People Who Need and Deserve Our Help

 One argument Jordan Peterson made stood out when I first heard of him.

Peterson discussed the challenges faced by individuals with an IQ below 83. He emphasized that people in this IQ range often struggle with tasks that require even moderate levels of cognitive ability, making traditional employment difficult.

Peterson argued that this segment of the population, constituting roughly 10% of people, is often unable to perform many jobs without supervision or make significant errors. This presents an important societal challenge, as these individuals need to be integrated into society (and the economy) without being marginalized.

Peterson pointed out that the U.S. military doesn’t accept recruits with an IQ below 83, as experience has shown they are more likely to become a liability than an asset.

This policy underscores the broader issue that many roles in modern society are too complex for those with lower cognitive abilities.

Peterson concluded these individuals require special consideration and tailored support to thrive.

Let’s expand that special consideration to unskilled laborers. The average IQ of an unskilled laborer typically falls around 90.

How many Americans have an IQ of 90 or less (which includes the sub-83 IQers Peterson talks about above)? (Skip the italics if you don’t want the math.)

The distribution of IQ scores in the population follows a normal distribution (bell curve), with an average IQ score set at 100 and a standard deviation of 15. This means that most people (about 68%) have an IQ score between 85 and 115.

Given the normal distribution of IQ scores:

• Approximately 50% of the population has an IQ score below 100.
• Roughly 16% of the population has an IQ score below 85.
• Approximately 2.5% of the population has an IQ score below 70.

To determine the percentage of the American population with an IQ of 90 or below, we look at the distribution:

An IQ of 90 is about two-thirds of a standard deviation below the mean (100 – 90 = 10, and 10/15 ≈ 0.67).

Using the cumulative distribution function (CDF) of a normal distribution, we find that the area under the curve to the left of 90 (or a z-score of -0.67) is approximately 25%.

Therefore, about 25% of Americans have an IQ of 90 or below.

Twenty-five percent. One-quarter of the population. My friend, that’s over 83 million Americans.

As Peterson mentioned in the link above, liberals think if you spread educational resources around, everyone will get educated to the same level. This simply isn’t true.

Conservatives think if people would just get up off their asses, they’d get a well-paying job. This is also untrue.

Though I’m a free trader, I can see the damage NAFTA and its successor free trade agreement have wrought on these Americans.

Unemployment isn’t just a statistical blip for unskilled workers; it’s a persistent and pervasive issue affecting Europe and North America.

The unemployment rate for those with only basic education is a staggering 9.3% in OECD countries. This isn’t a minor inconvenience; it’s a systemic issue that needs addressing.

Let’s examine why unskilled laborers and those with lower cognitive abilities are left out in the cold and, crucially, what we can do to fix it.

The Wage-Setting Trap

One common scapegoat for high unemployment among low-skilled workers is the minimum wage. The theory goes that setting a wage floor above the productivity level of low-skilled workers will price them out of the market. If an employer has to pay more than the worker’s output is worth, they simply won’t hire. But to my immense surprise, this theory doesn’t hold water when we look at real-world data.

In reality, the negative impact of minimum wages on employment isn’t as clear-cut.

In countries where firms have monopsony power (where they are the dominant employer and thus can set wages), a modest minimum wage increase can boost employment.

This is because it forces these firms to pay closer to the actual market value of labor, making jobs more attractive without reducing the number of positions available.

Moreover, in many OECD countries, collective bargaining agreements set wage floors for various sectors and occupations. These agreements don’t necessarily lead to higher unemployment.

Countries like the Scandinavian nations, which have high union density and coordinated wage bargaining, often see lower unemployment rates among low-skilled workers.

Employment Policy Failures

Generous unemployment benefits are often blamed for reducing the incentive to work. If people can live comfortably on unemployment checks, why would they rush to take a job? This logic seems sound, but it’s overly simplistic.

While generous benefits can reduce the intensity of job searches, they also allow for better job matching.

When people have time to find jobs that suit their skills and preferences, they are less likely to cycle back into unemployment.

However, the duration of these benefits is crucial. Long-term unemployment benefits can trap workers in joblessness, particularly the low-skilled, who already face significant barriers to re-entry into the workforce.

The solution here isn’t to slash benefits but to combine them with active labor market policies (ALMPs).

These include job search assistance, training programs, and hiring subsidies, which make the unemployed more attractive to employers and more efficient in their job search.

Globalization’s Double-Edged Sword

International trade and labor migration are often touted as boons for the economy but also present challenges for low-skilled workers.

As developed countries trade with emerging economies, the demand for unskilled labor in high-income countries diminishes. Jobs that require low levels of education and skill are outsourced to places where labor is cheaper.

Furthermore, increased immigration increases competition for low-skilled jobs. If immigrants are willing to work for less, wages and employment prospects for native low-skilled workers will decrease.

However, this issue is more complex than it seems. Immigrants also contribute to the demand for goods and services, potentially creating jobs.

The key is managing immigration to balance these effects, ensuring that the influx of workers doesn’t overwhelm the job market, something the President seems to have just learned.

Monetary Policy and Aggregate Demand

Monetary policy plays a significant role in determining employment levels. High real interest rates can stifle investment and consumption, increasing unemployment.

Low-skilled workers are especially vulnerable during economic downturns because they are often the first to be laid off and the last to be rehired.

The persistence of high unemployment among low-skilled workers during recessions leads to structural unemployment. Long-term joblessness erodes skills and makes workers less attractive to employers, creating a vicious cycle.

The key is keeping interest rates at a level that spurs employment.

The Role of Active Labor Market Policies

Active labor market policies (ALMPs) are critical in combating unemployment among low-skilled workers. These policies include:

1. Job Search Assistance: Helping workers find available jobs more efficiently.

2. Training Programs: Enhancing workers’ skills to make them more competitive.

3. Hiring Subsidies: Encouraging employers to hire workers who might otherwise be considered too risky.

Countries that invest heavily in ALMPs, like Denmark and the Netherlands, see significantly lower unemployment rates among low-skilled workers. These programs improve job matching and ensure that workers remain engaged in the labor market, preventing the erosion of skills.

Solutions to the Problem

So, what can address the high unemployment rates among low-skilled workers and those with lower cognitive abilities? Here are some practical solutions:

Reform Wage-Setting Mechanisms: Ensure minimum wages are set at levels that don’t price low-skilled workers out of the market. This can be achieved by tying minimum wage increases to productivity growth rather than arbitrary benchmarks.

Enhance Active Labor Market Policies: Governments need to increase investment in ALMPs. This includes better funding for job search assistance, vocational training programs, and hiring subsidies. These measures help bridge the gap between job seekers and available positions.

Manage Immigration Effectively: Implement immigration policies that balance the influx of low-skilled workers with the domestic labor market’s capacity to absorb them. This can include quotas or temporary work permits that adjust according to economic conditions.

Encourage Lifelong Learning: Promote continuous education and training programs for all workers, regardless of their current employment status. This ensures that the workforce remains adaptable and competitive in a rapidly changing job market.

Promote Inclusive Economic Policies: Governments should focus on policies that promote economic growth across all sectors, ensuring that the benefits of globalization and technological advancements are widely shared. This includes investing in infrastructure and supporting industries that create jobs for low-skilled workers.

Wrap Up

High unemployment rates among low-skilled workers and those with lower cognitive abilities aren’t an inevitable consequence of modern economies. They result from specific policy choices and economic conditions that can be changed.

By reforming wage-setting mechanisms, enhancing active labor market policies, effectively managing immigration, encouraging lifelong learning, and promoting inclusive economic policies, we can create a more equitable and prosperous labor market for all.

With the right mix of policies, we can ensure that everyone, regardless of their skill level or cognitive abilities, has the opportunity to contribute to and benefit from economic growth. The path to full employment for all workers is clear — we just need the will to follow it.

https://dailyreckoning.com/the-people-who-need-and-deserve-our-help/

FDA reverses order taking Juul vaping products off market in US, opens door to possible authorization

 The U.S. Food and Drug Administration rescinded its marketing ban on Juul Labs on Thursday, opening the door to possible authorization of its products.

The reversal comes nearly two years after the federal health agency ordered the company's e-cigarettes and vaping products be taken off the market.

The FDA had initially blocked Juul's application to sell its vaping device and tobacco- and menthol-flavored pods in June 2022, after completing a nearly two-year review of the manufacturer's application, finding that the applications "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law."

The company has long claimed its product can be used as a tool to stop smoking cigarettes.

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The FDA subsequently paused the block just weeks later in July 2022 to conduct additional scientific review.

Since then, the FDA said Thursday it has "conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology."

The reversal is based on a "review of information provided by the applicant" as well as new case law stemming from court decisions involving marketing denial orders, or MDOs, for e-cigarette products, the FDA said.

"Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied," the FDA said in a statement. "Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA."

Juul Labs said in a statement Thursday that they "appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products."

https://www.yahoo.com/gma/fda-reverses-order-taking-juul-162241745.html

Staff at WuXi under U.S. scrutiny worked with Chinese military scientists

 Employees of drugmaker WuXi AppTec, under U.S. scrutiny for its links to the Chinese military, co-invented altitude sickness treatments with People's Liberation Army (PLA) scientists, according to public patent records and science papers reviewed by Reuters.

The news agency identified 10 patent filings that list six of WuXi AppTec's staff as co-inventors of altitude sickness drugs with six scientists from the PLA General Hospital in Beijing - China's top military medical school and research centre. The filings, which Reuters is reporting for the first time, were made in the U.S., Europe and China between 2018 and 2023.

Treatments for such illnesses are a top priority for the PLA, which fought with India - an increasingly important U.S. security partner - as recently as 2022 on their Himalayan frontier. The PLA has said high altitude disease, which include disorientation as well as fatal pulmonary and cerebral edema, is the major cause of reduced combat effectiveness to Chinese soldiers in such areas and can influence the results of war.

The drug development ties go beyond the links between WuXi AppTec and the PLA that have been publicly alleged by a U.S. congressional committee.

The House Select Committee on the Chinese Communist Party has accused the Shanghai-headquartered company, which reported U.S. sales of about $3.6 billion last year, of being a threat to Washington's national security interests.

WuXi AppTec, which denies allegations that it is a threat to U.S. national security, said in a statement to Reuters that it "did not collaborate with PLA General Hospital or any other PLA-related entity in the performance of this work" and that it has "no special ties" to China's military.

It said its employees were listed in the patent documents because they had earlier "invented compounds related to hypertension treatment" while doing research for a client, Shijiazhuang Sagacity New Drug Development.

Sagacity included the compounds "in a subsequent project that we had no knowledge of and did not involve our company or employees," WuXi AppTec said.

Sagacity, whose founder was the legal representative of a company acquired by WuXi AppTec's parent in 2016, told Reuters it is independent of WuXi AppTec but cooperates with it on certain services. It did not respond to questions about the patent's inventors.

China's defence ministry did not respond to a request for comment on the PLA's relationship with WuXi AppTec.

PLA General Hospital senior official Kunlun He, lead author of the studies behind the patented treatments and a co-inventor, did not return an email seeking comment.

PATENT TRAIL

Reuters found two U.S. Patent and Trademark Office documents dated March 2021 that show the six WuXi AppTec employees signed over rights to the patents to Sagacity and PLA General Hospital.

Asked about the documents, WuXi AppTec said that it was "standard patent application practice" to sign over the rights to the applicants and that neither the company nor the six employees owned those patents.

In a June 2022 study related to altitude sickness treatments, He, the scientist who led PLA General Hospital's altitude research efforts, thanked WuXi AppTec's team for “helpful discussions regarding initiating and promoting" a Beijing-funded high-level defence science project.

U.S. Republican lawmaker John Moolenaar, who chairs the congressional committee, said that Reuters' findings "only adds to the urgent need for Congress" to pass proposed legislation that would restrict U.S. agencies and firms from cooperating with some biotech companies, including WuXi AppTec.

"People forget that public health really for the most part has been run by the PLA," said Anna Puglisi, a former U.S. counterintelligence officer focused on biotechnology and China, who reviewed Reuters' findings.

China's foreign ministry said in a statement responding to Reuters' questions that many well-known U.S. companies also have ties with the U.S. military.

It said that Washington should "stop overstretching the concept of national security" and "stop politicizing, instrumentalizing and weaponizing tech and trade issues".

MILITARY RESEARCHERS

Reuters also identified seven people listed in research documents or science seminar documents as graduate students or researchers at Shanghai's Navy Medical University while they were WuXi AppTec employees.

Sheng Chunquan, a four-star military officer who heads the university's pharmacy school, wrote in a 2021 article in China's Journal of Pharmaceutical Practice and Service that it trained "military pharmacy" researchers under a plan created by the Communist Party's top military decision-making body.

Sheng, whose drug development work was previously recognised with a WuXi AppTec prize, said in a 2016 interview - recently deleted from the company's social media account - that cooperation between the firm and the university would "greatly promote the process of new drug R&D and launches."

University officials did not respond to emails and a fax seeking comment.

A Reuters review of over a dozen science papers found that at least three Navy Medical University graduate students hired by WuXi AppTec in Shanghai during the same period also worked on projects related to pain treatments and an antibiotic for WuXi AppTec clients from the U.S., Europe and Canada, including Novartis.

A Novartis spokeswoman told Reuters the Swiss company would not disclose details of its collaboration with third parties but that it is "committed to conducting our business in a fully compliant manner."

WuXi AppTec said all military medical universities in China enrol civilian students. It also said its internal security controls prevent access by unauthorized employees to labs and files and that all employees signed agreements that "prohibit them from sharing company data or intellectual property with third parties, including for the purpose of academic research and/or graduate studies."

Puglisi, now adjunct faculty at Georgetown University, said Chinese companies were obliged by a 2017 law - which states they must "assist and cooperate with the state intelligence work" - to share information upon the request of authorities "regardless of who owns that IP."

WuXi AppTec said the law was "subject to substantive and procedural restrictions" and Beijing has not asked it to "provide proprietary data or confidential information in connection with this law."

https://www.yahoo.com/news/staff-drugmaker-under-u-scrutiny-103629006.html

'Novo Nordisk braces for challenge to Ozempic and Wegovy from wave of generics in China'

  Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed.

The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world's highest number of people who are overweight or obese.

Ozempic won approval from China in 2021 and Novo Nordisk saw sales of the drug in the greater China region double to 4.8 billion Danish Krone ($698 million) last year. It is expecting Wegovy to be approved this year.

But the patent on semaglutide, the active ingredient in both Wegovy and Ozempic, expires in China in 2026. Novo is also in the midst of a legal fight in the country over the patent.

An adverse court ruling could make it lose its semaglutide exclusivity even sooner and turn China into the first major market where it is stripped of patent protection for the drugs.

Those circumstances have drawn several Chinese drugmakers to the fray. At least 11 semaglutide drug candidates from Chinese firms are in the final stages of clinical trials, according to records in a clinical trial database reviewed by Reuters.

"Ozempic has witnessed unprecedented success in mainland China … and with patent expiry so close, Chinese drugmakers are looking to capitalise (on) this segment as soon as possible," said Karan Verma, a healthcare research and data analyst at information services provider Clarivate.

Front-runner Hangzhou Jiuyuan Gene Engineering has already developed one treatment that it says has "similar clinical efficacy and safety" as Ozempic and applied for approval for sale in April. The company has not published efficacy data and did not respond to a request for the information.

The company said in January that it expected approval in the second half of 2025, but cautioned that it will not be able to commercialise the drug before Novo's patent expires in 2026, unless a Chinese court makes a final ruling that the patent is invalid.

The Danish company's semaglutide patent is expiring in China far ahead of its expiry in other key markets such as Japan, Europe and the U.S. Analysts attribute variations in patent expiry timelines to term extensions Novo has won in specific regions.

https://finance.yahoo.com/news/novo-nordisk-braces-generic-challenge-230604035.html

Diminished Hamas switches to full insurgent mode in Gaza

 Hamas has seen about half its forces wiped out in eight months of war and is relying on hit-and-run insurgent tactics to frustrate Israel's attempts to take control of Gaza, U.S. and Israeli officials told Reuters.

The enclave's ruling group has been reduced to between 9,000 and 12,000 fighters, according to three senior U.S. officials familiar with battlefield developments, down from American estimates of 20,000-25,000 before the conflict. By contrast, Israel says it has lost almost 300 troops in the Gaza campaign.

Hamas fighters are now largely avoiding sustained skirmishes with Israeli forces closing in on the southernmost city of Rafah, instead relying on ambushes and improvised bombs to hit targets often behind enemy lines, one of the officials said.

Several Gaza residents, including Wissam Ibrahim, said they too had observed a shift in tactics.

"In earlier months, Hamas fighters would intercept, engage and fire at Israeli troops as soon as they pushed into their territory," Ibrahim told Reuters by phone. "But now, there is a notable shift in their mode of operations, they wait for them to deploy and then they start their ambushes and attacks."

The U.S. officials, who requested anonymity to discuss sensitive matters, said such tactics could sustain a Hamas insurgency for months to come, aided by weapons smuggled into Gaza via tunnels and others repurposed from unexploded ordnance or captured from Israeli forces.

This kind of protracted timeframe is echoed by Israeli Prime Minister Benjamin Netanyahu's national security adviser who said last week the war could last until the end of 2024 at least.

A Hamas spokesperson didn't respond to requests for comment on its battlefield strategy.

In a parallel propaganda drive, some of the group's fighters are videotaping their ambushes of Israeli troops, before editing and posting them on Telegram and other social media apps.

Peter Lerner, a spokesperson for the Israel Defense Forces (IDF), told Reuters they were still some way from destroying Hamas, which he also said had lost roughly half of its fighting force.

Lerner said the military was adapting to the group's shift in tactics and acknowledged Israel couldn't eliminate every Hamas fighter or destroy every Hamas tunnel.

"There is never a goal to kill each and every last terrorist on the ground. That's not a realistic goal," he added. "Destroying Hamas as a governing authority is an achievable and attainable military objective," he added.

HAMAS LEADERS SINWAR AND DEIF

Netanyahu and his government are under pressure from Washington to agree to a ceasefire plan to end the war, which began on Oct. 7 when Hamas fighters stormed into southern Israel, killing more than 1,200 people and seizing over 250 hostages, according to Israeli tallies.

Israel's subsequent ground-and-air campaign in Gaza has left the territory in ruins and killed more than 36,000 people, according to Palestinian health authorities. The United Nations says over a million people face "catastrophic" levels of hunger.

There are about between 7,000-8,000 Hamas fighters reportedly entrenched in Rafah, the last significant bastion of the group's resistance, according to Israeli and U.S. officials. Top leaders Yahya Sinwar, his brother Mohammed, and Sinwar's second-in-command Mohammed Deif are still alive and believed to be hiding in tunnels with Israeli hostages, they said.

The Palestinian group has shown the ability to withdraw rapidly after attacks, take cover, regroup, and pop up again in areas that Israel had believed to be cleared of militants, a U.S. administration official said.

Lerner, the IDF spokesperson, agreed Israel faced a protracted battle to overcome Hamas, which has ruled the Gaza Strip since 2006.

"There is no quick fix after 17 years of them building their capabilities," he added.

Hamas has constructed a 500 km (310 miles) subterranean city of tunnels over the years. The labyrinth, dubbed the Gaza metro by the Israeli military, is roughly half the length of the New York subway system. Equipped with water, power and ventilation, it shelters Hamas leaders, command and control centers, and weapons and ammunition stores.

The Israeli military said last week that it had taken control of the entire Gaza-Egypt land border to prevent weapons smuggling. About 20 tunnels used by Hamas to carry arms into Gaza were found within the zone, it added.

Egypt's State Information Service didn't immediately respond to a request for comment on Israel's claims of arms-smuggling from the country. Egyptian officials have previously denied any such clandestine trade is taking place, saying they destroyed the tunnel networks leading to Gaza years ago.

ECHOES OF FALLUJA INSURGENCY?

The Gaza incursion is Israel's longest and fiercest conflict since it invaded Lebanon to oust the Palestinian Liberation Organization in 1982.

Netanyahu has defied domestic and international calls to outline a post-war plan for the territory. U.S. Secretary of State Antony Blinken has warned that the absence of such a roadmap could trigger lawlessness in the enclave.

One Arab official told Reuters that criminal gangs had already emerged in Gaza amid the power vacuum, seizing food deliveries and conducting armed robberies.

The official and two other Arab government sources, who all requested anonymity to speak freely, said the IDF could face similar threats to those encountered by America in the city of Falluja in 2004-2006 following the U.S.-led invasion of Iraq.

A broad insurgency in Falluja swelled the ranks first of al Qaeda and then Islamic State, miring Iraq in conflict and chaos from which it has yet to fully emerge two decades later.

Washington and its Arab allies have said they are working on a post-conflict plan for Gaza which involves a time-bound, irreversible path to Palestinian statehood.

When the plan, part of a "grand bargain" envisioned by the United States that aims to secure a normalizing of relations between Saudi Arabia and Israel, is complete, Washington aims to put it to Israel, the U.S. officials said.

A United Arab Emirates official with direct knowledge of the discussions said a Palestinian invitation was needed for countries to assist Gaza in an emergency operation, as well as an end to hostilities, full Israeli disengagement, and clarity on Gaza's legal status, including control of borders.

The emergency process could last a year and be potentially renewable for another year, according to the UAE official who said the aim to be to stabilize the enclave rather than rebuild it.

For reconstruction to begin, a more detailed roadmap towards a two-state solution was needed, he added, as well as serious and credible reform of the Palestinian Authority.

How the United States aims to overcome Netanyahu's repeated rejection of a two-state solution, which Riyadh says is a condition to normalizing ties, is unclear.

David Schenker, a former U.S. Assistant Secretary of State for Near Eastern Affairs, dismissed any suggestion of a clean IDF pullout from the Palestinian territory.

"Israel says it's going to maintain security control which means that it's going to constantly fly drones over Gaza and they're not going to be limited if they see Hamas re-emerging, they're going to go back," said Schenker, a senior fellow at the Washington Institute U.S.-based think-tank.

Gadi Eisenkot, a former Israeli military chief serving in Netanyahu's war cabinet, has proposed an Egyptian-led international coalition as an alternative to Hamas rule in Gaza.

In a closed-door briefing last week to the Knesset Foreign Affairs and Defense Committee, he emphasized the complex nature of anti-militancy warfare.

"This is a religious, nationalistic, social, and military struggle with no knock-out blow but rather protracted warfare that will last many years," he said.

https://uk.news.yahoo.com/diminished-hamas-switches-full-insurgent-050349025.html

American Oncology Network Expands Radiation Oncology Services, Opens New Clinic

  American Oncology Network (AON) (Nasdaq: AONC), one of the nation’s largest and fastest-growing networks of community oncology practices, announced the expansion of its radiation oncology services with the opening of Low Country Radiation in Waycross, Georgia. 

The clinic can deliver external beam radiation therapy (EBRT), an effective treatment for various cancers. Radiation therapy uses high doses of radiation to kill or slow the growth of cancer cells. When successful, it can shrink early-stage cancer, stop cancer from returning or treat the symptoms associated with cancer metastases.

Under AON’s leadership and with access to the network’s array of resources and support, Low Country Radiation will further improve its radiation therapy services with no disruption to patient care. Current patients will continue to receive care from their trusted physicians at the same location, and the practice will remain a participant in patients’ insurance networks.

https://www.globenewswire.com/news-release/2024/06/06/2894614/0/en/American-Oncology-Network-Expands-Radiation-Oncology-Services-Opens-New-Clinic.html

In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

 

• Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.

• The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.

• If approved, donanemab would be the third amyloid-targeted drug to launch. Biogen has withdrawn the first, called Aduhelm, after much controversy and few sales. Eisai, along with Biogen, more recently won approval of a second, called Leqembi, which brought in sales of $19 million in the first quarter.

When members of the Peripheral and Central Nervous System Drugs Advisory Committee convene Monday, it will have been 364 days since FDA reviewers received Lilly’s application for approval. Lilly had expected a decision by the end of March, but said the FDA decided it needed the committee’s input because of Lilly’s unique trial design.

The FDA appears to be proceeding more cautiously with reviews of Alzheimer’s drugs, particularly since the controversy over the approval of Aduhelm, which came over the negative views of many of the agency’s own staff, as well as members of the advisory committee because of muddy clinical data. The decision led to the resignation of three members of the advisory committee.

With donanemab, the issues before the committee center on Lilly’s decision to restrict enrollment to people with tau deposits in their brains alongside amyloid — the protein primarily blamed as a cause of Alzheimer’s.

Lilly’s TRAILBLAZER-ALZ 2 trial measured cognitive impairment in people with low or medium levels of tau and across the overall study population, which included those with high levels of the protein, after 76 weeks of treatment.

The trial found donanemab slowed progression by 35% for those with low and medium levels and 22% for the entire population, when compared to those on placebo. Trial researchers didn’t do a separate analysis for the high-tau group because not enough were enrolled to measure statistical significance.

The FDA has asked its advisers to vote on whether they believe donanemab is effective across the entire trial population, or more narrowly for a subset of Alzheimer's patients. Leqembi has no restriction on its use based on presence or levels of tau.

https://finance.yahoo.com/m/06ffb2b5-e7a1-35d1-827d-198d2a71414d/in-review-of-lilly.html