A top U.S. opioid distributor is pointing fingers at the government for the deluge of prescription painkillers that have poured into Native American communities at alarmingly high rates.
McKesson Corp., one of the country’s three big wholesale drug distributors, is embroiled in litigation brought by Oklahoma-based Cherokee Nation, the country's largest tribal group, which has suffered severely from abuse and overdose. As part of its defense, the company recently pointed to its $31 billion, multiyear contract to supply drugs to the Veterans Affairs Department and other federal agencies, arguing it was just following the government’s guidance.
“It is clear that the acts for which McKesson (and the other defendants) are being sued occurred while performing its required duties for the VA and because of what it was required to do for the VA, e.g. distribute opioids in and around the alleged Tribal Area,” McKesson’s lawyers argued in a brief filed in mid-March with the U.S. court in the Eastern District of Oklahoma.
It’s a new kind of argument from McKesson. The company and other major opioid makers and distributors are facing lawsuits from hundreds of cities, counties and states for their role in the sweeping opioid epidemic, which now claims more lives than car accidents every year.
The industry is being forced to explain how huge supplies of painkillers found their way into certain parts of the country – as a House Energy and Commerce investigation recently shed light on – and why suspicious prescriptions went filled and federal reporting requirements were not followed. (You can read more about those lawsuits in this Health 202.)
For its part, Cherokee Nation's lawyers contend the industry failed to prevent the diversion of pain pills to the black market, profited from the growing opioid crisis and decimated homes and communities in its 14 counties.
It’s certainly true that addiction is is even more pronounced in the tribe’s case. Native Americans have the highest opioid overdose death rate of any group in the United States, with 8.4 deaths per 100,000 people in 2014 – a rate double or triple that of African Americans and Latinos, according to CDC data.
And Cherokee Nation is based in Oklahoma, which is among a dozen states where doctors write more prescriptions than there are people. In 2012, there were 128 prescriptions written for every 100 Oklahoma residents, per a 2014 Centers for Disease Control and Prevention study.
“It’s affecting our next generation,” Chrissi Ross Nimmo, Cherokee Nation’s deputy attorney general, told me last week. She said the Cherokee Nation’s biggest hospital -- W.W. Hastings in Tahlequah, Okla. -- has seen a marked shift in the drugs on which newborns are dependent based on their mother's drug choices. A decade ago, the drug of choice was primarily methamphetamine. Now, it’s predominantly opioids.
“We’re seeing three, four, five years out the impact on development and learning disabilities,” Nimmo said. “The mothers of those children were not getting those pills through legitimate means – they were getting diverted.”
Many Cherokee children are now being born with drug dependencies that there aren’t enough tribal members to care for them while their parents recover, Nimmo said.
“We don’t have enough foster homes so we’re in the situation of placing our children in non-Cherokee homes because we just don’t have any other options,” she told me.
The Indian Health Service — which funds health programs for Native Americans and is contributing to a large-scale expansion of Cherokee Nation’s Hastings Hospital — is among the federal agencies for which McKesson supplies drugs and medical supplies.
McKesson, which is the seventh-largest federal contractor, dodged a major bullet last year when it struck a deal with top attorneys at the Drug Enforcement Administration and the Justice Department, who had been poised to bring the first-ever criminal case against a drug distribution company.
Federal investigators said they could show the company had failed to report suspicious orders involving millions of highly addictive painkillers sent to drugstores from Sacramento, Calif., to Lakeland, Fla., my colleagues Lenny Bernstein and Scott Higham reported in December.
Instead, after failing to convince the U.S. attorney in Denver they had enough evidence to bring a case, federal prosecutors struck an agreement with McKesson that was far more lenient than the field division wanted.
As the Cherokee Nation’s fight with McKesson winds its way through the court system, the tribe’s lawyers are quick to note the pharmaceutical giant’s lucrative agreement with the federal government. “They’re sort of biting the hand that feeds them by saying the VA made me engage in some of this conduct,” outside counsel Tyler Ulrich told me.
A spokeswoman for McKesson said she didn’t have a specific comment on McKesson’s most recent court filing. But she provided a statement saying the company for years has reported to the DEA orders of controlled substances -- in the past year alone, it reported “hundreds of thousands” of suspicious orders without fulfilling them, she maintained.
“As a distributor, McKesson only distributes opioid medications to pharmacies that are DEA-registered and state-licensed, and we only distribute in response to orders that pharmacies place – we do not drive demand,” the statement said.
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AHH: Walmart is in the early stages of talks to buy insurer Humana in what could be the latest major health-care industry merger, the Wall Street Journal reports. A deal isn't guaranteed, but it would be big if it happened, Dana Mattioli, Sarah Nassauer and Anna Wilde Mathews report. “It also would be Walmart’s largest deal by far, eclipsing its 1999 acquisition of the U.K.’s Asda Group PLC for $10.8 billion,” they write. “The two companies are discussing a range of options, including an acquisition, one of the people familiar said.”
Why would Walmart want to buy Humana? Some context on both companies: Walmart already has a pharmacy business, some primary-care clinics and wants to work with labs to offer lab-testing services. Humana, which owns its own pharmacy-benefit manager, is the second biggest provider of private Medicare plans, Dana, Sarah and Anna write.
The Journal’s Melanie Evans also reports hospitals are anxious about the preliminary talks. “Hospitals have been eyeing Walmart nervously for years as it advances into health care, seeking to leverage its enormous purchasing heft, physical reach and focus on price,” Melanie writes. “Now, a deal for Louisville, Ky.-based insurer Humana could accelerate Walmart’s transformation into a direct competitive threat and a force in tamping down spending on hospital services, according to industry executives and consultants.”
OOF: With a nationwide order issued late Friday, a federal judge is temporarily preventing the government from blocking access to abortions and counseling for teens detained in immigration custody, saying current administration policy and practices are probably unconstitutional, The Post's Ann E. Marimow, Spencer H. Hsu and Maria Sacchetti report.
The case pertains to a Central American girl in a government-funded shelter that set off a national debate over the constitutional rights of such undocumented teens to terminate their pregnancies. U.S. District Judge Tanya S. Chutkan is allowing the case to proceed as a class action on behalf of any other teens who have crossed the border illegally and while in federal custody may want to seek abortions. The U.S. government has acknowledged there were at least 420 pregnant unaccompanied minors in custody in 2017, including 18 who requested abortions.
The Trump administration has refused to “facilitate” such procedures for pregnant teenagers traveling alone, a marked departure from the Obama administration, whose Office of Refugee Resettlement did not block immigrants in U.S. custody from having abortions at their own expense, and paid for services for teens in cases of rape, incest or a threat to the woman’s life. Chutkan wrote the change in policy posed irreparable harm to pregnant teens, writing that “ORR’s absolute veto nullifies [unaccompanied children's] right to make her own reproductive choices.”
OUCH: Companies are starting to realize that loneliness experienced by their employees not only impairs their mood and health — it can also hurt productivity and profits. "The economic damage caused when employees suffer feelings of isolation could soon worsen as offices become increasingly automated and more people work remotely," The Post's Danielle Paquette reports.
The share of American adults who say they're lonely has doubled since the 1980s to 40 percent. Though the U.S. doesn't track the financial effect of disconnected workers, researchers in Britain (where the problem is acute) estimate the penalty to businesses can reach $3.5 billion a year, accounting for higher turnover and heftier health-care burdens.
A recent study in the Harvard Business Review found 61 percent of lawyers surveyed ranked “above average” on a loneliness scale from the University of California at Los Angeles. Other particularly lonely groups were engineers (57 percent), followed by research scientists (55 percent), workers in food preparation and serving (51 percent), and those in education and library services (45 percent).
—Former Veterans Affairs Secretary David Shulkin denied over the weekend that he voluntarily left the role last week. In a series of interviews, Shulkin's account conflicted with the White House’s description of his exit, our colleague Dave Weigel reports. “I would not resign, because I’m committed to making sure this job was seen through to the very end,” Shulkin told Jake Tapper on CNN’s “State of the Union." “I did not resign.”
Shulkin said he believed he was fired primarily because of opposition from political appointees, not the president. “I don’t think that this was the president,” Shulkin said. “The president is committed to improving the care for veterans. These appointees had a belief that there was a different way to do that than I did … these individuals, when they didn’t see that their way was being adopted, used subversive techniques to change the leadership at VA.”
Shulkin also told NBC’s “Meet the Press" that he didn't submit a letter of resignation, nor was he asked to do so. On Friday, Shulkin had told The Post he was told by White House Chief of Staff John Kelly he was being pushed out.
But deputy White House press secretary Lindsay Walters told Politico on Saturday that Shulkin "resigned from his position as Secretary of the Department of Veterans Affairs.” Asked on Sunday about Shulkin’s description of what happened, Walters repeated that statement.
“The questions about Shulkin’s removal may well end up in court,” Dave writes. “Democrats, who, like Shulkin, believe that the Trump administration is attempting to elevate people who favor privatizing VA’s services, could sue over any major decisions made by,” Robert Wilkie, undersecretary of defense for personnel and readiness, who is now running the department.
—New CDC Director Robert Redfield Jr., gave a personal address last week in which he highlighted science and data as keys to the agency’s mission. The 66-year-old, who had sought the top role at the agency and at the National Institutes of Health for more than a decade, became emotional twice during his remarks, our colleague Lena H. Sun reports. Redfield, a University of Maryland medical professor who was appointed in March, spoke about taking over the best “science-based, data-driven agency in the world. I've dreamed of doing this for a long time.”
“He takes the agency's helm at a time when scientists and public health experts are concerned about the commitment of the CDC and HHS to science- and evidence-based research,” Lena writes. “Just three months ago, CDC employees were advised to avoid seven words or phrases in narratives in preparing the fiscal 2019 budget.” Lena noted that “words to avoid” were included in an HHS style guide, such as “evidence-based” and “science-based.”
But Redfield struck a different tone on Thursday, saying the CDC is “science-based and data-driven, and that's why CDC has the credibility around the world that it has." He also talked about the importance of vaccines and about tackling the AIDs epidemic, the ongoing opioid crisis and the CDC’s role in protecting from emerging health threats.
—FDA Commissioner Scott Gottlieb signaled last week that he's building on the Obama administration's nutrition agenda of reducing salt in food, Politico’s Helena Bottemiller Evich and Liz Crampton report. “There remains no single more effective public health action related to nutrition than the reduction of sodium in the diet,” Gottlieb said while speaking at the Consumer Federation of America conference in Washington.
In 2016, the Obama administration proposed reducing salt in about 150 food categories from frozen pizza to canned olives, but the most recent appropriations bill from the GOP-led Congress includes language urging the FDA to suspend the effort until the National Academy of Medicine has finished reviewing the latest sodium science.
“Gottlieb said the FDA would update its short-term sodium targets in 2019, which signaled the agency would comply with the letter of the spending bill language, but act soon after," Helena and Liz write. "The targets are voluntary, but put considerable pressure on food companies to cut back on salt over time...Gottlieb said he would also direct the agency to continue to discuss longer-term reduction efforts.”
The need for cutting salt intake remains in question, Helena and Liz note. Some research has questioned the benefits of cutting back, and others argue it is a crucial ingredient for food flavor, safety and shelf life. But public health advocates say high sodium is linked with high blood pressure, increased heart attack and stroke risks, and that reducing sodium could lead to lower health costs.
—Coffee companies in California will have to carry a cancer warning because of a carcinogen that may be present in your cup of Joe. The warning will take effect because of a ruling late last week by Superior Court Judge Elihu Berle. Berle sided with a nonprofit's case against dozens of coffee companies, including Starbucks, Peets and other chains, saying businesses that sold coffee were in violation of a state regulation to disclose the prevalence of carcinogens and toxic chemicals in coffee being served by bigger establishments, The Post's Eli Rosenberg reports.
“While plaintiff offered evidence that consumption of coffee increases the risk of harm to the fetus, to infants, to children and to adults, defendants’ medical and epidemiology experts testified that they had no opinion on causation,” Berle wrote. “Defendants failed to satisfy their burden of proving by a preponderance of evidence that consumption of coffee confers a benefit to human health.”
But the science doesn't exactly hold up here. Experts told Rosenberg and Post reporter Ben Guarino that coffee drinkers should not change their habits on the basis of the new ruling. Rodents fed massive amounts of acrylamide — a chemical found in coffee —do develop cancer, but anything, including water and oxygen, can be unsafe at the wrong dosage. Those lab rats and mice were dosed at rates 1,000 to 10,000 times higher than what humans consume in food, according to the American Cancer Society. Several experts said links between cancer and acrylamide in humans are weak or need to be replicated in additional studies.
—A few more good reads from The Post and beyond:
- The National Academies of Sciences Engineering Medicine holds a workshop today and Tuesday.
- The Economic Club of Washington, D.C.'s 2018 Medical Panel is on Tuesday.
- The Bipartisan Policy Center holds an event on “Advancing Innovation, Competition, and Access for Biologics Through Patent Policy” on Wednesday.
- MedPAC holds a public meeting on Thursday and Friday.
- The Advisory Committee to the Director of the National Institutes of Health will host a meeting on an opioid report on Friday.
- Harvard School of Public Health holds an event on the gun violence epidemic on Friday.
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