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Thursday, January 16, 2025
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Crest, Colgate lawsuits target fluoride in kids' toothpaste, mouth rinse
Procter & Gamble and Colgate-Palmolive are among the defendants in six new lawsuits targeting the sale of toothpaste and mouth rinse for young children because the products contain fluoride, which can be harmful if swallowed in large quantities.
Parents filed complaints on Monday in federal courts in Illinois and California over products such as Procter & Gamble's Kid's Crest toothpaste and several products sold under Colgate's namesake, Tom's of Maine and Hello brands.
Other challenged products include Perrigo's Firefly anti-cavity rinse and Sanofi's ACT Kids rinse.
The proposed class actions cite warnings from U.S. health regulators that fluoride-based toothpastes and rinses not be used by children under ages 2 and 6, respectively, and that the toothpastes be kept out of reach of children under age 6.
They also say the products are marketed as "candy-like" with bright colors, cartoon images and flavors such as Groovy Grape and Silly Strawberry. The color of one Kid's Crest product is shown changing to pink from blue as children brush.
Fluoride helps prevent cavities when applied topically to the teeth, but when ingested can pose significant risks to and even kill young children, according to the lawsuits.
Procter & Gamble, Colgate, Perrigo and Sanofi did not immediately respond to requests for comment.
The lawsuits seek restitution, compensatory damages and triple or punitive damages for violations of various consumer protection laws.
"These lawsuits are not about whether fluoride toothpaste should be available to those who want it," Michael Connett, a partner at the law firm Siri & Glimstad representing the parents, said in an interview. "They are about companies that mislead consumers into believing these products are harmless to young children."
The relationship between fluoride and human health has long been debated.
Robert F. Kennedy Jr., who is U.S. President-elect Donald Trump's pick to become secretary of health and human services, has questioned fluoride's safety and use in public water systems.
Last week, a study published in the journal JAMA Pediatrics linked higher fluoride exposures in children to lower IQ scores.
In September, a San Francisco federal judge ordered the Environmental Protection Agency to further regulate fluoride in drinking water because of the possible link to lower IQ. Connett represented advocacy groups seeking additional regulation.
The Illinois cases are Gibson et al v. Perrigo Co, Gurrola et al v. Procter & Gamble Co, Harden et al v. Colgate-Palmolive Co, and Gurrola et al v. Chattem Inc, U.S. District Court, Northern District of Illinois, Nos. 25-00348, 25-00358, 25-00362 and 25-00366.
The California cases are Verbish et al v. Colgate-Palmolive Co, U.S. District Court, Northern District of California, No. 25-00426; and Miller et al v. Hello Products LLC, U.S. District Court, Southern District of California, No. 25-00071.
UnitedHealth lacks antidote for chronic anger
UnitedHealth Chief Executive Andrew Witty stated the obvious when he wrote last month that no one would design a healthcare system like the one in the United States. He neglected to detail how the medical goliath he runs helped create the “patchwork” structure and takes full advantage of it. With dissatisfaction among patients and politicians crystallising following the murder of a senior UnitedHealth executive last month, the company finds itself in the improbable position of transforming from being a big part of the disease to contributing to the cure.
Since it was started 50 years ago to process insurance claims for doctors in Minnesota, UnitedHealth has turned into a sprawling nationwide conglomerate worth some $500-billion. Instead of reducing costs for patients, the heft has mostly generated ever-increasing market power and profit. Only 44% of Americans surveyed in November rated healthcare quality as excellent or good, the lowest figure since Gallup started the annual poll in 2001. Seven out of 10 said the system is in crisis or has major problems.
Wall Street is nevertheless optimistic about UnitedHealth’s prospects. A combination of providing more services to members, rising healthcare expenses, and the expansion of Medicare, the federal program for people 65 and older, all contribute to the bullishness.
On the day the head of UnitedHealth’s insurance business, Brian Thompson, was shot last month, the company told investors the division he ran would grow nearly 10% annually, unregulated businesses were set to expand even faster and overall return on equity would be 20% or higher. Its shares have already returned more than 450% over the past decade, twice as much as the S&P 500 Index.
The exuberance depends on US healthcare policy staying largely unchanged, despite the shockingly callous reaction to Thompson’s death. How UnitedHealth intends to grow may nevertheless harden displeasure in Washington and beyond and spur some overdue changes. The United States, for example, spends more than twice as much on healthcare as any of its 37 peer nations in the Organisation for Economic Co-operation and Development.
Until now, the government and the private sector have turned to insurers to control costs. The industry provides the gateway to most patients, and therefore demands discounts from hospitals and drugmakers. They also can limit access to care they deem unnecessary, while encouraging protective measures, such as vaccines or weight loss, that often reduce longer-term expenses.
It hasn’t worked. US healthcare spending increased 7.5% in 2023 from the year before, reverting to a lengthy pattern of growing faster than GDP. Although the United States is the best in preventative care among 10 developed nations, it rated last in quality by life expectancy, avoidable death and other measures, according to a 2024 study by research outfit Commonwealth Fund. The country also was found to have the worst access to care and finished near the bottom in billing disputes and required paperwork.
Lack of competition explains a lot of the problem. Nearly all major US metropolitan areas are highly concentrated markets for commercial health insurance and Medicare Advantage, the government program run by private insurers, the American Medical Association found. While policy providers are motivated to save money on care to maximize profit, they only pass on savings to consumers in the form of lower premiums when there’s choice, a 2015 Journal of Health Economics study found.
Lawmakers tried to fix the problem with the 2010 Affordable Care Act, which stipulated that insurers spend 80% to 85% of premiums on care, depending on the type of coverage. The rest was earmarked for administrative costs and profit.
The effort introduced distortions, however. UnitedHealth, for one, snapped up medical practices, hospice providers and home healthcare services, giving it additional power to cut costs by sending insurance customers to its own doctors and nurses if outsiders charged too much. Its prowess can be spotted on the books through intercompany eliminations. Since accountants can’t count revenue twice, they must adjust earnings to reflect instances where one division bills another.
This creates conflicts of interest. An insurer can be doubly rewarded for forcing patients to see high-cost medical professionals working under the same roof. The company not only pockets the practice’s profit, but it can seek higher premiums to cover rising costs and keep some for itself. Insurance plans that have more expenses from related parties spend more, according to a Brookings Institute study.
The idea that insurers are the answer runs oddly deep, which explains another way UnitedHealth keeps getting bigger and wielding more influence. More than half of Medicare recipients are in plans run by insurers operating in the Medicare Advantage program. The rate has grown because patients pay less out of their own pockets, get extras like dental cleanings and are protected against catastrophic charges.
President-elect Donald Trump’s plans are unclear, although he spent much of his first term trying to eliminate the ACA. Many Republicans also favor an expanded private sector role. The Heritage Foundation’s Project 2025, for example, called for senior citizens to be automatically enrolled in Medicare Advantage, where UnitedHealth is the largest insurer. Premium revenue from the government division that runs Medicare and Medicaid, a sister program for poor Americans, accounted for 40% of the company’s consolidated revenue last year.
Medicare Advantage, however, increases the healthcare bill for taxpayers. One nonpartisan government agency estimates the program spent 22%, or $83 billion, more on Medicare Advantage patients.
One reason is that insurers pick and choose healthier patients. An estimated $50 billion comes from differences in risk scores between the traditional program and Medicare Advantage, because insurers appear to be claiming that patients are sicker than they are. By doing so, they can ask for more money from the government. Cutting reimbursements to better reflect risk would save the government more than $1 trillion by 2035, the Congressional Budget Office reckons, a step that clearly would eat into insurer profit margins.
The arrangement also doesn’t help the industry’s public image. The Office of the Inspector General for Health and Human Services estimated in October that there were $7.5 billion of payments based on diagnoses without follow-up visits, procedures or tests. This implies that as many 1.7 million patients received either irrelevant exams or inadequate care. UnitedHealth received about half those funds.
UnitedHealth disputes the claim and is also fighting a lawsuit from Justice Department trustbusters seeking to block its $3.3 billion acquisition of home healthcare provider Amedisys. And the company seems convinced it can gloss over rising consumer ire and the intensifying aims to cut government waste. If nobody would ever design the existing system, however, as Witty himself concedes, then there’s no reason for insurers to retain their pricing power, clout or profitability. It’s too late for preventative fiscal care, but it’s beyond time for some triage.
Novartis Wins Temporary Stay on Heart Failure Drug's Generic Version in US
A federal appeals court temporarily paused drugmaker MSN Pharmaceuticals' launch of a generic version of Novartis' blockbuster
https://today.westlaw.com/Document/I3496bed0d39f11ef941ba006662c756f/View/FullText.html
Los Angeles ‘Red Flag’ wildfire warnings expire, but dangers persist
Red Flag warnings advising of extreme wildfire danger expired across the Los Angeles area late on Wednesday, but forecasters warned that dry and windy conditions will persist on Thursday, and that the threat of blazes remained.
The National Weather Service added that the respite for fire-ravaged Los Angeles will be short, with high chances for renewed Red Flag warnings – when ideal fire conditions of high winds and low humidity dominate – starting again on Sunday.
Some 6.5 million people remained under a critical fire threat, after the fires consumed an area nearly the size of Washington DC, resulting in at least 25 deaths so far, authorities said.
Firefighters on Wednesday confronted persistently strong and dry winds fuelling two giant wildfires that have terrified Los Angeles for eight days, testing the resolve of a city upended by the worst disaster in its history.
Officials urged residents to remain vigilant and be prepared to evacuate at a moment’s notice with peak wind gusts forecast to last through Thursday afternoon.
“We want to reiterate the particularly dangerous situation today. Get ready now and be prepared to leave,” County Supervisor Lindsey Horvath told a press conference on Wednesday.
Forecasted winds of up to 112km/h (70mph) did not materialise on Wednesday. Still, firefighters reported winds of 48 to 64km/h combined with low humidity in a region that has failed to receive any appreciable rain in nine months, meaning fire threats remain.
The fires have damaged or destroyed more than 12,000 homes and other structures, and forced as many as 200,000 people from their homes. Some 82,400 people were under evacuation orders and another 90,400 faced evacuation warnings as of Wednesday, County Sheriff Robert Luna said.
Entire neighbourhoods have been levelled, leaving smouldering ash and rubble. Many homes only have a chimney stack left standing.
Some 8,500 firefighters from the western United States, Canada and Mexico have kept the growth of the fires in check for three days.
The Palisades Fire on the west edge of the city held steady at 9,596 hectares (96 sq km) burned, and containment nudged up to 19 per cent – a measurement of how much of the perimeter was under control. The Eaton Fire in the foothills east of the city stood at 5,712 hectares with containment at 45 per cent.
A fleet of air tankers and helicopters dropped water and fire retardant into the rugged hills while ground crews with hand tools and hoses worked to contain the fires.
Aerial firefighters – or fire bombers – operate without precision equipment or autopilot, just a pilot’s view through the windscreen and his experience.
“I call it ‘feeling the force’,” said pilot Diego Calderoni, from a New Mexico-based contractor, referring to a mystical energy in the Star Wars films.
Hundreds of visiting firefighters and emergency workers are staying outside the Rose Bowl football stadium, a base camp where colleagues build camaraderie in between shifts of 24 hours on followed by 24 hours off.
“You’re all in it for the same mission,” said Martin Macias of the St Helena Fire Department in Northern California. “We all got into this as service, to make somebody’s day better at the worst time.”
A new fire broke out on Wednesday in San Bernardino County east of Los Angeles, burning 12 hectares, Cal Fire reported. Two other fires in Southern California were largely under control.
Some Angelenos have been attempting to return to a semblance of normalcy.
Students and teachers displaced by wildfire from Palisades Charter Elementary School found a new home on Wednesday at the nearby Brentwood Elementary Science Magnet, where they were welcomed with open arms.
“For children who lost homes and also lost their school, it’s absolutely devastating. And the way that I can help and the way that I can give back is to make sure that those children have a place to go. And even though we lost the physical building, we still have our community,” Palisades Charter Elementary Principal Juliet Herman said.
While the fires rage on, critics have questioned whether the city properly prepared for fire danger in the face of National Weather Service warnings about hazardous weather, even though firefighters were on alert and able to deploy assets beforehand.
Fire Chief Kristin Crowley fielded queries on Wednesday about a Los Angeles Times report that fire officials had opted against ordering 1,000 firefighters to remain on duty for a second shift last Tuesday as fires were beginning to grow out of control.
The Times cited critics who said the outgoing shift should have been kept on duty and that as many as 25 additional fire engines should have been moved into hillsides.
Crowley defended her department’s preparation, saying it was impossible to know exactly where fires might break out and that some firefighters needed to remain in place to field ordinary emergency calls anywhere in the city.
“We did everything in our capability to surge where we could,” Crowley said.
The Times quoted Deputy Chief Richard Fields, who was in charge of staffing and equipment decisions ahead of the fire, as saying the scrutiny was welcome but that critics were too easily second-guessing decisions after the fact.
Optinose prelims
Preliminary XHANCE prescription growth rate from third quarter to fourth quarter 2024 estimated to be approximately 20%
Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced preliminary unaudited XHANCE® (fluticasone propionate) net product revenue of $22.4 million for the three months ended December 31, 2024
“Our preliminary unaudited fourth quarter net product revenue of $22.4 million is in line with our prior guidance and demonstrates a sustained growth in XHANCE prescriptions through the fourth quarter of 2024,” stated CEO Ramy Mahmoud. “For prescriptions, we estimate an approximately 20% sequential growth rate from third quarter to fourth quarter 2024, which is encouraging as we continue to focus on commercial execution and continued growth in the year ahead. We look forward to reporting full financial results for fourth quarter 2024 and corporate updates in March.”
The fourth quarter net product revenue and prescription growth rate included in this press release are preliminary results based on the information available to the Company at this time. Actual results may vary materially from the preliminary results presented in this press release due to the completion of the Company’s financial closing procedures, review adjustments and other developments or information that may arise between now and the time the Company’s financial results for fourth quarter 2024 are finalized. Additionally, the preliminary results have not been audited or reviewed by the Company’s independent registered public accounting firm. Accordingly, you should not place undue reliance on this preliminary data. The Company expects to report full financial results for the fourth quarter of 2024 and corporate updates in March.
https://finance.yahoo.com/news/optinose-announces-preliminary-unaudited-fourth-120000490.html
Redcare Pharmacy NV: Europe's leading online pharmacy secures its position
A heavy sword of Damocles hangs over European pharmacies.
If they continue to defend one of the last bastions of traditional trade on the Old Continent, it will be difficult for them to remain eternally behind the times in the face of their online competitors.
In this respect, even if online sales of pharmaceutical products remain hesitant in France and Southern Europe, they are making steady progress in Northern Europe. The latest annual results from Redcare Pharmacy, formerly known as Shop Apotheke, bear witness to this.
The Redcare platform has established itself as the European leader in the sector by 2022. Following the merger with Mediplus, a specialist in the delivery of medication for long-term conditions, the gap with Switzerland's DocMorris - formerly known as Zur Rose - widened the following year.
Redcare now claims 12.5 million customers. That's twice as many as five years ago, and almost ten times as many as ten years ago. The year just ended was marked by the debut of electronic prescriptions in Germany, five years after the law that introduced the system.
This will lead to a 64% increase in sales in the prescription segment of the platform by 2024. The over-the-counter segment maintained a satisfactory growth rate of 21%. On a consolidated basis, total sales rose by 32%, well above the annualized growth rate observed since 2020, which had already reached 23%.
A few weeks after this strategic development for Redcare, its stock market valuation fell by almost a quarter. The market was anticipating an unfavorable impact on operating profit, given that neither Redcare nor DocMorris have yet managed to achieve profitable growth.
Although Redcare's accounts are still not in the black, the Group has been giving the market a pledge since 2023 - as it did at the start of the pandemic - by posting a very modestly positive operating profit before investments and stock options.
It has to be said that it has little choice, as the financing context has dried up for growing companies in Europe. In 2023, for example, the Group had to finance the acquisition of 51% of Switzerland's Mediplus with its own shares, at a time when their valuation was well off its highs.
Still valued at one times sales, Redcare continues to burn cash, albeit in reasonable and, above all, well-controlled proportions. Let's hope that this meticulous management will enable the company to prepare for a forthcoming refinancing that will give it the means to achieve its ambitions.
In any case, one thing is certain: posting a frankly positive EBITDA next quarter - thanks in particular to the boom in electronic prescriptions in Germany - would give a significant boost to its valuation, which has been languishing on the same plateau for far too long.
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