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Saturday, November 16, 2019

Policy Experts, Lawmakers Examine Barriers to Kidney Care

Trump administration executive order gets accolades even from Democrats

Opportunities to improve care for patients with kidney disease and where to put the blame for current gaps were topics of a panel discussion here Wednesday.
Roughly 37 million American adults have chronic kidney disease (CKD), the primary treatment for which is dialysis. The process can be taxing, with patients typically requiring three to four sessions a week for 3 or more hours, usually at a dialysis center and in some cases at home.
And even with dialysis, one in five patients die within 5 years, according to information from the Department of Health and Human Services (HHS) in documents outlining the administration’s new approach to kidney health.
The other common treatment for patients with kidney failure or end-stage renal disease (ESRD) is, of course, kidney transplants. However, patients must meet certain criteria to be eligible for the procedure, and once it has been completed, they have to take immunosuppressant drugs to ensure that the new organ is not rejected, and patients must also follow a very restrictive diet.
There are also additional challenges — one important one being the lack of available organs: There are currently about 95,000 patients on the waiting list for transplants, according to HHS information.
Targeted Action
In July, President Trump signed an executive order to improve care for patients with CKD, with the focus on:
  • Increasing awareness and prevention of the disease
  • Shifting more dialysis patients from in-center care to in-home dialysis
  • Growing the number of kidneys available for transplants
The order calls on Medicare to pay clinicians for diagnosing and treating these patients earlier. Currently, an estimated 90% of patients don’t know they have kidney disease, HHS notes.
The administration’s explicit goals, as outlined by HHS Secretary Alex Azar in a press call in July, include reducing the incidence of kidney disease by 25% in 2030 and ensuring that 80% of patients with kidney failure or ESRD receive dialysis at home or receive a transplant by 2025.
In conjunction with the order, the Center for Medicare & Medicaid Innovation released five new payment models focused on increasing prevention efforts, and improving care and treatment for patients with kidney disease.
Who’s to Blame for Poor Care?
During the panel discussion, hosted by Politico and sponsored by AstraZeneca, even Democrats applauded the Trump administration’s executive order and policy approach.
“You call out good ideas when they’re there,” said Jennifer Erickson, a member of the White House Office of Science and Technology Policy under President Barack Obama from 2015 to 2017 and now a member of the steering committee of Kidney X, a partnership between HHS and and the American Society of Nephrology. She said this could be a legacy issue for Azar.
Asked why there hasn’t been more political will to address this issue before, Erickson pointed to a lack of oversight and accountability, particularly of organ procurement organizations (OPOs).
“We haven’t had the kind of transparency and data that could drive the outrage,” she said. Erickson noted that none of these federal contractors, about 58, has lost a contract in years.
(Erickson wrote an editorial in the The Washington Post explaining her decision to enlist an investigative journalist, rather than relying on OPOs, to ensure that her organs are actually recovered after her death, underscoring her skepticism about the process. “I will take my policy issues to my grave,” she said.)
Up to 28,000 more kidney donations could be available each year if OPOs were more efficient and were held accountable for deceased donations, Erickson noted, citing a study President Trump also mentioned at the signing of the executive order from the University of Pennsylvania.
It’s this kind of data that lets patients see this is a “fixable problem,” she said.
Dialysis companies have also been criticized for charging exorbitant rates. In July, Fresenius, one of the two main dialysis providers in the country, agreed to waive a patient’s bill for $524,600.17, NPR , Kaiser Health News, and CBS This Morning reported.
Dialysis companies also need scrutiny, panelists said.
Charlie Alexander, an audience participant who is CEO and founder of the Living Legacy Foundation, an OPO in Maryland, spoke in defense of OPOs. He agreed with Erickson about the lack of oversight and accountability but argued that OPOs are not to blame.
He said that an estimated 20-25% of kidneys are never used, but this is often due to “a disconnect” between measures and metrics. He also suggested that there is variability in organ availability across the country that is simply not explainable.
He said he has been asking CMS for objective performance measures for 10 years — “We want this. We’re clamoring for it,” he emphasized.
Prevention, Payment Reform
When asked whether the executive order does enough to support minorities who are disproportionately impacted by kidney disease, Matthew Cooper, MD, director of Kidney and Pancreas Transplantation at MedStar’s Georgetown Transplant Institute here, said there has to be greater focus on prevention for all populations. He noted that the major drivers of kidney disease are high blood pressure and diabetes and that these problems can be compounded for underserved patients.
“We can probably fix a large portion of kidney care by preventing people from ever coming to the attention on dialysis,” by providing proper care and consistent follow-up for patients with these easier-to-treat conditions, he said.
Rep. Suzan DelBene (D-Wash.), co-chair of the Kidney Caucus, has expressed support for the Trump administration’s executive order, and highlighted another challenge to improving kidney care: reimbursement.
“You get what you pay for,” she said.
Speaking to MedPage Today in a phone call after the panel discussion, she said, “Part of the goal of the executive order … is to help make sure that where possible … patients have home dialysis availability or that we make sure transplant is available … We need to make sure that the incentives are in place to move people in that direction.”
The Trump administration rolled out a handful of new payment models, along with its executive order. One of those models the ESRD Treatment Choices (ETC) Model, which is mandatory, aims to move more dialysis patients from facilities to their homes. The model is slated to take effect in 2020.
Another model, the Kidney Care First model, which is optional, would pay nephrologists more for managing the care of patients with late-stage chronic kidney disease or ESRD.
DelBene; Rep. Larry Bucshon (R-Ind.), the other co-chair of the Kidney Caucus; and other lawmakers recently sent a letter to Azar providing feedback on the new payment models. In the Oct. 17 letter, the caucus pointed out ways to improve the model’s chances for success by revising the assessment process regarding who should be eligible for in-home care to include factors such as whether or not a patient has help at home; and by suggesting the HHS Secretary provide waivers to Stark and anti-kickback laws, when appropriate, to allow provider groups to coordinate care.
Asked during the panel whether it was possible for Democrats to proceed with impeachment hearings while trying to overhaul kidney care, DelBene said that the impeachment was a “totally separate conversation.”
As for knowing whether the Trump administration’s approach is succeeding, DelBene emphasized the need to measure rates of home dialysis and transplants.
“If we see those rates increase, we know we’re moving in the right direction,” she told MedPage Today.
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Heart Association Dedicates $20M to Youth Vaping Research

The American Heart Association (AHA) declared a multi-million dollar war on the electronic cigarette industry, and use of e-cigarettes by youth.
The AHA announced at its annual meeting “an aggressive, three-pronged initiative involving research, policy advocacy and youth activation intended to urgently address the epidemic of youth e-cigarette use,” according to a press release.
The “End the Lies Youth Vaping and Nicotine Research Initiative” will receive $20 million initially — an amount that is 40 times larger than the typical AHA grant, the association noted.
According to the CDC, 3.6 million U.S. teens used e-cigarettes in 2018. The agency also reported in October that the case count for vaping-related lung injury stood just shy of 1,300. Deaths confirmed as part of the outbreak total 26.
“It is going to take a big, unparalleled, and urgent commitment by national and community level stakeholders if we are going to beat big tobacco,” said Robert Harrington, MD, AHA president, at an AHA press conference. The initiative is an “unprecedented effort to drive scientific discovery, and is designed to help end the vaping and nicotine use in this country.”
The “End the Lies” initiative “will focus urgently on the impact of vaping and nicotine use on youth, funding two or three scientists who will work intensely over the next two years to address the fact that there is no knowledge about the long-term health effects in youth,” according to the release.
Two other key components of the AHA strategy are:
  • The nationwide #QuitLying (QuitLying.org) youth, school and community engagement and awareness campaign “designed to hold e-cigarette companies publicly accountable for their lies.”
  • A multi-year fund “dedicated to public policy change at all levels of government to prevent youth vaping and nicotine addiction.” Kaiser Permanente, which will provide additional support, has teamed up with the AHA to create the “Preventing Youth Nicotine Addiction Policy Fund.”
At the press conference, speakers lashed out at the FDA for a failure to regulate vaping products from companies such as JUUL (Altria Group, formerly Philip Morris, acquired a 35% stake in JUUL Labs for $12.8 billion in 2018). In April 2019, the FDA did issue a warning that identified a potential seizure risk associated with e-cigarettes, mostly in teens and young adults.
Harrington urged the FDA to “exercise its regulatory authority over these e-cigarettes, such as by removing all flavored e-cigarettes, including mint and menthol, from the market and prohibiting flavored tobacco products of any kind.” In September, the Trump administration announced plans to ban all flavored e-cigarette products in response to an “epidemic” rise in e-cigarette use among youth and increasing reports of vaping-related illness and death.
AHA CEO Nancy Brown noted that the association, along with other professional societies, are involved in an ongoing lawsuit against the FDA for failing to fully regulate the vaping industry.
“We are horrified to see the uptick of e-cigarette use by youth, estimated to have grown from 1% to 27% in a decade. Our worst nightmare plus has come true,” she said.
“We thought the FDA was going to do something about smoking and e-cigarettes…We were not prepared for the FDA not doing its job,” commented Regina Benjamin, MD, former U.S. surgeon general.
Benjamin told MedPage Today that “We believe that instead of waiting to ban a product when it is proven harmful, we should ban it until it is proven safe.”
While some research has suggested that e-cigarettes could play a part in helping smokers quit combustible tobacco products, Benjamin said she has never recommended that her patients trade one addiction (standard cigarettes) for another (e-cigarettes).
Martha Gulati, MD, of the University of Arizona in Phoenix, and a spokesperson for the American College of Cardiology (ACC), also chided the federal agency: “I think the FDA has let us down on this. We know what happened with [combustible] cigarettes. Why didn’t we learn from that?,” she said, adding that the ACC does not endorse e-cigarettes as an alternative to combustible cigarettes.
Gary Gibbons, MD, director of the National Heart, Lung, and Blood Institute, told press conference attendees that the NIH is “committed to addressing this public health threat.” He added that the agency is working to “fill in the gaps in the science about what we don’t know about vaping.”
Former vaper Katelyn Quezada, 16, of Los Angeles spoke at the press conference. She said that she started using e-cigarettes in sixth grade under intense peer pressure to try the different flavors. “Before I tried it, I knew it was something I shouldn’t be doing. After [she was caught and stopped], I was just very disappointed in myself,” Quezada said.
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Smokers who switch to vaping rapidly boost heart health in trial

Chronic smokers who switched from tobacco cigarettes to e-cigarette vapes in a large randomized control trial saw a significant improvement in markers of heart health after just a month, researchers said on Friday.
In study results likely to be closely scrutinized by health specialists worldwide, British scientists found that cigarette smokers who switched to nicotine-containing vapes saw a marked boost to their vascular function – a change that could lead to a significantly lower risk of cardiovascular disease.
“By switching from cigarettes to e-cigarettes we found an average percentage point improvement of 1.5 within just one month,” Jacob George, a professor of cardiovascular medicine and therapeutics at Britain’s Dundee University, told a briefing about the study.
“And to put that into context, each percentage point improvement in vascular function results in a 13% reduction in cardiovascular event rates, such as heart attack.”
Jacob stressed, however, that the study looked specifically at vaping compared with tobacco smoking, which causes lung and other cancers and sharply increases the risk of deadly strokes, heart attacks and many other cardiovascular diseases.

“It is crucial to emphasize that e-cigarettes are not safe, just less harmful than tobacco cigarettes when it comes to vascular health,” George said. “They should not be seen as harmless devices for non-smokers or young people to try.”
The findings, published in the Journal of the American College of Cardiology, will fuel further international debate about the potential risks and benefits of e-cigarettes amid more than 2,000 cases of vaping-related lung illness and more than 40 deaths in the United States in recent months.
U.S. Centers for Disease Control and Prevention experts say their investigations suggest the injuries are linked to vapes containing THC – the component of marijuana that gets people high – and Vitamin E acetate, which is believed to be used as a cutting agent in illicit THC vaping products.
British addiction and toxicology experts said last month that the American vaping illnesses were most likely “a U.S.-specific phenomenon,” and there was no evidence of a similar outbreak in Britain or elsewhere where the suspect products were not widely used.
For the Dundee-led switching trial, which took two years and was funded by the British Heart Foundation charity, researchers recruited 114 long-term cigarette smokers who had smoked at least 15 cigarettes a day for at least two years.

They were put into one of three groups for a month and had vascular testing before and after. One group stuck to tobacco cigarettes, the second switched to e-cigarettes with nicotine, and the third switched to e-cigarettes without nicotine.
The results showed that, whether or not the e-cigarettes contained nicotine, those who switched away from tobacco smoking found their endothelial function – a measure of how easily blood flows around the body – was significantly improved.
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Colchicine Scores for Secondary Prevention After Heart Attack

A low oral dose of gout medication colchicine reduced ischemic events in heart attack survivors, the COLCOT trial showed, further affirming the inflammatory hypothesis.
The potent anti-inflammatory drug reduced the primary composite endpoint of cardiovascular (CV) death, resuscitated cardiac arrest, myocardial infarction (MI), stroke, or urgent hospitalization for angina leading to coronary revascularization by 27% relative to placebo (rate 5.5% vs 7.1%, P=0.02).
The effect was especially driven by stroke and revascularization but trended in the same direction for the other components, reported Jean-Claude Tardif, MD, of the Montreal Heart Institute, at the American Heart Association (AHA) meeting.
“The benefits of colchicine with regard to cardiovascular end points in COLCOT were at least as large as those of canakinumab in CANTOS,” the researchers noted in a paper simultaneously published online in the New England Journal of Medicine.
COLCOT has been eagerly anticipated as a follow-on to the CANTOS trial with canakinumab (Ilaris), which cut nonfatal MI or stroke and CV death by 15%, although in a different setting — as noted by Tardif’s group — “early after myocardial infarction in COLCOT and stable coronary disease in CANTOS.”
But that pricey injectable monoclonal antibody was turned down by the FDA for a CV prevention indication, and a cheaper potential anti-inflammatory alternative, methotrexate, subsequently failed for prevention in the CIRT trial.
CIRT tempered enthusiasm for the inflammatory hypothesis, that targeting an inflammatory pathway can reduce heart attacks and stroke independent of lipids, noted Robert Harrington, MD, of Stanford University in California and AHA president.
That the biggest driver was stroke — not MI — was unexpected, he said. In CANTOS and most other trials in the post-MI setting, “the predominant effect of a therapy that works has been on reducing recurrent myocardial infarction,” he said, “and that’s not what we see here.”
In the COLCOT trial, the hazard ratios for colchicine compared with placebo were:
  • 0.26 (95% CI, 0.10 to 0.70) for stroke
  • 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to revascularization
  • 0.91 (95% CI, 0.68 to 1.21) for MI
  • 0.84 (95% CI, 0.46 to 1.52) for death from CV causes
  • 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest
“When you have a safe drug that’s easily available, it’s going to be hard to hold this one down,” suggested AHA press conference chair Donald Lloyd-Jones, MD, of Northwestern University in Chicago. While it’s only one trial, guidelines committees will have to wrestle with the question of “is this the sixth drug in our cocktail for our MI patients?” he said.
However, “I don’t think it has a strength of evidence that would compel me to go out and say I have to start using colchicine in my patients,” Harrington said. However, it’s worth more study in a larger trial, perhaps by the National Heart, Lung, and Blood Institute or Patient-Centered Outcomes Research Institute, given that it’s a generic medication, he noted.
Stroke is an important endpoint to patients, so “it’s very promising that we can show a reduction,” commented Laxmi Mehta, MD, director of preventive cardiology at The Ohio State University in Columbus, who was not involved in the trial.
Questions that now need to be answered are the mechanism behind that sizable stroke benefit, and how much of the reduction in revascularization might have been accounted for by the 7% of patients who didn’t have percutaneous coronary intervention for their index MI, she told MedPage Today.
Also, the 4,745 patients in COLCOT were randomized to colchicine (0.5 mg once daily) or placebo a mean of 13.5 days after their acute MI.
“Inflammation is highest right around the time of the myocardial infarction,” Mehta noted. “In future studies, does it warrant [looking at] not only the dose of colchicine, but the timing of colchicine? Is 13 days good enough or should we be doing it sooner?”
However, the researchers noted that this timing made clear that the effects seen with colchicine were not due to the drug’s known benefits for pericarditis.
“Postinfarction pericarditis typically occurs within the first few days after the injury,” they wrote. “There were only two patients with a first positively adjudicated event of urgent hospitalization for angina leading to coronary revascularization within 14 days after randomization, and the median time to this clinical end point was 258 days.”
Both arms in a subgroup with C-reactive protein measurements showed large decreases in the inflammatory marker, without a difference between them.
But there was a limited sample size to discern differences, noted AHA discussant Aruna Pradhan, MD, Brigham and Women’s and Hospital Harvard Medical School in Boston.
There was an increased risk of pneumonia reported as a serious adverse event (AE) with colchicine based on 21 versus 9 events (0.9% vs 0.4%, P=0.03). Overall AEs and serious events as well as GI events were similar between groups.
Patients were followed for a median of 22.6 months. Inclusion criteria included MI within 30 days of enrollment and treatment according to national guidelines with intensive use of statins. Exclusion criteria included severe heart failure, a left ventricular ejection fraction of <35%, stroke within the prior 3 months, type 2 MI as the index event, and coronary bypass surgery either within the prior 3 years or planned.
Three other large-scale trials with colchicine — LoDoCo2 in stable coronary disease, CLEAR-Synergy in ST-segment elevation MI with primary PCI, and CONVINCE in stroke survivors — are underway and will show whether the benefits can be replicated, Pradhan noted.
“One caveat: I saw a patient in clinic on Thursday, who has long-standing, now-stable coronary heart disease as well as gout, as many of our patients do with coronary heart disease. He told me that just in the last month his colchicine out-of-pocket costs went from $50 a month to $27o a month in Chicago,” Lloyd-Jones said. “That is very concerning to me. I really wonder whether there is some gaming going on here. I do not want to see that with this drug.”
Tardif countered that in Montreal, the drug costs just $0.27 a day (around $8 for a 30-day supply). “There’s something wrong with a system where 90 minutes [by air] away you get a drug for 50 times less than others are paying.”
“Amen,” responded Lloyd-Jones, adding, “It’s unacceptable, especially for very low-cost, inexpensively produced drugs to be seeing price increases like this. There’s no reason for it other than the profit.”
The trial was funded by the Government of Quebec and the Canadian Institutes of Health Research, and philanthropic foundations, with the funds administered by the Montreal Heart Institute.
Tardif discosed support from the Government of Quebec; relevant relationships with Amarin, AstraZeneca, DalCor, Esperion, Ionis, Pfizer, Sanofi, and Servier; and a patent pending on genetic markers for predicting responsiveness to therapy with an HDL-raising or -mimicking agent.
Harrington disclosed serving as chair of the drug safety and monitoring board for CIRT.
Mehta disclosed no relevant relationships with industry.
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FDA clears Pentax’s duodenoscope designed to reduce need for disinfection

The U.S. Food and Drug Administration said on Friday it had cleared medical equipment maker Pentax of America’s duodenoscope, which is designed to be easier to disinfect and clean than traditional devices.
The device is the first type of duodenoscopes with a disposable elevator component, a part of the device that has traditionally been difficult to clean and reprocess.
Duodenoscopes are a type of endoscope used to see the top of patient’s small intestines and are known to be difficult to clean as they have narrow channels and tiny crevices, which heightens the risk of infections in patients.

The FDA, in a push to make the devices safer, has in the past issued an advisory to makers of such devices to switch to scopes with disposable parts.
Pentax of America is a unit of Japan’s Hoya Corp.
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FDA OKs Pfizer biosimilar to Humira

The FDA approves Pfizer’s (NYSE:PFE) Abrilada (adalimumab-afzb), a biosimilar to AbbVie’s (NYSE:ABBV) top seller Humira.
Abrilada is the 25th biosimilar approved in the U.S. (although, to date, branded manufacturers have prevented any significant encroachment on their businesses).
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Friday, November 15, 2019

IPO Weekly Recap: NASH biotech 89bio jumps 69%

After delaying its offering in the previous week, 89bio (ETNB) priced its upsized $85 million IPO at the midpoint and popped 30% on its first day, the second highest of the 4Q19 so far, before finishing the week up 69%. The company’s target indication NASH represents a multi-billion-dollar market with no FDA-approved therapy, and 89bio’s FGF21 analog showed positive Phase 1 data in healthy volunteers. That said, it has yet to demonstrate proof-of-concept in NASH patients.
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