Firing Doctor, Christian Hospital Sets Off National Challenge To Aid-In-Dying Laws

DENVER — A Christian-run health system in Colorado has fired a veteran doctor who went to court to fight for the right of her patient to use the state’s medical aid-in-dying law, citing religious doctrine that describes “assisted suicide” as “intrinsically evil.”

Centura Health Corp. this week abruptly terminated Dr. Barbara Morris, 65, a geriatrician with 40 years of experience, who had planned to help her patient, Cornelius “Neil” Mahoney, 64, end his life at his home. Mahoney, who has terminal cancer, is eligible to use the state’s law, overwhelmingly approved by Colorado voters in 2016.

The growing number of state aid-in-dying provisions are increasingly coming into conflict with the precepts of faith-based hospitals, which oppose the practice on religious grounds.

Morris’ dismissal presents an early test of state laws. The Trump administration has moved to broaden the latitude of providers to refuse to participate in medical interventions they object to on religious grounds, though that has previously applied primarily to abortion and contraception.

As hospitals across the country have consolidated, five of the top 10 hospital systems by net patient revenue are associated with the Roman Catholic Church, according to Definitive Health. That includes hospitals that did not previously have any religious affiliation. Meanwhile, there are 10 U.S. jurisdictions where aid-in-dying has been approved and public support for the option is increasing.

The Aug. 26 firing came days after Morris joined with Mahoney in filing a state lawsuit that alleges that Centura’s faith-based policy violates the law that allows doctors to prescribe lethal drugs to dying patients who want to end their own lives.

Officials at Centura, a system jointly run by Catholic and Seventh-day Adventist churches, told Morris on Monday that she had defied church doctrines that govern her employment.

“I was shellshocked,” Morris said in an exclusive interview with Kaiser Health News. “Because of all the things I expected them to do, that was not in the playbook. Because it seemed so obvious that they can’t do it.”

But in legal documents filed Friday that ask to elevate the case to federal court and invoke the First Amendment in defense of their actions, Centura officials said Morris had violated terms of her physician’s employment agreement and “encouraged an option that she knew was morally unacceptable to her employer.”

Neil Mahoney, the former manager of a landscape company, was recently diagnosed with stage 4 cancer that had already spread through his body. Mahoney wants to use Colorado’s End of Life Options Act, but his hospital won’t allow it.(Heidi de Marco/KHN)

For Mahoney, the firing deals yet another setback in his quest to use the law. Mahoney, who in July was given four to 14 months to live, said he watched his mother die a slow, painful death and hopes to avoid that for himself.

“Knowing that I could die at home is huge,” said Mahoney, who has lost 30 pounds since April, even as his belly swelled painfully with fluid as a result of the cancer. “This gets dragged out too long.”

The Trump administration in May approved a so-called conscience rule that strengthens the rights of hospitals and health workers to refuse to participate in patient care based on religious or moral grounds.

At the same time, more doctors and patients in the country are providing and receiving health care subject to religious restrictions. About 1 in 6 acute care beds nationally is in a hospital that is Catholic-owned or -affiliated, said Lois Uttley, a program director for the consumer advocacy group Community Catalyst.

In Colorado, one-third of the state’s hospitals operate under Catholic guidelines.

In a letter hand-delivered to Morris, who has worked for the health care system since 2013, Centura president Vance McLarren said that she had violated the firm’s governing rules, the Ethical and Religious Directives for Catholic Health Care Services.

“Rather than encouraging patient Cornelius Mahoney to receive care consistent with that doctrine or transferring care to other providers, you have encouraged a morally unacceptable option,” the letter said.

The directives state that Catholic health care providers “may never condone or participate in euthanasia or assisted suicide in any way.” Such acts are described as “intrinsically immoral” and “intrinsically evil” in the document.

“Patients experiencing suffering that cannot be alleviated should be helped to appreciate the Christian understanding of redemptive suffering,” the document states.

Centura officials confirmed Thursday that Morris is no longer employed there, adding in a statement that the firm “expects all our caregivers to act in a manner consistent with our Mission and Core Values.”

Centura Health is a Catholic-run health system in Denver.(Heidi de Marco/KHN)

Company officials did not address claims that Centura violated state law but argued that its policy prohibiting doctors from prescribing drugs or otherwise participating in medical aid-in-dying is federally protected.

“We believe the freedom of religion doctrine at the heart of the First Amendment to the U.S. Constitution supports our policies as a Christian health-care ministry,” Centura spokeswoman Wendy Forbes said in an email. “We will vigorously defend our Constitutional rights.”

Legal experts said that Morris’ firing may be rare or even unprecedented, but the argument based on the First Amendment has gained support recently in conservative circles.

“In recent years, the radical right has gotten traction with the argument that religious peoples’ constitutional rights are violated if they have to follow the same law as everybody else,” said Robert Rivas, a Florida lawyer who serves as general counsel for the Final Exit Network, a nonprofit group that promotes right-to-die causes.

“When you look closely at what they are saying,” he said, “it turns out they really want to be empowered to force their religion on others.”

Officials with the Archdiocese of Denver said they supported Centura’s efforts to uphold church doctrine.

“Asking a Christian hospital to play any role in violating the dignity of human life is asking the Christian hospital to compromise its values and core mission,” spokesman Mark Haas said in a statement. “This is not the hospital forcing its beliefs upon others, but rather having outside views forced upon it.”

The issue is playing out against growing federal protections for religious views of health care, said Kathryn Tucker, executive director of the End of Life Liberty Project and co-counsel on the Centura lawsuit filed Aug. 21.

The Trump administration conscience rule, which was challenged by two dozen states and cities, including Colorado, has been delayed until Nov. 22.

“What’s getting lost here is the patient, and the doctor may hold equally strong ethical and religious views as Centura,” Tucker said. “Why should their views be overridden by the views of corporate religious medicine?”

Morris’ termination was immediate, according to the letter. She was asked to hand over her badge and her company laptop computer. The action abruptly halted her care of 400 geriatric  patients and left Morris worried about their future.

“These are complex, ill patients,” Morris said. “We have a pretty big thing in medicine about not abandoning patients, so that’s a pretty big issue.”

In the lawsuit, Morris joined with Mahoney, a Golden, Colo., nursery manager diagnosed in July with stage 4 metastatic cancer. The pair alleged that Centura’s policy prohibiting doctors from prescribing aid-in-dying drugs is broader than state law allows.

Colorado’s End of Life Options Act, approved by 65% of voters in 2016, allows hospitals and health systems to opt out of offering aid-in-dying drugs for use on their premises.

In addition, another Colorado law says health care facilities may not “limit or otherwise exercise control” over a physician’s medical judgment.

The suit asks a judge to rule that the hospital system may not bar Morris from prescribing the lethal drugs — or penalize her if she does.

Centura officials expressed sadness over Mahoney’s illness but said the institution promotes “the sacredness of every human life.”

After he received his grim diagnosis, Mahoney asked an oncologist and a social worker at his cancer center to help him access aid-in-dying. Both said no.

“I feel like I got slapped in the face,” Mahoney said.

Mahoney was advised to transfer his care to a secular provider, but he said he didn’t want to undergo additional tests, costs and travel as he struggled with debilitating symptoms.

Morris said she understood that Centura was religiously affiliated when she was hired but didn’t anticipate a problem.

“I didn’t think it was going to affect my general family practice,” she said. “Until these conversations about medical aid-in-dying, I hadn’t felt any interference.”

Once the law passed, however, a growing number of patients asked about the option.

“I’ve had patients as they face devastating illness or the end of life where they say, ‘Will you do this for me?’” she said, adding later: “At a certain point, we have to stand up for what’s right.”

Morris is considering her next steps, including separate legal action against Centura over her termination. Mahoney, who is scheduled for his third round of chemotherapy soon, said he’s not sure what to do in the wake of the firing.

Raised Catholic, he said, he rejected that theology long ago.

“I don’t believe in church. I don’t believe in religion,” he said. “I just think they’re getting way too much power.”

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Patent court to review Alexion’s Soliris patents on Amgen challenge

(Reuters) – The U.S. patent office will review patents on Alexion Pharmaceuticals Inc’s blood disorder treatment Soliris, after Amgen Inc challenged them, court filings showed on Friday.

FILE PHOTO: An Amgen sign is seen at the company’s office in South San Francisco, California in this October 21, 2013 file photo. REUTERS/Robert Galbraith

The move deals a blow to Alexion’s efforts to ward off competition for its top-selling drug, which accounted for nearly 82% of the drugmaker’s total revenue in the latest quarter.

Alexion’s shares fell 10.4% to $100.51, while Amgen’s were marginally higher at $208.21.

Amgen is contesting the U.S. patents to Soliris that extend the drug’s market exclusivity to 2027 from 2022.

The Patent Trial and Appeal Board, an administrative court run by the U.S. patent office, said on Friday it was instituting an inter partes review (IPR) on the patents.

The IPR is seeking to invalidate new patents covering the composition of the main ingredient of Soliris, eculizumab, its formulation, and its use to treat blood disorder proxysmal nocturnal hemoglobinuria (PNH).

Soliris is approved for four indications and brought in sales of $980.8 million in the quarter ended June 30.

Alexion said it will “vigorously defend” its patents and address the court’s specific concerns in the IPR proceedings.

The drugmaker is trying to retain its stronghold in the PNH market by converting patients to its Soliris-successor Ultomiris, which won U.S. approval last year.

Alexion has also been seeking to expand label for Soliris, which won U.S. approval to treat autoimmune disease neuromyelitis optica spectrum disorder (NMOSD) in June.

Besides PNH and NMOSD, Soliris is approved for atypical hemolytic uremic syndrome and generalized myasthenia gravis (gMG).

“Regardless of the ultimate outcome here, Soliris has orphan drug designation in the U.S. for gMG through late 2024 and for NMOSD through mid-2026,” the company said.

The U.S. Food and Drug Administration’s Orphan drug status comes with incentives, including a period of marketing exclusivity, to developers of rare disease treatments.

A decision on the validity of the new Soliris patents is expected in Q3 2020, as the U.S. patent office may require a full year for its assessment, SVB Leerink analyst Geoffrey Porges said.

Analysts were expecting Alexion to prevail over Amgen in the United States, where Soliris raked in about 51% of its total sales in the last quarter.

Amgen declined to comment on the court’s decision to review Soliris patents.

Alexion also awaits an impending European Patent Office (EPO) decision on its patent applications for Soliris, to extend the drug’s PNH market exclusivity in the European Union to 2027.

Reporting by Manojna Maddipatla and Manas Mishra in Bengaluru; Editing by Arun Koyyur and Shinjini Ganguli

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Oklahoma hospital used dirty gastroscopes on almost 1,000 patients; no infections reported

(Reuters) – An unnamed hospital in Oklahoma used contaminated gastroscopes in procedures performed on nearly a thousand patients in recent months, device maker Pentax Medical told U.S. regulators last month, putting the patients at risk of exposure to bacteria that can cause infections.

In a July 22 report here that only recently became public and was reviewed by Reuters, Pentax told the Food and Drug Administration that a hospital used up to four gastroscopes contaminated with bacteria in 998 procedures performed sometime last year through June 2019, when the problem was discovered. Pentax, a unit of Tokyo-based Hoya Corp, said it was not aware of any patient infections thus far.

Gastroscopes are inserted in the mouth and used to examine the stomach, conduct biopsies and perform other procedures.

The FDA redacts the names of hospitals from device injury reports before releasing them publicly. “Per FDA regulation, we are not permitted to disclose the facility identity publicly,” agency spokeswoman Alison Hunt said.

Neither Pentax nor the Oklahoma State Department of Health would name the hospital involved.

In a statement to Reuters, Pentax described the incident as a “failure by the facility reprocessing personnel to completely follow” the company’s cleaning instructions for gastroscopes.

The company said the “hospital has notified all potentially affected patients of their options for post-exposure medical screening.”

The FDA echoed Pentax’s assessment and said regulators “have determined that the manufacturer’s reprocessing instructions were not followed.” The agency said it is continuing to discuss the incident with Pentax and the hospital to learn more details.

Gastroscopes, like other endoscopes, are brushed and washed with disinfectants in preparation for the next patient. Despite those efforts, contamination can persist and patients can be exposed to drug-resistant bacteria and develop infections that are difficult or even impossible to treat.

They are not required to be sterilized, a process that for many manufacturers would require design changes to enable complex scopes to withstand gas or chemicals.

DESIGN HINDERS CLEANING

U.S. Senator Patty Murray of Washington state, who led a Senate investigation into duodenoscope infections following an outbreak at a Seattle hospital several years ago, expressed concern about the persistent lapses in patient safety related to endoscopy despite years of scrutiny by regulators and lawmakers.

Duodenoscopes are another type of endoscope.

Murray told Reuters that families “should be confident the medical equipment they rely on for critical procedures is safe. But I’m still very concerned about the risks here and I’m going to keep pushing for more transparency, more accountability and stronger protections for patients.”

Researchers say the intricate design of many endoscopes, with narrow channels and tiny crevices, hinders cleaning and those problems are compounded when health workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient.

In a study published last year in the American Journal of Infection Control, 71% of reusable scopes deemed ready for use on patients tested positive for bacteria at three U.S. hospitals. The study found problems with gastroscopes, colonoscopes and bronchoscopes, among others.

“Scopes get highly contaminated every time they’re used,” said Cori Ofstead, the study’s author and an epidemiologist in St. Paul, Minnesota. In the latest incident involving gastroscopes, she said, “It appears the institution continued to use damaged scopes, and inadequate cleaning allowed potential pathogens to remain on the scopes.”

In its filing to the FDA, Pentax said the “forward water jet channel” was not properly cleaned on three of the gastroscopes and a “foreign liquid was evacuated from at least one of the devices upon flushing” that channel. After discovering the problem, the hospital took the scopes out of service and returned them to Pentax.

Some infection-control experts have urged manufacturers and regulators to move toward sterilization for scopes, which would be a step above the current U.S. requirement for high-level disinfection.

Some companies are selling single-use scopes as a safer alternative, but reusable devices continue to be used widely.

In 2015, the FDA ordered Pentax and two other scope manufacturers – Olympus Corp and Fujifilm Holdings Corp – to conduct surveillance studies after the spread of antibiotic-resistant “superbugs” at U.S. and European hospitals from contaminated duodenoscopes. Those gastrointestinal scopes are put down a patient’s throat to diagnose and treat problems such as gallstones, cancers and blockages in the bile duct.

In April, the FDA said 5.4% of duodenoscopes tested positive during those industry studies for “high concern” organisms such as E. coli, even after being disinfected. The FDA said that contaminated duodenoscopes were linked to three deaths last year and 45 reports of patient infection from October 2018 to March 31.

This week, FDA urged hospitals and device makers to adopt newer models of duodenoscopes that have disposable parts that can aid cleaning and reduce the risk of infection.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Thursday.

Reporting by Chad Terhune; Editing by Leslie Adler

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CDC, FDA report 215 cases of respiratory illness possibly tied to vaping

(Reuters) – U.S. public health officials on Friday reported a rise in the number of cases of respiratory illness possibly related to the use of e-cigarettes from across 25 states.

The number of cases rose to 215 as of Aug. 27, from the U.S. Centers for Disease Control and Prevention’s (CDC) last update of 193 cases last week.

“While some cases in each of the states are similar and appear to be linked to e-cigarette product use, more information is needed to determine what is causing the respiratory illnesses,” the U.S. CDC and the Food and Drug Administration said in a joint statement. (bit.ly/2zwArPh)

The health agencies reiterated that in some cases, patients acknowledged the use of e-cigarettes containing tetrahydrocannabinol, the psychoactive component of cannabis.

Additional reports of pulmonary illness are also under investigation.

Illinois last week reported the death of a person who vaped, after being hospitalized with severe respiratory illness.

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Women may be missing out on outpatient hospital care in northern India

Women account for only a little over one third of appointments at a major hospital in India’s capital, New Delhi, highlighting extensive gender discrimination in access to healthcare services, researchers say.

Looking at outpatient visits to a large hospital in the capital, the analysis found that about half of the women who ought to have received care were “missing.” Women under age 30 and over age 60 were the most conspicuously absent, relative to their actual population numbers, the study team reports in BMJ Open.

Gender disparity in healthcare is usually studied by comparing mortality rates of females versus males, said study coauthor Mudit Kapoor, an associate professor of economics at the Indian Statistical Institute in New Delhi.

However, missing out on healthcare services may not always result in death, so death rates may not capture the extent of gender disparity, he told Reuters Health in a phone interview.

For the current study, Kapoor’s team analyzed data from more than 2.3 million visits to New Delhi’s All India Institute of Medical Sciences (AIIMS) in 2016, across all departments excluding obstetrics and gynecology, made by more than 880,000 outpatients.

More than 90% of these patients were from Delhi and three neighboring states: Haryana, Uttar Pradesh and Bihar. The researchers also used census data to characterize the populations of the four states by sex and age.

Overall, the ratio of male AIIMS patients to female patients was 1.69, meaning nearly two thirds of the outpatient visits were made by males.

But among children and adults up to age 30, twice as many males as females made visits. Between ages 31 and 59, there were about four women patients for every 10 men, then after age 60, women started disappearing again, with one woman for every three men.

The gender disparity worsened for women living farther from the hospital. The sex ratio increased from 1.41 in Delhi to 2.37 in Bihar, which is furthest from Delhi. This ratio is also much higher than Bihar’s overall sex ratio of 1.09, according to 2011 census data.

Disparities may be driven by the perceived productivity of women across various stages of their life, which ultimately determines whether they get to visit a healthcare center, the researchers note.

“If you’re in the middle-aged group, then you are a useful member in the family. The moment you become elderly or when you’re a child, you’re not a useful member to the family, and as a result this discrimination goes up,” Kapoor said.

Younger and older women are also likely to rely on people to accompany them to the hospital, which may result in them not getting timely care, noted Dr. Ambuj Roy, a study co-author and professor at AIIMS.

“When resources are limited and distributed in a skewed manner, the more dominant people in the society, which are unfortunately men, would get more of it than the less fortunate ones,” Roy said in a phone interview.

Changing people’s perceptions to provide women with better access to healthcare is not enough when the public health system in India remains inadequate for most people, said Kapoor, citing the example of serious doctor and nurse shortages in community health centers in the northern state of Uttar Pradesh.

Compared to northern India, public health facilities in southern states such as Tamil Nadu and Kerala are better equipped and are well-utilized by people of various income groups, and this gives the government the incentive to maintain healthcare centers in these areas, he said.

Dr. Meghana Kabra, a senior consultant for internal medicine at the Batra Hospital & Medical Research Centre in New Delhi, hasn’t seen gender disparities in outpatient visits at her hospital.

Patients visiting private hospitals such as Batra may belong to middle-class households while AIIMS caters to patients from various sections of the society including those of lower socioeconomic status, noted Kabra, who wasn’t involved in the study.

The study is limited by being based on outpatient visits from a single hospital and does not account for women who visit healthcare facilities closer to their homes instead of the AIIMS hospital in New Delhi, the team acknowledged.

Extensive research on this gender disparity is required to raise awareness among policymakers to look beyond the areas of maternal and child healthcare and focus on setting up as well as maintaining local hospitals and wellness centers, the authors said.

SOURCE: bit.ly/2ZCABmS BMJ Open, online Aug 7, 2019.

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Researchers discover unique biological marker for rare autoimmune disease

University of Alberta researchers have identified a unique biological marker that can be used to identify the presence of the rare autoimmune disease myasthenia gravis, predict the course of the disease and identify new, personalized treatments.

In a study published in the journal Metabolomics, neurologist Zaeem Siddiqi, graduate student Derrick Blackmore and their team used metabolic analysis of serum (blood with all cells removed) to find a unique pattern of metabolites–products of the body’s metabolic processes such as amino acids, vitamins or antioxidants–that is specific to myasthenia gravis.

Siddiqi and his team first compared the serum of patients with myasthenia gravis to a healthy control group. They then performed a comparison of serum from myasthenia patients to serum from rheumatoid arthritis, another autoimmune disease. After identifying more than 10,000 compounds in the serum samples, they found a unique pattern of 12 metabolites exclusive to patients with myasthenia gravis.

This is really important because now we have a way to easily separate a patient with myasthenia gravis from someone with rheumatoid arthritis or another autoimmune disease.

What’s more, now we’re able to explore how those 12 metabolites change in mild, moderate or severe cases so we can make this biomarker more robust and more effective for predicting the course of the disease and developing treatment plans.”

Zaeem Siddiqi, member of the U of A’s Women’s and Children’s Health Research Institute and the Neuroscience and Mental Health Institute

The rare autoimmune disease affects approximately one in 5,000 people, most often women under age 40 or men over 60. Typically, the disease affects the voluntary muscles in the face, head and neck and may affect torso and limb muscles as well. Patients can experience eyelid drooping and double vision, difficulty speaking and chewing, and weakness in the limbs. In severe cases, the disease can affect breathing and swallowing muscles, which can be fatal.

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The results highlight the potential metabolomic profiling has in identifying disease biomarkers.

“Right now we don’t have the ability to manage myasthenia gravis in a more specific way; we treat all patients the same,” said Siddiqi.

“Now we have a unique fingerprint or map of metabolites that can easily separate healthy individuals from those with myasthenia gravis, and a path to the discovery of more accurate and specific treatments.”

Biomarkers are useful in managing diseases because they not only help in early diagnosis of a disease, but can also help outline its severity, predict the course and expected outcomes, and indicate what treatments would be the most effective.

“Biomarker discovery is an important step in individualized medicine,” said Siddiqi.

According to Siddiqi, current methods for diagnosing myasthenia gravis only tell physicians whether or not a patient has the disease. There are no other biomarkers that can reliably predict the course of myasthenia gravis in a patient, or the best therapeutic response. Although there is no known cure, there are treatments for the disease that can manage the symptoms throughout the rest of the patient’s life. Even so, because myasthenia gravis is so rare, treatments can be extremely expensive, hard to find and not tailored to the patient, Siddiqi said.

“Finding the antibodies is good for diagnosis, but they do not tell us how the patient will react to a specific drug or which drug will be most effective,” Siddiqi said. “What we’re trying to do with this biomarker discovery is develop treatments specific to the needs of the patient, to have more precise management and to be able to more accurately predict the effects of the treatments.”

Siddiqi is hoping to soon expand the team’s research by examining patients at different stages of the disease to get a more precise picture of how each stage affects the metabolites, and make their biomarker more robust.

Source:

University of Alberta Faculty of Medicine & Dentistry

Journal reference:

Blackmore, D. et al. (2019) Beyond the antibodies: serum metabolomic profiling of myasthenia gravis. Metabolomics. doi.org/10.1007/s11306-019-1571-9.

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In India’s Slums, ‘Painkillers Are Part Of The Daily Routine’

A man stands outside Dr. Sunil Sagar’s clinic, which caters to residents of Bhagwanpur Khera.(Saumya Khandelwal/The Guardian)

This story is the second in a two-part series. Read part one here: “In India’s Slums, Painkillers Part Of Daily Routine.”

NEW DELHI — In the crowded waiting room of Dr. Sunil Sagar’s clinic, in the working-class neighborhood of Bhagwanpur Khera, a toddler breathes from a nebulizer. Fever is widespread, and the air quality in Delhi has reached “severe-plus emergency.” The patients sit, motionless, but there is somehow tremendous noise. The clinic is a squat cement building draped in wires, a red cross on the door. Sagar sits behind a desk in a small, open room, as a squad of assistants escort patients to him. He seems utterly unflappable.

A father with a troubled look sits down next to the doctor, holding a baby. Sagar listens to the baby’s chest with a stethoscope, pulls out scrap paper and writes a prescription. The father hands over a few rupees, and Sagar places the bills into a money drawer under his desk. The entire exchange takes perhaps two minutes.

Medicine in India is transactional. A well-liked doctor hands over a prescription at the end of every visit. Why else have I paid cash to see the doctor, if not for relief? The precariousness of daily life leaves little room for downtime.

As the Indian government reluctantly loosens its prescription opioid laws after decades of lobbying by palliative care advocates desperate to ease their patients’ acute pain, the nation’s sprawling, cash-fed health care system is ripe for misuse. The sheer size of India’s system — tens of millions of doctors and pharmacies spread across the subcontinent — makes oversight difficult but presents a tantalizing opportunity for India’s burgeoning pain industry and multinational pharmaceutical companies seeking new markets.

A popular spot to purchase these bulk drugs is the Bhagirath Palace in the Chandni Chowk market, one of India’s largest wholesale markets that dates to the 17th century. It is a dense maze where men — and it almost entirely men — press their bodies into a current of commercial ecstasy, frequently thrown off course by honking auto rickshaw drivers. One after the next, stalls of drug distributors advertise on brightly painted signs “all types of medicines,” “life-saving anti-cancer drugs,” “deal in Glaxo … Johnson & Johnson.” Inside the stalls, boxes of medicine are stacked from floor to ceiling.

Dr. Sunil Sagar checks medicines after he examines a patient at his clinic. (Saumya Khandelwal/The Guardian)

An outside view from Dr. Sunil Sagar’s clinic.(Saumya Khandelwal/The Guardian)

One drug wholesaler in the market said the government has been cracking down lately on certain medicines. Recently, he had received a list of 328 drugs that he was not supposed to stock, including Sulpitac, an antipsychotic medication used to treat schizophrenia. The wholesaler said people had been taking it like “dal and rice” for headaches.

Like its rigid caste system, India’s pain industry is stratified. The well-to-do visit well-appointed pain clinics, the working class turn to their neighborhood doctors, and the lower castes, especially those living in India’s vast slums, scramble for relief at roadside pharmacies, called chemists.

In the Mankhurd slum in Mumbai, where the average life expectancy is 39, toddlers wander bare-bottomed, defecating in the street. Children scratch at infections on their legs. Without any municipal water, hawkers sell plastic sandwich bags filled with dirty water for 2 rupees. In this place, pain remedies are readily available.

At Shiv Medical & General Stores, an older boy tending the stall wrote out a receipt for Ultracet, branded tramadol tablets — an opioid analgesic — made by a Johnson & Johnson subsidiary. “Doctor’s name?” he asked. Our guide, Mayur Helia, a community organizer, made one up. “Shagmu,” Helia said, giggling, and the shopkeeper wrote it down.

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Helia and his colleagues are activists agitating for drinking water and sanitation in the Mumbai-area slums. “Painkillers are part of the daily routine,” said social worker Alfiya Mulla. “They have become more normalized.”

“You go to the chemist,” Helia added, “and you say, ‘I have this pain,’ and he will give you painkillers without any prescription.”

Daily life here is a pageant of hustle. For women in the slums, Mulla said, that means lugging 35-liter buckets of water. “You have to take that from half a kilometer away, and that’s why women have to take that” — she motioned to the box of Ultracet — “because they are hurting their backs.”

She turned the box over in her hands. “Women are more affected and are more addicted to this tablet.”

Shopkeepers work inside a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi.(Saumya Khandelwal/The Guardian)

Beautiful Laws, Lax Enforcement

As India flirts with liberalizing access to painkillers, government surveys show addiction to prescription opioids is on the rise. The northern state of Punjab, where heroin addiction is endemic, recently opened more than 160 outpatient opioid-assisted treatment clinics where addicts can receive substitute opioids like buprenorphine while they fight withdrawal.

But buprenorphine is also widely prescribed to treat chronic pain and has become a problem in its own right. Dr. Debasish Basu, a psychiatrist and professor at the Postgraduate Institute of Medical Education and Research in Chandigarh, one of India’s top medical institutes, said “the main prescription medicine that we’re seeing [people becoming addicted to] is buprenorphine.”

“The source for buprenorphine is a licit source; they are made in drug-manufacturing factories,” he said, but then “the diversion takes place.”

Basu echoed health experts across the country in saying the central government tightly regulates the production of narcotic painkillers, but there is little faith in its ability to control distribution. “The legal system is so lax, the monitoring system is so lax,” Basu lamented. “The laws are all there. Oh, there are beautiful laws. But the implementation is so lax that once something comes over here, it’s very difficult. It’s like a bonfire.”

A patient enters Dr. Sunil Sagar’s office at his clinic.(Saumya Khandelwal/The Guardian)

If there is a precursor to an American-style opioid epidemic in India, it is tramadol, a painkiller that became available here in the early 1990s. Drugmakers — often citing studies they had funded — touted tramadol as less addictive than other painkillers.

“Tramadol information would come to every single clinician,” said Dr. Bobby John, a Delhi-based health expert. “Why? Because there is some drug salesperson sitting outside your door saying, ‘Hey, there’s a new drug. It’s non-addictive.’ Standard playbook.”

Tramadol flourished in India. Unlike morphine, fentanyl and other painkillers, the government initially placed few restrictions on its sale. But in 2018, after reports of abuse in the state of Punjab and reports of illicit Indian tramadol being sold to Boko Haram militants in Nigeria and elsewhere in Africa, Indian regulators enacted stricter controls.

If you cannot see the direct influence of American pharmaceutical companies in India, you can detect their shadow. In October 2018, just months after the Indian government clamped down on tramadol, a group of pain specialists from seven Southeast Asian countries, including three from influential hospitals in India, published a paper in the Journal of Pain Research.

Loose pills at Dr. Sagar’s clinic dispensary.(Saumya Khandelwal/The Guardian)

“Tramadol: A Valuable Treatment for Pain in Southeast Asian Countries” made the case that “the weak opioid tramadol has become the analgesic most frequently used in the region to treat moderate to severe pain.” The paper concluded: “If it were to become a controlled substance, the standard of pain management in the region would decline.”

The paper was funded by Grünenthal GmbH of Germany, a company that signed a deal in May 2018 to allow Mundipharma to market and distribute its tramadol product, Tramal, in China. Authors included pain specialists who have received consulting and lecturing fees from Pfizer, Johnson & Johnson and Mundipharma, a network of companies controlled by the Sackler family, owners of Connecticut-based Purdue Pharma.

Dr. Pooja Garg runs an opioid-assisted addiction recovery clinic on the outskirts of Chandigarh, one of five in the area. Addicts in the area favor heroin, she said, but when they cannot find or afford heroin, “they take whatever they can get over the counter from chemists.” That tends to be tramadol, which, despite the new restrictions, remains widely available.

The bustling waiting room led into a peaceful inner courtyard where, on a weekday morning last November, dozens of young men, in their late teens and 20s, had come for inpatient treatment. In one bedroom, several men sat cross-legged on a pair of metal cots. The young men said they took tramadol or buprenorphine, whatever they could get. “It depends on the availability at that particular moment,” one said. They all agreed tramadol was easy to buy from local chemists.

India sits between the two largest illicit opium-growing regions, the Golden Crescent of Afghanistan, Iran and Pakistan, and the Golden Triangle of Laos, Myanmar and Thailand; and India itself is one of the largest producers of legal opium. Much of the heroin passes through Punjab, a state of 28 million in northwestern India that has struggled with opioid addiction.

That history of heroin addiction makes those in Punjab and other nearby states especially vulnerable to synthetic opioids, said Dr. Anshu Garg, an addiction counselor in Mohali. Heroin “is freely available in the villages,” he said. “People try it without knowing the consequences. They try it once or twice, they get addicted to it.”

A pharmacy shop in Bhagwanpur Khera, New Delhi.(Saumya Khandelwal/The Guardian)

Sharing The Spoils

Vijay Bhatia can attest to how the business acumen propelling India toward economic prosperity has been brazenly co-opted by eager pharmaceutical companies.

Bhatia worked in pharmaceutical sales for two decades for a handful of companies, including GlaxoSmithKline and Ranbaxy Laboratories, an Indian generics maker owned by Sun Pharma. He now works in Chandigarh, where he oversees sales for Atulaya Healthcare, a chain of diagnostic imaging centers. Bhatia was among several current or former pharma representatives interviewed who described how multinational drugmakers deploy sophisticated methods in India for getting their products prescribed.

Drugmakers routinely give sales representatives extra money to offer doctors cash or gifts — iPads, cars, trips to conferences — to prescribe the drug they’re selling, Bhatia said. He described how sales reps give influential doctors free products to test with patients and how some doctors, in turn, deliver lectures at all-expenses-paid symposia, often presenting research papers sponsored by the drug companies.

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The multinational companies “have access to all these top opinion leaders,” Bhatia said. They will sponsor doctors to live “abroad for studies being done there. It is circumventing the entire marketing process. It’s another way of taking the doctor into the loop.”

“Suppose a product costs $100. To the company, it is costing $20. Now they have $80 to play with,” Bhatia explained. “So they’ll keep a safe margin, say, ‘OK, fine, this much money you can keep for ongoing practices or for sponsoring the doctor or, right or wrong, bribing the doctor.’”

Engendering loyalty with chemists is a top priority. To make his sales targets, Bhatia said, he would offer financial incentives to chemists who would “substitute [a product] with my product. In India, the chemist becomes king.”

Multinational pharmaceutical companies maintain they are ethical purveyors of their products. “Opioid pain medications play an essential role in the management of severe pain and it’s important they be recognized by health authorities as important therapeutic options, especially in cancer pain,” Manmohan Singh, a vice president at Modi-Mundipharma in New Delhi, said in a written statement. But, he said, “they need to be appropriately prescribed, monitored and reviewed to minimize the risks of misuse and abuse.”

In all sales promotions, Singh said, his company stresses that patients should be carefully selected, prescribed the lowest effective dosage, and made aware of both the treatment goals and potential side effects. “The exact prevalence of addiction with opioids is difficult to determine,” he said. “Signs of addictive behavior should be monitored and addressed.”

A woman looks out from a balcony of a house near Sagar’s clinic, which caters to residents of Bhagwanpur Khera.(Saumya Khandelwal/The Guardian)

In Thiruvananthapuram, in the southern state of Kerala, Dr. M.R. Rajagopal knows all too well that a powerful drug company, a greedy pharmaceutical salesman, an unscrupulous pain doctor, a reckless morphine addict or any whiff of scandal somewhere on the subcontinent could sink his life’s work. Widely viewed as the father of palliative care here, he is frankly tired of “opiophobia,” the “prejudice and misinformation” that the medical use of opioids will lead to addiction and crime. He is tired of reassuring Indian bureaucrats they are not ushering in a U.S.-style opioid epidemic. He has no time for doomsday scenarios; there are too many Indians in agony.

“This is a rather horrible country to die in,” Rajagopal told a roomful of doctors and medical students last fall at Sree Gokulam Medical College, on the outskirts of Thiruvananthapuram. He stood unassumingly at the front of a hospital conference room darkened by thick red drapes. Even with a microphone, his voice was gentle. “If a patient cries in pain for two weeks” at the end of his life, Rajagopal said, “it is hard to remember any good times.” When they are dying, he urged the crowd, “Give morphine.”

Despite the blossoming pain industry, Rajagopal estimates no more than 2% of Indians have access to palliative care. In his testimony for a three-year study of untreated pain published by the Lancet medical journal in 2018, he recounted the story of “Mr. S,” who came to a palliative care clinic in Calicut, Kerala, with crippling pain from lung cancer. He put the man on morphine, and a few hours later, Mr. S “surveyed himself with disbelief. He had neither hoped nor conceived of the possibility that this kind of relief was possible.”

When Mr. S returned the following month, the clinic had run out of morphine. The patient “told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree.’

“He pointed to the window. I believed he meant what he said.”

Read part one of this two-part series: “Beset By Lawsuits And Criticism In U.S., Opioid Makers Eye New Market In India“

Related Topics

Cost and Quality Health Industry Pharmaceuticals

Chronic Disease Care Doctors Drug Costs Opioids Prescription Drugs Substance Abuse

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FTC probes marketing practices of e-cigarette maker Juul: source

WASHINGTON (Reuters) – The Federal Trade Commission is investigating the marketing practices of e-cigarette maker Juul Labs Inc sending shares of tobacco stocks down, a person briefed on the matter said Thursday.

FILE PHOTO: A Juul e-cigarette and pods are seen in this picture illustration taken September 16, 2018. REUTERS/Ronen Zvulun

Shares of Altria Group Inc (MO.N), which has a 35% stake in Juul, fell 4.1% to $43.96 in afternoon trading after the Wall Street Journal earlier reported the probe.

Juul has already come under scrutiny for its marketing efforts, including its use of social media influencers to promote its vaping devices, which have become extremely popular among teens.

The U.S. House of Representatives and some state attorneys general have also launched separate investigations into the company’s promotion practices. Last year, the Food and Drug Administration conducted a surprise inspection at Juul’s San Francisco headquarter and seized documents.

“Without commenting on any specific investigation, we fully cooperate and are transparent with any government agency or regulator who have interest in our category,” a Juul spokesman said.

The company “never marketed to youth” but has changed its advertising to feature adult smokers aged 35 and above, and has stopped promoting on social media, the spokesman added.

A May 2019 court filing from lawyers, who filed a proposed class action lawsuit against Juul on behalf of customers, disclosed that an unnamed government agency was investigating the company’s marketing practices.

The group is seeking refunds for purchases of Juul products and an injunction to prevent the company from continuing to market to children and non-smokers.

The filing said that while Juul had not turned over documents about its marketing practices to the lawyers, it “has presumably already gathered and produced many of these documents in response to investigatory demands from the FDA, (REDACTED), and Attorneys General for California, Massachusetts, and Washington, as well as the Los Angeles District Attorney.”

FTC investigators are examining Juul’s involvement in deceptive marketing, including by targeting minors or using influencers, and is also determining whether to seek monetary damages, according to the Wall Street Journal report.

Altria did not immediately respond to Reuters’ request for comment, while an FTC spokesman declined to comment.

Shares of Philip Morris International Inc (PM.N), which is in talks to merge with Altria, fell 2.7%.

Separately on Thursday, Juul said it was giving over $100 million of incentives to retailers to install new age-verification systems at stores, part of efforts to curb sales of e-cigarettes to minors.

Reporting by Tamara Mathias, Saumya Sibi Joseph, Chris Kirkham and David Shepardson; Editing by Shinjini Ganguli

Our Standards:The Thomson Reuters Trust Principles.

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