In The News

Vaccine Against Urinary Tract Infections in Development

Medscape / By Dominique Baudon, MD, PhD

Urinary tract infections are among the most common bacterial infections. They can be painful, require antibiotic treatments, and recur in 20%-30% of cases. With the risk for the emergence or increase of resistance to antibiotics, it is important to search for potential therapeutic alternatives to treat or prevent urinary tract infections.

The MV140 Vaccine

The MV140 vaccine is produced by the Spanish pharmaceutical company Immunotek. MV140, known as Uromune, consists of a suspension of whole heat-inactivated bacteria in glycerol, sodium chloride, an artificial pineapple flavor, and water. It includes equal percentages of strains from four bacterial species (V121 Escherichia coli, V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris). MV140 is administered sublingually by spraying two 100-µL doses daily for 3 months.

The vaccine is in phase 2-3 of development. It is available under special access programs outside of marketing authorization in 26 countries, including Spain, Portugal, the United Kingdom, Lithuania, the Netherlands, Sweden, Norway, Australia, New Zealand, and Chile. Recently, MV140 was approved in Mexico and the Dominican Republic and submitted to Health Canada for registration.

randomized study published in 2022 showed the vaccine's efficacy in preventing urinary tract infections over 9 months. In total, 240 women with a urinary tract infection received MV140 for either 3 or 6 months or a placebo for 6 months. The primary outcome was the number of urinary tract infection episodes during the 9-month study period after vaccination.

In this pivotal study, MV140 administration for 3 and 6 months was associated with a significant reduction in the median number of urinary tract infection episodes, from 3.0 to 0.0 compared with the placebo during the 9-month efficacy period. The median time to the first urinary tract infection after 3 months of treatment was 275.0 days in the MV140 groups compared with 48.0 days in the placebo group.

Nine-Year Follow-Up

On April 6 at the 2024 congress of The European Association of Urology, urologists from the Royal Berkshire NHS Foundation Trust presented the results of a study evaluating the MV140 vaccine spray for long-term prevention of bacterial urinary tract infections.

This was a prospective cohort study involving 89 participants (72 women and 17 men) older than 18 years with recurrent urinary tract infections who received a course of MV140 for 3 months. Participants had no urinary tract infection when offered the vaccine and had no other urinary abnormalities (such as tumors, stones, or kidney infections).

Postvaccination follow-up was conducted over a 9-year period, during which researchers analyzed the data from the electronic health records of their initial cohort. They queried participants about the occurrence of urinary tract infections since receiving the vaccine and about potential related side effects. Thus, the results were self-reported…

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Draft OASIS E-1 Manual and Instruments

The draft Guidance Manual for the OASIS-E1 version of the OASIS data set, effective January 1, 2025, is available in the Downloads section of the OASIS User Manuals | CMS page, www.cms.gov/medicare/quality/home-health/.... The draft OASIS-E1 Instruments (All Items and Time Points versions) are available in a zip file in the Downloads section of the OASIS Data Sets | CMS page. 

 

Why is Cancer Called Cancer? We Need to go Back to Greco-Roman Times for the Answer

The Conversation / By Konstantine Panegyres

One of the earliest descriptions of someone with cancer comes from the fourth century BC. Satyrus, tyrant of the city of Heracleia on the Black Sea, developed a cancer between his groin and scrotum. As the cancer spread, Satyrus had ever greater pains. He was unable to sleep and had convulsions.

Advanced cancers in that part of the body were regarded as inoperable, and there were no drugs strong enough to alleviate the agony. So doctors could do nothing. Eventually, the cancer took Satyrus' life at the age of 65.

Cancer was already well known in this period. A text written in the late fifth or early fourth century BC, called Diseases of Women, described how breast cancer develops:

"Hard growths form […] out of them hidden cancers develop […] pains shoot up from the patients' breasts to their throats, and around their shoulder blades […] such patients become thin through their whole body […] breathing decreases, the sense of smell is lost […]"

Other medical works of this period describe different sorts of cancers. A woman from the Greek city of Abdera died from a cancer of the chest; a man with throat cancer survived after his doctor burned away the tumor.

Where does the word 'cancer' come from?

The word cancer comes from the same era. In the late fifth and early fourth century BC, doctors were using the word karkinos—the ancient Greek word for crab—to describe malignant tumors. Later, when Latin-speaking doctors described the same disease, they used the Latin word for crab: cancer. So, the name stuck.

Even in ancient times, people wondered why doctors named the disease after an animal. One explanation was the crab is an aggressive animal, just as cancer can be an aggressive disease; another explanation was the crab can grip one part of a person's body with its claws and be difficult to remove, just as cancer can be difficult to remove once it has developed. Others thought it was because of the appearance of the tumor.

The physician Galen (129–216 AD) described breast cancer in his work A Method of Medicine to Glaucon, and compared the form of the tumor to the form of a crab:

"We have often seen in the breasts a tumor exactly like a crab. Just as that animal has feet on either side of its body, so too in this disease the veins of the unnatural swelling are stretched out on either side, creating a form similar to a crab."…

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‘This Battle Is Far From Over’: Federal Court Dismisses NAHC’s Lawsuit Against CMS

Home Health Care News / By Joyce Famakinwa 
 
Last summer, the National Association for Home Care & Hospice (NAHC) made waves when it filed a lawsuit against the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) over Medicare home health payment calculations.
 
Last week, a federal court in Washington D.C., dismissed NAHC’s lawsuit against CMS and HHS.
 
The lawsuit claimed that CMS and HHS utilized an “invalid” methodology to decide payment, and that recent home health payment cuts were unlawful. 
 
“The primary claim in our lawsuit is that the methodology violated the plain language of the Medicare law,” NAHC wrote in its latest report.
 
CMS implemented a 3.925% rate reduction for 2023, and a 2.89% one for 2024. 
 
On April 26, the U.S. District Court for the District of Columbia ruled that NAHC skipped an agency review process prior to suing. 
 
“The Court ruling addresses a combination of the NAHC arguments and the defenses presented by the U.S. Department of Justice on behalf of CMS,” NAHC wrote. “DOJ argued that the Court did not have the power to hear any challenges to the PDGM budget neutrality adjustment methodology, that NAHC failed to exhaust all administrative appeal steps, and that the challenged methodology was in compliance with the law.” 
 
Still, NAHC noted that the Court ruled in its favor on something it considers a crucial element of the case. 
 
“[The court rejected] DOJ’s argument that all judicial review was precluded on anything related to the PDGM system,” NAHC wrote. “The Court specifically held that NAHC could challenge the budget neutrality adjustment methodology once administrative remedies are exhausted. Of further note, the Court did not rule on or evaluate the merits of the NAHC claim that the methodology violated Medicare law.” 
 
Last year, the Biden administration asked a federal judge to throw out NAHC’s lawsuit against CMS and HHS. 
 
Looking ahead, NAHC is considering its next move. One of the things the organization is thinking about is appealing the court’s ruling on exhaustion of administrative appeals. 
Pursuing a request for expedited judicial review with CMS is also on the table. If a judicial review is expedited, NAHC plans to refine its lawsuit.
 
“The Court did not rule on the merits of NAHC’s claims that it had violated Medicare laws,” NAHC wrote. “As such, a lawsuit can be pursued once the administrative steps are completed.” 
 
Ultimately, NAHC President William A. Dombi believes that the lawsuit dismissal is a stumbling block, but one that the organization will prevail over. 
 
“We are disappointed with the court’s ruling. However, it is a minor setback that we can readily overcome,” Dombi said in the report. “Often justice delayed is justice denied. Here, we will have our day in court. This battle is far from over.”
 
In addition to his role as president, Dombi also served as legal counsel to NAHC.

 

Investigation Finds Home Care Agency Failed to Protect Visiting Nurse Who Died in Willimantic

NBC Connecticut / By Angela Fortuna

A federal investigation following the death of a Connecticut visiting nurse found that the home care agency she worked for did not provide enough safeguards to protect her.

The Department of Labor's Occupational Safety and Health Administration found that Elara Caring, one of the nation's largest home-based care providers, failed to protect Joyce Grayson, who was killed on Oct. 28, 2023.

Michael Reese, the man accused of killing Grayson, has been charged with murder. Grayson, a visiting nurse, had an appointment with Reese at his residence, a halfway house for sex offenders in Willimantic.

Around 2 p.m., Willimantic police received a call asking them to check on Grayson after she missed several patient appointments. The caller said Reese was Grayson’s first appointment of the day and there had been no contact with her since early that morning.

Police eventually found Grayson's body in the padlocked basement of the Chapman Street home, and they found her cell phone in a bucket of liquid in the bathtub, according to the arrest warrant.

Grayson died of compression of the neck and her death was ruled a homicide, according to authorities.

Federal OSHA officials found that on the day of Grayson's death, and at times prior, Elara Caring "exposed home healthcare employees to workplace violence from patients who exhibited aggressive behavior and were known to pose a risk to others."

Jordan Health Care Inc. and New England Home Care Inc., who both did business as Elara Caring, have been cited for willful violation under the agency's general duty clause, officials said.

Feds cited the home care agency for "not developing and implementing adequate measures to protect employees from the ongoing serious hazard of workplace violence." Elara Caring was also cited for not providing work-related injury and illness records to OSHA within four business hours, as required by law.

The home care agency will have to pay over $163,000 in proposed penalties…

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