One Diet Appeared Tops for Short-Term Seizure Control in Pediatric Epilepsy

 In children with drug-resistant epilepsy, the modified Atkins and ketogenic diets were more effective than usual care in achieving large short-term reductions in seizures and short-term seizure freedom, a systematic review and network meta-analysis found.

Across 12 randomized trials, all three dietary interventions evaluated -- ketogenic, modified Atkins, low glycemic index therapy (LGIT) -- showed a short-term benefit (3 months or less) in seizure reductions of at least 50% compared with usual care, reported Dipika Bansal, DM, of the National Institute of Pharmaceutical Education and Research in Punjab, India, and colleagues.

But as described in JAMA Pediatrics

opens in a new tab or window, only the modified Atkins and ketogenic diets were effective for short-term seizure reductions of 90% or more compared with usual care (OR 5.1, 95% CI 2.2-12.0, and OR 6.5, 95% CI 2.3-18.0, respectively) and for achieving short-term freedom from seizures (OR 4.4, 95% CI 1.3-14.5, and OR 5.0, 95% CI 1.3-19.5).

These may be more meaningful outcomes for children with a very high burden of daily seizures, such as those with drug-resistant epilepsy, according to the researchers.

While direct comparisons showed no significant differences, they concluded that with its better tolerability, the modified Atkins diet "may be a sounder option than ketogenic diet."

Across dietary interventions, pooled results showed that 36% of children achieved short-term seizure reductions of 50% or more, 17% had reductions of 90% or more, and 10% achieved short-term seizure freedom. Data on intermediate outcomes were more mixed and only one study examined long-term outcomes.

Modified Atkins and ketogenic diets were both associated with more adverse event-related discontinuations versus usual care (OR 6.5, 95% CI 1.4-31.2, and OR 8.6, 95% CI 1.8-40.6, respectively). Adverse events included constipation, lack of energy, and vomiting.

Participants also withdrew from the diets for reasons including "inefficacy, parental unhappiness, behavioral food refusal, dissatisfaction with randomization results, and food texture," Bansal and co-authors noted. "This echoes with the fact that parental food habits

opens in a new tab or window and feeding strategies determine their child's eating behavior."

Dietary therapies have long been used to treat the nearly 30% of pediatric epilepsy patients who are resistant to antiseizure medication, but investigations into the comparative efficacy of various interventions, along with their safety, have been lacking.

"Although epilepsy surgery is a curative treatment option for surgically amenable DRE [drug-resistant epilepsy], alternative modalities such as dietary therapies are often used on the failure of two or more appropriately chosen antiseizure medications while awaiting epilepsy surgery, in nonsurgical DRE, and specific neurometabolic disorders," wrote Bansal and colleagues.

In addition to patient-specific factors such as primary diagnosis and child/family dietary preferences, selection of a drug-resistant epilepsy diet should take into account the interactions of different dietary therapies, including the possible adverse effects of carbonic anhydrase inhibitors and valproic acid in patients on a ketogenic diet, the group advised.

For their systematic review and network meta-analysis, the researchers identified 12 eligible randomized trials (11 open-label, one single-blinded) involving patients ages 18 years and younger with drug-resistant epilepsy, according to criteria

opens in a new tab or window of the International League Against Epilepsy (failure of two or more appropriately chosen antiseizure medications).

Trials were conducted in multiple countries -- India, Iran, Korea, The Netherlands, and the U.K. -- and compared the three dietary interventions with each other or with usual care, which included ongoing use of antiseizure medications. Dietary interventions included the ketogenic diet (classic ketogenic diet or the medium-chain triglyceride ketogenic diet [MCT-KD]), modified Atkins, and LGIT.

Ketogenic diets "have been used for over a century with promising results," according to the researchers, but adherence difficulties have limited their use.

"The classic KD [ketogenic diet], with a ketogenic ratio of 4:1, derives 80% of total energy intake from fat (mostly long-chain triglycerides; medium-chain triglycerides in MCT-KD) and the rest from carbohydrate and protein combined," the authors explained. Less restrictive diets assessed included modified Atkins and LGIT, which use low-glycemic index foods to limit daily carbohydrate intake to 10-20 g and 40-60 g, respectively, without any fixed ketogenic ratios.

Overall, 907 patients in the studies were randomized (676 to dietary interventions, 257 to care as usual). Two-thirds of the children were boys, and the average age at enrollment was 4.6 years (SD 2.4). Initiation of dietary therapies was delayed to an average age of over 4 years in seven studies.

Mean age at seizure onset was 1.4 years (SD 1.6) and the mean seizure frequency was 27.1 per day (SD 31.8), ranging from 4 to 59.5 per day due to different seizure types in all likelihood, according to the researchers.

As noted, short-term seizure reductions of 50% or more was achieved with all three interventions when compared with usual care:

• LGIT: OR 24.7 (95% CI 5.3-115.4)
• Modified Atkins: OR 11.3 (95% CI 5.1-25.1)
• Ketogenic: OR 8.6 (95% CI 3.7-20.0)

Limitations, the team noted, included within-study bias due to the open-label nature of most of the trials, the "clinical heterogeneity" of patients involved, and the "imprecision and unavailability of robust evidence for indirect comparison between different dietary interventions and for intermediate- and long-term outcomes."

They added that "direct head-to-head comparison studies in the future are needed to confirm these findings further."

Disclosures

Bansal and co-authors reported no conflicts of interest.

Primary Source

JAMA Pediatrics

Source Reference: opens in a new tab or windowDevi N, et al "Efficacy and safety of dietary therapies for childhood drug-resistant epilepsy: a systematic review and network meta-analysis" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2022.5648.

https://www.medpagetoday.com/neurology/seizures/102902

Colorado Doc Put on Probation for Ivermectin Prescriptions

 The Colorado Medical Board put a family medicine physician's license on probation

opens in a new tab or window after he admitted to prescribing ivermectin for COVID-19 without properly informing patients of the drug's risks or discussing the FDA-approved treatments for the disease.

Scott Rollins, MD, who practices in Grand Junction, and the board reached an agreementopens in a new tab or window on the matter late last month, according to an online records search through the Colorado Department of Regulatory Agencies' Division of Professions and Occupations. In the agreement, it was decided that Rollins' medical license would be placed on indefinite probation pending the completion of a physician education program after Rollins admitted that his actions constituted "unprofessional conduct."

The agreement specifically referred to three patients -- unnamed and listed as Patients 1-3 -- for whom Rollins did not perform or did not document the performance of clinical assessments, and did not discuss or document the discussion of several factors related to the prescription of the antiparasitic drug for the treatment and prevention of COVID.

These factors included the risks or perceived benefits associated with ivermectin; patient participation in clinical decision making or Rollins' application of clinical judgment; the availability, risks, and benefits of FDA-approved treatments or vaccines for COVID; and other non-pharmaceutical measures to reduce the likelihood of COVID infection.

"For each of Patients 1-3, respondent failed to adequately document elements of medical decision-making, clinical assessments, risk/benefit analyses of important decisions, application of clinical judgment to situation, the plans for patient treatment, the purpose of those plans, and the patient's participation in medical decision-making," the agreement stated.

Rollins' license was placed on indefinite probation until his successful completion of a medical record-keeping seminar from the Center for Personalized Education for Physicians, which he completed in September 2022, as well as a 6-month follow-up program to be completed within a year of the agreement.

Neither Rollins nor his legal counsel provided comment to MedPage Today by press time.

Upon expiration of the probation period, Rollins may submit a written request for restoration of his license to an unrestricted status. The request would be granted if the terms of the probation have been complied with and the probationary period has not been tolled, the agreement noted.

A spokesperson for the Colorado Department of Regulatory Agencies declined MedPage Today's request for additional details, citing confidentiality.

Rollins has been licensed to practice medicine in Colorado since 1993, and he has continuously held that license ever since.

https://www.medpagetoday.com/special-reports/features/102904

Early release from prison for organ donations? Maybe in Mass.

 A proposal by a state lawmaker would grant prisoners early release from their court imposed sentences of up to one year if they volunteer to donate their organs or bone marrow.

If made law, the bill would “allow eligible incarcerated individuals to gain not less than 60 and not more than 365 day reduction in the length of their committed sentence in Department of Corrections facilities, or House of Correction facilities if they are serving a Department of Correction sentence in a House of Corrections facility, on the condition that the incarcerated individual has donated bone marrow or organ(s),” the proposal reads in part.

Submitted to this year’s Legislature by state Reps. Carlos González, Springfield, and Judith A. Garcia, Chelsea and Everette, the bill would “establish a Marrow and Organ Donation Program within the Department of Correction and a Bone Marrow and Organ Donation Committee.”

According to Garcia, who took to Twitter to explain the proposal, there isn’t currently a way for an incarcerated person to donate bone marrow or organs, even if a close relative would benefit from the donation.

“Nearly 5,000 MA residents are currently awaiting organ transplants,” a graphic she shared explains, before saying the bill would “restore bodily autonomy to incarcerated folks by providing opportunity to donate organs and bone marrow.”

Twitter users did not seem to respond well to the plan, some calling the incentive to leave prison up to a year early coercion, others simply referring to it as “abhorrent.”

Garcia and González could not be reached for comment by press time.

https://www.bostonherald.com/2023/01/30/early-release-from-prison-for-organ-donations-maybe-in-massachusetts/

"Objectivity Has Got To Go": News Leaders Call For End Of Objective Journalism

 by Jonathan Turley,

We previously discussed the movement in journalism schools to get rid of principles of objectivity in journalism. Advocacy journalism is the new touchstone in the media even as polls show that trust in the media is plummeting. Now, former executive editor for The Washington Post Leonard Downie Jr. and former CBS News President Andrew Heyward have released the results of their interviews with over 75 media leaders and concluded that objectivity is now considered reactionary and even harmful. Emilio Garcia-Ruiz, editor-in-chief at the San Francisco Chronicle said it plainly: “Objectivity has got to go.” 

Notably, while Bob Woodword and others have finally admitted that the Russian collusion coverage lacked objectivity and resulted in false reporting, media figures are pushing even harder against objectivity as a core value in journalism.

We have been discussing the rise of advocacy journalism and the rejection of objectivity in journalism schools. Writers, editors, commentators, and academics have embraced rising calls for censorship and speech controls, including President-elect Joe Biden and his key advisers. This movement includes academics rejecting the very concept of objectivity in journalism in favor of open advocacy.

Columbia Journalism Dean and New Yorker writer Steve Coll decried how the First Amendment right to freedom of speech was being “weaponized” to protect disinformation. In an interview with The Stanford Daily, Stanford journalism professor, Ted Glasser, insisted that journalism needed to “free itself from this notion of objectivity to develop a sense of social justice.”

He rejected the notion that journalism is based on objectivity and said that he views “journalists as activists because journalism at its best — and indeed history at its best — is all about morality.” 

Thus, “Journalists need to be overt and candid advocates for social justice, and it’s hard to do that under the constraints of objectivity.”

Lauren Wolfe, the fired freelance editor for the New York Times, has not only gone public to defend her pro-Biden tweet but published a piece titled “I’m a Biased Journalist and I’m Okay With That.” 

Former New York Times writer (and now Howard University Journalism Professor) Nikole Hannah-Jones is a leading voice for advocacy journalism.

Indeed, Hannah-Jones has declared “all journalism is activism.” Her 1619 Project has been challenged as deeply flawed and she has a long record as a journalist of intolerance, controversial positions on rioting, and fostering conspiracy theories. Hannah-Jones would later help lead the effort at the Times to get rid of an editor and apologize for publishing a column from Sen. Tom Cotten as inaccurate and inflammatory.

Polls show trust in the media at an all-time low with less than 20 percent of citizens trusting television or print media. Yet, reporters and academics continue to destroy the core principles that sustain journalism and ultimately the role of a free press in our society. Notably, writers who have been repeatedly charged with false or misleading columns are some of the greatest advocates for dropping objectivity  in journalism.

Now the leaders of media companies are joining this self-destructive movement. They are not speaking of columnists or cable hosts who routinely share opinions. They are speaking of actual journalists, the people who are relied upon to report the news.

Saying that “Objectivity has got to go” is, of course, liberating. You can dispense with the necessities of neutrality and balance. You can cater to your “base” like columnists and opinion writers. Sharing the opposing view is now dismissed as “bothsidesism.” Done. No need to give credence to opposing views. It is a familiar reality for those of us in higher education, which has been increasingly intolerant of opposing or dissenting views.

Downie recounts how news leaders today

“believe that pursuing objectivity can lead to false balance or misleading “bothsidesism” in covering stories about race, the treatment of women, LGBTQ+ rights, income inequality, climate change and many other subjects. And, in today’s diversifying newsrooms, they feel it negates many of their own identities, life experiences and cultural contexts, keeping them from pursuing truth in their work.”

There was a time when all journalists shared a common “identity” as professionals who were able to separate their own bias and values from the reporting of the news.

Now, objectivity is virtually synonymous with prejudice. Kathleen Carroll, former executive editor at the Associated Press declared “It’s objective by whose standard? … That standard seems to be White, educated, and fairly wealthy.”

Outlets like NPR are quickly erasing any lines between journalists and advocates. NPR announced that reporters could participate in activities that advocate for “freedom and dignity of human beings” on social media and in real life.

Downie echoes such views and declares “What we found has convinced us that truth-seeking news media must move beyond whatever ‘objectivity’ once meant to produce more trustworthy news.”

Really? Being less objective will make the news more trustworthy? That does not seem to have worked for years but Downie and others are doubling down like bad gamblers at Vegas.

Indeed, the whole “Let’s Go Brandon” chant is as much a criticism of the media as it is President Biden.

If there is little difference between the mainstream media and alternative media, the public will continue the trend away from the former. MSM has the most to lose from this movement, but, as individual editors, it remains popular to yield to advocates in their ranks. That is what the New York Times did when it threw its own editors under the bus to satisfy the mob.

As media outlets struggle to survive, these media leaders are feverishly sawing at the tree branch upon which they sit.

https://www.zerohedge.com/political/objectivity-has-got-go-news-leaders-call-end-objective-journalism

FDA chief: No one getting fired over baby formula crisis

 FDA’s major overhaul of its foods division won’t include reassigning or firing any employees involved in the agency’s delayed response to the baby formula crisis, Commissioner Robert Califf said Tuesday.

Califf rolled out his “new, transformative vision” of the main agency tasked with overseeing food safety in the U.S. He didn’t include any specific plans to address internal FDA breakdowns around infant formula, and instead focused on general restructuring to boost food safety efforts. But the FDA chief, asked during a press briefing, said he doesn’t have any plans to fire or reassign any FDA officials involved in the internal agency breakdowns as part of the larger reforms to the FDA’s Human Foods Program.

Califf said there had been some “leadership changes.” His remarks come just days after senior FDA foods official Frank Yiannas’ resignation last week. In his resignation letter, Yiannas called for structural reforms at the troubled division.

“But the short answer is no one’s going to be reassigned or fired because of the infant formula situation,” Califf told reporters.

Scrutiny of the FDA’s foods division increased after advocates and lawmakers accused the agency of failing to rapidly and effectively address an infant formula contamination event that had a major impact on U.S. supply. The actions unveiled by Califf on Tuesday follow an external review of the foods division that found “constant turmoil” within its ranks, and a complex leadership structure that left staff “wondering which program is responsible for decision-making.”

Baby formula supplies have bounced back since the widespread shortages triggered by a recall that sent parents scrambling for supplies last year. But some families — especially those with medically vulnerable children — are still struggling to find formula.

Top FDA officials were warned about food safety concerns at a key infant formula plant months before the agency’s inspectors found strains of a bacteria that can be deadly to babies. Months after those warnings, Abbott, the company at the center of the formula crisis, issued a recall of some formula products and shut down the facility, triggering widespread shortages across the country. The company, which maintains there is no connection between the bacteria found at the plant and the deaths of several babies, is now under criminal investigation by the Justice Department.

“Where there could have been better performance, that’s reflected in the performance evaluation system. And, of course, that’s confidential information between supervisors and employees,” Califf said in response to the question from POLITICO.

Califf said the proposed foods division reforms included streamlining reporting structures; clarifying the relationship between the Office of Regulatory Affairs, which is the lead for field food safety inspections, and the food oversight division; and creating a Center for Excellence in Nutrition. Califf also proposed unifying much of the foods program under a single leader who reports directly to him, which would mean “removing redundancies” and “enabling the agency to oversee human food in a more effective and efficient way.”

FDA Principal Deputy Commissioner Janet Woodcock told reporters on Tuesday that FDA’s formula response was “a systems problem, not an individual problem.” She also noted an internal review of FDA’s infant formula supply chain response last year. As POLITICO reported, the report didn’t name any specific teams responsible for breakdowns at FDA and surprised stakeholders with its lack of accountability.

“And so the system fixes that we are putting in place, both the information technology support as well as many of the changes, will address all the different issues,” Woodcock said.

“This was a failure of the systems — to the extent there was a failure — to provide the information to the right people at the right time,” Woodcock added.

Califf and other top FDA officials, despite acknowledging to lawmakers a string of internal breakdowns that contributed to the crisis, have pushed back against claims that there were any major failures at the agency. That includes a breakdown in internal FDA communication that some senior FDA officials said prevented them from knowing about the food safety issues until just weeks before the recall.

Califf and Yiannas said a whistleblower report alleging food safety problems at the plant, which was mailed in October 2021, did not reach the FDA’s highest ranks until mid-February 2022. Califf, in testimony to lawmakers, said senior officials didn’t receive the whistleblower report due to pandemic “mailroom issues.”

https://www.politico.com/news/2023/01/31/fda-califf-baby-formula-reforms-00080460

JAMA-China study in UK: 'Even Low Levels of Air Pollution Could Be Bad for Mental Health'

 Long-term exposure to air pollution may be a driver of mental health issues, a prospective cohort study suggested.

In an analysis of nearly 400,000 people in the U.K., long-term exposure to various air pollutants were linked with a higher risk for incident depression and anxiety, reported Jing Huang, PhD, of the Peking University School of Public Health in Beijing, and colleagues.

Compared with the lowest quartile of air pollution score, those falling into the second, third, and fourth quartiles had a significant 8%, 17%, and 16% higher risk for incident depression, respectively, they stated in JAMA Psychiatryopens in a new tab or window.

Likewise, people falling into the second, third, and fourth quartiles for air pollution score had 9%, 14%, and 11% higher risks for developing anxiety compared with people in the lowest quartile over the 11-year follow-up.

Air pollution score was based on combined exposure to small particulate matteropens in a new tab or window with aerodynamic diameter of 2.5 μm or less (PM_2.5), nitrogen dioxideopens in a new tab or window (NO₂), and nitric oxide (NO). Particulate pollution is often in the form of dust or smoke and can be small enough where its naked to the eye. NO₂ and NO pollution often comes from car, power plant emissions, and other sources of burning gas.

Models in the study were adjusted for age, sex, ethnicity, level of deprivation, length of time at residence, and more.

Even at relatively low levels of exposure, all three of these air polluters were individually tied with depression and anxiety.

First looking just at PM_2.5 exposure, higher levels of exposure showed significantly increased risks for incident depression compared with the lowest quartile of exposure, representing pollutant level less than 9.3 μg/m³:

• 9.3-9.9 μg/m³: HR 1.09 (95% CI 1.03-1.14)
• 9.9-10.6 μg/m³: HR 1.14 (95% CI 1.08-1.20)
• 10.6 μg/m³ or more: HR 1.15 (95% CI 1.08-1.21)

In a subgroup analysis, the link between PM_2.5 exposure and anxiety was higher for males in the highest quartile of pollutant levels at HR 1.18 (95% CI 1.08-1.29) versus HR 1.07 (95% CI 1.00-1.14) for females.

The same pattern was seen at all higher levels of NO₂ exposure compared with the lowest quartile of exposure, representing a pollutant level less than 21.3 μg/m³:

• 21.3-26.0 μg/m³: HR 1.11 (95% CI 1.06-1.17)
• 26.0-31.1 μg/m³: HR 1.15 (95% CI 1.09-1.22)
• 31.1 μg/m³ or more: HR 1.14 (95% CI 1.07-1.21)

And the same was also seen for NO exposure at the higher quartiles versus the lowest quartile of less than 11.6 μg/m³:

• 11.6-15.9 μg/m³: HR 1.07 (95% CI 1.02-1.13)
• 15.9-20.6 μg/m³: HR 1.11 (95% CI 1.06-1.17)
• 20.6 μg/m³ or more: HR 1.12 (95% CI 1.06-1.18)

Nearly identical patterns were seen in terms of new anxiety cases, with steep inclines between the first and second quartiles of exposure, then plateauing through the fourth quartile, the authors reported.

For context, median concentration of pollutants were 9.9 μg/m³ for PM_2.5, 26.0 μg/m³ for NO₂, and 15.9 μg/m³ for NO -- all high enough to be significantly linked to a higher risk for depression or anxiety.

Huang's group pointed out that these increased associated risks for depression and anxiety were both seen at concentration levels below the annual values in U.K. air quality standards.

While they called for more research to better understand the mechanisms behind how air pollution may up the risk for these mental burdens, they suggested that it could be due to the way the pollutant affects the central nervous system thru inflammatory and oxidative stress.

Data for the study came from the U.K. Biobank and participants were recruited from 2006 to 2010. Of the 389,185 participants (mean age 56.7; majority female and white), 13,131 were diagnosed with depression and 15,835 were diagnosed with anxiety according to ICD-10 codes.

Considering that many countries' air quality standards are still well above the latest World Health Organization global air quality guidelines 2021

opens in a new tab or window, stricter standards or regulations for air pollution control should be implemented in the future policy making," Huang and colleagues advised, adding that the current "results may provide important evidence for the assessment of mental health associated with air pollution to be considered in the Global Burden of Disease."

Disclosures

The study was supported by the State Scholarship Fund of China Scholarship Council.

Huang and co-authors disclosed no relationships with industry.

Primary Source

JAMA Psychiatry

Source Reference: opens in a new tab or windowYang T, et al "Long-term exposure to multiple ambient air pollutants and association with incident depression and anxiety" JAMA Psychiatry 2023; DOI: 10.1001/jamapsychiatry.2022.4812.

https://www.medpagetoday.com/publichealthpolicy/environmentalhealth/102911

Varex guides lower

 Global demand for our products was in line with our expectations, resulting in revenue of $206 million in the first quarter," said Sunny Sanyal, Chief Executive Officer of Varex. Sanyal added, "However, we are beginning to see some cautiousness from our customers as they assess an uncertain economic environment."

Varex’s revenue of $206 million was down 11% sequentially and up 3% year-over-year. Medical segment revenue of $160 million was down 12% sequentially and up 3% year-over-year. Industrial segment revenue of $46 million was down 9% sequentially and up 5% year-over-year. Non-GAAP gross margin was 32% in the quarter compared to 33% in the fourth quarter of fiscal year 2022 and non-GAAP EPS declined to $0.21 from $0.42 last quarter.

Balance Sheet & Cash Flow

Cash flow from operations was a use of $4 million in the first quarter of fiscal year 2023, due to higher inventory levels and annual employee incentive payments, as is typical in the first quarter of the fiscal year. Cash, cash equivalents and marketable securities declined $5 million sequentially to $108 million at the end of the first quarter.

Outlook

The following guidance is provided for the second quarter of fiscal year 2023:

• Revenues are expected to be between $205 million and $225 million

• Non-GAAP net earnings per diluted share is expected to be between $0.05 and $0.25

Guidance for the company's net earnings per diluted share is provided on a non-GAAP basis only. This non-GAAP financial measure is forward-looking, and the company is unable to provide a meaningful or accurate GAAP forecast of net earnings per diluted share without unreasonable effort due to the uncertainty of amounts and timing of unusual items.

Non-GAAP Financial Measures

*Please refer to "Reconciliation between GAAP and non-GAAP Financial Measures" below for a reconciliation of non-GAAP items to the comparable GAAP measures.

Conference Call Information

Varex will conduct its earnings conference call for the first quarter of fiscal year 2023 today at 3:00 p.m. Mountain Time. The conference call, including a supplemental slide presentation, will be webcast live and can be accessed at Varex’s website at vareximaging.com/news. Access will also be available by dialing 877-524-8416 from anywhere in the U.S. or by dialing 412-902-1028 from non-U.S. locations. The webcast and supplemental slide presentation will be archived on Varex’s website at vareximaging.com/quarterly-reports. A replay of the call will be available from today through February 14th at 877-660-6853 from anywhere in the U.S. or 201-612-7415 from non-U.S. locations. The replay access code is 13735486. The listen-only webcast link is: https://event.choruscall.com/mediaframe/webcast.html?webcastid=YcwMaGcv

https://finance.yahoo.com/news/varex-announces-financial-results-first-210500774.html