Under the crush of thousands of lawsuits, Purdue filed for bankruptcy restructuring in September 2019, which automatically put a hold on all the claims against it.
Nearly two years later, Judge Robert Drain, the bankruptcy court judge in White Plains, N.Y., confirmed a plan that had been approved by a majority of creditors who voted. Purdue would be formally dissolved and would re-emerge as a new company called Knoa Pharma that would still produce OxyContin but also other drugs. The new company’s profits would go to states and communities to fund opioid treatment and prevention efforts.
The Sacklers would renounce their ownership, eventually sell their foreign pharmaceutical companies as well, and contribute $4.5 billion of their fortune to the state and local opioid abatement funds.
In exchange, all lawsuits against Purdue would be extinguished, a benefit typical of bankruptcy. What made the settlement so contentious was the Sacklers’ insistence on being released from all Purdue-related opioid claims, although they had not personally filed for bankruptcy.
In court, lawyers said there are more than 800 lawsuits that name the Sacklers.
After Judge Drain approved the plan, it was immediately appealed by the United States Trustee, a branch of the Justice Department that monitors bankruptcy cases; eight states, including Maryland, Washington and Connecticut; the District of Columbia; and about 2,000 individuals. The appeal was filed in federal district court.
Lawyers challenging the plan argued that the Sacklers had essentially gamed the bankruptcy system. Moreover, they argued, Judge Drain lacked the authority to shut off a state’s power to pursue the Sacklers under its own civil consumer protection laws.
“Today’s ruling is a critical development that restores the state’s ability to protect the safety of Marylanders by holding fully accountable those who created or contributed to the opioid crisis, particularly members of the Sackler family,” said Brian E. Frosh, the Maryland attorney general.
BEIRUT, Lebanon — Built on the ashes of 10 years of war in Syria, an illegal drug industry run by powerful associates and relatives of President Bashar al-Assad has grown into a multi-billion-dollar operation, eclipsing Syria’s legal exports and turning the country into the world’s newest narcostate.
Its flagship product is captagon, an illegal, addictive amphetamine popular in Saudi Arabia and other Arab states. Its operations stretch across Syria, including workshops that manufacture the pills, packing plants where they are concealed for export, and smuggling networks to spirit them to markets abroad.
An investigation by The New York Times found that much of the production and distribution is overseen by the Fourth Armored Division of the Syrian army, an elite unit commanded by Maher al-Assad, the president’s younger brother and one of Syria’s most powerful men.
Major players also include businessmen with close ties to the government, the Lebanese militant group Hezbollah, and other members of the president’s extended family, whose last name ensures protection for illegal activities, according to The Times investigation, which is based on information from law enforcement officials in 10 countries and dozens of interviews with international and regional drug experts, Syrians with knowledge of the drug trade and current and former United States officials.
found 84 million pills hidden in huge rolls of paper and metal gears last year. Malaysian officials discovered more than 94 million pills sealed inside rubber trolley wheels in March.
hub of hashish production and a stronghold of Hezbollah, an Iran-backed militant group that is now part of Lebanon’s government.
While the pharmaceutical Captagon contained the amphetamine fenethylline, the illicit version sold today, often referred to as “captagon” with a lowercase c, usually contains a mix of amphetamines, caffeine and various fillers. Cheap versions retail for less than a dollar a pill in Syria, while higher quality pills can sell for $14 or more apiece in Saudi Arabia.
After the Syrian war broke out, smugglers took advantage of the chaos to sell the drug to fighters on all sides, who took it to bolster their courage in battle. Enterprising Syrians, working with local pharmacists and machinery from disused pharmaceutical factories, began making it.
Syria had the needed components: experts to mix drugs, factories to make products to conceal the pills, access to Mediterranean shipping lanes and established smuggling routes to Jordan, Lebanon and Iraq.
As the war dragged on, the country’s economy fell apart and a growing number of Mr. al-Assad’s associates were targeted with international sanctions. Some of them invested in captagon, and a state-linked cartel developed, bringing together military officers, militia leaders, traders whose businesses had boomed during the war and relatives of Mr. al-Assad.
Mr. Khiti and Mr. Taha. It called Mr. Taha an intermediary for the Fourth Division whose businesses “generate revenue for the regime and its supporters.”
Captagon is still produced in and smuggled through Lebanon. Nouh Zaiter, a Lebanese drug lord who now lives mostly in Syria, links the Lebanese and Syrian sides of the business, according to regional security officials and Syrians with knowledge of the drug trade.
A tall, longhaired Bekaa Valley native, Mr. Zaiter was sentenced in absentia to life in prison with hard labor by a Lebanese military court this year for drug crimes.
Reached by phone, Mr. Zaiter said his business was hashish and denied that he had ever been involved with captagon.
“I have not and will never send such poisons to Saudi Arabia or anywhere else,” he said. “Even my worst enemy, I won’t provide him with captagon.”
sewn into the linings of clothes.
In May, after Saudi authorities discovered more than five million pills hidden inside hollowed out pomegranates shipped from Beirut, they banned produce from Lebanon, a major blow to local farmers.
According to The Times’ database, the number of pills seized has increased every year since 2017.
The street value of the drugs seized has outstripped the value of Syria’s legal exports, mostly agricultural products, every year since 2019.
Last year, global captagon seizures had a street value of about$2.9 billion, more than triple Syria’s legal exports of $860 million.
Law enforcement agencies have struggled to catch the smugglers, not least because the Syrian authorities offer little if any information about shipments that originated in their country.
The name of shippers listed on manifests are usually fake and searches for the intended recipients often lead to mazes of shell companies.
The Italian seizure of 84 million pills in Salerno last year, the largest captagon bust ever at the time, had come from Latakia. Shipping documents listed the sender as Basil al-Shagri Bin Jamal, but the Italian authorities were unable to find him.
GPS Global Aviation Supplier, a company registered in Lugano, Switzerland, that appears to have no office.
Phone calls, text messages and emails to the company received no response, and the wealth management firm that the company listed as its mailing address, SMC Family Office SA, declined to comment.
Greek investigators have hit similar roadblocks.
In June 2019, workers in Piraeus found five tons of captagon, worth hundreds of millions of dollars, inside sheets of fiberboard on their way to China.
Seehog, a Chinese logistics firm. When reached by phone, she denied knowing anything about the shipment and refused to answer questions.
“You are not the police,” she said, and hung up.
There was one more clue in the documents: The sender was Mohammed Amer al-Dakak, with a Syrian phone number. When entered into WhatsApp, the phone number showed a photo of Maher al-Assad, the commander of Syria’s Fourth Armored Division, suggesting the number belonged to, at least, one of his fans.
A man who answered that number said that he was not Mr. al-Dakak. He said that he had acquired the phone number recently.
Loukas Danabasis, the head of the narcotics unit of Greece’s financial crime squad, said the smugglers’ tactics made solving such cases “difficult and sometimes impossible.”
Spilling Into Jordan
While officials in Europe struggle to identify smugglers, Jordan, one of the United States’ closest partners in the Middle East, sits on the front lines of a regional drug war.
“Jordan is the gateway to the Gulf,” Brig. Gen. Ahmad al-Sarhan, the commander of an army unit along Jordan’s border with Syria, said during a visit to the area.
Overlooking a deep valley with views of Syria, General al-Sarhan and his men detailed Syrian smugglers’ tricks to bring drugs into Jordan: They launch crossing attempts at multiple spots. They attach drugs to drones and fly them across. They load drugs onto donkeys trained to cross by themselves.
Sometimes the smugglers stop by Syrian army posts before approaching the border.
“There is clear involvement,” General al-Sarhan said.
The drug trade worries Jordanian officials for many reasons.
The quantities are increasing. The number of Captagon pills seized in Jordan this year is nearly double the amount seized in 2020, according to Colonel Alqudah, the head of the narcotics department.
And while Jordan was originally just a pathway to Saudi Arabia, as much as one-fifth of the drugs smuggled in from Syria are now consumed in Jordan, he estimated. The increased supply has lowered the price, making it easy for students to become addicted.
Even more worrying, he said, is the growing quantity of crystal meth entering Jordan from Syria, which poses a greater threat. As of October, Jordan had seized 132 pounds of it this year, up from 44 pounds the year before.
“We are now in a dangerous stage because we can’t go back,” said Dr. Morad al-Ayasrah, a Jordanian psychiatrist who treats drug addicts. “We are going forward and the drugs are increasing.”
Reporting was contributed by Niki Kitsantonis in Athens; Gaia Pianigiani in Rome; Kit Gillet in Bucharest, Romania; Hannah Beech in Bangkok; and employees of The New York Times in Damascus, Syria, and Beirut, Lebanon.
SAN JOSE, Calif. — In 2014, Dan Mosley, a lawyer and power broker among wealthy families, asked the entrepreneur Elizabeth Holmes for audited financial statements of Theranos, her blood testing start-up. Theranos never produced any, but Mr. Mosley invested $6 million in the company anyway — and wrote Ms. Holmes a gushing thank-you email for the opportunity.
Bryan Tolbert, an investor at Hall Group, said his firm invested $5 million in Theranos in 2013, even though it did not have a detailed grasp of the start-up’s technologies or its work with pharmaceutical companies and the military.
And Lisa Peterson, who handles investments for Michigan’s wealthy DeVos family, said she did not visit any of Theranos’s testing centers in Walgreens stores, call any Walgreens executives or hire any outside experts in science, regulations or legal matters to verify the start-up’s claims. In 2014, the DeVos family invested $100 million into the company.
The humiliating details of bad investments like Theranos are rarely displayed so prominently to the public. But they have been laid bare in recent weeks at the trial of Ms. Holmes, 37, who faces a dozen counts of wire fraud and conspiracy to commit wire fraud; she has pleaded not guilty. She and Theranos fell from grace — with investor money evaporating and the company shutting down in 2018 — after claims about its blood-testing technology were shown to be false.
frenzied state of record-breaking fund-raising.
With so many new investors flocking to start-ups, due diligence is sometimes so minimal that it is used as a punchline, investors said. An overheated market “definitely creates an environment for people to make more inflated claims” and may even tempt them to lie, said Shirish Nadkarni, a longtime entrepreneur, investor and author.
During its lifetime, Theranos exemplified that dynamic. The company raised $945 million from famous venture capitalists including Tim Draper, Donald Lucas and Dixon Doll; wealthy heirs to the founders of Amway, Walmart and Cox Communications; and powerful tech and media moguls such as Larry Ellison and Rupert Murdoch.
Understand the Elizabeth Holmes Trial
Elizabeth Holmes, the founder of the blood testing start-up Theranos, is currently standing trial for two counts of conspiracy to commit wire fraud and 10 counts of wire fraud.
And as investors have testified at Ms. Holmes’s trial, a central tension has emerged around due diligence. Could these investors have avoided disaster if they had simply done better research on Theranos? Or were they doomed because their research was based on lies?
added pharmaceutical company logos to validation reports indicating the pharmaceutical firms had endorsed its technology when they hadn’t, according to evidence and testimony. Theranos also claimed in late 2014 that it would bring in $140 million in revenue that year when it had none, according to evidence and testimony. The start-up also faked demos of its blood-testing machines to investors, witnesses have testified.
Wade Miquelon, the former chief financial officer of Walgreens, to admit that he didn’t know if his company had ever gotten one of Theranos’s devices in its offices for testing before entering into a partnership. The lawyers also got Mr. Mosley to concede he never directly asked Ms. Holmes whether a pharmaceutical company had written the validation report.
The strategy has sometimes veered into condescension. That was evident last week when Lance Wade, a lawyer for Ms. Holmes, asked Ms. Peterson, an investment professional, if she was familiar with the concept of due diligence.
“You understand that’s a typical thing to do in investing?” he said.
The investors have pushed back, explaining that they were acting on false information supplied by Ms. Holmes.
“You’re trying to measure our sophistication as an investor when we weren’t given complete information,” Ms. Peterson said. Mr. Wade asked the judge to strike the comment from the record.
Still, testimony from pharmaceutical company executives who interacted with Theranos showed it was possible to see through at least some of Ms. Holmes’s grandiose claims.
Constance Cullen, a former director at Schering Plough, said this week that she was responsible for evaluating Theranos’s technology in 2009. She said she came away “dissatisfied” with Ms. Holmes’s answers to her technical questions, calling them “cagey” and indirect. She said she stopped responding to emails from Ms. Holmes.
Shane Weber, a director at Pfizer, looked into Theranos in 2008 and concluded that the company’s responses to his technical questions were “oblique, deflective or evasive,” according to a memo used as evidence. He recommended Pfizer cease working with Theranos.
But investors were less probing, especially when Ms. Holmes appealed to their egos. Her persona as a visionary, bolstered by magazine cover stories and personal eccentricities, created a sense that backing Theranos was an exclusive and elite opportunity.
In testimony and evidence, Ms. Holmes was shown to have guarded information about the business, calling it a trade secret. She told investors she sought out wealthy families who would not want to see a return on their investment anytime soon, making those that she picked feel special with formal invitations. And she controlled the company tightly with “supervoting” shares worth 100 times the power of other shares.
“She has a firm grasp on the company, let there be no mistake,” Christopher Lucas, a Theranos investor, said on a call with other investors that was recorded and played in court. “She would have the right to cast out investors.”
Mr. Lucas’s firm, Black Diamond Ventures, invested around $7 million into Theranos, despite not getting access to its financial information or examining all of its corporate records. This was unusual, Mr. Lucas testified on Thursday, but Ms. Holmes told him the information was sensitive because a leak could “give competitors a chance to crush the company.”
That secrecy extended to due diligence. Ms. Peterson testified that she was scared Ms. Holmes would cut her firm out of the deal if they dug deeper into the details of Theranos’s business.
“We were very careful not to circumvent things and upset Elizabeth,” she said. “If we did too much, we wouldn’t be invited back to invest.”
Mr. Nadkarni, the longtime investor, said such behavior sounded familiar. He said he had observed a loosening of diligence in deals he’s been involved with over the last year.
It hasn’t led to many problems while times were good, he said, but “if something happens to the economy, then everyone is going to be toast.”
Moderna’s market value has nearly tripled this year to more than $120 billion. Two of its founders, as well as an early investor, this month made Forbes magazine’s list of the 400 richest people in the United States.
As the coronavirus spread in early 2020, Moderna raced to design its vaccine — which uses a new technology known as messenger RNA — and to plan a safety study. To manufacture the doses for that trial, the company received $900,000 from the nonprofit Coalition for Epidemic Preparedness Innovations.
The nonprofit group said Moderna had agreed to its “equitable access principles.” That meant, according to the coalition, that the vaccine would be “first available to populations when and where they are needed and at prices that are affordable to the populations at risk, especially low- and middle-income countries or to public sector entities that procure on their behalf.”
Moderna agreed in May to provide up to 34 million vaccine doses this year, plus up to 466 million doses in 2022, to Covax, the struggling United Nations-backed program to vaccinate the world’s poor. The company has not yet shipped any of those doses, according to a Covax spokesman, although Covax has distributed tens of millions of Moderna doses donated by the United States.
Mr. Bancel said that many more doses would have gone to Covax this year had the two parties reached a supply deal in 2020. Aurélia Nguyen, a Covax official, denied that, saying, “It became clear early on that the best we could expect was minimal doses in 2021.”
Late last year, the Tunisian government was hoping to order Moderna doses. Dr. Hechmi Louzir, who led Tunisia’s vaccine procurement efforts, didn’t know how to contact Moderna to begin talks and asked the U.S. Embassy in Tunisia for help, he said. Officials there contacted Moderna, he said, but nothing came of it.
“We were very interested in Moderna,” Dr. Louzir said. “We tried.”
The handwritten doctor’s order was just eight words long, but it solved a problem for Dundee Manor, a nursing home in rural South Carolina struggling to handle a new resident with severe dementia.
David Blakeney, 63, was restless and agitated. The home’s doctor wanted him on an antipsychotic medication called Haldol, a powerful sedative.
“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”
But there was no evidence that Mr. Blakeney actually had schizophrenia.
Antipsychotic drugs — which for decades have faced criticism as “chemical straitjackets” — are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents.
one in 150 people.
Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.
“People don’t just wake up with schizophrenia when they are elderly,” said Dr. Michael Wasserman, a geriatrician and former nursing home executive who has become a critic of the industry. “It’s used to skirt the rules.”
refuge of last resort for people with the disorder, after large psychiatric hospitals closed decades ago.
But unfounded diagnoses are also driving the increase. In May, a report by a federal oversight agency said nearly one-third of long-term nursing home residents with schizophrenia diagnoses in 2018 had no Medicare record of being treated for the condition.
hide serious problems — like inadequate staffing and haphazard care — from government audits and inspectors.
One result of the inaccurate diagnoses is that the government is understating how many of the country’s 1.1 million nursing home residents are on antipsychotic medications.
According to Medicare’s web page that tracks the effort to reduce the use of antipsychotics, fewer than 15 percent of nursing home residents are on such medications. But that figure excludes patients with schizophrenia diagnoses.
To determine the full number of residents being drugged nationally and at specific homes, The Times obtained unfiltered data that was posted on another, little-known Medicare web page, as well as facility-by-facility data that a patient advocacy group got from Medicare via an open records request and shared with The Times.
The figures showed that at least 21 percent of nursing home residents — about 225,000 people — are on antipsychotics.
The Centers for Medicare and Medicaid Services, which oversees nursing homes, is “concerned about this practice as a way to circumvent the protections these regulations afford,” said Catherine Howden, a spokeswoman for the agency, which is known as C.M.S.
“It is unacceptable for a facility to inappropriately classify a resident’s diagnosis to improve their performance measures,” she said. “We will continue to identify facilities which do so and hold them accountable.”
significant drop since 2012 in the share of residents on the drugs.
But when residents with diagnoses like schizophrenia are included, the decline is less than half what the government and industry claim. And when the pandemic hit in 2020, the trend reversed and antipsychotic drug use increased.
A Doubled Risk of Death
For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.
In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.
But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.
11 percent from less than 7 percent, records show.
The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.
A Substitute for Staff
Caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.
Studies have found that the worse a home’s staffing situation, the greater its use of antipsychotic drugs. That suggests that some homes are using the powerful drugs to subdue patients and avoid having to hire extra staff. (Homes with staffing shortages are also the most likely to understate the number of residents on antipsychotics, according to the Times’s analysis of Medicare data.)
more than 200,000 since early last year and is at its lowest level since 1994.
As staffing dropped, the use of antipsychotics rose.
Even some of the country’s leading experts on elder care have been taken aback by the frequency of false diagnoses and the overuse of antipsychotics.
Barbara Coulter Edwards, a senior Medicaid official in the Obama administration, said she had discovered that her father was given an incorrect diagnosis of psychosis in the nursing home where he lived even though he had dementia.
“I just was shocked,” Ms. Edwards said. “And the first thing that flashed through my head was this covers a lot of ills for this nursing home if they want to give him drugs.”
Homes that violate the rules face few consequences.
In 2019 and 2021, Medicare said it planned to conduct targeted inspections to examine the issue of false schizophrenia diagnoses, but those plans were repeatedly put on hold because of the pandemic.
In an analysis of government inspection reports, The Times found about 5,600 instances of inspectors citing nursing homes for misusing antipsychotic medications. Nursing home officials told inspectors that they were dispensing the powerful drugs to frail patients for reasons that ranged from “health maintenance” to efforts to deal with residents who were “whining” or “asking for help.”
a state inspector cited Hialeah Shores for giving a false schizophrenia diagnosis to a woman. She was so heavily dosed with antipsychotics that the inspector was unable to rouse her on three consecutive days.
There was no evidence that the woman had been experiencing the delusions common in people with schizophrenia, the inspector found. Instead, staff at the nursing home said she had been “resistive and noncooperative with care.”
Dr. Jonathan Evans, a medical director for nursing homes in Virginia who reviewed the inspector’s findings for The Times, described the woman’s fear and resistance as “classic dementia behavior.”
“This wasn’t five-star care,” said Dr. Evans, who previously was president of a group that represents medical staff in nursing homes. He said he was alarmed that the inspector had decided the violation caused only “minimal harm or potential for harm” to the patient, despite her heavy sedation. As a result, he said, “there’s nothing about this that would deter this facility from doing this again.”
Representatives of Hialeah Shores declined to comment.
Seven of the 52 homes on the inspector general’s list were owned by a large Texas company, Daybreak Venture. At four of those homes, the official rate of antipsychotic drug use for long-term residents was zero, while the actual rate was much higher, according to the Times analysis comparing official C.M.S. figures with unpublished data obtained by the California advocacy group.
make people drowsy and increases the risk of falls. Peer-reviewed studies have shown that it does not help with dementia, and the government has not approved it for that use.
But prescriptions of Depakote and similar anti-seizure drugs have accelerated since the government started publicly reporting nursing homes’ use of antipsychotics.
Between 2015 and 2018, the most recent data available, the use of anti-seizure drugs rose 15 percent in nursing home residents with dementia, according to an analysis of Medicare insurance claims that researchers at the University of Michigan prepared for The Times.
in a “sprinkle” form that makes it easy to slip into food undetected.
“It’s a drug that’s tailor-made to chemically restrain residents without anybody knowing,” he said.
In the early 2000s, Depakote’s manufacturer, Abbott Laboratories, began falsely pitching the drug to nursing homes as a way to sidestep the 1987 law prohibiting facilities from using drugs as “chemical restraints,” according to a federal whistle-blower lawsuit filed by a former Abbott saleswoman.
According to the lawsuit, Abbott’s representatives told pharmacists and nurses that Depakote would “fly under the radar screen” of federal regulations.
Abbott settled the lawsuit in 2012, agreeing to pay the government $1.5 billion to resolve allegations that it had improperly marketed the drugs, including to nursing homes.
Nursing homes are required to report to federal regulators how many of their patients take a wide variety of psychotropic drugs — not just antipsychotics but also anti-anxiety medications, antidepressants and sleeping pills. But homes do not have to report Depakote or similar drugs to the federal government.
“It is like an arrow pointing to that class of medications, like ‘Use us, use us!’” Dr. Maust said. “No one is keeping track of this.”
published a brochure titled “Nursing Homes: Times have changed.”
“Nursing homes have replaced restraints and antipsychotic medications with robust activity programs, religious services, social workers and resident councils so that residents can be mentally, physically and socially engaged,” the colorful two-page leaflet boasted.
Last year, though, the industry teamed up with drug companies and others to push Congress and federal regulators to broaden the list of conditions under which antipsychotics don’t need to be publicly disclosed.
“There is specific and compelling evidence that psychotropics are underutilized in treating dementia and it is time for C.M.S. to re-evaluate its regulations,” wrote Jim Scott, the chairman of the Alliance for Aging Research, which is coordinating the campaign.
The lobbying was financed by drug companies including Avanir Pharmaceuticals and Acadia Pharmaceuticals. Both have tried — and so far failed — to get their drugs approved for treating patients with dementia. (In 2019, Avanir agreed to pay $108 million to settle charges that it had inappropriately marketed its drug for use in dementia patients in nursing homes.)
‘Hold His Haldol’
Ms. Blakeney said that only after hiring a lawyer to sue Dundee Manor for her husband’s death did she learn he had been on Haldol and other powerful drugs. (Dundee Manor has denied Ms. Blakeney’s claims in court filings.)
During her visits, though, Ms. Blakeney noticed that many residents were sleeping most of the time. A pair of women, in particular, always caught her attention. “There were two of them, laying in the same room, like they were dead,” she said.
In his first few months at Dundee Manor, Mr. Blakeney was in and out of the hospital, for bedsores, pneumonia and dehydration. During one hospital visit in December, a doctor noted that Mr. Blakeney was unable to communicate and could no longer walk.
“Hold the patient’s Ambien, trazodone and Zyprexa because of his mental status changes,” the doctor wrote. “Hold his Haldol.”
Mr. Blakeney continued to be prescribed the drugs after he returned to Dundee Manor. By April 2017, the bedsore on his right heel — a result, in part, of his rarely getting out of bed or his wheelchair — required the foot to be amputated.
In June, after weeks of fruitless searching for another nursing home, Ms. Blakeney found one and transferred him there. Later that month, he died.
“I tried to get him out — I tried and tried and tried,” his wife said. “But when I did get him out, it was too late.”
Women at tech start-ups wrote to her thanking her for saying what they had been feeling, Ms. Esponnette said.
Lola Priego, 30, the founder of Base, which offers at-home blood and saliva tests that are processed at traditional labs, hears a Theranos comparison at least once a week, she said. The references come directly or indirectly from potential partners, advisers, investors, customers and reporters, she said.
She said she understood the need for skepticism, since new health care companies should be looked at critically to prevent malpractice. Often the comparisons stopped after people learned that Base works with Quest Diagnostics, a multinational company, for analysis of its tests.
“But the additional bias and skepticism is challenging to overcome,” Ms. Priego said.
The biggest blow came from a scientific adviser whom Ms. Priego said she had tried to recruit in 2019. The adviser took the meeting only to tell her that bringing technology into health care was doing a disservice to the industry, just like Theranos. It caused Ms. Priego to question whether she could hire the caliber of advisers she had hoped for.
“It was quite demoralizing,” she said. She has since recruited six advisers.
In July, Verge Genomics struck a three-year partnership with the pharmaceutical giant Eli Lilly to work on drugs for the treatment of amyotrophic lateral sclerosis, or A.L.S., Ms. Zhang said. The company also published a paper about its methods in a scientific journal last year and recruited a chief science officer this year.
It was a relief to have something to show to those who were doubtful, Ms. Zhang said.
“The most fragile part of the company is the earliest stage, when you have to buy into the people, the vision and the idea,” she said. Reflecting on Ms. Holmes and Theranos, she added, “It’s where these types of associations can be really harmful and curtail potential.”
Johnson & Johnson’s Covid vaccine was supposed to be one of Africa’s most important weapons against the coronavirus.
The New Jersey-based company agreed to sell enough of its inexpensive single-shot vaccine to eventually inoculate a third of the continent’s residents. And the vaccine would be produced in part by a South African manufacturer, raising hopes that those doses would quickly go to Africans.
That has not happened.
South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.
At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.
donated by the United States. But about four million of the country’s 60 million residents are fully vaccinated.
That left the population vulnerable when a third wave of cases crested over the country. At times in recent months, scores of Covid-19 patients at Helen Joseph Hospital in Johannesburg were waiting in the emergency department for a bed, and the hospital’s infrastructure struggled to sustain the huge volumes of oxygen being piped into patients’ lungs, said Dr. Jeremy Nel, an infectious-disease doctor there.
“The third wave, in terms of the amount of death we saw, was the most heartbreaking, because it was the most avoidable,” Dr. Nel said. “You see people by the dozens dying, all of whom are eligible for a vaccine and would’ve been among the first to get it.”
a United Nations-backed clearinghouse for vaccines that has fallen behind on deliveries. South Africa was slow to enter negotiations with manufacturers for its own doses. In January, a group of vaccine experts warned that the government’s “lack of foresight” could cause “the greatest man-made failure to protect the population since the AIDS pandemic.”
announced in November. Aspen’s facility in Gqeberha, on South Africa’s southern coast, was the first site in Africa to produce Covid vaccines. (Other companies subsequently announced plans to produce vaccines on the continent.)
Understand the State of Vaccine and Mask Mandates in the U.S.
Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
Vaccine rules . . . and businesses.Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.
College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.
Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
South African officials hailed Aspen’s involvement as indispensable.
Aspen “belongs to us as South Africans, and it is making lifesaving vaccines,” South Africa’s president, Cyril Ramaphosa, said during a visit to Aspen’s plant in March. He said he had pushed Johnson & Johnson to prioritize the doses made there for Africans.
“I want them now,” Mr. Ramaphosa added. “I’ve come to fetch our vaccines.”
results of a clinical trial suggested that the vaccine from AstraZeneca offered little protection from mild or moderate infections caused by the Beta variant that was circulating in South Africa.
Weeks later, Johnson & Johnson and the government signed a contract for 11 million doses. South Africa ordered another 20 million doses in April. That would be enough to vaccinate about half the country.
South Africa agreed to pay $10 per dose for the 11 million shots, according to the contract. That was the same price that the United Statespaid and slightly more than the $8.50 that the European Commission agreed to pay.The South African contract prohibited the government from banning exports of the vaccine, citing the need for doses to “move freely across national borders.”
introduced export controls this year to conserve scarce supplies. India halted exports produced by the Serum Institute, which was supposed to be a major vaccine supplier to poor countries. In the United States, officials said they didn’t ban exports, but they didn’t need to. The combination of the extensive vaccine production on American soil and the high prices the U.S. government was willing to pay meant that companies made the delivery of shots for Americans a priority.
Other benefits for Johnson & Johnson were embedded in the South African contract.
While such contracts typically protect companies from lawsuits brought by individuals, this one shielded Johnson & Johnson from suits by a wider range of parties, including the government. It also imposed an unusually high burden on potential litigants to show that any injuries caused by the vaccine were the direct result of company representatives engaging in deliberate misconduct or failing to follow manufacturing best practices.
“The upshot is that you have moved almost all of the risk of something being wrong with the vaccine to the government,” said Sam Halabi, a health law expert at Georgetown University who reviewed sections of the South African contract at the request of The Times.
Mr. Halabi said the contract’s terms appeared more favorable to the pharmaceutical company than other Covid vaccine contracts he had seen. South African officials have said Pfizer, too, sought aggressive legal protections.
The contract said Johnson & Johnson would aim to deliver 2.8 million doses to South Africa by the end of June, another 4.1 million doses by the end of September and another 4.1 million doses by the end of December. (The government expects the 20 million additional doses to be delivered by the end of this year, Mr. Maja said.)
The company has so far fallen far short of those goals. As of the end of June, South Africa had received only about 1.5 million of the doses from its order. The small number of doses that have been delivered to the African Union were on schedule.
The difficulties in procuring doses have revealed the limits of fill-and-finish sites, which leave countries dependent on vaccines from places like the European Union or the United States, said Dr. Salim Abdool Karim, who until March was co-chairman of South Africa’s ministerial advisory committee on Covid.
“Ultimately,” he said, “the solution to our problem has to be in making our own vaccines.”
Lynsey Chutel and Choe Sang-Hun contributed reporting.
Paul J. Hanly Jr., a top trial lawyer who had been central to the current nationwide litigation against pharmaceutical companies and others in the supply chain for their role in the deadly opioid epidemic, died on Saturday at his home in Miami Beach. He was 70.
The cause was anaplastic thyroid cancer, an extremely rare and aggressive disease, said Jayne Conroy, his longtime law partner.
Over his four-decade career, Mr. Hanly, a class-action plaintiffs’ lawyer, litigated and managed numerous complex legal cases, involving among other things the funding of terrorists, stemming from the attacks of Sept. 11, 2001, and allegations of the sexual abuse of dozens of boys by a man who ran an orphanage and school in Haiti.
But nothing compares to the national opioid cases that are pending in federal court in Cleveland on behalf of thousands of municipalities and tribes against the manufacturers and distributors of prescription opioid pain medications. The federal opioid litigation is regarded by many as perhaps the most complex in American legal history — even more entangled and far-reaching than the epic legal battles with the tobacco industry.
settled with Purdue for $75 million. It was one of the few instances in which a drug maker agreed to pay individual patients who had accused it of soft-pedaling the risk of addiction.
Mr. Hanly had a history of taking on complex cases with vast numbers of plaintiffs. Shortly after the 2001 terrorist attacks, he represented some of the families who had lost loved ones on the planes and in the World Trade Center. He also filed suit to stop the sale of tanzanite, a raw stone used as a cash alternative to fund terrorist activities. That lawsuit was expanded to include foreign governments, banks and others that supported Al Qaeda. Portions of it remain pending.
Another of his important cases was a 2013 landmark settlement of $12 million on behalf of 24 Haitian boys who said they had been sexually abused by Douglas Perlitz, who ran programs for underprivileged boys and was subsequently sentenced to 19 years in prison. Mr. Hanly said the defendants, including the Society of Jesus of New England, Fairfield University and others, had not properly supervised Mr. Perliitz. Mr. Hanly filed additional charges in 2015, bringing the total number of abused youths to more than 100 between the late 1990s and 2010.
“Paul was a lawyer’s lawyer,” said Ms. Conroy, his law partner. She said he was renowned for his exhaustive trial preparation, his creative trial strategies and his nearly photographic memory of the contents of documents.
He was also known for veering sartorially from the muted grays and blacks of most lawyers to more jaunty attire in bright yellows, blues and pinks. He favored bespoke styles that were flashy yet sophisticated. His two-tone shoes were all handmade.
John V. Kenny, a former mayor of Jersey City and a powerful Hudson County Democratic boss known as “the pope of Jersey City,” who was jailed in the 1970s after pleading guilty to charges of income tax evasion.
Mr. Hanly took a different path. He went to Cornell, where his roommate was Ed Marinaro, who went on to play professional football and later became an actor (best known for “Hill Street Blues”). Mr. Hanly, who played football with him, graduated in 1972 with a major in philosophy and received a scholar-athlete award as the Cornell varsity football senior who combined the highest academic average with outstanding ability.
He earned a master’s degree in philosophy from Cambridge University in 1976 and a law degree from Georgetown in 1979. He then clerked for Lawrence A. Whipple, a U.S. District Court judge in New Jersey.
Mr. Hanly’s marriage in the mid-1980s to Joyce Roquemore ended in divorce. He is survived by two sons, Paul J. Hanly III and Burton J. Hanly; a daughter, Edith D. Hanly; a brother, John K. Hanly; and a sister, Margo Mullady.
He began his legal career as a national trial counsel and settlement counsel to Turner & Newall, a British asbestos company, one of the world’s largest, in its product-liability cases. The company was purchased by an American firm, Federal-Mogul, in 1998, after which it was overwhelmed with asbestos claims and filed for bankruptcy in 2001.
Mr. Hanly and Ms. Conroy spent much of their time steeped in negotiations with plaintiffs’ lawyers. They soon switched to representing plaintiffs themselves.
“We recognized over time that that was more important to us,” Ms. Conroy said, “to make sure victims were compensated for what happened.”
ISLAMABAD, Pakistan — The coronavirus was ripping through Pakistan, and Muhammad Nasir Chaudhry was worried. Long lines and tight supplies plagued the government’s free vaccine campaign. Newspapers were filled with reports of well-connected people jumping the line for a free dose.
Then Mr. Chaudhry, a 35-year-old government consultant, discovered he could pay to leapfrog the long lines himself. He registered to take two doses of the Russian-made Sputnik V vaccine for about $80 from a private hospital. That’s a lot of money in a country where the average worker makes about $110 per month, but Mr. Chaudhry was ready to make the commitment.
Critics have assailed such private sales in Pakistan and around the world, saying that they make inoculations available only to the wealthy. But in Pakistan, like elsewhere, tight supplies have stymied those efforts. The private hospitals are out of supplies, and Mr. Chaudhry still hasn’t been vaccinated.
“I am willing to pay double the price for the vaccine, but I don’t want to wait on and on,” Mr. Chaudhry said.
bought up most of the world’s vaccine supplies to protect their own people, leaving millions of doses stockpiled and in some places unused. Less developed countries scramble over what’s left.
To speed up vaccinations, some countries have allowed doses to be sold privately. But those campaigns have been troubled by supply issues and by complaints that they simply reflect the global disparities.
blocked them over fears that counterfeit vaccines would be sold. In the United States, some well-connected companies, like Bloomberg, have secured doses for employees.
can’t find vaccines to buy. Demand has been strong. The government sets a ceiling on prices but has been locked in a dispute with private importers over how much that should be.
In April, in the city of Karachi, long lines formed when two private hospitals began selling the Sputnik V vaccine to walk-ins. Private hospitals in Islamabad, the capital, and Lahore faced a similar rush of people and ran short within days. Hospitals in the major cities have now stopped taking walk-ins, and online registration has also been put on hold.
Sputnik V isn’t the only vaccine that the government allows to be sold privately. A one-dose shot made by CanSino Biologics of China is priced at around $28. Demand has been weaker because of greater public confidence in the Russian vaccine. Still, supplies sold out quickly after the CanSino doses went on sale last month. The government has said another 13.2 million doses will arrive in June.
AGP Limited, a private pharmaceutical company that has imported 50,000 doses of Sputnik, is urging patience.
“Sputnik V received an overwhelming response in Pakistan with thousands of people being vaccinated in just a few days and an even higher number of registrations confirmed in hospitals across Pakistan,” said Umair Mukhtar, a senior official of AGP Limited. He said the company has placed large orders for more.
The government price dispute could delay further expansion. The drug regulatory authority wants Sputnik V to be sold at a lower price. AGP won an interim court order on April 1 to sell the vaccine until a final price is fixed.
For those who can afford the doses, frustration is growing. Junaid Jahangir, an Islamabad-based lawyer, said several of his friends got private inoculations. He registered with a private lab for Sputnik V but got a text message later saying that the vaccination drive was on hold.
“I am being denied a fair chance to fight this virus if I end up getting infected,” Mr. Jahangir said. “The demand is there, and I don’t see what could possibly be the reason behind the inefficiency in supply.”
Some of the people who paid for private doses justified their decision by citing media reports that some well-connected people were jumping the line to get free, public doses. In May, at least 18 low-level health care workers were suspended by the authorities in Lahore for vaccinating people out of turn after taking bribes.
Iffat Omar, an actor and talk show host, apologized publicly in April for jumping ahead of the line to get the vaccine. “I am sorry,” she said on Twitter. “I am ashamed. I apologise from the bottom of my heart. I will repent.”
Fiza Batool Gilani, an entrepreneur and the daughter of Yusuf Raza Gilani, the former prime minister, said she knows of several young people who jumped the queue and got the free government vaccine in recent weeks.
“I was myself offered out of turn, free vaccine, but I declined as I wanted to avail the private vaccine,” said Ms. Gilani. Wealthy people should pay for their doses, she said, adding that her family would pay for CanSino shots for its household staff.
Many people, like Tehmina Sadaf, don’t have that option.
Ms. Sadaf, 35, lives along with her husband and a seven-year old son in a working-class neighborhood on the outskirts of Islamabad. Her husband is a cleric at a mosque. She gives Quran lessons to young children. She said the pandemic had negatively impacted the family’s income of around $128 per month. “After paying the house rent and electricity bill, we are not left with much,” she said.
She had her doubts about the public vaccine, “but the price of the private vaccine is very high,” she said. “It should have been lower so that poor people like us can also afford it.”
Zia ur-Rehman contributed reporting from Karachi, Pakistan. Richard C. Paddock and Muktita Suhartono contributed reporting.
WASHINGTON — President Biden, heeding widespread calls to step up his response to the pandemic’s surge abroad, said on Monday that his administration would send 20 million doses of federally authorized coronavirus vaccine overseas in June — the first time he has pledged to give away doses that could be used in the United States.
The donation is another step toward what Mr. Biden promised would be an “entirely new effort” to increase vaccine supplies and vastly expand manufacturing capacity, most of it in the United States. He also put Jeffrey Zients, the White House coronavirus response coordinator, in charge of developing a global strategy.
“We know America will never be fully safe until the pandemic that’s raging globally is under control,” Mr. Biden said in a brief appearance at the White House. “No ocean’s wide enough, no wall’s high enough, to keep us safe.”
With new cases and deaths plummeting as vaccination rates rise in the United States, the epicenter of the crisis has moved to India and other nations. A growing and bipartisan chorus of diplomats, health experts and business leaders has been pushing the president to do more to end what the AIDS activist Asia Russell calls “vaccine apartheid.”
There is a huge disconnect growing where, in some countries with the highest vaccination rates, there appears to be a mind-set that the pandemic is over, while others are experiencing huge waves of infection,” Dr. Tedros said.
Variants like B.1.617, first discovered in India and recently designated a variant of concern by the W.H.O., are contributing to the spread of infections and worry many researchers.
Dr. Tedros called for well-supplied nations to send more of their vaccine allocations to harder-hit countries, and for vaccine developers and manufacturers to hasten delivery of hundreds of millions of doses to Covax, an international initiative dedicated to equitable distribution of the vaccine, noting an appeal by Henrietta Fore, UNICEF’s executive director.
Mr. Biden took office vowing to restore the United States as a leader in global public health, and he has taken certain steps to do so: rejoining the World Health Organization, pledging $4 billion to an international vaccine effort and providing financial support to help Biological E, a vaccine manufacturer in India, produce at least one billion doses of coronavirus vaccines by the end of 2022.
To broaden supply further, Mr. Biden recently announced he would support waiving intellectual property protections for coronavirus vaccines. But activists say simply supporting the waiver is not enough; Mr. Biden must create the conditions for pharmaceutical companies to transfer their intellectual property to vaccine makers overseas, they argue. They view his efforts as piecemeal.
“We’re after 100 days into the administration, and what Biden should be delivering is a global battle plan against vaccine apartheid, and the announcement today is lines on a Post-it note,” Ms. Russell said, adding, “There must be a global strategy led by the U.S. that’s based on technology transfer, on forcing pharma to come to the table to share the recipe.”
assert that a fix is already at hand as they aggressively expand production lines and contract with counterparts around the world to yield billions of additional doses.
An open letter to the president, made public last week by a bipartisan group including business leaders, diplomats and a former defense secretary, argued that such a waiver “would make little difference and could do harm.”
While global health activists are strongly in favor of the waiver, some said they welcomed the views of the business community. They see clear parallels to their work fighting the global AIDS epidemic.
“It shows an unprecedented willingness of pharma and its allies in the private sector to admit what all of us having been saying for months — the private sector alone cannot and will not ensure global vaccine access,” James Krellenstein, a founder of PrEP4All, a nonprofit aimed at ensuring universal access to H.I.V. prevention and treatment, wrote in an email on Sunday. “It really shifts the burden to the Biden administration,” he added.
The organizer of the open letter, Hank Greenberg, the chairman of Starr Companies and former chairman of American International Group, the insurance industry giant, said in an interview on Monday that Mr. Biden’s announcement did not go far enough.
Mr. Greenberg, 96, a veteran of World War II, said he was inspired to write after a former chief executive of an A.I.G. subsidiary who later became the ambassador from the Philippines to the United States told him he was not able to get vaccinated. Like Mr. Biden, he used language that evoked the war effort.