Roni Caryn Rabin

In hospitals around the world, the snakelike duodenoscope is regarded as an indispensable tool for diagnosing and treating diseases of the pancreas and bile ducts.

But these fiber-optic devices have a remarkable drawback: Although they are inserted into the upper part of the small intestine through the mouth and constantly reused, they cannot be sterilized by the usual methods.

Instead, they are hand-scrubbed and then put through dishwasherlike machines that use chemicals to kill microorganisms. Even when cleaned as instructed, the devices may still retain bacteria that can be transmitted to patients.

As a result, duodenoscopes have sickened hundreds of patients in hospitals in the United States and Europe. Recent testing now suggests regulators severely underestimated the risks. Worse, the devices have been shown to be capable of transmitting antibiotic-resistant infections that are almost impossible to cure.

Alarmed medical experts are urging the Food and Drug Administration to force the manufacturers to develop scopes that can be properly sterilized — or to take all duodenoscopes off the market.

“The infection data are overwhelming and irrefutable, and the need is urgent,” William A. Rutala, director of the statewide program for infection control and epidemiology at the University of North Carolina, said in an email.

Recent tests performed by the manufacturers at the demand of the FDA found that 1 in 20 duodenoscopes retained disease-causing microbes like E. coli even after proper cleaning.

The agency had expected that fewer than 1 in 200 would retain bacteria after cleaning. Dr. David Jay Weber, medical director of the statewide program at UNC, said the finding was “astounding” and called on the FDA to set a deadline for manufacturers to fix the problem.

“Would you go on an airplane if the pilot said, ‘By the way, there is a 5% chance the engines will fail?’” Weber said. “Would you go in a car if the manufacturer said, ‘There are air bags, but 5% of the time they won’t deploy?’”

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, suggested the agency may take additional regulatory action. “Improvements are necessary,” he said in a statement in April. No action has yet been taken, however.

Hidden Defects

Duodenoscopes are long, flexible tubes with a fiber-optic camera at one end. The tube is inserted through the patient’s mouth and stomach, then into the first part of the small intestine, called the duodenum.

The procedure, called endoscopic retrograde cholangiopancreatography, is used to diagnose and treat diseases of the pancreas, bile duct and gallbladder, such as life-threatening jaundice, tumors, blocked bile ducts and stones. More than half a million such procedures are performed each year in the United States.

The alternative is open surgery, which carries its own risks, said Dr. Bret Petersen, a gastroenterologist at Mayo Clinic in Rochester, Minnesota. “Taking a gallstone out surgically would be almost unheard of today,” he said.

But the inability to properly clean the instrument between patients has proved to be its “Achilles heel,” he added. The devices cannot be exposed to high heat to be sterilized, as many instruments are.

It is difficult to clean the narrow inner tubing by hand, and duodenoscopes, unlike other endoscopes, have a movable elevatorlike mechanism at the tip that can be manipulated to adjust the position of surgical instruments.

The mechanism makes the scope more versatile but also more difficult to clean, as it contains microscopic crevices where bodily fluids and bacteria can lodge.

Olympus Medical Systems Corp., Pentax of America and Fujifilm Medical Systems USA manufacture most of the duodenoscopes in use in the United States, with the lion’s share made by Olympus. Until recent hospital outbreaks, the FDA had never asked to review manufacturers’ data about cleaning the complex instruments.

The agency allows many medical devices onto the market without subjecting them to the kind of safety and effectiveness testing required for new drugs if the devices are deemed “substantially equivalent” to a medical device already on the market. It is the manufacturer’s responsibility to make sure the new device works properly — and that it can be properly cleaned between uses.

The manufacturers claim that as long as health facilities clean and disinfect the devices according to the instructions — a complicated process that can involve more than 100 steps, including visual inspections to check that no “soil or debris is visible” after cleaning — duodenoscopes are safe for patients.

The instructions also say devices should be returned to the manufacturer once a year for service and maintenance.

Since 2012, however, hundreds of patients in the United States and Europe have been infected in dozens of outbreaks linked to contaminated duodenoscopes. Among the infectious agents is carbapenem-resistant Enterobacteriaceae, bacteria that do not respond to a powerful class of antibiotics. The infection has a 50% mortality rate.

More than 30 patients in Seattle were infected with resistant strains of bacteria such as CRE by duodenoscopes between 2012 and 2014, and 11 died, though many were already critically ill. Dozens of patients at a Park Ridge, Illinois, hospital were infected with CRE in 2013.

In 2015, two patients died and five were sickened after being infected with CRE during procedures involving duodenoscopes at the Ronald Reagan UCLA Medical Center in Los Angeles.

Recently, doctors in Boston reported the first known transmission of a microorganism resistant to colistin, a last-resort antibiotic, through a duodenoscope that had been cleaned according to the manufacturer’s guidelines and FDA recommendations.

When the scope was sent back to the manufacturer and taken apart, an internal defect was discovered that left the dangerous bacteria clinging to the instrument. The manufacturer, Pentax, recalled the defective devices last year.

“There is really no way we could have been able to pick up on these internal defects — that’s one of the main takeaways of this story,” said Dr. Erica S. Shenoy, associate chief of infection control at Massachusetts General Hospital.

An FDA advisory panel called for sterilization of duodenoscopes four years ago, when the outbreaks first came to light. Today, steam heat — the gold standard for cleaning and sterilization — can still damage the scopes, creating cracks where bacteria can lodge and necessitating more frequent replacements.

In February 2015, the FDA asked manufacturers to analyze the contamination rates of their devices. But so far, manufacturers have only completed about 60% of the required sampling. One of the smaller companies has only completed 15% of the required tests.

Single-Use Scopes

The flurry of infection outbreaks puts patients, hospitals and health care providers in a quandary.

Modern medicine relies extensively on duodenoscopes and other flexible tubular “scopes” with cameras at the tips — including bronchoscopes to check the lungs and colonoscopes to screen for colon cancer — to diagnose and treat diseases without surgery.

Alternatives to scoping are limited and include substitute medical tests and procedures, like stool tests that screen for colon cancer in lieu of colonoscopies. (Scopes used for colon cancer screening are considered much less risky, however, since they are used in a part of the body already teeming with bacteria.)

New low-temperature sterilization technologies may make it possible to disinfect scopes more effectively. And it is possible to manufacture disposable scopes that could be discarded after a single use.

Single-use bronchoscopes already are making their way to market, although they are not expected to replace reusable scopes. But there is no disposable duodenoscope.

The rising prevalence of superbugs — life-threatening germs that are resistant to powerful antibiotics — has heightened the sense of urgency.

“As long as organisms were susceptible to antibiotics, there really wasn’t a problem, because even if the scopes were transmitting bacteria, you give patients antibiotics prophylactically before and after procedures, and you take care of it,” said Larry Muscarella, a health care consultant who scours medical device reports submitted to the FDA and has often been the first to identify infection risks.

But prophylactic antibiotics no longer guarantee protection. A rise in antibiotic-resistant infections worldwide is nearing a crisis point: The persistent misuse and overuse of antibiotics in people, plants and farm animals has led to the proliferation of bacteria that resist treatment to most available antibiotics.

The World Health Organization has called the growth in antibiotic-resistant disease one of the most significant threats to global health. The design of duodenoscopes makes them particularly susceptible to harboring these and other bacteria.

But the risk to any given patient is small, and duodenoscopes are not significant factors in the rise of drug-resistant bacteria, said Dr. Alexander J. Kallen, an epidemiologist at the Centers for Disease Control and Prevention.

“It’s more of a public health concern than a concern for the individual patient,” he said. “The majority of people who get exposed to a scope contaminated with bacteria don’t suffer an adverse consequence.”

“For most patients, it’s a risk they should absolutely be aware of,” Kallen added. “But in most situations the benefits of the procedure probably outweigh the risks of an adverse event.”

The controversy has raised concerns about the safety of other reusable, flexible “scopes,” all of which have long, closed channels that are difficult to clean, let alone sterilize.

The FDA warned health care providers in 2015 that bronchoscopes, which are used to examine the lungs, had been linked to more than 100 infections and might remain contaminated even after proper cleaning.

Late last year, researchers inspected two dozen bronchoscopes that had been cleaned and disinfected at three medical centers and found that all retained “residual contamination” after the cleaning process, including pathogens like mold and E. coli.

All 24 bronchoscopes had irregularities apparent to the naked eye, including residues, retained fluid, scratches and other damage. An accompanying editorial said the results were alarming and that the pulmonology community had “buried its head in the sand regarding this issue.”

In January, researchers at the University of Pittsburgh reported on a cluster of intensive care unit patients whose drug-resistant infections were all traced back to a single bronchoscope.

Ambu, a Danish company, is already marketing a disposable bronchoscope, officials said. The company also is testing a disposable colonoscope. It anticipates having additional endoscopes — including a disposable duodenoscope — on the market in the United States by 2020.

Though many hospitals in the United States have purchased single-use bronchoscopes, Ambu’s former chief executive, Lars Mercher, said the company encountered resistance to disposables when the product was launched.

“It was hard to even get acceptance for the idea that there was contamination in the hospital,” he said.

This article originally appeared in <a href="https://www.nytimes.com/2019/08/06/health/duodenoscopes-infections-hospitals-antibiotics.html" id="0395c9f9-26dc-383e-a9e8-55ecdd35664d">The New York Times</a>.

These Medical Devices Are Inserted Into 500,000 Patients Each Year -- but Are Tough to Sterilize

(Science Times)

They declared that they love him and praised his work to protect the environment. “However, on vaccines he is wrong,” they wrote in a column published in Politico under the headline: “RFK Jr Is Our Brother and Uncle. He’s Tragically Wrong About Vaccines.”

Kennedy’s sister, Kathleen Kennedy Townsend, a former lieutenant governor of Maryland; his brother, Joseph P. Kennedy II, a former Massachusetts congressman; and his niece, Maeve Kennedy McKean, executive director of Georgetown University’s Global Health Initiatives, criticized him for participating in social media campaigns that have stoked fear and mistrust of vaccines and for attacking public health institutions seeking to stem the spread of infectious diseases.

Robert Kennedy, an attorney, author and environmental activist, could not immediately be reached for comment. Lara Bono, a spokeswoman for a group he leads, Children’s Health Defense, said Kennedy was occupied with a court case Wednesday but plans to make a statement and respond to questions.

Robert Kennedy is chairman of the board of Children’s Health Defense. Its website ties the increase in chronic childhood conditions such as asthma, autism and diabetes to a range of factors, including environmental toxins, pesticides and vaccines.

The group links to information and videos that blame vaccines for food allergies; claim that vaccines against diphtheria, pertussis and tetanus are killing people; and charge that media coverage of the current measles outbreak has been “orchestrated” by the World Health Organization.

In their column, Kennedy’s relatives took a tempered tone for the most part, but noted that researchers have concluded there is no link between vaccines and autism, and that their family has had a long-standing commitment to vaccination as a critical tool for improving public health.

They pointed out that President John F. Kennedy in 1961 urged Americans to take advantage of a new “miraculous” polio vaccine; in 1962, he signed the Vaccination Assistance Act to help ensure all American children were immunized.

“On this issue, Bobby is an outlier in the Kennedy family,” they wrote.

The United States is now experiencing the worst measles outbreak since the disease was declared eliminated in the U.S. in 2000. As of Monday, 764 cases had been identified in 23 states, most of them in people who were never vaccinated.

Government health officials have made an urgent plea to parents to vaccinate their children if they have not already done so, and they are urging Americans to be immunized before traveling overseas.

Robert Kennedy’s relatives wrote that his anti-vaccine messages are having “heartbreaking,” and even deadly, consequences.

This article originally appeared in <a href="https://www.nytimes.com/2019/05/08/health/vaccines-kennedy-measles.html" id="659f44f5-0d6e-3b6f-ad31-f653cd332231">The New York Times</a>.

A brother, sister and niece of Robert F. Kennedy Jr. on Wednesday chastised him for campaigning against vaccines, saying he has been disseminating “dangerous misinformation” that discourages immunization even as measles spreads throughout the United States.

Robert F. Kennedy Jr.'s Brother and Sister Accuse Him of Spreading Misinformation on Vaccines

The racial disparity has persisted, even grown, for years despite frequent calls to improve access to medical care for women of color. Sixty percent of all pregnancy-related deaths can be prevented with better health care, communication and support, the researchers concluded.

“Ensuring quality care for mothers throughout their pregnancies and postpartum should be among our nation’s highest priorities,” said Robert R. Redfield, director of the CDC. “I urge the public health community to increase awareness with all expectant and new mothers about the signs of serious pregnancy complications and the need for preventive care that can and does save lives.”

Maternal health among black women has emerged as an issue in the 2020 presidential campaign. Sen. Kamala Harris, D-Calif., and Sen. Elizabeth Warren, D-Mass., have both raised the glaring racial discrepancy in maternal outcomes on the campaign trail.

“Everyone should be outraged this is happening in America,” Harris said on Twitter, blaming the deaths on racial bias in the health system.

The American College of Obstetricians and Gynecologists, which was not involved in the CDC report, recently acknowledged that racial bias within the health care system is contributing to the disproportionate number of pregnancy-related deaths among minority women.

“We are missing opportunities to identify risk factors prior to pregnancy, and there are often delays in recognizing symptoms during pregnancy and postpartum, particularly for black women,” Lisa Hollier, immediate past president of the American College of Obstetricians and Gynecologists, said in a statement.

The United States has an abysmal record on maternal health, compared with other high-income countries. Even as maternal death rates fell by more than one-third from 2000 to 2015 across the world, outcomes for U.S. mothers worsened, according to UNICEF.

The CDC examined pregnancy-related deaths in the United States from 2011 to 2015 and also reviewed more detailed data from 2013 to 2017 provided by 13 states’ maternal mortality review committees.

The agency found that black women were 3.3 times more likely than white women to suffer a pregnancy-related death; Native American and Alaska Native women were 2.5 times more likely to die than white women.

Obstetric emergencies involving complications like severe bleeding caused most of the deaths at delivery. But cardiovascular disease — not typically associated with a young pregnant women — was a leading cause of pregnancy-related deaths.

Heart disease and strokes caused more than one-third of pregnancy-related deaths, the CDC found. Cardiac disease, which disproportionately affects black women, may be present in a woman before pregnancy but also can be acquired during pregnancy, which doctors say acts as a sort of “stress test.”

If heart disease goes undetected, it may become acute after the baby is born. Indeed, a greater proportion of the deaths among black women occurred in the later postpartum period, between seven weeks and a year after the delivery, compared with white women, the CDC found.

“When we look at the proportion of pregnancy-related deaths by cause, the proportion due to cardiomyopathy has been increasing,” Hollier said. “It can occur in all women, but it is more common among black women.”

One of the surprises in the new report was how often death occurred after childbirth. More than half of pregnancy-related deaths occurred after the day of the delivery, and the heightened risk to a new mother persisted for as long as a year.

Concern about high pregnancy-related death rates among black women has already resulted in some changes in policy. The American College of Obstetricians and Gynecologists this week released new guidelines for treating heart disease during pregnancy.

The standard postpartum doctor visit for new mothers is typically scheduled for six weeks after delivery. The group now says that postpartum care should be an ongoing process, rather than a single appointment, and that services and support should be tailored to the woman’s individual needs.

Women should have some contact with a care provider within the first three weeks postpartum and a comprehensive visit no later than 12 weeks after birth. Women who qualify for Medicaid, the government health care program for low-income people, because they’re pregnant often lose coverage 60 days after giving birth.

The CDC, however, found that 18.5% of pregnancy-related deaths occurred one to six days postpartum, and that 21.4% of these deaths occurred between the seventh and 42nd days after delivery.

A new federal law, the Preventing Maternal Deaths Act, provides grants to states that investigate pregnancy-related deaths, including deaths occurring up to a year after the birth.

This article originally appeared in <a href="https://www.nytimes.com/2019/05/07/health/pregnancy-deaths-.html" id="1c7468ad-4320-3ee0-aea2-9d868baf7807">The New York Times</a>.

Huge Racial Disparities in Deaths Linked to Pregnancy

African-American, Native American and Alaska Native women die of pregnancy-related causes at a rate about three times higher than those of white women, the Centers for Disease Control and Prevention reported Tuesday.

Sixty percent of all pregnancy-related deaths can be prevented with better health care, communication and support, the researchers concluded.

The agency found that black women were 3.3 times more likely than white women to suffer a pregnancy-related death; Native American and Alaska Native women were 2.5 times more likely to die than white women. More than half of these deaths were preventable, regardless of race or ethnicity.

Heart disease and strokes caused more than one-third of pregnancy-related deaths, the CDC found.

The lawsuit, filed by state Attorney General Letitia James, is one of the very few in a wave of opioid litigation across the country that name the Sacklers. It targets eight family members: Richard, Jonathan, Mortimer, Kathe, David, Beverly and Theresa Sackler, as well as Ilene Sackler Lefcourt.

The Sacklers are one of the richest families in the United States, known for their generous philanthropy in the arts. But they have come under increasing scrutiny after new documents came to light in a Massachusetts case suggesting that some family members helped direct misleading marketing efforts for OxyContin and ignored evidence that the drug was being abused.

Over the past several weeks, a number of cultural institutions in the United States and abroad have said they will no longer accept the family’s money.

The lawsuit, filed in New York state Supreme Court in Suffolk County, seeks to recover the state’s costs for unnecessary prescriptions and related health care expenses, along with financial penalties.

The suit also seeks to claw back funds that it alleges were transferred from Purdue Pharma to private or offshore accounts held by members of the Sackler family in an effort to shield the assets from litigation; to order the Sacklers to return any transferred assets; and to restrain them from disposing of any property.

A spokesman for Purdue Pharma said the company and its former directors “vigorously deny” the charges set forth in the complaint, and will defend themselves against the “misleading allegations.”

A spokesman for the Sackler family called the allegations “a misguided attempt to place blame where it does not belong for a complex public health crisis. We strongly deny these allegations, which are inconsistent with the factual record, and will vigorously defend against them.”

Over the past two decades, more than 200,000 people have died in the United States from overdoses involving prescription opioids, according to the Centers for Disease Control and Prevention. About 200,000 more have died from overdoses involving illegal opioids, like heroin.

In New York state, where prescriptions for opioids increased ninefold between 2000 and 2011, opioid-related deaths have more than doubled since 2013, the lawsuit said. Nine New Yorkers die each day.

The New York lawsuit alleges that Sackler family members methodically went about erasing a paper trail that could reveal Purdue’s profits. The complaint, which is heavily redacted, charges that they abolished quarterly reports, insisted that numbers be recounted only orally to board members, and voted to pay themselves millions of dollars, often through offshore companies.

In 2007, while Purdue was being investigated by federal prosecutors, the family created a new company to sell opioids, called Rhodes, which a former Purdue official said was specifically set up as a “landing pad” for the Sacklers because of the crisis surrounding OxyContin, according to the lawsuit.

Rhodes, which is owned by trusts benefiting the Sacklers and is overseen by members of the family, started selling generic opioids in 2009, the lawsuit says. By 2016, Rhodes had a far greater share of the opioid market than did Purdue, according to a Financial Times article quoted by the lawsuit.

“Whereas the Sacklers have reduced Purdue’s operations and size, Rhodes continues to grow and sell opioids for the benefit of the Sackler families,” the legal complaint said.

By 2014, fearing that Purdue could face catastrophic financial judgments, the Sacklers directed Purdue to pay family members hundreds of millions of dollars a year in distributions, sending money to offshore companies, the lawsuit claims, an act of clear “bad faith.”

As a result of these distributions, the lawsuit says, “assets are no longer available to satisfy Purdue’s future creditor, the state of New York.”

The complaint takes a skeptical view of recent reports that the company is considering filing for bankruptcy. It charges that the company is actually conducting “a well-thought out and deliberate media campaign to intimidate the litigating states, including New York, by threatening to commence bankruptcy proceedings.”

The lawsuit also goes well beyond other cases in spelling out in granular detail how pharmaceutical distributors played a role in the opioid epidemic by ignoring blatant “red flags” that indicated mountains of opioids were being diverted for illegal use.

The distributors — Cardinal, McKesson and Amerisource Bergen — are far less known than opioid makers and retailers, but they are among the wealthiest companies in the United States. (The lawsuit says all three are in the top 20 in terms of revenue.)

Distributors buy drugs in bulk from manufacturers and then sell them to pharmacies and other distributors, such as clinics. They are legally bound to monitor the quantities sold to each vendor and alert regulators if the amounts seem excessive.

The suit (which also names a regional distributor, Rochester Drug) alleges that the distributors turned “a collective blind eye as orders for opioids in New York skyrocketed” and drugs known to be dangerous “came to be dispensed like candy.”

Rather than alerting regulators, the suit alleges, the distributors warned pharmacies when their monthly opioid limits were approaching, then helped them manipulate the timing and volume of orders to circumvent the limits. And on the rare occasion when a distributor would conduct “surprise” audits of its customers, the complaint says, it would often alert them in advance.

A spokeswoman for McKesson said the company would not issue a statement in response to the lawsuit, but has stated in the past that it is deeply concerned about the opioid epidemic and continuously enhancing programs to detect and prevent illicit diversion and sales of controlled substances.

The other distributors were not immediately available for comment. In response to previous lawsuits, they have expressed regret for the epidemic, denied direct responsibility and noted that the opioids in question are federally approved prescription medications.

The lawsuit alleges that Cardinal Health — which distributed 780 million oxycodone pills to its New York state customers between 2010 and 2018 — appointed people with no experience to key compliance positions and gave them no training.

The company fired employees who alerted executives to pharmacies who repeatedly requested excessive orders, and even, for a time, did away with written site visit reports, according to the suit.

One drugstore in Suffolk County was in the 99th percentile of opioid sales in the state from 2011 through the first quarter of 2018, the complaint said; Cardinal reported an average of 85 suspicious orders a year from the pharmacy. Still, in 2018, the drugstore continued to receive opioids from Cardinal.

The lawsuit amends an earlier suit New York state filed against Purdue Pharma, the company considered primarily responsible for unleashing the current opioid epidemic by misleading doctors about the OxyContin’s dangers and ignoring evidence that the drug was being abused.

The lawsuit adds other opioid manufacturers, including Janssen Pharmaceuticals, a subsidiary of Johnson &amp; Johnson; Mallinckrodt; Endo Pharmaceuticals; Teva Pharmaceuticals; Allergan; and many of their affiliated companies.

New York is one of three dozen states to sue opioid manufacturers, litigation that is separate from the bundle of 1,600 opioid-related federal cases being overseen by a U.S. District Court judge in Ohio, who hopes to help craft a single comprehensive settlement — an objective that may be out of reach.

With the exception of Alabama, which joined the federal consolidation, these states potentially stand to wrest swifter, bigger paydays for their constituents, as long as the states can prove their cases. This week Purdue Pharma and the Sacklers agreed to pay $270 million to settle a case in Oklahoma that was to go to trial in May.

This article originally appeared in <a href="https://www.nytimes.com/2019/03/28/health/new-york-lawsuit-opioids-sacklers-distributors.html" id="2c06260d-7a39-31a7-a19a-9737bc751fdf">The New York Times</a>.

New York Sues Sackler Family Members and Drug Distributors

New York state on Thursday laid out one of the most detailed and sweeping legal cases yet against the family that owns Purdue Pharma, maker of the opioid OxyContin, as well as the companies that distributed alarming amounts of prescription painkillers amid a rising epidemic of abuse that has killed hundreds of thousands of people nationwide.

The legal complaint, released at a news conference by state Attorney General Letitia James, was heavily redacted. Even so, it contains striking details alleging systematic fraud not only by the Sacklers but also by a group of large but lesser-known companies that distributed alarming amounts of prescription painkillers amid a rising epidemic of abuse that has killed hundreds of thousands of people nationwide.

The major pharmaceutical distributors — Cardinal Health, McKesson and Amerisource Bergen — warned pharmacies when their monthly opioid limits were approaching, then helped them manipulate the timing and volume of orders to circumvent the limits, the complaint charged. On the rare occasion when a distributor would conduct “surprise” audits of its customers, it would often alert them in advance, the complaint says.

The suit, filed in New York state Supreme Court in Suffolk County, names eight Sacklers: Richard, Jonathan, Mortimer, Kathe, David, Beverly and Theresa Sackler, as well as Ilene Sackler Lefcourt. It seeks to claw back funds that it alleges were transferred from Purdue Pharma to private or offshore accounts held by family members in an effort to shield the assets from litigation; to order the Sacklers to return any transferred assets; and to restrain them from disposing of any property.

The Sacklers are one of the richest families in the United States, known for their generous philanthropy in the arts. But they have come under increasing scrutiny after new documents came to light in a Massachusetts case suggesting that some family members helped direct misleading marketing efforts for OxyContin and ignored evidence that the drug was being abused. Over the past several weeks, a number of cultural institutions in the United States and abroad have said they will no longer accept the family’s money.

The New York lawsuit alleges that Sackler family members abolished quarterly reports, insisted that numbers be recounted only orally to board members, and voted to pay themselves millions of dollars, often through offshore companies.

It further charges that in 2007, while Purdue was being investigated by federal prosecutors, the family created a new company to sell opioids, called Rhodes, which a former Purdue official said was specifically set up as a “landing pad” for the Sacklers because of the crisis surrounding OxyContin, according to the lawsuit.

The distributors are far less known than opioid makers and retailers, but they are among the wealthiest companies in the United States. (The lawsuit says all three are in the top 20 in terms of revenue.) Distributors buy drugs in bulk from manufacturers and then sell them to pharmacies and other distributors, such as clinics. They are legally bound to monitor the quantities sold to each vendor and alert regulators if the amounts seem excessive.

A spokeswoman for Cardinal Health said the company has a rigorous system in place to flag and report suspicious orders and has enhanced the program over time.

“We report suspicious orders to the federal Drug Enforcement Administration and state regulators, but we do not know what they do with those reports, if anything,” the spokesman said, adding, “Our people operate in good faith, and our goal is to get it right.”

One drugstore in Suffolk County was in the 99th percentile of opioid sales in the state from 2011 through the first quarter of 2018, the complaint said; Cardinal reported an average of 85 suspicious orders a year from the pharmacy yet continued to deliver opioids to the drugstore.

As investigators closed in on Purdue Pharma, maker of the opioid painkiller OxyContin, more than a decade ago, members of the family that owns the company began methodically erasing a paper trail of profits and shifting hundreds of millions of dollars from the business to themselves through offshore entities, the state of New York alleged in a lawsuit Thursday.

The legal complaint, released at a news conference by state Attorney General Letitia James, was heavily redacted. Even so, it contains details alleging fraud not only by the Sacklers but also by a group of companies that distributed alarming amounts of prescription painkillers amid a rising epidemic of abuse that has killed hundreds of thousands of people nationwide.

Over the past two decades, more than 200,000 people have died in the United States from overdoses involving prescription opioids, according to the Centers for Disease Control and Prevention.

The suit names eight Sacklers. It seeks to claw back funds it alleges were transferred from Purdue Pharma to private or offshore accounts held by family members in an effort to shield the assets from litigation; to order the Sacklers to return any transferred assets; and to restrain them from disposing of any property.

A spokesman for the Sackler family called the allegations “a misguided attempt to place blame where it does not belong for a complex public health crisis.”

A spokesman for Purdue Pharma said the company and its former directors “vigorously deny” the charges set forth in the complaint, and will defend themselves.

The New York lawsuit alleges Sackler family members abolished quarterly reports, insisted numbers be recounted only orally to board members, and voted to pay themselves millions of dollars, often through offshore companies.

The suit alleges the distributors turned “a collective blind eye as orders for opioids in New York skyrocketed” and drugs known to be dangerous “came to be dispensed like candy.”

As investigators closed in on Purdue Pharma, maker of the opioid painkiller OxyContin, more than a decade ago, members of the family that owns the company began erasing a paper trail of profits and shifting hundreds of millions of dollars from the business to themselves through offshore entities, the state of New York alleged in a lawsuit Thursday.

The lawsuit, filed by state Attorney General Letitia James, is one of the few in a wave of opioid litigation across the country that name the Sacklers. It targets eight family members.

The Sacklers are one of the richest families in the United States. But they have come under scrutiny after new documents came to light in a Massachusetts case suggesting some family members helped direct misleading marketing efforts for OxyContin and ignored evidence the drug was being abused.

The suit also seeks to claw back funds it alleges were transferred from Purdue Pharma to private or offshore accounts held by members of the Sackler family in an effort to shield the assets from litigation; to order the Sacklers to return any transferred assets; and to restrain them from disposing of any property.

The New York lawsuit alleges that Sackler family members methodically went about erasing a paper trail that could reveal Purdue’s profits. The complaint, which is heavily redacted, charges they abolished quarterly reports, insisted that numbers be recounted only orally to board members, and voted to pay themselves millions of dollars, often through offshore companies.

The lawsuit also goes well beyond other cases in spelling out in detail how pharmaceutical distributors played a role in the opioid epidemic by ignoring blatant “red flags” that indicated mountains of opioids were being diverted for illegal use.

New York state on Thursday laid out one of the most detailed and sweeping legal cases yet against the family that owns Purdue Pharma, maker of the opioid OxyContin, as well as the companies that distributed alarming amounts of prescription painkillers amid a rising epidemic of abuse.

Babies should receive only breast milk or formula, the panel said. Water may be added to the diet at 6 months; infants receiving formula may be switched to cow’s milk at 12 months. For the first five years, children should drink mostly milk and water, according to the guidelines.

Children aged 5 and under should not be given any drink with sugar or other sweeteners, including low-calorie or artificially sweetened beverages, chocolate milk or other flavored milk, caffeinated drinks and toddler formulas.

Plant-based beverages, like almond, rice or oat milk, also should be avoided. (Soy milk is the preferred alternative for parents who want an alternative to cow’s milk.)

In what may come as a shock to parents with pantries full of juice boxes, the panel also said that young children should drink less than a cup of 100% juice per day — and that none at all is a better choice.

The new guidelines were produced by Healthy Eating Research, a nutrition advocacy group, and funded by the Robert Wood Johnson Foundation. The recommendations are likely to be influential, as they have been endorsed by the American Academy of Pediatrics, the Academy of Nutrition and Dietetics, the American Heart Association and the American Academy of Pediatric Dentistry.

The cautions against sweetened beverages arrive amid persistent concerns about childhood obesity, which can set the stage for lifelong chronic illness. About 19% of children in the United States are obese.

“Close to half of all 2- to 5-year-olds in the U.S. drink sugary drinks every day, which we know increases their risk of obesity, diabetes and other health problems,” said Megan Lott, deputy director of Healthy Eating Research.

“These recommendations simplify everything for parents — water, milk and limited amounts of 100% fruit juice,” she added.

Children do not need juice and are better off eating fruit, the panel said. Excessive juice consumption can lead to dental decay and weight gain, and is linked to overall poor nutrition.

“When we talk about empty calories that are consumed through beverages and the number of calories people get from sugar-sweetened drinks, we’re not just talking about soda,” said Dr. Richard Besser, president and chief executive of the Robert Wood Johnson Foundation. “Juice is another source of calories that nutritionally aren’t terrific.”

Recommendations to limit juice are not new: The pediatrics academy has long advised that babies not be given juice till they are a year old, and that the amount of juice be limited to 4 ounces per day for children between ages 1 and 3.

Plant-based milk beverages like almond, oat and rice milk often contain added sweeteners or artificial flavorings, and are less nutritious than cow’s milk, a glass of which contains 8 grams of protein along with nutrients such as calcium.

With the exception of soy milk, plant-based milks are poor in protein. Though they are often fortified, scientists do not know whether people are able to absorb these nutrients as efficiently as those naturally present in other foods.

Formulas marketed for toddlers are usually unnecessary, since most toddlers eat solid food; the products tend to be expensive and often contain added sugars, Lott said.

There is no rigorous data from studies of children about the safety of artificially sweetened drinks and other low-calorie sweetened beverages, she said, and the products can condition a child to prefer sweet drinks generally.

A spokesman for the American Beverage Association, William Dermody, said beverage companies agree that “it’s important for families to moderate sugar consumption to ensure a balanced, healthy lifestyle, and this is especially true for young children."

A spokesman for the Juice Products Association, however, said that for children with limited access to fresh produce, juice can help improve fruit intake. Federal dietary guidelines recognize three-quarters of a cup of 100% juice as equivalent to three-quarters of a cup of fruit.

But many products that appear to contain natural juice may actually contain only a small amount of real juice, experts cautioned, saying parents must read labels carefully.

Children develop preferences for foods and beverages at a young age, and the recommendations are made with an eye to shaping a healthy palate.

About a third of children and adolescents in the United States are overweight or obese, conditions that increase the risk of developing chronic illnesses, such as high blood pressure, high cholesterol, sleep apnea, Type 2 diabetes, heart disease, stroke and some cancers.

“The hope is that through this approach, you’ll help your child develop a taste for what’s good for them,” Besser said. Though the occasional glass of 100% juice is not going to be harmful, “what you want your children as they grow older to be drinking primarily is water.”

The new recommendations are broken down by age group:

Birth to six months: Infants should drink only breast milk or infant formula. They should not drink juice, milk, flavored milk, so-called transition or weaning formulas (also called toddler milks, growing-up milks or follow-up formula), low-calorie sweetened beverages (diet or “light” drinks, or those sweetened with Stevia or Sucralose).

These children also should not receive plant-based and nondairy “milks,” caffeinated beverages (soda, coffee, tea, energy drinks) or sugar-sweetened beverages (soda, fruit drinks and fruit-flavored drinks, sports drinks, energy drinks, sweetened water, and sweetened coffee or tea).

6 to 12 months: Babies should still rely on breast milk or infant formula. Once they have begun eating solid food, they can start sipping water. Parents should avoid juice, milk, flavored milk, transition formulas, low-calorie sweetened beverages, plant-based and nondairy milks, caffeinated beverages, and sugar-sweetened beverages.

12 to 24 months: Children should drink one to four cups of water daily, and they can start drinking plain pasteurized whole milk. They should have no more than 4 ounces of 100% fruit juice per day; the juice may be watered down. Parents should avoid other drinks (flavored milk, transition formulas, caffeinated drinks, plant-based and nondairy milks, sugar-sweetened beverages and low-calorie sweetened beverages).

2 to 3 years old: Toddlers should drink one to four cups of water daily and transition to fat-free or low-fat (1% fat) milk. They should drink no more than 4 ounces of 100% juice and should not be given other drinks.

4 to 5 years old: These toddlers should drink 1.5 to five cups of water a day, skim or low-fat milk, and no more than 4 to 6 ounces of 100% fruit juice. They should not be given other drinks.

This article originally appeared in

What Should Young Children Drink? Mostly Milk and Water, Scientists Say

A panel of scientists issued new nutritional guidelines for children on Wednesday, describing in detail what they should be allowed to drink in the first years of life. The recommendations, among the most comprehensive and restrictive to date, may startle some parents.

The recommendation all but assures the agency will approve the drug, called Palforzia and made by Aimmune Therapeutics. The FDA typically follows the advice of its expert advisory committees.

The drug’s goal is not to cure the allergy, but to reduce the risk that an accidental exposure to small amounts of peanut will trigger a life-threatening reaction. It might also relieve some of the fear and anxiety of many families struggling to cope with a child’s severe peanut allergy.

“This is one of the most important unmet needs of medicine,” James Baker, director of the Mary H. Weiser Food Allergy Center at University of Michigan, told the agency’s advisory committee. He was paid by Aimmune.

The demand for treatment among patients and their families is enormous, Baker noted. “Right now the only approved approach to this allergy is to avoid peanuts, and the amount of effort and cost involved in making sure everything your child is exposed to is peanut-free is overwhelming to most families,” he said.

But even scrupulous efforts to prevent exposures fail, resulting in life-threatening medical emergencies. “Families spend incredible efforts, often altering their entire lifestyle to practice avoidance,” Baker said.

“The quality of life of patients and their caregivers is adversely affected due to fear and anxiety about accidental ingestions,” he added.

The new drug is an oral immunotherapy regimen that aims to reduce sensitivity to peanut allergens. It gradually exposes children to small amounts of peanut protein over the course of six months, until they can safely eat the equivalent of two peanuts.

The treatment does not work for everyone, and it is accompanied by side effects, including severe allergic reactions to the peanut exposure. One in five children who were treated stopped because of side effects; 14% experienced severe allergic reactions, double the percentage in a comparison group receiving a placebo.

The FDA will require Aimmune to restrict use of the drug to patients who agree to carry epinephrine at all times to treat sudden allergic reactions. The agency also will require that the initial doses and increased doses be given at a medical facility capable of treating allergic reactions.

There will be a black-box warning on the package, and Aimmune must warn patients that they still must avoid peanuts.

The regimen begins with trace amounts of the protein, which are carefully measured and increased incrementally under medical supervision as tolerance develops.

About 1.2 million American children have a peanut allergy. These allergies are believed to cause more deaths from anaphylaxis — an acute physiological response that includes lowered blood pressure, shock and constriction of the airways — than any other food allergy, though the precise number is not known.

Because children generally do not outgrow peanut allergies, they must avoid peanuts, peanut oil and foods contaminated with traces of peanuts for their entire lives.

More than a dozen parents traveled to the hearing in Silver Spring, Maryland, with their children to urge the advisory committee to approve the drug, often breaking into tears as they spoke. They recounted how their children’s lives had changed after they took part in the study. (The company paid travel expenses for some of the families.)

Guiliana Ortega, who participated in the Aimmune study, described life as an 8-year-old with a severe peanut allergy: sitting at a separate peanut-free lunch table in the cafeteria, for example, and asking relatives if they have eaten peanuts before giving them a hug.

“It means getting only two friends at lunch instead of 20,” she told the committee. “It means not getting to eat cake at parties, and eating my safe snack while watching others enjoy it.

“It means feeling different all the time,” she said. “It’s a world of no. ‘No, you can’t have that — it may not be safe.’”

Tessa Grosso, 16, a high school junior from Menlo Park, California, told the panel she was allergic to peanuts, dairy and many other foods until she was 10, when she was treated with an early form of oral immunotherapy at Stanford University.

Now, she said, she eats just about anything and has peanut butter every morning before school.

A Food and Drug Administration committee on Friday recommended approval of the first-ever drug to treat life-threatening peanut allergies in children, offering patients the only alternative to strict, lifelong avoidance of even trace amounts of peanuts.

Roni Caryn Rabin

Articles written by the author

These Medical Devices Are Inserted Into 500,000 Patients Each Year -- but Are Tough to Sterilize

Robert F. Kennedy Jr.'s Brother and Sister Accuse Him of Spreading Misinformation on Vaccines

Huge Racial Disparities in Deaths Linked to Pregnancy

Huge Racial Disparities in Deaths Linked to Pregnancy

Huge Racial Disparities in Deaths Linked to Pregnancy

New York Sues Sackler Family Members and Drug Distributors

New York Sues Sackler Family Members and Drug Distributors

New York Sues Sackler Family Members and Drug Distributors

New York Sues Sackler Family Members and Drug Distributors

What Should Young Children Drink? Mostly Milk and Water, Scientists Say

For Children With Peanut Allergies, FDA Experts Recommend a New Treatment

Peanut Allergy Drug Will Protect Children, Experts Tell FDA

A better way to manage your period? Try the menstrual cup, scientists say

On vaccines 'he is wrong,' family says of Kennedy

Huge racial disparities persist in pregnancy-related deaths, and are growing

McKesson, drug distribution giant, settles lawsuit over opioids in West Virginia

OxyContin makers stashed assets amid scrutiny, New York suit says

Marijuana edibles may pose special risks