess whether a pancreatic cancer test accurately detects cancer proteins, not whether the detection of the proteins is a reliable way to diagnose pancreatic cancer. Or CMS regulation would determine whether a test detects Prader-Willi in fetal DNA, not establish the likelihood that the fetus actually has the condition -- as FDA regulation would. Consequently, regulation under FDA would be much more comprehensive, include communication to doctors and patients, and would allow the agency to track the tests on the market. In sum, it would close critical gaps that allow the marketing of inaccurate LDTs.

The issues arising from the lack of LDT regulation can be seen as similar to the challenges in the early fumbled approach to COVID. Early COVID-19 diagnostic tests were in effect regulated like LDTs in that FDA, anxious to get new tests into the market, allowed them to be marketed without review until the agency had a chance to review their applications for emergency use authorization. Once the agency was able to review the applications, it found validation or design issues in over 65% of a sample of 125 tests submitted for authorization. False-positive COVID-19 tests may have led to unnecessary quarantining and false-negative tests may have led to additional spread of the virus.

By establishing a risk-based framework for FDA regulation of all in vitro clinical tests, regardless of where they are produced and used, the Verifying Accurate Leading-edge IVCT Development Act of 2021 (VALID) sets forth a potential solution to the problem of inaccurate LDTs. The bill creates a tiered system whereby tests that carry risks of serious harm if inaccurate undergo full premarket review, those that pose less-serious risks of harm submit less-detailed documentation of their analytical and clinical validity, and those that are likely to result in minimal harm are exempt from review. The bill also authorizes FDA to require test developers to conduct surveillance of higher-risk tests once they are on the market and mandates adverse event reporting by developers. These processes are standard for drugs. While not a perfect solution, VALID would help ensure the highest-risk tests are properly vetted by the FDA for their safety and effectiveness.

In May 2022, VALID was incorporated into the Senate version of the user fee reauthorization bill, a piece of legislation that must pass every 5 years because it funds a large portion of FDA activities. Unfortunately, Congress instead passed a stripped-down continuing resolution that left out all LDT provisions.

Now that the midterms are behind us, Congress gets a second bite at the apple when the continuing resolution expires on December 16. FDA's current commissioner, Robert Califf, MD, and device chief, Jeffrey Shuren, MD, JD -- and even former Trump-era FDA commissioner Scott Gottlieb, MD -- have supported Congressional action on LDTs. The window of opportunity for LDT reform appears to be closing; let's pass consumer-protective legislation before it slams securely shut.

Stephanie Rogus, PhD, RDN, is a research scientist and campaign manager for scientific integrity at the Center for Science in the Public Interest. Peter G. Lurie, MD, MPH, is president of the Center for Science in the Public Interest, and a former associate commissioner of the FDA.

https://www.medpagetoday.com/opinion/second-opinions/102161

American Girl stands behind ‘Body Image’ book after backlash over gender identity content

 The company American Girl is standing behind its recent “Body Image” book following backlash it has received from critics for mentioning gender identity. 

Julie Parks, a spokesperson for the company, told USA Today that no other American Girl book has ever received similar criticism. She said “Body Image” is the first American Girl book to address gender identity and expression. 

“Our Smart Girls Guides are known for supporting young people and their families through a variety of complex adolescent topics,” Parks said. 

As of Dec. 9, the book had received more than 200 negative reviews on American Girl’s website, many of which refer to the book addressing gender identity. 

“When did American Girl decide to force its worldview on readers of every belief system?” one reviewer asked.

Apart from the ratings giving the book the lowest score of one star, the reviews have been overwhelmingly positive, with 55 reviewers giving it five stars. Two people gave it three stars, and one person gave it two stars. 

The description of the book on the website states it will provide girls everything they need to “know about loving her unique self, staying confident through her body‘s many changes, and appreciating her body for the life it lets her live.”  

“Full of activities, tips, crafts, and real-girl stories, this book is a feel-good reminder that all bodies are worthy of love and respect,” it states. 

The book is 96 pages long, but the company said the negative reviewers and conservative media especially highlighted two pages. A sentence of one page directs children to resources if they do not have an adult who will support them, according to USA Today. 

The company said medical experts were consulted for the book to have accurate information. 

“The content in this book was developed in partnership with medical and adolescent care professionals and consistently emphasizes the importance of having conversations and discussing any feelings with parents or trusted adults,” the company said.

https://thehill.com/homenews/state-watch/3769013-american-girl-stands-behind-body-image-book-after-backlash-from-critics-over-gender-identity-content/