WASHINGTON -- For Health and Human Services Secretary Alex Azar, Monday's announcement on how his agency is changing financial incentives for treating kidney disease was in part a personal affair.
"What kidney patients endure is grueling," Azar said at the annual Kidney Patient Summit, sponsored by the National Kidney Foundation. "I know this firsthand, because my dad suffered from end-stage renal disease [ESRD]. Like others with the disease, my dad initially had to go to dialysis three or four times a week. I saw how draining it is."
"My dad's situation did improve," he continued. "First, we figured out that he could receive peritoneal dialysis, allowing him to be dialyzed at night. This was a revolutionary change in his lifestyle. Then, we were blessed enough that he was offered a kidney transplant from a kind and generous living donor."
And while Azar's father was lucky, "too many Americans don't shift to more convenient dialysis options, and too many Americans never get a chance at a kidney transplant," Azar said. "But with better policies, we can make these outcomes possible for many more Americans."
Currently, more than 30 million Americans have some stage of kidney disease, and in 2016 it was the ninth leading cause of death in the U.S., he noted. And more than 100,000 people are on kidney transplant waiting lists.
It's also expensive to treat, said Azar, with Medicare spending $113 billion in 2016 on treating kidney disease and ESRD. "That represents more than one in five dollars we spend on Medicare." Azar urged the audience to imagine what it would be like to pay for "kidney health, rather than kidney disease."
First, he said, "we need more efforts to prevent, detect, and slow the progression of kidney disease ... [This can be done by] better investment in effective efforts to treat early kidney disease and related conditions, and researching what drives the progression of the disease."
Although the Medicare program currently covers most kidney failure patients, "we don't begin spending a great deal on these patients until they're already sick," Azar said. "[And] for all we do know about prevention, we don't know much about how to predict which patients' conditions will worsen at what rates, and why."
To help figure that out, 2 years ago the NIH began the Kidney Precision Medicine Project "to better understand the different types of kidney disease, and how they progress, using the same kind of techniques that have yielded leaps forward in targeted cancer treatments. Enrollment for this study will begin in the next several months."
Enrollment also will begin shortly in a study on the APOL1 gene, which is often found among African Americans and is strongly associated with kidney disease. Transplants in patients with the gene are much less successful than with other patients, he added.
Azar also criticized the way dialysis is provided for ESRD patients in the U.S., noting that 88% of ESRD patients usually start with dialysis at a center while only 12% begin hemodialysis or peritoneal dialysis at home. "This is the complete opposite of the situation in some of our peer nations, including Hong Kong, where more than 80% of patients benefit from some form of in-home dialysis," he said. "Heck, Guatemala is at 56% peritoneal!"
Changes in payment incentives are needed to improve that situation, Azar said. "For one, we believe we may simply underpay for these alternatives, even though we know how much they can benefit patients' lives. It's also more appealing for a dialysis company to add patients to a center where one machine can accommodate multiple patients than it is to provide new services to each patient at home."
Adam Boehler, director of HHS's Center for Medicare & Medicaid Innovation, noted in a February 2019 speechat a healthcare information technology meeting that the majority of kidney disease spending by Medicare isn't actually in dialysis centers. "The majority of spend is in other places -- hospitals, complications arising from them, etc.," he said. "That doesn't mean we have to cut the spend there; it means you have to change around the way people make money." Right now, he said, for the dialysis centers, "if somebody gets a transplant, that's a lost customer."
In his talk, Azar noted that 4 years ago, Medicare began testing on a payment plan allowing traditional dialysis providers to provide more comprehensive patient care, sharing in the savings as long as patients' outcomes improve. "It worked remarkably well: In just the first year, the model saved almost $2,000 per patient per year in Medicare costs, reducing hospitalizations while maintaining quality of care," Azar said.
HHS is also looking at ways to encourage more kidney transplants, such as "ensuring that we're not discarding healthy, safe organs -- which we believe we may be doing today," he said. An HHS committee that develops guidelines for testing organs for HIV and hepatitis will be hearing new data next month that might allow for more kidneys to be used, Azar added.
The agency also is hosting a KidneyX competition to encourage development of products like artificial kidneys to help improve patient quality of life. "First round submissions closed last week and we got 165 submissions, including a number of proposals that could help advance an artificial kidney," Azar said. "We're thrilled with this level of interest, and it shows what a prize competition can drive in an otherwise neglected investment space."
Paul Conway, immediate past president and chair of public policy at the American Association of Kidney Patients, in Tampa, Florida, said afterward that Azar's speech "is the most substantive policy speech on kidney disease [and its prevention] in the past 15 years. What the secretary outlined was a vision for more transplantation and better access to home care and prevention. That's what patients want; they want treatment to match their aspirations."
At 3 years, combined cardiac death, target vessel-related MI, and target vessel revascularization reached 10%, 8.8%, and 8.5% to the Resolute Integrity, Synergy, and Orsiro stents, respectively, with no significant differences between groups.
This story was first published Sunday, March 3, 2019, by MedPage Today.
By Nicole Lou, Reporter, MedPage Today/CRTonline.org March 03, 2019
WASHINGTON -- Further follow-up of patients who got the Orsiro and Synergy biodegradable polymer-coated drug-eluting stents (DES) continues to show no benefit of these devices over a traditional durable DES, according to the BIO-RESORT trialists.
At 3 years, when the Orsiro should have completely lost its biodegradable coating, target vessel failure (combined cardiac death, target vessel-related MI, and clinically-driven target vessel revascularization) reached 10%, 8.8%, and 8.5% of those randomized to the Resolute Integrity, Synergy, and Orsiro stents, respectively, with no significant differences between groups in this primary endpoint or its components.
Orsiro was associated with reduced target lesion revascularizations compared to the durable-polymer Resolute (0.5% vs 1.5%, P=0.04) between years 1 and 2, but this was not reproduced in the period between years 2 and 3, reported Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente in Enschede, the Netherlands, at the Cardiovascular Research Technologies meeting.
Stent thrombosis rates were statistically indistinguishable between groups at about 1% out to 3 years, though it appeared at that point that events with the Orsiro were still accumulating, whereas they had plateaued somewhat with the durable-polymer Resolute and the Synergy.
"As far as I can judge, there is no clear signal of late catch-up [in stent thrombosis]. There was a small numerical advantage of events in favor of Orsiro in the second year followed by a small numerical excess of events in the third year. All this speaks for a random difference more than anything else," commented Marco Valgimigli, MD, PhD, of Inselspital University Hospital in Bern, Switzerland, who was not involved with the study.
"The study was not powered for these endpoints so, to me, the only conclusion is that the study observed a similar outcome across stent types at 3 years," he added.
BIO-RESORT is a trial of all-comers getting percutaneous coronary intervention (n=3,514) who were randomized 1:1:1 to one of the three DES. Three-year follow-up was complete in 96.6%.
The three stents differ in virtually all aspectsof their design, including strut thickness, metal type, polymer, degradation time, and the drug eluted.
Von Birgelen's group first reported that the Orsiro and Synergy were non-inferior to the durable-polymer Resolute Integrity at 1 year. Patients will be followed out to 5 years, he said.
"In my mind, in addition to longer term outcomes, i.e. 5 years, the only missing data is outcomes for Orsiro upon early discontinuation of DAPT [dual antiplatelet therapy]. Will it be safe to discontinue DAPT due to bleeding or a need for urgent surgery at 1-3 months? This data is pending," according to Paul Teirstein, MD, of Scripps Clinic in La Jolla, California, who also was not involved in the study.
"We just got the Orsiro in our lab and in my first 'real-world' case with very complex anatomy, it delivered extremely well. Of course, we will need a lot more comparative experience before forming opinions about deliverability and radial strength in challenging lesion subtypes," Teirstein told MedPage Today.
Von Birgelen disclosed institutional support from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic.
Valgimigli disclosed no relevant relationships with industry.
The Bureau of Labor Statistics found healthcare and social workers are nearly five times more likely to be seriously and violently injured at work compared with workers in other sectors.
This story was first published Friday, March 1, 2019, by MedPage Today.
By Shannon Firth, Washington Correspondent, MedPage Today
WASHINGTON -- House members discussed legislation aimed at protecting healthcare workers from violent patients during a hearing on Wednesday.
Witnesses told of threats and injuries on the job. Some said the incidents ended their careers and shattered their health.
"My head snapped backwards, and I heard a bang and a pop and all of the air rushed out of me," said Patricia Moon-Updike, RN, of the Wisconsin Federation of Nurses and Health Professionals, recalling the moment in June 2015 when a large, agitated teenage boy kicked her in the throat.
At the time, Moon-Updike and the patient's assigned nurse had been trying to bring the teenager "screaming and thrashing" into a seclusion room. One of her colleagues called security and Moon-Updike believed that four guards were on their way -- one to hold each of the teenager's four limbs, as Moon-Updike noted in written testimony.
Only two arrived.
Moon-Updike said she remembers holding her throat with both hands, knowing that if she let go her trachea would collapse and she would die. "I was praying to stay conscious," she said.
Her trachea was undamaged, but soon she started having nightmares and grew frightened of people and children being unpredictable. She was ultimately diagnosed with post-traumatic stress disorder, anxiety, depression, insomnia, and social phobia, and she could no longer work.
In her last position as a nurse she made $62,000 annually. She now makes $12,720 a year in Social Security Disability, after Medicare deductions, noted her written testimony.
"I loved being a nurse. I do not know what to call myself now," she said.
She said the hospital's procedures and policies to prevent violent attacks like the one she suffered were inadequate.
The Bureau of Labor Statistics found healthcare and social workers are nearly five times more likely to be seriously and violently injured at work compared with workers in other sectors, said subcommittee chairwoman Rep. Alma Adams (D-N.C.). However, such incidents are "predictable and preventable."
"OSHA [Occupational Safety and Health Administration] has not ignored this problem, but it currently lacks the tools to address it adequately," she said, stressing the need for congressional action.
Under the Obama administration, OSHA began rulemaking for workplace violence on OSHA's agenda, but the Trump administration put a freeze on any efforts to establish a national workplace violence prevention standard. Adams stressed that the agency is "years away" from proposing a standard.
"Where we are today isn't good enough," Adams said.
Mandating Change
Courtney's bill would mandate that OSHA create a national standard requiring health care and social service employers to develop and execute comprehensive workplace violence prevention plans.
Adams explained that such a plan "would identify risks, specify both work practice and environmental controls, and require training, reporting and incident investigation."
It would also require employers to keep a log of violent incidents and prepare annual summaries. In addition, the bill would expand protections to public employees in the 24 states that are currently not covered by OSHA by forcing compliance from any healthcare institutions and social service agencies that receive Medicare funds.
Finally, the bill calls for OSHA to meet strict deadlines. The agency would be required to publish an interim final standard within 1 year of enactment and a final standard within 42 months of its enactment.
"These are not radical, impractical, infeasible or unaffordable requirements," said Adams.
She noted that the legislation mirrors much of what has already been recommended to the agency. "The difference is that these measures would, for the first time, be enforceable."
"As nurses who work at the bedside, our union has seen violence reach epidemic proportions in our hospitals and clinics, " said NNU co-president Jeans Ross, RN, in a press statement. "Employers failure to prevent violence not only harms nurses and other healthcare workers, but it harms our patients too."
Due Process versus Speed
Another witness at the hearing, attorney Manesh Rath, JD, who has represented industry in previous OSHA rulemaking, said Congress shouldn't rush the rulemaking.
While he agreed that employers have a role in mitigating risk of violence to healthcare and social workers, the reintroduced bill does not take the time to gather the appropriate evidence for its proposed solutions.
"The causes of workplace violence are far from understood and the remedy remains unclear," Rath said, citing a CDC report that stated more research is needed.
He also argued that the bill "would direct OSHA to adopt and implement an enforceable final rule without the well-accepted principle of administrative due process" required by Congress, and without time for input from affected stakeholders to be submitted and considered.
"Those are the cherished cornerstones in administrative law and have been so for 72 years."
But Jane Lipscomb, PhD, RN, an epidemiologist and professor of nursing and medicine at the University of Maryland, said enough is enough.
"If you think about the testimony that you heard today from Ms. Moon-Updike and you multiply that story by tens of thousands of healthcare workers all around the country ... you'll realize why we need this mechanism to encourage OSHA to make this a priority and promulgate an interim final standard and a final standard in the shortest amount of time possible."
In her written testimony, Lipscomb cited research from Wayne State University in Detroit that found a "data driven, worksite-based intervention, based on OSHA guidelines" decreased the risk of "patient-to-worker violence-related injuries" by 60% within months of implementation.
States including California, New York, New Jersey, Oregon, Washington, and Maryland have enacted workplace violence laws and they have gathered enough stakeholder comment to inform a national rule, she argued.
"Experts in healthcare safety and patient safety have all written documents that recommend pretty much the same measures that are described in this bill," Lipscomb testified. "So, I completely disagree that there hasn't been an opportunity for stakeholder input. In fact, I think there's a consensus in industry on what's needed."
A little more than 9% of Americans were uninsured during the first nine months of 2018, according to survey data released Wednesday by the National Center for Health Statistics.
A total of 29.7 million people of all ages (9.2%) were uninsured at the time of being interviewed -- "not significantly different from 2017, but 18.9 million fewer persons than in 2010," the authors noted.
Among adults, ages 18-64, 13.0% were uninsured at time of interview, 19.7% had public coverage, and 69.0% had private health insurance coverage. (Numbers add up to more than 100% because some patients had both public and private coverage and were included in both categories.)
The authors also looked at children, ages 0-17 years, and found that 4.9% were uninsured, 42.5% had public coverage, and 54.1% had private health insurance coverage. All estimates come from the agency's National Health Interview Survey, which includes data for 61,484 people.
The investigators also examined longer-term trends and found that, although the percentage of uninsured adults (ages 18-64) had been increasing, in more recent months, it declined and then stabilized. Similarly, the percentage of adults with public coverage recently stabilized following a decrease.
As for children, their rate of being uninsured had been dropping but more recently has leveled off, and rates for both private and public insurance coverage for children have also stabilized, the researchers found.
They also looked at how adults were insured, including enrollment trends in the Affordable Care Act health insurance marketplaces. Interestingly, "in the first 9 months of 2018, adults 18-64 in states with a federally facilitated marketplace were more likely to be uninsured than those in states with a state-based marketplace or states with a partnership marketplace," the authors noted.
In addition, "among adults 18-64, significant decreases were observed in the uninsured rates from 2013 through the first 9 months of 2018 in states with a state-based marketplace, a partnership marketplace, and a federally facilitated marketplace."
The popularity of high-deductible health plans (HDHPs) has been going up in recent years, according to the researchers. "Among those with private health insurance, enrollment in HDHPs has generally increased since 2010," they wrote.
In fact, during the first 9 months of 2018, 45.6% of those under age 65 with private health insurance were enrolled in an HDHP -- these included both HDHPs alone as well as HDHPs combined with health savings accounts, a combination known as a consumer-directed health plan (CDHP).
CDHPs have been gaining in popularity recently, rising from 18.2% of those with private health insurance in 2017 to 20.6% in the first 9 months of 2018.
On the other hand, the percentage of those with private insurance who were using an HDHP without a health savings account didn't change significantly, dropping slightly from 25.5% in 2017 to 25.0% in the first 9 months of 2018, the researchers said.
Washington state attorney general Bob Ferguson said he will be seeking a temporary injunction to prevent the rule from taking effect until the case -- which he said he expects to win -- is decided.
This story was first published Monday, February 25, 2019, by MedPage Today.
Washington state attorney general Bob Ferguson announced plans to sue the Trump administration over the rule it announced Friday barring physicians and other healthcare providers from mentioning the possibility of abortion to pregnant women seeking reproductive healthcare at any clinic funded under Title X, even if the woman specifically asks about abortion.
"This time, President Trump is inserting his politics between a woman and her healthcare provider. President Trump's Title X rule is unacceptable and unlawful," Ferguson said at a press conference. "The government should not tell patients what medical care is right for them; these sensitive decisions should remain between patients and their medical providers ... We will not allow the federal government to dictate what a provider can or cannot say to a patient."
Under the rule, which is slated to take effect 60 days after it is published (with publication is expected in the next few days), providers at clinics funded under a 49-year-old federal program known as Title X are required to refer pregnant women only for prenatal care even if the patient doesn't want or need it, and are not allowed to discuss abortion, Ferguson said.
Under the program, which serves about 4 million women annually, two-thirds of whom have incomes at or below the federal poverty level. Providers in the program also screen for non-reproductive-related conditions including hypertension and diabetes.
The rule, which covers clinics at 85 sites in Washington state, has two unlawful provisions, Ferguson said. The provision barring providers from discussing abortion violates an Affordable Care Act (ACA) provision requiring full disclosure of all relevant information needed to make healthcare decisions.
This rule also violates a provision from Congress saying all pregnancy counseling provided using Title X funding must be "non-directive" and not push patients to one option or another.
The rule also requires Title X clinics that perform abortion or refer patients to abortion providers to physically separate their abortion facilities from the rest of the family planning clinic, with a separate entrance, separate clinic personnel, separate websites, and separate medical records. "Forcing providers to find or create separate facilities jeopardizes some clinics ... and will force most Washington state healthcare providers to forego Title X funds altogether."
This will leave 11 counties in the state without any Title X providers, leaving some patients to travel hundreds of miles to get family planning care, he said, adding that the rule violates a provision of the ACA that bars anything which creates unreasonable barriers to individuals from obtaining appropriate medical care.
Ferguson said he will be seeking a temporary injunction to prevent the rule from taking effect until the case -- which he said he expects to win -- is decided. Ferguson is planning to bring his case in the federal district court for the Eastern district of Washington, and he said he expects that other organizations will sue as well, including the National Family Planning and Reproductive Health Association (NFPRHA).
Deborah Oyer, MD, medical director of the Cedar River Clinics in Seattle, said her clinic was planning to join the NFPRHA lawsuit when it is filed. "This new policy ... demonstrates clear and dangerous disregard for the role birth control and cancer screening play in peoples' lives," she said.
Erin Berry, MD, medical director of Planned Parenthood of the Greater Northwest and the Hawaiian Islands, called the rule "shameful and dangerous." "It's my job to make sure patients have the very best information available so they can make decisions that are best for themselves," she said. "The Trump/Pence gag rule needs to be challenged; it prevents providers like me from being able to refer patients for safe, legal abortion ... It's unethical and defies the oath I took to take care of my patients."
It's possible that any of the cases people are now talking about filing could make their way to the Supreme Court, Ferguson said, adding that if his cases was elevated to that level, "we are prepared to do that."
In 1988, a similar case, Rust v. Sullivan, went before the high court, in which the plaintiffs argued that a new rule from the Reagan administration that prevented Title X recipients from counseling patients about abortion services violated the First and Fifth amendments to the constitution. The court ruled 5-4 in the government's favor, declaring that Title X was unclear when it came to abortion counseling, so the court would defer to the administration on the issue.
However, several things have changed since that case was decided, Ferguson said, including new statutes passed by Congress that impose new requirements on the Title X program.
"It's frustrating that we have to file lawsuits ... to help women get their healthcare," he added. "It's not the business of politicians to insert themselves in the room with a doctor communicating with a patient. The reason we win case after case against this administration ... is that the cases are simple. This administration flouts the rule of law, and flouts it over and over again."
Medtronic says the revised analysis still supports earlier conclusions that there was no statistically significant difference in all-cause mortality between the IN.PACT Admiral drug-coated balloon and plain balloon angioplasty at five years.
This article was published on February 20, 2019, inMedPage Today.
Key data supporting the safety of paclitaxel-coated devices placed in femoropopliteal lesions has been undermined by serious errors, suggesting the mortality risk shown in a hotly debated meta-analysis may be real after all.
When that meta-analysis in the Journal of the American Heart Association turned up a 68% greater mortality risk for paclitaxel-coated balloons and stents (7.2% vs 3.8% crude rate) at 2 years, it sparked an FDA investigationand brought a halt to several ongoing trials.
Medtronic quickly responded with analysis from its IN.PACT Admiral drug-coated balloon trial program showing no increased all-cause mortality through 5 years compared with uncoated devices. But the company issued a press release Feb. 15, 2019 noting a programming error that led to omission of some mortality data beyond 1 year from that paper in the Journal of the American College of Cardiology.
"While a component of the recent patient-level meta-analysis will need to be updated," it said, "Medtronic has found the revised analysis still supports earlier conclusions that: there was no statistically significant difference in all-cause mortality between the IN.PACT Admiral drug-coated balloon (DCB) and plain balloon angioplasty at five years; there is no correlation between paclitaxel dosing and long-term survival in the studied population; and, there was no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB and those who died."
The updated numbers remain to be released or published, and their impact remains to be seen.
More concerning, a correction notice was issued in Circulation on Feb. 20, 2019 reversing the mortality findings of the Zilver PTX trial, which had been cited as some of the strongest evidence for paclitaxel-coated device safety due to its long follow-up.
The paper originally showed a 5-year all-cause mortality advantage to paclitaxel-eluting stents in the femoropopliteal artery, at 10.2% versus 16.9% for the percutaneous transluminal angioplasty comparator (PTA, P=0.03).
"The authors regret that the numbers for the two groups were inadvertently reversed," the correction notice said.
In fact, the paclitaxel-coated stent had a significantly higher mortality risk ("The 5-year all-cause mortality rate was 13.6% [16.9% for the primary DES group and 10.2% for the PTA group, P=0.03], and no deaths were adjudicated as procedure or device related").
The Twitter response was stunned: "Wow," said Ved Ramnani, Head Clinical Vascular Scientist at Royal Free London NHS Foundation Trust. "Between this and the admitted error in the Medtronic DCB analysis, it's been a bad week for paclitaxel."
David Cohen, MD, of Saint Luke's Mid America Heart Institute in Kansas City, Missouri, agreed.
The "paclitaxel plot thickens," said Joseph Mills, MD, of Baylor College of Medicine in Houston.
A new study finds that as many as half of the patients taking highly potent transmucosal immediate-release fentanyl should not have been prescribed them.
This article was published on February 19, 2019, inMedPage Today
By Judy George, Contributing Writer
The FDA did not take action when evidence emerged that potentially lethal fentanyl products were being prescribed inappropriately to patients, researchers suggested.
Based on a review of 4,877 pages of FDA reports and other documents obtained through the Freedom of Information Act (FOIA), as many as half of the patients taking highly potent transmucosal immediate-release fentanyl (TIRF) drugs should not have been prescribed them, reported G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues in JAMA.
And when this evidence emerged, the FDA and fentanyl makers did not review prescribing records of any physicians or consider disqualifying them from a special certification program to prevent them from prescribing the drugs, Alexander said.
TIRF drugs are used to manage breakthrough pain in adult patients with cancer. Because fentanyl's potency can cause life-threatening respiratory depression in patients who are not already taking opioids, TIRF medicines are designed to be limited to opioid-tolerant patients.
"Not only did we see that large numbers of patients were unsafely prescribed these products, but we also found that the FDA and manufacturers missed opportunities to revise the program once these deficiencies were identified," Alexander told MedPage Today.
"Rather than having rapid, iterative assessments and revisions to the program to ensure safe use, we found that the identification of unsafe, off-label prescribing was delayed; it didn't occur until 3 years in," he added. "And even when it occurred, even the FDA and manufacturers failed to substantially overhaul the program."
Under the FDA's Risk Evaluation and Mitigation Strategy (REMS) for the drugs, TIRF medicine application holders must ensure that outpatient prescribers and dispensing pharmacies are specially certified, that distributors supply TIRF drugs only to certified pharmacies, and that patients are enrolled in the REMS. Prescribers also must attest that they understand the risks TIRF medicines pose.
The TIRF REMS program was approved in December 2011. In their analysis, Alexander and colleagues examined six annual REMS assessment reports from 2012 to 2017, the FDA evaluations of these reports, and FDA correspondence about safety issues. They found:
In the second-year report (2013), 39.4% of responding prescribers reported prescribing TIRFs off-label for patients with chronic, non-cancer pain. Comparable levels of prescribers responded this way in subsequent years.
After the third-year report (2014), the FDA asked TIRF makers to analyze health insurance claims to provide a clearer picture of the level of inappropriate prescribing.
These claims-based assessments, provided as part of the fourth-year report (2015), showed 51% of patients who received TIRFs (12,916 of 25,322 people) lacked opioid tolerance.
The fifth-year report (2016) showed the problem persisted: on a product-by-product basis, between 34.6% and 55.4% of TIRF patients lacked opioid tolerance.
While surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge about proper TIRF prescribing, some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use, Alexander and colleagues concluded.
"Despite these findings, the FDA did not require substantive changes to the program," they wrote.
The analysis mirrors findings presented in August 2018, when FDA advisory committee membersreviewed problems in TIRF REMS program that seemingly had been apparent for years.
"These findings -- that many people who received these TIRF products did not have breakthrough cancer pain, or in fact did not have cancer, and nearly half were not tolerant to opioids -- show that the REMS was ineffective at doing what it was supposed to do, which is protecting the public," said Raeford Brown Jr., MD, chair of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee.
"Fifty percent is not good enough when you're talking agents that can kill people almost instantly," Brown told MedPage Today.
The initial TIRF REMS included Abstral, Actiq, Fentora, Lazanda, Onsolis, and generic equivalents. Subsys, a sublingual fentanyl spray from Insys Therapeutics, joined in January 2012 when it was approved by the FDA.
During the period covered by the study, Insys was found to have engaged in a nationwide conspiracy to bribe physiciansto prescribe Subsys for off-label use. "The U.S. Attorney's Office of the District of Massachusetts brought a criminal indictment against seven executives at the company for this scheme and has securedtwo guilty pleas to date," noted Ameet Sarpatwari, JD, PhD, of the Program on Regulation, Therapeutics, and Law at Brigham and Women's Hospital and Harvard Medical School, and Gregory Curfman, MD, JAMA deputy editor, in an accompanying editorial.
"But there's a thread that suggests the problem is not just with Insys," Alexander noted. The follow-up claims analysis showed that from 34.6% to 55.4% of patients lacked opioid tolerance, depending on the specific TIRF drug, he pointed out: "That means that even the lowest level of use among opioid-naïve patients was far higher than should ever have occurred."
The study has several limitations, the authors noted. Some of the information requested was redacted, and the context for regulatory decisions may not have been visible. There may be additional documents not provided that could give a clearer picture of the history or relevant advice provided by the FDA.
The documents viewed also did not measure the potential burdens the REMS program placed on prescribers, pharmacists, and patients, they added, and did not assess whether additional requirements might pose undue restrictions in the future.
Alexander disclosed serving as the chair of the FDA Peripheral and Central Nervous System Advisory Committee and relevant relationships with IQVIA, Monument Analytics, and OptumRx. Co-authors disclosed relevant relationships with the FDA.
Sarpatwari disclosed institutional support from the Laura and John Arnold Foundation, the Harvard Program in Therapeutic Science, the Engelberg Foundation, and the Open Society.
The intervention involved bathing with antiseptic soap, use of mouthwash, and use of the nasal antibiotic ointment for 5 days twice a month for 6 months.
This article was published February 14, 2019, byMedPage Today.
A 6-month methicillin-resistant Staphylococcus aureus decolonization protocol that included antiseptic cleansing of the skin, mouth, and nose reduced MRSA infections by 30% among colonized patients over 1 year of follow-up.
More than 2,000 patients colonized with MRSA at discharge from several Southern California hospitals from 2011 to 2014 were randomized to receive the 6-month decolonization protocol plus hygiene education or hygiene education alone, according to Susan Huang, MD, of the University of California Irvine School of Medicine, and colleagues.
In the per-protocol population, MRSA infection occurred in 98 of 1,063 participants (9.2%) in the education group and in 67 of 1,058 (6.3%) in the decolonization group; 84.8% of the MRSA infections led to hospitalization, they wrote in the New England Journal of Medicine.
Infection from any cause occurred in 23.7% of the participants in the education group and 19.6% of those in the decolonization group; 85.8% of the infections led to hospitalization, they also reported.
The decolonization intervention involved bathing with chlorhexidine antiseptic soap, use of chlorhexidine mouthwash, and use of the nasal antibiotic ointment mupirocin for 5 days twice a month for 6 months.
MRSA is responsible for more than 80,000 invasive infections in the U.S. each year, and it is the most common cause of skin, soft-tissue and procedure-related infections.
Huang told MedPage Today that it is now clear that patients who have MRSA infections, or positive cultures for MRSA during hospitalization, have an elevated risk of infections for around a year after discharge, with the highest risk occurring during the first 6 months after leaving the hospital.
"These are often serious infections that require another hospitalization," she said.
Earlier studies from Huang's group and others confirmed that an aggressive decolonization within the hospital ICU setting reduced the risk of surgical-site infections, and decolonization protocols are now standard in ICU care.
"The success in the ICU led us to ask the question, 'Where else can decolonization reduce infection risk?'" Huang said.
The primary outcome in the current trial was MRSA infection as defined by CDC criteria. Secondary outcomes included MRSA infection determined on the basis of clinical judgment, infection from any cause, and infection-related hospitalization.
Analyses were performed using proportional-hazards models in the per-protocol population (all participants who underwent randomization met the inclusion criteria and survived beyond the recruitment hospitalization) and as-treated population (participants stratified according to adherence).
The researchers estimated the number needed to treat in the newly published trial to be 25 to 30 to prevent one infection and hospitalization.
The authors reported that the risk of MRSA infection was significantly lower in the decolonization group compared with the education group (hazard ratio 0.70, 95% CI 0.52-0.96, P=0.03; number needed to treat to prevent one infection 30, 95% CI 18-230). This lower hazard led to a lower risk of hospitalization due to MRSA infection (HR 0.71, 95% CI 0.51-0.99).
The decolonization group had lower likelihoods of clinically judged infection from any cause (HR 0.83, 95% CI 0.70-0.99) and infection-related hospitalization (HR 0.76, 95% CI 0.62-0.93).
In the as-treated analyses, participants in the decolonization group who adhered fully to the regimen had 44% fewer MRSA infections than the education group (HR 0.56, 95% CI 0.36-0.86) and had 40% fewer infections from any cause (HR 0.60, 95% CI 0.46-0.78).
Mild side effects involving antibiotic bathing were reported by around 2% of patients, and 1% each reported mild side effects to the antiseptic mouthwash and nasal ointment.
Although the researchers have not yet completed a cost analysis, Huang said the decolonization intervention, which costs around $150 to $200 over 6 months, should prove to be highly cost effective.
Study limitations included the unblinded intervention -- although outcomes were assessed in a blinded fashion – and the substantial attrition over the 1-year follow-up. Also, "adherence was based on reports by the participants, with spot checks of remaining product, both of which may not reflect actual use," the authors noted.
It is estimated that around 1.8 million MRSA carriers are discharged from hospitals each year.
"That represents about 5% of hospitalized patients, and we have shown that around one in 10 of these will get infected, and end up back in the hospital," Huang said. "For patients whose risk for infection is high, it is terrific news that there is now a proven topical strategy that can lower that risk."
The study was funded by the Agency for Health Research and Quality.
Huang disclosed support from the AHRQ Healthcare-Associated Infections Program and the University of California Irvine Institute for Clinical and Translational Science, and relevant relationships with Stryker (Sage Products), Mölnlycke, 3M, Clorox, Xttrium Laboratories, and Medline. Co-authors disclosed multiple relevant relationships with industry.
Last year's flu season had the highest mortality since the 2009 pandemic, including a record number of flu-related hospitalizations and the largest number of pediatric flu-related deaths since the 2009 pandemic.
This article was published February 7, 2019, by MedPage Today
End-of-season influenza vaccine efficacy for the 2017-2018 flu season was a mediocre 38% (95% CI 31%-43%), but flu shots were still estimated to have prevented 7 million illnesses and 8,000 deaths, researchers found.
With respect to individual flu strains, vaccine efficacy last season ranged from 62% (95% CI 50%-71%) against influenza A(H1N1)pdm09 to 22% (95% CI 12-31%) against influenza A(H3N2), reported Melissa A. Rolfes, PhD, of the CDC, and colleagues.
Influenza vaccinations are estimated to have prevented 10% of expected hospitalizations overall, and 41% among children ages 6 months to 4 years, the authors wrote in Clinical Infectious Diseases.
Last year's widely publicized "high severity" flu season featured "the highest morbidity and mortality since the 2009 pandemic," the authors noted, including a record number of flu-related hospitalizations and the largest number of pediatric flu-related deaths since the 2009 pandemic year. However, only 42% of the U.S. population received the flu shot during the 2017-2018 season, the researchers added.
Among persons age ≥6 months who were eligible for the flu shot, the researchers estimated that there were 47.9 million illnesses, about 22 million medical visits, 953,000 hospitalizations, and 79,400 influenza-associated deaths in 2017-2018. Adults ages ≥65 comprised 15% of the illnesses, but 70% of flu-related hospitalizations and 90% of flu-related deaths.
Influenza A(H3N2) was linked with the highest rates of illness, and the authors found this strain affected 15% of adults ages 50-64 and 9% of children ages 6 months to 4 years. When applying these rates to the total U.S. population, the researchers estimated that influenza A(H3N2) was linked with 28.4 million illnesses, 13.0 million medical visits, 587,000 hospitalizations, and 49,000 deaths overall.
Examining data from the U.S. Flu VE Network, the authors found that influenza A(H3N2) viruses accounted for 84% of influenza A virus infections. Moreover, the authors found that among those enrolled in this network, 42% of influenza-positive case-patients and 53% of influenza-negative controls were vaccinated against influenza.
Further estimates found that influenza vaccination prevented 3.7 million medical visits and 109,000 hospitalizations. Not only were an estimated 8,000 deaths prevented by influenza vaccination, but 9% of expected deaths overall, the authors said. In addition, influenza vaccines prevented an estimated 39% of influenza-related mortality in children ages 6 months to 4 years.
An accompanying editorialby Kathleen Neuzil, MD, and Meagan C. Fitzpatrick, PhD, both of the University of Maryland School of Medicine in Baltimore, said that while the data "strongly support use of the influenza vaccine," it also illustrates the large burden of illness and "a lot of disease we are not preventing." While the wait is on for better vaccines, the editorialists advised clinicians not to forget about using antiviral medications to prevent and treat influenza, but also emphasized the importance of "strongly recommending" the flu shot to patients.
"Unfortunately, last year, influenza vaccine coverage dropped in the U.S. across all age groups, [which] ... may be partially driven by public perceptions that a moderately effective vaccine is not worth the effort," Neuzil and Fitzpatrick wrote. "However, improving coverage is likely to avert more disease than a similar improvement in efficacy – and furthermore, we can emphasize that personal risk is heightened when vaccine efficacy is low."
Limitations to the data, the researchers said, include that because "multipliers are used to scale surveillance data to national burden estimates" and the data to calculate these multipliers often lag by 2 years, the team used multipliers measured during previous influenza seasons, which would not take into account 2017-2018 changes in testing practices, disease severity, or care-seeking behavior. Rolfes and colleagues also noted that this model does not "currently account for waning effectiveness of influenza vaccination over the season."
The research was supported by the CDC through Emerging Infections Programs, the Influenza Hospital Surveillance Project, the University of Michigan, Kaiser Permanente Washington Research Institute, Marshfield Clinic Research Institute, the University of Pittsburgh, Baylor Scott and White Healthcare, and the National Institutes of Health.
Rolfes disclosed no conflicts of interest; other co-authors disclosed support from Sanofi, Seqirus, Merck, Pfizer, Micron, MedImmune, PaxVax, AbbVie, and the CDC; one co-author received payment to co-edit a book on infectious disease surveillance, with royalties donated to the Minnesota Department of Health.
Neuzil and Fitzpatrick disclosed no conflicts of interest.
Republicans and Democrats in the House Health Subcommittee met for the first time on Wednesday and spent most of their time yelling and accusing each other of disserving the American people.
This article was published Febrary 6, 2019, in MedPage Today.
WASHINGTON -- A House hearing Wednesday that was supposed to be about the possible effect of the district court case in Texas on the Affordable Care Act degenerated into a heated discussion about whether the committee should be discussing the case at all.
"I am glad that we are holding our first hearing of the year ... It's unfortunate we're having a hearing that doesn't move toward the development of any policies to improve healthcare for Americans," Rep. Michael Burgess, MD (R-Texas), ranking member of the Energy & Commerce Health Subcommittee, said in remarks that appeared to be directed mainly toward committee chairwoman Anna Eshoo (D-Calif.). "To that effect, there are numerous options that you could bring before us that could moot the [case we're discussing], but the subcommittee apparently has chosen not to do so."
Burgess suggested that the subcommittee instead hold a hearing about a "Medicare for All" government-run healthcare system, pointing out that other committees have already announced hearings on the subject. "Do I agree with [that] policy or think it would be a good idea for the American people? ... No, I do not," he said. "And I would gladly engage in a meaningful dialogue about what such a policy would mean for the American people."
Sharp Rebukes
Burgess's remarks brought a swift rebuke from several Democrats on the committee. "I was going to try to be nice today but after I listened to Mr. Burgess, I can't be ... I have to speak out," said Rep. Frank Pallone (D-N.J.), chairman of the full Energy & Commerce Committee.
"You were the chairman of this subcommittee the whole time that the Republicans tried unsuccessfully to repeal the Affordable Care Act. I've had so many meetings where I saw you come in ... and repeatedly tell us the ACA was bad law, terrible law, it needs to be repealed. I saw no effort at all in the time you were the chairman to try to work toward solutions, toward improving the ACA; what I saw were constant efforts to join with President Trump to sabotage it."
"And the reason this hearing is so important is the ultimate sabotage would be to have the courts rule the ACA was unconstitutional, which is totally bogus," he added.
"Republicans spent all their time [last term] trying to take healthcare away from the majority of Americans," said committee member Nannette Diaz Barragán (D-Calif.) in response to a complaint by Rep. Buddy Carter (R-Ga.) that the subcommittee should be looking at high drug prices instead. "We're trying to highlight the importance of this lawsuit ... You're darn right we're going to take this up and you're darn right we're going to have hearings on this."
The Lawsuit Explained
The lawsuit in question, known as Texas v. the United States of America, was filed in February by the state of Texas along with 19 other states, all led at the time by Republican governors. It argues that because the tax reform bill passed by Congress -- the Tax Cuts and Jobs Act (TCJA) of 2017 -- gets rid of the ACA's "individual mandate" penalty for not having health insurance, the requirement for individuals to have health insurance is void, and because of that, the rest of the law -- which they say hinges on the mandate -- should be invalidated.
"In NFIB [another court case involving the ACA], the Supreme Court held the individual mandate was unconstitutional under the Interstate Commerce Clause but could fairly be read as an exercise of Congress's tax power because it triggered a tax," O'Connor wrote. "The TCJA eliminated that tax. The Supreme Court's reasoning in NFIB ... thus compels the conclusion that the individual mandate may no longer be upheld under the tax power. And because the individual mandate continues to mandate the purchase of health insurance, it remains unsustainable under the Interstate Commerce Clause -- as the Supreme Court already held."
The judge's verdict is currently on hold while the case makes its way through the appeals process, and the Department of Health and Human Services has declared that it will continue enforcing the law in the meantime. But if the verdict does take hold, argued hearing witness Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, a left-leaning think tank here, "In many ways, things would look like what they were before the ACA was in place ... The Congressional Budget Office estimated that repeal of the ACA would result in as many as 24 million additional uninsured Americans."
Avik S.A. Roy, president of the Foundation for Research on Equal Opportunity, in Austin, Texas, pointed out that so far, getting rid of the mandate "has not blown up the insurance market; indeed, it has had no effect." In addition, it is the law's limited enrollment period, not the guaranteed issue provision, that ensures no gaming of the system because you can only enroll during a certain time of the year, he argued.
Roy disagreed with critics of the current law who suggest that a separate insurance pool needs to be created for individuals at high risk of expensive health problems. "The largest impact is from the ACA's age bands, which on their own double the cost of insurance for Americans in their 20s and 30s, forcing many to drop out of the market because younger people consume one-sixth of the healthcare that older people do."
Instead, he said, "the most market-based approach for covering those with preexisting conditions is not to repeal the ACA's guaranteed issue [and other] provisions, but to preserve and integrate the principles of a high-risk pool into a single insurance market through reinsurance ... I hope both parties can work together to achieve this."
Preexisting Conditions in the Spotlight
As for the case itself, assuming it gets appealed all the way to the Supreme Court, "the probability of the Supreme Court ruling to overturn the entire ACA remains very low," said Thomas Miller, JD, resident fellow at the American Enterprise Institute, a right-leaning think tank here. "Even if appellate courts also find some form of constitutional injury in what remains of the ACA's individual mandate ... the severability stage of such proceedings will become far more uphill for the plaintiffs."
Another question about the lawsuit is whether the plaintiffs have grounds to sue at all, said Simon Lazarus, a constitutional lawyer and writer. He noted that under the ACA, people who chose to pay the penalty rather than buy insurance are considered to have complied with the law, and now that the penalty has been reduced to zero, "no one is compelled to buy insurance to avoid a penalty ... So there is no injury and no standing to sue."
Much of the subcommittee's discussion centered around the ACA's guarantee of coverage for people with pre-existing conditions. "Before the ACA, insurance companies didn't have to pay for HIV tests, or individuals with HIV couldn't get coverage until they were really sick, or on their deathbeds," said Rep. Raul Ruiz, MD (D-Calif.). "Insurance coverage for these patients went from only 10% to 99.9% because of the ACA ... [taking that away] would be devastating to HIV patients."
Rep. Larry Bucshon, MD (R-Ind.), was one of several Republicans who said that all the subcommittee members supported protecting patients with pre-existing conditions. "I think we need a policy discussion about the most appropriate way to do that," he said, noting that because deductibles under the ACA can be very high, not everyone is getting the healthcare they need. "I'm hoping we can have hearings on how we can get the costs down, and insurance can almost solve itself if we can do that."