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Why 73 Veterans Died In Understaffed Soldiers Home

Reprinted with permission from ProPublica.

On March 10, trustees of the Holyoke Soldiers' Home in Massachusetts heard a glowing review of the facility's operations. For the third year in a row, the home's superintendent reported to the board, the 247-bed nursing home met or provisionally met the U.S. Department of Veterans Affairs health care standards.

We “are happy to report a 'three peat,'" Superintendent Bennett Walsh told the board, according to minutes of the meeting.

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As Doctors Don Trash Bags, Firm Recalls 9 Million Surgical Gowns

Reprinted with permission from ProPublica.

There's an overlooked reason why hospitals treating COVID-19 patients are so short of protective gear. In January, just before the pandemic hit the United States, a key distributor recalled more than 9 million gowns produced by a Chinese supplier because they had not been properly sterilized.

"At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination," Cardinal Health wrote to customers on Jan. 15. It added, "We recognize the criticality of our gowns and procedure packs to performing surgeries, and we apologize for the challenges this supply disruption will cause."

The recall immediately forced the canceling of some elective surgeries. It also meant that supplies of medical gowns were already low when hospitals and state governments began desperately searching for protective gear to cope with the pandemic. Most gowns are supposed to be worn once and not reused. As some doctors and nurses have resorted to covering themselves with trash bags, raincoats and hazardous materials suits bought online, many health care workers have contracted the virus, further taxing already overwhelmed hospitals.

"Demand has gone up at a time when supply was already constrained," said Bindiya Vakil, the chief executive of Resilinc, a Milpitas, California, firm that monitors supply chain disruptions worldwide. "Coronavirus made what was already a bad situation a lot worse."

Colin Milligan, a spokesman for the American Hospital Association, said that the group's members continue to experience shortages of medical gowns and that the Cardinal recall "has had a ripple effect."

A Cardinal spokeswoman said that "the supply of surgical gowns should not impact the supply of PPE," or personal protective equipment, for health care workers because they usually wear another type of outer garment, isolation gowns, when tending to coronavirus patients.

Cardinal received approval Tuesday from the federal government to donate the 2.2 million recalled gowns that remain in its inventory to the Strategic National Stockpile for distribution as isolation gowns. Each pallet must be "labeled in with a warning that the articles are for use for non-sterile apparel purposes only," according to the approval letter.

The company is "working around the clock to meet the needs of healthcare providers so they can safely serve the patients who depend on them," a Cardinal spokeswoman wrote in an email.

The shortage of gowns even before the coronavirus outbreak highlights the vulnerabilities of a U.S. health care system that depends on protective equipment largely made in other countries, led by China. The quality of gowns and other gear has been a recurring problem, including a dead insect in the packaging of a Cardinal gown, complaint records show. Replacing an overseas supplier can take months, and even if a new one is found quickly, it still has to ramp up production and arrange shipping.

"Unfortunately, like others, we are learning in this crisis that overdependence on other countries as a source of cheap medical products and supplies has created a strategic vulnerability to our economy," U.S. Trade Representative Robert Lighthizer said at a meeting Monday. "For the United States, we are encouraging diversification of supply chains and seeking to promote more manufacturing at home."

The recall also exposes flaws in how both companies and government regulators monitor the overseas manufacturers that produce much of the country's inventory of protective medical gear. Because surgical gowns are considered a medical device, their quality is monitored by the U.S. Food and Drug Administration, which inspects manufacturing plants every two years.

A spokeswoman for Cardinal, which is based in Dublin, Ohio, said that it has a "broad and diverse manufacturing and supplier network" that includes the U.S. and is not dependent on any one locale. Cardinal is also one of the largest prescription drug distributors in the world. It had revenues in 2019 of more than $145 billion, making it the 16th largest company in the U.S., according to Fortune.

Cardinal chief executive Mike Kaufmann told Wall Street analysts in February that the company understood "the gravity" of the recall. He said it had hired outside experts to review Cardinal's quality assurance procedures.

The company's board has established a special committee to review management's actions pertaining to the recall, according to Cardinal's website. The outside experts continue to scrutinize the company's practices, a spokeswoman said.

Of the recalled gowns, Cardinal had already distributed almost 8 million to health care facilities; the others had not reached customers. Some had been manufactured as early as the fall of 2018, the company has said. Cardinal does not have information on how many of the gowns were used but believes a majority of them were, a spokeswoman told ProPublica. Asked if any health workers or patients were infected as a result, she said that "we continue to track and analyze complaint data."

The FDA last inspected the problematic Chinese plant in April 2018 and did not identify any violations, an agency spokeswoman said. Manufacturers are responsible for detecting problems and reporting them to the FDA, she said, adding that the Chinese company did not report any such issues during the period covered by the recall.

The January recall was not the first time Cardinal had a problem with the supplier, which it has identified as Siyang HolyMed Products Co. in Jiangsu province on China's coast. Cardinal disclosed in a January press release that in the spring of 2018, around the same time the FDA was inspecting the Chinese company's manufacturing facility, the company learned that Siyang outsourced some of its production to an unqualified facility. Cardinal tested products at the time and determined there was no reason to take further action such as a recall, it said.

Then, last Dec. 10, Cardinal received a tip that Siyang was making gowns at two sites that weren't approved by the U.S. company or registered with the FDA, a Cardinal spokeswoman said. Ten days later, an on-site investigation confirmed the tip, she said.

In a Jan. 21 letter to customers, Cardinal said it couldn't guarantee that the gowns were sterile because Siyang made some of them at locations that "did not maintain proper environmental conditions as required by law." They were "commingled with properly manufactured gowns," Cardinal said.

Phone and email attempts to contact Siyang were unsuccessful. The FDA said in January that it was investigating how the gowns may have been contaminated. An agency spokeswoman did not respond to questions about the status of that investigation.

Health care workers wear gowns to protect themselves from coming in contact with blood and other bodily fluids, microorganisms and particulate material. The gowns offering the highest level of protection are sterilized. A gown that is not properly sterilized increases the risk of infection, which can be transmitted to a patient during a procedure.

Health care workers use two kinds of medical gowns. Surgical gowns, like those sold by Cardinal, provide the highest level of protection and are more heavily regulated by the FDA. Isolation gowns, which are produced in larger amounts, are not sterilized but are appropriate for many interactions with COVID-19 patients. Both are in short supply right now as hospitals are quickly burning through any gowns they have and, in some cases, using already depleted supplies of surgical gowns when isolation gowns are unavailable.

The 9.1 million gowns recalled by Cardinal likely represent about 30 percent of the company's global distribution, according to Premier, a Charlotte, North Carolina, company that negotiates prices on supplies bought by more than 4,000 hospitals and health care systems. The recall "absolutely contributed to the challenges that some of our hospitals are having treating their patients," Chaun Powell, a group vice president at Premier, said. "That put burden on the supply chain prior to COVID outbreaks, and then the COVID outbreaks only exacerbated that issue."

In the past two years, the FDA has received several complaints about the quality of Cardinal gowns. Adverse event reports filed with the agency include accounts of inadequate and improper protective wrapping on sterile gowns, holes in gowns, and blood soaking through the protective material. The reports disclosed to the public do not name the facilities or individuals reporting the product defects. Complaints have been filed about gowns purchased from distributors other than Cardinal as well.

In 2019, a hospital reported that a sterile gown arrived from Cardinal improperly wrapped, rendering it non-sterile. "This was noticed before it was opened to the surgical field; however, had it been opened it would have contaminated the entire field," the report said. Ten days later, another report noted another packaging defect that could have caused contamination. "This is not the first time this has happened," according to the report. "The gowns are coming from the manufacturer this way."

In February, after the recall, a hospital found a dead insect in the packaging of a Cardinal sterile gown, according to a report filed with the FDA. The hospital said the gown was not part of the recall. The report noted there had been previous, unconfirmed reports of hair, gum and a cigarette butt found in Cardinal products labeled as sterile.

Cardinal did not respond to questions about the adverse event reports.

China is the source of 45 percent of all the protective medical garments imported to this country, according to an analysis last month by the Peterson Institute for International Economics. Other countries where gowns for U.S. health care workers are manufactured include Mexico, Thailand, Cambodia, Honduras and the Dominican Republic, according to the nonprofit ECRI Institute in Plymouth Meeting, Pennsylvania.

Another major distributor of surgical gowns, Medline Industries Inc., declined to answer questions about where its gowns are made. Attempts to contact another supplier, Halyard, were unsuccessful.

At a health care conference last month, Halyard's parent company reported making surgical gowns at a plant in San Pedro Sula, Honduras.

For Cardinal, the recall has been a costly blow to its bottom line and reputation. The company's operating earnings declined 34 percent in the second quarter ending Dec. 31, in part due to a $96 million charge related to the recall.

"We don't know how this could affect our business going forward, and we're hoping that it doesn't," Cardinal's Kaufman said in a conference call with investment analysts in February. "But we know that we have created some pain."

Sealed Evidence: Sackler Schemed to Hide OxyContin Strength From Doctors

In May 1997, the year after Purdue Pharma launched OxyContin, its head of sales and marketing sought input on a key decision from Dr. Richard Sackler, a member of the billionaire family that founded and controls the company. Michael Friedman told Sackler that he didn’t want to correct the false impression among doctors that OxyContin was weaker than morphine, because the myth was boosting prescriptions — and sales.

“It would be extremely dangerous at this early stage in the life of the product,” Friedman wrote to Sackler, “to make physicians think the drug is stronger or equal to morphine….We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that.”

“I agree with you,” Sackler responded. “Is there a general agreement, or are there some holdouts?”

Ten years later, Purdue pleaded guilty in federal court to understating the risk of addiction to OxyContin, including failing to alert doctors that it was a stronger painkiller than morphine, and agreed to pay $600 million in fines and penalties. But Sackler’s support of the decision to conceal OxyContin’s strength from doctors — in email exchanges both with Friedman and another company executive — was not made public.

The email threads were divulged in a sealed court document that ProPublica has obtained: an Aug. 28, 2015, deposition of Richard Sackler. Taken as part of a lawsuit by the state of Kentucky against Purdue, the deposition is believed to be the only time a member of the Sackler family has been questioned under oath about the illegal marketing of OxyContin and what family members knew about it. Purdue has fought a three-year legal battle to keep the deposition and hundreds of other documents secret, in a case brought by STAT, a Boston-based health and medicine news organization; the matter is currently before the Kentucky Supreme Court.

Meanwhile, interest in the deposition’s contents has intensified, as hundreds of cities, counties, states and tribes have sued Purdue and other opioid manufacturers and distributors. A House committee requested the document from Purdue last summer as part of an investigation of drug company marketing practices.

In a statement, Purdue stood behind Sackler’s testimony in the deposition. Sackler, it said, “supports that the company accurately disclosed the potency of OxyContin to healthcare providers.” He “takes great care to explain” that the drug’s label “made clear that OxyContin is twice as potent as morphine,” Purdue said.

Still, Purdue acknowledged, it had made a “determination to avoid emphasizing OxyContin as a powerful cancer pain drug,” out of “a concern that non-cancer patients would be reluctant to take a cancer drug.”

The company, which said it was also speaking on behalf of Sackler, deplored what it called the “intentional leak of the deposition” to ProPublica, calling it “a clear violation of the court’s order” and “regrettable.”

Much of the questioning of Sackler in the 337-page deposition focused on Purdue’s marketing of OxyContin, especially in the first five years after the drug’s 1996 launch. Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.

Taken together with a Massachusetts complaint made public last month against Purdue and eight Sacklers, including Richard, the deposition underscores the family’s pivotal role in developing the business strategy for OxyContin and directing the hiring of an expanded sales force to implement a plan to sell the drug at ever-higher doses. Documents show that Richard Sackler was especially involved in the company’s efforts to market the drug, and that he pushed staff to pursue OxyContin’s deregulation in Germany. The son of a Purdue co-founder, he began working at Purdue in 1971 and has been at various times the company’s president and co-chairman of its board.

In a 1996 email introduced during the deposition, Sackler expressed delight at the early success of OxyContin. “Clearly this strategy has outperformed our expectations, market research and fondest dreams,” he wrote. Three years later, he wrote to a Purdue executive, “You won’t believe how committed I am to make OxyContin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again.”

During his deposition, Sackler defended the company’s marketing strategies — including some Purdue had previously acknowledged were improper — and offered benign interpretations of emails that appeared to show Purdue executives or sales representatives minimizing the risks of OxyContin and its euphoric effects. He denied that there was any effort to deceive doctors about the potency of OxyContin and argued that lawyers for Kentucky were misconstruing words such as “stronger” and “weaker” used in email threads.

The term “stronger” in Friedman’s email, Sackler said, “meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent.”

Emails introduced in the deposition show Sackler’s hidden role in key aspects of the 2007 federal case in which Purdue pleaded guilty. A 19-page statement of facts that Purdue admitted to as part of the plea deal, and which prosecutors said contained the “main violations of law revealed by the government’s criminal investigation,” referred to Friedman’s May 1997 email to Sackler about letting the doctors’ misimpression stand. It did not identify either man by name, attributing the statements to “certain Purdue supervisors and employees.”

Friedman, who by then had risen to chief executive officer, was one of three Purdue executives who pleaded guilty to a misdemeanor of “misbranding” OxyContin. No members of the Sackler family were charged or named as part of the plea agreement. The Massachusetts lawsuit alleges that the Sackler-controlled Purdue board voted that the three executives, but no family members, should plead guilty as individuals. After the case concluded, the Sacklers were concerned about maintaining the allegiance of Friedman and another of the executives, according to the Massachusetts lawsuit. To protect the family, Purdue paid the two executives at least $8 million, that lawsuit alleges.

“The Sacklers spent millions to keep the loyalty of people who knew the truth,” the complaint filed by the Massachusetts attorney general alleges.

The Kentucky deposition’s contents will likely fuel the growing protests against the Sacklers, including pressure to strip the family’s name from cultural and educational institutions to which it has donated. The family has been active in philanthropy for decades, giving away hundreds of millions of dollars. But the source of its wealth received little attention until recent years, in part due to a lack of public information about what the family knew about Purdue’s improper marketing of OxyContin and false claims about the drug’s addictive nature.

Although Purdue has been sued hundreds of times over OxyContin’s marketing, the company has settled many of these cases, and almost never gone to trial. As a condition of settlement, Purdue has often required a confidentiality agreement, shielding millions of records from public view.

That is what happened in Kentucky. In December 2015, the state settled its lawsuit against Purdue, alleging that the company created a “public nuisance” by improperly marketing OxyContin, for $24 million. The settlement required the state attorney general to “completely destroy” documents in its possession from Purdue. But that condition did not apply to records sealed in the circuit court where the case was filed. In March 2016, STAT filed a motion to make those documents public, including Sackler’s deposition. The Kentucky Court of Appeals last year upheld a lower court ruling ordering the deposition and other sealed documents be made public. Purdue asked the state Supreme Court to review the decision, and both sides recently filed briefs. Protesters outside Kentucky’s Capitol last week waved placards urging the court to release the deposition.

Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family. During his deposition, which took place over 11 hours in a law office in Louisville, Kentucky, Richard Sackler said “I don’t know” more than 100 times, including when he was asked how much his family had made from OxyContin sales. He acknowledged it was more than $1 billion, but when asked if they had made more than $5 billion, he said, “I don’t know.” Asked if it was more than $10 billion, he replied, “I don’t think so.”

By 2006, OxyContin’s “profit contribution” to Purdue was $4.7 billion, according to a document read at the deposition. From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

During the deposition, Sackler was confronted with his email exchanges with company executives about Purdue’s decision not to correct the misperception among many doctors that OxyContin was weaker than morphine. The company viewed this as good news because the softer image of the drug was helping drive sales in the lucrative market for treating conditions like back pain and arthritis, records produced at the deposition show.

Designed to gradually release medicine into the bloodstream, OxyContin allows patients to take fewer pills than they would with other, quicker-acting pain medicines, and its effect lasts longer. But to accomplish these goals, more narcotic is packed into an OxyContin pill than competing products. Abusers quickly figured out how to crush the pills and extract the large amount of narcotic. They would typically snort it or dissolve it into liquid form to inject.

The pending Massachusetts lawsuit against Purdue accuses Sackler and other company executives of determining that “doctors had the crucial misconception that OxyContin was weaker than morphine, which led them to prescribe OxyContin much more often.” It also says that Sackler “directed Purdue staff not to tell doctors the truth,” for fear of reducing sales. But it doesn’t reveal the contents of the email exchange with Friedman, the link between that conversation and the 2007 plea agreement, and the back-and-forth in the deposition.

A few days after the email exchange with Friedman in 1997, Sackler had an email conversation with another company official, Michael Cullen, according to the deposition. “Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain,” Cullen wrote to Sackler. “Physicians are positioning this product where Percocet, hydrocodone and Tylenol with codeine have been traditionally used.” Cullen then added, “It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera.”

“I think that you have this issue well in hand,” Sackler responded.

Friedman and Cullen could not be reached for comment.

Asked at his deposition about the exchanges with Friedman and Cullen, Sackler didn’t dispute the authenticity of the emails. He said the company was concerned that OxyContin would be stigmatized like morphine, which he said was viewed only as an “end of life” drug that was frightening to people.

“Within this time it appears that people had fallen into a habit of signifying less frightening, less threatening, more patient acceptable as under the rubric of weaker or more frightening, more — less acceptable and less desirable under the rubric or word ‘stronger,’” Sackler said at his deposition. “But we knew that the word ‘weaker’ did not mean less potent. We knew that the word ‘stronger’ did not mean more potent.” He called the use of those words “very unfortunate.”

He said Purdue didn’t want OxyContin “to be polluted by all of the bad associations that patients and healthcare givers had with morphine.”

In his deposition, Sackler also defended sales representatives who, according to the statement of facts in the 2007 plea agreement, falsely told doctors during the 1996-2001 period that OxyContin did not cause euphoria or that it was less likely to do so than other opioids. This euphoric effect experienced by some patients is part of what can make OxyContin addictive. Yet, asked about a 1998 note written by a Purdue salesman, who indicated that he “talked of less euphoria” when promoting OxyContin to a doctor, Sackler argued it wasn’t necessarily improper.

“This was 1998, long before there was an Agreed Statement of Facts,” he said.

The lawyer for the state asked Sackler: “What difference does that make? If it’s improper in 2007, wouldn’t it be improper in 1998?”

“Not necessarily,” Sackler replied.

Shown another sales memo, in which a Purdue representative reported telling a doctor that “there may be less euphoria” with OxyContin, Sackler responded, “We really don’t know what was said.” After further questioning, Sackler said the claim that there may be less euphoria “could be true, and I don’t see the harm.”

The same issue came up regarding a note written by a Purdue sales representative about one doctor: “Got to convince him to counsel patients that they won’t get buzzed as they will with short-acting” opioid painkillers. Sackler defended these comments as well. Well, what it says here is that they won’t get a buzz. And I don’t think that telling a patient ‘I don’t think you’ll get a buzz’ is harmful,” he said.

Sackler added that the comments from the representative to the doctor “actually could be helpful, because many patients won’t get a buzz, and if he would like to know if they do, he might have had a good medical reason for wanting to know that.”

Sackler said he didn’t believe any of the company sales people working in Kentucky engaged in the improper conduct described in the federal plea deal. “I don’t have any facts to inform me otherwise,” he said.

Purdue said that Sackler’s statements in his deposition “fully acknowledge the wrongful actions taken by some of Purdue’s employees prior to 2002,” as laid out in the 2007 plea agreement. Both the company and Sackler “fully agree” with the facts laid out in that case, Purdue said.

The deposition also reveals that Sackler pushed company officials to find out if German officials could be persuaded to loosen restrictions on the selling of OxyContin. In most countries, narcotic pain relievers are regulated as “controlled” substances because of the potential for abuse. Sackler and other Purdue executives discussed the possibility of persuading German officials to classify OxyContin as an uncontrolled drug, which would likely allow doctors to prescribe the drug more readily — for instance, without seeing a patient. Fewer rules were expected to translate into more sales, according to company documents disclosed at the deposition.

One Purdue official warned Sackler and others that it was a bad idea. Robert Kaiko, who developed OxyContin for Purdue, wrote to Sackler, “If OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled.”

Nevertheless, Sackler asked a Purdue executive in Germany for projections of sales with and without controls. He also wondered whether, if one country in the European Union relaxed controls on the drug, others might do the same. When finally informed that German officials had decided the drug would be controlled like other narcotics, Sackler asked in an email if the company could appeal. Told that wasn’t possible, he wrote back to an executive in Germany, “When we are next together we should talk about how this idea was raised and why it failed to be realized. I thought that it was a good idea if it could be done.”

Asked at the deposition about that comment, Sackler responded, “That’s what I said, but I didn’t mean it. I just wanted to be encouraging.” He said he really “was not in favor of” loosening OxyContin regulation and was simply being “polite” and “solicitous” of his own employee.

Near the end of the deposition — after showing Sackler dozens of emails, memos and other records regarding the marketing of OxyContin — a lawyer for Kentucky posed a fundamental question.

“Sitting here today, after all you’ve come to learn as a witness, do you believe Purdue’s conduct in marketing and promoting OxyContin in Kentucky caused any of the prescription drug addiction problems now plaguing the Commonwealth?” he asked.

Sackler replied, “I don’t believe so.”

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