Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported that the United States Food and Drug Administration (US FDA) has agreed to the selection of Ryoncil™ as the commercial name for its lead allogeneic cell therapy remestemcel-L in the treatment of pediatric steroid-refractory acute graft versus host disease (aGVHD). Commercial plans for Ryoncil™ were presented at the 2020 Biotech Showcase being held this week in San Francisco, CA.
Mesoblast Chief Executive Dr. Silviu Itescu said: “We begin 2020 with great excitement as we prepare for potential FDA approval and US launch of our lead product candidate Ryoncil™ in pediatric aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant. The continued growth in revenues from royalties on sales in Japan of the related product TEMCELL®1 for aGVHD by our licensee provides important insight for our own US commercial plans. Together with our strategic partners, we are also looking forward to readouts of Phase 3 trials for our blockbuster product candidates in advanced chronic heart failure and chronic low back pain due to degenerative disc disease.”
The final module of the rolling Biologics License Application for Ryoncil™ will be filed with the FDA in January, following which the Company will request a priority FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, Ryoncil™ is planned to be launched in the US in 2020.
A new Gallup survey shows that support for vaccination in the United States is declining, particularly among parents of young children.
The survey, conducted in December 2019, shows that 84% of Americans feel it’s extremely or very important that parents vaccinate their children. That matches Gallup’s prior reading in 2015, but is down 10% from 2001, when 94% of Americans felt this way.
“Widespread public support for childhood vaccines creates a wall preventing contagious diseases like measles and polio from spreading in the US, but a breach in that wall appeared in 2015 and it has not been repaired,” Gallup said in a news release.
Among parents of children younger than 18 years old, 77% feel vaccination is important in 2019, down from 92% in 2001.
The decline in Americans’ belief in the importance of vaccinating children between 2001 and 2015 occurred among almost all subgroups of the public.
Highly educated Americans with postgraduate degrees is the only group that has maintained its 2001 level of support for vaccines; 90% of this subgroup continues to believe vaccination is important, essentially unchanged from the 92% in 2015 and 2001. Perceptions of the importance of vaccination declined by at least 5 percentage points among all other education subgroups, Gallup reported.
Public Awareness Campaigns Working?
Most Americans say they are aware of the advantages and disadvantages of vaccines. In the latest survey, nearly 9 in 10 (89%) say they have heard “a great deal” or “a fair amount” about the advantages of vaccinations, up from 83% in 2015 and 73% in 2001.
More than three quarters (79%) say they have heard a great deal or a fair amount about the possible disadvantages of vaccines — up modestly from 73% in 2015 but a substantial increase from 39% in 2001.
“Pro-vaccine public awareness campaigns appear to be working to the extent that more Americans — now a majority for the first time — report having heard a lot about the medical advantages of vaccines for children,” Gallup reports.
“However, more have also heard about the disadvantages. While they are not as pervasive and are being exposed as untrue, these counterarguments are still getting through, perhaps explaining why public support for vaccines remains lower than at the start of this century,” they point out.
Uncertainty on Vaccine-Autism Link Persists
Although many Americans who oppose vaccinations argue that they are more dangerous than the diseases they prevent, the vast majority of Americans (86%) continue to disagree. This is unchanged from the 87% who felt that vaccines were less dangerous in 2015 and only modestly lower than the 90% in 2001.
Currently, 11% of US adults think vaccines are more dangerous than the diseases they prevent.
Although the vast majority of Americans see vaccines as less dangerous than the diseases they prevent, only 62% feel the federal government should make all parents get their children vaccinated. In a 1991 Princeton survey, 81% felt the government should require vaccination.
Despite the well-publicized and debunked claim that vaccines cause autism, 10% of US adults still believe that vaccines cause autism in children, marking a modest increase from 6% in 2015. Nearly half (45%) do not think vaccines cause autism, up modestly from 41% who said the same almost 5 years ago, whereas 46% still aren’t sure. In 2001, 94% of Gallup survey respondents were unsure whether vaccines cause autism.
Americans with more formal education were more apt to say vaccines do not cause autism. The figure is 73% among those with postgraduate education, falling to 61% among those with a college degree only, 42% of those with some college, and 28% of those with no college experience.
Lesser-educated Americans were much more likely to have no opinion than to say they believe vaccines do cause autism. The percentage making the causal connection tops out at 12% among Americans with no college education vs 5% of postgraduates.
There was also a partisan split in opinions, with 55% of Democrats saying vaccines do not cause autism, compared with 37% of Republicans, according to Gallup.
The results are based on telephone interviews with a random sample of 1025 adults, aged 18 and older, from all 50 US states and the District of Columbia, with the margin of sampling error of ±4 percentage points.
The annual J.P. Morgan health care conference is taking place this week in San Francisco. Here are some of the hot topics under discussion at the four-day event, which wraps up Thursday.
Politics Looms Too Large
Investors are overreacting to political developments, Centene Corp. CEO Michael Neidorff said in a Wednesday interview during the conference, and added that he is “beyond surprised” at how shares of managed-care companies have been moving around due to news related to the presidential campaign.
“There is no rational reason to let a Des Moines Register poll” affect investment decisions in the sector, he said. Mr. Neidorff said the U.S. can’t afford a single-payer government health-care system and he doesn’t expect one to be enacted.
“Single payers control cost by limiting access,” he said. “All we’re talking about with Medicare for All is politics, we’re not talking about good policy.”
Congress Could Act on Drug Prices
The pharmaceutical industry’s top U.S. lobbyist sees signs that Congress could agree on legislation to reduce drug costs this year, potentially in May when certain government health funding expires and is up for renewal.
Steve Ubl, president of the Pharmaceutical Research and Manufacturers of America, said there are areas of overlap between certain drug-price bills in the Democratic-controlled House and a bipartisan bill that passed the Senate Finance Committee last year.
“To be honest, we don’t love every aspect of every one of these bills, but if Congress wants to act on drug pricing, the contours of an agreement are there,” Mr. Ubl said during a panel discussion at the conference on Tuesday. “The real question is whether politics will supersede the discussion.”
The trade group, known as PhRMA, opposes provisions of a House bill that gives the federal Medicare program power to negotiate drug prices and cap U.S. prices at a percentage of foreign prices. But PhRMA supports provisions that cap patients’ out-of-pocket costs for drugs.
J&J Sees Price Pressure
Johnson & Johnson says it is counting on prescription volume growth rather than price hikes to fuel U.S. sales growth in its pharmaceutical unit.
While J&J has raised U.S. list prices for some of its drugs, average net prices — those J&J realizes after paying rebates and discounts — have declined in the past couple of years.
“I don’t see pricing getting easier,” Jennifer Taubert, head of J&J’s pharmaceuticals unit, said at the conference on Monday.
Cigna, Oscar Plan a Plan
Cigna Corp. and Oscar Insurance Corp. will launch their joint small-business insurance plan in a handful of markets by the start of next year, Oscar CEO Mario Schlosser said in an interview.
The product will first roll out around the third quarter of 2020, he said, and “my hope would be, over time, we can go into all the markets.”
Cigna isn’t taking a stake in Oscar, he said, though the two companies will share risk on the new product, which will use Cigna’s provider network relationships and Oscar’s technology.
CVS Expanding Health Hubs
CVS Health Corp. says it has around 50 of its new health hub stores open, in markets including Philadelphia, and aims for more than 600 by the end of this year.
The company doesn’t disclose the hub stores’ profitability, but says it has seen increased front-store sales, greater customer engagement and greater pharmacy penetration.
“That is what is giving us the confidence to move with the rapid rollout, ” CEO Larry Merlo said. The company says it will offer more financial detail once it has a critical mass of stores, this summer.
Lilly Injects New Thinking
A year ago, Eli Lilly & Co. struck a deal to acquire cancer-drug developer Loxo Oncology Inc. for $8 billion. Recently Lilly took the unusual step of putting Loxo executives in charge of Lilly’s oncology research.
More typically, a biotech’s leadership departs after being bought by a larger company. But in Lilly’s case, “in a 145-year-old company, it helps to inject new thinking, new people,” Lilly’s R&D chief, Daniel Skovronsky said on the sidelines of the conference. He said the move will allow Lilly to be more agile in developing cancer drugs.
BD Doesn’t Expect Big Deals
Medical-supplies giant Becton, Dickinson and Co. has no near-term plans for another major acquisition on the scale of its purchases of CareFusion Corp. and C.R. Bard Inc. in recent years.
Instead, once BD pays down debt from the $24 billion Bard deal to a certain level, “we’ll redirect a large amount” of the freed-up cash flow for smaller, “tuck-in” deals, incoming CEO Tom Polen told The Wall Street Journal on the sidelines of the conference.
A nonpartisan health policy brain trust is shifting gears in 2020 to help state lawmakers tackle hospital costs, and the switch is funded by a Texas billionaire couple who have become major players in the national healthcare policy debate.
The National Academy for State Health Policy late last year created a new center to help states address healthcare system costs. The center plans within the next month to release between eight and 12 pieces of model legislation to help states lower healthcare spending, academy Executive Director Trish Riley said.
The group had previously been focused on developing policy solutions to lower prescription drug prices and providing technical support for drug importation proposals, but Riley said she has seen an appetite from states to address spending including hospital costs.
“We have always been deeply concerned about healthcare costs,” Riley said. “Pharmacy was a toe in the water, and is a smaller part of the overall cost picture.”
The new center is being funded by the Laura and John Arnold Foundation, a not-for-profit that has been deeply entangled in funding drug-pricing policy change on several fronts. The group has funded the hospital-led not-for-profit generic-drug manufacturer Civica Rx; a patient advocacy group based in D.C.; the controversial drug-value research group the Institute for Clinical and Economic Review; and other initiatives.
A spokesman for the Arnold Foundation’s parent entity said the not-for-profit is expected to give the academy $2.2 million in grant funds in 2020 for several projects, a nearly $200,000 increase from 2019 funding levels.
The policy development will be guided by a group of 17 state health policy officials, lawmakers, and attorney general staff from states including California, Connecticut, Colorado, Delaware, Georgia, Maine, Maryland, Massachusetts, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Utah, Vermont, Washington and Wisconsin.
There is no industry representation in the working group, but Riley said the group is aware that healthcare system landscapes vary greatly state-by-state and is conscious of protecting access to care through rural hospitals.
“All states have different situations, and different issues will lead to different policy solutions,” Riley said.
The new initiative is led in part by Deborah Fournier, a former New Hampshire Medicaid director who most recently worked at the Association of State and Territorial Health Officials, where she addressed rural hospital sustainability and alternative payment structures.
Anya Rader Wallack, a professor at Brown University who has held leadership positions in state government agencies and insurers, and Nancy Kane, who served on the Medicare Payment Advisory Commission and the Massachusetts Special Commission on Health Care Cost Containment, will serve as consultants on the template legislation.
The Medicare Payment Advisory Commission on Thursday voted unanimously to recommend hospitals receive a 3.3% raise in 2021.
The CMS has scheduled a 2.8% pay raise to hospitals for inpatient and outpatient services. MedPAC recommended that Congress increase net payments by 3.3% but change the structure of the pay boost to close the gap between reimbursement rates for physician offices and hospital outpatient departments. They also recommended incentivizing hospitals to reduce mortality and improve patient satisfaction by tying some of their raise to quality improvements.
The commission needs to find a way to make sure that hospitals are more accountable for the total cost of care, said MedPac Commissioner Dana Safran, head of measurement for Haven, the healthcare venture formed by Amazon, Berkshire Hathaway and JPMorgan Chase.
“(MedPAC is allowing hospitals) to thrive on fee-for-service revenue,” she said.
If Congress followed MedPAC’s recommendation, Medicare base payment rates to acute care hospitals would increase by 2%, which is 0.8% lower than the current plan. That loss would be offset by corresponding financial rewards under the hospital value incentive program. The commission also recommended eliminating current quality penalties, which should increase hospital payments by 0.5%.
Under MedPAC’s recommendations, hospital payments would increase by $750 million to $2 billion in 2021 and $5 to 10 billion over five years.
The new payment structure wouldn’t affect Medicare beneficiaries’ access to care or Medicare providers’ willingness to deliver care, according to MedPAC’s staff. They believe it would also control hospital cost growth, reduce payment differentials across care sites and reward high-performing hospitals.
MedPAC’s recommendation represents another nudge toward value-based payment. The updated payment structure would limit the strictly fee-for-service portion of the pay increase, while providing hospitals with additional financial incentives to improve quality.
It could also reduce hospitals’ financial incentives to acquire physician groups, which some health systems have done to take advantage of reimbursement differences that are based on the location of care, rather than the type of care that is provided.
The plan lets hospitals keep “a foot in two canoes,” Safran said.
Several commissioners think that MedPAC will need to develop a better long-term solution in order to increase hospitals’ responsibility for the total cost of care. It’s a project that they’ll likely focus on for next year’s recommendations.
“I think taking on the question of how hospitals are paid is … essential,” MedPAC chairman Dr. Francis Crosson, founder of the Permanente Foundation. “I think it’s going to be one of the heaviest lifts that this commission has ever attempted.”
MedPAC also voted to recommend that Congress maintain the 2020 payment rates for physicians in calendar year 2021. The commission’s staff said that the recommendation wouldn’t affect Medicare spending or access to care because it’s consistent with what’s already on the books.
There’s no planned pay increase for doctors in 2021, but clinicians that participate in the merit-based incentive program should be eligible for a 7% adjustment and an exceptional performance bonus. Physicians that participate in an advanced alternative payment model could receive a 5% incentive payment.
Gwyneth Paltrow’s reaction to the description of the vulva in episode three of her new Netflix show, ironically titled “The Goop Lab,” suggests that she didn’t previously know that the vagina is inside the body and the vulva is outside, or that she didn’t know much about pelvic floor muscles.
While this knowledge gap is common among women, I expected more from Paltrow, whose lifestyle business is partially built on monetizing the vagina. Her comment makes me wonder what body part she is really referencing with her “This smells like my vagina” candle.
Those looking for a lot of Paltrow in the series, which airs next Friday, will be disappointed in the first three labisodes. She appears only briefly, offering largely forgettable commentary peppered with a swear word or two to remind us that Paltrow thinks of herself as the shock jock of natural health.
While the show and the adulation preceding it lead us to believe that Paltrow is forward thinking when it comes to health and wellness, she doesn’t personally take the risks she asks of others. She doesn’t take psychedelics, jump into cold water, have an orgasm on camera, or expose her fears or traumas.
The first three episodes — “Healing Trip” (psychedelics), “Cold Comfort” (cold therapy), and “The Pleasure Is Ours” (the vulva and orgasm) — are approximately 35 minutes long. Each one begins with a disclaimer that the show is for entertainment only.
If only.
They were so boring I couldn’t manage to watch beyond episode three.
“The Healing Trip” takes Goop employees to Jamaica to do mushrooms. I knew little about the medical use of psychedelics before watching this episode, and ended up knowing very little about it afterward. The episode is largely centered around the Goop troop revealing personal traumas, talking about using psychedelics, experiencing the effects of hallucinogens, and offering some revelations. It seemed to go on forever.
There are also testimonials: anecdotes from three people who tried psychedelics in the United States — two in clinical trials and one who did microdosing on her own.
This is classic Goop: stoke fear about conventional medical therapy and gloss over any risks of novel therapies while neglecting to mention that the lack of studies means we know far less about the risks. The risk-benefit ratio always favors the Goop message.
The experts specifically mentioned that taking psychedelics for mental health reasons should be done only in a controlled setting with a trained provider, but we hear this only after the episode has been largely devoted to the Goop gang doing the exact the opposite. At that point the medical disclaimer was a distant memory.
“The Cold Comfort” episode is largely about Wim Hof, a man who claims that the triad of exposure to cold, hyperventilating to the point of lowering the levels of carbon dioxide in the blood, and meditation can beneficially alter the immune system and heal trauma. He implies that he can use his mind to fight off the negative effects of bacteria in his blood.
In 2003 I developed sepsis, a life-threatening condition caused by my body’s response to an infection of E. coli. So I took particular umbrage to this assertion. The evidence supporting Hof’s claims is slim but emphasized in a science-ish fashion.
Goop employees follow Hof’s method and, under his guidance, hyperventilate until they get tingling in their hands, muscle cramps, and euphoria. These changes are chalked up to be physical conditioning and some sort of mind-body revelation instead of what they really are: symptoms of respiratory alkalosis, a low level of carbon dioxide that increases the pH of the blood. This makes it harder for the body to deliver oxygen and reduces blood flow to the brain.
This hyperventilation is followed by snowga — you got it, yoga in the snow — that culminates with jumping into a cold lake.
This, apparently, is a lesson in how to treat a panic disorder, deal with stress, get in tune with your body, and heal trauma.
Could people watch this episode and think that they should abandon proven therapies such as cognitive behavioral therapy to follow Hof’s method? Could someone trying this at home hallucinate? Or have a seizure? We don’t get that information.
The combination of training and genetic advantage can prompt people to push their bodies to extremes. That’s why the Guinness World Records exist. Hof holds several endurance records, although the last time I checked endurance was not synonymous with health or longevity. Despite his prowess for enduring the cold, if you left Hof outside in the winter in my home city of Winnipeg, Canada, he would eventually die of exposure, just like the rest of us mortals.
Hof’s skill set seems similar in many ways to those of magician David Blaine, except that Blaine makes no health or spiritual claims about holding his breath for unimaginably long times — and actually emphasizes the risks — while explaining that this is all for the purpose of pushing himself to his limits.
In this episode, Goop’s chief content officer Elise Loehnen muses about injecting toxins into Goop employees to see if Hof’s training can alter their immune systems, then bemoans the negative response from the Netflix lawyers. You worry about the lawyers over the safety of your employees?
And while I’m on the subject of workplace safety, I wondered what the U.S. Occupational Health and Safety Administration might think about subjecting employees to hyperventilation to the point of reducing cerebral blood flow.
Hof’s method is offered as proof of the mind-body connection, something that those of us who practice medicine know exists. It is why many clinicians recommend biofeedback or talk about the impact of stress on the immune system. We also know that optimism and anxiety may influence antibody response to vaccination.
The mind-body connection is not some secret known only to men who sit on ice. But an old biofeedback machine in a medical office has no shock value and isn’t Instagram-worthy high-resolution video of gorgeous Goopsters doing snowga.
The episode on vulvas and sex, “The Pleasure Is Ours,” is the only one I can recommend. It was informative because Betty Dodson and Carlin Ross did most of the talking and education. Vulvar anatomy was discussed, and I’m always pleased when a model of the clitoris is on display. We get a guided tour of the vulva with a real model (Ms. Ross I presume) and photos of others to show variation. Ross also masturbated on screen, although little is shown. This is all useful, both the images of the vulva and the orgasm, especially the latter, as many women believe false scripts of female orgasm that involve vocalizations and contortions — orgasms that look like Sally Albright’s fakery in the movie “When Harry Met Sally.”
I laughed out loud at the look on Paltrow’s face when Dodson asked why she should care about wrinkles when she can orgasm. This would have been an amazing moment to explore. After all, Goop has loads of products geared towards the quest for the adaptogenic fountain of youth.
I initially thought that “The Goop Lab” would simply be an infomercial for a nutraceutical and lifestyle company paid for by Netflix subscribers. While Goop products weren’t mentioned in the episodes I watched, discussing medical conditions is a tried-and-true strategy of big pharma: generating interest in a disease or problem generates interest in a solution to that problem, which in turn generates business. If you see a vibrator on the orgasm episode and then head to goop.com, might you buy one of its vibrators? I wouldn’t be surprised if at some point we are invited to shop the Netflix stories on Goop.
But the series is more than an infomercial. Loehnen said she wanted to understand herself in the context of a bigger universe. The theme of seeking guidance and the need for quests runs through the episodes I watched. It is also a large part of the Goop experience.
It’s no wonder that Goop has embraced mediums and mysticism. With spirits and the divine on board, Goop finally has the missing ingredients to cement lifestyle as the new religion with Paltrow as high priestess. I see “The Goop Lab” as televangelism, bringing the ministry to a larger audience and possibly opening more wallets.
Whether the series gets them any new converts — and hurts anyone along the way — remains to be seen.
