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Black Lung Clinics Call For Action But Top Regulator Plans No New Measures

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Former mining executive David Zatezalo leads the U.S. Mine Safety and Health Administration. Photo: Jesse Wright, WVPB

In the wake of an NPR and PBS Frontline investigation into the surge in cases of black lung disease, a coalition of black lung clinics is calling for action to better protect coal miners from dust exposure.

NPR reports that more than 2,300 miners in central Appalachia are sick with the most serious form of the disease. The investigation also documents the inaction by industry and government regulators, despite decades of warnings that tighter controls on coal and rock dust exposure were needed.

An X-ray image of an Appalachian coal miner with black lung lesions. Photo: Adelina Lancianese, NPR

The National Coalition of Black Lung and Respiratory Disease Clinics said in a statement Monday that the federal government has “more than enough data demonstrating the risks associated with current mining practices to implement new measures.”

Specifically, the Coalition asks regulators to enact a standard to control the dust generated when mining equipment cuts into rock containing silica, or quartz. Silica dust is highly toxic and, as the NPR investigation shows, health advisors urged tighter control standards on that dust decades ago. 

But in a recent call with mining industry stakeholders, the government’s top mine safety and health regulator, David Zatezalo, said he would have “no announcements” on any new measures to control dust or to address lung disease among miners.

“What we are doing is enforcing the law,” Zatezalo said. Zatezalo is the Assistant Secretary of Labor for Mine Safety and Health and leads the Mine Safety and Health Administration, or MSHA.

Zatezalo, a former mining industry executive, appears to be at odds not only with the black lung clinics but with the findings of the National Academy of Sciences, which last year called for a “fundamental shift” in the way the industry controls dust exposure in order to prevent lung disease among miners.

MSHA Response

In a sometimes testy exchange with reporters, Zatezalo defended MSHA’s current approach to monitoring dust exposure in mines.  

“The system has changed and it has increased sampling a lot,” Zatezalo said, referring to changes made during the Obama administration which strengthened standards for dust exposure and introduced new monitoring technology called the continuous personal dust monitor, or CPDM.  

“That CPDM has lowered miners’ exposures and we have proof of that,” Zatezalo said. “We sample over twice as much as we used to.”

He said the number of incidents where samples exceed the dust standard is now one-third or one-fifth of what it was before the new monitoring was put in place.

“Quartz exposure has dropped, look at past few years and you will see compliance records have changed dramatically,” Zatezalo said.

He said that due to the latency period between dust exposure and the onset of disease, the current cases of black lung are linked to exposures from when the earlier dust standard was in place.

However, the new devices do not specifically monitor for dust from quartz, or silica. And as the NPR investigation points out, MSHA’s own data show that earlier attempts to use an overall dust standard to control quartz dust exposure resulted in thousands of incidents where miners were exposed to excessive quartz dust.

Calls For Action

Those who work on the front lines of the current epidemic of black lung are concerned that Zatezalo’s agency is not doing enough to respond to the surge in disease.

“I am very fearful that this is not enough, that at these levels disease will continue,” black lung clinic coalition member Debbie Wills said.

Wills, who works at Valley Health in Cedar Grove, West Virginia, has nearly 30 years of experience serving miners’ health.

“We would like MSHA to have a silica standard and testing to see that the standard is really being met,” she said. “And we would like operators to take responsibility for their workforce.”

She and her black lung clinic colleagues are not alone in calling for action. A June report from the prestigious National Academy of Sciences said the coal mining industry needs a “fundamental shift” in the way it controls exposure to coal and rock dust.  

The report called specifically for better monitoring of the highly toxic silica or quartz dust that is formed when cutting into some kinds of rock, such as quartz-bearing sandstone.

The central Appalachian mining region where Wills works is experiencing the bulk of the new black lung cases. In a study published last summer, researchers at the National Institute for Occupational Safety and Health said the rate of black lung disease among experienced miners in central Appalachia is the highest they have seen in a quarter century, with as many as 1 in 5 showing signs of disease.

Mackie Branham views a lung X-ray with Dr. James Brandon Crum, who was among the first physicians to note an uptick in black lung diagnoses. Photo: Howard Berkes, NPR

Wills said some miners she sees show signs of the worst form of the disease, Progressive Massive Fibrosis, sometimes called complicated black lung.

“We have these awful cases of complicated black lung, we see it in even young miners,” Wills said. 

“It is ridiculous for miners to have black lung and to have PMF in this day and time,” Wills said. “It could have been prevented, and that’s what makes me angry about it.”

Hearings Ahead

Zatezalo will likely face tough questions about MSHA’s response to black lung when a Congressional committee takes up the issue.

Shortly after NPR first aired its investigation, Rep. Bobby Scott, the Virginia Democrat who chairs the House Committee on Education and the Workforce, issued a statement.

“I will be calling hearings in the 116th Congress to forge legislative solutions so that we can prevent the physical, emotional, and financial toll of this completely preventable disease,” Scott said.  

The mining industry could also face new questions about its compliance with dust monitoring when a trial gets underway in a federal court in Kentucky later this year.

Eight employees of the now-bankrupt Armstrong Energy coal company face federal charges for falsifying dust monitoring samples in two Kentucky mines. The case renewed suspicions about widespread industry cheating.

Mine safety expert and Lexington, Kentucky, attorney Tony Oppegard said fraud in dust monitoring undermines MSHA’s new dust control measures. “Anyone who thinks that that is going to eliminate black lung is just fooling themselves, as long as cheating goes on.”

Celeste Monforton, a former federal mine safety official, echoed that concern. 

“It would just be folly to think that cheating is not one of the factors that have contributed to this resurgence of black lung,” she said.

This article was originally published by Ohio Valley ReSource.

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West Virginia Coal Miners Rally For Black Lung Legislation

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Photo: Perry Bennett, WV Legislative Photography

Miners and advocates rallied Wednesday at the West Virginia Capitol in support of a series of bills aimed at preventing and treating severe black lung disease.

Five bills introduced by lawmakers would make it easier to make qualify for state benefits and provide benefits to miners who have early-stage black lung.

The bills come at a time when the Ohio Valley is facing a surge in cases of severe black lung disease, also called Progressive Massive Fibrosis.

“We’re here because so many of the people that’s worked years and years years, 30, 35 years in the mines, and been exposed to coal dust their whole life and they fall through the cracks,” said Terry Abbott, president of United Mine Workers of America Local 8843, which represents miners in West Virginia’s Fayette and Kanawha counties.

A miner is tested for lung function and signs of black lung disease. Photo: Coal Miners Respiratory Clinic

We’re here to support all the miners that should be receiving compensation for the the years they put in the mines.”

Black lung is caused by exposure to coal dust and the debilitating and progressive disease has no cure. The state and federal government both have benefits systems that allow miners to make a claim against their employer for medical expenses and a small stipend.

Advocates and miners argue access to health and financial benefits increases the likelihood sufferers can seek medical treatment.

Getting those benefits through federal or state programs can be challenging, and recent changes on the state level has  made it tougher for miners to qualify.

Obstacles To Benefits

Kentucky lawmakers last year eliminated radiologists from the process miners use to qualify for benefits. In West Virginia, a decision by the state Supreme Court made it harder for miners to file a claim.

Now, advocates for black lung victims are rallying behind new legislation in West Virginia which they say can help sick miners. Kentucky representatives have also proposed a bipartisan bill that would repeal the state’s 2018 law that limits which doctors can evaluate black lung workers compensation claims.

One bill in West Virginia with bipartisan support is Senate Bill 260. Co-sponsored by two doctors, it would change the law to allow miners to receive partial disability awards if they are diagnosed with the disease. Miners diagnosed with early-stage black lung would qualify for 20 weeks of benefits.

Members of the Southeastern Kentucky Black Lung Association light candles in memory of those lost to the disease. Photo: Benny Becker, Ohio Valley ReSource

Miners would only have to have X-rays that show the presence of severe black lung disease, not a diagnosis that the disease has yet impacted their health.

Supporters of the bill argue that because black lung is progressive, there is no doubt symptoms will worsen. Providing some benefits to miners early on may boost their ability to seek treatment or assist in re-training to allow early career miners to find other employment and limit coal dust exposure.

Benefits Boost

Another bill, Senate Bill 144, would create a state black lung program that would provide $300 in monthly benefits for West Virginia miners with at least 10 years of coal dust exposure.

“We want to simplify the black lung program here in West Virginia, so the state can take care of its own, give them what they’re due, what they’re entitled to and what they’ve worked for,” said Charles Dixon, with UMWA Local 1440 in Matewan, West Virginia.

He was one of dozens of miners who rallied at the Capitol Wednesday in support of the black lung bills.

A third bill, House Bill 2588, would challenge the recent West Virginia Supreme Court decision that made it harder for miners to file a state workers’ compensation case. It stipulates a person seeking an evaluation from the state Occupational Pneumoconiosis Board can do so at any time regardless of the time limits set to file a claim and that insurance carriers must pay for the exam.

The bills have not yet advanced to a floor vote.

Dave Mistich of ReSource partner station WVPB contributed to this story. This article was originally published by Ohio Valley ReSource.

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OxyContin Maker Explored Expansion Into “Attractive” Anti-Addiction Market

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Protestors leave pill bottles outside the headquarters of Purdue Pharma in Stamford, Connecticut. Photo: AP Photo, Jessica Hill

Secret portions of a lawsuit allege that Purdue Pharma, controlled by the Sackler family, considered capitalizing on the addiction treatment boom — while going to extreme lengths to boost sales of its controversial opioid.

Not content with billions of dollars in profits from the potent painkiller OxyContin, its maker explored expanding into an “attractive market” fueled by the drug’s popularity — treatment of opioid addiction, according to previously secret passages in a court document filed by the state of Massachusetts.

In internal correspondence beginning in 2014, Purdue Pharma executives discussed how the sale of opioids and the treatment of opioid addiction are “naturally linked” and that the company should expand across “the pain and addiction spectrum,” according to redacted sections of the lawsuit by the Massachusetts attorney general. A member of the billionaire Sackler family, which founded and controls the privately held company, joined in those discussions and urged staff in an email to give “immediate attention” to this business opportunity, the complaint alleges.

ProPublica reviewed the scores of redacted paragraphs in Massachusetts’ 274-page civil complaint against Purdue, eight Sackler family members, company directors and current and former executives, which alleges that they created the opioid epidemic through illegal deceit. These passages remain blacked out at the company’s request after the rest of the complaint was made public on Jan. 15. A Massachusetts Superior Court judge on Monday ordered that the entire document be released, but the judge gave Purdue until Friday to seek a further stay of the ruling.

The sections of the complaint already made public contend that the Sacklers pushed for higher doses of OxyContin, guided efforts to mislead doctors and the public about the drug’s addictive capacity, and blamed misuse on patients.

Citing extensive emails and internal company documents, the redacted sections allege that Purdue and the Sackler family went to extreme lengths to boost OxyContin sales and burnish the drug’s reputation in the face of increased regulation and growing public awareness of its addictive nature. Concerns about doctors improperly prescribing the drug, and patients becoming addicted, were swept aside in an aggressive effort to drive OxyContin sales ever higher, the complaint alleges.

Among the allegations: Purdue paid two executives convicted of fraudulently marketing OxyContin millions of dollars to assure their loyalty, concealed information about doctors suspected of inappropriately prescribing the opioid, and was advised by global consulting firm McKinsey & Co. on strategies to boost the drug’s sales and burnish its image, including how to “counter the emotional messages” of mothers whose children overdosed. Since 2007, the Sackler family has received more than $4 billion in payouts from Purdue, according to a redacted paragraph in the complaint.

“The payments were the motivation for the Sacklers’ misconduct,” the complaint says. “And the payments were deliberate decisions to benefit from deception in Massachusetts, at great cost to patients and families.”

In 1998, two years after OxyContin was launched, Dr. Richard Sackler, a son of Purdue co-founder Raymond Sackler, instructed executives in an email that its tablets were not merely “therapeutic” but also “enhance personal performance,” like Viagra. Fifteen years later, he complained in another email that a Google alert he set up for OxyContin news was giving him too much information about the drug’s dangers.

“Why are all the alerts about negatives and not one about the positives of OxyContin tablets?” he asked a company vice president. Staff immediately offered to replace Sackler’s alert with a service that supplied more flattering stories, according to the complaint.

The redacted paragraphs leave little doubt about the dominant role of the Sackler family in Purdue’s management. The five Purdue directors who are not Sacklers always voted with the family, according to the complaint. The family-controlled board approves everything from the number of sales staff to be hired to details of their bonus incentives, which have been tied to sales volume, the complaint says. In May 2017, when longtime employee Craig Landau was seeking to become Purdue’s chief executive, he wrote that the board acted as “de-facto CEO.” He was named CEO a few weeks later.

n a statement today in response to questions about the redacted material, the company said that Massachusetts “seeks to publicly vilify Purdue, its executives, employees and directors by taking out of context snippets from tens of millions of documents and grossly distorting their meaning. The complaint is riddled with demonstrably inaccurate allegations.”

Purdue acknowledged in the statement that it was considering acquiring the rights to sell drugs that combat addiction or reverse the effects of an overdose. It criticized the state for “casting in a negative light” the company’s exploration of a potential acquisition of an addiction treatment that was already on the market, “even though the company never actually made the acquisition.”

Purdue also pointed out that OxyContin is approved by the Food and Drug Administration. It said that most opioid overdoses “now result from heroin and illicit fentanyl.”

The Sackler family was once best known for its philanthropy. Its name is engraved on museums and university buildings across the world. A group of activists has called on organizations to stop accepting Sackler donations and for the family name to be stripped from some institutions. Aggressive marketing of OxyContin is blamed by some analysts for propelling the crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.

After its 1996 launch, OxyContin rapidly became a top seller. But reports of patients abusing the drug soon followed. OxyContin contained more pain relief medication than older drugs, and crushing and snorting it was a simple way to get high fast. In 2007, Purdue pleaded guilty to federal charges of understating the risk of addiction and agreed to pay $600 million in fines and penalties. Still, the company argued publicly that OxyContin has “done far more good than harm,” and it sought to place responsibility for the bad acts on “certain of its supervisors and employees.”

Privately, the complaint suggests, the Sacklers were concerned about alienating two executives, then-CEO Michael Friedman and then-legal counsel Howard Udell. Friedman and Udell each pleaded guilty in 2007 in U.S. District Court in Abingdon, Virginia, to a misdemeanor charge of misbranding OxyContin, as did a former executive. The board signed off on the three executives’ decisions to plead guilty. No member of the Sackler family pleaded guilty.

Purdue paid $5 million to Udell in November 2008, and up to $1 million in November 2009, the complaint states. In February 2008, the company paid $3 million to Friedman. The complaint doesn’t mention any payments to the former executive.

“The Sacklers spent millions to keep the loyalty of people who knew the truth,” the complaint alleges.

Udell died in 2013. A person answering a phone number listed to Friedman declined comment.

The plea deals did little to hinder OxyContin sales or the Sacklers’ hands-on management. At the direction of the board, Purdue repeatedly increased its sales force, which pushed doctors to prescribe higher opioid doses.

Protesters outside the headquarters of Purdue Pharma on Aug. 17, 2018. Photo: AP Photo, Jessica Hill

In 2008, the same year that Purdue paid Udell and Friedman, Richard Sackler advised other family members that it was important to select a new chief executive who was loyal to the family. “People who will shift their loyalties rapidly under stress and temptation can become a liability from the owners’ viewpoint,” he allegedly wrote. A defendant in the Massachusetts lawsuit, Richard Sackler served in a number of different positions at the company before being named president in 1999 and then co-chairman of the board in 2003.

The company did install five new, non-family board members in the wake of the federal investigation. But in hundreds of board votes, the new directors never opposed the family, according to the complaint. Although Purdue does not operate outside the U.S., board meetings took place at a castle in Ireland as well as in Bermuda, London, Portugal and Switzerland.

When sales results disappointed, Sackler family members didn’t hesitate to intervene. In late 2010, Purdue told the family that sales of the highest dose and most profitable opioids were lower than expected, according to the complaint. That meant an expected quarter-end payout to the family of $320 million was at risk of being reduced to $260 million and would have to be made in two installments in December instead of one in November.

That news prompted a sharp email question from Mortimer D.A. Sackler, whose late father, also named Mortimer, was a Purdue co-founder. “Why are you BOTH reducing the amount of the distribution and delaying it and splitting it in two?” he asked. “Just a few weeks ago you agreed to distribute the full 320 [million dollars] in November.” The complaint doesn’t say how much was ultimately paid.

From 2009 until at least 2014, McKinsey helped Purdue shape its message for selling OxyContin and overcoming concerns about addiction and overdoses, according to redacted passages. The consultant told Purdue in a slide presentation that it could increase prescriptions by convincing doctors that opioids provide “freedom” and “peace of mind” and give patients “the best possible chance to live a full and active life.”

Purdue staff, according to the complaint, told the Sacklers that McKinsey would study “patient pushback” to encourage hesitant doctors to prescribe opioids. In a meeting with Purdue executives, McKinsey planned how to “counter the emotional messages from mothers with teenagers that overdosed in [sic] OxyContin” by recruiting pain patients to talk about the need for the drugs.

In a 2013 report, McKinsey recommended directing sales representatives to focus on the most prolific opioid prescribers because that group writes “25 times as many OxyContin scripts” as less prolific prescribers. Because prescription rates rose in tandem with visits from sales reps to doctors, McKinsey recommended increasing each salesperson’s quota from 1,400 visits a year to closer to 1,700. McKinsey estimated that targeting the most frequent prescribers could boost OxyContin sales by hundreds of millions of dollars. The quotas rose, as did total visits, the complaint states. Purdue said it planned to decrease visits relating to opioid products, and any increase was due to promoting a laxative.

Purdue Pharma headquarters in Stamford, Connecticut. Photo: AP Photo, Jessica Hill

McKinsey also recommended Purdue fight back against efforts by a major pharmacy chain, the U.S. Drug Enforcement Agency and the U.S. Department of Justice to stop illegal opioid prescribing, the complaint states. These new rules were cutting into sales of the highest doses, which were also the most profitable, it says. The complaint doesn’t say if Purdue followed McKinsey’s recommendation. Purdue said the recommendations “actually relate to ensuring continued access to pain medicines for appropriate patients.”

A McKinsey spokesman declined comment.

In September 2014, Purdue embarked on a secret project to join an industry that was booming thanks in part to OxyContin abuse: addiction treatment medication. Code-named Project Tango, it involved Purdue executives and staff as well as Dr. Kathe Sackler, a daughter of the company co-founder Mortimer Sackler and a defendant in the Massachusetts lawsuit. She participated in phone calls and told staff that the project required their “immediate attention,” according to the complaint.

Internally, Purdue touted the growth of an industry that its aggressive marketing had done so much to foster.

“It is an attractive market,” the team working on the project wrote in a presentation. “Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

While OxyContin sales were declining, the internal team at Purdue touted the fact that the addiction treatment marketplace was expanding.

“Opioid addiction (other than heroin) has grown by ~20%” annually from 2000 to 2010, the company noted. Although Richard Sackler had blamed OxyContin abuse in an email on “reckless criminals,” the Purdue staff exploring the new business opportunity described in far more sympathetic terms the patients whom it now planned to treat.

“This can happen to any-one – from a 50 year old woman with chronic lower back pain to a 18 year old boy with a sports injury, from the very wealthy to the very poor,” it said.

Company documents recommended becoming an “end-to-end pain provider.” Initially, Purdue intended to sell one such medication, Suboxone, which is commonly retailed as a film that melts in the mouth. When Kathe Sackler asked staff members to look into reports that children might be swallowing the film, they reassured her. They responded, according to the complaint, that youngsters were overdosing on pills, but not the films, “which is a positive for Tango.”

In 2015, Purdue turned its attention to another potential product, the overdose reversing agent known as Narcan, calling it a “strategic fit.” Purdue executives discussed how its sales force could promote Narcan to the same doctors who prescribed the most opioids. Purdue said in the statement Wednesday that it decided against acquiring the rights to sell Suboxone and Narcan.

While those initiatives appear to have stalled or ended, Richard Sackler received a patent last year for a drug to treat addiction, according to the complaint. The patent application states that opioids are addictive and refers to people who suffer from substance use disorders as “junkies.”

Besides being a defendant in the Massachusetts case, Richard Sackler was deposed in a lawsuit against Purdue in Kentucky, which the company settled. It’s believed to be the only time a member of the family has been questioned under oath about OxyContin and its addictive properties. The Kentucky Court of Appeals has ordered the release of his deposition, in response to a motion by STAT, but Purdue is asking the state Supreme Court to review the ruling. Hundreds of other lawsuits filed by states, cities, counties and tribes against Purdue have been consolidated in a pending case in federal court in Ohio.

The Massachusetts complaint cites multiple incidents of Purdue allegedly sitting on information, sometimes for years, about doctors it had reason to believe were inappropriately prescribing OxyContin. In 2012, a Purdue employee appealed to the company’s head of sales to alert health insurers to data the company collected about doctors suspected of abusing or illegally prescribing OxyContin. The list of doctors was code-named Project Zero.

“At a basic level, it just seems like the right and ethical thing to do,” the employee wrote. “Doing so could help those companies identify those physicians that may be of a concern, not just with respect to our products, but also other” pain medications. “As a result, if it reduces abuse and diversion of opioids then it seems like something we should be doing.”

The idea was rejected and the employee left the company a month later, according to the complaint.

This story was co-published with STAT. It was originally published by ProPublica.

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West Virginia Research Reveals Disparity in Infant Mortality Rates

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Dr. Lauri Andress, an assistant professor at the West Virginia University School of Public Health, speaks about infant mortality issues during the Mountain State Racial Justice Summit, Saturday, at the BridgeValley Community and Technical College in South Charleston. Photo: Chris Dorst, Gazette-Mail

In West Virginia, it is 1.7 times more likely for a black infant to die before their first birthday, compared to a white infant.

This is one of the figures that came from Dr. Lauri Andress’ research on infant mortality.

At first, Andress, an assistant professor in the West Virginia University School of Public Health, struggled to find state-specific data on the issue, she said during a presentation at the Mountain State Racial Justice Summit, held at BridgeValley Community and Technical College’s South Charleston campus in West Virginia.

Each state is required to submit raw data of infant mortality rates to the Centers for Disease Control and Prevention. Some can request an analysis back, but Andress said West Virginia did not because the state has such a small population of African-Americans.

“That’s a factual statement by a statistician that I would expect, but it’s not a statement by your state government that you should stand for,” Andress said. “Because there are ways to think about minorities in the state and get at that analysis.”

Andress worked with CityMatCH, a Nebraska-based public health organization, to use those raw numbers to create an analysis. What that report found was that even though black infants account for only 4 percent of births, they make up 6 percent of infant deaths in the state.

Initially her research wasn’t about minority health, but she said the lack of attention the subject was receiving made her want to look into it more.

“I wasn’t until I got here and found out that African-Americans were not on the agenda in West Virginia that I became passionate about it,” she said. “I can go anywhere else in the United States and they will talk about African-Americans.”

She said other states that also don’t have large minority populations have created reports, adding that it’s not impossible, rather a matter of political will.

West Virginia has a law that requires the state to look into infant and maternal deaths, specifically infant deaths that occur before one year of age. This state law requires the health department to investigate and put together panels for other suspicious deaths, such as opioid and other drug abuse deaths.

There are national standards that must be adhered to while investigating infant deaths, including that the mother or family members are interviewed, according to the National Center for Fatality Review and Prevention.

There are numerous reasons to interview the mother, Andress said. For example, the mother would be able to speak about her experience during the pregnancy and the prenatal care she received.

“There’s things you can’t get from the four corners of a death record,” Andress said. “If they interviewed mothers, we would at least know if there was a difference in what was happening to black moms and white moms that would make a difference in the percentage of black-versus-white infant deaths.”

Andress said there are two reasons she suspects the state might not do that. One is that it can be difficult to get grieving families and mothers to agree to talk, she said. Another reason is because of privacy laws.

“But you’re still up against a national standard and it’s the recommendation that when you’re trying to understand why infants are dying in your region, you’ll do an interview,” she said.

Even when black women have an education and high levels of income, their infants are still dying, but it’s not clear why, Andress said.

Another possible solution, she said, would be to create specialized panels in regions where there is a higher percentage of black women living. She said there is one panel at the state level that convenes in Charleston, but she said that they are overworked.

She adds that this problem is not unique to the Mountain State. Nationally, twice as many black infants die before they reach their first birthday, according to the National Birth Equity Collaborative, and in some cities, the rate of black infant mortality is three-times the national average.

“To understand this issue we need to look at the lives of these women,” Andress said. “This is a historical problem, it doesn’t matter where you are, it’s something that is happening everywhere.”

This article was originally published by the Charleston Gazette-Mail

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