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Wednesday, December 12, 2018

J&J willing to pay $400M-plus in hip device cases


Johnson & Johnson (NYSE:JNJ) is willing to pay more than $400M to settle some of the thousands of consumer allegations that it sold defective artificial hips and hid the health risks of the devices, Bloomberg reports.
JNJ has settled or is in the process of settling 3,300 of ~10K lawsuits targeting its Pinnacle line of hip replacement devices, a judge said in a court filing earlier this week.
Company officials have agreed to pay an average of ~$125K per case to resolve about a third of the suits pending against the company over Pinnacle hips, according to the report; an average $125K payout for 3,300 cases would cost JNJ ~$413M.
JNJ is said to want to resolve the remaining Pinnacle cases before a trial gets underway in January.

Amazon: Labor Groups Call for Better Warehouse Working Conditions in NJ

Labor groups are pressing for greater protections for warehouse workers in New Jersey, one of the biggest and fastest-growing distribution areas in the U.S., after an accident at an Amazon.com Inc. facility there that sickened dozens of employees last week.
A coalition of regional labor, community and advocacy groups said in a report Wednesday that the jobs in regional warehouses were often unsafe, grueling and poorly paid. The group, Warehouse Workers Stand Up, called on Amazon and other warehouse employers to embrace a code of conduct that includes paying workers a minimum of $15 an hour, respecting workers’ right to organize, and providing effective workplace safety and hazard training.
The coalition wants such protections to be a condition of subsidies for logistics real-estate projects in a state where warehouse construction is surging.
The push comes as strong economic growth and rising e-commerce volumes are driving new warehouse development along the New Jersey Turnpike and near the Port of New York and Jersey, the busiest maritime gateway on the East Coast.
“As e-commerce has come along, as Amazon has grown, the demand for same-day delivery and overnight delivery is creating intense pressure for workers,” Megan Chambers, co-manager of the Laundry Distribution and Food Service Joint Board of Workers United, SEIU, which organizes and represents warehouse workers in New Jersey, said at a news conference at Port Newark.
Workers are being expected to meet unrealistic production quotas, she said, and permanent jobs “are being replaced with part-time jobs, seasonal jobs, or so-called temporary jobs where workers work full-time hours but without benefits” or other rights.
An Amazon spokeswoman said in an email the company already pays a $15 hourly minimum wage and provides health-care and other benefits outlined in the code of conduct. Amazon is “proud of its focus on safety,” she said. “We encourage anyone to compare our compensation, benefits, and workplace to other retailers…and we respect employees’ right to choose to join or not join a labor union.”
Demand for warehouse labor to handle goods has soared across the U.S. as retailers and e-commerce firms have opened sprawling fulfillment centers where workers pick, pack and ship millions of online orders. Storage and warehousing companies have boosted payrolls by nearly 50,000 workers in the past 12 months, and added 6,200 jobs in November as they headed into the seasonal peak.
That has also drawn more attention to working conditions and pay at warehouses across the country.
Last week, Democratic lawmakers in Congress called for an investigation of working conditions at XPO Logistics Inc. after allegations of worker mistreatment in shipping operations in Tennessee and California. An XPO spokeswoman said the company takes the allegations seriously, is investigating them and is committed to taking necessary action.
Two dozen Amazon workers were taken to hospitals last week after a punctured can of bear spray released harmful fumes at a Robbinsville, N.J., warehouse. A separate Amazon spokeswoman said the company is removing that item from all robotic fulfillment centers and making other adjustments “to ensure it doesn’t happen again.”
The mayors of Newark, Perth Amboy and New Brunswick, where many warehouses have opened in recent years, support the labor group’s push. “If we are going to be counting on warehouse jobs to reduce unemployment, to get people into the workforce…we need to make sure we get them there with decent wages and conditions that are safe,” Newark Mayor Ras Baraka said at Wednesday’s press conference.

Radical surgery for some prostate cancers adds three years to life


In men with localized prostate cancer discovered because they had symptoms or noticed during a work-up for another medical problem, radical prostate surgery leads to an average of three extra years of life compared to a “watchful waiting” approach, researchers say.
The benefit of surgery was most pronounced in men who were under age 65 when their tumor was diagnosed, a new, long-term Scandinavian study found.
The results, published in The New England Journal of Medicine, don’t apply to prostate cancer detected during screening, such as with blood tests to measure prostate specific antigen (PSA).
The study does, however, add new information to help guide treatment of men with symptomatic or “incidentally” discovered prostate cancer.
But the findings are complicated by the fact that treatment options have changed since the study began in the 1990s.
Today, PSA testing often spots prostate tumors much earlier, and patients have the option of so-called active surveillance, or watchful waiting, wherein doctors closely monitor tumors and begin treatment when the cancer seems to be getting aggressive. Typically, prostate tumors grow so slowly that men will likely die from something else before the cancer claims them.
Nonetheless, the results are “important because this is the longest follow-up we have,” said Dr. David Penson, chairman of urology at Vanderbilt University Medical Center in Nashville, who wasn’t involved in the study. “It shows that if I have a long life expectancy and if I have higher-grade disease, I probably need to get some treatment because there’s an advantage to surgery, and it’s not an insignificant advantage.”
“If I’m an older, sicker guy with heart disease and my life expectancy is less, maybe I don’t have to have it treated,” Penson told Reuters Health in a telephone interview. “If I have low-grade disease, maybe I don’t need to be treated at all regardless of how old I am.”
“What we show is that radical prostatectomy can cure prostate cancer but it’s only for those who develop a lethal disease and who are healthy enough to not die from something else,” study leader Dr. Anna Bill-Axelson of Uppsala University in Sweden told Reuters Health by phone.

Most people have low-risk disease, she said.
“Even in our study with advanced tumors, almost 70 percent of the men died from other causes, so it shows you shouldn’t treat immediately, especially low- or intermediate-risk tumors,” she said. “You should wait and see if they get more aggressive and then treat them.”
The trial involved 695 men at 14 centers in Sweden, Finland and Iceland.
During follow-up for an average of 23 years, there were 45 percent fewer prostate cancer-related deaths in men who got radical surgery.
By 2017, 80 percent had died from any cause. Among men who had immediate surgery, 72 percent died; among those who didn’t, 84 percent died.
Prostate cancer accounted for 20 percent of deaths in the surgery group and 31 percent of deaths in the watchful waiting cohort.
All volunteers were under age 75 at the start, with a life expectancy of at least 10 years.
The cancer spread in 27 percent of the surgery group and in 43 percent of the watchful waiting group.
Radical prostatectomy produced the most benefit among men diagnosed before age 65. Among these men, “overall mortality was 15 percentage points lower, mortality due to prostate cancer was 15.1 percentage points lower, and the risk of metastasis was 18.6 percentage points lower in the radical-prostatectomy group than in the watchful-waiting group,” the researchers conclude.
SOURCE: bit.ly/2UrK62J The New England Journal of Medicine, online December 12, 2018.

Increase the Calories You Burn When Walking


Walking is not only a great first exercise, it can also be a forever exercise.
Here are some ideas to show you how to take it to the next level.
Making walking more of a challenge enables you to burn more calories and raise your working heart rate. You can do this by working out on a treadmill with an incline setting and wearing a weighted vest. You can start with either one to scale up or combine both ideas for a greater challenge.
According to the American Council on Exercise, wearing a weighted vest is a great option if you’re relatively new to exercise because it won’t feel as difficult as ramping up your speed, for instance. If you choose a vest that weighs about 15 percent of your bodyweight, you can burn 12 percent more calories when walking at 2.5 miles per hour — an easy pace. You can achieve a slightly higher calorie burn by wearing a vest that’s just 10 percent of your bodyweight if you walk on a treadmill at that speed and at an incline with a 5 or 10 percent grade.
To ease into the combined approach, walk for 5 minutes at a flat or 0 grade, then 5 minutes at 5 percent grade, followed by 5 minutes at 10 percent grade. Finish up by going back to the 5 percent grade before a cool-down period at 0 grade.
You can also adapt the vest and use of incline to interval training. After a warm-up, walk at a 10 percent grade for 2 minutes, then at 0 grade for 4 minutes. Repeat the sequence for up to 30 minutes.
Remember that if you haven’t exercised in some time, check with your doctor before starting any routine.
More information
Find out more about the calorie-burning benefits of wearing a weighted vest at ACEFitness.org.

U.K.’s NICE issues preliminary ‘no’ on Alnylam’s Onpattro and Ionis’ Tegsedi


Alnylam and Ionis are in a head-to-head battle for market share with their new treatments for the rare disease hereditary transthyretin-mediated amyloidosis (ATTR), and they both won approval in Europe over the summer. But now England’s influential drug-cost watchdog, the National Institute for Health and Care Excellence (NICE), has refused to back either drug.
NICE issued preliminary guidance on Wednesday stating neither drug is cost-effective and therefore shouldn’t be routinely used by England’s National Health Service (NHS). The agency is taking comments until Jan. 9 and plans to meet again in February to re-evaluate the drugs.
Onpattro carries a list price of £7,176.45 ($9,052) per vial and is infused every three weeks, while Tegsedi is a once-weekly, £5,920 ($7,467) injection that patients can give themselves. Both companies offered undisclosed discounts, and NICE determined that the treatments do, in fact, slow the disease’s progress and improve quality of life.
“However, it is uncertain whether these benefits are maintained in the longer-term,” NICE said in a statement emailed to FiercePharma. “In addition, there were uncertainties in the economic modelling for both treatments.”
A spokesperson for Ionis told FiercePharma that NICE’s decision was “not unexpected” and that the company plans to address the agency’s concerns. Brendan Martin, general manager of Alnylam UK & Ireland, said in a statement that the company would work with NICE on “securing a positive, sustainable agreement that represents value for the NHS and that would help transform the lives of people living with this terrible disease.”
Indeed, it has become standard practice for companies to negotiate with NICE, and often those discussions lead to reversals of previously negative opinions. So there’s little doubt investors will keep an eye on NICE developments over the coming months.

ATTR causes an abnormal buildup of a protein in the liver that accumulates in tissues throughout the body, leading to progressive loss of muscle function and ultimately death. About 150 people in the U.K. have the condition, NICE estimated in its preliminary guidance documents. The only available treatment before Onpattro and Tegsedi was supportive care, so there’s a significant need for drugs that relieve disability and improve quality of life, the agency said.
But NICE’s standard method for determining cost effectiveness revolves around the commonly used measure of quality-adjusted life year gains (QALY), and Onpattro and Tegsedi both fell short, the agency reported. That’s because they delivered incremental cost-effectiveness ratios above £100,000 per QALY gained when compared with the standard of care. That figure needs to fall below £100,000 for the drugs to be considered an effective use of NHS resources, NICE said.
In Tegsedi’s case, the guidance document noted that Ionis’ best-case scenario produced an incremental cost-effectiveness ratio of £369,569 per QALY gained, and NICE concluded that the real ratio would be nearly twice as high.
NICE picked on both companies for failing to account for certain risk factors in their cost-benefit analyses. For example, Alnylam didn’t properly factor in treatment compliance rates when analyzing the cost of administering Onpattro and other medications that are recommended prior to the treatments, including steroids and antihistamines, NICE said.

Alnylam has been under the gun to rev up sales of Onpattro. The RNAi therapy, which suppresses transthyretin (TTR) production in the liver, has brought in just $460,000 in sales since its August approval. That prompted Jefferies’ Maury Raycroft to declare the launch “disappointing” after Alnylam’s third-quarter earnings release.
During a conference call after the earnings announcement, Alnylam President Barry Greene said the company is working hard both to increase awareness of the disease and to boost genetic screenings that would improve the diagnosis rate. The company estimates that at least 20,000 ATTR patients are eligible for the drug, but only 5,000 have actually been diagnosed.
Ionis, meanwhile, is stepping up its effort to gain a toehold in the market. It won approval for Tegsedi in October and promptly priced it in the U.S. at $450,000 a year, matching Alnylam’s price tag on Onpattro. And Ionis is playing up the fact that its drug is more convenient than Alnylam’s because patients can administer it to themselves at home.
As if the marketing task isn’t challenging enough for Alnylam and Ionis, there’s a third aTTR player waiting in the wings that has been attracting attention of late: Pfizer. In August, Pfizer releasedpositive clinical trial data for its candidate, tafamidis, in the related condition ATTR cardiomyopathy. Although the three companies won’t initially be courting the same patients, there could eventually be some overlap in their marketing efforts. Alnylam, for one, is hoping to gain approval for Onpattro in ATTR cardiomyopathy, too.

Public Still Suspicious of Metabolic Surgery


Much of the public holds negative perceptions of metabolic surgery, a recent survey indicated.
About half of U.S. adults responding to a telephone survey said they believed weight loss surgery was mainly for cosmetic — rather than health-related — reasons, Heather Yeo, MD, MHS, of New York–Presbyterian and Weill Cornell Medicine in New York City, and colleagues reported in JAMA Surgery.
On top of that, nearly 40% of individuals felt that people who opted for weight loss surgery were choosing the “easy way out.”
Around 8% of respondents also thought that insurance should not cover medical procedures to help people lose weight under any circumstances. On the other hand, about one-fifth of respondents said these types of procedures should always be covered, while the majority felt that procedures should be covered by insurance but solely for the health benefits.
“[M]any patients who are eligible for weight loss surgery are either not being offered it or not seeking it, with highly prevalent negative attitudes toward weight loss surgery being a potential reason,” Yeo and co-authors wrote, adding that the “high prevalence of these attitudes potentially creates a difficult social environment for patients who opt for weight loss surgery.”
The analysis included responses from 948 adults — the majority of whom were non-Hispanic white individuals — who responded to the Cornell National Social Survey via telephone.
Male versus female participants tended to hold very different attitudes toward metabolic surgery, with women generally more favorable. Specifically, women were more likely to say weight loss surgery is mostly for health reasons compared with responses from men (OR 1.34, 95% CI 1.02-1.75).
Women were also about half as likely as men to feel as though surgery was the “easy was out” (OR 0.54, 95% CI 0.40-0.71) and that it should not be covered by health insurance (OR 0.48, 95% CI 0.29-0.81).
Perceptions of weight loss surgery also varied across difference races and ethnicities. For example, non-Hispanic black individuals were the most likely to feel that surgery is the easy way out compared with other races.
Those older than age 62 were more likely to hold negative perceptions of surgery, more often reporting that they think surgery is an easy way out and that it should not be covered by insurance, compared with younger participants. However, the older group were also the most likely to believe surgery is mostly for health reasons.
Politics also mattered, with those endorsing conservative views more likely to hold negative attitudes toward surgery versus those who said they had moderate or liberal political views. In particular, conservatives were less likely to think surgery is mostly for health reasons and more likely to think surgery is an easy way out and that insurance shouldn’t cover it.
The researchers said that based upon these findings, “the association between higher prevalence of negative attitudes and demographic groups not opting for weight loss surgery supports the hypothesis that these attitudes may be at least partly responsible for such low utilization of weight loss surgical procedures.”
As for tackling the public misperceptions regarding metabolic surgery, Yeo and co-authors said it will take both time and education. “There is no simple way to fix this problem,” they wrote. “It may take years of public and physician education regarding the health benefits of weight loss surgery to improve its perception and increase its utilization.”
The study was supported by a grant from the Agency for Healthcare Research and Quality.
Yeo and co-authors reported no conflicts of interest.

Wells Fargo Takeaways From Canopy Growth CEO’s New York Presentation


On Dec. 11, the Consumer Analyst Group of New York hosted a group luncheon where Canopy Growth Corp. CGC 3.41% CEO Bruce Linton presented.
Wells Fargo analysts attended the luncheon and presented their main takeaways. Overall, the analysts said they are optimistic about the company’s prospects and its relationship withConstellation Brands, Inc. STZ 1.04%

Wells Fargo’s Main Takeaways

Wells Fargo analysts did not provide their outlook on Canopy Growth’s stock, but cited a number of positive aspects from Linton’s presentation.
Canopy Growth is expected to see more revenue, as its supply constraints were mainly caused by government bottlenecks, analyst Bonnie Herzog said in a note. In addition, the company has adequate production assets in Canada, with 4.3 million square feet of production facilities and 1.7 million pending, she said.
As s it completes its investments in Canada, CGC will continue to increase its presence in international markets and introduce more products.

Regarding the collaboration with Constellation Brands, which acquired a 38-percent stake in Canopy Growth, Herzog noted the upcoming release of CBD-infused beverages the companies are developing. (See her track record here.)
Canopy plans to launch a scalable, calorie-free and transparent beverage with a quick onset and long shelf life, the analyst said.
Canopy plans to begin trials for a cannabidiol, or CBD, sleep aid in January, according to Wells Fargo.

Canopy To Enter US Market

Wells Fargo believes Canopy Growth is well-positioned to enter the U.S. market following the descheduling of hemp in the pending 2018 US Farm Bill and the transfer of its supervision to the Department of Agriculture from the Drug Enforcement Administration.
Herzog noted the FDA’s role in hemp regulation “given the emergent nature of the category and clear lack of longitudinal data.”