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.”
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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.)
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.
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