Business
Trial of New Alzheimer’s Drug Reports Disappointing Results
A carefully watched scientific trial of a possible Alzheimer’s drug failed to forestall or sluggish cognitive decline, one other disappointment within the lengthy and difficult effort to search out options for the illness.
The last decade-long trial was the primary time individuals who had been genetically destined to develop the illness — however who didn’t but have any signs — got a drug supposed to cease or delay decline. The individuals had been members of an prolonged household of 6,000 individuals in Colombia, about 1,200 of whom have a genetic mutation that nearly ensures they’ll develop Alzheimer’s of their mid-40s to mid-50s.
For a lot of family members, who stay in Medellín and distant mountain villages, the illness has shortly stolen their capability to work, talk and perform fundamental capabilities. Many die of their 60s.
Within the trial, 169 individuals with the mutation obtained both a placebo or the drug, crenezumab, produced by Genentech, a part of the Roche Group. One other 83 individuals with out the mutation obtained the placebo as a technique to defend the identities of individuals more likely to develop the illness, which is extremely stigmatized of their communities.
The trial investigators had hoped that intervening with a drug years earlier than reminiscence and considering issues had been anticipated to emerge may maintain the illness at bay and supply necessary insights for addressing the extra frequent sort of Alzheimer’s that’s not pushed by a single genetic mutation.
“We’re disenchanted that crenezumab didn’t present a big scientific profit,” Dr. Eric Reiman, the chief director of Banner Alzheimer’s Institute, a analysis and therapy heart in Phoenix, and a pacesetter of the analysis workforce, stated at a information convention concerning the outcomes. “Our hearts exit to the households in Colombia and to everybody else who would profit from an efficient Alzheimer’s prevention remedy as quickly as doable. On the identical time, we take coronary heart within the information that this examine launched and continues to assist form a brand new period in Alzheimer’s prevention analysis.”
The outcomes are additionally one other setback for medication that concentrate on a key protein in Alzheimer’s: amyloid, which types sticky plaques within the brains of sufferers with the illness. Years of research with varied medication that assault amyloid in several levels of the illness have fallen flat. In 2019, Roche halted two different trials of crenezumab, a monoclonal antibody, in individuals within the early levels of the extra typical Alzheimer’s illness, saying the research had been unlikely to point out profit.
Final 12 months, in a extremely controversial determination, the Meals and Drug Administration granted its first approval of an anti-amyloid drug, Aduhelm. The F.D.A. acknowledged that it was unclear if Aduhelm might assist sufferers, however greenlighted it beneath a program that enables authorization of medication with unsure profit if they’re for critical illnesses with few therapies and if the medication have an effect on a organic mechanism that’s moderately doubtless to assist sufferers. The F.D.A. stated that organic mechanism was Aduhelm’s capability to assault amyloid, however many Alzheimer’s consultants criticized the choice due to the poor observe report of anti-amyloid therapies. The trial outcomes on Thursday solely added to the disappointing proof.
“Want there have been one thing extra constructive to say,” stated Dr. Sam Gandy, the director of Mount Sinai’s Middle for Cognitive Well being, who was not concerned within the Colombia analysis.
“The pathogenic mutation within the Colombian household is thought to be concerned in amyloid metabolism,” Dr. Gandy stated, including, “The considering was that these had been the sufferers most probably to answer anti-amyloid antibodies.”
Dr. Pierre Tariot, the director of the Banner Alzheimer’s Institute and a pacesetter of the Colombian analysis, stated a few of the knowledge did counsel that sufferers receiving crenezumab fared higher than these receiving the placebo, however the variations weren’t statistically important.
He additionally stated there have been no security issues with the drug, an necessary discovering as a result of many anti-amyloid therapies, together with Aduhelm, have triggered mind bleeding or swelling in some sufferers.
Extra knowledge from the trial can be offered at a convention in August. Dr. Tariot and Dr. Reiman famous that Thursday’s outcomes didn’t embody extra detailed data from mind imaging or blood evaluation of the drug’s results on proteins and different features of the biology of Alzheimer’s. In addition they didn’t replicate will increase within the dose of crenezumab, which researchers started giving to sufferers as they realized extra concerning the drug, Dr. Tariot stated. He stated some sufferers obtained as much as two years of the very best dose in the course of the 5 to eight years they had been within the scientific trial.
Dr. Francisco Lopera, a Colombian neurologist and one other chief of the analysis, started working with the members of the family many years in the past and helped decide that their affliction was a genetic type of Alzheimer’s. He stated the trial had satisfied him that “prevention is one of the best ways of searching for the answer for Alzheimer’s illness, even when right now we don’t have an excellent outcome.”
“We all know that we did a giant step within the contribution to the investigation of Alzheimer’s illness,” he added. “And now we’re ready to begin different steps in trying on the answer for this illness.”
One participant’s spouse, Maria Areiza of Medellín, stated her husband, Hernando, whose surname is being withheld to guard his privateness, was among the many first sufferers to enroll within the trial. Hernando, 45, who labored fixing phone cables, started growing signs of cognitive decline about eight years in the past. He has since progressed to Alzheimer’s dementia however can nonetheless maintain a dialog. As a result of his deterioration has been comparatively sluggish, his household had been hopeful that he was benefiting from the trial.
“I had put all my hopes on this examine,” his spouse stated.
Jennie Erin Smith contributed reporting from Medellín, Colombia.
Business
Cookies, Cocktails and Mushrooms on the Menu as Justices Hear Bank Fraud Case
In a lively Supreme Court argument on Tuesday that included references to cookies, cocktails and toxic mushrooms, the justices tried to find the line between misleading statements and outright lies in the case of a Chicago politician convicted of making false statements to bank regulators.
The case concerned Patrick Daley Thompson, a former Chicago alderman who is the grandson of one former mayor, Richard J. Daley, and the nephew of another, Richard M. Daley. He conceded that he had misled the regulators but said his statements fell short of the outright falsehoods he said were required to make them criminal.
The justices peppered the lawyers with colorful questions that tried to tease out the difference between false and misleading statements.
Chief Justice John G. Roberts Jr. asked whether a motorist pulled over on suspicion of driving while impaired said something false by stating that he had had one cocktail while omitting that he had also drunk four glasses of wine.
Caroline A. Flynn, a lawyer for the federal government, said that a jury could find the statement to be false because “the officer was asking for a complete account of how much the person had had to drink.”
Justice Ketanji Brown Jackson asked about a child who admitted to eating three cookies when she had consumed 10.
Ms. Flynn said context mattered.
“If the mom had said, ‘Did you eat all the cookies,’ or ‘how many cookies did you eat,’ and the child says, ‘I ate three cookies’ when she ate 10, that’s a false statement,” Ms. Flynn said. “But, if the mom says, ‘Did you eat any cookies,’ and the child says three, that’s not an understatement in response to a specific numerical inquiry.”
Justice Sonia Sotomayor asked whether it was false to label toxic mushrooms as “a hundred percent natural.” Ms. Flynn did not give a direct response.
The case before the court, Thompson v. United States, No. 23-1095, started when Mr. Thompson took out three loans from Washington Federal Bank for Savings between 2011 and 2014. He used the first, for $110,000, to finance a law firm. He used the next loan, for $20,000, to pay a tax bill. He used the third, for $89,000, to repay a debt to another bank.
He made a single payment on the loans, for $390 in 2012. The bank, which did not press him for further payments, went under in 2017.
When the Federal Deposit Insurance Corporation and a loan servicer it had hired sought repayment of the loans plus interest, amounting to about $270,000, Mr. Thompson told them he had borrowed $110,000, which was true in a narrow sense but incomplete.
After negotiations, Mr. Thompson in 2018 paid back the principal but not the interest. More than two years later, federal prosecutors charged him with violating a law making it a crime to give “any false statement or report” to influence the F.D.I.C.
He was convicted and ordered to repay the interest, amounting to about $50,000. He served four months in prison.
Chris C. Gair, a lawyer for Mr. Thompson, said his client’s statements were accurate in context, an assertion that met with skepticism. Justice Elena Kagan noted that the jury had found the statements were false and that a ruling in Mr. Thompson’s favor would require a court to rule that no reasonable juror could have come to that conclusion.
Justices Neil M. Gorsuch and Brett M. Kavanaugh said that issue was not before the court, which had agreed to decide the legal question of whether the federal law, as a general matter, covered misleading statements. Lower courts, they said, could decide whether Mr. Thompson had been properly convicted.
Justice Samuel A. Alito Jr. asked for an example of a misleading statement that was not false. Mr. Gair, who was presenting his first Supreme Court argument, responded by talking about himself.
“If I go back and change my website and say ‘40 years of litigation experience’ and then in bold caps say ‘Supreme Court advocate,’” he said, “that would be, after today, a true statement. It would be misleading to anybody who was thinking about whether to hire me.”
Justice Alito said such a statement was, at most, mildly misleading. But Justice Kagan was impressed.
“Well, it is, though, the humblest answer I’ve ever heard from the Supreme Court podium,” she said, to laughter. “So good show on that one.”
Business
SEC probes B. Riley loan to founder, deals with franchise group
B. Riley Financial Inc. received more demands for information from federal regulators about its dealings with now-bankrupt Franchise Group as well as a personal loan for Chairman and co-founder Bryant Riley.
The Los Angeles-based investment firm and Riley each received additional subpoenas in November from the U.S. Securities and Exchange Commission seeking documents and information about Franchise Group, or FRG, the retail company that was once one of its biggest investments before its collapse last year, according to a long-delayed quarterly filing. The agency also wants to know more about Riley’s pledge of B. Riley shares as collateral for a personal loan, the filing shows.
B. Riley previously received SEC subpoenas in July for information about its dealings with ex-FRG chief executive Brian Kahn, part of a long-running probe that has rocked B. Riley and helped push its shares to their lowest in more than a decade. Bryant Riley, who founded the company in 1997 and built it into one of the biggest U.S. investment firms beyond Wall Street, has been forced to sell assets and raise cash to ease creditors’ concerns.
The firm and Riley “are responding to the subpoenas and are fully cooperating with the SEC,” according to the filing. The company said the subpoenas don’t mean the SEC has determined any violations of law have occurred.
Shares in B. Riley jumped more than 25% in New York trading after the company’s overdue quarterly filing gave investors their first formal look at the firm’s performance in more than half a year. The data included a net loss of more than $435 million for the three months ended June 30. The shares through Monday had plunged more than 80% in the past 12 months, trading for less than $4 each.
B. Riley and Kahn — a longstanding client and friend of Riley’s — teamed up in 2023 to take FRG private in a $2.8-billion deal. The transaction soon came under pressure when Kahn was tagged as an unindicted co-conspirator by authorities in the collapse of an unrelated hedge fund called Prophecy Asset Management, which led to a fraud conviction for one of the fund’s executives.
Kahn has said he didn’t do anything wrong, that he wasn’t aware of any fraud at Prophecy and that he was among those who lost money in the collapse. But federal investigations into his role have spilled over into his dealings with B. Riley and its chairman, who have said internal probes found they “had no involvement with, or knowledge of, any alleged misconduct concerning Mr. Kahn or any of his affiliates.”
FRG filed for Chapter 11 bankruptcy in November, a move that led to hundreds of millions of dollars of losses for B. Riley. The collapse made Riley “personally sick,” he said at the time.
One of the biggest financial problems to arise from the FRG deal was a loan that B. Riley made to Kahn for about $200 million, which was secured against FRG shares. With that company’s collapse into bankruptcy in November wiping out equity holders, the value of the remaining collateral for this debt has now dwindled to only about $2 million, the filing shows.
Griffin writes for Bloomberg.
Business
Starbucks Reverses Its Open-Door Policy for Bathroom Use and Lounging
Starbucks will require people visiting its coffee shops to buy something in order to stay or to use its bathrooms, the company announced in a letter sent to store managers on Monday.
The new policy, outlined in a Code of Conduct, will be enacted later this month and applies to the company’s cafes, patios and bathrooms.
“Implementing a Coffeehouse Code of Conduct is something most retailers already have and is a practical step that helps us prioritize our paying customers who want to sit and enjoy our cafes or need to use the restroom during their visit,” Jaci Anderson, a Starbucks spokeswoman, said in an emailed statement.
Ms. Anderson said that by outlining expectations for customers the company “can create a better environment for everyone.”
The Code of Conduct will be displayed in every store and prohibit behaviors including discrimination, harassment, smoking and panhandling.
People who violate the rules will be asked to leave the store, and employees may call law enforcement, the policy says.
Before implementation of the new policy begins on Jan. 27, store managers will be given 40 hours to prepare stores and workers, according to the company. There will also be training sessions for staff.
This training time will be used to prepare for other new practices, too, including asking customers if they want their drink to stay or to go and offering unlimited free refills of hot or iced coffee to customers who order a drink to stay.
The changes are part of an attempt by the company to prioritize customers and make the stores more inviting, Sara Trilling, the president of Starbucks North America, said in a letter to store managers.
“We know from customers that access to comfortable seating and a clean, safe environment is critical to the Starbucks experience they love,” she wrote. “We’ve also heard from you, our partners, that there is a need to reset expectations for how our spaces should be used, and who uses them.”
The changes come as the company responds to declining sales, falling stock prices and grumbling from activist investors. In August, the company appointed a new chief executive, Brian Niccol.
Mr. Niccol outlined changes the company needed to make in a video in October. “We will simplify our overly complex menu, fix our pricing architecture and ensure that every customer feels Starbucks is worth it every single time they visit,” he said.
The new purchase requirement reverses a policy Starbucks instituted in 2018 that said people could use its cafes and bathrooms even if they had not bought something.
The earlier policy was introduced a month after two Black men were arrested in a Philadelphia Starbucks while waiting to meet another man for a business meeting.
Officials said that the men had asked to use the bathroom, but that an employee had refused the request because they had not purchased anything. An employee then called the police, and part of the ensuing encounter was recorded on video and viewed by millions of people online, prompting boycotts and protests.
In 2022, Howard Schultz, the Starbucks chief executive at the time, said that the company was reconsidering the open-bathroom policy.
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