Gunvor pulled its offer to buy the international assets of sanctioned Russian oil producer Lukoil after the U.S. Treasury Department said it opposed the deal and called the Swiss commodities trader the “Kremlin’s puppet.”
The move signals the Trump administration is taking a hard-line approach in its recently launched effort to use economic pressure on Moscow to end the war in Ukraine.
Most patients are unlikely to develop severe disease or die if they get the current variants of COVID-19 as immunity levels have climbed given higher levels of vaccination.
That’s according to the World Health Organization, which updated its COVID-19 guidelines on Friday for the 13th time.
The guidelines highlight that fewer patients will require hospitalization as they are more likely to have non-severe COVID.
“The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease,” the agency said in a statement.
People who are immunosuppressed remain at higher risk, however, with an estimated hospitalization rate of 6%. But people who are older than 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.
And patients who belong to neither of those groups are at low risk of hospitalization, at an estimated rate of just 0.5%. Most people are now considered low-risk, said the WHO.
The agency continues to recommend the use of Paxlovid for anyone at high or moderate risk of hospitalization. The antiviral developed by Pfizer Inc. PFE, -1.20%
is still the best choice for most eligible patients, given its therapeutic benefits, ease of use and fewer concerns about potential harms.
In cases where Paxlovid is not available, the WHO recommends molnupiravir, an antiviral developed by Merck MRK, -1.11%,
or remdesivir, an antiviral developed by Gilead Sciences Inc. GILD, +0.92%
“For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol,” said the agency.
The WHO said it recommends against the use of a new antiviral called VV116 for patients, apart from those who are enrolled in clinical trials.
That oral antiviral is being developed by Junshi Biosciences and Vigonvita in China.
It issued a warning against the use of ivermectin for people with non-severe COVID. The drug used to treat parasites in animals proved highly controversial during the pandemic when many people were persuaded by fraudulent research and online misinformation that it was an effective treatment.
Pfizer Inc. PFE, -1.73%
said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease.
The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers.
Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement.
The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions.
The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine.
The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine.
A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said.
The green light for Penbraya gives Pfizer the edge in its race with GSK GSK, +0.54%,
which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine.
The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.
Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500 SPX
has gained 10%.
The Consumer Financial Protection Bureau is taking steps toward removing all medical debt information from Americans’ credit reports, a move meant to help the millions of Americans whose credit scores drop after bills for expenses like unexpected hospital visits go unpaid.
While the information surrounding most unpaid medical debts has already been removed from credit reports by the three major reporting agencies — Equifax, Experian and TransUnion — the CFPB on Thursday announced plans for a rule- making process that would…
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It may be time to get your COVID-19 vaccine again.
There’s a new booster that’s coming out to guard against the virus. The Centers for Disease Control and Prevention said Tuesday that it was recommending the vaccine, which is being produced in versions by Moderna MRNA, +3.18%
and Pfizer PFE, -0.20%
-BioNTech BNTX, -2.06%,
for people 6 months of age and older.
Here are answers to some common questions about the shot — and what you may need to know before you receive it.
Why are we seeing another booster?
Boosters are all about maintaining protection against the virus as new COVID-19 variants emerge. The CDC said: “The updated vaccines should work well against currently circulating variants of COVID-19, including BA.2.86, and continue to be the best way to protect yourself against severe disease.” The CDC also noted that “protection from COVID-19 vaccines and infection decline over time. An updated COVID-19 vaccine provides enhanced protection against the variants currently responsible for most hospitalizations in the United States.”
So, everyone who is 6 months or older should receive it?
That’s the CDC’s recommendation, but not everyone sees this booster as a firm requirement, depending on various medical and other factors.
Dr. Paul A. Offit, a pediatrician with the Children’s Hospital of Philadelphia who specializes in infectious diseases, told MarketWatch that the new vaccine is a must for some who are at higher risk for developing serious illness, such as people who are over 75, people who have certain health problems (including diabetes, obesity or chronic lung or heart disease) and people who are immune compromised.
And what about the others? Offit said it can be a case of “low risk, low reward.” Meaning there’s little harm in getting the booster and it may buy “a few months protection against mild disease,” Offit said. But he stops short of saying the booster is an absolute necessity for such people.
Still, CDC director Dr. Mandy K. Cohen counters such an argument. In a column for the New York Times, Cohen noted that all the members of her family, including her 9- and 11-year-old daughters, would be getting the booster. “Some viruses…change over time. This coronavirus is one of them. It finds ways to evade our immune systems by constantly evolving. That’s why our vaccines need to be updated to match the changed virus,” Cohen explained.
What if you recently had COVID? Or have just gotten the previous COVID booster?
Offit said you should wait at least two months — and possibly as long as four months — before receiving the new vaccine.
The CDC said, “You should get a COVID-19 vaccine even if you already had COVID-19,” adding “you may consider delaying your next vaccine by 3 months from when your [COVID] symptoms started or, if you had no symptoms, when you received a positive test.”
When and where can you get the new booster?
The CDC said the vaccine “will be available by the end of this week at most places you would normally go to get your vaccines.”
How much will it cost?
The new shots are expected to have list prices of $110 to $130, but the CDC said, “Most Americans can still get a COVID-19 vaccine for free.” That is, most health-insurance plans will cover the cost.
As for those without insurance, the CDC said there are still plenty of free options, including programs run by local health centers and health departments as well as pharmacies participating in the CDC’s Bridge Access Program. For more information about where to get the booster, go to Vaccines.gov.
The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.
Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc. MRNA, -0.53%
and Pfizer Inc. PFE, +0.62%
-BioNTech BNTX, -1.97%
should become available later this week.
“We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”
The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.
The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.
The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines.
The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.
Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.
Under the Bridge Access program, CVS Health Corp. CVS, +2.57%
will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc. WBA, +1.35%
will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.
The World Health Organization has upgraded COVID-19 variant EG.5 to a variant of interest, or VOI, from a variant under monitoring, or VUM, as it continues to become more prevalent around the world.
The variant — which has been nicknamed Eris by some media, following the Greek-alphabet designation used for other variants — has been found in 51 countries, with most sequences, 30.6%, stemming from China, said the WHO.
Other countries that have submitted at least 100 sequences to a central database include the U.S., the Republic of Korea, Japan, Canada, Australia, Singapore, the United Kingdom, France, Portugal and Spain, the WHO said in a statement.
Eris is a descendent lineage of XBB.1.9.2, which is an omicron subvariant. It was first detected on Feb. 17 and designated as a VUM on July 19.
Its latest designation means it’s more prevalent than it was, has a growth advantage over earlier variants and merits closer monitoring and tracking.
Here’s what you need to know about Eris.
Eris is spreading around the world
The strain is increasing in global prevalence, accounting for 17.4% of cases sequenced in the week through July 23, up from 7.6% four weeks earlier. The WHO has been tracking COVID data on a 28-day basis, largely because countries have cut back on testing and surveillance as they emerge from the pandemic, meaning the agency has far less data than it did during the pandemic.
It’s already dominant in the U.S.
Eris has become dominant in the U.S., according to projections made by the Centers for Disease Control and Prevention, although a shortage of data is hampering the agency’s efforts to surveil the illness.
The CDC said last week it was unable to publish its “nowcast” projections, which it releases every two weeks, for where EG.5 and other variants are circulating for every region, because it did not have enough sequences to update the estimates.
“Because nowcast is modeled data, we need a certain number of sequences to accurately predict proportions in the present,” CDC representative Kathleen Conley told MarketWatch.
“For some regions, we have limited numbers of sequences available and therefore are not displaying nowcast estimates in those regions, though those regions are still being used in the aggregated national nowcast,” she said.
It is estimated that EG.5, an omicron subvariant, accounted for 17.3% of COVID cases in the U.S. in the two-week period through Aug. 5. That was up from an estimated 11.9% in the previous period and was more than any other variant.
The public-health risk is deemed to be low at the global level, lining up with the risk posed by XBB.1.16 and other currently circulating VOIs, according to the WHO statement. But it’s likely more infectious.
“While EG.5 has shown increased prevalence, growth advantage, and immune escape properties, there have been no reported changes in disease severity to date,” said the WHO.
That growth advantage and immune-escape properties mean Eris may cause a rise in case incidence over time and become dominant in some countries or even the world, according to the WHO.
It has the same symptoms as other strains
The Eris variant causes the same symptoms as seen with other strains of COVID, such as sore throat, runny nose, cough, congestion, fever, fatigue, body aches and a possible loss of taste or smell.
The best defense against Eris is vaccination
Like earlier strains of COVID, the best protection is to be vaccinated with any of the vaccines developed by Pfizer Inc. PFE, -0.03%
and German partner BioNTech SE BNTX, -0.32%,
Moderna Inc. MRNA, -1.01%
or Novavax Inc. NVAX, +9.83%
The vaccines that will be made available in the fall will be designed to protect against all subvariants of XBB, including Eris.
The Institute for Supply Management’s manufacturing index is due for release Tuesday, which outside of inflationary periods (i.e., now), tends to be one of the more important economic indicators for financial markets, given its record as a bellwether.
ISM manufacturing data during the current rate-hike cycle (in red) has lagged other periods.
Even compared to other rate-hike cycles, the ISM manufacturing series has been one of the worst in history, points out Jason Daw, head of North America rates strategy at RBC Dominion Securities. Daw makes the case that the U.S. economy overall is not very strong for this period of the cycle, and the manufacturing data, not just ISM but also industrial production, has been particularly feeble.
But the call of the day comes from JPMorgan’s economic team. They note that while global manufacturing stalled in the first half, the non-manufacturing components rose at a 3.2% annualized rate, allowing the global economy to grow at an above trend 2.7% rate.
The team led by Bruce Kasman say that the typical channels through which weak manufacturing would bring down the broader economy haven’t materialized. “A major channel by which weakness in goods sectors broadens out is through depressing corporate income and pricing power. While our start-of-year outlook anticipated elevated wage gains to pressure corporate profits, the surprising strength in [first-half] global GDP was accompanied by upside surprises to inflation,” they say. In turn, there have been solid gains in both labor income and profits, and while margins have come off their peaks, they are well above pre-pandemic levels.
Business hiring, they add, is the ultimate signal of confidence, and employment growth has continued even though expectations have soured.
Now, say the JPMorgan team, the stage is set for a goods sector recovery. Labor income, when adjusted for inflation, is rising, while finished goods inflation is falling sharply.
Also, business capital spending continues to expand, particularly in emerging economies outside of China. And importantly, inventories are swinging from a drag to a lift. In the first half, the step down in the pace of stock building depressed global industrial production by 3.4 percentage points.
“Even if the pace of stockbuilding was only to level off, the impulse to global industry would be material. Add to that a potential desire to align the pace to firming demand growth and the boost could generate a jump in factory output in the coming months,” they say.
Finally, they note, the tech spending decline after the 2020 to 2021 surge looks to be ending, and global motor vehicle production is picking up as supply-chain bottlenecks ease.
The markets
After an okay finish for the S&P 500 SPX, -0.29%
to a strong July, U.S. stock futures ES00, -0.36%
NQ00, -0.42%
were a bit lower as the seasonally weak month of August commenced. Gold futures GC00, -1.28%
were trading below $2,000 an ounce. The dollar DXY, +0.42%
rose.
The ISM report is due out at 10 a.m. Eastern, when the job openings and construction spending reports also come out. Monthly auto sales also will be released throughout the day.
The inflation-adjusted equity premium is looking pretty bleak. That’s calculated by taking the expected return to the S&P 500 and subtracting 10-year TIPS yields. “While admittedly this graphic is skewed by the few megacaps trading at huge multiples, it’s sobering nonetheless,” says Michael Ashton, better known as the Inflation Guy.
Need to Know starts early and is updated until the opening bell, but sign up here to get it delivered once to your email box. The emailed version will be sent out at about 7:30 a.m. Eastern.
Listen to the Best New Ideas in Money podcast with MarketWatch financial columnist James Rogers and economist Stephanie Kelton.
When Amazon.com Inc. and Apple Inc. report quarterly results on Thursday, we’ll get a look at two big companies, with big expectations, trying to do smaller things — or at least less exciting things, or things that might be more inconveniencing to customers — to stay bigger.
For Apple AAPL, +1.35%,
D.A. Davidson analyst Tom Forte said, the focus will be on the iPhone, as always, as well as demand abroad and a new VR headset, as its stock hovers near record highs and its market value holds above $3 trillion. And he said that Amazon AMZN, +3.09%,
meanwhile, could face questions about the impact of cost cuts on e-commerce growth, and what AI could do to boost slower growth in its cloud business.
The results from those companies, which are big enough to make or break a single quarter’s worth for the S&P 500 Index SPX, +0.99%,
will follow those from the other tech giants like Microsoft Corp. MSFT, +2.31%
and Facebook parent Meta Platforms Inc. META, +4.42%.
And they’ll arrive as Wall Street starts to get a tad more realistic about AI: Microsoft shares fell after management said the expansion of its AI capabilities would be “gradual” — and gradually more expensive.
D.A. Davidson analyst Tom Forte, in a research note this month, said Amazon, like other big tech companies, was taking more steps to control its costs. That might help margins, he said. But he said he’d be watching for any impact to e-commerce sales growth, following thousands of layoffs and pulling back on its expansion of Amazon Fresh.
Amazon began tacking on servicing fees onto some Amazon Fresh delivery orders this year. And Forte noted what he said were other tweaks to service: Charging for a home pickup of a defective smoke alarm that used to be free, and incentives to wait longer during Prime Day.
“In our view, Amazon is playing a ‘game of chicken’ and banking on other e-commerce companies not to offer a superior service, instead of its historical approach of working backwards with a customer-obsessed approach,” D.A. Davidson analyst Tom Forte said in a research note.
He added later: “We believe there is something to be said about the experience of having an Amazon-branded delivery vehicle show up at your house EVERY day. Having one show up once a week or twice is not the same.”
At Apple, Forte said in a separate note, the iPhone, whose sales were still solid, had turned into more of a consumer staple than a discretionary buy. He also said he’d be looking for more detail about the upcoming iPhone 15 — likely to be modestly fancier than previous iPhones — the recovery in China and growth in India. Apple last month also unveiled its Vision Pro VR headset — for $3,499. Forte said he had his doubts.
“We believe Apple will have to overcome a number of structural challenges to achieve mass adoption for its AR/VR headset,” he said.
This week in earnings
Apple and Amazon will report as more companies than normal report quarterly profit ahead of estimates, according to a FactSet report on Friday. For the week ahead, 170 S&P 500 companies report results, with four from the Dow, the repot said.
Results from Uber Technologies Inc. UBER, +3.28%
and DoorDash Inc. DASH, +4.20%
will offer an update on the gig economy and how far app-based deliveries can go, while results from Kraft Heinz Inc. KHC, -0.11%
will offer an update on food prices and how much they might ease from the highs seen in recent months.
With the “Barbie” movie lifting rival Mattel Inc. MAT, -2.40%,
results from Hasbro Inc HAS, -0.29%
during the week will offer a glance at the rest of the toy industry, where demand hasn’t exactly been great, and what entertainment options Hasbro has up its sleeve to keep apace with its archrival. Drug maker Pfizer Inc. PFE, -0.36%
reports, as does video-game maker Electronic Arts Inc. EA, +0.25%.
Starbucks Corp. SBUX, +0.47%
reports as well.
The call to put on your calendar
“Barbie,” the Hollywood strike and Warner Bros. Discovery: Mattel has said it wants to turn “Barbie” into a content franchise. Now we’ll hear what Warner Bros. Discovery Inc. WBD, +4.07%,
the media conglomerate that produced the film, thinks about the film’s results and its prospects, as studios increasingly pump out sequels or offshoots of well-known, established character universes like “Star Wars,” Marvel and DC. The company — which reports oversees Warner Bros. CNN, TNT and the streaming service Max — reports quarterly results on Thursday. But even as “Barbie” and “Oppenheimer” carry the parts of the entertainment industry that are still functioning through the Hollywood strike, Wall Street will likely be focused on contingency plans, and any sense of whether more viewers are turning to streaming with productions on pause.
The number to watch
Payments and crypto volumes: Results this week from trading app Robinhood Markets Inc. HOOD, +4.09%
and crypto exchange Coinbase Global Inc. COIN, +2.23%,
along with PayPal Holdings Inc. PYPL, +2.71%
and Block SQ, +3.42%,
will land at the intersection of rebounding markets and job-market concerns.
UBS analysts predicted solid growth and cost control for Block, and “steady” e-commerce trends for PayPal. But BofA analysts said PayPal’s search for a new chief executive, following the announcement of Dan Schulman’s retirement at the end of the year, would become more important, adding that “we think investors should rightfully expect the CEO search to conclude in the near-term.” While Bitcoin’s rebound helped Coinbase, the company and others in the industry face the prospect of tougher regulations. Robinhood and PayPal report on Wednesday. Coinbase and Block report on Thursday.
A leading global health body has declared that the artificial sweetener aspartame, commonly used as an ingredient in diet soda, chewing gum and vitamins, may cause cancer.
But the World Health Organization’s report late Thursday also noted that people would have to be exposed to extreme amounts of aspartame — whether through diet, occupational exposure or other means — to be at risk.
So how much aspartame is too much?
It’s safe to consume up to 40 milligrams of aspartame per kilogram, or 2.2 pounds, of body weight per day, a WHO and Food and Agriculture Organizations joint committee of experts on food additives said. So, a person who weighs 154 pounds would need to drink nine to 14 cans of, say, Diet Pepsi or Diet Coke per day to exceed that level, assuming there are 200 to 300 milligrams of aspartame in each can.
“We’re not advising consumers to stop consuming [aspartame] altogether,” said WHO’s nutrition director, Dr. Francesco Branca. “We’re just advising a bit of moderation.”
The Food and Drug Administration has an even higher daily aspartame-exposure limit: 50 milligrams per kilo of body weight.
Even heavy aspartame users — Donald Trump, the former U.S. president, for example, drank a reported 12 cans of Diet Coke a day in his White House years — would struggle to consume that much of the sweetener in an average day.
But consumers should also note that a food being labeled “safe” is not equivalent to its being healthy. There has been plenty of research to suggest that sipping too many sweetened beverages, including diet drinks with artificial sweeteners, may be linked to health problems and elevated risk of death.
Aspartame is used in products that millions of people use every day, including Diet Coke and Diet Pepsi, Pepsi Zero Sugar and Coca-Cola Zero Sugar, the Mars Wrigley chewing gum Extra and some Snapple drinks, as well as some protein drinks, among thousands of others, by the Calorie Control Council’s count.
Aspartame was developed beginning in the mid-1960s by Skokie, Ill.–based G.D. Searle & Co., now a Pfizer PFE, +0.72%
subsidiary, which branded the sweetener NutraSweet. It secured ultimate FDA approval, after initial hiccups, for use in dry goods and then in carbonated soft drinks in 1981 and 1983, according to the Calorie Control Council.
The organization that this week labeled aspartame possibly carcinogenic was the World Health Organization’s cancer-research arm, the International Agency for Research on Cancer. The IARC said its aspartame declaration is based on “limited evidence” of cancer in humans, specifically a type of liver cancer called hepatocellular carcinoma.
What should consumers do with this aspartame news? “At least when it comes to beverages, our message is your best choice is to drink water or an unsweetened beverage,” said Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, which previously nominated aspartame for IARC review.
A leading global health body has declared that the artificial sweetener aspartame, commonly used as an ingredient in diet soda, chewing gum and vitamins, may cause cancer.
But the World Health Organization’s report late Thursday also noted that people would have to be exposed to extreme amounts of aspartame — whether through diet, occupational exposure or other means — to be at risk.
So how much aspartame is too much?
It’s safe to consume up to 40 milligrams of aspartame per kilogram, or 2.2 pounds, of body weight per day, a WHO and Food and Agriculture Organizations joint committee of experts on food additives said. So, a person who weighs 154 pounds would need to drink nine to 14 cans of, say, Diet Pepsi or Diet Coke per day to exceed that level, assuming there are 200 to 300 milligrams of aspartame in each can.
“We’re not advising consumers to stop consuming [aspartame] altogether,” said WHO’s nutrition director, Dr. Francesco Branca. “We’re just advising a bit of moderation.”
The Food and Drug Administration has an even higher daily aspartame-exposure limit: 50 milligrams per kilo of body weight.
Even heavy aspartame users — Donald Trump, the former U.S. president, for example, drank a reported 12 cans of Diet Coke a day in his White House years — would struggle to consume that much of the sweetener in an average day.
But consumers should also note that a food being labeled “safe” is not equivalent to its being healthy. There has been plenty of research to suggest that sipping too many sweetened beverages, including diet drinks with artificial sweeteners, may be linked to health problems and elevated risk of death.
Aspartame is used in products that millions of people use every day, including Diet Coke and Diet Pepsi, Pepsi Zero Sugar and Coca-Cola Zero Sugar, the Mars Wrigley chewing gum Extra and some Snapple drinks, as well as some protein drinks, among thousands of others, by the Calorie Control Council’s count.
Aspartame was developed beginning in the mid-1960s by Skokie, Ill.–based G.D. Searle & Co., now a Pfizer PFE, +0.72%
subsidiary, which branded the sweetener NutraSweet. It secured ultimate FDA approval, after initial hiccups, for use in dry goods and then in carbonated soft drinks in 1981 and 1983, according to the Calorie Control Council.
The organization that this week labeled aspartame possibly carcinogenic was the World Health Organization’s cancer-research arm, the International Agency for Research on Cancer. The IARC said its aspartame declaration is based on “limited evidence” of cancer in humans, specifically a type of liver cancer called hepatocellular carcinoma.
What should consumers do with this aspartame news? “At least when it comes to beverages, our message is your best choice is to drink water or an unsweetened beverage,” said Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, which previously nominated aspartame for IARC review.
That’s a notion that has long fueled hope for many of the more than 40% of Americans who are considered obese — and fueled criticism by those who advocate for wider weight acceptance. Soon, it may be a reality.
High-dose oral versions of the medication in the weight-loss drug Wegovy may work as well as the popular injections when it comes to paring pounds and improving health, according to final results of two studies released Sunday night. The potent tablets also appear to work for people with diabetes, who notoriously struggle to lose weight.
Drugmaker Novo Nordisk NOVO.B, +0.22%
plans to ask the U.S. Food and Drug Administration to approve the pills later this year.
“If you ask people a random question, ‘Would you rather take a pill or an injection?’ People overwhelmingly prefer a pill,” said Dr. Daniel Bessesen, chief of endocrinology at Denver Health, who treats patients with obesity but was not involved in the new research.
That’s assuming, Bessesen said, that both ways to take the medications are equally effective, available and affordable. “Those are the most important factors for people,” he said.
There have been other weight-loss pills on the market, but none that achieve the substantial reductions seen with injected drugs like Wegovy. People with obesity will be “thrilled” to have an oral option that’s as effective, said Dr. Katherine Saunders, clinical professor of medicine at Weill Cornell Health and co-founder of Intellihealth, a weight-loss center.
Novo Nordisk already sells Rybelsus, which is approved to treat diabetes and is an oral version of semaglutide, the same medication used in the diabetes drug Ozempic and Wegovy. It comes in doses up to 14 milligrams.
But results of two gold-standard trials released at the American Diabetes Association’s annual meeting looked at how doses of oral semaglutide as high as 25 milligrams and 50 milligrams worked to reduce weight and improve blood sugar and other health markers.
A 16-month study of about 1,600 people who were overweight or obese and already being treated for Type 2 diabetes found the high-dose daily pills lowered blood sugar significantly better than the standard dose of Rybelsus. From a baseline weight of 212 pounds, the higher doses also resulted in weight loss of between 15 and 20 pounds, compared to about 10 pounds on the lower dose.
Another 16-month study of more than 660 adults who had obesity or were overweight with at least one related disease — but not diabetes — found the 50-milligram daily pill helped people lose an average of about 15% of their body weight, or about 35 pounds, versus about 6 pounds with a dummy pill, or placebo.
That’s “notably consistent” with the weight loss spurred by weekly shots of the highest dose of Wegovy, the study authors said.
But there were side effects. About 80% of participants receiving any size dose of oral semaglutide experienced things like mild to moderate intestinal problems, such as nausea, constipation and diarrhea.
In the 50-milligram obesity trial, there was evidence of higher rates of benign tumors in people who took the drug versus a placebo. In addition, about 13% of those who took the drug had “altered skin sensation” such as tingling or extra sensitivity.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles. Plus, tablets would be more portable than injection pens and they don’t have to be stored in the refrigerator.
But the pills aren’t necessarily a better option for the hundreds of thousands of people already taking injectable versions such as Ozempic or Wegovy, said Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital.
“I don’t find significant hesitancy surrounding receiving an injection,” she said. “A lot of people like the ease of taking a medication once a week.”
In addition, she said, some patients may actually prefer shots to the new pills, which have to be taken 30 minutes before eating or drinking in the morning.
Paul Morer, 56, who works for a New Jersey hospital system, lost 85 pounds using Wegovy and hopes to lose 30 more. He said he would probably stick with the weekly injections, even if pills were available.
“I do it on Saturday morning. It’s part of my routine,” he said. “I don’t even feel the needle. It’s a non-issue.”
Some critics also worry that a pill will also put pressure on people who are obese to use it, fueling social stigma against people who can’t — or don’t want to — lose weight, said Tigress Osborn, chair of the National Association to Advance Fat Acceptance.
“There is no escape from the narrative that your body is wrong and it should change,” Osborn said.
Still, Novo Nordisk is banking on the popularity of a higher-dose pill to treat both diabetes and obesity. Sales of Rybelsus reached about $1.63 billion last year, more than double the 2021 figure.
Other companies are working on oral versions of drugs that work as well as Eli Lilly and Co.’s LLY, +0.25%
Mounjaro — an injectable diabetes drug expected to be approved for weight-loss soon. Lilly researchers reported promising mid-stage trial results for an oral pill called orforglipron to treat patients who are obese or overweight with and without diabetes.
Pfizer PFE, -1.11%,
too, has released mid-stage results for dangulgipron, an oral drug for diabetes taken twice daily with food.
Novo Nordisk officials said it’s too early to say what the cost of the firm’s high-dose oral pills would be or how the company plans to guarantee adequate manufacturing capacity to meet to demand. Despite surging popularity, injectable doses of Wegovy will be in short supply until at least September, company officials said.
A national obsession with a new class of weight-loss drugs is turning dangerous, doctors and researchers say, as many patients are inappropriately prescribed Wegovy, Ozempic and similar medications and supply shortages generate a market for unauthorized, potentially risky copycat versions of these drugs.
Social media buzz about the drugs has promoted the mistaken perception that the medications are appropriate for a broad swath of people who may want to shed a few pounds–with disastrous consequences for some patients, doctors say. Patients who previously recovered from eating disorders, for example, are coming in for treatment because they “have had their eating disorder reactivated by use of these medications,” said Dr. Elizabeth Wassenaar, a regional medical director at the Eating Recovery Center, which specializes in treating the disorders. Some patients have wound up in the hospital, she said, and in some cases the providers who prescribed the drugs were unaware of the patients’ eating-disorder history. “It’s a real warning to people who prescribe these medications that it’s not without risk,” she said.
Some doctors also question whether the safety of the drugs has been adequately studied in older adults, who may have an undesirable loss of lean muscle mass when taking the medications. That complicates an ongoing debate about whether Medicare should cover these drugs for weight loss.
And patients of all types are put at risk, experts say, by the illegal production of knock-off versions of the medications. The Food and Drug Administration and several state pharmacy boards in recent weeks have warned that some compounding pharmacies are producing unauthorized versions of the drugs–which poses particular safety concerns for injectable drugs such as Wegovy, said David Margraf, a pharmaceutical research scientist with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy. “It’s not just a victimless crime,” he said. “People can be severely injured.”
Novo Nordisk NVO, +0.33%,
the maker of Wegovy and Ozempic, itself sought to tap the brakes on the craze around these drugs in a statement posted on its website this month, saying it’s concerned about reports of the drugs being used “for purely cosmetic or aesthetic weight loss,” unauthorized versions of the drugs hitting the market, and “insufficient clinical evaluations by some telehealth providers” promoting the drugs.
Drugs such as Novo Nordisk’s Wegovy, Ozempic and Rybelsus and Eli Lilly’s LLY, -0.36%
Mounjaro mimic the effects of a gut hormone known as GLP-1, which can help control blood-sugar levels and reduce appetite. (Mounjaro also affects another hormone called GIP.) Ozempic, Rybelsus and Mounjaro are FDA-approved for treatment of type 2 diabetes, while Wegovy is approved for people with obesity and certain people with excess weight combined with weight-related medical problems.
Billions of dollars in drug sales hinge on the breadth of the patient population prescribed these medications. Last year, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy were written for weight management, up from just 230,000 in 2019, according to data and analytics firm Komodo Health. Obesity drugs could be a $54 billion market by 2030, up from $2.4 billion in 2022, Morgan Stanley said in a report last year. Reports of GLP-1 drug users seeing improvements in addictive behaviors such as smoking and drinking have lately amplified interest in the medications.
The drugs have become such a cultural phenomenon that Walmart during its quarterly earnings call last week blamed the medications for a shift in consumer-spending patterns that pressured its margins. In the first quarter, the company saw “a shift to health and wellness,” John Rainey, Walmart Inc.’s WMT, +0.18%
executive vice president and chief financial officer, said on the call with analysts. “And part of that is related to these GLP-1 drugs that are to treat diabetes,” he said, adding that the shift “comes at a lower margin, and so that has some impact on our business as well.”
Noom, a digital health company that for years has emphasized a behavioral approach to weight management, this week announced a new program that will make Ozempic, Wegovy, Mounjaro and other medications available to eligible patients. “Prescriptions are not the goal of our program. They’re very much an adjunct,” Dr. Linda Anegawa, Noom’s chief of medicine, told MarketWatch. Medical professionals will review patients’ entire health history, order labs to assess their metabolic health, and engage in video visits with patients as they determine what treatments might be appropriate, she said.
Telling your brain you’re not hungry
The reason GLP-1 drugs help control weight is pretty straightforward, said Dr. Daniel Drucker, who helped discover GLP-1 and is senior scientist at Lunenfeld-Tanenbaum Research Institute in Toronto. When people take these drugs, he said, they simply eat less because they feel more full. “GLP-1 will tell your brain that you’re not hungry,” he said, and people taking these medications may feel less stressed about food or find themselves thinking less about food. And the effects may go beyond eating, he said, as some people also see improvements in smoking, drinking, and other addictive or compulsive behaviors. “These are really interesting areas for further investigation,” he said. Drucker has been a consultant or speaker for Novo Nordisk, Pfizer PFE, -0.61%
and other pharmaceutical companies.
Novo Nordisk said in a statement to MarketWatch that it is not conducting any dedicated clinical studies to evaluate Ozempic, Rybelsus or Wegovy in patients with substance-use disorders or addiction-related illnesses, and Eli Lilly said it does not have any studies planned for investigating tirzepatide–the active ingredient in Mounjaro–for treatment of addiction.
Adolescents’ use of the drugs for weight loss is a particular concern for some doctors. Wegovy is approved for treatment of obesity in children 12 and older. “The adolescent mental health crisis is unprecedented,” said Wassenaar, with many teens suffering severe mood disorders, eating disorders, and suicidality, and teens struggling with depression may think, “if I lose weight, I’ll feel better and people will like me. There’s this magic drug, and all I have to do is inject it.” And if patients can start taking these drugs as early as 12 years of age, “we just don’t know what that’s going to do to them in 10 or 20 years,” she said, because there’s not enough long-term data.
Novo Nordisk said in a statement to MarketWatch that “teenage obesity is linked to weight-related health problems such as high blood pressure, high cholesterol and type 2 diabetes,” and that cutting calories and increasing physical activity may not be enough for some patients. “The decision to prescribe an anti-obesity medication is at the discretion of the physician and the patient/parents,” the company said.
Eli Lilly said that tirzepatide is not currently being studied for chronic weight management in children or adolescents.
Many patients may have trouble filling lower-dose Wegovy prescriptions through September, according to drugmaker Novo Nordisk.
Novo Nordisk via AP
Some doctors are also concerned about broad use of the drugs among older adults. Many older adults have sarcopenia, an age-related loss of muscle mass and strength that can contribute to frailty and fall risk later in life–and losing weight can mean an additional loss of muscle mass that may not be advisable for some patients, doctors and researchers say.
While “there’s a huge push to get Medicare to cover these drugs, it’s not really certain whether they would be helpful in this population or actually more harmful,” said Judy Butler, a research fellow at PharmedOut, a research and education project at Georgetown University Medical Center. Noom is not enrolling patients over age 60 in its new program, Anegawa said, partly because “we really don’t have enough data yet with many of these drugs in the geriatric population.”
In the pivotal clinical trials for Wegovy, 9% of the Wegovy-treated patients were between 65 and 75 years of age, and 1% were 75 and older, Novo Nordisk said in a statement. “No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients,” the company said. In an ongoing cardiovascular outcomes trial, about 38% of patients are 65 or older, the company said.
By law, Medicare generally does not cover drugs prescribed for weight loss–although some drugmakers and industry groups are pushing to change that. Some of the drugs now generating intense demand also come with a hefty sticker price: Wegovy, for example, has an estimated annual net cost of about $13,600, according to the Institute for Clinical and Economic Review. If Medicare coverage rules changed and 10% of beneficiaries with obesity used Wegovy, total annual Medicare Part D spending on the drug could be as much as $26.8 billion, according to a recent study published in the New England Journal of Medicine. That’s more than 18% of the net total Part D spending by beneficiaries and the Medicare program in 2019.
Dangerous copycats
There are potential physical as well as financial costs. Side effects of the drugs can range from nausea and vomiting to gallbladder problems, inflammation of the pancreas, and thyroid cancer.
More broadly, some doctors question the prescribing of drugs solely based on obesity, absent other risk factors. “If somebody is obese and has diabetes, high blood pressure, and high cholesterol, losing weight may improve those parameters, but obesity on its own does not need to be treated,” said Dr. Adriane Fugh-Berman, a professor at Georgetown University Medical Center and director of PharmedOut. “It’s cardiovascular fitness that is important, no matter what weight you are,” she said. “We should stop focusing on the weight itself as a risk factor.”
Dr. Robert Gabbay, chief science and medical officer at the American Diabetes Association, counters that “obesity is a disease, and therefore needs to be treated as such.” Although there are people with obesity who don’t have other serious conditions, he said, “that’s relatively uncommon.”
Despite the concerns, shortages of the drugs persist. Novo Nordisk says it anticipates that many patients will have trouble filling lower-dose Wegovy prescriptions through September.
For patients who are relying on GLP-1 drugs for treatment of diabetes, even a short-term interruption in access to the drugs can cause blood-glucose levels to rise and result in serious complications, Gabbay said. Patients also tend to gradually ramp up dosage of these drugs to get to the effective dose, he said, and if they lose access to the medication “they might have to start back at the beginning again,” putting them several months behind on their treatment.
The shortages can also create risks for a broader set of patients, experts say, as they spur demand for copycat versions of the drugs. The approved active ingredient in Wegovy and Ozempic is semaglutide in its base form, but some compounding pharmacies may be using salt forms of semaglutide, the FDA said in a late April letter to the National Association of Boards of Pharmacy. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements” restricting the types of active ingredients used in compounding, the FDA said in the letter. Boards of pharmacy in several states, including West Virginia, North Carolina and Mississippi, have also recently issued warnings about compounded semaglutide.
Novo Nordisk said in the statement posted on its website this month that it is “actively monitoring and taking action against” entities unlawfully selling compounded semaglutide, adding that no FDA-approved generic versions of semaglutide currently exist.
Unauthorized compounded versions of the drugs could raise serious concerns about sterility and other quality-control issues, the Resilient Drug Supply Project’s Margraf said. “If this drug is in high demand and there isn’t enough supply, people will find a way to get it from a gray-market source,” he said. “People are going to find ways around the laws and potentially harm patients.”
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