Search This Blog

Monday, July 9, 2018

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.

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.

>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.
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.
Get Data Sheet, Fortune’s technology newsletter.
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.

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.
Old and new cartons of Aptamil baby formula
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.”

HHS Confirms DNA Testing of Migrant Families With Additional Details


 The US Department of Health and Human Services last week confirmed that it is DNA testing migrant families to help it meet court-mandated deadlines for reuniting children separated at the border from their parents.
An HHS spokesperson maintained that the government is only using DNA testing for the purpose of verifying parentage, but added without elaborating that HHS is not publicizing the contractor doing the testing “due to privacy and security.” According to the spokesperson, HHS has not consulted with the lab contractor to get permission to publicize this information.
Last week, following press reports that HHS was DNA testing migrant families separated at the border as a result of the Trump Administration’s “zero tolerance policy,” genetic ethicists and legal experts expressed concern about the government’s lack of transparency in terms of which lab was involved, the type of testing being performed, if the information would be used beyond family reunification purposes, and if the data were being saved in any kind of database.
Subsequently, HHS held a press conference and issued a statement that DNA testing was being done to “expedite verification of parentage” in light of a court order from Judge Dana Sabraw of Federal District Court in San Diego, requiring that the government reunite all children under age five with their parents by July 10 and older children by July 26.
HHS said in a statement that “a DNA test is done only when there is a specific parent-child relationship that needs to be validated. It will be used only for this purpose.”
HHS further noted that its Office of Refugee Resettlement (ORR) already uses DNA testing as a parentage verification tool in its Unaccompanied Alien Children program when proof cannot be provided with regular documentation — a scenario that may not be uncommon for refugees fleeing locales riddled with violence or ravaged by natural disasters.
According to an HHS spokesperson, organizations with grants from ORR to provide care to minors are collecting cheek swab samples from children, and Department of Homeland Security personnel or HHS-deployed field teams are collecting samples from the adults in the custody of US Immigration and Customs Enforcement (ICE). The samples are sent to an unnamed third party lab for analysis.
Although the government is not publicizing the lab doing testing, it has a number of options in this regard, including a commercial lab with AABB accreditation for kinship testing, a state lab, or one of the Federal Bureau of Investigation’s accredited labs.
Once testing is done, the lab electronically transmits the results to the incident management team at the securities operations center, which share them with grantees, and the information is used for verifying parentage. After the parent/child relationship is verified, HHS has instructed the testing contractor to destroy the samples and the results, according to the spokesperson.
In a statement, HHS estimated it has more than 11,800 minors in its custody, 80 percent of whom are male teens who have crossed the border unaccompanied by an adult. An audit identified that fewer than 3,000 of these minors currently in ORR’s care could have been separated from a parent.
On May 7, Attorney General Jeff Sessions announced the “zero tolerance policy,” stipulating that all who illegally cross the southwest border would be prosecuted for illegal entry, and as a result, when families are caught, children crossing with their parents are put in government custody as unaccompanied minors and the parents are sent to jail. Since this policy went into effect, the government estimates more than 2,300 children have been separated from their parents. However, the court order requires the government to also reunite children separated from parents before the policy went into effect.
Meanwhile, the government has asked the court to extend the reunification deadline for the estimated 101 children under age five. According to reports, the government’s usual record-keeping system for tracking children and their parents has been a bureaucratic mess. Some of the parents of the youngest detained children have already been deported or released and their whereabouts are unknown, according to US Department of Justice lawyers cited in a report.
HHS indicated that before releasing detained children from its care, it needs to properly vet the adults claiming to be their parents and ensure they’re telling the truth and don’t have criminal backgrounds. Although Trump Administration officials have indicated that child trafficking is a significant problem among those crossing the border illegally, experts GenomeWeb spoke to said while this does happen there aren’t good estimates of how big the problem is in the present situation.
“We are working with other federal agencies to perform background checks on purported parents,” the HHS spokesperson said. According to HHS, while working to reunite children under age 5 with their parents, ICE criminal background checks identified two “purported parents” with criminal histories, “including charges of child cruelty, rape, and kidnapping.”

Inhaled Heroin Tied to ‘Peculiar, Often Catastrophic’ Brain Damage


“Chasing the dragon” (CTD) — a method of inhaling heroin in which users heat heroin over aluminium foil with a lighter and then chase the fumes — is growing in popularity and may lead to “peculiar and often catastrophic brain complications,” new research shows.
“The distinct pharmacology of CTD correlates with its specific clinical and radiological features and prompts grave concern for potential morbidity and long-term disability costs,” write Vilakshan Alambyan, MD, from The Neurological Institute, University Hospitals Cleveland Medical Center in Ohio, and colleagues.
Roughly 2.4 million Americans are addicted to opioids and nearly 1 million abuse heroin, costing the US $51 billion annually. Inhaled heroin is approaching epidemic levels east of the Mississippi River as well as among urban young people. CTD is of particular concern because it is easier to administer and provides a greater high compared with injected heroin.
Alambyan and colleagues review the emerging role of inhaled heroin, specifically CTD, in the opioid epidemic in an article published online July 9 in JAMA Neurology.
They say CTD is associated with a “unique spectrum” of health outcomes, including an aggressive toxic leukoencephalopathy with pathognomonic neuropathologic features, along with sporadic instances of movement disorders and hydrocephalus.
For example, CTD led to spongiform leukoencephalopathy in 116 of 141 reported cases (82.3%), as compared with 25 cases (17.7%) arising from other forms of heroin inhalation (ie, sniffing, smoking, and snorting).
The literature suggests three distinct degrees of CTD clinical severity. Among 88 patients, 18 (21%) developed a mild syndrome consistent with inattentiveness, confusion, ataxia, and psychomotor symptoms; 46 (52%) exhibited moderate severity with corticospinal or extrapyramidal involvement and impaired alertness ranging from severe confusion to delirium; and 24 patients (27%) developed the most severe form involving generalized motor impairment, abulia without concomitant language disorders or apraxia, and noticeable alertness deficits.  Mild cases typically survive with minor sequelae, while moderate to severe presentations may deteriorate and lead to death.
As for treatment, preliminary evidence suggests a role for coenzyme Q10. For example, among nine patients with CTD administered coenzyme Q10, five improved to varying degrees, and four remained unchanged or deteriorated. Given its negligible adverse effect profile, Alambyan and colleagues recommend a coenzyme Q10 trial regimen of 300 mg four times a day in all patients meeting criteria for possible or probable CTD.
They propose the following clinical diagnostic criteria and categories for CTD leukoencephalopathy.
Inclusion criteria
1. Presence of a clinical syndrome suggestive of leukoencephalopathy
2. Positive results on heroin toxicologic testing
3. Confirmed report of CTD inhalation by the patient, his or her next of kin, or a witness
4. Supportive neuroimaging
5. Neuropathology findings consistent with spongiform leukoencephalopathy
Exclusion Criteria
1. Confirmed history of acute intoxication or exposure to a toxin other than heroin that is capable of producing a CTD-like outcome
2. Overt clinical picture suggesting an infectious, demyelinating, vascular, or paraneoplastic cause
3. Neuroimaging consistent with a predominantly cortical involvement along with sparing of subcortical areas and posterior fossa
Diagnostic Category
Definite CTD: Patient fulfills all the inclusion criteria
Probable CTD: Patient fulfills inclusion criteria 1 through 4
Possible CTD: Only inclusion criteria 1 through 3 are met, or criteria 1 through 4 are accompanied by confirmed polysubstance or polyroute heroin abuse

The investigators suggest establishing a case registry or database using these suggested criteria as a means to further clarify the syndrome. “However, clinical utility necessitates a permissive approach, where even a possible suspicion for CTD leukoencephalopathy should prompt appropriate therapy,” they advise.
This research had no commercial funding. The authors have disclosed no relevant financial relationships.
JAMA Neurol. Published online July 9, 2018. Abstract

OncoCyte Reports Encouraging New Study Results for Lung Cancer Blood Test


– Results suggest improved performance of next-generation test– Study results support move to new diagnostic testing platform Significant development work required to fully validate this recent progress
OncoCyte Corporation(NYSE American:OCX), a developer of novel tests for early detection of cancer, today reported that its most recent study of clinical samples in the development of DetermaVu™, its lung cancer diagnostic blood test, has produced encouraging results. This study supports moving the test to a leading clinical diagnostic testing platform and indicates that the clinical performance of the test may be better than was previously expected.
The move to a leading diagnostic testing platform is expected to resolve the inconsistent data issues OncoCyte encountered with the diagnostic testing platform it had previously used in the development of DetermaVu™. OncoCyte believes that the precision of Next Generation Sequencing (NGS) platforms may increase test performance. In addition, the use of a NGS platform could allow for decentralized operations beyond OncoCyte’s CLIA lab, potentially enabling development of a CE marked kit product for distribution in Europe and other markets, if OncoCyte’s upcoming studies are successful.
In addition, the study incorporated newly discovered biomarkers into a new, next-generation version of DetermaVu™. These biomarkers appear to be more robust than those used in the earlier biomarker panel and may enhance the utility and accuracy of DetermaVu™. The use of the new biomarkers in combination with the existing Wistar biomarkers achieved encouraging results even without the inclusion of clinical data such as nodule size, while the original DetermaVu™ algorithm included nodule size as a contributing factor.
The study found that an enhanced algorithm incorporating the best-performing new biomarkers with the best-performing biomarkers used in previous DetermaVu™ studies yielded accuracy results (as measured by Area Under the Curve (AUC) data) equivalent or superior to results of previous studies using the earlier biomarker panel and algorithm. Because the error bar or potential range of results from the small sample set in the study is wide, these results must be confirmed in a larger sample set.
This most recent study was performed on two assay platforms, the Illumina Nova Seq 6000 and Thermo Fisher Chef-S5. DetermaVu™ ran successfully on both platforms. OncoCyte anticipates that the use of one of these widely commercialized diagnostic platforms will increase the likelihood that DetermaVu will offer the consistent and robust results necessary for product development and commercial operations.
“We are extremely pleased with the results of this study, which provide us with a new diagnostic testing platform and a route forward for the development of a next-generation DetermaVu™,” said William Annett, President and Chief Executive Officer.
Lyndal Hesterberg, Senior Vice President of Research and Development, stated, “The study results are very encouraging. Although further studies testing larger numbers of samples are necessary, it appears the addition of the new biomarkers in DetermaVu™ may enhance the accuracy of our diagnostic test.”
While these initial results are very encouraging, significant development work remains. OncoCyte will engage in a series of studies intended to retrain and validate the algorithm on the new platform. The company will further test its biomarkers on a broader set of clinical samples, with the goal of selecting the optimal biomarker panel and algorithm.
OncoCyte is currently in the process of moving to the new platform. Next, OncoCyte will perform a prospective, blinded R&D Validation Study on approximately 250 patients to assess the performance of the algorithm in a blinded set of clinical samples. If successful, the R&D Validation Study will be followed by an Analytical Validation Study in the Company’s CLIA laboratory. Finally, OncoCyte plans to conduct a Clinical Validation Study to confirm test performance. OncoCyte has collected all the samples it expects to require for the R&D Validation study.
With the necessary samples in hand, OncoCyte has expanded the R&D Validation study protocol to include a larger number of samples than were used in the comparable 2017 study. This larger sample set is intended to provide OncoCyte with a clearer picture of the potential accuracy of DetermaVu™, and more confidence in the results expected in the Clinical Validation Study that will follow. OncoCyte’s goal is to complete the expanded R&D Validation Study by the end of 2018 and to complete the Clinical Validation Study during the first half of 2019.
OncoCyte believes that it has the opportunity to create a highly accurate test which, if confirmed in a large clinical data set, could successfully address what it estimates could be a $4.7 billion annual market in the U.S. for confirmatory lung cancer liquid biopsy tests, depending on pricing, market penetration, and the availability of Medicare and private payer reimbursements.