Warren Blasts United Health CEO for Monopolistic Practices that Harm Patients
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https://jamanetwork.com/journals/jama/fullarticle/2821502
The World Health Organization (WHO) is warning of counterfeit Ozempic discovered in 2023 in regulated supply chains in Brazil, the UK, and the US, amid an uptick in similar reports worldwide. Besides potentially being ineffective, fake versions of the drug pose a serious, perhaps life-threatening risk because they are injected under the skin, according to the alert.
An authentic Ozempic needle, left, and a counterfeit needle, right.
Ozempic, a branded version of the drug semaglutide, is a once-weekly injection to treat type 2 diabetes and cardiovascular disease; it’s also prescribed for weight management off-label or at a different dose under the brand name Wegovy. Demand for these hugely popular glucagon-like peptide 1 (GLP-1) receptor agonists has often exceeded supply—at least 25 000 patients are starting Wegovy every week in the US, according to drug maker Novo Nordisk—and earlier this year, the WHO linked shortages of drugs like Ozempic to a rise in counterfeit versions sold though unregulated outlets including social media platforms.
The recent WHO warning is the first public alert to verify falsified Ozempic’s infiltration into legitimate drug supply chains in 3 different countries. It asks health care professionals, regulatory authorities, and the public worldwide to be on the lookout for suspicious medicines and to report any irregularities.
“WHO has received reports of falsified Ozempic detected in at least 14 countries across 4 different WHO regions,” Rutendo Kuwana wrote in an email to JAMA Medical News. Kuwana is the team lead for substandard and falsified medical products at WHO, which has been actively monitoring and responding to reports of counterfeit Ozempic since September 2022. WHO does not know how many people were affected or how many units were counterfeit in Brazil, the UK, or the US, he said.
According to Kuwana, no serious or uncommon adverse reactions were noted in the incidents reported to WHO. “WHO is however aware of media reports of adverse effects, especially when the incorrect active substance is used,” he added.
“Counterfeit drugs are illegal, and they could contain the wrong ingredients, other harmful ingredients, or contain too little, too much or no active ingredient at all,” Sangeeta Chatterjee, PharmD, deputy director of the US Food and Drug Administration (FDA) Office of Drug Security, Integrity, and Response, wrote in an email.
What Are Signs of Fake Ozempic?
The WHO’s medical alert is a roundup and verification of previously reported fakes, which Ozempic manufacturer Novo Nordisk confirmed were falsified.
In December, the FDA reported:
Thousands of units of counterfeit Ozempic (1 mg) with serial number 430834149057, lot NAR0074—a combination that does not correspond to genuine manufacturing records
Needles from the lot were also counterfeit and of unknown sterility and read “NovoFine” rather than the authentic “NovoFine Plus.”
Packaging and prescribing information were also falsified.
Some of these counterfeit products may still have been available for purchase in December 2023.
In October, the UK Medicines and Healthcare products Regulatory Agency (MHRA) reported:
Counterfeit prefilled Ozempic pens (1 mg) identified at 2 UK wholesalers that were bought from legitimate suppliers in Austria and Germany.
Batch number MP5E511 of the pens is genuine but the product is counterfeit.
Dose selectors protrude beyond the counterfeit pens when setting doses, unlike authentic Ozempic pens.
None of the falsified pens were dispensed to patients, and there were no reports of harm.
Also, in October, Novo Nordisk informed Brazil’s national health surveillance agency about counterfeit Ozempic batch number LP6F832.
How Did Fake Ozempic Get Into Regulated Drug Supply Chains?
In the US, the regulated supply chain for drugs starts with a manufacturer like Novo Nordisk, and includes repackagers, wholesale distributors, third-party logistic providers, and pharmacies.
“The US has a very safe drug market, but it’s not unheard of that [counterfeits] happen,” said Kristina Acri, PhD, an economist at Colorado College who studies counterfeit medications.
A buyer at a midsize pharmaceutical distributor warehouse in New York purportedly found the fake batch, according to a Vanity Fair article, and the New York Times quoted a Novo Nordisk representative who said the falsified products were found in warehouses outside the company’s authorized supply chain. The FDA recommends that pharmacies only buy Ozempic through distributors authorized by Novo Nordisk.
As of March 2024, the FDA is aware of 9 adverse event reports for products with the lot number of the counterfeit Ozempic, Chatterjee wrote.
“The agency continues to monitor adverse event reports through MedWatch. However, we are not able to provide additional details about an ongoing investigation,” Chatterjee wrote in response to a request for information about the counterfeit products’ quality and safety and how they came into the legitimate supply chain.
The UK has a similarly regulated drug market to the US, Acri said, adding that some developing countries with less sophisticated markets can present more opportunities for counterfeit drugs to slip in.
“Producing counterfeit drugs and inserting them into the legitimate supply chain is an illegal activity and puts patients at considerable risk,” a spokesperson for Novo Nordisk said in an email.
What Other Counterfeits Are Out There?
In June 2023, Novo Nordisk reported that a counterfeit Ozempic pen, reportedly bought at a retail pharmacy in the US, actually contained insulin and led to an adverse reaction.
Novo Nordisk has filed 21 lawsuits as of May 2024 against businesses such as medical spas, weight loss clinics, and pharmacies selling compounded versions of semaglutide that could be harmful and deceptively marketed. A compounded version of a drug may be allowed when a commercially available drug appears on the FDA’s drug shortage list. Compounded drugs are not approved by the FDA, and the agency cannot verify their safety or effectiveness. Novo Nordisk said it does not directly or indirectly sell bulk semaglutide to compounding pharmacies.
A search of the FDA’s site showed that between last October and early July of this year, the agency sent warning letters to 6 online retailers selling unapproved or misbranded semaglutide or tirzepatide. The latter is a GLP-1 and glucose-dependent insulinotropic polypeptide agonist drug that works similarly to semaglutide to suppress appetite and delay gastric emptying. It’s sold by Lilly under the name Mounjaro for diabetes and as Zepbound for weight management.
Lilly has filed lawsuits against business purporting to sell products containing tirzepatide and in an open letter said it “is deeply concerned about the proliferation of online sales and posts on social media involving counterfeit, fake, compounded, and any other unsafe or untested versions of what they say is tirzepatide.”
Why Are Counterfeits Happening?
John Buse, MD, PhD, a professor of medicine at University of North Carolina School of Medicine, said his patients with diabetes and obesity continue to intermittently struggle to fill prescriptions for semaglutide and tirzaptide, often calling dozens of pharmacies to find inventory. “It is driving doctors and patients crazy.”
Wegovy, Mounjaro, and Zepbound continue to be in short supply, according to the FDA. These shortages coupled with increasing demand has fueled the market for counterfeit Ozempic, Acri noted.
“It comes down to economics,” she said. “There is a tremendous amount of money that can be made in making and passing along counterfeit drugs, and that’s a great incentive for some really evil people.”
In addition to fighting counterfeits, drug manufacturers are trying to relieve shortages fueling the market for fakes. In late June, Novo Nordisk announced it plans to invest $4.1 billion in a North Carolina manufacturing facility to expand production of its obesity drugs and other medications, but the construction is not expected to be complete until between 2027 and 2029.
To avoid purchasing falsified medications, the FDA recommends that consumers only buy Ozempic from state-licensed pharmacies that require a valid prescription and that they check the packaging for signs of counterfeiting. Clinicians and consumers should report adverse effects to FDA’s MedWatch program by submitting an online report or downloading a report that they can fax to 1-800-FDA-0178.
Acri and Buse said consumers may never know if they used a counterfeit version of a drug unless they have an adverse reaction.
Buse said, “If someone is good at creating counterfeit material, unfortunately, I think it’s going to be very difficult for patients and pharmacists to know when they might have these bootleg products.”
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https://www.startribune.com/unitedhealth-protest-minnetonka-arrests/600380907/
Critics have held a series of events highlighting what they describe as a pattern of improper coverage denials by the nation’s largest health insurer.
Protest organizers say 11 people were arrested Monday outside UnitedHealthcare’s headquarters in Minnetonka during an event spotlighting what critics say is a pattern of improper coverage denials by the nation’s largest health insurer.
Protestors blocking a road were arrested by the Minnetonka Police Department, according to a news release from People’s Action Institute, a consumer group that protested at UnitedHealth Group’s Optum headquarters in Eden Prairie in April.
Minnetonka police said the protestors were cited with misdemeanors and released from the scene. Three of those arrested were from Minnesota, according to police, while others came from Illinois, Maine, New York, Texas and West Virginia.
“UnitedHealthcare policyholders and medical professionals have petitioned, protested and spoken directly to the chief medical officer of UnitedHealth Group about our concerns, but their leadership has refused to acknowledge that prior authorizations and claim denials are a widespread problem,” Aija Nemer-Aanerud, a director with Chicago-based People’s Action Institute, said in a news release Monday.
In a statement, UnitedHealthcare said: “The safety and security of our employees is a top priority. We have resolved the member-specific concerns raised by this group and remain open to a constructive dialogue about ensuring access to high-quality, affordable care.”
UnitedHealthcare is the health insurance business at Minnetonka-based UnitedHealth Group, the largest company in Minnesota by revenue. Its Optum division runs clinics, manages pharmacy benefits and consults with health care providers on data and information technology needs.
Health policy experts say there’s been a lack of comprehensive data on the frequency of and causes for insurance coverage denials.
Critics in recent years have focused on prior authorization rules that patients and health care providers say have wrongly led to coverage denials, blocking needed care in the process. Insurers contend the rules help control costs and can improve quality.
UnitedHealthcare announced in March 2023 that it was dialing back some requirements for prior authorizations. The subject, however, has been a source of controversy for decades, including a pledge by UnitedHealthcare in 1999 to move away from “restrictive ‘mother-may-I-medicine,'” the Wall Street Journal reported at the time.
People’s Action Institute says it launched a campaign in 2022 to fight back against coverage denials by health insurers. After the protest at Optum headquarters in April, critics met with UnitedHealthcare executives, pushing to help individual patients and for broader reforms at the company.
“Health insurance coverage has expanded in America,” Nemer-Aanerud said, “but we are finding it is private health insurance corporations themselves that are often the largest barrier for people to receive the care they and their doctor agree they need.”
In Monday’s incident, Minnetonka police said, public nuisance citations were issued for interfering/obstructing/rendering dangerous for passage any public highway or right-of-way.
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In this interview on Fox Cable Fox & Friends today, they were actually talking about illicit street fentanyl analog that is killing our citizens. Not just stating that the person OD’d from Fentanyl.
There are some 100-200 known different Fentanyl analogs and only two are approved by the FDA to be used in humans. Fentanyl citrate is the one most – and longest being used in humans.
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https://cdernextgenportal.fda.gov/publicportal/s/dsm-submission
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A now-deleted Facebook post by a staffer of Mississippi’s lone Democrat congressman appeared to support the attempted assassination of former President Donald Trump on Saturday.
The deleted post by Jacqueline Marsaw, a field director for U.S. Rep. Bennie Thompson, D-Mississippi, said “I don’t condone violence but please get you some shooting lessons so you don’t miss next time ooops [sic] that wasn’t me talking.”
The Mississippi Republican Party’s X account said Thompson should “FIRE his field director for condoning the attempted assassination of President @realDonaldTrump !!!” The post also said state Democrats “must repudiate these despicable statements.”
Trump was wounded in the ear and rushed off the stage Saturday at a rally in Butler, Pa. by U.S. Secret Service agents and other law enforcement officers.
In a post to X after the shooting, Thompson said “There is no room in American democracy for political violence. I am grateful for law enforcement’s fast response to this incident. I am glad the former President is safe, and my thoughts and prayers go out to everyone involved.”
With Trump having already been convicted in May of 34 counts in New York of falsifying business records related to hush money paid to porn actress Stormy Daniels, the bill by the ranking Democrat on the House Committee on Homeland Security is clearly aimed at the former president.
The bill introduced on April 19 has yet to receive a committee hearing or a floor vote.
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On Monday, in a donors-only call given to Politico, Mr. Biden said he wanted to “move forward” and was “done talking about the debate.” It was then that he made the remark about “bullseye.”
This incident invites comparison to Ms. Palin — known to readers of the Sun as the Alert Alaskan — the Republican vice-presidential nominee in 2008. In 2010, a graphic designer for her PAC used what the New York Times deemed “stylized crosshairs” to mark congressional districts the PAC was contesting.
One of Ms. Palin’s aides said the illustrations were “surveyors symbols,” and the creative flourish was politically inert until the following January. An Arizona Democrat representing one of the enumerated districts, Congresswoman Gabrielle Giffords, was targeted by an assassin.
Jared Loughner wounded 12 and killed six, leaving Ms. Giffords with brain injuries that forced her retirement. Loughner had a murky political ethos, although he listed “The Communist Manifesto” among his favorite books. The opportunity to blame his act on Ms. Palin and others on the right — including my late boss, Rush Limbaugh — proved irresistible to their opponents.
In 2017, the Times resurrected the map myth after a left-wing gunman, James Hodgkinson, targeted congressional Republicans at baseball practice. He shot six and almost killed the House Majority Whip, Congressman Steve Scalise.
Unlike Loughner, Hodgkinson had a political motive. He railed against Republicans and worked for the campaign of the presidential Democratic-Socialist, Senator Sanders. “Conservatives and right-wing media were quick,” the Times wrote, “to demand forceful condemnation of hate speech and crimes by anti-Trump liberals.”
The Times agreed that the left “should of course be held to the same standard of decency that they ask of the right.” It then cited Ms. Palin’s map as a moral equivalence, writing that “the link to political incitement was clear” between it and Loughner. After an outcry, they added a correction that “no connection … was ever established.”
The Washington Post wrote that the editorial “showed how pervasive this debunked talking point still is on the political left.” Ms. Palin sued the Times for libel. The case was dismissed in 2022, but her appeal is pending before the Second Circuit.
As the Times did with Ms. Palin’s map, Mr. Biden has made hay of divining evil motives to Trump’s rhetoric. In March, Mr. Biden stripped a speech his opponent gave to Ohio automobile employees of all context to pluck out a single word.
The autoworkers, Trump said, are “not going to be able to sell” cars if he loses. “It’s going to be a bloodbath.” One definition of the word in Merriam-Webster’s is “a major economic disaster.” Mr. Biden chose the more violent definition and cast it as threatening murder in the streets.
Unlike bloodbath, “bullseye,” has no banal application. Mr. Biden can say he was using hyperbole and colorful language; he’s welcome to do so. If he’s going to infer the most extreme intent from Trump’s words as the Times did with Ms. Palin’s map, though, then turnabout is fair play.
There’s little doubt that if Mr. Biden’s “forceful message,” as Politico described it, had come out of Trump’s mouth, the left would be outraged and the incumbent would be exploiting it to the hilt.
As tiresome as this “What if…?” game is in politics, Mr. Biden’s “bullseye” crack cries out for application of that even-handed “standard of decency” the Times mentioned in its correction, yet nobody has printed a word of objection.
After the FBI was given an authorization to use lethal force in its raid on Mar-a-Lago, Trump accused Mr. Biden of trying to “assassinate” him.
If he repeats the allegation in light of the “bullseye” remark, expect to find that those who imagine links between the right’s rhetoric and violence to shrug until the next time seizing on someone’s words aligns with their political bent.
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https://www.beckerspayer.com/payer/cms-cites-aetna-in-1st-no-surprises-act-audit.html
Aetna failed to accurately calculate qualified payment amounts for air ambulance services, CMS’ first audit of an insurer’s No Surprises Act compliance found.
The audit, issued May 29, examined the rates Aetna Health in Texas charged for an out-of-network air ambulance provider between January and June 2022.
The No Surprises Act requires insurers to calculate a qualified payment rate for out-of-network emergency services. This rate is generally the median contracted rate the insurer has with other providers for similar services in the area.
CMS’ audit found Aetna used the wrong methodology to calculate the qualified payment rates, calculating the amount based on claims paid rather than contracted rates.
In its audit, CMS instructed Aetna to conduct a self-audit of all of the qualified payment amounts it calculated for air ambulance services in Texas during the audit period, and refund members if their cost-sharing should have been lower based on the correct payment amount.
The agency also found that Aetna failed to give providers required notice that they may initiate the independent dispute resolution process within four days after the end of the open-negotiation process. Aetna also failed to share the qualified payment amount it calculated to providers in notice or denial of payment.
“This routine audit took place during the first six months of 2022, following the initial implementation of the requirements,” an Aetna spokesperson said in a statement shared with Becker’s. “We addressed all the report’s findings to CMS’ satisfaction.”
Aetna could be subject to more audits of its payment rates in the future, CMS said.
The audit is the first examination CMS has published on an insurer’s compliance with the No Surprises Act. The bill passed at the end of 2020 in an effort to end surprise medical bills for emergency care.
In February, the American Hospital Association called on CMS to up its oversight of payers compliance with the act, adding it is “deeply concerning that the departments have not completed a single audit of payers when the law has been in effect for nearly two full years.”
Provider groups have expressed concerns that the act’s current enforcement and dispute resolution process favors payers.
The law has faced several legal challenges, and a backlog of disputed claims. Data published in February found the number of disputes initiated during the first six months of 2023, were 13 times greater than federal agencies initially anticipated.
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