Common cause of dementia may be treatable

A new study — led by the University of Edinburgh in the United Kingdom — has now uncovered how a disease that affects the brain’s small blood vessels contributes to dementia and stroke.

Treating CSVD could help to prevent dementia.

The disease in question is called cerebral small vessel disease (CSVD).

In a paper now published in the journal Science Translational Medicine, researchers led by Prof. Anna Williams, who heads the MRC Centre for Regenerative Medicine at the university, note how they studied molecular features of the disease in rats.

They made some important discoveries. They identified, for example, a mechanism through which blood vessel changes from CSVD harm the myelin covering of nerve fibers that carry signals between brain cells.

The scientists also showed how certain drugs reversed the blood vessel changes and prevented damage to the nerve fibers in the rats’ brains.

Brain scans of individuals with dementia often show abnormalities in white matter, which consists mostly of nerve fibers and their myelin covering.

But until this study, the underlying mechanisms implicating CSVD as a driver of myelin damage in white matter were unknown.

Should the mechanism be the same in human CSVD, these findings could pave the way to new treatments for dementia and stroke.

Dr. Sara Imarisio, who is head of research at Alzheimer’s Research UK — one of the organizations that sponsored the study — says that the findings point to “a promising direction for research into treatments that could limit the damaging effects of blood vessel changes and help [to] keep nerve cells functioning for longer.”

Dementia is a major cause of disability

Dementia is a general term for a group of conditions in which brain function worsens over time. As the condition progresses, it diminishes ability to remember, think, interact socially, make decisions, and lead an independent life.

Worldwide, there are 50 million people with dementia and “10 million new cases every year.”

Dementia is a major cause of disability in older people and is the main reason that they become dependent on others. The social and economic burden of the condition also affects carers, families, and the wider community.

The majority of dementia cases are caused by Alzheimer’s, a progressive disease in which toxic proteins build up in the brain.

Other conditions that directly or indirectly damage the brain — such as stroke — also cause dementia.

‘Dysfunction of endothelial cells’

CSVD is common among older individuals. Not only does it directly cause stroke and dementia, but it can also worsen the effects of Alzheimer’s disease and give rise to depression and problems with gait.

For a long time, it was thought that the “different features” of CSVD were signs of “different types of tissue changes.” But more recently, scientists have come to realize that these features likely share many similar changes that affect small blood vessels.

And, as imaging technology advances, they are finding it easier to explore underlying mechanisms.

Prof. Williams and her colleagues discovered that CSVD causes dysfunction of endothelial cells, which are the cells that form the inner lining of blood vessels.

They also found that dysfunctional endothelial cells stop precursor cells from maturing into cells that make the myelin covering on nerve fibers.

‘A potential therapeutic approach’

Closer investigation revealed that the rats that developed CSVD had a mutated form of an enzyme called ATPase, and that this led to dysfunction of their endothelial cells. The mutation has also been found in the brain tissue of humans with CSVD.

In a final set of experiments, the scientists showed how using drugs to stabilize the endothelial cells “could reverse the white matter abnormalities in early-stage SVD in the rat model, suggesting a potential therapeutic approach.”

Prof. Williams and team explain that more research is now needed to find out whether the drugs work after CSVD has established itself and whether they might also “reverse the symptoms of dementia.”

“There are currently no drugs that slow down or stop Alzheimer’s disease and no treatments to help people living with vascular dementia.”

Dr. Sara Imarisio

https://bit.ly/2L02Gdb

Mylan slashes list price of its Copaxone copy

Mylan has slashed its list price on generic Copaxone, and the move has industry watchers scratching their heads.

According to Bernstein analyst Ronny Gal, the company has sunk its sticker to $1,900 per month, well below the $5,000-per-month price it used to sport. And the way Gal’s contacts see it, “under the current system, this change makes no commercial sense.”

The reason? Teva’s branded Copaxone is “essentially free for Medicaid,” which is “the segment that often prefers low upfront cost,” Gal wrote. So why would Mylan make the move?

Two potential reasons: The first, that “this was done in response to the government pressure” to drop list prices, which would fulfill U.S. President Donald Trump’s promises for price cuts without actually impacting products’ postrebate prices or the out-of-pocket costs for patients, Gal notes. And the second, that Mylan is looking to force down its rival’s prices and “deny Teva profits,” perhaps as a way to woo shareholders.

“Mylan sees itself as competing with Teva for investor money and as signaling to future innovators in complex markets (Advair, Neulasta) it is willing to erode market prices, if they do not cede fair share,” Gal wrote of the possibility.

So far, Teva has been able to fend off its generic attacker, which after long delays won a surprise approval last October. To start, Mylan set its list price just $800 per month below Teva’s $5,800 and then served up discounts.

Mylan “got only moderate share using this strategy with Copaxone,” though, Gal points out. The copycat grabbed just a 15% to 20% piece of the pie, thanks in part to rebating competition from Teva.

Now, the Israeli drugmaker will have to work to protect its market share from the impact of Mylan’s latest play. With pricing pressure hurting the generics industry across the board, Teva could use some help from its specialty portfolio. And while the company is counting on new product Austedo and forthcoming fremanezumab—as well as $3 billion in cost cuts—to dig it out of a major hole, it certainly wouldn’t say no to higher-than-expected revenue contributions from its top seller.

https://bit.ly/2KGGKYF

Depomed confirms settlement discussions with Purdue Pharma

Depomed announced that it is currently engaged in settlement discussions with Purdue Pharma in connection with ongoing patent infringement litigation between the company and Purdue. As the order issued by the Court indicates, the case and any pending motions have been administratively terminated, pending the outcome of such discussions. The Court’s order does not constitute a dismissal with prejudice of the case under the Federal Rules of Civil Procedure. As further indicated in the Court’s order, if settlement cannot be consummated, either party may request that the action be reopened.

https://bit.ly/2MYqizF

Settlement reached in Colgate-Palmolive baby powder lawsuit

A settlement has been reached between Colgate-Palmolive and a Southern California man who claimed in a lawsuit that he developed cancer by using the company’s talc-based baby powder.

City News Service reports no terms were divulged in the deal announced Monday as the two sides prepared to go to trial.

Paul Garcia suffers from mesothelioma, a lung cancer linked to asbestos exposure. Garcia claimed it was caused by inhaling asbestos fibers present in baby powder made by one of Colgate-Palmolive’s predecessor firms, Mennen.

The 67-year-old Garcia said Colgate-Palmolive and Mennen failed to adequately warn consumers that its powder contains asbestos and could cause cancer — charges the company denied.

Several companies, including Johnson & Johnson, are facing lawsuits related to the alleged presence of asbestos particles in baby powders.

https://bit.ly/2J9S3mu

CMS risk-adjustment payment freeze to hit high-cost insurers hardest

The Trump administration’s latest shock to the Obamacare system by freezing more than $10 billion in 2017 risk-adjustment transfers has even small companies that don’t benefit from the program lambasting the CMS.

The risk-adjustment program has long divided insurers, as larger plans with more-sophisticated data teams and a longer history in the market have raked in more money to pay for their higher-cost patients. But even smaller carriers are framing the move as an eleventh-hour, arbitrary whiplash for the exchanges. Some analysts worry the move also signals a shift away from the Affordable Care Act’s core tenet of guaranteed issue as it threatens a financial toll for insurers with older, sicker enrollees.

CMS Administrator Seema Verma hung the agency’s controversial decision Saturday to suspend transfers on a federal court decision in New Mexico from February that sided with insurance co-op New Mexico Health Connections against HHS’ risk-adjustment formula. Yet a separate, earlier decision in Massachusetts upheld the federal program.

Although small plans and co-ops—many of which failed and have shuttered—have complained that Obamacare risk adjustment skews in favor of more entrenched players, the feeling now is that the program freeze won’t help anything.

“My belief here is that CMS is picking and choosing which court ruling to act on. It is very strange that administration would decide to freeze payment,” said Sean Creighton, vice president of the Avalere consulting firm, “given that there are two opinions in different courts.”

The agency had options, Creighton said. It could have asked the New Mexico court to stay the judgment pending clarification of the regulation, to apply the ruling only to New Mexico, or to take it to an appeals court.

“CMS’ current course of action is hard to understand from either a legal or programmatic point of view,” he said.

Michael Adelberg, a consultant with the Washington firm Faegre Baker Daniels, said that even if observers take the CMS justification of its decision at face value, the suddenness of the agency’s announcement is problematic for everyone.

“This court decision came out in February,” Adelberg said. “So HHS could have messaged this months ago, even as it filed motions in court to regain prerogative on the risk-adjustment transfers. It is confusing to announce this a week beyond HHS’ own regulatory deadline, and the timing is unhelpful to all parties involved.”

Ceci Connolly, president of the not-for-profit Alliance of Community Health Plans, which represents smaller carriers that largely lost rather than gained under the federal formula, said ultimately the timing hurts everyone as the calendar runs on toward 2019.

“If you are a smaller plan, you may not have squadrons of experts at your disposal to capture every bit of that risk,” Connolly said. “So I understand why the New Mexico co-op filed the suit, and I would say that some of our small community health plans have probably been in similar circumstances over the past few years. But this is not the way to address those problems.”

Greg Fann, a consulting actuary with Axene Health Partners and a fellow with the Society of Actuaries, urged a more tempered response to the freeze, comparing the action to President Donald Trump’s cutoff last year of the cost-sharing reduction payments.

“I have been in the insurance industry for a long time, and I think that these catastrophic projections are overblown,” Fann said. “I think it is very unlikely we go into 2019 with tremendous uncertainty in how risk adjustment gets applied. It won’t get worked out this week. But I think and I hope that the final rates reflect the methodology, and I’ll say this—this is an actuarial point—insurers can operate if they know what the rules are.”

But Fann acknowledged that he has questions about the timing of the announcement and if there is a strategy behind it, noting that he does not know what the CMS was doing to react to the New Mexico case ahead of its missed June 30 deadline to release the 2017 risk-adjustment results.

Blue Cross and Blue Shield-branded plans—which are generally the last remaining major players in the individual market—are set to lose the most in the immediate future, analysts say. These plans have benefited the most from the transfers.

Some, like Connolly, attribute the Blues plans’ risk-adjustment success to the data sets and reserves they have to devote to figuring out the formula. Others, like Creighton, say it’s because these plans have higher-tiered plans and a broader risk pool—a fundamental of the methodology that Fann criticized as penalizing insurers with lower premiums and narrower networks.

“In general, it is fair to say that the transfers were leaning from bronze plans and low-cost silver plans to other plans—which makes sense,” Creighton said. “I think honestly the program is working as intended, therefore plans that enroll more expensive enrollees will hurt the most from this.”

The Blue Cross and Blue Shield Association was one of the first to come out swinging against the CMS announcement. The group’s CEO, Scott Serota, in a statement praised the program’s design to “keep costs down for consumers while meeting the medical needs of those requiring significant care.”

“This action will significantly increase 2019 premiums for millions of individuals and small business owners and could result in far fewer health plan choices,” Serota warned. “It will undermine Americans’ access to affordable coverage, particularly those who need medical care the most.”

While the CMS in its statement downplayed the freeze as pending a resolution between the Massachusetts and New Mexico court decisions, the timing of the announcement—several months after both rulings came down, and falling in the midst of plans’ rate-setting season—has sparked dismay and undone good will that the agency has garnered with small plans through other tweaks to the program for next year.

“It’s disheartening because the administration has had several options available to it along the way over the past several months,” Connolly said. “In fact, its decision to make changes to the formula for 2019 demonstrates the administration understands some of the problems. But it could have challenged the rulings; it could have asked for the stay; it could have made administrative fixes over the past several months.”

Connolly said that for insurance companies, the administration’s actions since taking office undermine Verma’s assurance over the weekend that the CMS wants to resolve the matter quickly and initiate the transfers.

“The behavior doesn’t jibe with the statement this weekend, and we are wondering which statement to believe,” Connolly said.

Now, insurers will watch what the CMS does next.

Creighton painted a dimmer picture for the key Obamacare idea of guaranteed issue as he placed the risk-adjustment move in the context of significant changes to the law made by the GOP-led Congress and the Trump administration.

“The bargain back in the day was that everybody gets to sign up, and for those who do you have guaranteed issue,” Creighton said. “Now, already the administration has undermined the penalty and idea that everybody has to sign up.”

The CMS announcement promised additional guidance on how the agency will manage appeals of 2017 risk-adjustment transfer amounts, rules for how carriers should treat risk-adjustment amounts when calculating medical loss ratios, as well as EDGE server data collection that is used to determine risk-adjustment transfers.

The big picture implication for Obamacare’s individual market depends on whether the CMS reverts to the original formula, but it follows a series of significant changes and disappointments for ACA carriers that are reshaping the exchanges.

First, President Donald Trump halted cost-sharing reduction payments that insurers are mandated by law to pay out on behalf of their poor enrollees. In response, most states required carriers to load the cost of those payments into benchmark silver plans in order to increase subsidies and keep low-income people covered. As a result, the populations subsidized with advance premium tax credits have seen their premiums go down while the unsubsidized face higher prices than ever.

In June, a federal appeals court sided with the government against insurers who claimed they were owed billions in risk-corridor payments after Congress slapped a budget-neutrality requirement on the program through appropriations riders.

“None of the health plans want to go back to the bad old days, but the administration’s action here is not helpful in that respect,” Creighton said.

https://bit.ly/2KW0JSd

>200 Infected by Parasite Linked to Del Monte Vegetables

Two hundred twelve people have been infected with an intestinal parasite in four upper Midwest states after reportedly eating pre-packed vegetable trays under the Del Monte Fresh Produce brand, according to the Centers for Disease Control and Prevention. The trays were purchased at various retailers including Kwik Trip or Kwik Star convenience stores.

The outbreak was first tracked by the CDC in mid-June, and is most severe in Wisconsin. As many as 54 cases have also been reported in Minnesota, along with a handful in Iowa and Michigan. Seven victims have been hospitalized, according to the CDC.

A recall was also issued in mid-June for the Del Monte trays, which included baby carrots, broccoli, cauliflower, and dill dip, and were labeled for sale by Jun 17. But the number of infections has grown since then, and the CDC is warning that more cases could still be reported, because the cyclosporiasis infection has a delayed onset for symptoms of roughly one week and can last for weeks. Anyone who might still have a recalled product should dispose of it–washing contaminated produce is not enough to get rid of the pathogen.

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Cyclosporiasis is caused by Cyclospora cayetanensis, a single-celled protozoa most commonly transmitted on produce contaminated with human fecal matter, particularly from tropical or subtropical regions where the parasite is native. According to the Food and Drug Administration, symptoms of cyclosporiasis include severe diarrhea, stomach cramps, bloating, nausea, and fatigue. Without treatment, the infection can last from as little as a few days to more than a month. Cyclosporiosis is usually not life threatening.

A previous major cyclosporiasis outbreak was reported in 2015, when 546 individuals were infected across 31 states. That outbreak was linked to contaminated cilantro from Mexico, and led to no fatalities.

https://yhoo.it/2J9qqKh

Danone probes reports Aptamil baby milk formula makes some infants ill

French food giant Danone is looking into reports that its Aptamil baby milk formula is making some infants ill.

Aptamil recently changed the recipe of three of its baby milk formulas.

Hundreds of parents in the UK have complained on social media that the revised formula milk is making their babies sick.

Danone said it had carried out extensive safety checks, but added that it was “taking all feedback very seriously”.

The food giant is now investigating the complaints and has set up a free helpline that parents can call for advice.

Parents in the UK are advised to call 0800 996 1000, pressing option 0 followed by option 1.

There have also been complaints that the size of the revised products has been reduced from 900g to 800g a tub, but the price remains about £11.

Image captionThe new version of the formula (left), next to the old version (right)

Several mothers have told the BBC that their babies experienced upset stomachs after they started using the new version of Aptamil First Infant Milk powder (stage 1).

The parents said they noticed that the milk powder did not dissolve in the bottles, leaving clumps of residue.

“It smelled different, like gone-off milk that had been left out for a day,” Rosie Menzies, from Lymington, Hampshire, told the BBC.

She said that her 11-week-old son Harry would be sick soon after feeds and began to refuse bottles, until she started using a different brand.

Danone UK said: “We would like to reassure parents that the quality and safety of our products is our number one priority. We have recently introduced new Aptamil formulations and we recognise that some families have not found the transition to the new formula easy.

“We have undertaken extensive quality and safety checks, including clinical trials, product testing and product experience tests on these products. The results have shown that babies take to this formula well and that it is safe.

“We have updated the mixing instructions on our packs as this new formula requires parents to mix it up slightly differently, compared to the previous formulation – specifically, shaking vigorously for 10 seconds to dissolve the powder.”

Aptamil said it had changed the recipes of three products: Aptamil First Infant Milk powder (stage 1), Aptamil Follow On Milk powder (stage 2) and Aptamil Growing Up Milk powders (stages 3 & 4).

‘Scientific research’

When asked why the baby milk formula was changed, Danone did not immediately reply.

Rebecca Heal in Larkfield, Kent, told the BBC that she complained to Aptamil about the new recipe and smaller packaging, and was told that the formula was changed because of “scientific research and costs to cover that”.

Ms Heal, who has a three-month-old daughter Olivia, said that she tried to follow Danone’s new mixing instructions, but the milk still wasn’t right.

“It took a lot of effort and shaking to get it to mix properly,” she said.

“Even after a minute or so of vigorous shaking, the milk still had gritty residue on the sides of the bottle, but just increased the amount of froth on the top as a result.”

However, some parents using the revised formula posted on Aptamil’s Facebook page that they had not experienced any problems.

One mother, who did not want to be named, told the BBC that her four-month-old baby had successfully transitioned from breast milk to Aptamil First Infant Milk.

“There is some residue after mixing, but then I found this was was often the case with the old formula anyway,” she said. “Coming from a science background, I’d rather look at things analytically, than just jumping on hysteria.”

Courtney Wheeldon, based in Hull, said that her 17-week-old son Jenson, who was born prematurely, had benefited from being on the new revised formula.

“My son appears a lot more content and happy… he’s putting on a lot more much-needed weight,” she told the BBC.

“My only complaint about the new formula would be that there is 100g less in the tubs for the exact same price.”

https://bbc.in/2L35Dd5