Minnesota sues opioid manufacturer Insys over drug marketing

(Reuters) – Minnesota on Wednesday became the latest state to sue Insys Therapeutics Inc (INSY.O), accusing the drugmaker of illegally marketing a powerful fentanyl-based pain medicine intended for cancer patients for other uses and improperly paying doctors to prescribe it.

FILE PHOTO: A box of the Fentanyl-based drug Subsys, made by Insys Therapeutics Inc, is seen in an undated photograph provided by the U.S. Attorney’s Office for the Southern District of Alabama. U.S. Attorney’s Office for the Southern District of Alabama/Handout/File Photo via REUTERS

The lawsuit, filed by Minnesota Attorney General Lori Swanson amidst a nationwide epidemic of deaths caused by opioid painkillers like fentanyl, added to the legal woes of Insys, whose former top executives have been caught up in a federal criminal investigation involving its opioid product Subsys.

Chandler, Arizona-based Insys also is fighting similar suits by attorneys general in New York, North Carolina, Arizona, New Jersey and New Mexico.

The U.S. Food and Drug Administration in 2012 approved Subsys for use only in managing pain in cancer patients. Minnesota’s lawsuit, filed in Hennepin County District Court, accused Insys of encouraging doctors to prescribe Subsys to people with other medical conditions and at unapproved doses.

The suit also alleged that Insys improperly paid two doctors who became the top Subsys prescribers in Minnesota more than $43,000 in “speaker fees.” Subsys is an under-the-tongue spray that contains fentanyl, an opioid 100 times stronger than morphine.

The Minnesota Board of Pharmacy also brought an administrative case seeking civil penalties.

Insys did not respond to a request for comment.

A wave of lawsuits by state attorneys general have sought to hold drugmakers responsible for the opioid epidemic. Opioids were involved in more than 42,000 overdose deaths nationwide in 2016, according to the U.S. Centers for Disease Control and Prevention.

Earlier this month, the Justice Department announced it had joined five whistleblower lawsuits accusing Insys of paying kickbacks to doctors to prescribe Subsys.

In October, federal prosecutors in Boston announced the arrest of billionaire founder John Kapoor on charges he participated in a scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it.

Prosecutors said Kapoor, former Insys Chief Executive Michael Babich and others schemed to bribe medical practitioners, paying them using sham speaker programs ostensibly meant to educate healthcare professionals about Subsys.

Kapoor, Babich and five other former executives and managers in the case have pleaded not guilty. Insys has said it is in settlement talks with the Justice Department and may need to pay at least $150 million to resolve the probe.

Insys previously agreed to pay $9.45 million to resolve investigations by attorneys general in Oregon, New Hampshire, Massachusetts and Illinois.

Reporting by Nate Raymond in Boston; Editing by Will Dunham and Bill Berkrot

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Researchers uncover the cause of rheumatoid arthritis

By May 30, 2018

A team of researchers led by Osaka University have identified the cellular network involved in initiating and maintaining rheumatoid arthritis.

Credit: sciencepics/Shutterstock.com

The researchers suggest that this network can be targeted using a novel immunotherapeutic approach that will reduce joint inflammation.

In a mouse model of the disease, the team found out how Th17 cells interact with other cells at the site of inflammation to influence the production of inflammatory molecules called cytokines.

Chronic inflammatory disorders such as the autoimmune disease rheumatoid arthritis involve the action of various cytokines produced by the immune system. One such cytokine is IL-17, which is produced by TH17 cells.

Although TH17 cells are known for the role they play in autoimmune disease, researchers have been unclear on how they control other inflammatory cells.

As reported in the journal Immunity, Keiji Hirota and colleagues have now shown that the inflammatory cytokine GM-CSF is essential for the development of arthritis in mice.

The team found that GM-CSF produced by both stromal cells in the connective tissue and T cells contributed to joint inflammation in the animals, but only stromal cell-derived GM-CSF was required to initiate arthritis.

“We also showed that stromal cells secreted GM-CSF in response to stimulation by IL-17 from inflammatory Th17 cells,” says Hirota.

In addition, the study found that GM-CSF was secreted by a group of innate immune cells, the cells involved in non-specific defense mechanisms.

These cells expanded in number within inflamed joints in response to the production of IL-17 by Th17 cells and other inflammatory cytokines. This contributed to the development and maintenance of rheumatoid arthritis in the mice.

Our findings outline an inflammatory network controlled by autoimmune Th17 cells and involving stromal cells and innate immune cells, which leads to the onset and development of autoimmune arthritis.”

Shimon Sakaguchi, Co-Author

When the researchers removed the cells that produce GM-CSF from the joint lining (synovium), they observed a significant reduction in the severity of arthritis.

“This suggests the usefulness of developing such a novel immunotherapeutic approach that targets the cellular network to reduce chronic joint inflammation,” concludes Sakaguchi.



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Cameras On Preemies Let Family In, Keep Germs Out

Hospitals around the country have been upgrading their neonatal intensive care units to include personal webcams for each tiny patient. It’s a convenience for parents — and reduces worries about visitors bringing in germs.

The neonatal intensive care unit at St. Thomas Midtown in Nashville is the latest hospital to join the webcam wave, among facilities around the country from big cities to towns that are installing cameras over each infant.

At St. Thomas, Sherri Anderson has 20 years of experience as a neonatal nurse, watching parents run themselves ragged trying to be at the hospital every waking hour, sometimes commuting long distances.

“The parents go through a lot — emotionally, spiritually, physically,” Anderson said. “It’s very taxing, and sometimes they just need to go home and just recover.”

The $1,200 cameras — which St. Thomas paid for through a special fundraiser — come from a company called Natus Medical. They provide a close-up shot that anyone in the world can log on to see — using a password.

Jill Brothers had twin boys born at 27 weeks, requiring a two-month stay in the NICU. Her husband, who plays professional baseball, was away for spring training most of that time, but he could get on the computer and watch the boys’ progress.

“This has been a crucial element to just being a part and feeling like you’re involved with their growth,” she said. “There’s lots of other people in the family that have been able to log on and see the boys and see them [in] real time, which is great.”

Brothers still came to the hospital every day, but she found herself checking the web stream when she was up in the middle of the night — to watch the boys breathing.

“I really just felt like it was safe and comfortable,” she said.

Parents’ peace of mind is only one aim, though. St. Thomas NICU nursing director Donna Darnell said the new cameras could cut down on germs sneaking into the unit from other relatives stopping by.

“There are times throughout the year that we worry about a lot of visitors. Flu season is the best example,” Darnell said.

Even during normal times, access for family and friends is highly restricted because of germs — and the cameras give many more people the opportunity to see the tiny patients.

While baby Duke Brothers stayed in the NICU, his parents could watch over him via webcam. (Blake Farmer/WPLN)((Blake Farmer/WPLN))

In the little research that has been done, parents have loved the video access. Doctors also are OK with it, but a study published in the American Journal of Perinatology found that some nurses have misgivings about being watched all day and all night.

One of the study’s authors, Dr. Gene Dempsey from the University College Cork in Ireland, helped conduct the survey and said nurses worry they will get even more after-hours calls, wanting an explanation for what’s on screen. But, he said, that doesn’t seem to happen.

“In fact some of the workers [in hospitals with these cameras] suggested that the interaction at parent level — in terms of phone calls in the evening and at nighttime — are less when the system is in place,” he said.

Dempsey’s own hospital is launching a webcam system in the next few weeks and he has made a point of getting nurses on board.

“What we’re probably going to do, and we’ve had much discussion with the nursing staff initially, is that this would be a phased-in process,” he said.

Dempsey said they’ll start with “virtual visitation hours.” At St. Thomas, the nursing director decided to turn off the livestreams whenever a nurse is working with a child — a compromise that seems to have everyone smiling for the camera.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

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Benefit Change Could Raise Costs For Patients Getting Drug Copay Assistance

Since Kristen Catton started taking the drug Gilenya two years ago, she’s had only one minor relapse of her multiple sclerosis, following a bout of the flu.

She can walk comfortably, see clearly and work part time as a nurse case manager at a hospital near her home in Columbus, Ohio. This is a big step forward; two drugs she previously tried failed to control her physical symptoms or prevent repeated flare-ups.

This year, Catton, 48, got a shock. Her health insurance plan changed the way it handles the payments that the drugmaker Novartis makes to help cover her prescription’s cost. Her copayment is roughly $3,800 a month, but Novartis helps reduce that out-of-pocket expense with payments to the health plan. The prescription costs about $90,000 a year.

Those Novartis payments no longer counted toward her family plan’s $8,800 annual pharmacy deductible. That meant once she hit the drugmaker’s payment cap for the copay assistance in April, she would have to pay the entire copayment herself until her pharmacy deductible was met.

Catton is one of a growing number of consumers taking expensive drugs who are discovering they are no longer insulated by copay assistance programs that help cover their costs. Through such programs, consumers typically owe nothing or have modest monthly copayments for pricey drugs because many drug manufacturers pay a patient’s portion of the cost to the health plan, which chips away at the consumer’s deductible and out-of-pocket maximum limits until the health plan starts paying the whole tab.

Since her insurance company changed its rules, Kristen Catton is responsible for nearly $9,000 of the cost of her multiple sclerosis drug.(Courtesy of Kristen Catton)

Under new “copay accumulator” programs, that no longer happens.

In these programs, the monthly copayments drug companies make don’t count toward patients’ plan deductibles or out-of-pocket maximums. Once patients hit the annual limit on a drugmaker’s copay assistance program, they’re on the hook for their entire monthly copayment until they reach their plan deductible and spending limits.

Catton put the $3,800 May copayment on a credit card. She knows her insurer will start paying the entire tab once she hits the pharmacy deductible. But, she said, she can’t afford to pay nearly $9,000 a year out-of-pocket for the foreseeable future.

“I’m talking to my doctor to see if I can I take it every other day,” she said. “I guess I’m winging it until I can figure out what to do.”

Drug copay assistance programs have long been controversial.

Proponents say that in an age of increasingly high deductibles and coinsurance charges, such help is the only way some patients can afford crucial medications.

But opponents say the programs increase drug spending on expensive brand-name drugs by discouraging people from using more cost-effective alternatives.

Switching to a cheaper drug may not be an option, said Bari Talente, executive vice president for advocacy at the National Multiple Sclerosis Society.

“Generally the multiple sclerosis drugs are not substitutable,” she said. “Most have different mechanisms of action, different administration and different side effect profiles.” Generics, when they’re available, are pricey too, typically costing $60,000 or more annually, she said.

Most MS drug annual copay assistance limits, if they have them, are between $9,000 and $12,000, Talente said.

Employers argue that the drug copayment programs are an attempt to circumvent their efforts to manage health care costs. For example, employers may try to discourage the use of a specialty drug when there’s a lower-cost drug available by requiring higher patient cost sharing.

There’s also the issue of fairness.

“From an employer perspective, everyone under the plan has to be treated the same,” said Brian Marcotte, president and CEO of the National Business Group on Health (NBGH), which represents large employers.

If someone needs medical care such as surgery, for example, that person doesn’t get help covering his deductible, while the person with the expensive drug might, he said.

According to an NBGH survey of about 140 multistate employers with at least 5,000 workers, 17 percent reported they have a copay accumulator program in place this year, Marcotte said. Fifty-six percent reported they’re considering them for 2019 or 2020.

If there is no comparable drug available, drug copayment programs may have a role to play if they can be structured so that participating patients are paying some amount toward their deductible, Marcotte said. But, he said, assistance programs for drugs that are available from more than source, such as a brand drug that is also available as a generic, shouldn’t be allowed.

In 2016, 20 percent of prescriptions for brand-name drugs used a drug copay assistance coupon, according to an analysis by researchers at the USC Schaeffer Center for Health Policy and Economics. Among the top 200 drugs based on spending in 2014, the study found that 132 were brand-name drugs, and 90 of them offered copay coupons. Fifty-one percent of the drugs with copay coupons had no substitute at all or only another brand drug as a close therapeutic substitute, the analysis found.

Advocates for people with HIV and AIDS say copay accumulators are cropping up in their patients’ plans and beginning to cause patients trouble. Drugs to treat HIV typically don’t have generic alternatives.

The biggest impact for the community their organizations serve may be for PrEP, a daily pill that helps prevent HIV infection, said Carl Schmid, deputy executive director at the AIDS Institute, an advocacy group. A 30-day supply of PrEP (brand-name Truvada) can cost nearly $2,000. Drug manufacturer Gilead offers a copay assistance program that covers up to $3,600 annually in copay assistance, with no limit on how much is paid per month.

“They’re at risk for HIV, they know it and want to protect themselves,” Schmid said. “It’s a public health issue.”

Earlier this month, the AIDS Institute was among 60 HIV organizations that sent letters to state attorneys general and insurance commissioners across the country asking them to investigate this practice, which has emerged in employer and marketplace plans this year.

Compounding advocates’ concerns is the fact that these coverage changes are frequently not communicated clearly to patients, Schmid said. They are typically buried deep in the plan documents and don’t appear in the user-friendly summary of benefits and coverage that consumers receive from their health plan.

“How is a patient to know?” Schmid asks. They learn of the change only when they get a big bill midway through the year. “And then they’re stuck.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

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Portugal parliament rejects legal euthanasia in divisive vote

LISBON (Reuters) – Portugal’s parliament rejected on Tuesday a bill that would have legalized voluntary euthanasia for terminal patients in the Catholic-majority country by a narrow margin, but it secured enough support to ensure continued debate on the issue.

Parliamentary members attend a voting on legalizing euthanasia at the parliament in Lisbon, Portugal May 29, 2018. REUTERS/Rafael Marchante

Drafted by the ruling Socialists, the bill garnered 110 votes in the 230-seat parliament but was stymied by 115 opponents, with 4 abstentions, after a heated debate and a vote that required each lawmaker to declare his or her stance.

Earlier, a few hundred people of all ages – mostly from religious groups and Catholic schools – protested in front of the parliament building, chanting “Yes to life, no to euthanasia!” and carrying placards, “We demand palliative care for ALL” and, “Euthanasia is a recipe for elder abuse”.

The Portuguese Doctors’ Association opposed the change, saying it violated key principles of the medical profession.

Demonstrators attend a protest against euthanasia in front off the parliament in Lisbon, Portugal May 29, 2018. REUTERS/Rafael Marchante

Proponents of the bill, which was inspired by a 2016 petition signed by over 8,000 people and promoted by groups defending the right to a “death with dignity” for those seriously ill, said the fight had only just begun.

“The issue is now firmly on the political agenda, it is now in detailed debate in society,” said Catarina Martins, leader of the Left Bloc – a key government ally in parliament, which had its own version of a legalization proposal.

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“It is no longer a problem that each family with a suffering loved one has to face on its own, it now becomes a problem for all of us to find answers to…The state cannot continue to close its eyes to the suffering,” she said.

Another of the government’s hard left allies, the Communists, voted against the legislation, joining the conservative CDS-PP on the other end of the political spectrum. Several lawmakers from the main opposition Social Democrats supported the bill, but that was not enough to get it passed.

The Socialist bill envisaged legalization for medically-assisted death based on an informed request by patients suffering profoundly from a serious, incurable illness with no expected improvement in sight, in a terminal state, or suffering from widely incapacitating lesion.

On a national level, only a few countries in the world have legalized euthanasia – which usually means a doctor administering lethal doses of drugs to patients willing to die – or medically-assisted suicide where patients take the final action themselves.

Laws in Belgium, the Netherlands, Colombia and Luxemburg allow euthanasia. In Switzerland, Germany, Japan and Canada, doctor-assisted suicide is legal.

Portugal, which spent a large part of the 20th century until the 1974 Carnation revolution ruled by an ultra-conservative fascist regime, has since made strides in liberal reforms upholding human rights.

It legalized abortions in 2007 and then allowed same-sex marriage in 2010, becoming only the eighth country in the world at the time to allow same-sex marriage nationwide.

Reporting by Andrei Khalip; Editing by Axel Bugge and Mark Heinrich

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Roche, chasing Merck, notches another lung cancer win

ZURICH (Reuters) – Roche’s bid to keep Merck’s cancer blockbuster Keytruda within striking distance got a lift on Tuesday when the Swiss drugmaker said its immunotherapy Tecentriq mixed with chemotherapy boosted lung cancer patients’ survival.

FILE PHOTO: Swiss drugmaker Roche’s logo is seen at their headquarters in Basel, Switzerland January 28, 2016. REUTERS/Arnd Wiegmann/File Photo

Its phase III IMpower130 study, one of eight trials it has going against lung cancer that rely on Tecentriq, met goals of boosting overall survival and progression-free survival in the initial treatment of advanced non-squamous non-small cell lung cancer (NSCLC) compared to chemotherapy alone, Roche said.

This is the third late-stage study of Tecentriq alone or in a cocktail to show an overall survival benefit for people with NSCLC, Roche said.

Roche’s third-to-market drug after Keytruda and Bristol-Myers Squibb’s Opdivo has just a fraction of their sales. Roche is under pressure to see as many trials succeed as possible because Tecentriq is central to its strategy to replace falling revenue from older, off-patent medicines.

“The results of the IMpower130 study add to the growing evidence showing the clinical benefit of Tecentriq-based combinations in the treatment of advanced non-squamous non-small cell lung cancer,” Roche Chief Medical Officer Sandra Horning said.

Analysts remain sceptical about Tecentriq’s prospects of displacing Keytruda. [nL3N1SU48D]

“Merck’s Keytruda has shown similar success and now has four pivotal trial wins in this disease, and has established a clear lead,” said Berenberg analyst Alistair Campbell, who sees peak annual Tecentriq sales of $4 billion.

Detailed IMpower 130 results are not due until later this year, possibly in September at the International Association for the Study of Lung Cancer conference in Toronto or October’s European Society for Medical Oncology in Munich.

Given that, it “is still very difficult to interpret how Tecentriq stacks up against competitors”, said Deutsche Bank analyst Tim Race.

Race sees $4.7 billion in Tecentriq sales by 2022 but has a “hold” rating on Roche shares for fear biosimilar copies of Roche’s older cancer medicines will limit the company’s growth.

Rituxan is already being hammered by copies in Europe. The patent clock is also ticking on Herceptin and Avastin, putting $21 billion in annual revenue at risk by 2020.

In the first quarter, Tecentriq posted revenue of 139 million Swiss francs ($138.9 million), a tenth of Keytruda and Opdivo revenue. [nL8N1S30TG] It is already approved to treat bladder cancer and lung cancer where other treatments have failed.

Still, Roche remains optimistic Tecentriq trials will carve out a place for the drug as an essential part of lung cancer treatment. It is holding out hope to beat rivals to market in first-line treatment of small cell and squamous cell lung cancer. [nL8N1SE0KT]

Roche stock fell 0.3 percent by 1100 GMT, just less than the Stoxx Europe healthcare index’s decline.

Editing by Michael Shields

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Northern Ireland rally calls on Britain’s May to ease abortion rules

BELFAST (Reuters) – Hundreds of women’s rights activist rallied in Belfast on Monday to put pressure on British Prime Minister Theresa May to reform Northern Ireland’s highly restrictive abortion rules after neighboring Ireland’s vote to liberalize its laws.

Britain’s Prime Minister Theresa May leaves 10 Downing Street in London, Britain, May 23, 2018. REUTERS/Toby Melville

Voters in Ireland on Friday backed the removal of a constitutional abortion ban by two-to-one.

That leaves British-ruled Northern Ireland as the only part of the British Isles with a restrictive abortion regime, and May on Sunday faced calls from within her cabinet and the opposition to scrap Northern Ireland’s strict rules.

A spokeswoman for May said on Sunday changing the rules should only be undertaken by a government in Northern Ireland.

The province, divided between unionists who favor continued British rule and nationalists who want to unify with Ireland, has had no devolved regional government since January last year after a power-sharing agreement collapsed between the two communities’ main parties.

Activists gathered outside Belfast City Hall carrying placards emblazoned with messages such as “I am not a vessel” and “Mind Your Own Uterus”. They said it was May’s responsibility to act.

“1, 2, 3, 4, we wont’ be silenced any more,” the crowd chanted. “5, 6, 7, 8, it’s time for May to legislate.”

Abortion is permitted in Northern Ireland only if a woman’s life is at risk or there is a risk to her mental or physical health that is long-term or permanent. It is not permitted in cases of rape, incest or fatal fetal abnormality.

Both Northern Ireland’s mainly unionist Protestants and its mainly nationalist Catholics tend to be more socially conservative than elsewhere in Ireland or Britain.

The main unionist party, the DUP, opposes liberalizing abortion laws, while the main nationalist party, Sinn Fein, backs some changes. DUP lawmakers in London provide votes needed to support May’s minority government.

It is estimated that around three women travel from Northern Ireland to England for an abortion every day, while others risk prosecution by self-medicating with abortion pills.

“It is awfully unfair that people here should not be able to get an abortion,” said schoolgirl George Poots, at the rally with her mother and brother. “At present they have to worry about traveling to England and I also think of the women who cannot travel.”

Anti-abortion group Precious Life said Ireland’s vote would spur it to “up the battle to protect Northern Ireland’s unborn children”. “Northern Ireland is now the beacon of hope to the pro-life movement around the world,” leader Bernie Smyth said.

Reporting by Amanda Ferguson; Editing by Conor Humphries and Peter Graff

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India steps up hunt for origin of mysterious brain-damaging virus

MUMBAI/KOCHI (Reuters) – India began a fresh round of tests to trace the origin of a rare brain-damaging virus that has killed 13 people, a health official said on Monday, as initial tests on animals suspected of carrying the Nipah virus showed no sign of the disease.

People wear masks as they wait outside a casualty ward at a hospital in Kozhikode in the southern state of Kerala, India, May 23, 2018. REUTERS/Stringer

All animal samples, including those from bats, cattle, goats and pigs from the southern state of Kerala, sent to the National Institute of High Security Animal Diseases, in Bhopal, Madhya Pradesh, were negative for Nipah, said animal husbandry officer A. Mohandas.

The department was now collecting samples of fruit bats from Perambra, the suspected epicenter of the infection and nearby areas, Mohandas said.

Separately, tests run on dead bats in the northern state of Himachal Pradesh were negative for Nipah, an official there said.

The dead bats were discovered on the roof of a school and had triggered a new Nipah scare last week.

Of some 116 suspected cases sent for testing in recent weeks, 15 have been confirmed as Nipah, the Kerala government said on its website bit.ly/2GUSi3T on Monday.

Thirteen of those 15 people have died and two are undergoing treatment.

The latest victim was a 26-year-old rickshaw driver from Kerala’s Kozhikode district who died on the weekend, hospital officials told Reuters.

No confirmed cases of the virus have yet been found outside Kerala, despite fears it has spread. Some neighboring states including Maharashtra, Telangana and Karnataka have sent samples for testing of people who reported Nipah-like symptoms in the last few days.

There is no vaccine for the virus, which is spread through body fluids and can cause encephalitis, or inflammation of the brain, the World Health Organization (WHO) says.

The usual treatment is to provide supportive care.

Infectious disease outbreaks can be a challenge in India, the world’s second most populous country, where infection control and surveillance systems are weak, leading to hundreds of deaths annually from diseases such as mosquito-borne dengue.

The Coalition for Epidemic Preparedness Innovations (CEPI) said last week that Profectus BioSciences and Emergent BioSolutions would receive up to $25 million to accelerate work on a vaccine against Nipah virus.

Reporting by Subrat Patnaik in Mumbai and D. Jose in Kochi; Editing by Euan Rocha, Darren Schuettler

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New study finds no link between HPV vaccination and risk of autoimmune disorders

May 28, 2018

A new study in CMAJ (Canadian Medical Association Journal) found no increased risk of autoimmune disorders in girls who received quadrivalent human papillomavirus (HPV4) vaccination, adding to the body of evidence for the safety of the vaccine.

Human papillomavirus is the most common sexually transmitted disease worldwide, affecting 50%-75% of sexually active people. The HPV4 vaccine is effective at protecting against 90% of the strains that cause cervical and anal cancer. Despite studies showing safety of the vaccine, there have been concerns about a possible link to autoimmune disorders.

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“Despite demonstrated effectiveness in real-world settings, concerns continue to persist regarding the safety of the HPV4 vaccine. In light of these concerns, we wanted to study the HPV4 vaccination since it was being offered free to all grade 8 girls in Ontario through school-based clinics,” says Dr. Jeffrey Kwong, a study author and a senior scientist at the Institute for Clinical Evaluative Sciences (ICES) and at Public Health Ontario.

To determine whether the HPV4 vaccination triggered autoimmune conditions such lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis, researchers looked at data on 290 939 girls aged 12 to 17 years in Ontario who were eligible for vaccination between 2007 and 2013. Of the total 180 819 girls who received the HPV4 (Gardasil and Merck) vaccination in school-based clinics, there were 681 diagnosed cases of autoimmune disorders between one week and two months after vaccination. This rate is consistent with the general rate of diagnosed cases in this age group.

“These findings add to the body of evidence on the safety of the HPV4 vaccine and should reassure parents and health care providers,” says Dr. Linda Lévesque, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario.



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U.S. jury fails to reach verdict in latest J&J talc trial

NEW YORK (Reuters) – A South Carolina jury on Friday could not agree on a verdict in a case of a woman whose family said her long-term use of Johnson & Johnson’s Baby Powder led to her death from asbestos-related cancer, resulting in a mistrial.

A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake

The case of Bertila Boyd-Bostic, who died of a rare form of cancer in 2017 at the age of 30, is the latest in a series of trials in the United States that center around allegations that the company’s talc-based powder contained asbestos.

“We’re disappointed the jury did not reach a unanimous verdict for Johnson & Johnson,” the company said in a statement emailed to Reuters.

“The talc in Johnson’s Baby Powder does not contain asbestos, which is supported by more than 50 years of independent, non-litigation driven scientific evaluations.”

Asbestos is a known carcinogen linked to mesothelioma, the type of cancer Boyd-Bostic had been diagnosed with at the age of 29.

After two weeks of trial, the jury in the Darlington County Court of Common Pleas said it could not decide whether J&J was responsible for the disease. Under South Carolina law, a jury has to make a unanimous decision.

Christopher Swett, a lawyer for the family of Boyd-Bostic, said in a statement that the plaintiffs would retry the case at the earliest opportunity.

“We continue to believe that the daily use of baby powder on Bertila from birth led to her death,” Swett said.

The case also named as a defendant the U.S. unit of talc supplier Imerys SA, as well as a local unit of Rite Aid, one of the largest U.S. drugstore chains, which allegedly sold the baby powder used by the woman.

Gwen Myers, a spokeswoman for Imerys Talc America, said: “We remain confident that talc does not cause cancer. Imerys follows all FDA and other regulatory guidelines and utilizes rigorous testing to ensure that our talc meets the highest quality standards. We continue to stand by the safety of our product.”

Rite Aid did not immediately respond to a request for comment.

J&J is battling some 9,000 cases claiming its talc products cause ovarian cancer, but litigants have recently focused on claims based on alleged asbestos contamination.

A California jury on Thursday awarded $25.7 million in damages to a woman and her husband over allegations that the company’s baby powder had caused her mesothelioma.

A New Jersey court jury in April ordered J&J and Imerys Talc America to pay $117 million to a man who alleged he developed mesothelioma due to asbestos exposure from talc-based products.

The company won the only other asbestos-related trial in November, when a Los Angeles Superior Court jury ruled in its favor.

Reporting by Tina Bellon, Editing by Rosalba O’Brien and Diane Craft

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