MANILA (Reuters) – A Philippine government agency on Thursday exhumed the bodies of two children whose parents suspect they died of dengue after receiving a new vaccine against the disease, although its maker said it was not known to have caused any deaths in the country.
More than 800,000 Filipino children aged nine or more received Dengvaxia last year in a government immunization drive against the mosquito-borne tropical disease that kills about 20,000 people a year.
The Department of Health (DOH) stopped using Dengvaxia last month after its maker, Sanofi Pasteur, said the vaccine itself may in some cases increase the risk of severe dengue in recipients not previously infected.
One of the two exhumed bodies showed signs of excessive bleeding, said officials of the Public Attorney’s Office (PAO), which provides free legal assistance to the poor.
PAO forensic expert Erwin Erfe said bleeding was observed on the scalp of the second body.
“Bleeding is a prominent symptom of dengue,” Erfe told Reuters by telephone.
PAO is also investigating the deaths of five other children who received Dengvaxia and initial findings reveal a pattern in how they died, PAO chief Persida Acosta said.
“There was bleeding in the vital organs, the lungs, heart, liver, kidney, brain,” Acosta told Reuters. “These are all compatible with hemorrhagic shock.”
She said the PAO had received numerous requests to exhume bodies after the government launched its investigation.
The DOH said it would look at the findings. The DOH has also submitted cases involving the deaths of 14 children who received Dengvaxia to a review panel of doctors from a state university and a state-owned hospital.
While Dengvaxia is the first-ever approved vaccine for dengue, scientists had recognized it was imperfect and did not protect equally against the four different types of the virus in clinical tests.
A new analysis from six years of clinical data showed Dengvaxia provided persistent protective benefit against dengue fever in those who had prior infection.
But those not previously infected could suffer more severe symptoms in the long term, following vaccination upon a subsequent dengue infection, Sanofi has said.
“Up to this date, there has been no death established to have been causally linked to the dengue vaccine, not even among the 40,000 people involved in clinical trials conducted across 15 countries,” Sanofi said in a statement.
(Reporting by Karen Lema; Editing by Clarence Fernandez)
(Reuters Health) – – Women with infertility unrelated to a common hormonal disorder may have more options when they try in-vitro fertilization, two large new studies show.
Whereas in women with polycystic ovary syndrome (PCOS), freezing and thawing embryos before implantation offers a better chance of pregnancy and birth, in women without this condition thawed embryos and are no better or worse than fresh embryos, researchers in China and Vietnam have found.
The findings may encourage doctors to just implant one embryo at a time, lowering the risks that come when doctors try to implant more, producing multiple births and their associated complications.
The papers, published in The New England Journal of Medicine, are “good news for women seeking in-vitro fertilization,” said Dr. Lan Vuong, chief author of the Vietnamese study.
After an earlier study by the Chinese team showed that frozen embryos were better for women with PCOS, “a lot of people jumped to the conclusion that we should always do frozen. Some programs around the country won’t do fresh transfers anymore,” said Dr. Christos Coutifaris of the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, who was not connected with the new research.
“Now these two papers, equally large and done in non-PCOS patients, show that in terms of live birth, which is what we care about, there is no difference,” he told Reuters Health by phone. “So to apply the rule to everybody that we should freeze your embryos is probably not correct.”
Dr. Vuong said that in the past, doctors have often implanted more than one fresh embryo in women because of concerns that a frozen transfer may not work as well.
The fact that thawed embryos “produce the same pregnancy rate with less complications should transform the way in-vitro fertilization is practiced,” she told Reuters Health by email. “After the first fresh embryo transfer, it will be possible to freeze the remaining embryos and transfer them one by one, if necessary, without reducing the chance of pregnancy.”
Dr. Vuong, of the University of Medicine and Pharmacy at Ho Chi Minh City, and her colleagues also found that women with high levels of the female hormone progesterone might be better off receiving a thawed frozen embryo.
Dr. Coutifaris, who is president of the American Society for Reproductive Medicine, said a higher progesterone level may indicate that the development of the embryo and the womb are out of synch, and using a thawed embryo allows for better timing of the implantation.
It’s one example where “the challenge for us, as practitioners, is to determine who are the patients who will benefit from a freeze-only approach,” he said.
In the Chinese study of 2,157 women undergoing their first in-vitro fertilization cycle, the birth rate was 48.7 percent with thawed embryos and 50.2 percent with fresh. Doctors typically implanted two embryos per attempt.
In the Vietnam study of 782 women undergoing their first or second attempt, the live birth rates after the first transfer were 33.8 percent with frozen and 31.5 percent for fresh. They also implanted, on average, two at a time.
In both studies, the difference in birth rates between the groups was so small that it might have been due to chance.
Neither study found a higher risk of neonatal or obstetrical complications in either group, although frozen embryo transfer produced a statistically lower risk of over-stimulated ovaries, which leads to swollen and painful ovaries and is potentially dangerous.
The rates of the syndrome in the Chinese study were 0.6 percent with frozen embryos and 2.0 percent with fresh. The senior author was Dr. Zi-Jiang Chen of Shandong University, who did not respond to emailed questions.
It was the Chen group that, in 2016, reported that frozen-then-thawed embryos offered a 7-percentage-point edge when it came to producing live births among infertile women with polycystic ovary syndrome: 49 percent versus 42 percent. The improvement came primarily from a lower rate of pregnancy loss.
“The cost for freezing embryos is about 30 percent more than that for fresh transfer,” said Dr. Vuong. “However, the effectiveness of the treatment should be considered in decisions about which approach is more cost-effective. We have done a cost-effectiveness analysis of the two treatments and found that freezing embryos and subsequent transfer is not cost-effective over fresh transfer.”
SOURCES: http://bit.ly/2m2bPYw and http://bit.ly/2CxHmro The New England Journal of Medicine, online January 10, 2018.
(Reuters Health) – – Socially isolated people may be more likely to develop diabetes than adults with closer ties to family and friends, a recent study suggests.
Loneliness has long been linked to a wide variety of physical and mental health problems, particularly among chronically ill and elderly people. With diabetes in particular, close friends and family can influence how patients eat, how much they exercise, and how well they keep the disease in check.
To see how these relationships may influence the odds of getting diabetes in the first place, researchers examined data on 2,861 adults who ranged in age from 40 to 75 and were 60 years old on average.
More than half of these people had normal blood sugar and no diagnosis of diabetes. But 430 people, or 15 percent, had slightly elevated blood sugar classified as “pre-diabetes,” while about 4 percent were newly diagnosed with diabetes when they joined the study and 24 percent already had the disease.
On average, people without diabetes had 11 friends and family members in their social network, compared with fewer than 8 friends for people with newly or previously diagnosed diabetes, researchers report in BMC Public Health.
“Currently, high-risk groups receive advice to become more physically active and eat healthier without any inquiries about their social situation,” said lead study author Stephanie Brinkhues, a researcher at Maastricht University in the Netherlands.
“We think that this could be improved . . . as socially isolated people may even have a higher risk for disease,” Brinkhues said by email.
Every one-person reduction in the size of people’s social networks was associated with 12 percent higher odds of newly diagnosed diabetes in women and 10 percent higher odds for men, the study found. This was also tied to 8 percent greater likelihood of a previous diabetes diagnosis in women, and 5 percent greater odds for men.
At the same time, each 10 percent drop in the number of social network members living within walking distance was associated with 21 percent higher odds of a new diabetes diagnosis for women.
Every 10 percent increase in the proportion of the social network made of household members, meanwhile, was associated with 25 percent higher odds of a new diabetes diagnosis in women and 29 percent higher odds for men.
Living alone didn’t appear to influence the odds of diabetes for women. But for men, living alone was associated with 84 percent higher odds of a new diabetes diagnosis and 94 percent higher odds of a previous diagnosis.
The study wasn’t a controlled experiment designed to prove whether or how the number of people in social networks or the types of interactions within networks might influence the risk of diabetes.
Even so, the study adds to the evidence linking social isolation to diabetes and other chronic illnesses that can impact both quality of life and longevity, said Dr. Carla Perissinotto, a geriatrics researcher at the University of California, San Francisco.
“Social isolation doesn’t cause diabetes, but there is a relationship,” Perissinotto, who wasn’t involved in the study, said by email.
One theory is that too much time alone might lead to increased stress and inflammatory reactions in the body, Perissinotto added. Stress hormones are thought to influence how the body processes glucose, or sugars, and may contribute to the development of diabetes.
The study results offer fresh evidence of the importance of maintaining an active social life in middle age and beyond, said Dawn C. Carr, a researcher at Florida State University in Tallahassee who wasn’t involved in the study.
People who have many close relationships with friends and family members may be more motivated to be socially engaged, physically active and follow a healthy lifestyle, Carr said by email.
By contrast, people who live alone may have less motivation to cook healthy meals, get out and exercise or do other things that can keep health problems at bay.
“We need to nurture important relationships and be sure that we take our social health as seriously as our physical and psychological health,” Carr advised. “This is something we need to cultivate throughout our lives before we reach old age.”
SOURCE: http://bit.ly/2EucMzy BMC Public Health, online December 19, 2017.
(Reuters Health) – – Women with breast cancer often feel rushed to make a decision about surgery, and some of them might benefit from more time and better educational materials to inform their treatment choices, two recent studies suggest.
One study surveyed 487 women after they underwent either a lumpectomy that removes malignant tissue while sparing the rest of the breast, a mastectomy that removes the entire breast, or both procedures.
Regardless of what path they took, at least one in five women said choosing quickly was more important than making an informed decision, and at least as many patients felt like they didn’t have all the facts before their operations.
“A breast cancer diagnosis can feel like an emergency when you are the patient,” said lead study author Dr. Sunny Mitchell, a breast surgeon in Stratford, Connecticut.
“There is actually plenty of time to review all treatment options since survival rates are very high for early-stage breast cancer and do not change if a woman starts treatment within a few weeks,” Mitchell said by email.
Most early-stage breast cancer patients have either a lumpectomy or a mastectomy, and many of them get chemotherapy or radiation afterward to destroy any remaining abnormal cells and reduce the risk of cancer coming back.
In the survey, only 47 percent of lumpectomy patients, 67 percent of mastectomy patients, and 28 percent of women who had both procedures said they felt completely informed before they had these surgeries, Mitchell and colleagues found.
A quick decision was more important than an informed decision for 35 percent of the lumpectomy patients, 31 percent of the mastectomy patients, and 22 percent of the women who had both procedures.
A separate study in the same journal offers one way to help women understand their options.
For that study, researchers randomly assigned 227 women newly diagnosed with breast cancer to use an online decision-making tool or to read materials available on websites run by groups like the American Cancer Society and the National Cancer Institute.
All of the women participated in the study before their first surgical consultation.
With the decision aid, half of the women scored at least 80 out of 100 on tests of their knowledge about breast cancer and treatment options, compared with a median score of 66 for women who reviewed material on various websites.
At the same time, 72 percent of the women who used the decision aid recognized that they could wait a few weeks to make an informed treatment choice without affecting their survival odds, compared with just 54 percent for the other women.
“Women benefit from receiving high-quality information about breast cancer prior to their first visit with a surgeon,” senior study author Dr. Heather Neuman, a researcher at the University of Wisconsin School of Medicine and Public Health in Madison, said by email.
Decision aids can help women clarify their personal values and preferences, for example by focusing on whether they want to avoid radiation or concentrate on preserving their breasts, said Dr. Clara Lee, a cancer researcher at The Ohio State University Wexner Medical Center in Columbus.
This process can also prepare women to talk to their provider about treatment options and make an informed decision, Lee, who wasn’t involved in the study, said by email.
Women can still make an educated choice, aided by information online, even when they don’t use a decision aid, Lee added.
“Women should look for information that presents multiple treatment options and the pros and cons of those options – not just the pros,” Lee advised. “Making a decision is about more than just information; it’s also about being clear on what is important to you and being prepared to discuss these things actively with your provider.”
SOURCES: http://bit.ly/2EvQygi and http://bit.ly/2Ev7wLP Journal of the American College of Surgeons, online December 12, 2017.
WASHINGTON (Reuters) – Alex Azar, a former drug industry executive and lobbyist nominated to run the U.S. Department of Health and Human Services, indicated on Tuesday he supported a Republican bid to overhaul Medicaid and again vowed to tackle high drug prices.
Azar appeared before the Senate Finance Committee on Tuesday, which will ultimately decide whether to move his nomination forward. Azar also vowed to uphold Obamacare as long as it remained the law but said that the program needed changes.
“I believe I have a very important obligation to make the program work as well as possible,” Azar said during the wide-ranging hearing that lasted more than two hours. “What we have now is not working for people.”
Republicans have been trying to dismantle the 2010 Affordable Care Act, former President Barack Obama’s signature domestic policy achievement. Repealing and replacing Obamacare was one of President Donald Trump’s most frequently repeated campaign promises but Congress has repeatedly tried and failed to do so.
Azar said he favored elements of a Republican Senate Obamacare repeal bill that failed to garner enough support last year, which would have fundamentally restructured Medicaid, the government insurance program for the poor and disabled.
The doomed measure proposed repealing enhanced federal funding for Medicaid under Obamacare and instead providing block grants to states based on the number of enrollees in each state. The block grants, coupled with the repeal of Medicaid expansion, would slash funding to the 31 states that expanded the government program under Obamacare.
Azar said he supported that element of the legislation because it would provide states more flexibility in deciding how to run their Medicaid programs. Some Republican lawmakers have floated the idea of taking on Medicaid reform as a legislative priority this year.
Azar spent about a decade at Eli Lilly & Co, including five years as president of its U.S. unit. Democrats on Tuesday pointed to a handful of Lilly drugs whose prices more than doubled under Azar’s watch and fiercely questioned how seriously he would work to make prescription drugs more affordable.
During the questioning, Azar did not dismiss the possibility of allowing Medicare, the government health program for the elderly, to negotiate drug prices, a favored proposal among Democrats.
Azar vowed to work with Republicans and Democrats on his four top priorities: drug pricing, making healthcare more affordable and helping people who cannot purchase insurance on the Obamacare market, Medicare reform and the opioid epidemic.
Senator Ron Wyden, the top-ranking Democrat on the committee, said Azar’s promise to work on a bipartisan basis was a welcome change from the previous health secretary, Tom Price, who Wyden said did not work with Democrats.
Price, a former U.S. Republican Representative, resigned in September amid a furor over his use of expensive taxpayer-funded private charter jets for government travel.
(Reporting by Yasmeen Abutaleb; Editing by Jeffrey Benkoe)
(Reuters) – A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG and Johnson & Johnson of failing to warn of internal bleeding risks of their drug Xarelto, the companies said.
Judge Michael Erdos, in the Philadelphia County Court of Common Pleas, ruled following a hearing on the drugmakers’ motion to reverse the December verdict, which was their first trial loss in litigation over the blood thinner, the companies said.
J&J’s Janssen Pharmaceuticals Inc unit and Bayer, which jointly developed Xarelto, in separate statements welcomed the decision and said they will continue to defend against the allegations in related litigation.
“Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it,” Bayer said in a statement.
The verdict came in a lawsuit by Lynn Hartman, who was prescribed Xarelto to prevent strokes as a result of atrial fibrillation, an irregular heartbeat.
Hartman said that she took the drug for approximately one year and in June 2014 was hospitalized with severe gastrointestinal bleeding, which she blamed on Xarelto. She has since recovered.
Hartman and her husband sued the drugmakers in 2015. A jury in December awarded $1.8 million in compensatory damages and $26 million in punitive damages.
The lawsuit was one of around 21,400 that J&J says are pending in federal and state courts blaming injuries on Xarelto. The trial was the first to result from roughly 1,400 Xarelto cases pending in the Philadelphia court.
Michael Weinkowitz, a lawyer for the couple, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia.
The U.S. Food and Drug Administration approved Xarelto in 2011. It is prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.
Bayer and J&J contend Xarelto’s label adequately warns of bleeding risks.
Federal juries have cleared the companies of liability in three previous trials. The latest verdict in the federal litigation came in August in the case of a Mississippi woman.
(Reporting by Nate Raymond in Boston; Editing by Leslie Adler)
CHICAGO (Reuters) – Wal-Mart Stores Inc misled U.S. shoppers by selling organic eggs laid by hens raised in enclosed structures under package labels that said the birds had access to the outdoors, a federal lawsuit alleged on Monday.
The suit highlights uncertainty among consumers about production practices in the $500 million organic egg industry, farmers said, after the U.S. Department of Agriculture (USDA) last month shelved plans to spell out for the first time what it means for birds to have access to the outdoors.
Wal-Mart sells cartons of eggs to shoppers at a premium under its Organic Marketside brand with labels saying the eggs came from hens with “outdoor access,” according to the lawsuit filed by a customer.
However, the birds are raised by Cal-Maine Foods Inc inside enclosed structures that have screens to let in air, the complaint said.
“Consumers paying more for these eggs have been deceived,” the lawsuit said. “The theoretical ability to view the outdoors is not the same as having access to it.”
Wal-Mart said it had not reviewed the allegations, but was taking them seriously.
“We hold our suppliers to high standards and are committed to providing our customers the quality products they expect,” spokesman Randy Hargrove said.
Representatives of Cal-Maine, which is the biggest U.S. egg producer and also named in the lawsuit, did not immediately respond to requests for comment.
Enclosed structures, known as porches, meet USDA standards for producers of organic livestock to provide “year-round access for all animals to the outdoors,” experts said.
But many consumers expect egg-laying hens will be able to touch the soil and have access to sunshine, said David Bruce, general manager of eggs for Organic Valley, the largest U.S. cooperative of organic farmers.
“It’s very important that consumers get what they think they’re paying for,” he said. “You can’t have holes like this that allow that kind of deception.”
The USDA in 2016 issued a proposal that would have defined outdoors as an area in the open air with at least 50 percent soil.
The move was part of an attempt to increase confidence among consumers about organic labels at a time when the USDA said at least half organic egg production came from operations that exclusively used roofed porches to provide outdoor access to hens.
The USDA last year withdrew the proposal.
The case is Donnie Lee Gibson v Wal-Mart Stores et al, U.S. District Court, Northern District of California, No. 18-00134.
(This version of the story was refiled to delete an extraneous word in the first sentence)
(Additional reporting by Nandita Bose in New York; editing by G Crosse)
LONDON (Reuters) – An $11 billion burst of biotech bids in just four days has fueled expectations of a 2018 surge in life science deals as large drugmakers shop for promising assets from smaller rivals.
Separate reports on Monday by consultancy EY and law firm Baker McKenzie both predict a significant rise in mergers and acquisitions (M&A) this year, helped by U.S. tax changes that may lift big companies’ appetite for deals.
Celgene’s <CELG.O> up to $7 billion agreed takeover of Impact Biomedicines, Novo Nordisk’s <NOVOb.CO> $3.1 billion offer for Ablynx <ABLX.BR> and Takeda Pharmaceutical’s <4502.T> plan to buy TiGenix <G9U.BR> for $630 million have already got 2018 off to a flying start.
This follows a relatively subdued 2017, when total life sciences M&A totaled around $200 billion, dominated by Johnson & Johnson’s <JNJ.N> $30 billion purchase of Actelion and Gilead’s <GILD.O> $12 billion acquisition of Kite.
EY is confident this year’s deal value will exceed $200 billion, given companies’ increased financial firepower and balance sheet strength. There is also substantial pent-up demand, with 60 percent of life sciences executives surveyed in October 2017 planning to actively pursue M&A in the next 12 months, compared with 46 percent in April.
Baker McKenzie, meanwhile, predicts global healthcare M&A could rise 50 percent in 2018, with North America accounting for well over half of transactions.
Driving the demand is the increasingly pivotal role of biotech firms in discovering the drugs of tomorrow.
“I believe you will see a higher proportion of innovation at an industry level — and also at Novo Nordisk — coming from external resources,” Novo’s Chief Financial Officer Jesper Brandgaard told Reuters.
“Ablynx is an example of strong technology development occurring in a smaller biotech setting, with considerable speed and a lack of some of the bureaucracy you can get at large pharma companies.”
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light and a growing share of new products coming from younger biotech companies.
For large drugmakers, as well as big biotech businesses like Gilead and Celgene, small and innovative upstarts are now a vital source of experimental drugs with which to top up in-house development pipelines.
Pricing pressures on established medicines for conditions like diabetes and respiratory disorders, as well as patent expiries on yesterday’s blockbusters, are driving big players into niche disease areas where biotech groups often excel, according to Edison analyst and former fund manager Andy Smith.
“The pressures at big pharma look to be increasing and 90 percent of prescriptions in the U.S. are now for generics, so that pushes companies to look at cutting-edge therapies and it takes them straight into the biotech wheelhouse,” he said.
Whether 2018 will turn out to be a golden year for biotech M&A remains to be seen, but investors like event-driven hedge fund Case Equity Partners have high hopes for the drugs sector, following recent implementation of U.S. tax changes.
“U.S. companies with lots of cash trapped overseas can now put capital to work in the global M&A market more easily. We hence expect 2018 to be immensely active with multiple competitive auctions at significant premia,” the fund said in a an end-of-year letter.
Although bankers say the U.S. tax overhaul and particularly a lower tax rate for the repatriation of cash held offshore has so far had limited impact on deal negotiations, they believe companies may decide to allocate more cash to M&A in 2018.
The M&A outlook is likely to be a hot topic at the annual JP Morgan Healthcare Conference starting on Monday in San Francisco, when many biotech deals and alliances are often announced.
(Additional reporting by Maiya Keidan; editing by Alexander Smith)
NEW DELHI (Reuters) – India’s Supreme Court on Monday put on hold a lower court’s order that quashed federal rules mandating larger health warnings on tobacco packages, in a setback for the country’s $11 billion tobacco industry.
The High Court of southern Karnataka state last month struck down federal government rules requiring 85 percent of a tobacco pack’s surface to be covered in health warnings, up from 20 percent earlier. The rules had been in force since 2016.
The Supreme Court, which heard petitions brought forward by tobacco-control activists, stayed the Karnataka court’s order on Monday, citing the need to protect the health of citizens.
“Health of a citizen has primacy and he or she should be aware of that which can affect or deteriorate the condition of health,” the Supreme Court said in its 13-page order.
“Deterioration may be a milder word and, therefore, in all possibility the expression ‘destruction of health’ is apposite.”
The court’s decision comes as a relief for health advocates and federal health ministry who say bigger health warnings deter tobacco consumption. More than 900,000 people die each year in India due to tobacco-related illnesses, the government estimates.
India’s tobacco packaging rules are among the world’s most stringent. A government survey last year found that 62 percent of cigarette smokers thought of quitting because of such warning labels on the packets.
The court’s decision is a blow to cigarette makers such as India’s ITC Ltd and Philip Morris International Inc’s Indian partner, Godfrey Phillips India Ltd, whose representatives call the rules extreme. In protest at the health warning measures, the industry briefly shut its factories across the country in 2016 and filed dozens of legal cases. (http://reut.rs/1Of3fKL)
On Monday, both federal health ministry officials and tobacco industry executives were in attendance inside a packed courtroom to hear the proceedings which lasted for about 40 minutes. The three judges took time to look over examples of health warning pictures used on cigarette packs.
Kapil Sibal, a lawyer who argued for the industry, urged the court to reduce the size of tobacco pack warnings. At one point, he cited the absence of health warnings on a glass of whisky to argue against such displays on tobacco products.
The attorney general of India, K. K. Venugopal, defended the government’s stringent rules, saying they were “one of the most progressive” steps to protect the health of people.
The case will next be heard on March 12.
(Reporting by Aditya Kalra; Additional reporting by Suchitra Mohanty; Editing by Tom Lasseter and Richard Balmforth)
By Jacob Gronholt-Pedersen and Robert-Jan Bartunek
COPENHAGEN/BRUSSELS (Reuters) – Denmark’s Novo Nordisk, the world’s biggest insulin maker, went public with a 2.6 billion euro ($3.1 billion) bid for Belgian biotech group Ablynx on Monday, seeking a new source of growth by bolstering its treatments for rare blood disorders.
Ablynx rejected Novo’s latest takeover approach and analysts predict the Danish group, whose new chief executive is trying to expand by buying drugs developed by competitors, might face counterbidders and would need to raise its bid.
Shares in Ablynx closed up 45 percent at 30.80 euros, above the 30.50 euros per share Novo has offered. The bid represents a 60 percent premium to the Belgian company’s share price on Dec. 6, which was before Novo’s first approach.
The unsolicited bid comes at a time of renewed interest by large drugmakers in smaller biotech firms, with U.S.-based Celgene clinching a deal to buy Impact Biomedicines for up to $7 billion on Sunday and Japan’s Takeda Pharmaceutical agreeing last week to buy another Belgian biotech group TiGenix for $630 million.
Ablynx said in a statement that its board “unanimously concluded that the proposal fundamentally undervalues Ablynx and its strong prospects for continued growth and value creation”.
It later said that Peter Fellner, its chairman since 2013, had decided to resign with immediate effect. It did not say why.
The Belgian group specializes in the research of novel drugs based on nano-bodies found in the immune systems of llamas and alpacas, for which it partners with several of the world’s largest pharmaceutical companies.
The main attraction for Novo is Ablynx’s experimental drug caplacizumab for the rare bleeding disorder acquired thrombotic thrombocytopenic purpura, which would complement Novo’s line-up of blood products focused on haemophilia.
The $11 billion haemophilia market is facing upheaval and Novo stands to lose sales following approval of a new Roche drug Hemlibra.
Biopharmaceutical treatments, led by haemophilia, make up around 20 percent of Novo’s sales, with diabetes and obesity products accounting for the remaining 80 percent.
“We have solid growth in our diabetes and obesity business but we are struggling a little bit to maintain the same level of growth momentum in biopharma,” Novo’s Chief Financial Officer Jesper Brandgaard said.
NEW NOVO CEO ACTS
The Danish company said it would pay 28.00 euros per share in cash for Ablynx and an additional 2.50 euros in a so-called contingent value right (CVR) if certain conditions related to other drugs in Ablynx’s research portfolio were met.
An acquisition would be the first by Novo Nordisk CEO Lars Fruergaard Jorgensen, who took over a year ago. He has said the firm needs external innovation to broaden its product line-up.
Under previous chief executive Lars Rebien Sorensen, Novo sat out a spate of deal-making across the drugs industry and instead focused on its market-leading position making insulin and other diabetes treatments.
But in March, the company approached Global Blood Therapeutics, a U.S. biotech company focused on serious blood disorders, to discuss a potential takeover, people familiar with the situation said.
Finance chief Brandgaard said the current bid could be revised if Ablynx agreed to engage in talks.
“I think it would be natural to update the bid following a detailed discussion with the board of directors of Ablynx,” he said on a conference call, adding that it would be premature to speculate on any increase.
Brandgaard also played down the threat of an interloper, saying: “In terms of counter proposals it is not our understanding that any other bidder is pursuing the target.”
BELGIUM’S THRIVING BIOTECH SCENE
Ablynx had already rejected an offer by the Danish group on Dec. 14 and Novo Nordisk said the new bid, made on Dec. 22, was some 14 percent higher.
“Novo Nordisk regrets that the board of directors of Ablynx has so far declined to engage in any discussions, despite the proposals which have been put forward,” it said in a statement.
Analysts at Jefferies said they had a fair value of Ablynx at 29 euros per share, rising to 36 euros under a long term upside scenario.
“We envisage Novo needing to hike the offer and could see counterbids,” the analysts said.
Tax breaks and other incentives have created a thriving biotech industry in Belgium, with many companies spun off from university projects now listed on its stock exchange.
Ablynx’s shares have almost doubled in price in the past 12 months, buoyed by successful clinical trial data.
Its products, which are all still undergoing medical trials, target many different diseases such as rheumatoid arthritis, psoriasis or cancer.
Evercore is advising Novo, while JPMorgan is working for Ablynx.
($1 = 0.8353 euros)
(Additional reporting by Stine Jacobsen in Copenhagen, Philip Blenkinsop in Brussels, Ben Hirschler in London and Abinaya Vijayaraghavan in Bengaluru; Editing by Keith Weir/David Evans/Alexander Smith)
CHICAGO (Reuters) – Monsanto Co has won support from eleven U.S. states in its attempt to stop California from requiring cancer warnings on products containing glyphosate, ratcheting up a legal fight over the company’s popular weed killer.
Missouri, home to Monsanto’s headquarters, along with other farm states including Iowa and Indiana, said in court documents on Tuesday that the warnings would be misleading because there is no definite link between glyphosate and cancer.
Midwest businesses would need to include warnings on glyphosate products if California requires them or stop selling such goods because they may end up in the Golden State, according to the states’ filing.
California added glyphosate, the main ingredient in Monsanto’s Roundup herbicide, to its list of cancer-causing chemicals in July 2017 and will require products containing the chemical to carry warnings by July 2018.
The state acted after the World Health Organization’s International Agency for Research on Cancer concluded in 2015 that glyphosate was “probably carcinogenic.”
“The mandate imposes confusing and potentially inconsistent obligations on non-resident businesses, creating a strong incentive to abandon glyphosate markets altogether,” the states’ filing said.
For more than 40 years, farmers have applied glyphosate to crops, most recently on soybeans that Monsanto genetically engineered to resist the herbicide. Roundup is also sprayed on residential lawns and golf courses.
The controversy in California is a headache for the company as it faces a crisis around another herbicide based on a chemical known as dicamba that has been linked to U.S. crop damage.
Monsanto, which is being acquired by Bayer AG for $63.5 billion, developed the dicamba-based product following an increase in weeds resistant to glyphosate.
The 11 states are supporting a federal lawsuit Monsanto, the National Association of Wheat Growers and other agricultural groups filed in November to stop the state from requiring glyphosate warnings.
Monsanto said Wednesday it had discussed California’s mandate with officials in agricultural states as it proceeded with the lawsuit.
California’s Office of Environmental Health Hazard Assessment (OEHHA), which is named in the lawsuit, declined to comment. The office previously said it stands by the decision to include glyphosate on the state’s list of products known to cause cancer, as required under a rule known as Proposition 65.
“Proposition 65 is 30 years old and for every one of those years there have been strenuous attempts to kill it on the ground that it’s different from other states,” said David Roe, the rule’s primary author.
“They’ve always failed.”
(Reporting by Tom Polansek; Editing by Matthew Lewis)
(Reuters Health) – – Women who breathe polluted air during the month right before or after they get pregnant may be more likely to have babies with birth defects, a U.S. recent study suggests.
Researchers examined data on birth defects for almost 290,000 infants born in Ohio from 2006 to 2010, matching these records with air pollution measurements near mothers’ homes.
They focused on what’s known as fine particulate matter, or PM 2.5, a mixture of solid particles and liquid droplets smaller than 2.5 micrometers in diameter that’s found in traffic exhaust and can include dust, dirt, soot, and smoke.
Higher levels of PM 2.5 exposure in the month before and after pregnancy were associated with a small but statistically meaningful increased risk of congenital birth defects, the study found.
“Our study indicates that there are several particularly vulnerable exposure periods near the time of conception, both before and after conception, in which exposure to higher levels of particulate matter in the air may pose an increased chance for a birth defect to occur,” said senior study author Dr. Emily DeFranco of the University of Cincinnati College of Medicine in Ohio.
The impact of particulate matter on birth defects varied based on how far women lived from air quality monitoring stations.
Overall, when researchers looked at every mother in the study, women were exposed to average PM 2.5 levels of 13.79 micrograms per cubic meter of air (ug/m3) during the months just before and after they conceived. This included women who lived within 10 kilometers (6.2 miles) of an air quality monitoring station.
When researchers looked at a subset of women who lived within 5 kilometers of a monitoring station, they found that for every 10 ug/m3 increase in PM 2.5 levels women experienced during the month after conception, their babies were 19 percent more to be born with birth defects.
Certain types of birth defects appeared more strongly connected to air pollution, including abdominal malformations and what’s known as hypospadias, an abnormality in boys that occurs when the opening of the urethra doesn’t develop on the tip of the penis and instead forms on the shaft or on the scrotum.
At the time of the study, the U.S. Environmental Protection Agency standard for particulate matter levels was 15 ug/m3, while the current standard is 12 ug/m3, researchers note in the Journal of Pediatrics.
“Our study results support the importance of public health education and initiatives to minimize population exposure to airborne pollutants,” DeFranco said.
The study wasn’t a controlled experiment designed to prove whether or how mothers’ exposure to air pollution might influence the odds of birth defects in their babies. The study also only examined air pollution near women’s homes, and not necessarily near where they worked or spent the most time outdoors.
Even so, it makes sense for women to limit their exposure to air pollution whenever possible whether by avoiding outdoor commutes during rush hour or concentrating on indoor air quality, said Dr. Shruthi Mahalingaiah, an environmental health researcher at Boston University who wasn’t involved in the study.
“If you live in areas of the world with high levels of ambient air pollution, you may consider installing appropriate air or ventilation systems so that your in-home air quality is excellent,” Mahalingaiah advised. “Ideally, working together with policy makers, companies, and nations to reduce emissions and innovate around sequestering current levels of emissions would be a goal.”
SOURCE: http://bit.ly/2E47lqR Journal of Pediatrics, online December 10, 2017.
NEW YORK (Reuters) – Drugmakers opened the new year by raising U.S. prices on dozens of medicines, but early data showed the increases generally remained within a 10 percent self-imposed limit in response to a backlash from consumers and politicians.
Soaring U.S. prices for both branded and generic drugs have sparked public outrage and government investigations over the past few years.
“Drug price increases are somewhat more constrained in 2017 and 2018 than they have been previously,” Cowen and Co analyst Eric Schmidt said.
Allergan Inc <AGN.N> raised prices on 18 different drugs, including dry eye treatment Restasis and irritable bowel syndrome drug Linzess, by 9.5 percent, according to a research note released by Jefferies on Tuesday.
Jefferies cited data collected by Medi-Span Price Rx and refers to list price increases, before potentially significant discounts and rebates that drugmakers provide to win preferred coverage by insurers. Medi-Span did not respond to requests to confirm the data.
Allergan’s chief executive, Brent Saunders, in late 2016 pledged to keep price increases below 10 percent as part of what he called the company’s “Social Contract with Patients.”
Allergan spokesman Mark Marmur said the increases will be the only ones taken on those brands in 2018, adding that discounts to various payers should bring the actual increases to consumers down to the low single digits.
Other drugmakers raising prices include Amgen Inc <AMGN.O>, Teva Pharmaceutical Industries Inc <TEVA.TA> <TEVA.N> and Horizon Pharma <HZNP.O>, according to Jefferies and Cowen. Amgen raised the price on its blockbuster rheumatoid arthritis and psoriasis drug Enbrel by 9.7 percent and Teva increased prices on its ProAir HFA and ProAir RespiClick asthma inhalers by 6 and 3 percent, respectively.
Drug price increases are coming under more scrutiny from states. California Governor Jerry Brown in October signed legislation requiring drug manufacturers to give 60-day notice if prices are raised more than 16 percent over a two-year period.
Shares of Allergan rose 4.1 percent on Tuesday, while Teva and Horizon Pharma shares were up 0.8 percent and 2.9 percent, respectively.
(Reporting by Michael Erman; Editing by Leslie Adler)
(Reuters) – Sangamo Therapeutics Inc and Pfizer Inc said on Wednesday they would work together to develop a gene therapy to treat ALS, a disease that affects nerve cells in the brain and the spinal cord.
The gene therapy will also be used to treat patients with a brain disorder caused by mutations of a gene that is linked to about a third of hereditary ALS cases.
The partnership comes at a time when gene therapy is gaining momentum, after several high profile failures in the late 1990s and early 2000s, with the U.S. Food and Drug Administration recently updating guidance to help speed up development of such treatments.
The agency last month approved Spark Therapeutics Inc’s treatment for a rare form of blindness, marking the first approval of a gene therapy for an inherited disease.
Under the terms of the deal, Sangamo will receive a $12 million upfront payment from Pfizer and an additional $150 million in milestone payments, the companies said.
ALS (amyotrophic lateral sclerosis), whose sufferers include renowned British physicist Stephen Hawking, attracted international attention in 2014 with the “Ice Bucket Challenge”, in which people posted videos of pouring ice-cold water on themselves to encourage donations to research.
Shares of Sangamo were up 5.4 percent at $18.50, while those of Pfizer were up marginally before the bell on Wednesday.
(Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Saumyadeb Chakrabarty)
LONDON (Reuters) – U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the European Union.
The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world’s second biggest market behind the United States.
Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies.
Consultancy Deloitte said last month that projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent.
Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. (http://tmsnrt.rs/2hGom21)
Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has hailed these products as “a whole new scientific paradigm for the treatment of serious diseases”. However, there is debate as to how cash-strapped healthcare systems will pay for them.
Under Gottlieb, the FDA has taken advantage of policy changes implemented in recent years to accelerate the drug approval process.
Procedures such as the agency’s “breakthrough therapy” designation have cut review times and helped to stimulate competition by adding multiple new drugs that often work in a similar way.
A wide choice of medicines with the same mechanism of action can be a double-edged sword for manufacturers, since it gives insurers and governments ammunition to drive down prices.
Pfizer and Merck’s new diabetes drug Steglatro, for example, was the fourth product of its kind to win a green light in the United States, while Novo Nordisk’s Ozempic was the sixth of its type. Both were approved in December.
In cancer, AstraZeneca’s Imfinzi was the fifth medicine to target a key protein found on the body’s immune cells when it won approval last May.
For the current year, companies have more new products waiting in the wings, although the pace of FDA approvals may be tempered by the fact that several drugs that had been expected to be cleared in the first quarter of 2018 were actually approved in 2017.
In Europe, meanwhile, the focus will be on any disruption or delays to the approval process as the European Medicines Agency prepares to relocate from London to Amsterdam as a result of Britain’s decision to leave the European Union.
(Reporting by Ben Hirschler; Editing by Keith Weir)
FRANKFURT (Reuters) – Siemens will test the appetite of sovereign wealth funds ahead of the planned listing of its healthcare unit Healthineers next year, its chief executive told a German weekly, possibly to secure anchor investors for the flotation.
The listing of a minority of the unit, which makes X-ray and MRI machines, is set to take place in the first half of 2018 and is expected to value Healthineers as a whole at around 40 billion euros ($48 billion).
Siemens is expected to sell 15-25 percent of Healthineers, sources have said, implying stock worth 6-10 billion euros could be sold – Germany’s biggest share offering since Deutsche Telekom in 1996.
“Internal preparations are going well and we are still planning the listing in the first half of 2018, if markets play along,” Joe Kaeser told Frankfurt Allgemeine Sonntagszeitung in an interview published on Sunday.
“In any case, we are planning to test the interest of relevant anchor shareholders, including sovereign wealth funds.”
Asked whether this included Norway and China, home to the world’s largest and third-largest state funds, respectively, Kaeser said: “We will probably cover the range of the most important state funds, yes. The advantage would be that we would gain anchor investors. The disadvantage: the free float of shares is not as high.”
The move is designed to enable the unit to raise its own funds for takeovers and investments in the healthcare sector as well as crystallizing its standalone value, removing some of the “conglomerate discount” that weighs on Siemens’ valuation.
In 2016, utility RWE won BlackRock as an anchor investor in the initial public offering of its Innogy unit. RWE ended up selling a 23.2 percent stake in the networks, renewables and retail unit.
(Reporting by Christoph Steitz; Editing by Alison Williams)
ADEN (Reuters) – Nahla Arishi, chief pediatrician at the al-Sadaqa hospital in this Yemeni port city, had not seen diphtheria in her 20-year career. Then, late last month, a three-year-old girl with high fever was rushed to Arishi’s ward. Her neck was swollen, and she gasped for air through a lump of tissue in her throat. Eight days later, she died.
Soon after, a 10-month-old boy with similar symptoms died less than 24 hours after arriving at the hospital.
Two five-year-old cousins were admitted; only one survived.
A 45-day-old boy, his neck swollen and bruised, lasted a few hours. His last breath was through an oxygen mask.
One morning in early December, 16-month-old Sameh arrived at the hospital carried by his aunt and delirious with fever. Arishi immediately recognized a new case of diphtheria. “Put on your mask,” she ordered the aunt.
Sameh’s father, a fighter in Yemen’s three-year war, rushed in, grabbed his son, yanked off the baby’s shoes and threw them on the floor. “Sameh is the light of the house,” he wailed, feeling the boy’s feverish brow and body.
This is the emergency ward to a nation. After three years of warfare, cholera and hunger, Yemen faces a new battle: In the past four months, doctors across the country have recorded at least 380 cases of diphtheria, a bacterial disease that last appeared here in 1992.
Arishi, like her country around her, is struggling to cope. Every month, she and her team drip-feed dozens of Yemen’s half a million severely malnourished children. Her ward has also treated hundreds of the one million people infected by cholera.
This spring, Arishi and her colleagues reopened an abandoned wing of al-Sadaqa hospital, fenced it with chicken wire and created a makeshift cholera treatment center. Now, they are converting part of that center into a diphtheria ward, cordoning off isolation units by barring hallway doors.
But with rusty oxygen tanks and only two functional ventilators in a different part of the hospital – and with the expectation that the cholera epidemic will worsen in coming months — her triage upon triage is no longer working.
“We’re getting more patients but we can’t deal with them. We don’t have supplies. We don’t have money,” said Arishi, “This war has got to end.”
For the past three years, Yemen has been the combat zone of a struggle for regional supremacy between Saudi Arabia and Iran. Riyadh and some of its Arab allies jumped into Yemen’s civil war in 2015 to help quell an uprising by the Houthis, an Islamic political-religious movement backed by Iran. In addition to airstrikes, Riyadh – with U.S. and U.N. backing – has positioned ships in Yemeni waters as a way to stop arms reaching Houthi militia.
But the blockade has ended up isolating a country that was already the poorest in the Middle East. Vital provisions – food, medicine, fuel, medical equipment, batteries, solar panels and more – are not getting through. Humanitarian shipments of food and medicine have mostly been allowed into the country. Yet Saudi-led forces have severely delayed aid shipments or closed ports outright, especially in northern Yemen where fighting and the humanitarian crisis are most acute.
The war and blockade have also thwarted Yemen’s vaccination programs.
Seven years ago, 80 percent of children were fully immunized with three doses of diphtheria, whooping cough and tetanus vaccine, or DTP as the combined shot is called, according to Zaher Sahloul, a critical-care specialist who cofounded a nonprofit called MedGlobal. Now, he says, that has dropped to 60 percent.
Poor record keeping means there are discrepancies in data related to vaccine coverage. Yemen’s Ministry of Health says 85 percent of Yemeni children have been immunized against diphtheria, whooping cough, tetanus, Hepatitis B and bacterial influenza since the beginning of the conflict, a mere two percentage point drop from pre-war years.
In late November, the U.N.’s World Health Organization (WHO) sent a shipment of diphtheria antitoxins – designed to treat those already infected – and vaccines to the capital Sanaa. The vaccines were delayed by the Saudi blockade for a week, the WHO said.
In July, the Geneva-based International Coordinating Group on Vaccine Provision earmarked a million cholera vaccines for Yemen. An initial shipment of 500,000 doses was sent to the African Horn country of Djibouti, and was ready to send on to Sanaa. But the WHO and local authorities in Sanaa decided together to scrap the vaccination plan, citing logistical and technical issues.
“Yemen needs a Marshall Plan,” said Sahloul, who was visiting al-Sadaqa’s treatment center in December. “It is difficult to foresee an optimistic scenario if the current conditions persist,” he said.
DISEASE AFTER DISEASE
Arishi began her medical career in the mid-1990s after Yemen unified following years of conflict between communist and pro-western forces. She joined the al-Sadaqa hospital, which was built in the 1980s with funds from the Soviet Union.
In her two decades at the hospital’s pediatric ward, Arishi has seen Yemen slowly come apart again. Even in the mid 2000s, the country faced widespread hunger because of rising food prices. The feeding center of al-Sadaqa’s hospital, she said, was crowded even before the new civil war began.
In the spring of 2015, Houthi forces, aided by the now-deceased former president Ali Abdullah Saleh, advanced south from their stronghold in the Yemeni capital Sanaa and took over Aden’s airport. It was then that the coalition of Arab states led by Saudi Arabia joined the war and began launching airstrikes against Houthi-held enclaves. Fighting raged until troops backing the officially-recognized government wrenched Aden from Houthi control in July of that year.
During the first months of fighting, al-Sadaqa filled with hundreds of wounded children and adults.
By the middle of 2016, another group of patients began pouring into the hospital. A cholera outbreak that started in Sanaa had spread to Aden. Dehydrated children, their condition made worse by malnutrition, flooded into her pediatric ward. Many did not survive, Arishi said.
Cholera can kill because patients quickly lose their fluids through vomiting and watery diarrhea. When caught early, it can be treated by replacing fluids.
When a second wave of cholera infections swept Yemen in April this year, Arishi and her colleagues decided to set up the new treatment center. They picked a building away from the main wings of the hospital to avoid contamination and repaired it with funds from the WHO and medical aid group Médecins Sans Frontières (MSF). Converting the building, which had been abandoned for two years after the war, required “heavy cleaning work, electricity, water system repairs as well as installing air conditioners,” according to MSF.
Yet, like the country itself, al-Sadaqa was overwhelmed by the cholera epidemic. Nationwide, a million people have been infected, according to the International Committee of the Red Cross. The WHO says cholera has killed more than 2,200 people.
Most of the infected were in the populous north of the country. But al-Sadaqa, which took in patients from across south Yemen, was also unprepared. Arishi and her colleagues had expected 10 patients at a time. Instead, by the summer, they were treating more than a hundred, mostly adults, a day.
Since September, the spread of cholera across the country has abated. However, doctors agree that a new wave of infections is likely in March, when the country’s rainy season returns. Cholera spreads more easily in wet weather, because the bacteria live in rivers and coastal waters which swell with the rain. Rain brings sewage into sources of drinking water.
In August, a new disease began to emerge. In Ibb governorate, 170 km south of Sanaa, a 17-year-old boy was diagnosed with diphtheria, according to the WHO.
Diphtheria is caused by bacteria that mainly infect the throat, nose and airways and send toxins into the bloodstream. It has largely receded as a global health threat, because much of the world’s population is protected through routine immunization.
But the disease is highly contagious once it takes root, doctors say, since it spreads in the droplets from coughing and sneezing. Small children are particularly vulnerable because toxins from the bacteria build up a coating of dead tissue that blocks their small airways.
Since the mid-August case, more than 380 patients have been admitted to hospitals across Yemen with diphtheria-like symptoms, according to the WHO. Doctors diagnosed the cases based solely on patients’ symptoms. Close to 40 of the patients have died, by WHO estimates.
The first case of suspected diphtheria reached al-Sadaqa in November. Of the seven children who arrived within a fortnight, nearly all were initially misdiagnosed with mumps or flu. Four died.
Arishi faced the problem of isolating children with symptoms of diphtheria. She asked hospital administrators to block a hallway door with a cupboard. Behind it, she tried to isolate those who might infect others.
But she lacked basic resources to treat the new disease. Al-Sadaqa hospital, like most others in Yemen, does not have the reagents needed to test for diphtheria. In fact, none of Arishi’s diagnoses has been confirmed by laboratory tests.
Marc Poncin, an MSF emergency coordinator in Ibb governorate, said the lack of recent experience means it could be harder to treat diphtheria.
“There has been a loss of knowledge regarding its treatment, because it’s become something of a neglected and forgotten disease,” he said.
After a diagnosis, treatment is far from easy. Doctors can prescribe antitoxins and antibiotics. But until a few weeks ago, Yemen had no such antitoxin stocks.
The United Nations Children’s Fund and the WHO have imported more than 5 million doses of vaccines to immunize children in the worst affected areas. The WHO has already distributed antibiotics to patients and, as prophylactics, to their families.
Some diphtheria patients need emergency surgery to remove blockages from their airways or need machines to breathe. But most of Yemen’s hospitals don’t have such equipment. As of early December, only two of al-Sadaqa’s three mechanical ventilators were working, and the hospital didn’t have an isolated operating room for diphtheria patients.
The lack of resources has caused strains with the hospital’s supporters. When Arishi cordoned off a part of the cholera ward for the incoming diphtheria patients a couple of weeks ago, the WHO was not happy with the decision, according to Hussein Hassan, head of the WHO’s Aden office.
“We cannot confidently say that cholera is over. It is a seasonal problem and it may come back. What happens if another wave starts and the ward is filled with diphtheria patients?” said Hassan.
“I DIDN’T WANT TO LOSE MY KID”
Arishi says there is another sign that Yemen is breaking down: parents’ waning faith.
She sees more examples of families that have not vaccinated their children because they distrust both their government and international organizations.
Earlier this month she confronted Saleh Khaled, the father of a five-year-old boy called Yasir, who arrived with severe diphtheria symptoms.
“Why did you not vaccinate your son?” Arishi asked.
Yasir’s first cousin, who was also five years old and unvaccinated, had died a few days earlier. When the first symptoms had appeared on Yasir’s neck and chin, the boy’s parents had given him honey.
Khaled said he had heard rumors, years earlier, about children who had died after healthcare workers had allegedly switched vaccine vials with insulin during a door-to-door vaccination campaign.
“I didn’t want to lose my kid because of something like this,” he said. “We don’t trust the people who work in the health department.”
Others in the al-Sadaqa ward that day echoed similar fears.
“We live only because of God’s mercy,” said Khaled Nasser, the father of 16-month-old Sameh. Nasser, a member of a local armed group that fights alongside Saudi-allied forces, said fellow fighters had helped him buy medicine when Sameh got sick.
Arishi herself barely ekes out a living. She makes $210 a month at al-Sadaqa and works at a private clinic three days a week to supplement her income. The mother of three treats neighbors and relatives without getting paid. Her husband, also a pediatrician, works at another clinic in Aden.
For Arishi, war is both burden and inspiration. She says it has made her commitment to medicine stronger.
“If I leave and my husband leaves and everyone leaves, who will stay to treat our patients?” she said. “Aden is my city. It is my responsibility.”
(Additional reporting by Kate Kelland in London and Stephanie Nebehay in Geneva. Edited by Alessandra Galloni and Simon Robinson)
(Reuters) – Health workers in Rohingya refugee camps in Bangladesh are struggling with a shortage of medics able to administer antitoxins to patients infected with diphtheria that has killed nearly two dozen people, aid officials said.
Neighboring Myanmar’s military cracked down on Muslim Rohingya from Rakhine state following Rohingya militant attacks on an army base and police posts on Aug. 25. More than 650,000 Rohingya have fled mainly Buddhist Myanmar to Bangladesh since August, on top of more than 200,000 who fled earlier, according to latest United Nations data.
Doctors Without Borders (MSF), the lead agency dealing with an outbreak of the bacterial disease in camps sheltering the Rohingya, has treated around 2,000 patients in the past few weeks and is receiving around 100 new cases daily.
The World Health Organization (WHO) describes diphtheria as a widespread, severe infectious disease with epidemic potential and a mortality rate of up to 10 percent. MSF has called diphtheria a disease “long forgotten in most parts of the world thanks to increasing rates of vaccination”.
MSF has managed to provide antitoxins to only around 12 patients daily due to the lack of trained medics, said Crystal van Leeuwen, an MSF emergency medical coordinator now in Cox’s Bazar where the refugee camps are located.
“Once we do have enough people and other organizations start to administer as well, we may get into a situation where we don’t have enough antitoxins anymore,” she told Reuters by phone on Thursday.
“It’s a double-edged sword. We need both the human resources to administer it, and we need more antitoxins at the same time.”
According to a U.N. report in February, supply of diphtheria antitoxin serum has been limited for many years and the shortage is expected to continue through 2017.
The British government said on Thursday it was sending a team of more than 40 doctors, nurses and firefighters to Cox’s Bazar for six weeks to deal with the diphtheria outbreak following a request by the WHO and Bangladesh government.
The refugees live in densely populated camps and shacks made from bamboo and plastic sheets, with poor access to clean water, sanitation and health services.
(Reporting by Krishna N. Das in NEW DELHI and Nurul Islam in COX’S BAZAR; additional reporting by Serajul Quadir in DHAKA)
LONDON (Reuters) – A cafe in London is taking barista art to a new level by giving customers the chance to sip on their own self-portraits.
The Tea Terrace, based in House of Fraser’s Oxford Street branch, has become Europe’s first location to deliver the “Selfieccino,” which features an image of customers’ faces on the frothy topping of their drinks.
Patrons send their headshots via an online messaging app to the barista and are given the choice of either a cappuccino or hot chocolate as their canvas.
The image is uploaded to the “Cino” machine while the drink is placed in position. The picture is then scanned and reproduced onto the froth using a flavorless food coloring.
The process takes around four minutes before an image is presented on the froth, ready to be photographed and sent to all points via social media before drinking, and costs around 5.75 pounds. ($7.5)
“Due to social media, the dining experience has completely shifted,” Ehab Salem Shouly, owner of The Tea Terrace told Reuters. “It’s not enough any more to just deliver great food and great service – it’s got to be Instagram worthy.”
Over 400 of the personalized drinks have been sold since they launched on Saturday, with the hash tag “Selfieccino” going viral across various social media platforms.
The Tea Terrace hopes to trademark the term as they expand the service across their other two locations in London Victoria and Guildford, Surrey.
(Reporting by Elliot Moses; editing by Stephen Addison.)
CHICAGO (Reuters) – The U.S. government on Tuesday lifted a 2014 temporary ban on funding research involving the flu and other pathogens in which scientists deliberately make them more transmissible or more deadly.
The ban covered federal funding for any new so-called “gain-of-function” experiments that enhance pathogens such as Avian influenza, SARS and the Middle East Respiratory Syndrome or MERS viruses.
It followed a series of safety breaches at federal laboratories involving the handling of anthrax and avian flu that raised questions about lab safety at high-security national laboratories.
The concern with “gain-of-function” research is that while the work may produce useful insights about how a pathogen might naturally evolve and become more deadly, laboratory-enhanced pathogens could be used for biowarfare or bioterrorism if they fell into the wrong hands.
The U.S. National Institutes of Health (NIH) said in a statement on Tuesday that such work is important to help scientists understand and develop effective countermeasures “against rapidly evolving pathogens that pose a threat to public health.”
NIH director Dr. Francis Collins said in a statement the funding ban was lifted after the Department of Health and Human Services issued a framework to guide decisions over work involving enhanced pathogens with the potential to cause a pandemic.
That framework lays out an extensive review process for federally funded research on enhanced pathogens – considering both the benefits of the research and the potential safety risks.
Dr. Sam Stanley, president of Stony Brook University and chairman of the National Science Advisory Board for Biosecurity, which provided guidance on the new policy, noted the world’s deadliest pathogens are evolving naturally. He said research is needed to understand and prevent devastating pandemics, such as the 1918-1919 Spanish flu pandemic that killed some 50 million people.
“I believe nature is the ultimate bioterrorist and we need to do all we can to stay one step ahead,” Stanley said in an email, adding “basic research on these agents by laboratories that have shown they can do this work safely is key to global security.”
(Reporting by Julie Steenhuysen; Editing by Chris Reese)
(Reuters) – The paramedics find them everywhere – slumped over car steering wheels, barely breathing in doughnut shop bathrooms or dead in derelict apartments and expensive mansions.
For the Cataldo Ambulance Service crews outside Boston on the front lines of the U.S. opioid epidemic, the flood of overdose calls is a grim daily reality, despite expanded access to overdose reversal drugs.
“When I started, this was a rare thing. You did one or two here and there. Now, we do quite a few,” said Dave Franklin, 44, a supervisor at the private service that contracts with cities who has worked in the field for more than 20 years.
In Massachusetts, EMS opioid overdose calls hit 20,978 in 2016, up from 8,389 in 2013, according to a state report.
Amid wider use by bystanders and police of naloxone, a drug that reverses overdose symptoms, state figures showed a small drop in opioid deaths in the first nine months of 2017 compared with 2016. But Franklin does not yet see a turning point.
“It’s not going away anytime soon. People are still dying regularly,” he said.
In the United States, deaths from drug overdoses have surpassed deaths by firearms and motor vehicle crashes, according to a 2017 Drug Enforcement Administration report.
President Donald Trump has declared a public health emergency over opioid abuse, promising to increase treatment but initially dedicating no money for it.
Opioids, primarily prescription painkillers, heroin and synthetic drugs like fentanyl, a pain medicine 50 to 100 times more powerful than morphine, are fueling the crisis. Opioid-related overdoses kill 91 people in the United States each day, the Drug Enforcement Administration said.
On Thursday, the Centers for Disease Control reported, based on the latest available figures, that the U.S. rate of drug overdose deaths in 2016 grew 21 percent from the prior year.
“It’s hard to watch, and it’s devastating,” said Domenic Corey, 27, who has seen the evidence up close working as a Cataldo paramedic.
Mornings before starting his shift, another Cataldo paramedic, Andrew Simpson, grabs his stethoscope, intravenous supplies, scissors and pen light.
At the ambulance, he checks to make sure there is enough naloxone. They carry more than double the amount they once did because stronger opioids mean that multiple doses of naloxone are often required for someone who is barely breathing.
Simpson, 34, works at least two 24-hour shifts a week in a high-turnover job that can be stressful and where pay starts at $14 an hour. Just touching Fentanyl can send an EMS worker into overdose.
Simpson’s radio crackles with calls. Difficulty breathing. Person down. Unresponsive. Overdose. They turn on the lights and roll. From experience, they know it might be a man who overdosed into unconsciousness while driving, a teen or elderly user passed out in a park or an already stiffened corpse in a hotel room strewn with needles and powder.
On arrival, they spray naloxone up the nose or inject it into the user, pump oxygen into lungs and wait. Some respond gulping for air or vomiting and confused.
“Why are you in my house? What’s going on?” Simpson recalled as a common question from recipients of his aid. Some people are grateful and repentant, crying, shaking hands and promising to get treatment. Others deny they took drugs at all.
The calls often come in waves when fentanyl too potent for users hits the streets. Time of day matters, too.
“If it’s in the afternoon, there’s a much better chance they are still alive,” he said. “If we get the call at 7 a.m., they probably shot up the night before.”
The paramedics say they often see families torn apart in front of their eyes or bereaved parents.
“You see the parents, they’re crushed; just the look of defeat, you know? They lost the most important person in the world to them. I can’t even imagine. But you see it over and over again,” Corey said.
The cost of naloxone has risen with demand, eating into the service’s budgets, Franklin said. But they are also using their steady overdose runs to help some cities map drug hotspots and for police to visit users to urge them into treatment.
“In the back of the ambulance, you talk to them and hope they get treatment,” Simpson said, explaining that most agree they need to get help. “But then at times I’ll see the same person three months down the line and they have overdosed.”
(Reporting by Chris Kenning; Editing by Toni Reinhold)
SAN FRANCISCO (Reuters) – A second U.S. judge on Thursday blocked President Donald Trump’s administration from enforcing new rules that undermine an Obamacare requirement for employers to provide insurance that covers women’s birth control.
U.S. District Judge Haywood Gilliam Jr. in Oakland, California, said the federal government likely did not follow proper administrative procedures in promulgating the new rules, and put them on hold while a lawsuit challenging their legality proceeds.
The decision followed a similar ruling from a federal judge in Philadelphia last Friday that blocked the administration from enforcing rules it announced in October allowing businesses or nonprofits to obtain exemptions on moral or religious grounds.
Gilliam ruled on a lawsuit pursued by Democratic attorneys general in California, Delaware, Maryland, New York and Virginia.
He said that a preliminary injunction was necessary given the “dire public health and fiscal consequences” that could result as a result of the administration adopting the rules without the input of interested parties.
“If the Court ultimately finds in favor of Plaintiffs on the merits, any harm caused in the interim by rescinded contraceptive coverage would not be susceptible to remedy,” he wrote.
California Attorney General Xavier Becerra said in a statement that, given last week’s decision in Pennsylvania, “today’s ruling amounts to a one-two punch against the Trump administration’s unlawful overreach.”
The U.S. Justice Department defended the rules in court. Lauren Ehrsam, a department spokeswoman, said the agency disagreed with the ruling and was evaluating its next steps.
“This administration is committed to defending the religious liberty of all Americans and we look forward to doing so in court,” Ehrsam said in a statement.
The lawsuit is among several that Democratic state attorneys general filed after the Republican Trump administration revealed the new rules on Oct. 6, which targeted the contraceptive mandate implemented as part of 2010’s Affordable Care Act, popularly known as Obamacare.
The rules will let businesses or nonprofits lodge religious or moral objections to obtain an exemption from the law’s mandate that employers provide contraceptive coverage in health insurance with no co-payment.
Conservative Christian activists and congressional Republicans praised the move, while reproductive rights advocates and Democrats criticized it.
(Reporting by Dan Levine in San Francisco and Nate Raymond in Boston; editing by Leslie Adler and Jonathan Oatis)
(Reuters) – Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its contraceptive patch for the second time, sending the drug developer’s shares down about 50 percent.
The health regulator cited deficiencies related to its quality adhesion test methods and asked the company to resolve the observations found during an inspection of its third-party manufacturing facility, Corium International Inc.
Agile’s lead product, Twirla, is a once-weekly, low-dose contraceptive patch made from a combination of ethinyl estradiol and levonorgestrel.
In 2013, the FDA rejected Twirla, citing efficacy issues and sought additional clinical data. After that, Agile completed a late-stage trial in 2,032 women and once again applied for approval in June.
Expressing surprise over the decision, Agile said on Friday the drug regulator has not identified any safety issue related to the product and it intends to seek a meeting with the regulator soon.
The company also pointed out that an amendment addressing the regulator’s concerns about the manufacturing facility and issues related to quality adhesion test methods was not reviewed before the FDA decided to reject the drug.
The amendment was submitted on Dec 1, Chief Executive Al Altomari said on a conference call, adding that he is surprised the FDA didn’t review it.
If approved, Agile’s Twirla would have competed with Mylan NV’s Xulane, a generic version of a Johnson & Johnson’s Ortho Evra product that was withdrawn in 2015.
Xulane generated sales of $211 million last year, a fraction of the $5.5 billion U.S. contraceptive market.
Shares of the Princeton, New Jersey-based Agile were trading at $2.43, while that of Corium dropped 4.6 percent to $10.74.
(Reporting by Divya Grover in Bengaluru and Toni Clarke in Washington; Editing by Anil D’Silva and Arun Koyyur)
(Reuters) – Shares of Chipotle Mexican Grill Inc fell as much as 3.3 percent after a report that public health officials are investigating a possible illness outbreak in one of the company’s restaurant in Los Angeles.
An email from the Los Angeles Health Department’s Acute Communicable Disease Control unit says the agency “is aware of reports of illness and is investigating” according to the Business Insider report.
Chipotle said the company is aware of a few online reports, but there is no clinical validation associated with them. The company also said it has not been contacted by customers directly to substantiate these claims.
At least three reports from customers on iwaspoisoned.com say they suffered from vomiting and diarrhea after eating at a Chipotle restaurant located at 4550 W. Pico Blvd. in Los Angeles. However none of the customers said they visited a doctor.
(Reporting by Uday Sampath, Sruthi Ramakrishnan and Vibhuti Sharma in Bengaluru; Editing by Shounak Dasgupta)
WASHINGTON (Reuters) – Two Republican U.S. senators who had previously demanded that an Obamacare stabilization bill be part of a deal to keep the federal government funded said on Wednesday they were dropping their request until after the new year.
Republican Senators Lamar Alexander and Susan Collins said they would instead ask Senate Majority Leader Mitch McConnell to bring up the two pieces of legislation in January. Collins previously had said her vote for the Republican tax overhaul legislation that won final congressional approval on Wednesday hinged in part on a promise to pass two bills to prop up individual insurance markets set up under Obamacare.
They said they dropped their demands after it became clear that Congress would be able to pass only a short-term funding bill to keep the government open past Friday.
(Reporting By Yasmeen Abutaleb; Editing by Will Dunham)
LONDON (Reuters) – Raw chocolate KitKats, Dark Milk, vegan bars with quinoa and now “ruby” chocolate: the world’s biggest chocolate makers are looking for ways to keep increasingly health-conscious consumers coming back for more.
Sales of mainstream milk chocolate bars have stagnated as consumers worried about obesity and heart disease turn to snacks with less sugar and fat, or hold out for the occasional indulgent splurge on expensive, high-end chocolate.
The shift in attitudes is forcing global firms from Mars Inc. to Mondelez International to Nestle to rebrand or reformulate their mass-market chocolates to create a healthier image, or sell a more expensive premium experience.
Smoother dark chocolate bars, protein bars with chocolate, sugar-free chocolate and single-origin chocolate are an answer to consumer demand for healthier and higher-quality bars, the companies say.
Critics of the confectionery industry say the new products are gimmicks to boost sales by giving a premium feel or a “healthy halo” to snacks still high in sugar and fat.
The companies want to find growth somewhere. The volume of confectionery products sold worldwide rose just 0.5 percent in 2016-17 after falling for two years, according to research company Euromonitor International.
“It’s going to be very difficult to persuade consumers to buy more chocolate,” said Wiebke Schoon, food analyst at Euromonitor. “But they are open to being convinced to have better chocolate, to spend more money on it.”
While the volume of chocolate sales has been largely static, the value of sales rose 3.6 percent in 2016-17, according to Euromonitor, suggesting consumers may be prepared to pay more for chocolate they believe is healthier or better quality.
“Natural, locally-sourced ingredients are and will continue to be at the heart of what people are looking for,” said Sandra Martinez, Nestle’s global head of chocolate and confectionery. “Combined with that artisan flair.”
The Swiss food giant, which sells $8.8 billion (£6.59 billion) of confectionery a year, has turned to so-called chocolatories to try to turn its mass-market KitKat bar into a luxury, personalized product – with a premium price.
At boutiques in Japan, chefs conjure up creative recipes and customers can buy KitKats in more than 10 flavors including matcha, strawberry maple and Japanese citrus.
They can also buy KitKats made from premium dark, milk and raw – less processed – chocolate, or print a message on white chocolate bars and wrap them in custom packaging.
“It’s cool to have your name on confectionery,” said Shiho Sudo, 20, in a KitKat boutique in Tokyo, holding a trio of white chocolate wafers with her name and birthday printed in gold-colored letters. “This is a special gift for myself.”
To print a message on three KitKat wafers costs nearly 2,600 yen ($23) while a regular KitKat costs 100 yen ($0.89).
Nestle says the boutiques have been successful in taking KitKat upmarket. It is rolling out similar shops across Asia and has trialed pop-up versions in Europe with a view to making them permanent.
Rival Mondelez, which owns well-known brands such as Cadbury Dairy Milk, Cote d’Or, Milka and Toblerone, is also looking to make mainstream products appeal to more demanding consumers.
Mondelez is trying to widen the appeal of its premium dark chocolate brand Green & Black’s by expanding in the United States and launching a Velvet edition in Britain that offers consumers a smoother, less bitter taste.
“It brings dark chocolate a little bit more to the mainstream,” said Mary Barnard, president of Mondelez International’s chocolate business in Europe.
While there is doubt over whether dark chocolate has health benefits, the perception it is healthier than milk chocolate has prompted a 31 percent rise in dark chocolate product launches in the past four years, according to market research firm Mintel.
In countries such as Australia and Russia, Mondelez has begun marketing high-cocoa versions of its mainstream bars such as Cadbury and Milka under the label Dark Milk.
Mars – the chocolate retail market leader according to Euromonitor – launched Dove Peanut Butter & Dark Chocolate Promises as well as Twix Dark in North America this year.
Large confectionery companies are also venturing into snack and cereal bars including chocolate, seeking to take advantage of growing global demand for healthier snacks.
According to Euromonitor, the volume of snack bar sales has risen an average 2.6 percent a year for the past five years and is expected to grow 2.4 percent a year going forward.
While these snacks are often smaller than traditional chocolate bars, they typically earn companies a bigger margin.
This year, Mars unveiled its goodnessKNOWS snack bars in Britain, its biggest product launch in the country in two decades. The bar, split into three bite-sized pieces, is made of nuts, dried fruit and dark chocolate.
Mars, which makes M&Ms and Snickers bars, has also taken a stake in KIND, the third-biggest maker of snack bars worldwide.
Other chocolate makers have turned to creating recipes with ingredients geared toward health-conscious consumers.
Germany’s Ritter Sport, for example, has launched vegan chocolate with grains such as quinoa and amaranth and is working on a vegan “milk” chocolate bar, using a dairy substitute.
Emma Calvert, food policy officer at the European Consumer Organisation lobby group, is skeptical, however, about the health drive by major chocolate makers.
“For us, this is a marketing tool rather than any strategy to actually help improve the health of consumers,” she said.
“They might be using coconut oil for fat or agave syrup instead of sugar,” said Calvert. “But it’s still a type of sugar and would contribute to your excess calories. It’s a way to give a healthy halo to products that really shouldn’t have it.”
Some niche chocolate makers are focusing on a combination of luxury and health.
At Rabot 1745 in London, a cafe, restaurant and shop owned by Hotel Chocolat, bars with cocoa beans from a defined part of the company’s Saint Lucia plantation are sold alongside sugar-free 65 percent chocolate made with buffalo milk.
Angus Thirlwell, co-founder and CEO of Hotel Chocolat, a British company with more than 70 outlets across the country, hopes different kinds of cocoa beans will attract the same premium value attached to certain coffee beans or grapes.
“The wine world has achieved a much better balance between growing grapes and the added value of the final product,” he said. “Chocolate has lost its way but is finding it again.”
While companies such as Hotel Chocolat source specialty cocoa with a more distinct flavor from Ecuador or Brazil, most mainstream chocolate is made from mass-processed beans grown in Ivory Coast and Ghana, the world’s top two producers.
The beans are usually mixed together without regard for whether cocoa from different trees or plantations can produce varied tastes, textures or colors.
But this could be changing. Barry Callebaut, the world’s leading provider of chocolate products for businesses, unveiled a new type of chocolate this year with a pink hue and fruity taste: ruby chocolate.
Barry Callebaut determines if beans have the properties that make ruby chocolate by testing cocoa pods on plantations for particular genetic properties.
“The market is moving more toward understanding taste,” said Bas Smit, head of global marketing for Barry Callebaut. “It’s about hunting for the unique.”
(Reporting by Ana Ionova; additional reporting by Osamu Tsukimori in Tokyo, Marcy Nicholson in New York and Silke Koltrowitz in Geneva; editing by David Clarke)
(Reuters Health) – – Both LGBQ sexual identity and traumatic experiences in childhood are linked to a heightened risk of suicidal thoughts and behaviors, U.S. researchers say.
Teens who identify as lesbian, gay, bisexual or are questioning their sexual identity are also more likely than their heterosexual peers to have had adverse childhood experiences (ACEs) in childhood, the study team reports in Journal of Adolescent Health.
Suicide is the second leading cause of death among adolescents and young adults and there is evidence that suicide rates are increasing in this age group, they write.
“It is imperative that we identify adolescent populations at greatest risk to guide our prevention efforts,” lead author Kristen Clements-Nolle, of the School of Community Health Sciences of the University of Nevada, Reno, told Reuters Health by email.
“Furthermore, cumulative exposure to ACEs greatly increased suicide risk behaviors among sexual minority adolescents. For example, compared with heterosexual students with no exposure to ACEs, LGB/not sure students with two or more ACEs had approximately 13 times higher odds of attempting suicide in the past year,” Clements-Nolle said.
To examine the relationships among teen sexual identity, childhood trauma and suicide risk, Clements-Nolle and colleagues enrolled approximately 5,000 students from 97 high schools in Nevada to fill out questionnaires and answer questions about their sexual identity and exposure to adverse childhood experiences.
Adverse childhood events included such things as being physically forced to have sex with someone, or being beaten, kicked or physically hurt by an adult. In addition, students were asked about their exposure to domestic violence, mental illness and substance abuse by family members.
Participants were also asked if they had ever seriously considered suicide during the past year and how many times had they attempted suicide during that time.
About 10 percent of students self-identified as lesbian, gay or bisexual (LGB), and nearly 5 percent were not sure of their sexual identity. Just over 85 percent of students identified as heterosexual.
The LGB and questioning students were more likely to be exposed to adverse childhood events. More than half of LGB and 40 percent of questioning students reported at least two ACEs, compared to about one-quarter of heterosexual students reporting the same exposure.
For all students, the greater the number of adverse experiences they reported, the greater was their risk of having had suicidal thoughts during the past year.
Sexual identity was also linked to risk of suicidal thinking. Compared with heterosexual students with no ACEs, LGB and questioning students overall were three times more likely to report suicidal thoughts.
LGB and questioning students who reported one ACE were almost 7 times more likely to think about suicide compared to heterosexual students with one ACE. With three or more ACEs, LGB and questioning students were 14 times more likely to think about suicide compared to heterosexual counterparts.
Compared to heterosexual students with no ACEs, LGB and unsure students were almost 4 times more likely to have attempted suicide.
“Studies have shown that family acceptance and parental caring may reduce suicidal behaviors among LGB adolescents and young adults,” Clements-Nolle said.
Future research should evaluate whether interventions that support families with sexual minority youth and promote acceptance of adolescent sexual identity can also impact childhood victimization and household dysfunction, said Clements-Nolle.
“While the assessment of intervention effectiveness was beyond the scope of the current study, the higher prevalence of ACEs among adolescents who are LGB or are not sure of their sexual identity and the demonstrated inﬂuence on suicide risk behaviors highlight the need to ensure that suicide prevention efforts for sexual minority youth are trauma-informed,” Clements-Nolle said.
SOURCE: http://bit.ly/2nVoMXc Journal of Adolescent Health, online December 6, 2017.
(Reuters Health) – – Babies who are born too soon or arrive weighing too little are about three times more likely to develop attention deficit hyperactivity disorder (ADHD) than full-term, healthy-sized infants, a research review suggests.
Researchers examined data from 12 previous studies with a total of 1,787 participants and found that even among these high-risk babies, the odds of ADHD increased as babies spent fewer months in the womb and were born at even tinier sizes.
“There is robust evidence that very preterm or very low birth weight individuals have an increased risk of ADHD,” said senior study author Dr. Carlos Renato Moreira-Maia of the Federal University of Rio Grande do Sul in Porto Alegre, Brazil.
It’s possible that the stress of the early birth or premature development of vital organs and systems in the body might lead to inflammation and hormonal changes that contribute to ADHD, Moreira-Maia said by email.
Many factors including mothers’ medical histories as well as smoking, eating and drinking habits during pregnancy can influence the odds of preterm birth or an underweight infant, and these things might also contribute to ADHD in kids, Moreira-Maia added.
“The reasons for increased vulnerability to ADHD in preterm/low birth weight individuals remain unknown,” Moreira-Maia said.
Pregnancy normally lasts about 40 weeks, and babies born after 37 weeks are considered full term. The study focused on the most vulnerable preterm infants, delivered before 32 weeks’ gestation or weighing less than 1,500 grams (3.3 pounds) at birth.
In the weeks immediately after birth, preemies often have difficulty breathing and digesting food. They can also encounter longer-term challenges such as impaired vision, hearing and cognitive skills, as well as social and behavioral problems.
For the current study, researchers looked at data on healthy babies who were born weighing at least 2,500 grams (5.5 pounds) or arrived after 37 weeks’ gestation and they also considered smaller, earlier arrivals.
Compared with these healthy babies, infants born at less than 32 weeks’ gestation or weighing less than 1,500 grams (3.3 pounds) were more than twice as likely to develop ADHD, researchers report in Pediatrics.
When babies were born at less than 28 weeks’ gestation or weighing less than 1,000 grams (2.2 pounds) their odds of ADHD were more than four times higher than healthy infants, the study also found.
One limitation of these results is that all but one of the smaller studies in the analysis was done in a high-income country, which means the results may not reflect what might happen in lower-income nations, the authors note.
Even so, the findings offer fresh evidence of the connection between an ADHD diagnosis and starting life too early or weighing too little, said Joel Nigg, author of an accompanying commentary and director of the ADHD and Attention Disorders Program at Oregon Health and Science University in Portland.
Women, in high-income countries where malnutrition isn’t a concern can help to minimize their odds of having a preterm or underweight baby by doing several things during pregnancy, Nigg advised. These include eating well, gaining a healthy amount of weight, not smoking, avoiding stress and getting enough sleep.
When they do have preemies or underweight babies, women may still be able to minimize the chances of ADHD by breastfeeding infants as long as possible and making sure babies get plenty of calories, Nigg said.
“If you have a low birth weight or pre-term baby, follow medical advice,” Nigg said by email. “But the first principle is nutrition, nutrition, nutrition.”
SOURCES: http://bit.ly/2kdFay6 and http://bit.ly/2CXClZL Pediatrics, online December 18, 2017.
NEW YORK (Reuters) – The early hope that stem cell therapy would make the paralyzed walk, the blind see and cure diabetes have given way to a long list of failures, highlighted by early stem cell champion Geron Corp abandoning the field in 2011.
But two small companies, Athersys Inc and Mesoblast Ltd, are beginning final stage trials in hundreds of patients that they – along with loyal investors – say could change the course of devastating stroke and heart failure.
Both have overcome major hurdles to manufacturing stem cell treatments on a large scale that are off-the-shelf products derived from healthy donor bone marrow and do not face immune system rejection issues.
Cleveland-based Athersys, with a market value of about $200 million, demonstrated evidence in a midstage trial that its therapy may be able to expand the emergency treatment window for major strokes to up to 36 hours, compared with about four hours with current drugs, potentially allowing many more patients to avoid crippling disabilities.
Australia’s Mesoblast, with a market value of about $500 million, is attempting to alter advanced heart failure, a leading cause of hospitalizations and deaths and an enormous cost burden.
They are among the farthest along in the stem cell industry at a time when Wall Street investors have focused on potentially big payoffs from immune-system based cancer therapies and rare disease treatments.
Perception of the field has also been hurt by unscrupulous actors selling unapproved, possibly unsterile cell therapies for everything from cancer to lung disease and ALS, prompting a U.S. crackdown this past summer.
“The market tends to test these companies sometimes to the brink,” said Tom Dobell, who manages a fund for U.K.-based M&G Investment Management that specializes in supporting promising companies during difficult periods. “We’re comfortable that the progress that’s going on is going to be worth it.”
M&G is a long-time holder of Mesoblast, with about a 15 percent stake, and Athersys, with about 4 percent.
Athersys’s experimental Multistem treatment was one of the first companies to be designated by the U.S. Food and Drug Administration as a promising cell-based therapy with potential to address unmet needs for serious or life threatening conditions, potentially easing the approval process.
FDA Commissioner Scott Gottlieb said in a recent interview the agency is seeking an approval pathway for legitimate stem cell therapies “that’s not overly burdensome.”
“The regenerative medicine space has been a tough road clinically and Athersys is one of the bright, shining stars,” said Steven Martin, managing member of Chicago-based Aspire Capital and a long-time holder of Athersys shares.
REDUCING THE RISKS
Athersys believes Multistem – 1.2 billion cells delivered via simple intravenous drip – dampens the immune system’s hyper-inflammatory reaction to signals that the brain is under attack during stroke, and promotes healing.
The body’s reaction to stroke may also severely deplete the immune system, leading to later complications beyond paralysis or speech impairment. In the Phase II trial, Multistem patients had significantly fewer incidents of pneumonia, acute pulmonary distress and other serious complications.
That trial, attempting to extend the treatment window to 48 hours, failed. But researchers were encouraged by patients treated up to 36 hours post stroke.
“It’s reason to be cautiously optimistic,” said Dr. Ken Uchino, a leading Multistem investigator from Cleveland Clinic.
The company plans to begin a 300-patient Phase III study of Multistem in early 2018, aiming for U.S. and European approval after regulators agreed to protocols for one pivotal trial.
“This reinforces and cements an efficient path forward for us,” Athersys Chief Executive Gil Van Bokkelen said. A separate 220-patient Multistem trial in Japan for that market began enrolling patients through partner Healios KK.
“Of the many entities in this field, they have been careful and deliberate in their movement forward” and do not engage in “overwrought claims,” said Dr. S. Thomas Carmichael, co-director of UCLA Broad Stem Cell Center, who was not involved in Multistem trials.
Mesoblast’s MPC-150-IM therapy aims to mitigate advanced heart failure, a progressive condition in which the heart cannot pump enough blood to efficiently serve the body.
The company believes the therapy reduces inflammation, increases blood flow and spurs blood vessel formation that helps repair the heart muscle. A single dose consists of 150 million highly purified stem cells delivered directly to the heart’s left ventricle by injection or catheter.
An ongoing Phase III trial of 600 advanced heart failure patients is currently enrolling. Reducing the severity of a patient’s heart failure “would give them back potentially many years of good quality life,” said Mesoblast CEO Silviu Itescu.
Independent monitors who oversee and can halt blinded clinical trials for futility gave a green light to continue the Mesoblast study in April after a review of the first 270 treated patients, suggesting the therapy might be effective.
A separate U.S. National Institutes of Health-sponsored Phase II study of 159 end-stage heart failure patients dependent on an implanted pumping assist device completed enrollment in September, with results expected in the first quarter of 2018.
Some 250,000 people in the United States alone have been diagnosed with most serious class IV heart failure, and only about 9,000 receive a transplant or left ventricular assist device (LVAD) each year, Itescu said.
If such patients can recover enough to again rely on their own heart, said Dr. Joseph Woo, a heart surgeon at Stanford University and an investigator of the NIH trial, “this would be considered one of the big advances of this century.”
OTTAWA (Reuters) – Canadians consumed an estimated C$5 billion ($3.8 billion) to C$6.2 billion worth of cannabis in 2015, a study by Statistics Canada showed on Monday, ahead of the nationwide legalization of recreational use of the drug next year.
Using existing data sources, the study estimated there were 4.9 million medical and recreational users of cannabis aged 15 and older in 2015.
Medical marijuana is already legal in Canada, and the country plans to allow recreational cannabis federally by July 2018, making it the first Group of Seven country to do so.
The study estimated Canadians used 697.5 tonnes of cannabis in 2015. Using a price range of C$7.14 to C$8.84 per gram, that puts the value of marijuana sales at C$5 billion and up.
That would make the cannabis market about one-half to two-thirds the size of the C$9.2 billion beer market, the study said, though it noted there is “considerable uncertainty” around the level of cannabis consumption because of methodological difficulties and missing information.
Consulting firm Deloitte has estimated sales of recreational marijuana could be as high as C$8.7 billion a year once legalized.
The study also found that the demographics of marijuana use have changed in recent decades. While cannabis was predominantly used by young people in the 1960s and 1970s, two-thirds of users were over the age of 25 by 2015.
The study is part of Statistics Canada’s efforts to measure the economic and social impacts of legalized cannabis. The agency said last month it will begin incorporating marijuana consumption and spending estimates into economic growth figures in November 2019.
The provinces and the federal government came to an agreement last week on how to divide an estimated C$400 million in annual tax revenue from cannabis sales for the first two years.
(Reporting by Leah Schnurr; Editing by Steve Orlofsky)
CHICAGO (Reuters) – Hamburger chain Wendy’s Co <WEN.O> laid out plans on Friday to trim the use of antibiotics that are important to human medicine from its beef supply, the latest step by a food company to fight concerns about resistance to the drugs in people.
Starting in 2018, the company will buy about 15 percent of its beef from producers that have each pledged to reduce by 20 percent their use of Tylosin, the one medically important antibiotic they routinely feed to cattle, according to Wendy’s.
Wendy’s, which says it is the world’s third-largest quick-service hamburger chain, plans to increase the amount of beef it purchases from these producers and others that raise cattle in similar ways.
The company also said it finished removing antibiotics important to human medicine from its chicken supply, after pledging to do so last year.
“Moving away from routine antibiotic use in their beef production is certainly welcome, and we’d urge them to move quicker,” said Matt Wellington, antibiotics program director for advocacy group U.S. PIRG.
Scientists and public health experts for years have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals contributes to the development and spread of drug-resistant superbugs that can infect people.
Last month, the World Health Organization recommended that meat producers end such practices.
There is “a growing public health concern about antibiotic resistance,” Wendy’s said, adding that the company believes it “could help by reducing or eliminating antibiotic use in our food supply.”
In the United States, the sale and distribution of antibiotics approved for use in food-producing animals fell by 10 percent from 2015 to 2016, in the first such decline since the Food and Drug Administration started tracking the data in 2009.
The drop came as restaurants such as McDonald’s Corp <MCD.N> and meat suppliers inducing Tyson Foods Inc <TSN.N> backed away from using antibiotics in U.S. chicken supplies.
Removing antibiotics from cattle is more difficult, experts said, because the animals live longer than chickens and have more chances to fall ill.
In August, Consumers Union, the policy division of Consumer Reports, said McDonald’s told the group that the company hoped to have a timeline soon for reducing medically important antibiotics from its beef supply.
McDonald’s, the world’s largest restaurant chain by revenue, says on its website it prefers beef raised with a “responsible use of antibiotics.”
Wendy’s plan is more concrete, Wellington said.
“It’s starting to set the example of what the industry should be following,” he said.
(Reporting by Tom Polansek; Editing by James Dalgleish)
FREETOWN (Reuters) – Two Ebola survivors in Sierra Leone filed a lawsuit in a regional court on Friday, accusing the government of mismanaging funds during an epidemic that killed more than 3,000 people in the West African nation.
More than 11,300 people died in total during the worst outbreak of the highly contagious disease, which mainly affected Guinea, Liberia and Sierra Leone from 2013 to 2016.
Foreign governments and health organizations poured millions of dollars into the three nations to halt the epidemic’s spread, but local authorities in Sierra Leone were dogged by allegations of corruption and misuse of the funds.
Sierra Leone’s government has pledged to investigate any accusations but so far there have been no prosecutions related to misspent government Ebola resources.
“Sierra Leoneans have repeatedly demanded accountability and justice for the mismanagement of Ebola response funds, but their demands have fallen on deaf ears,” said Ibrahim Tommy of the Centre for Accountability and Rule of Law, which is assisting the plaintiffs.
The two Ebola survivors, who contracted the virus while serving as health workers, blame inadequate resources provided by the government for their infection and the subsequent deaths of many of their colleagues.
Around 250 health workers died in Sierra Leone over the course of the epidemic.
The suit, filed with the Nigeria-based court of regional bloc ECOWAS, alleges the government’s actions during the health crisis violated its citizens’ “right to life and right to health”.
The plaintiffs are seeking both financial and non-financial compensation, Tommy said.
Sierra Leone’s Attorney General Joseph Kamara told Reuters that the government had not yet received notification of the complaint, adding that until it did he was unable to comment on the case.
An internal government audit in 2015 found that a third of resources earmarked to fight the epidemic during a six-month period a year earlier could not be properly accounted for. It added that proper use of the funds could have saved more lives.
“We want to know what happened with the money,” said Yusuf Kabbah, the head of Sierra Leone’s Ebola survivors association. “We are very much interested to give our own support, so that all those that were actors in the fight will be held responsible.”
(Reporting by Umaru Fofana; Writing by Joe Bavier; Editing by Hugh Lawson)
COPENHAGEN (Reuters) – Following a string of food safety scandals, Chinese tourists visiting Copenhagen have this year stocked up on Danish-made organic infant milk formula, prompting some supermarkets to limit the number of cans each customer can buy.
More conventional exports are strong too. Arla Foods, one of Europe’s biggest dairy companies, says Chinese demand for premium products and high food safety standards in Denmark have helped it almost double its sales to China this year.
Food safety has been an important issue in China since a 2008 scandal killed six infants who had been fed milk powder that had been adulterated with the toxic melamine, normally used to make plastics.
Milk powder and long-lasting UHT milk account for most of Arla’s exports to China but its organic infant formula is gaining popularity among Chinese consumers, said Arla Foods’ Chief Executive Peder Tuborgh.
“We found a niche in the market for organic infant formula that didn’t exist even two years ago but it’s starting to unfold and that’s part of what drives the revenue growth,” Tuborgh said in an interview.
Strong Chinese appetite for Western luxury goods such as handbags and watches has been well documented for years.
More recently, retailers across Europe and in countries including Australia and New Zealand have also seen Chinese travelers seek out infant milk powder in response to food safety concerns.
French food company Danone said sales of baby milk formula in China itself rose strongly in the third quarter.
Arla and Danone are facing fierce competition in the China baby food market from Nestle and Reckitt Benckiser.
“China is probably the most competitive dairy market in the world,” Tuborgh said.
Exports to China are set to reach 100 million euros ($118 million) this year, up from 55.9 million in 2016 and 51.7 million the year before, he said. He expects growth rates of 25-30 percent in the coming years.
As a result of higher demand, Chinese visitors to Denmark have raided supermarket shelves for locally-made organic infant milk formula, leaving some retailers scrambling to supply domestic consumers.
In October, Denmark’s biggest supermarket chain Coop was forced to limit the amount of milk formula to 7 kilos (12 cans) per customer, after seeing some Chinese shoppers literally empty their shelves buying more than 40 kilos.
Arla’s organic infant milk powder can fetch three to four times the price in China compared to the price in Denmark.
($1 = 0.8487 euros)
(Reporting by Julie Astrid Thomsen; Editing by Jacob Gronholt-Pedersen and Keith Weir)
LONDON (Reuters) – An ingredient in cannabis called cannabidiol or CBD has shown promise in a clinical trial as a potential new treatment for psychosis, scientists said on Friday.
Scientists conducted a small trial of people with psychosis and found patients treated with CBD had lower levels of psychotic symptoms than those who received a placebo. Psychosis is characterized by paranoia and hallucinations.
The study found that they were also more likely to be rated as “improved” by their psychiatrist and there were signs of better cognitive performance and functioning.
The most common forms of psychosis are part of mental illnesses such as schizophrenia – which affects more than 21 million people worldwide – and bipolar disorder, but psychotic symptoms can also occur in conditions like Parkinson’s disease and alcohol or drug abuse.
The main psychoactive ingredient in cannabis is delta-9-tetrahydrocannabinol, or THC. It can induce paranoia and anxiety and hallucinations and has been found in studies to increase the risk psychotic illness in people who regularly use potent forms of cannabis such as skunk.
But its second major constituent, CBD, has the opposite effects to THC – leading scientists to think it might one day be useful as a treatment in mental health.
Scientists at King’s College London’s Institute of Psychiatry, Psychology & Neuroscience conducted a placebo-controlled trial of CBD in patients with psychosis and published their findings in the American Journal of Psychiatry.
In the trial, 88 patients with psychosis received either CBD or placebo for six weeks, alongside their existing antipsychotic medication. Beforehand and afterwards, the scientists assessed symptoms, functioning and cognitive performance, and the patients’ psychiatrists rated their overall condition overall.
“The study indicated that CBD may be effective in psychosis: patients treated with CBD showed a significant reduction in symptoms, and their treating psychiatrists rated them as having improved overall,” said Philip McGuire, who co-led the trial.
He noted that trial patients also reported few adverse side effects, and added: “Although it is still unclear exactly how CBD works, it acts in a different way to antipsychotic medication, and .. could represent a new class of treatment.”
(Reuters) – An investor coalition that presses for corporate responsibility is calling on U.S. food companies McDonald’s Corp, Denny’s Corp and Sanderson Farms Inc to stop buying or producing meat raised with medically important antibiotics.
Members of the Interfaith Center on Corporate Responsibility (ICCR) have filed shareholder resolutions at each of the companies, ICCR said in a statement on Thursday.
If the resolutions are not successfully challenged by the companies, they will come up for vote at the companies’ next shareholders meetings.
ICCR members, alongside other campaigners, have had previous success in convincing most U.S. chicken producers to stop using medically important antibiotics.
Scientists and public health experts for years have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals contributes to the development and spread of drug-resistant superbugs that can infect people.
The World Health Organization earlier this year recommended that meat producers end such practices.
Fast-food chain McDonald’s USA last year shifted to chicken raised without medically important antibiotics. The latest shareholder resolution, sponsored by the Congregation of Benedictine Sisters of Boerne, Texas, calls on McDonald’s Corp <MCD.N> to adopt a similar sourcing policy for beef or pork.
Adopting such a policy would move McDonald’s closer to rivals Chipotle Mexican Grill Inc <CMG.N> and Panera Bread Co, which serve chicken, pork and beef from animals raised without antibiotics important to human health.
The Benedictine Sisters also want restaurant chain Denny’s <DENN.O> to make a “starter” commitment to reduce the use of such drugs in its chicken supply, said Nadira Narine, senior program director at ICCR.
McDonald’s and Denny’s did not immediately reply to requests for comment.
ICCR member As You Sow is pressuring Sanderson Farms <SAFM.O> to shift its stance on antibiotics. Sanderson is the only large U.S. chicken producer that has not committed to curbing the use of the drugs.
A similar proposal at Sanderson’s annual meeting in February 2017 received the backing of around 30 percent of shareholder votes.
Sanderson declined to comment.
In the past, the low-cost chicken producer has said that the preventative use of antibiotics in food animals has not been shown to harm human health.
(Reporting by Lisa Baertlein in Los Angeles, Editing by Rosalba O’Brien)
CLEVELAND (Reuters) – Women in Ohio would be prohibited from receiving abortions because of a fetal Down syndrome diagnosis under a bill that passed the state senate on Wednesday and is heading to Republican Governor John Kasich’s desk.
Lawmakers voted 20-12 in favor of the law, which criminalizes abortion if the physician has knowledge that the procedure is being sought due to a diagnosis of Down syndrome, a genetic disorder caused when abnormal cell division results in an extra full or partial copy of chromosome 21.
Doctors would lose their medical licenses in the state and face a fourth-degree felony charge under the law if they were to perform an abortion with that knowledge. Mothers would not face criminal charges.
The bill makes Ohio the third state to pass a law outlawing abortions due to fetal anomalies. Similar laws were passed in Indiana and North Dakota. The Indiana provision was struck down by a U.S. District Judge in September after a lawsuit filed by the American Civil Liberties Union.
Kasich spokesman Jon Keeling declined to say whether the governor would sign the measure into law. He added that when Kasich was asked about a similar bill in the Ohio House, he had called it “appropriate.”
Abortion opponents cheered the move and said they expected the governor to sign the law.
“Every Ohioan deserves the right to life, no matter how many chromosomes they have,” said Mike Gonidakis, president of Ohio Right to Life.
Abortion-rights supporters wore “STOP THE BANS” T-shirts in the Senate chamber on Wednesday as the vote went forward.
The law “will create a chilling effect on the medical profession in our state and could result in a shortage of gynecologists willing to practice in Ohio,” Kellie Copeland, executive director of NARAL Ohio, an abortion-rights advocacy group, said in a phone interview on Wednesday.
The ACLU of Ohio said it was still evaluating the final bill before deciding whether to pursue legal action.
Kasich has 10 days to sign the bill into law after it is delivered to his office. If he does so, it will mark the 20th piece of Ohio legislation restricting abortion rights and funding for reproductive health passed in the six years he has been governor.
Unlike many other anti-abortion laws in the state, the Down syndrome bill did not pass strictly along party lines, with some Republicans joining the entire Democratic caucus in voting against the measure.
(Reporting by Kim Palmer; Editing by Patrick Enright and Matthew Lewis)
CHICAGO (Reuters) – A new study sheds light on how the mosquito-borne Zika virus causes a rare neurological condition, and the findings could have implications for companies working on Zika vaccines, U.S. researchers said on Wednesday.
The Zika outbreak that swept through the Americas in 2015 and 2016 showed the virus could, in rare cases, cause Guillain-Barre, an autoimmune disorder in which the body attacks itself in the aftermath of an infection.
Since the Zika virus attacks nerve cells, scientists were not sure whether the Guillain-Barre cases they had seen in Zika patients were caused by an autoimmune response to the Zika infection or a direct attack by the virus on nerve cells.
In pregnant women, the virus infects fetal brain cells, resulting in the birth defect known as microcephaly.
To study the nerve disorder, Dr. Tyler Sharp of the U.S. Centers for Disease Control and Prevention’s Dengue Branch in San Juan and colleagues in Puerto Rico examined the rare case of a 78-year-old man from San Juan who had been infected with Zika in 2016, developed Guillain-Barre and subsequently died.
An autopsy showed inflammation and erosion of the protective sheath known as myelin in two nerves, but no evidence of the Zika virus in nerve cells.
“In this case, it looks like it was antibodies that led to destruction of that myelin sheath,” said Sharp, whose study was published in Emerging Infectious Diseases, the CDC’s public health journal.
Although it was just a single case, Sharp said it suggested the mechanism that causes Guillain-Barre after a Zika infection was the same as in other cases of the nerve disorder.
Sharp said the study raised a caution flag, however, for companies testing experimental Zika vaccines. Although Guillain-Barre typically occurs in the aftermath of an infection, it has been known to occur in response to a vaccine.
“Vaccine manufacturers do need to be thinking about Guillain-Barre as a potential outcome of vaccination against Zika,” he said.
Several companies are developing Zika vaccines, including Takeda Pharmaceutical Co, which said earlier this month it had begun an early stage safety trial. Results are expected next year.
Dr. Rajeev Venkayya, president of Takeda’s Global Vaccine Business Unit, had not seen the study, but said in a telephone interview that the company “would be looking for any safety issues, including Guillain-Barre syndrome,” in its clinical trials.
(Reporting by Julie Steenhuysen; Editing by Peter Cooney)
NEW YORK (Reuters) – The number of consumers who signed up for 2018 Obamacare health insurance next year surpassed the 1 million mark in the second-to-last week of enrollment on the federally-run HealthCare.gov website, picking up the pace ahead of the Dec. 15 deadline.
Through Dec. 9, 4.68 million consumers signed up for the insurance in the 39 states that use the federally run HealthCare.gov website, but that may not be enough for 2018 enrollment to grow from 2017.
Based on the pace last week, Wall Street analysts predicted that initial enrollment would be less than 10 million, short of the nonpartisan Congressional Budget Office forecast for enrollment of 11 million in 2018.
An average of 10 million customers had enrolled and paid for Obamacare individual insurance as of Sept. 15, 2017, the U.S. Department of Health and Human Services said on Wednesday, down from 12.2 million who signed up at the beginning of the year.
More than 1.07 million consumers selected 2018 Obamacare individual insurance plans and of those, 388,984 were new to the Obamacare individual insurance program. That is a 30 percent increase from week 5, when 823,180 people signed up in all.
The subsidized individual insurance market is part of former President Barack Obama’s healthcare law, commonly known as Obamacare. The government’s weekly reports exclude sign-ups in the 11 states and Washington D.C. that run their own websites and have later deadlines.
(Reporting by Caroline Humer; Editing by Meredith Mazzilli and David Gregorio)
PARIS (Reuters) – L’Oreal is launching its first wholly plant-based hair dye as cosmetics companies look to win over customers who are becoming increasingly wary of chemical ingredients.
The French company, the world’s biggest maker of skincare and beauty products, said on Wednesday the new range based on ingredients such as henna would be aimed at professionals for use in salons across Europe from May 2018.
The organic cosmetics boom has been driven by rising numbers of younger consumers rejecting chemical-based products in favor of plant-based ones.
The natural and organic beauty market was worth around $11 billion worldwide in 2016, consultants Ernst & Young said, adding that it was likely to double by 2024.
L’Oreal believes the natural beauty market already stands at 24 billion euros ($28.2 billion) and is growing at 12 percent a year, said Marion Brunet, the international manager of L’Oreal’s professional-products business.
“There’s very strong demand from women to move toward healthier formulas,” Brunet said, adding that a branch of cosmetics that used to be the preserve of more militant “green” consumers 15 to 20 years ago had spread across society.
The vegan range, called Botanea, is sourced from three plants found in India and is not available for mass market consumption yet, as the different shades need to be mixed to measure.
Revenue growth at L’Oreal – founded almost 100 years ago by a chemist as a hair dye company – has benefited from a make-up boom in the age of “selfies” on social media, while its luxury brands such as Lancome are also doing well.
But its professional products division has lagged, however, with like-for-like sales growth down 0.3 percent in the nine months to September, while other areas including the smaller active cosmetics business, which caters to dermatological conditions, expanded.
L’Oreal, which spent 3.3 percent of its 26 billion euros ($30.6 billion) in sales last year on research, rivals large groups such as Estee Lauder.
But small start-ups in skincare and beauty have acquired visibility and are reaching a greater audience through online sales and marketing in recent years.
L’Oreal sold The Body Shop earlier this year to Brazil’s Natura Cosmeticos, after the label, one of the pioneers in the field of natural-based cosmetics, struggled against rising competition.
(Reporting by Sarah White; editing by Richard Lough and Louise Heavens)
BRUSSELS (Reuters) – The European Commission said on Tuesday it had renewed for five years the license for the weed-killer glyphosate, a key ingredient in Monsanto Co’s <MON.N> top-selling Roundup, following a heated debate over whether it causes cancer.
A sufficient majority of EU countries voted at the end of November to clear the license extension, but opposition to the herbicide remained, including from a citizens’ initiative wanting it banned and demanding greater transparency in future.
The Commission said in a statement it would introduce measures early in 2018 to make decisions on pesticides more transparent and to enhance the quality and independence of scientific assessments.
(Reporting by Philip Blenkinsop; Editing by Alastair Macdonald)
LONDON (Reuters) – GlaxoSmithKline will scout for deal opportunities in cancer medicine, as well as immunology, as the drugmaker seeks to rebuild its presence in oncology, its new head of pharmaceuticals told Reuters.
In his first public comments since joining GSK in September, Luke Miels said the focus would be mainly on buying or licensing early-stage drugs. The hunt is set to gather pace in the new year with the arrival of new research chief Hal Barron.
Both men have been parachuted into Britain’s biggest drugmaker by Chief Executive Emma Walmsley, who has made improving returns in the core prescription drugs business her top priority since taking over in April.
GSK has lagged behind rivals in recent years in producing multibillion-dollar blockbusters and has suffered a number of high-profile failures, undermining faith in its research and development skills.
Both Miels and Barron have considerable experience in oncology and worked together for more than five years at Roche, the world’s biggest maker of cancer drugs.
Miels, who was most recently at AstraZeneca, said the existing GSK drug pipeline was a promising start.
“The cupboard is not as bare as people think but there is a lot of work to do,” he said.
“Where there are gaps in the pipeline, both Hal and myself have a bit of experience with business development. Hopefully, if we did see something outside then we would make a good call and invest sensibly on behalf of shareholders.”
GSK’s position on cancer medicine has left some investors scratching their heads. The company sold its marketed cancer drugs to Novartis in 2015, but it continues to invest in early-stage research and has recently made advances with a promising multiple myeloma drug.
“The areas we are interested in are oncology and immunology,” Miels said of the hunt for deal opportunities.
“I’m sure Hal will have a lot of ideas but our focus is really on early-stage business development where we can spot things that we can pick up, target and accelerate.”
While improving the drug pipeline is a priority, analysts say GSK’s ability to make big acquisitions will be constrained by the need to conserve firepower for potential consumer health deals, such as buying out joint venture partner Novartis or bidding for Pfizer’s over-the-counter business.
MULTIPLE MYELOMA DRUG
Further early clinical trial results with GSK’s multiple myeloma drug, which targets a protein called BCMA, are being presented at the American Society of Hematology’s annual meeting this week.
Miels described the drug – a rival to Genmab and Johnson & Johnson’s Darzalex – as “extremely exciting”. He also cited the promise of two other experimental programs, NY-ESO and ICOS.
This year, GSK has won approval for three new products – a shingles vaccine, a two-drug HIV cocktail and a three-in-one lung inhaler called Trelegy, the last of which Miels said analysts were “underestimating”.
“Those three things are going to keep us pretty busy,” Miels said. “The key thing is can we be more commercially assertive in vaccines against Merck, against Gilead in HIV, and against AstraZeneca and Boehringer in asthma and COPD? I think with the changes we are driving in the company we can be.”
After these three new drugs there will be a gap in product launches until after 2020 – and a key task for Miels will be to show investors that a more focused pipeline approach, announced by Walmsley in July, can deliver value.
Miels sees clear parallels with AstraZeneca, which has also concentrated its bets in a few core areas in recent years.
“I saw that happen at Astra and I think the conditions are in place where we can do something very, very interesting at GSK.”
(Reporting by Ben Hirschler; Editing by Susan Fenton)
(Reuters) – The U.S. Department of Justice asked on Thursday for documents related to a Senate committee’s report on the transfer of fetal tissue by abortion provider Planned Parenthood, according to a letter seen by Reuters.
The Department of Justice’s investigation will likely revive the controversy over fetal tissue transfers, which was sparked by videos released by the anti-abortion group Center for Medical Progress in 2015.
The activist group said the videos showed Planned Parenthood officials negotiating prices for fetal tissues collected from abortions. However, Planned Parenthood called the videos heavily edited and misleading and said 13 states that investigated the group’s claims cleared Planned Parenthood of wrongdoing.
In the latest development, a Department of Justice assistant attorney general, in a copy of the letter dated Thursday and seen by Reuters, asked Senators Charles Grassley and Dianne Feinstein for unredacted documents held by a Senate committee.
Those documents relate to a December 2016 Senate Committee on the Judiciary report that examined fetal tissue transfers and Planned Parenthood’s policies.
“At this point, the records are intended for investigative use only – we understand that a resolution from the Senate may be required if the department were to use any of the unredacted materials in a formal legal proceeding, such as a grand jury,” DoJ Assistant Attorney General Stephen Boyd wrote in the letter.
In the U.S. legal system, a grand jury may be convened to determine if criminal charges should be filed in a case.
The letter does not mention Planned Parenthood by name.
Grassley, the Republican chairman of the committee, in releasing the report in December 2016, called on the Department of Justice to investigate and possibly prosecute Planned Parenthood and companies involved in fetal tissue transfers.
A representative for Planned Parenthood declined to comment on the letter, but she cited a statement in which an official with the organization said in November that Planned Parenthood never profited from facilitating its patients’ choice to donate fetal tissue for use in medical research.
Attorney General Jeff Sessions opposed abortion when he was a Republican senator, but has pledged to follow the 1973 Supreme Court ruling that legalized abortion, in his role now as head of the Department of Justice.
A representative for the Department of Justice declined to comment.
California authorities criminally charged two anti-abortion activists this year, accusing them of filming Planned Parenthood workers without their consent when they made the videos for the Center for Medical Progress.
(Reporting by Alex Dobuzinskis in LOS ANGELES; Editing by Paul Tait and Richard Borsuk)
(Reuters) – Patients with advanced breast cancer tied to an inherited gene mutation who were treated with an experimental Pfizer Inc <PFE.N> drug went about three months longer before their disease worsened than those who received chemotherapy in a late stage study, according to data released on Friday.
The drug, talazoparib, a once daily pill that Pfizer acquired with its $14 billion purchase of Medivation, belongs to a class of medicines called PARP inhibitors that may induce tumor cell death. They have shown promise in advanced ovarian and breast cancers.
Patients in the Phase III study had mutations of the BRCA1/2 genes, the type of mutation that led actress Angelina Jolie to have preventive breast removal surgery.
About 3 percent of breast cancers occur in people with inherited BRCA1 or BRCA2 mutations that lower a cell’s ability to repair damaged DNA. Up to 65 percent of women who inherit the mutations will develop breast cancer, often much younger than is typical for the disease.
In the 431-patient trial, those who received talazoparib went 8.6 months before half of them experienced disease progression, a measure known as median progression-free survival (PFS). Among those who received standard chemotherapy, the median PFS was 5.6 months.
In addition, 62.6 percent of talazoparib patients experienced a complete or partial response to the treatment compared with a 27.2 percent response rate for chemotherapy.
Twelve patients who received the Pfizer drug, or 5.5 percent, had a complete response, meaning no detectable sign of cancer. There were no complete responses in the chemotherapy group. The results, unveiled at the San Antonio Breast Cancer Symposium, were highly statistically significant.
Researchers also reported a significant delay in time to meaningful deterioration of quality of life among talazoparib patients.
Dr. Jennifer Litton, the study’s lead investigator from MD Anderson Cancer Center, said there are currently no drugs specifically approved for this group of patients aside from standard chemotherapies.
The results were consistent whether patient had received up to three courses of chemotherapy or none at all, or whether patients’ cancers had spread to the brain.
The incidence of serious adverse side effects was similar in both groups — 31.8 percent for the Pfizer drug and 29.4 percent for chemotherapy. Discontinuations due to adverse events occurred in 7.7 percent of talazoparib patients and 9.5 percent in the chemotherapy group.
(Reporting by Bill Berkrot; Editing by Sandra Maler)
CHICAGO (Reuters) – The sale and distribution of antibiotics approved for use in food-producing animals in the United States decreased by 10 percent from 2015 to 2016, a U.S. Food and Drug Administration (FDA) report said on Thursday.
It was the first decline in year-to-year sales since the FDA began collecting the data in 2009, according to food and consumer health groups.
For years scientists have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals fuels dangerous, antibiotic-resistant “superbug” infections in people.Major U.S. food companies including McDonald’s and Tyson Foods have stepped up efforts to curtail, and in some cases eliminate, antibiotics in their products.
“Actions speak louder than words, and the most action we’ve seen on antibiotics has come from food companies,” said Matthew Wellington, Antibiotics Program Director of public interest campaigning group U.S. PIRG. “We’re cheering this good news.”
Last month, the World Health Organization urged farmers to completely stop using antibiotics to enhance growth and prevent disease in healthy animals.
An estimated 70 percent of the kinds of antibiotics that are also used to fight human infections and in surgery are sold in the United States for use in meat production.
In 2016, sales and distribution of those medically important antibiotics for food production fell 14 percent, the FDA said.
Medically important antimicrobials accounted for 60 percent of the domestic sales of all antimicrobials approved for use in farm animals in 2016, the agency said.
The FDA’s data show chicken accounting for 6 percent of medically important antibiotic sales, with swine at 37 percent and cattle at 43 percent.
Avinash Kar, senior attorney at environmental activist group the Natural Resources Defense Council, said the overall decline offers a “glimmer of hope” that the growing epidemic of drug-resistant infections can be beaten.
While Kar attributed the progress to significant changes undertaken by the chicken industry, he said the pork and beef sectors lag behind.
Tyson Foods, the nation’s leading meat producer, this year became the world’s largest producer of no-antibiotic-ever chicken, the company said in an e-mail to Reuters on Thursday.
Tyson said it was working with independent farmers to reduce human-use antibiotics from its beef and pork supply chain.
(Reporting By Theopolis Waters, Editing by Rosalba O’Brien)
WASHINGTON (Reuters) – Josh Brookhart has four health insurers to choose from in Seattle’s King County for 2018, more than many Americans like him who buy coverage on the Obamacare individual market.
Yet none of the plans cover all the complex medical care needed for his seven-year-old son, Gabriel.
Born with an extreme form of Chiari malformation, Gabriel required surgery to reinsert a part of his brain into his skull. He lives with hydrocephalus, or extra fluid in his brain, and spina bifida, which causes abnormal development of the spinal cord.
The Brookharts’ insurer, Regence BlueShield of Washington, said in June it would exit the Obamacare markets in 2018, citing unsettled marketplaces across the country, a move common to many insurers uncertain about the program’s future under President Donald Trump.
All of Gabriel’s specialists, who span multiple medical centers and practices and have been coordinating his care for five years, were covered under Regence.
Based on the limited options for 2018 enrollment, the Brookharts plan to pick an insurer that will cover some of Gabriel’s care and expect to pay tens of thousands of dollars for the rest of his needs.
“I would pay a high price for a good policy. It’s just mind-boggling to me that it doesn’t exist no matter how much I would want to pay,” Brookhart said.
Gabriel’s case shows how difficult it can still be to find adequate healthcare for very complex conditions four years after Obamacare took full effect. In many cases, an insurer will cover medical care but not certain prescription drugs. In other cases, an insurer may cover one specialist doctor but not others, or cut expensive academic medical centers out of their networks to lower costs.
Patients with complex medical cases often take high-cost prescription drugs, rely on specialists who sometimes coordinate their care and may require sophisticated surgeries, among other needs.
The challenge of finding adequate healthcare on the Obamacare market is expected to intensify as the Trump administration strips away aspects of the law, healthcare experts say.
“Instability is just a very stressful thing for people dependent on a stable connection to the healthcare system,” said Daniel Polsky, professor at the University of Pennsylvania and executive director of the Leonard Davis Institute of Health Economics. “Even just a change of doctors could result in some difficult health consequences.”
U.S. consumers have often complained that subsidized health insurance under former President Barack Obama’s Affordable Care Act restricted their choice of doctors, or forced them to change providers. In some cases, that may mean switching primary care providers. But for patients with serious medical needs it can prevent them from seeing their specialists.
The Obama administration attempted a fix, directing more federal oversight of the plans, requiring transparency from insurers on what they did, and did not, cover and setting guidelines for insurers to cover enough healthcare providers.
Trump has promised to repeal Obamacare and is using executive powers to undermine it, including a rule finalized in April that allows individual states to determine whether insurers provide enough access to doctors.
The administration has also proposed giving states more authority over their insurance markets and allowing them to water down some Obamacare benefits in 2019. That could create wide discrepancies in access to doctors among states, said Sabrina Corlette, an expert on health insurance markets at Georgetown University.
There is no national estimate of how many people with complex medical cases may struggle to find a plan that covers their particular doctors. About 2.2 million people on the individual market have some form of a pre-existing chronic condition, according to Avalere Health, a research and consulting firm.
Seventy-three percent of the Obamacare 2018 individual market is comprised of restrictive plans, or those that cover fewer providers, according to Avalere, up from 68 percent in 2017 and 54 percent in 2015.
Research has shown that insurers are more likely to offer limited access to doctor practices in markets where they compete against one or more rivals. This helps keep insurer costs down, and therefore allows them to offer lower prices.
Matt Slaby of Denver, Colorado, can choose between six Obamacare insurers, but none cover all the care for his genetic blood clotting disorder, called Factor V Leiden. He relies on the bloodthinner Xarelto, which costs about $400 per month without insurance, to prevent life-threatening clots.
His insurer from last year, Cigna Corp <CI.N>, dropped his plan from the Denver market for 2018.
“There are no plans that cover everything I need,” Slaby said. “Finding two or three, the intersection of things that keep me alive, that’s the challenge.”
In U.S. counties with a single insurer, there is less incentive to whittle down the provider list because there is no competition. The departure of major insurers including Aetna Inc <AET.N> and Humana Inc <HUM.N> from Obamacare markets has left about half of U.S. counties with only one insurer selling plans, up from one-third in 2017.
But that does not guarantee that a sole insurer in a market will cover medical care at any specific hospital or physician practice.
In Virginia’s Chesterfield County, a single insurer, Cigna, is offering Obamacare coverage, presenting a tough choice for Jodi Smith Lemacks, whose son was born with a heart defect. The plan does not cover her son’s specialists at Children’s Hospital of Philadelphia (CHOP) five hours away, where Joshua Lemacks, 14, has been treated since he was in utero for hypoplastic left heart syndrome.
There is no cure for his condition. In three major surgeries, doctors at CHOP have rerouted Joshua’s anatomy so that his blood can pump through one heart chamber instead of two. They have also provided medication, some through a clinical trial, to help prolong his heart’s ability to function in this way.
Lemacks spends $6,000 to $7,000 a year out-of-pocket for Joshua’s medical expenses, and once had medical debt close to $100,000 due to the surgeries. She decided to put him on her employer’s plan for 2018, but says if anything were to happen to her job at a nonprofit or she chooses to change jobs, she would need to return to the Obamacare market.
“You do everything you can to protect your kids but at the end of the day if you can’t get coverage, you can’t get coverage,” she said.
ZURICH (Reuters) – Adding Roche’s <ROG.S> immunotherapy Tecentriq to older drugs doubled the percentage of lung cancer patients who survived a year without their disease advancing, an outcome some experts on Thursday labeled unprecedented.
Its shares retreated, however, as analysts said uncertainty lingers over whether the result is sufficient to give the Swiss drugmaker a jump on rivals Merck & Co <MRK.N> and Bristol-Myers Squibb <BMY.N>, whose immunotherapy sales dwarf Roche’s own.
Thirty-seven percent of patients in Roche’s closely watched clinical trial who got Tecentriq, Avastin and chemotherapy reached the one-year mark without their cancer progressing (PFS), according to data released at the European Society for Medical Oncology meeting in Geneva.
For patients getting just Avastin and chemotherapy in the Impower 150 study, that fell to 18 percent.
Roche is counting on Tecentriq to help replace revenue from its $20 billion-per-year trio of Avastin, Herceptin and Rituxan whose patents have expired or will shortly, exposing them to cheaper competition.
Chief Executive Severin Schwan hopes Roche can leap-frog ahead of Merck and Bristol-Myers Squibb, both of which are still awaiting key lung cancer combination trial results of their own.
“This is very, very promising,” Dr. Solange Peters, the head of Medical Oncology at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, said of the latest results.
“Doubling PFS (progression-free survival) at one year is something we have not seen with any targeted therapy in unselected patients to date.”
Tecentriq, already approved in bladder cancer treatment and second-line lung cancer treatment, is seen posting annual sales of $4.6 billion by 2023, according to the average forecast of analysts polled by Reuters.
It costs $150,000 per patient a year.
Roche, which said it would submit Thursday’s results to regulatory authorities, had said in November that the Impower 150 trial had broadly succeeded in first-line lung cancer patients, helping spur a one-day, $12 billion rally in the Basel-based drugmaker’s shares.
With the release of the specific numbers, however, the Swiss company’s shares had fallen 2.2 percent by 1330 GMT, giving up a quarter of their gain since mid-November, while Bristol-Myers and Merck shares both rose.
Roche investors feared Thursday’s results might not be good enough, analysts said.
For instance, patients getting the Swiss company’s immunotherapy survived an average of 8.3 months without their disease getting worse, compared with the PFS of 6.8 months for those getting chemotherapy and Avastin, according to the study.
That trailed the benefit of Merck’s Keytruda plus chemotherapy in a trial that led to U.S. approval for treatment of first-line lung cancer in May.
“The market’s view is that the 1.5 months difference versus the Avastin plus chemo arm is insufficient, as Merck’s Keytruda has shown a 4.3 months difference,” Morgan Stanley analyst Vincent Meunier said.
Still, several analysts said such comparisons are difficult and potentially misleading given vast differences in how trials are organized.
For instance, Merck’s trial of its Keytruda cocktail was earlier stage and involved just 123 patients, tiny compared to Roche’s 1,202-person study of Tecentriq. It also did not include a targeted therapy like Avastin.
“Impower 150 is one important piece of a complex, still largely incomplete, puzzle,” wrote Bernstein’s Tim Anderson.
Martin Reck, a chief oncology physician at the Lung Clinic in Grosshansdorf, Germany, and lead author of the Tecentriq study, said that a larger PFS benefit would have been better.
Still, Reck said the combination’s 38 percent reduction in risk of disease progression or death, combined with a durable survival benefit that improved at the six- and 12-month treatment marks, should carry more weight.
And while the trial’s overall survival data will not be mature until the first half of 2018, Reck said, a preliminary reading of 19.2 months versus 14.5 months among patients not getting Tecentriq suggests an “encouraging trend”.
“In the end, I’m not really disappointed … because this is something we’ve seen in other trials with immunotherapies,” he told a news conference.
Some analysts were also optimistic, saying Thursday’s results will clearly be enough to help Roche win expanded U.S. approval in first-line lung cancer treatment by next year.
“We see the highly significant 38 percent reduction in risk of disease progression or death securing a swift adoption of Tecentriq on top of Avastin,” wrote Bruno Bulic, a Baader Helvea analyst with a “buy” rating on Roche shares.
Roche said serious adverse events were seen in 25.4 percent of patients getting the Tecentriq combination, compared with 19.3 percent in the Avastin-chemo group.
(Reporting by John Miller; Editing by Ben Hirschler, Mark Potter and Susan Fenton)
(Reuters) – Two years ago, Alan Gertner was head of Google’s Asia-Pacific sales team in Singapore, handling more than $100 million in business.
Now, he begins his day in a small Toronto office, building a cannabis brand that sells fancy smoking accessories such as vaporizers and bongs that cost up to $335 CAD ($261.72 USD).
Gertner is among a growing group of entrepreneurs and investors who are trading in high-paid corporate jobs in the technology and finance sectors to launch start-ups focused on the fast-growing marijuana industry.
Two decades after the first legalization of medical marijuana by a U.S. state, pot-based businesses are professionalizing their operations by luring top talent from other industries and billions of dollars in investments from Wall Street firms. A new commodity index even offers data on the going rates for greenhouse and field-grown weed.
Gertner still gets surprised reactions to his career change, as when his mother asked: “Can’t you just get another job at Google?”
And yet he’s raised $10 million in capital in ten months as the chief executive of Toyko Smoke, despite the continuing taboos and legal risks in the industry.
The legal cannabis market, currently worth about $8 billion, is predicted to triple in size to $22.6 billion in total annual sales by 2021, according to cannabis industry tracker, Arcview Market Research. That could make it bigger than the America’s most profitable sports organization, the National Football League, which saw about $13 billion in revenue last year and aims to reach $25 billion by 2027.
So far in 2017, there have been at least 27 investments by venture capital funds in cannabis companies, compared with just 10 deals in 2016 and 9 deals in 2015, according to venture capital data provider CB Insights.
The influx of capital helps finance the paychecks of 150,000 workers in the legal U.S. pot industry, representing job growth of 20 percent from a year ago, according to an estimate from the cannabis website Leafly, a marketing firm for dispensaries and other cannabis firms.
Eric Eslao, founder of Defonce Chocolatier – which makes artisanal cannabis-infused chocolates costing $20 a bar – was a senior production manager at Apple just over a year ago. He feared the stigma of joining the weed industry, but it didn’t stop him.
“The opportunity was too good not to make the jump,” he said.
LEGAL RISKS, CHALLENGES
Thirty states have legalized marijuana for recreational or medical use, but possession and sale is still banned at the federal level.
The administration of President Donald Trump has sent mixed signals on its enforcement policy. Attorney General Jeff Sessions has vowed to crack down on the pot trade in states with legalization laws, but Trump has extended a ban on using federal funds to interfere with the industry through the end of this year.
Americans increasingly support marijuana legalization, according to the Reuters/Ipsos opinion poll. The number of adults who believe it “should be legal” to possess small amounts of marijuana rose to 54 percent in a poll conducted between Oct. 27 and Nov. 10, up from 41 percent in a similar poll in 2012.
Still, the specter of federal enforcement makes it difficult for cannabis-related firms to get banking services. Many continue to deal in cash or pay hefty fees for accounts.
The banks that work with cannabis-related firms are mostly community institutions in states where the industry is legalized, and their service is limited to accepting cash deposits.
Cannabis investment is still dominated by wealthy individuals, but that is changing as the industry grows, attracting venture capitalist and equity investors who until recently were reluctant to finance cannabis firms.
They are drawn by a wide-open landscape of opportunity, said Eric Hippeau, managing partner at Lerer Hippeau Ventures, a New York-based venture capital firm well-known for its investments in high-profile media startups such as Twitter Inc and Buzzfeed.
“It’s an industry that is starting from scratch with no infrastructure,” Hippeau said. “There are many promising cannabis-related software startups that are able to easily raise money.”
Some of these startups provide seed-to-sale cannabis tracking system software and inventory management. Hippeau Ventures earlier this year joined a $3 million funding round for LeafLink, a business-to-business platform that provides a market for dispensary owners to buy inventory.
Other prominent venture firms that have warmed to cannabis include Founders Fund, started by PayPal co-founder Peter Thiel, which has invested in Privateer Holdings, a cannabis private equity firm. Prominent Silicon Valley venture capitalists 500 Startups, DCM Ventures, along with New York-based Great Oaks Venture Capital, have all backed Eaze, a medical marijuana delivery app that allows patients to order cannabis on demand.
“The stigma is slowly going away, and you are seeing some real talent, in terms of technology entrepreneurs and quality engineers,” said Kyle Lui, a principal at DCM Ventures.
Investors who have taken the initial plunge into the quasi-legal marketplace seem eager to take on more exposure, said Jim Patterson, CEO of Eaze, a three-year old company has raised $51.5 million in five rounds from more than a dozen investors.
Such firms believe its “a good time to double down,” Patterson said.
Some investors have steered toward technology and support services, which carry less legal risk than cultivating or selling the weed itself.
These include dating apps for cannabis users such as High There and My420Mate, as well as WeGrow, an educational app that teaches people how to grow cannabis. HelloMD is an online platform connecting doctors and cannabis patients.
Among the signs the market is maturing is the development of information services that collect data on trading of cannabis and publish guideline prices. Similar services are common across commodity markets – from oil and gas to corn and cotton – and are used by industry participants as price benchmarks.
New Leaf Data Services LLC, a Stamford, Connecticut-based start-up, published its first assessment of U.S. cannabis prices about two years ago. Newleaf compiles information gathered from cultivators and dispensaries, transaction data from market participants and data from vendors and associations.
Investors can also follow the value of marijuana firms through stock market indexes such as the Horizons Marijuana Life Sciences Index ETF, which tracks the performance of a selection of publicly listed cannabis companies in North America.
The value of the index is up about 70 percent over the last three months, thanks to star performers such as Canopy Growth Corp, a producer and retailer of medical cannabis products – up 112 percent for the year – and Aphria Inc, a cannabis producer, up 132 percent this year. “The cannabis business is really about risk arbitrage. There are chances of a higher return because the risk is high,” Patterson said. “Investors get that.”
The long-term risk may be lower, however, as a growing number of Americans express support for marijuana legalization and the industry creates jobs and tax revenues.
U.S. residents also seem increasingly aware of the futility in preventing illegal marijuana use, said Ian Laird, a lawyer and co-founder of New Leaf.
“The evolution or rollback of prohibition is inevitable,” he said. “It’s not like it stopped anyone from getting it.”
(Additional reporting by Chris Kahn and Saqib Iqbal Ahmed; Editing by Simon Webb and Brian Thevenot)
WASHINGTON (Reuters) – The number of people signing up for 2018 Obamacare plans picked up significantly during the fifth week of open enrollment, a U.S. government agency reported on Wednesday, but the number of people signed up for such plans appears to be falling short of last year’s numbers with just over a week of enrollment left.
The U.S. Department of Health and Human Services said 823,180 people signed up for 2018 Obamacare individual insurance in the 39 states that use the federal government website Healthcare.gov for the week ended Dec. 2, up from 504,181 people in the previous week. About 3.6 million people so far have signed up for Obamacare plans using the federal website.
New consumer sign-ups rose to 271,207 from 152,243 during the previous week.
The Trump administration halved the Obamacare open enrollment period for 2018 to six weeks ending Dec. 15, and cut the healthcare law’s advertising budget by 90 percent. In 2017, more than 9.2 million consumers signed up for insurance plans using Healthcare.gov during the 12-week open enrollment period, which includes people who were automatically re-enrolled at the close of the enrollment period.
The figures do not include enrollment in Washington, D.C., or the 11 states that run their own enrollment and websites, some of which have enrollment periods that are weeks longer. The subsidized individual insurance market is part of former President Barack Obama’s healthcare law, commonly known as Obamacare.
(Reporting by Yasmeen Abutaleb; Editing by Jonathan Oatis and David Gregorio)
(Reuters) – The U.S. Food and Drug Administration on Tuesday approved Novo Nordisk A/S’s diabetes drug Ozempic, setting the stage for a heated battle with Eli Lilly & Co’s Trulicity.
Ozempic, known generically as semaglutide, will compete with others in a class known as glucagon-like peptide-1 (GLP-1) analogs, which imitate an intestinal hormone that stimulates the production of insulin.
Ozempic is a once-weekly injection that Novo Nordisk hopes will take market share from Trulicity, which has been cutting into sales of Novo Nordisk’s once-daily Victoza. Novo Nordisk is also developing an oral form of semaglutide.
The company said it plans to price the drug at $676 per prescription, which it described as “at parity” to current market-leading drugs in the same class.
The approval comes as Novo Nordisk faces pricing competition to its existing diabetes products. The company is banking on Ozempic to help drive the overall growth of the GLP-1 market, which includes Trulicity and AstraZeneca Plc’s once-weekly Bydureon.
Novo Nordisk is betting that Ozempic’s proven heart benefit and weight-loss advantage over rival products will increase its attractiveness both to physicians and insurers.
Analysts on average expect annual sales of Ozempic to reach $3.17 billion by 2023, with sales of Trulicity, which was approved in the United States in late 2014, reaching $3.71 billion over the same period, according to Thomson Reuters data.
Analysts at Credit Suisse estimate that by 2022 Novo Nordisk will have captured roughly 60 percent of the GLP-1 market compared with an expected 53 percent in 2017. They expect Lilly’s GLP-1 share will increase to 33 percent from 29 percent over the same period.
Diabetes drug companies are under pressure from insurers to offer attractive prices in return for a formulary position, the list of medicines approved by an insurance company for reimbursement.
Dr Todd Hobbs, Novo Nordisk’s chief medical officer, has said the company planned to “take a very competitive strategy with the payors” in order to gain market share. He said the company has strong relationships with prescribers built up over the years with Victoza.
GLP-1 products are also expected to face increased competition from biosimilars, less expensive versions of rival diabetes drugs.
(Reporting by Toni Clarke in Washington and Bill Berkrot in New York; Editing by Marguerita Choy and Matthew Lewis)
NEW YORK (Reuters) – CVS Health Corp’s <CVS.N> proposed purchase of Aetna Inc <AET.N> will change the way many major U.S. corporations buy health coverage for employees and raise new questions over the cost of those benefits, benefit consultants said.
CVS on Sunday said it planned to buy Aetna for $69 billion.
Most national companies employing more than 20,000 people keep their prescription drug benefits separate from medical coverage. They believe they are paying less by shopping those contracts around to competitors within each industry.
CVS and Aetna argue that their deal will lower healthcare costs for employees of their large corporate customers, giving the company greater clout to negotiate down drug prices and better manage the use of those medicines.
“It’s the lower overall cost of therapy. It’s not just the drugs. It’s not just the PBM (prescription benefit manager). It’s the overall outcome for the patient,” Aetna CEO Mark Bertolini told Reuters in an interview.
But employers are expected to scrutinize that kind of claim closely, according to benefit consultants in touch with hundreds of large employers.
So far, they are taking a “wait-and-see attitude as to whether there is a direct favorable impact on their pricing” of a CVS-Aetna combination, said Jim Winkler, senior vice president for health at Aon, part of Aon Plc <AON.N>.
Last year, large employers’ concerns over two proposed mergers between health insurers Aetna and Humana Inc <HUM.N> and between Anthem Inc <ANTM.N> and Cigna Corp <CI.N> were a major factor in U.S. antitrust regulators blocking the deals.
Industry experts say that is less likely to happen with CVS-Aetna because of their minimal direct overlap, historically the main concern for customers. “By and large they are in separate places in the value chain, so it’s more of a vertical integration,” said Winkler.
CVS is the No. 2 U.S. provider of prescription drug benefits and competes with larger rival Express Scripts Holding Co <ESRX.O>. Aetna is the nation’s No. 3 health insurer, competing against UnitedHealth Group Inc <UNH.N>, Anthem and Cigna to provide coverage for doctor and hospital visits.
A NEW LANDSCAPE
A combined CVS-Aetna will reorder those options, leaving Express Scripts as the only standalone company big enough to easily provide pharmacy benefits to top employers.
Aon’s Winkler expects this will lead large companies to turn to their insurer for pharmacy benefits the same way mid-sized companies have. About 63 percent of large corporations use a separate pharmacy benefit company, consultant Mercer’s 2016 employer survey found.
In scale, CVS and Aetna offer a much bigger pharmacy benefits manager than UnitedHealth, which expanded its OptumRx business with the $13 billion purchase of Catamaran in 2015.
Anthem in October said it would expand its own pharmacy benefits business, and hired CVS to help do so. That partnership could be thrown into jeopardy by the new Aetna agreement, health industry analysts said.
Insurers say combining the two benefits saves money. Large employers who combine the benefits under one insurer have begun to demand insurers hit a specific dollar figure of medical cost savings per member, per year, said David Dross, national pharmacy practice leader at Mercer, part of Marsh & McLennan Co. <MMC.N>.
Insurers may also try to make it more pricey for large companies to keep the benefits separate.
Some have started charging mid-size corporate customers, who employ 2,000 to 10,000 people, additional fees for integrating medical claims and pharmaceutical claims when they are managed by different companies, Dross said, and could require those fees for larger clients as well.
“The plans have sort of decided this is the model we need to move to now,” Dross said. He expects that next year, as large companies negotiate their benefits contracts, they will be asking much more than in the past “will a carve-out option look better, or does the carve-in option look better?”
(Reporting by Caroline Humer; Editing by Michele Gershberg, Meredith Mazzilli and Sandra Maler)