Roche's combo lymphoma treatment wins U.S. FDA approval

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FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann

(This June 10 story deletes paragraph 9 to clarify that retreatment with Polivy has not been studied.)

(Reuters) - The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG’s antibody- Polivy for treatment of patients with advanced lymphoma.

Polivy was approved in combination with Roche’s older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.

Antibody-drug conjugates are designed to deliver a toxic chemotherapy directly to tumors. Roche said the average U.S. list price for a four-month course of Polivy would be $90,000. Rituxan is priced at $39,500 for four months.

Wall Street analysts estimate Polivy sales at nearly $1 billion by 2024, according to IBES data from Refinitiv.

Side effects seen in studies of Polivy included low blood cell counts, nerve damage, fatigue and pneumonia, the FDA said in a statement.

Cell therapies Yescarta, from Gilead Sciences Inc and Kymriah, sold by Novartis AG, are also approved for patients with advanced DLBCL.

Dr. Matthew Matasar, a hematologist at New York’s Memorial Sloan Kettering Cancer Center who was involved in the development of Polivy, said the drug could be an option for some patients to try before determining whether they need to move on to CAR-T treatments.

Roche estimates that nearly 25,000 new cases of DLBCL, a type of non-Hodgkin’s lymphoma (NHL), will be diagnosed in the United States this year. NHL, which is one of the most common cancers, accounts for about 4% of all types of cancers in the United States, according to the American Cancer Society. Continued approval for the treatment may depend on data from a confirmatory trial, Roche said. The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

Reporting by Aakash Jagadeesh Babu in Bengaluru and Deena Beasley in Los Angeles; Editing by James Emmanuel and Lisa Shumaker

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Health Canada to allow some edible cannabis products starting mid-December

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FILE PHOTO: Cannabis plants fill a room in an aquaponics grow operation by licensed marijuana producer Green Relief in Flamborough, Ontario, Canada January 25, 2019. Picture taken January 25, 2019. REUTERS/Carlos Osorio

(Reuters) - Health Canada said on Friday that some edible cannabis products, extracts and topicals would be sold in physical or online stores from mid-December.

The amended cannabis regulations will come into force on Oct. 17, the health regulator said, adding that cannabis producers with federal license will need to provide a 60-day notice of their intent to sell new products, as they are currently required to do.

“We think these new product forms are going to accelerate the shift away from black market into the legal market,” said Martin Landry, chief of corporate development & strategy at Neptune Wellness Solutions Inc. The Canadian firm specializes in the extraction, purification and formulation of cannabis products.

“They are critical for the legal market to capture a bigger part of the consumer spending,” Landry said.

The amendments will also limit the amount of tetrahydrocannabinol (THC), the substance in cannabis that makes people high, to 10 milligrams per serving in cannabis edibles and extracts. For cannabis topicals, the limit will be 1 gram of THC per package.

The Ontario Chamber of Commerce said even though the new proposed regulations will allow for the development of a range of products to meet consumer demand, the industry body was disappointed to see that multi-packs for edibles cannot exceed 10 mg of THC per package.

The OCC in a recent report had said it supports a THC limit of 10-mg per discrete unit of edibles, as well as the sale of multi-packs or multiple products up to a maximum of 100-mg of THC per package.

Ontario is home to more than half the licensed producers of recreational cannabis in Canada and a majority of employment.

Last year, Canada became one of the first major economies to legalize recreational marijuana, a move that has led to the creation of a multi-billion dollar industry.

Reporting by Shradha Singh in Bengaluru; Editing by Shinjini Ganguli and Maju Samuel

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U.S. drugmakers file lawsuit against requiring drug prices in TV ads

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FILE PHOTO: Used blister packets that contained medicines, tablets and pills are seen, in this picture illustration taken June 30, 2018. REUTERS/Russell Boyce/Illustration

(Reuters) - U.S. drugmakers filed a lawsuit on Friday challenging a new government regulation that would require them to disclose the list price of prescription drugs in direct-to-consumer television advertisements.

The lawsuit was jointly filed by Amgen Inc, Merck & Co, Eli Lilly and Co and the Association Of National Advertisers in the U.S. district court for the district of Columbia.

The new regulation, which was finalized on May 8 by the U.S. Department of Health and Human Services (HHS) and set to take effect in July, is part of the government’s efforts to bring down the cost of prescription medicines for U.S. consumers.

Drugmakers have argued against the regulation, saying list prices do not reflect the final price paid by patients as it excludes rebates and discounts drugmakers may offer, as well as patient assistance programs to make drugs more affordable for some.

“Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price,” Amgen said in a statement.

“Most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?’” Amgen said.

It remains to be seen whether the advertising regulation would have any actual impact on lowering costs if the requirement goes into effect.

“If the drug companies are embarrassed by their prices or afraid that the prices will scare patients away, they should lower them,” HHS spokeswoman Caitlin Oakley said in an emailed statement.

“President Trump and Secretary Azar are committed to providing patients the information they need to make their own informed healthcare decisions.”

Reporting by Ankit Ajmera in Bengaluru; Editing by James Emmanuel and Bill Berkrot

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U.S. drugmakers file lawsuit against rule requiring drug prices in TV ads

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FILE PHOTO: Used blister packets that contained medicines, tablets and pills are seen, in this picture illustration taken June 30, 2018. REUTERS/Russell Boyce/Illustration

(Reuters) - U.S. drugmakers on Friday filed a lawsuit to prevent the companies from disclosing the list price of prescription drugs in direct-to-consumer television advertisements as per a newly proposed government regulation.

The lawsuit was jointly filed by Amgen Inc, Merck & Co Inc, Eli Lilly and Co and the Association Of National Advertisers in the U.S. district court in Columbia.

The new regulation on advertisement, which was finalized on May 8 by the U.S. Department of Health and Human Services (HHS) and takes effect in July, is part of the government’s efforts to bring down costs for U.S. consumers.

However, drug companies have argued against the proposed rule, saying list prices do not reflect the final price paid by patients as it excludes rebates and discounts drugmakers may offer.

“Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price,” Amgen said in a statement.

“Most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?’”

HHS did not immediately respond to a request for comment.

Reporting by Ankit Ajmera in Bengaluru; Editing by James Emmanuel

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Canada's health regulator says some cannabis products to launch mid December

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FILE PHOTO: Cannabis plants fill a room in an aquaponics grow operation by licensed marijuana producer Green Relief in Flamborough, Ontario, Canada January 25, 2019. Picture taken January 25, 2019. REUTERS/Carlos Osorio

(Reuters) - Health Canada said on Friday that some edible cannabis products, extracts and topicals will be sold in physical or online stores from mid December.

The amended Cannabis regulations will come into force on October 17, the regulator said, adding that cannabis producers with federal license will need to provide 60-days notice of their intent to sell new products, as they are currently required to do.

The amendments will also limit the amount of tetrahydrocannabinol or THC, the substance in cannabis that makes people high, to 10 milligrams per serving in cannabis edibles and extracts. For cannabis topicals, the limit will be 1 gram of THC per package.

Last year, Canada became one of the first major economies to legalize recreational marijuana, a move that has led to the creation of a multi-billion dollar industry.

Reporting by Shradha Singh in Bengaluru; Editing by Shinjini Ganguli

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Indian doctors to widen strike demanding improved safety after attack

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KOLKATA/NEW DELHI (Reuters) - A leading Indian doctors’ association called for a nationwide strike on Monday, stepping up protests by medical staff demanding better security at hospitals after an attack on doctors in Kolkata.

A doctor holds a placard at a government hospital during a strike demanding security after the recent assaults on doctors by the patients' relatives, in Kolkata, India, June 14, 2019. REUTERS/Rupak De Chowdhuri

The move could paralyze hundreds of government-run health facilities across India. Thousands of doctors across the country went on a strike on Friday.

The state of West Bengal, of which Kolkata is capital, has been the worst hit by the strike with at least 13 big government hospitals affected.

The protests were launched in response to an attack at the NRS Medical College in Kolkata on Monday that left three junior doctors seriously injured after a dispute with a family whose relative had died.

Doctors demanding better security began a strike but their action was confined to the state. West Bengal Chief Minister Mamata Banerjee condemned them on Thursday, saying police did not strike when one of their colleagues was killed.

Banerjee’s remarks, which included a warning that junior doctors would be evicted from their hostels if they did not go back to work, triggered a nationwide reaction.

The Indian Medical Association (IMA) said the “barbaric” attack at the NRS reflected a national problem and called for a countrywide protest. It also demanded legislation to safeguard doctors.

Nearly 30,000 doctors were on a one-day strike on Friday, most in West Bengal, New Delhi and the western state of Maharashtra, according to figures proved by medical associations.

The IMA had previously called for a protest on Friday, but later in the day asked for the protests to continue over the weekend, and a nationwide withdrawal of non-essential services in all health care institutions on June 17.

All emergency and casualty services will continue to function, IMA, which represents nearly 350,000 doctors in the country, said.

The federal health minister, Harsh Vardhan, tried to calm the furor, promising better security at hospitals and calling on Banerjee to withdraw her ultimatum.

“I urge doctors to end their strike in the larger interest of society. I will take all possible measures to ensure a safe environment for them at hospitals across the country,” Vardhan said on Twitter.

India spent an estimated 1.4% of its gross domestic product on healthcare in 2017/18, among the lowest proportions in the world. Many millions of Indians depend on the cheap but inadequate public health system.

Saradamani Ray, whose 77-year old father is a patient at the NRS Medical College, said she would have to move him because of the strike.

“I will have to take my father somewhere else for his dialysis, maybe a private hospital,” she told Reuters.

“It will cause a lot of financial strain, but there’s nothing I can do. I will have to pay.”

Reporting by Rupak De Chowdhuri in KOLKATA and Shounak Dasgupta in NEW DELHI; Additional reporting by Subrata Nag Choudhury, Rajendra Jadhav and Devjyot Ghoshal; Writing by Devjyot Ghoshal; Editing by Euan Rocha and Angus MacSwan

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Experimental mobile app helps manage migraines

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(Reuters Health) - A smartphone-based relaxation app could help migraine sufferers reduce the number of headaches they get each month, a small study suggests.

Using the app twice a week was associated with an average of four fewer headache days per month, according to the report in Nature Digital Medicine.

“Migraine is now the second most disabling condition in terms of disability-adjusted years lost,” said lead author Dr. Mia Minen of NYU Langone Health in New York City.

Migraines affect about 1 in 6 adults in the U.S., with women most at risk.

“Previous research has shown that the best treatment for preventing migraine is a combination of migraine medication and behavioral therapy,” Minen told Reuters Health by email. However, “patients have significant difficulty accessing these safe, top evidence-based treatments.”

Minen and colleagues created RELAXaHEAD, an app based on the technique of progressive muscle relaxation, a proven method of migraine prevention, the authors note. The study team analyzed whether patients recruited from a neurology clinic would use the app regularly and whether they’d have fewer headache days.

During the study, 51 patients in their 30s and 40s who typically had 13 or more headache days per month were asked to complete a daily headache diary and to do progressive muscle relaxation with the app for 20 minutes a day for 90 days. Nearly one third of the participants were considered to have severe migraine disability when they enrolled, meaning they had missed considerable amounts of work, school and family activities due to the headaches.

On average, participants used the app on 22 days per month, for about 11 minutes per day. Roughly half used it once per week and a third used it two or more times per week. Overall, those who used the app twice per week had four fewer headache days the following month, and those who used it once per week had two fewer headaches days. Use of the app tended to drop over time.

Patients with higher depression scores were less likely to use the daily headache diary, and those with higher anxiety scores were more likely to use it.

“The number of mobile health apps available in the iOS and Google Play stores has ballooned, and recent studies show that most people download an app but then rarely use it,” Minen said. “Importantly, we were able to get a considerable number of study participants to use the app.”

The researchers have received inquiries about the app from patients with migraines outside the NYU Langone system, she noted. Although it was created as a research tool, Minen’s team is exploring ways to expand access to the app or include it in office visits. They’re also studying whether the app can help healthcare providers who don’t know where to refer patients with migraines who want behavioral therapy.

“I would encourage people who live with migraines to consider a behavioral treatment,” said Alice Pressman of Sutter Health in Walnut Creek, California, who wasn’t involved in the study.

“The great thing about starting a (behavioral therapy) BT is that you don’t have to stop your other treatments if you feel they are effective,” Pressman said by email. “BTs can be used as add-ons with no added side effects.”

However, an in-person a mindfulness-based stress reduction program targeting migraines that was offered at her center was difficult for some patients to attend due to time and location, Pressman said, so an online program may help. At the same time, patients should know that apps are still new and not fully studied.

“Research here is important to enable therapeutically effective and safe smartphone apps. Lots of apps are offered that are not based on any scientific evidence,” said Thomas Dresler of the University of Tuebingen in Germany, who wasn’t involved in the study.

“There are a lot of migraine apps out there, but customers need to know that the availability of an app per se does not guarantee effectiveness, safety or the developers’ adherence to specific quality standards,” Dresler said by email.

SOURCE: bit.ly/2X9Iwa1 Nature Digital Medicine, online June 4, 2019.

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Death toll from UK hospital listeria outbreak rises to five

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LONDON (Reuters) - The number of people to die from a listeria outbreak in British hospitals has risen to five from three, Public Health England (PHE) said on Friday.

The agency said that since the outbreak it had reviewed earlier cases and established that one other death had also been linked to the infection, which is thought to stem from sandwiches and salads. One patient who had been seriously ill has also since died, taking the number to five.

“To date, there have been no patients linked to this incident outside healthcare organizations, but we continue to investigate,” said PHE’s Nick Phin. “Swift action was taken to protect patients and any risk to the public is low.

Reporting by Kate Holton; editing by Stephen Addison

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Pharmacies may not stock naloxone, despite statewide orders

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(Reuters Health) - More than three years after Pennsylvania issued a statewide order expanding access to the life-saving opioid antidote naloxone, the product was still hard to purchase in Philadelphia pharmacies, researchers found.

In 2017, two-thirds of pharmacies in Philadelphia either did not stock naloxone, or they still insisted on a physician’s prescription, which the law said was no longer required.

In the wake of the opioid addiction crisis that has claimed thousands of lives, many U.S. states have passed laws like Pennsylvania’s, which allow the drug to be dispensed without a prescription and mandate that every drugstore carry it.

Laws that let pharmacists sell naloxone without prescription have been associated with a nearly 30% drop in the number of opioid overdose deaths, a separate team of researchers reported last month. (reut.rs/2WM3qMa)

Yet this study is not the first to find that drugstores are slow to comply. Research has shown that most pharmacies in California and Texas, for example, do not carry the drug or make it readily available.

The new results add to the growing body of evidence that these laws are not being enforced, experts said.

“While policy can be put in place, it’s not sufficient and has to be followed up with education, and reinforcement at the county and pharmacy level, and not just assume that the policy itself will ensure access to anyone who needs it,” Dr. Michael Lynch, a toxicologist and emergency medicine physician who was not involved in the study, told Reuters Health.

For the current study, Dima Qato of the University of Illinois, Chicago and colleagues contacted 418 drugstores in Philadelphia between February and August 2017 and found that only about 34% had naloxone in stock - and 38.5% of those drugstores required a physician’s prescription to dispense the drug.

People living in communities with elevated rates of opioid overdose deaths were the least likely to have access to naloxone without a prescription and had to pay more to buy the drug, the researchers wrote in JAMA Network Open.

“Areas that need this policy enforced the most are areas that lack it and that’s a concern,” Qato told Reuters Health by phone.

An overdose of opioids like morphine or heroin slows breathing, reducing the supply of oxygen to the body. Naloxone helps reverse the effects of an overdose and saves lives.

Lynch, who is also the medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, notes that the high importance of naloxone may not necessarily translate to high demand.

“If patients or individuals are not coming in and asking for it, pharmacies, especially a local independent pharmacy with pretty narrow margins, may not continue to stock a medication that isn’t being dispensed,” he added.

However, Mel Brodsky, executive director of PARD, an association of community pharmacies in Philadelphia, disputes the study’s findings.

“It is from 2 years ago - a lot has changed. Philadelphia mandates that every pharmacy have 2 doses of naloxone in stock. As I travel to my stores, I see 95% having naloxone in stock,” he told Reuters Health by email.

Dr. Michael Fingerhood, of Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Reuters Health that the low numbers in the study may be partly due to a shortage of naloxone in 2017.

“I would do a similar study now, (when) we don’t have a shortage of naloxone, and see if there has been any difference, two years later,” he said.

SOURCE: bit.ly/2IEd5LZ JAMA Network Open, online June 7, 2019

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Got an antibiotic prescription from your dentist? Chances are, it might be unnecessary

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(Reuters Health) - More than three-quarters of antibiotic prescriptions written by dentists before dental procedures are unnecessary and might do more harm than good, a new U.S. study found.

Dentists write one of every ten antibiotic prescriptions in the United States, and despite national declines, antibiotic prescribing by dentists has held steady over the years, researchers wrote.

Dentists need to be included in the public health conversation regarding appropriate antibiotic use and antimicrobial resistance, lead author Katie Suda of the University of Illinois, Chicago, told Reuters Health by phone.

Antibiotics before dental procedures are recommended for a small subset of patients with certain medical conditions, to prevent a serious heart infection that might arise from the release of oral bacteria into the bloodstream during the procedures. The infection, endocarditis, is an inflammation of the lining of the heart’s chambers and valves.

To see if antibiotics are being prescribed for dental patients according to established guidelines, Suda and her team used an insurance database to analyze prescriptions written during 168,000 dental visits from 2011 to 2015.

They found that 80.9% of prescriptions for antibiotics to be taken before procedures were unnecessary.

Among the 91,438 patients in the study, only 20.9% had a cardiac condition that put them at the highest risk of developing endocarditis and warranted an antibiotic prescription.

Patients with artificial joint implants had more than double the odds of receiving unnecessary antibiotic prescriptions compared with patients who did not have the implants. This is despite the fact that the American Academy of Orthopaedic Surgeons and the American Dental Association now say people with prosthetic joint devices do not need antibiotics before dental procedures.

In particular, the antibiotic clindamycin was highly likely to be unnecessarily prescribed. Clindamycin has been linked with a severe form of diarrhea known as Clostridium difficile (C. diff). A single dose of clindamycin carries the same risk of C. diff infection as a prolonged course of the antibiotic, the researchers wrote, making it all the more alarming that clindamycin was among the overused antibiotics.

Misuse and overuse of antibiotics encourages bacteria to evolve and find ways to resist the medicines. The World Health Organization has called antibiotic resistance a global health emergency.

Why is there so much over-prescribing by dentists? Experts say dentists may face pressure from patients or patients’ cardiologists and orthopedic surgeons, who insist on antibiotics.

“Dentists feel like they are in a really tough position,” said Dr. Emily Spivak of the University of Utah School of Medicine, who wrote an editorial that was published with the study.

“They’re not physicians and they feel like they have to give (antibiotics) because they will be held accountable from the surgeon or the cardiologist if the patient gets an infection,” she told Reuters Health.

Other factors driving unnecessary prescribing may include dentists’ lack of awareness of the most recent guidelines, lack of agreement with these guidelines and the practice of ‘defensive medicine,’ experts said.

Spivak, however, believes the current study may over-inflate the numbers as it includes only commercially insured patients.

The ‘worried well’ or those who suffer from health anxiety may be driving some of this prescribing, she added.

Experts say patients should feel empowered to ask questions when their dentists prescribe antibiotics, and they shouldn’t pressure dentists to provide them with the drugs.

“An informed patient who asks questions can allow for a discussion between the dentist and the patient to truly understand whether they need an antibiotic,” Dr. Salim Virani of the Baylor College of Medicine, told Reuters Health by email.

SOURCE: bit.ly/2KdK109 and bit.ly/2R91tEt JAMA Network Open, online May 31, 2019

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Enanta's lung infection therapy succeeds in mid-stage trial

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(Reuters) - Enanta Pharmaceuticals Inc said on Friday its treatment for a highly contagious respiratory infection met the main goal of reducing virus levels in the body and improving symptoms in patients in a mid-stage study.

The therapy, EDP-938, developed for treating respiratory syncytial virus (RSV) infection which currently has no available treatment, was compared with placebo, the company said.

RSV could lead to serious lung infections and even death in babies and the elderly who have a weaker immune system.

An average of 57,527 children younger than 5 years and 177,000 adults older than 65 years are hospitalized due to RSV infections every year, according to the Centers for Disease Control and Prevention.

Enanta said study results showed its therapy was generally safe and well tolerated and no drug discontinuations were observed.

Drugmakers Regeneron Pharmaceuticals Inc and Johnson & Johnson have abandoned their programs to find a treatment for the condition, and an experimental vaccine developed by Novavax Inc had failed a late-stage trial, earlier this year.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli

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WHO likely to declare Ebola an international emergency: experts

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GENEVA (Reuters) - The World Health Organization (WHO) should and is likely to declare an international emergency over the Ebola epidemic in the Democratic Republic of Congo that has now spread to Uganda, experts said as a WHO advisory panel met on Friday.

A health worker wearing Ebola protection gear enters the Biosecure Emergency Care Unit (CUBE) at the ALIMA (The Alliance for International Medical Action) Ebola treatment centre in Beni, in the Democratic Republic of Congo, April 1, 2019. Picture taken April 1, 2019.REUTERS/Baz Ratner

Congo’s epidemic is the second worst worldwide since West Africa’s Ebola outbreak in 2014-16, with 2,084 cases and 1,405 deaths since being declared in August. The WHO said on Thursday that two people had died in Uganda having arrived with the disease from Congo.

A panel of 13 independent medical experts on the WHO’s Emergency Committee (EC) were meeting from midday to evaluate the latest evidence and whether the epidemic constitutes a Public Health Emergency of International Concern (PHEIC).

Such a decision would lead to boosting public health measures, funding and resources, and could include recommendations on trade and travel, academic experts and aid groups said.

“Will @WHO declare global emergency for #Ebola? I predict yes. My sense is @DrTedros will call PHEIC if #EC recs it. He understands depth of crisis,” Lawrence Gostin, professor of global health law at Georgetown University Law School in Washington, D.C., who is not on the panel, said in a tweet.

People are still dying outside of Ebola treatment centers - exposing their families to the disease - and many don’t appear on lists of known contacts being monitored, he said.

“Vaccines alone can’t work if community hides cases due to distrust. Violence persists. We are in this for the long haul,” Gostin said, referring to deadly attacks on Congo health facilities.

The panel, which twice before decided not to declare an emergency, will make recommendations to WHO director-general Tedros Adhanom Ghebreyesus who takes the final decision.

Only 4 emergencies have been declared in the past decade: the H1 virus that caused an influenza pandemic (2009), West Africa’s Ebola outbreak, polio (2014) and Zika virus (2016).

SECOND WORST EPIDEMIC

Top WHO official Mike Ryan said on Thursday there had been no known person-to-person spread of Ebola in Uganda and that there were encouraging signs in Congo, with the disease’s spread slowing in cities of Butembo and Katwa. However it the virus was now entrenched in rural areas including Mabalako, he said.

“But these can be very volatile, these can go up and down week to week. So we have to be careful looking at one week of data and declaring victory.

“We have a hell of a long way to go in this response,” he told Reuters.

The WHO, in a statement overnight, said that given all three confirmed cases in Uganda belong to a single family cluster, the level of preparedness and experience of Ugandan authorities to manage previous Ebola outbreaks, and their rapid detection of cases in a limited geographical area, “the overall level of risk at national level is assessed as moderate”.

“However, the overall regional risk posed by the outbreak in DRC remains very high. The overall risk at international level remains low,” it said.

Jeremy Farrar, director of the Wellcome Trust global medical charity, said the WHO should declare a public health emergency of international concern.

“Doing so would raise the levels of international political support, which has been seriously lacking so far, show strong support for DRC and neighboring countries and WHO, and release more resources, including finance, healthcare workers, enhanced logistics, security and infrastructure,” he said.

Additional reporting by Kate Kelland in London; Editing by Raissa Kasolowsky

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Indonesia cracks down on online tobacco ads to deter young smokers

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FILE PHOTO: An Indonesian youth holds a cigarette while waiting for a train in Jakarta May 24, 2012. REUTERS/Beawiharta/File Photo

JAKARTA (Reuters) - Indonesia, the world’s fourth biggest producer of cigarettes, will crack down on online tobacco advertisements in a bid to target youthful smokers, the communication minister said on Thursday.

Health groups say more teenagers are taking to smoking in Indonesia, which already has nationwide curbs on cigarette ads, including a ban on sponsors’ promotion of tobacco products, though it is not consistently enforced by regional authorities.

The minister said he had given orders for his team to block all online cigarette advertisements after the health minister sought the ban.

“Immediately after receiving the letter, Minister of Communication and Information Rudiantara gives direction to cull cigarette advertising content on the internet,” the ministry said in a statement.

The minister, who uses only one name, like many Indonesians, said his team had already found content on 114 social media channels, including Facebook, Instagram and Youtube, that violated the law and would now be blocked.

“We hope by blocking cigarette advertisements on the internet we can reduce the smoking prevalence, especially among children,” Health Minister Nila Moelek said, according to the Jakarta Post newspaper.

“Three out of four teenagers know about cigarette advertising from online media.”

Media in Indonesia, which is famed for its “kretek” or clove cigarettes, cited health survey data that showed the prevalence of smoking aged those aged 10 to 18 had increased to 9.1 percent last year from 7.2 percent in 2013.

About two-thirds of Indonesian men smoke tobacco daily, and more than 21 percent of boys between 13 and 15 smoked cigarettes regularly, the World Health Organization said in 2017.

Reporting by Cindy Silviana and Fanny Potkin; Editing by Clarence Fernandez

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Father's smoking during pregnancy tied to asthma in kids

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(Reuters Health) - Children who are exposed to tobacco smoke from their fathers while they’re in the womb may be more likely than those who are not to develop asthma by age 6, according to a study of chemical changes to DNA.

While prenatal smoke exposure has long been linked to an increased risk of childhood asthma, the current study offers fresh evidence that it’s not just a pregnant mother’s smoking that can cause harm.

Researchers followed 756 babies for six years. Almost one in four were exposed to tobacco by fathers who smoked while the child was developing in the womb; only three mothers smoked.

Overall, 31% of kids with fathers who smoked during pregnancy developed asthma by age 6, compared with 23% of kids without fathers who smoked, the study found.

Asthma was also more common among kids whose fathers were heavier smokers, senior study author Dr. Kuender Yang of the National Defense Medical Center in Taipei said by email.

“Children with prenatal paternal tobacco smoke exposure corresponding to more than 20 cigarettes per day had a significantly higher risk of developing asthma than those with less than 20 cigarettes per day and those without prenatal paternal tobacco smoke exposure,” Yang said.

About 35% of the kids with fathers who were heavier smokers developed asthma, compared with 25% of children with fathers who were lighter smokers and 23% of kids with fathers who didn’t smoke at all during pregnancy.

Smoking by fathers during pregnancy was also associated with changes in methylation - a chemical code along the DNA strand that influences gene activity - on portions of genes involved in immune system function and the development of asthma.

Researchers extracted infants’ DNA from cord blood immediately after birth and examined methylation along the DNA strand. The more fathers smoked during pregnancy, the more methylation increased on stretches of three specific genes that play a role in immune function.

Children who had the greatest methylation increases at birth, affecting all three of these genes, had up to almost twice the risk of having asthma by age 6 as other kids in the study.

While smoking by fathers during pregnancy was linked to childhood asthma, it didn’t appear to impact children’s sensitivity to allergens or total levels of IgE, an antibody associated with asthma.

This suggests that the risk of asthma from tobacco exposure is unlike allergic asthma, which is driven by allergies or allergic sensitization via IgE antibody, said Dr. Avni Joshi, a researcher at the Mayo Clinic Children’s Center in Rochester, Minnesota, who wasn’t involved in the study.

The study wasn’t designed to prove whether or how prenatal smoking exposure might directly cause so-called epigenetic changes, or how those changes cause asthma in children.

It’s not yet clear how the alterations seen along the DNA strand where methylation increased might cause asthma, the study team notes in Frontiers in Genetics.

Still, the message to parents should be clear, Joshi said by email.

“Smoking is bad at ANY point in time: before the baby is born and after the baby is born,” Joshi said. “Many parents defer quitting until the baby is born, but this study stresses that the prenatal exposure to tobacco creates changes to the unborn child’s immune system, hence it is best to quit as a family decides to have children, even before the conception happens.”

SOURCE: bit.ly/2WG9lhM Frontiers in Genetics, online May 31, 2019.

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Mesh implants work for bladder leakage, long-term safety unclear

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(Reuters Health) - Several different types of mesh implant surgery may be effective for treating bladder leaks, but the long-term safety and effectiveness of the procedures isn’t yet clear, a new analysis suggests.

Researchers examined data from 175 clinical trials that randomly assigned a total of 21,598 women with stress urinary incontinence to receive different types of surgical treatments.

Over the short-term, three types of surgeries appeared most effective at curing the incontinence. Two newer procedures using slings to support the bladder had cure rates of about 89% and an older abdominal surgery to suture the bladder had a cure rate of about 77%.

“With regard to surgical treatments, there is limited evidence to suggest that there is one ‘best’ option for the treatment of stress urinary incontinence. Rather there are several trade-offs and risks that women need to be aware of and consider alongside their clinician when making their treatment choice,” said study co-author Dawn Craig of Newcastle University in the UK.

“Based on our findings, the jury is still out on the long-term risks of vaginal mesh for stress urinary incontinence,” Craig said by email.

Up to half of adult women experience stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem.

Surgical treatment for stress urinary incontinence has evolved over the past two decades from open abdominal operations to support the bladder with sutures to less invasive procedures that insert mesh slings instead. Recently, however, the safety of mesh implants for stress incontinence has come under scrutiny due to reports of severe complications, litigation and product withdrawals, researchers note in The BMJ.

One of the more effective mesh sling options in the study was a traditional suburethral sling, which involves placing a sling under the urethra and using one of a variety of techniques to secure it in place.

The other mesh sling option with similar effectiveness was the midurethral sling, a newer minimally-invasive procedure that enables surgeons to insert a narrow strip of synthetic mesh without the need to secure it in place.

In contrast, the older type of surgery known as an open coloposuspension requires cutting through the abdomen to reach the bladder and then using sutures to support the neck of the bladder, the group of muscles that connect the bladder to the urethra. These muscles tighten to hold urine in the bladder and relax to release urine.

Most of the available safety data was for the newer mesh sling procedures.

Mesh procedures done with one vaginal incision and two groin or thigh incisions - known as transobturator midurethral sling surgery - had more repeat surgeries and groin pain but fewer vascular complications, bladder or urethral perforations, or voiding difficulties than so-called retropubic midurethral surgery done with one vaginal incision and two abdominal incisions.

“We do not have good long-term follow up data for any of these surgeries as the trials analyzed lasted up to five years at most and mesh can cause problems many years after insertion,” said Rufus Cartwright of Oxford University Hospitals NHS Trust in the UK, who co-authored an accompanying editorial.

Some women might be able to address stress urinary incontinence without surgery, previous research has found. Lifestyle changes like avoiding caffeine, drinking small amounts of fluid, using the bathroom at scheduled times throughout the day and doing exercises that target the pelvic floor muscles can improve bladder control.

“Women should consider surgery for incontinence if their symptoms are severely affecting their quality of life, and they haven’t responded to conservative treatment (pelvic floor exercises),” Cartwright said by email. “The choice between the different procedures should be based on a process of shared decision making with the surgeon.”

SOURCE: bit.ly/31w78Jv and bit.ly/2KeSIIt The BMJ, online June 5, 2019.

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Female soldiers wanting to suppress periods face barriers

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(Reuters Health) - Military women wanting to stop menstruating while they are deployed may face a number of barriers, a new commentary suggests.

The majority of surveyed military women say they would like to suppress menstruation during deployment but very few are doing so, according to the paper in Obstetrics & Gynecology that explores why more military women are not accessing that option.

One answer may be that not enough military women and their health providers even know that hormonal contraceptives used continuously will suppress menstruation.

“Women are counseled to stop taking contraceptives before deployment and that negates all the valuable health benefits, including suppression, that come with them,” said the commentary’s author, Sheena Eagan, an assistant professor at the Brody School of Medicine at East Carolina University in Greenville, North Carolina, and a specialist in military medicine ethics. “There’s a recurring theme in surveys: women want to access cycle control and they want to suppress menstruation before they are deployed.”

Unfortunately, there are many barriers blocking women’s access to menses suppression in the military, Eagan said, including the instructions to stop taking contraceptives before deployment because there is a rule against sexual intercourse while deployed. “I wanted to highlight the misconception I saw throughout the literature that equates contraceptive use with pregnancy prevention,” she said.

After reviewing the medical literature on the topic of menses suppression in the military, Eagan found that 66% to 86% of women surveyed wanted the ability to stop menstruating during deployment. In contrast, a mere 7% reported having done so.

Part of the problem may be lack of education among both the women and their health providers, Eagan said. A 2009 report found that only a third of service women had received any pre-deployment counseling on menstrual regulation and suppression. Moreover, nearly 70% of women reported that their primary healthcare providers were medics or corpsmen. Although training varies depending on the branch of service, these types of providers normally do not hold professional or graduate degrees, Eagan noted.

Eagan said she isn’t suggesting that menses suppression be mandated for all female soldiers, but “it should be part of women’s autonomous choice.”

The issues of menses regulation and control aren’t limited to military women, said Dr. Charles Ascher-Walsh, director of gynecology for the Mount Sinai Health System in New York City. “Obviously, when women are deployed it’s more convenient not to be menstruating,” he said. “But there are many women who would have the same kinds of benefits, such as when they are traveling for work.”

In general, Ascher-Walsh said, “there’s a lack of education among women and their doctors that this is a possibility - and a safe possibility. And doctors don’t offer it as much as I think they should.”

Still, the article may have made the process sound more straightforward than it sometimes is, Ascher-Walsh said. “It’s not as simple as: do this and you are guaranteed not to bleed,” he explained.

That’s because not all women will stop cycling on hormonal contraceptives, Ascher-Walsh said. With some methods, “you can end up with spotting every day and that’s worse than having your period,” he added. “So you don’t want to do it right before you are deployed since that can make it worse rather than better.”

The best option if a female soldier wants to try a method to halt menstruation is to experiment with it well before deployment, Ascher-Walsh said. Among the possible options, continuous birth control is “the most likely to stop a woman’s periods and be reliable,” Ascher-Walsh said.

SOURCE: bit.ly/2F89nsS Obstetrics & Gynecology, online June 11, 2019.

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Many epinephrine self-injectors still potent long after expiration date

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(Reuters Health) - EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a new study that concludes patients might need expensive refills less often.

These autoinjectors contain a pre-set dose of epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis, a severe allergy attack. Untreated, anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making it difficult to breathe.

Patients who need these life-saving devices must carry at least one with them at all times and have access to one everywhere they go. Soaring prices and out-of-pocket costs for the autoinjectors have made it increasingly difficult for many patients to keep throwing out and replacing unused devices when they expire, researchers note in the Journal of Allergy and Clinical Immunology: In Practice.

The U.S. Food and Drug Administration (FDA) requires autoinjector expiration dates to ensure that the devices never contain less than 90% of the original dose of epinephrine, the study team notes.

For the study, researchers tested the contents of 46 different autoinjectors to see how much epinephrine remained after the expiration dates on the labels. Half of the devices were tested at least two years after their labeled expiration date. At this point, 80% of the devices still retained 90% or more epinephrine, indicating they were still effective under the FDA rules.

“If the expiration dating on these devices was changed, this means that patients would not need to replace their auto-injectors as frequently, limiting cost to them, their insurance, and the healthcare system, while still feeling secure that they have access to adequate treatment for anaphylactic reactions,” said lead study author Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa.

Devices six months past their labeled expiration date in the study still had 100% of the original epinephrine dose. One year after the labeled expiration date, devices still had 95% of the original epinephrine dose.

And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.

The study tested far too few devices to help determine with certainty whether all epinephrine autoinjectors in the U.S. might be safely used past their expiration dates, Kassel said by email.

The authors also note that they did not test the expired injectors’ effectiveness in stopping an anaphylaxis episode.

“Until the FDA changes the expiration dating guidance for these devices, patients with anaphylactic allergies should carry auto-injectors that have not yet expired,” Kassel advised.

“The greatest risk of using an expired auto-injector is that the epinephrine is no longer potent enough to combat the anaphylactic reaction, and this could result in death or critical illness.”

Right now, the expiration date is 18 months from the time the product is manufactured, a duration that is shorter than the expiration date for most other medications, said Dr. Kao-Ping Chua of the C.S. Mott Children’s Hospital and the University of Michigan Medical School in Ann Arbor.

While the study results build on a growing body of evidence suggesting that expiration dates for epinephrine autoinjectors could be extended, in the meantime, patients should use the devices as labeled, Chua, who wasn’t involved in the study, said by email.

“I don’t think anyone should postpone refilling an epinephrine auto-injector if they can afford it,” Chua said. “In a life-or-death situation, you want to have as much certainty as possible that the rescue medication is going to work.”

SOURCE: bit.ly/2F7WrTT Journal of Allergy and Clinical Immunology: In Practice, online May 28, 2019.

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IBM, Walmart, Merck in blockchain collaboration with FDA

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FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

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China agriculture ministry says no proof natural compound prevents swine fever

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BEIJING (Reuters) - China’s ministry of agriculture said on Thursday a company which claimed a natural compound was effective in preventing African swine fever did not have government approval to research the virus and its assertions were not scientifically sound.

Shopping mall operator Guangdong Highsun Group Co was questioned by the Shenzhen Stock Exchange earlier on Thursday after this week announcing it was backing development of an African swine fever vaccine.

Beijing strictly regulates research on, and handling of, the virus.

Highsun said on Tuesday it would spend 900 million yuan ($130.09 million), or 26% of its 2018 net assets, on supporting research into a natural compound it said had been shown to prevent the disease which is deadly to pigs and ravaging herds across Asia.

But the ministry said it had not received a research application and without experimental data, the claim that a polysaccharide injection is effective in preventing the virus lacked scientific proof.

Researchers around the world have been trying for years to develop a vaccine against African swine fever without success.

Highsun said that preliminary research had found the polysaccharide to be 92% effective in preventing the disease in clinical trials - an announcement which triggered a 10% surge in its shares on Wednesday, leading to a trading suspension.

The Shenzhen exchange said it was seeking clarity on several issues, including additional data regarding the vaccine’s effectiveness and whether the researchers had government approval to conduct research on the virus.

An official from Highsun, who asked not to be identified, said the company was preparing a response to the exchange’s questions and declined to comment further.

African swine fever kills almost all the pigs it infects. The breeding herd in China, the world’s top pork producer, has declined by a record 24% owing to the disease, the agriculture ministry said on Thursday.

The Bureau of Agriculture and Rural Affairs for Hainan province said on its website on Thursday that it had supported a research team that had isolated a polysaccharide compound from tropical plants which had shown a “certain preventive effect” against African swine fever.

However, it said more research was needed in areas including the possible impact of virus mutation and the safety, stability and feasibility of industrial production of the compound.

It is not clear if the bureau was referring to the same team backed by Highsun and it did not answer calls for a comment on the statement.

Highsun’s shares rose 7.3% to 3.38 yuan ($0.49) a share after resuming trading on Thursday.

Reporting by Dominique Patton and Beijing Newsroom; Meg Shen in Hong Kong; editing by Christian Schmollinger and Kirsten Donovan

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Philips upbeat on digital care as patients warm to data sharing

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AMSTERDAM (Reuters) - Dutch health technology company Philips expects sales at its digital care business to grow this year as patients see the benefits of sharing more medical data with doctors, Chief Executive Frans van Houten told Reuters.

FILE PHOTO: CEO Frans van Houten from the Dutch health technology company Philips presents the company's financial results for the fourth quarter and full year 2018, in Amsterdam, Netherlands, January 29, 2019. REUTERS/Eva Plevier

Philips’ connected care division offers platforms to remotely monitor patients and for doctors to share patient data.

“We expect to see a positive trend in connected care this year, with sales growth picking up,” Van Houten said in an interview.

Its sales have lagged those of the company’s bigger divisions, which sell large medical equipment and personal care devices, stagnating in 2018 and falling 1% in the first quarter of 2019.

But Philips, which has spun off its lighting and consumer electronics divisions and now focuses purely on healthcare, expects rising life expectancy and associated chronic diseases to lead to growing demand for devices that allow patients to stay at home, while being monitored.

That view was supported by an international study, published this week, which showed patients with access to their digital health records are more satisfied with the care they receive and are very willing to share that data with doctors.

The study, which involved 15,000 patients and 3,100 doctors across 15 countries and was commissioned by Philips, also showed that two thirds of people who don’t have access to their own records want doctors and other health professionals to have access to their data.

Some 70% of the doctors interviewed with access to digital records said it improved their work.

“Data is the new gold”, Van Houten said. “We are absolutely convinced that sharing more data leads to better diagnosis, better treatment and better outcomes, improving the productivity of doctors.”

Increasing use of digital records could help Philips, as it sells software tools for doctors to gather data from records and devices that allow patients to collect health data, such as blood pressure and cholesterol levels, at home and immediately share them with doctors.

“People want their data to be used”, Van Houten said. “Although the general perception seems to be of an aversion towards data sharing, we actually see the opposite when it comes to health care.”

Reporting by Bart Meijer. Editing by Jane Merriman and Mark Potter

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