Connect with us

International

Drugs that treat opioid use disorder are a good use for multibillion-dollar settlement funds

After battling drug manufacturers and distributors in court for years, local and state governments are about to receive a windfall that could expand access…

Published

on

Dr. Laura Kehoe gives a presentation about why emergency room physicians should prescribe buprenorphine for people recovering from opioid overdoses. Jonathan Wiggs/The Boston Globe via Getty Images

States, cities, counties and tribal governments across the nation will soon receive a windfall through several major opioid settlements. Drug distributors and manufacturers, including Purdue Pharma and the Sackler family members who own it, will relinquish a total of about US$32 billion for their role in the overdose crisis. Other litigation could yield more funds.

I am a sociologist who studies how the overdose crisis affects patient care. My research shows why these funds cannot come quickly enough for the communities poised to receive them.

Opioid overdoses soared 28.5% to a record high of 100,306 in the 12 months ending in April 2021 – according to the most recent data available. But, two decades after this crisis began, only 6.5% of Americans with substance use disorders receive any kind of treatment. And only 30% of those who get help receive medications that are effective at treating opioid use disorders.

In my view, money spent increasing access to methadone and buprenorphine, drugs backed with strong evidence, would significantly narrow this treatment gap.

More treatment funding

The settlements could help because they recommend that at least some of those billions fund treatment. However, state legislatures will ultimately decide where most of this money goes.

If settlements lead to a significant increase in treatment, it would mark an improvement over what happened to the Big Tobacco settlements reached in 1998. Most of the funds from those deals that were supposed to support smoking cessation and prevention have instead padded state budgets and funded unrelated projects.

3 drugs are prescribed for opioid use disorder

Ensuring that the settlement funds support what they’re supposed to pay for is only one hurdle.

A separate challenge is defining what counts as treatment – including who can provide it. The field is vast and varied. Treatment can come in a pill or consist of talk therapy. It can require a residential rehab stint or outpatient programs.

Anyone from physicians to peers can provide this care, and it’s hard to determine what will work for a specific person. While no approach works for everyone, clear evidence suggests that more people should have access to medications for opioid use disorder.

It might seem strange that the best treatment for people hooked on drugs is another drug. However, providing methadone and buprenorphine isn’t just substituting one drug for another. These medications interrupt chaotic drug use and remove the highs and lows of addiction. They regulate the body just as antidepressants or insulin do.

The FDA has approved three drugs: methadone, a solution taken by mouth dispensed in specialized clinics; buprenorphine, a tablet or film taken in doctors’ offices; and naltrexone, a pill or injection physicians may administer.

Their costs vary. Buprenorphine and methadone, which reduce opioid cravings and withdrawal symptoms, cost an average $6,250 per year. Naltrexone, which blocks the feelings of euphoria opioids create, costs about $14,000 annually. These costs include related services like office visits and counseling.

People treated for opioid use disorder take these drugs for a year or longer.

A study found that patients on methadone or buprenorphine were significantly less likely to die by overdose than patients who didn’t take them. Methadone was associated with a 53% reduction in overdose risk, and buprenorphine was associated with a 37% decline.

In contrast, people who took naltrexone were just as likely to overdose as those taking no medication. More research is needed to determine whether naltrexone makes a difference.

A nurse hands a cup to a woman in a black and white photo.
A nurse hands a cup of methadone to a patient at a clinic in 1971. US News & World Report Collection/Warren K Leffler/PhotoQuest/Getty Images

Evidence for detox and inpatient programs

Research suggests that residential programs, which can cost as much as $60,000 for 90 days of inpatient rehab, and other nonmedical approaches are less effective at treating opioid use disorder than drugs.

A study that reviewed different kinds of treatments found that patients who got detoxification or intensive behavioral health therapy were as likely to overdose or need acute care as those who received no treatment at all.

Sadly, some people enrolled inpatient, abstinence-based programs may even experience harm, because someone with an opioid use disorder is vulnerable to relapse right after treatment ends. Since abstaining from drugs altogether lowers tolerance, taking the the same amount of a substance as before rehab increases overdose risks.

Cost isn’t the only obstacle

If medication works well for treating opioid use disorders, why is it so hard for people who need help to get these drugs? I see four main barriers.

First, federal laws tightly restrict distribution. Methadone, used to treat opioid use disorders in the U.S. since 1972, can be provided only in federally certified opioid treatment programs, and physicians who prescribe it must register annually with the Drug Enforcement Administration. Patients getting methadone must attend counseling and visit a clinic daily to receive a single dose.

People on methadone call it “liquid handcuffs” because of the strict rules they must follow to get it.

Some restrictions have relaxed during the COVID-19 pandemic. The federal government now allows states to apply for an exemption that permits treatment programs to provide up to a month’s supply to take home. Many patients say they like not having to make daily trips to a clinic.

A second barrier is that physicians are reluctant to prescribe buprenorphine, which the FDA approved to treat opioid use disorders in 2002. Physicians can prescribe buprenorphine from their offices as long as they get a Drug Enforcement Administration waiver.

Until 2021, doctors had to complete eight hours of training to obtain waivers, but as of 2021 they can treat up to 30 patients without it. Still, fewer than 10% of general practitioners prescribe buprenorphine, and those who do see an average of only eight patients each month. Physicians say more education and resources would make them more likely to prescribe it.

Pharmacists could also take on this task. Pilot studies have shown that they can effectively treat patients with buprenorphine through collaboration with physicians. If scaled up, pharmacy-based programs could significantly expand access. Pharmacists in Canada, England and elsewhere already provide methadone, and pharmacy organizations in the U.S. have called for similar programs.

However, some pharmacists shy away from dispensing buprenorphine because they fear being targeted by law enforcement.

The third barrier is that although patients run a high risk of dying after surviving an overdose, most emergency departments send them away without helping them find long-term treatment.

Emergency medicine physicians I have interviewed tell me they don’t have ways to make these referrals, so they revive patients from overdose and discharge them without additional care. Some hospitals see this as a missed opportunity.

Dell Seton Medical Center in Austin, Texas, and Boston’s Massachusetts General Hospital have developed programs to put people on buprenorphine after an overdose and to connect them to physicians authorized to prescribe it long-term. Expanding access to treatment based in emergency departments would reduce the risk of overdose death.

Finally, studies show that harm reduction organizations such as syringe exchange programs and overdose prevention centers, along with efforts to distribute and administer the drug naloxone to quickly reverse an opioid overdose, can expedite the start of treatment for opioid use disorders.

However, political opposition to these programs persists, even in West Virginia and the other places hardest hit by the overdose crisis. When programs manage to take root, they are underfunded.

A tray holding syringes and vials
Syringes and vials of naloxone, a drug that can reverse opioid overdoses. Yuki Iwamura/AFP via Getty Images

Making the settlement money count

Many kinds of programs will compete for the funds made available through the settlements.

But the research is clear: Medications for opioid use disorder offer a substantial return on investment.

To be sure, these are chronic, relapsing conditions. People struggling with them need an array of services to get their lives on track. Still, medications are a critical tool.

Americans have lost more than 1 million loved ones to overdoses since 1999. I believe that states would save lives if they used money from legal settlements to make medications that treat opioid use disorders more widely available.

[Science, politics, religion or just plain interesting articles: Check out The Conversation’s weekly newsletters.]

Elizabeth Chiarello receives funding from a National Science Foundation CAREER Award.

Read More

Continue Reading

International

Analyst reviews Apple stock price target amid challenges

Here’s what could happen to Apple shares next.

Published

on

They said it was bound to happen.

It was Jan. 11, 2024 when software giant Microsoft  (MSFT)  briefly passed Apple  (AAPL)  as the most valuable company in the world.

Microsoft's stock closed 0.5% higher, giving it a market valuation of $2.859 trillion. 

It rose as much as 2% during the session and the company was briefly worth $2.903 trillion. Apple closed 0.3% lower, giving the company a market capitalization of $2.886 trillion. 

"It was inevitable that Microsoft would overtake Apple since Microsoft is growing faster and has more to benefit from the generative AI revolution," D.A. Davidson analyst Gil Luria said at the time, according to Reuters.

The two tech titans have jostled for top spot over the years and Microsoft was ahead at last check, with a market cap of $3.085 trillion, compared with Apple's value of $2.684 trillion.

Analysts noted that Apple had been dealing with weakening demand, including for the iPhone, the company’s main source of revenue. 

Demand in China, a major market, has slumped as the country's economy makes a slow recovery from the pandemic and competition from Huawei.

Sales in China of Apple's iPhone fell by 24% in the first six weeks of 2024 compared with a year earlier, according to research firm Counterpoint, as the company contended with stiff competition from a resurgent Huawei "while getting squeezed in the middle on aggressive pricing from the likes of OPPO, vivo and Xiaomi," said senior Analyst Mengmeng Zhang.

“Although the iPhone 15 is a great device, it has no significant upgrades from the previous version, so consumers feel fine holding on to the older-generation iPhones for now," he said.

A man scrolling through Netflix on an Apple iPad Pro. Photo by Phil Barker/Future Publishing via Getty Images.

Future Publishing/Getty Images

Big plans for China

Counterpoint said that the first six weeks of 2023 saw abnormally high numbers with significant unit sales being deferred from December 2022 due to production issues.

Apple is planning to open its eighth store in Shanghai – and its 47th across China – on March 21.

Related: Tech News Now: OpenAI says Musk contract 'never existed', Xiaomi's EV, and more

The company also plans to expand its research centre in Shanghai to support all of its product lines and open a new lab in southern tech hub Shenzhen later this year, according to the South China Morning Post.

Meanwhile, over in Europe, Apple announced changes to comply with the European Union's Digital Markets Act (DMA), which went into effect last week, Reuters reported on March 12.

Beginning this spring, software developers operating in Europe will be able to distribute apps to EU customers directly from their own websites instead of through the App Store.

"To reflect the DMA’s changes, users in the EU can install apps from alternative app marketplaces in iOS 17.4 and later," Apple said on its website, referring to the software platform that runs iPhones and iPads. 

"Users will be able to download an alternative marketplace app from the marketplace developer’s website," the company said.

Apple has also said it will appeal a $2 billion EU antitrust fine for thwarting competition from Spotify  (SPOT)  and other music streaming rivals via restrictions on the App Store.

The company's shares have suffered amid all this upheaval, but some analysts still see good things in Apple's future.

Bank of America Securities confirmed its positive stance on Apple, maintaining a buy rating with a steady price target of $225, according to Investing.com

The firm's analysis highlighted Apple's pricing strategy evolution since the introduction of the first iPhone in 2007, with initial prices set at $499 for the 4GB model and $599 for the 8GB model.

BofA said that Apple has consistently launched new iPhone models, including the Pro/Pro Max versions, to target the premium market. 

Analyst says Apple selloff 'overdone'

Concurrently, prices for previous models are typically reduced by about $100 with each new release. 

This strategy, coupled with installment plans from Apple and carriers, has contributed to the iPhone's installed base reaching a record 1.2 billion in 2023, the firm said.

More Tech Stocks:

Apple has effectively shifted its sales mix toward higher-value units despite experiencing slower unit sales, BofA said.

This trend is expected to persist and could help mitigate potential unit sales weaknesses, particularly in China. 

BofA also noted Apple's dominance in the high-end market, maintaining a market share of over 90% in the $1,000 and above price band for the past three years.

The firm also cited the anticipation of a multi-year iPhone cycle propelled by next-generation AI technology, robust services growth, and the potential for margin expansion.

On Monday, Evercore ISI analysts said they believed that the sell-off in the iPhone maker’s shares may be “overdone.”

The firm said that investors' growing preference for AI-focused stocks like Nvidia  (NVDA)  has led to a reallocation of funds away from Apple. 

In addition, Evercore said concerns over weakening demand in China, where Apple may be losing market share in the smartphone segment, have affected investor sentiment.

And then ongoing regulatory issues continue to have an impact on investor confidence in the world's second-biggest company.

“We think the sell-off is rather overdone, while we suspect there is strong valuation support at current levels to down 10%, there are three distinct drivers that could unlock upside on the stock from here – a) Cap allocation, b) AI inferencing, and c) Risk-off/defensive shift," the firm said in a research note.

Related: Veteran fund manager picks favorite stocks for 2024

Read More

Continue Reading

International

Major typhoid fever surveillance study in sub-Saharan Africa indicates need for the introduction of typhoid conjugate vaccines in endemic countries

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high…

Published

on

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

Credit: IVI

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

 

The findings from this 4-year study, the Severe Typhoid in Africa (SETA) program, offers new typhoid fever burden estimates from six countries: Burkina Faso, Democratic Republic of the Congo (DRC), Ethiopia, Ghana, Madagascar, and Nigeria, with four countries recording more than 100 cases for every 100,000 person-years of observation, which is considered a high burden. The highest incidence of typhoid was found in DRC with 315 cases per 100,000 people while children between 2-14 years of age were shown to be at highest risk across all 25 study sites.

 

There are an estimated 12.5 to 16.3 million cases of typhoid every year with 140,000 deaths. However, with generic symptoms such as fever, fatigue, and abdominal pain, and the need for blood culture sampling to make a definitive diagnosis, it is difficult for governments to capture the true burden of typhoid in their countries.

 

“Our goal through SETA was to address these gaps in typhoid disease burden data,” said lead author Dr. Florian Marks, Deputy Director General of the International Vaccine Institute (IVI). “Our estimates indicate that introduction of TCV in endemic settings would go to lengths in protecting communities, especially school-aged children, against this potentially deadly—but preventable—disease.”

 

In addition to disease incidence, this study also showed that the emergence of antimicrobial resistance (AMR) in Salmonella Typhi, the bacteria that causes typhoid fever, has led to more reliance beyond the traditional first line of antibiotic treatment. If left untreated, severe cases of the disease can lead to intestinal perforation and even death. This suggests that prevention through vaccination may play a critical role in not only protecting against typhoid fever but reducing the spread of drug-resistant strains of the bacteria.

 

There are two TCVs prequalified by the World Health Organization (WHO) and available through Gavi, the Vaccine Alliance. In February 2024, IVI and SK bioscience announced that a third TCV, SKYTyphoid™, also achieved WHO PQ, paving the way for public procurement and increasing the global supply.

 

Alongside the SETA disease burden study, IVI has been working with colleagues in three African countries to show the real-world impact of TCV vaccination. These studies include a cluster-randomized trial in Agogo, Ghana and two effectiveness studies following mass vaccination in Kisantu, DRC and Imerintsiatosika, Madagascar.

 

Dr. Birkneh Tilahun Tadesse, Associate Director General at IVI and Head of the Real-World Evidence Department, explains, “Through these vaccine effectiveness studies, we aim to show the full public health value of TCV in settings that are directly impacted by a high burden of typhoid fever.” He adds, “Our final objective of course is to eliminate typhoid or to at least reduce the burden to low incidence levels, and that’s what we are attempting in Fiji with an island-wide vaccination campaign.”

 

As more countries in typhoid endemic countries, namely in sub-Saharan Africa and South Asia, consider TCV in national immunization programs, these data will help inform evidence-based policy decisions around typhoid prevention and control.

 

###

 

About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO) and developed a new-generation typhoid conjugate vaccine that is recently pre-qualified by WHO.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, a Country Office in Austria, and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.

 

CONTACT

Aerie Em, Global Communications & Advocacy Manager
+82 2 881 1386 | aerie.em@ivi.int


Read More

Continue Reading

International

US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

Earlier today, CNBC’s…

Published

on

US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever... And Debt Explodes

Earlier today, CNBC's Brian Sullivan took a horse dose of Red Pills when, about six months after our readers, he learned that the US is issuing $1 trillion in debt every 100 days, which prompted him to rage tweet, (or rageX, not sure what the proper term is here) the following:

We’ve added 60% to national debt since 2018. Germany - a country with major economic woes - added ‘just’ 32%.   

Maybe it will never matter.   Maybe MMT is real.   Maybe we just cancel or inflate it out. Maybe career real estate borrowers or career politicians aren’t the answer.

I have no idea.  Only time will tell.   But it’s going to be fascinating to watch it play out.

He is right: it will be fascinating, and the latest budget deficit data simply confirmed that the day of reckoning will come very soon, certainly sooner than the two years that One River's Eric Peters predicted this weekend for the coming "US debt sustainability crisis."

According to the US Treasury, in February, the US collected $271 billion in various tax receipts, and spent $567 billion, more than double what it collected.

The two charts below show the divergence in US tax receipts which have flatlined (on a trailing 6M basis) since the covid pandemic in 2020 (with occasional stimmy-driven surges)...

... and spending which is about 50% higher compared to where it was in 2020.

The end result is that in February, the budget deficit rose to $296.3 billion, up 12.9% from a year prior, and the second highest February deficit on record.

And the punchline: on a cumulative basis, the budget deficit in fiscal 2024 which began on October 1, 2023 is now $828 billion, the second largest cumulative deficit through February on record, surpassed only by the peak covid year of 2021.

But wait there's more: because in a world where the US is spending more than twice what it is collecting, the endgame is clear: debt collapse, and while it won't be tomorrow, or the week after, it is coming... and it's also why the US is now selling $1 trillion in debt every 100 days just to keep operating (and absorbing all those millions of illegal immigrants who will keep voting democrat to preserve the socialist system of the US, so beloved by the Soros clan).

And it gets even worse, because we are now in the ponzi finance stage of the Minsky cycle, with total interest on the debt annualizing well above $1 trillion, and rising every day

... having already surpassed total US defense spending and soon to surpass total health spending and, finally all social security spending, the largest spending category of all, which means that US debt will now rise exponentially higher until the inevitable moment when the US dollar loses its reserve status and it all comes crashing down.

We conclude with another observation by CNBC's Brian Sullivan, who quotes an email by a DC strategist...

.. which lays out the proposed Biden budget as follows:

The budget deficit will growth another $16 TRILLION over next 10 years. Thats *with* the proposed massive tax hikes.

Without them the deficit will grow $19 trillion.

That's why you will hear the "deficit is being reduced by $3 trillion" over the decade.

No family budget or business could exist with this kind of math.

Of course, in the long run, neither can the US... and since neither party will ever cut the spending which everyone by now is so addicted to, the best anyone can do is start planning for the endgame.

Tyler Durden Tue, 03/12/2024 - 18:40

Read More

Continue Reading

Trending