Beauty buffs are showing up with “Ozempic body” — but it’s not the svelte physique they were promised.
Hollywood’s go-to rapid weight loss drug is leaving patients with lots of saggy skin where fat used to be, according to Kim Kardashian’s doctor.
Dr. Simon Ourian, 56, is the cosmetic dermatologist that stars, including the Kardashians, Lady Gaga, Jenna Dewan and Sofia Vergara, trust with their tuneups.
But, as he recently told the Hollywood Reporter, patients who have used injectable diabetes drug Ozempic are now coming back to him for filler to reverse the work of gravity prompted by fat loss.
“If you lose a lot of weight quickly, your skin gets saggy, everything from the face to the buttocks is deflated,” Ourian told the outlet, dubbing the unfortunate outcome “Ozempic body.”
“If you maintain your [new] weight for a year or two a lot of times your skin tightens up on its own. But if you want immediate results [because] you are in front of the camera, there are ultrasound and radiofrequency treatments, fillers or you can go as far as getting surgery,” the doctor explained.
Beverly Hills’ Dr. Simon Ourian is a cosmetic dermatologist to the stars.Getty Images The Post has reached out to Ourian for comment.
Semaglutide, sold under the brand names Ozempic and Wegovy, quickly sheds pounds by making people feel fuller for longer and slowing digestion. However, some users have gained the weight back — or even more of it — when they stopped taking it.
And an Ozempic diet is an investment, costing consumers more than $1,000 a month for off-label use.
Side effects associated with semaglutide include vomiting and diarrhea, runny nose or sore throat, headache, dizziness and tiredness.
But for Ourian’s wealthy clientele, their best bet may be his $8,000 monthly package that includes injections of Ozempic, lab tests for advance screening and monitoring, vitamin D and B shots to counteract side effects, menu plans and personalized body-contouring treatments.
A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating Type 2 diabetes and, more currently, weight loss.REUTERSKim Kardashian, who is one of Ourian’s patients, has never stated that she uses Ozempic.Instagram/@kimkardashian Despite the Kardashian doc’s dishing, sisterKhloé has deniedusing the drug, but other celebrities aren’t ashamed to share their Ozempic stories. Indeed, comedianChelsea Handlereven claimed to have taken the medication unknowingly because her doctor was practically giving it away.
President Biden was in no mood Tuesday to discuss the House Oversight Committee’s claim that bank records indicate nine members of his familybenefited from controversial foreign business dealings — doing his best to ignore the question at a Rose Garden event.
“President Biden, is it true that nine members of your family got millions from places like China?” The Post asked. “President Biden, did nine members of your family get millions from places like China? Is that allegation true, President Biden? Is it true, what House Republicans are saying?”
The 80-year-old president walked within about 15 feet of the inquiring reporter and almost certainly heard the question, but took off his sunglasses instead of approaching the press corps and walked straight ahead to the West Wing colonnade.
After not answering the questions, Biden posed for a photo with a group of female members of Congress, including former House Speaker Nancy Pelosi (D-Calif.), just outside the door to the Oval Office.
The Post again asked: “President Biden, do you have a response to House Republicans who say nine of your family members got money from overseas?”
President Joe Biden walked straight ahead to the West Wing colonnade avoiding reporter’s questions.AP/Manuel Balce Ceneta
Biden did not respond, instead walking into the presidential office.
House Oversight Committee Chairman James Comer (R-Ky.) on Monday said after reviewing bank records that it appears nine members of the first family benefitted financially from such dealings.
“The Biden family enterprise is centered on Joe Biden’s political career and connections, and it has generated an exorbitant amount of money for the Biden family,” Comer said. “We’ve identified six additional members of Joe Biden’s family who may have benefited from the Biden family’s businesses that we are investigating, bringing the total number of those involved or benefiting to nine.”
Biden has repeatedly denied knowledge about or involvement with the foreign business interests of his son Hunter Biden and brother James Biden in places like China, Mexico, and Ukraine — even though Biden himself regularly interacted with his relatives’ associates while vice president.
Comer last month revealed thatat least three members of Biden’s family received a portion of $3 million wired in March 2017 from Chinese energy company State Energy HK to Biden family associate Rob Walker. Walker, in turn, transferred about $1,065,000 to Hunter and James Biden — in addition to the president’s daughter-in-law Hallie, who was married to the late Beau Biden before dating Hunter following Beau’s death from brain cancer in 2015.
Hunter Biden’s legal team confirmed last month that he, Hallie Biden, and James Biden received a portion of those funds.
The Washington Post previously reported that at least $4.8 million flowed to Hunter and James Biden from a venture with CEFC China Energy, with which State Energy HK was affiliated.
Joe Biden gave a broad denial on the White House lawn on March 17, despite his son’s confirmation of Comer’s prior revelation.
“Any reaction to the House GOP memo about your family dealings, sir?” a journalist asked Biden on the lawn.
“My family dealings?” the president replied.
The journalist clarified: “That Hunter Biden’s business associate sent over a million dollars to three of your family members. Any reaction to that?”
“The Biden family enterprise is centered on Joe Biden’s political career and connections, and it has generated an exorbitant amount of money for the Biden family,” Rep. James Comer said.Getty Images/Alex Wong
“That’s not true,” the president said.
Biden has repeatedly made dubious denials about his family’s foreign income.
Republicans say such arrangements create conflicts of interest in foreign affairs and that it’s unclear what services Biden’s relatives provided in exchange for their employment.
Biden claimed in 2019 that he has “never spoken” with his son about “his overseas business dealings and said that “I have never discussed, with my son or my brother or with anyone else, anything having to do with their businesses.”
Last year, NBC News journalist Kristen Welker, who moderated the final 2020 presidential debate, pressed then-White House Communications Director Kate Bedingfield about the accuracy of Biden’s claim that “nothing was unethical” about his son’s business dealings in China and Ukraine and that “my son has not made money in terms of this thing about, talking about China.”
“We absolutely stand by the president’s comment,” Bedingfield said.
One of the Hunter Biden laptop documents reported by The Post ahead of the final 2020 debate, however, showed that Hunter Biden and Jim Biden were brokering a lucrative deal with CEFC and even appeared to cut in Joe Biden.
Joe Biden was referred to as the “big guy” in communications regarding the CEFC enterprise, according to two of Hunter’s former associates, and an email in May 2017 said he was due 10%.
Then-presidential candidate Biden dismissed The Post’s reporting on laptop documents linked to overseas business relationships as a “Russian plant,” though the trove has since been broadly corroborated.
During the 2020 campaign, then-President Donald Trump likened Hunter to a “vacuum cleaner” that would suck up money for the Biden family wherever his father traveled.
House Democrats impeached Trump in December 2019 for pressuring Ukraine to investigate Hunter’s position on the board of Ukrainian gas company Burisma while his dad led the Obama administration’s Ukraine policy. The position reportedly paid up to $1 million per year beginning in 2014.
Before the CEFC deal in China, Hunter in 2013 co-founded with Chinese state entities BHR Partners, which was registered 12 days after he joined then-VP Biden aboard Air Force Two for an official trip to Beijing.
The current status of Hunter’s 10% stake in the firm, which says it manages nearly $2.2 billion in assets, remains unclear.
At least three members of Biden’s family received a portion of $3 million wired in March 2017 from Chinese energy company State Energy.Irish Government via Getty Images
In 2016, Hunter Biden emailed one of them, Miguel Aleman Magnani, apparently while aboard Air Force Two with yet another business associate, Jeff Cooper, en route to Mexico, complaining that he hadn’t received reciprocal business favors.
At an April 16, 2015, dinner at DC’s Cafe Milano, then-VP Biden joined his son and a small group including Vadym Pozharskyi of Burisma, a trio of Kazakhstani leaders and the Russian billionaire Yelena Baturina and her husband, the former mayor of Moscow Yury Luzhkov.
Baturina allegedly paid $3.5 million to a firm associated with Hunter Biden in February 2014 as she sought out US property investments.
Baturina and another Russian billionaire who shopped property with Hunter have so far avoided President Biden’s sanctions against Moscow’s business elite over the invasion of Ukraine.
The first family’s pursuit of overseas income allegedly began even before Joe Biden took office as vice president in 2009.
“Don’t worry about investors,” James Biden allegedly told a corporate executive. “We’ve got people all around the world who want to invest in Joe Biden… We’ve got investors lined up in a line of 747s filled with cash.”
After his father assumed the presidency, Hunter Biden launched an art career seeking as much as $500,000 for his novice works. The House Oversight Committee is demanding that Hunter’s SoHo art dealer Georges Berges hand over a list of buyers.
Even hitting more lenient glycemic targets was enough to keep dementia risk at bay in older adults with type 2 diabetes, researchers assured.
Based on over a quarter of a million patients, those who kept more than half of their hemoglobin A1c (HbA1c) measures under 9% saw a significantly lower risk for dementia compared with those who had the majority of measurements over this threshold, reported Chris Moran, PhD, of Monash University and the National Centre for Healthy Ageing in Melbourne, Australia, and colleagues.
More specifically, patients who had more than half of HbA1c measures between 9% to just under 10% saw a 31% increased risk for dementia than those with less than half of their measures in this range (adjusted HR 1.31, 95% CI 1.15-1.51), the group wrote in JAMA Neurology
Likewise, those who had more than half of their HbA1c readings over 10% had a 74% higher risk for dementia than those with less than half of their measures in this category (adjusted HR 1.74, 95% CI 1.62-1.86). The highest incidence of dementia occurred among those with 75% or more of their HbA1c readings of 10% or higher over the average 5.9-year-long follow-up period.
"Importantly, we observed no significant change in hazard for individuals with HbA1c concentrations in the range of relaxed glycemic control recommended by the American Geriatrics Society and U.S. Department of Veterans Affairs for older patients with multiple comorbidities, poor health, or limited life expectancy," the researchers pointed out.
opens in a new tab or window recommend a target HbA1c goal between 7.5% and 8% for older adults or a higher target between 8% and 9% for those with multiple comorbidities, poor health, and limited life expectancy.
Ideal glycemic targets for older patients with diabetes has long been at the forefront of clinical discussion. While it's important to avoid any harms that come from hyperglycemia, intensive glucose control can put this population at jeopardy for the harmful effects of hypoglycemia, like falls.
"The harm associated with intensive glucose control has led the American Diabetes Association, American Geriatrics Society, Endocrine Society, and U.S. Department of Veterans Affairs to recommend that glycemic targets for people in middle to later life be individualized and to consider risk of hypoglycemia, number and severity of comorbidities, functional independence, cognitive impairment, and life expectancy," Moran's group explained. "Each of these organizations differs with regard to the exact therapeutic target recommended and encourages this to be developed based on a person's individual circumstances."
Beyond that, older patients in the study who had more than half of their HbA1c readings below 8% saw a modest, but significantly lower risk for developing dementia:
Less than 6%: adjusted HR 0.92 (95% CI 0.88-0.97)
6% to less than 7%: adjusted HR 0.79 (95% CI 0.77-0.81)
7% to less than 8%: adjusted HR 0.93 (95% CI 0.89-0.97)
Patients with type 2 diabetes ages 50 and older (average age 62) were included in the analysis. All were members of the Kaiser Permanente Northern California integrated health care system. Dementia was defined using ICD-9 codes.
Half of the patients were white, while 18% were Asian, 15% Hispanic, and 10% were Black. There were, on average, 11.6 HbA1c measurements per person during the course of follow-up among the cohort.
Disclosures
The study was funded by grants from the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Moran reported no disclosures.
Other study authors reported receiving grants from the NIH, NIDDK, and NIA during the study.
Primary Source
JAMA Neurology
Source Reference: opens in a new tab or windowMoran C, et al "Glycemic control over multiple decades and dementia risk in people with type 2 diabetes" JAMA Neurol 2023; DOI: 10.1001/jamaneurol.2023.0697.
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in abriefing document
On Wednesdayopens in a new tab or window, the Anesthetic and Analgesic Drug Products Advisory Committee will consider the advantages and limitations of using an EERW design to evaluate morphine sulfate ER in a phase IV trial -- part of a postmarketing requirement -- among patients with chronic non-cancer pain who had initial tolerability to the ER opioid.
The committee will also discuss looking at the incidence of opioid-induced hyperalgesia (OIH), a condition in which a patient's increase in pain can be attributed to the treatment with an opioid, among other objectives, such as changes in physical function and in levels of anxiety and depression.
FDA staff said the EERW study protocol might be the best available design amid the many challenges of conducting placebo-controlled clinical trials for chronic pain over an extended time period.
"Due to the unique clinical considerations regarding patients with chronic pain appropriate for long-term opioid therapy, the design of the clinical trials intended to evaluate the treatment effect of analgesics in this patient population poses certain challenges," they wrote. "There are different options with respect to clinical trial designs, each with their own advantages and disadvantages."
"There are also challenges in selecting appropriate patients, controls, and endpoints, as well as to retain enough patients to generate interpretable data," they added.
To address these concerns, FDA staff wrote that the EERW design "varies from the conventional clinical trial design in the timing of randomization and dichotomization to two treatment groups, opioid or placebo," noting that this design uses "a long prerandomization period and a relatively short period where patients will be on double-blind drug."
"The EERW design, while not ideal, appears to offer the best compromise to answer this public health question," they wrote.
In addition, the EERW study design "may inform the incidence of OIH provided that the protocol includes appropriate OIH surveillance and a prospective definition of OIH," they added.
The advisory committee will also be asked to discuss the likelihood of maintaining a sufficient number of study participants using the study design, specifically considering the acceptable degree of dropout related to its effects on the interpretation of outcomes.
FDA staff noted that dropout during a 12-month trial could be the most challenging aspect of evaluating the long-term efficacy of opioids. "Our prior experience suggests a substantial dropout rate even over the 12 weeks of prior randomized trials (in the 40-50% range), and therefore raises the real concern that a dropout rate in a 52-week duration trial would be higher, undermining the robustness of the between-group comparison at the trial primary timepoint," they wrote.
Other factors, such as the adequacy of the length of the study (38 to 52 weeks) and secondary endpoints, including time-to-treatment failure, pain scores, and a proposed tapering scheme to mitigate concerns over unblinding the participants, will also be discussed.
Finally, the advisory committee will be asked to consider other potential study designs that could be used in the assessment of long-term use of opioids.
"With respect to the parallel-group, placebo-controlled randomized controlled study, this approach poses the challenges of recruiting patients into a long duration placebo-controlled study -- in patients who have severe pain intensity having failed other treatments," FDA staff wrote. "The prior study included a long-term placebo-controlled period and failed due to recruitment issues."
After the original postmarketing requirement was issued in 2013, the Opioid Postmarketing Requirements Consortium (OPC) started a 26-week study in patients with high opioid requirements in 2016, but decided to end the study in 2018 due to several factors, including challenges with patients and changes to opioid prescribing requirements. The OPC submitted an updated protocol for a 52-week trial in January 2020. With guidance from FDA staff, the EERW protocol was refined and submitted for consideration.
opens in a new tab or window to the prescribing information and labeling for immediate-release (IR) and ER/LA opioids that will make the increased risk of overdose with increased doses more clear. The changes will also highlight the risk of OIH.
While the FDA typically follows the advice of its advisory committees, isn't required to do so.
Individuals with atrial fibrillation (Afib) who had undergone radiofrequency (RF) catheter ablation were significantly less likely to develop clinically relevant cognitive impairment than Afib patients managed with drugs, researchers reported.
In a prospective observational study called SAGE-AFopens in a new tab or window, odds that cognitive impairment would appear within 2 years of enrollment were 36% lower among Afib patients with a history of RF ablation, relative to medically managed participants (adjusted OR 0.64, 95% CI 0.46-0.88), according to Bahadar Singh Srichawla, DO, MS, of the University of Massachusetts Chan Medical School in Worcester.
Rates of hemorrhagic and ischemic events did not differ between groups, according to an abstract of the study, slated to be presented here next week at the American Academy of Neurology's (AAN) annual meeting
"Previous studies have found that people with arrhythmias may have long-term thinking and memory problems due to how this condition may affect the blood flow to the brain," Srichawla explained in an AAN press release issued prior to the conference. An unanswered question, however, was whether different forms of Afib treatment vary in their neurological outcomes.
The current study is an outgrowth of the SAGE-AF program, which enrolled more than 1,200 older Afib patients from 2016 to 2018 with the goal of finding relationships between clinical outcomes and factors recommended to be evaluated in standard geriatric exams. These factors included not only cognitive function but also frailty, depression, social isolation, and hearing and vision impairments. Participants were recruited from clinics in Massachusetts and Georgia.
For the analysis, Srichawla and colleagues identified 193 cohort members who had undergone RF ablation prior to enrollment and compared them to 694 others who received oral anticoagulants. Development of cognitive impairment -- defined as a Montreal Cognitive Assessment score of 23 or less -- over the 2 years following enrollment was the primary outcome tracked in the study.
Mean age in this subcohort was 75, just under half were women, and 87% were white. Those with the history of RF ablation differed somewhat from the medically managed group: more of the former had persistent Afib at enrollment and had also received an implanted cardiac device. Statistical adjustments were taken for these factors as well as for the presence of other cardiovascular diagnoses, sleep apnea, and kidney impairment.
Srichawla and colleagues also looked at whether onset of cognitive impairment differed between the types of drugs used in the medically managed group -- specifically, warfarin versus other agents, including newer ones that require less ongoing monitoring and dose adjustment. No significant difference was seen.
However, the data did not include measurements of cerebral blood flow, and therefore the researchers couldn't shed light on the underlying question of whether the lessened risk of cognitive impairment could be attributed to differences in such effects from treatment.
Disclosures
Srichawla declared that he had no relevant financial interests.
Primary Source
American Academy of Neurology
Source Reference: opens in a new tab or windowSrichawla B, et al "The effect of catheter ablation on cognitive outcomes in elderly patients with atrial fibrillation: SAGE-AF" AAN 2023.
The U.S. Supreme Court should restrict the availability of the abortion pill mifepristone, anti-abortion groups challenging the medication's federal regulatory approval told the justices in a filing on Tuesday, urging them to implement curbs ordered by a conservative federal judge in Texas.
The challengers urged the Supreme Court to reject emergency requests by Democratic President Joe Biden's administration and the pill's manufacturer to halt the April 7 preliminary injunction issued by U.S. District Judge Matthew Kacsmaryk in Amarillo that would greatly limit mifepristone's distribution, while litigation proceeds.
The New Orleans-based 5th U.S. Circuit Court of Appeals on April 12 declined to block the restrictions but halted a part of Kacsmaryk's order that would have suspended the U.S. Food and Drug Administration (FDA) approval of the drug that was given in 2000, effectively pulling it off the market. The FDA is the U.S. agency that signs off on the safety of food products, drugs and medical devices.
"The only effect of the lower court's order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician," attorneys at the Alliance Defending Freedom, a conservative religious rights group representing the pill's challengers, wrote in the filing.
The FDA and Danco Laboratories have for years disregarded "holes and red flags" in their safety data, "demonstrating callous disregard for women's well-being, unborn life, and statutory limits," they added.
The FDA asserts that mifepristone is safe and effective, a record that it has said is conclusively demonstrated over decades of use by millions of Americans and that adverse effects of mifepristone are exceedingly rare.
The case poses another major threat to abortion rights in the United States in the aftermath of the Supreme Court's decision last June to overturn the landmark 1973 Roe v. Wade ruling that had legalized the procedure nationwide. Mounting abortion bans and restrictions have been enacted by Republican-led states since then.
U.S. President Joe Biden, facing congressional resistance to his "care economy" proposals, on Tuesday signed an executive order aimed at advancing free preschool and expanding affordable care for children, older Americans and those with disabilities.
Biden signed the order, which includes over 50 specific actions, in the White House Rose Garden, flanked by family caregivers, people with disabilities, older adults and early childhood and long-term care workers.
The order instructs nearly every federal agency to take actions to increase Americans' access to high-quality childcare and long-term care, and to better support caregivers and workers, even as Biden continues to push for $750 billion in funding for those areas over 10 years included in his 2024 budget proposal to Congress.
"The executive order doesn't require any new spending. It's about making sure that taxpayers get the best value for the investments they've already made," Biden said.
“The actions we're taking today are about dignity, security and peace of mind for working families and caregivers all across the country and they're good for the economy as well," said Biden, who shared his own struggles with caregiving as a single father after the death of his first wife.
The White House is betting child- and elder-care programs, which are very popular with the public despite opposition by Republican lawmakers and some Democrats, can boost Biden's approval ratings as he nears an announcement of his candidacy for the 2024 presidential race.
Ai-jen Poo, president of the National Domestic Workers Alliance and Jenn Stowe, executive director of the National Domestic Workers Alliances, called the order "a major step toward modernizing" the U.S. care system.
"As the care workforce crisis intensifies across the country and families continue to struggle to afford care, this set of executive actions marks the all-in commitment we need to make sure care jobs are good jobs and that Americans can access care for generations to come," they said in a joint statement.
