“We’re flying blind,” said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. With so few tests run, she said, it’s impossible to know how many farmworkers have been infected, or how serious the disease is. A lack of testing means the country might not notice if the virus begins to spread between people — the gateway to another pandemic.

“We’d like to be doing more testing. There’s no doubt about that,” said Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. The CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use right now. Shah said the agency has distributed these tests to about 100 public health labs in states. “We’ve got roughly a million available now,” he said, “and expect 1.2 million more in the next two months.”

But Nuzzo and other researchers are concerned because the CDC and public health labs aren’t generally where doctors order tests from. That job tends to be done by major clinical laboratories run by companies and universities, which lack authorization for bird flu testing.

As the outbreak grows — with at least 114 herds infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing. In one case, the diagnostics company Neelyx Labs was on hold with a query for more than a month.

“Clinical labs are part of the nation’s public health system,” said Alex Greninger, assistant director of the University of Washington Medicine Clinical Virology Laboratory. “Pull us into the game. We’re stuck on the bench.”

The CDC recognized the need for clinical labs in a June 10 memo. It calls on industry to develop tests for the H5 strain of bird flu virus, the one circulating among dairy cattle. “The limited availability and accessibility of diagnostic tests for Influenza A(H5) poses several pain points,” the CDC wrote. The points include a shortage of tests if demand spikes.

Researchers, including former CDC director Tom Frieden and Anthony Fauci, who led the nation’s response to covid, cite testing failures as a key reason the U.S. fared so poorly with covid. Had covid tests been widely available in early 2020, they say, the U.S. could have detected many cases before they turned into outbreaks that prompted business shutdowns and cost lives.

In an article published this month, Nuzzo and a group of colleagues noted that the problem wasn’t testing capability but a failure to deploy that capability swiftly. The U.S. reported excess mortality eight times as high as other countries with advanced labs and other technological advantages.

A covid test vetted by the WHO was available by mid-January 2020. Rather than use it, the United States stuck to its own multistage process, which took several months. Namely, the CDC develops its own test then sends it to local public health labs. Eventually, the FDA authorizes tests from clinical diagnostic labs that serve hospital systems, which must then scale up their operations. That took time, and people died amid outbreaks at nursing homes and prisons, waiting on test results.

In contrast, South Korea immediately rolled out testing through private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Gear up, guys; we’re going to need a ton of tests,’” said Frieden, now president of the public health organization Resolve to Save Lives. “You need to get commercials in the game.”

Nuzzo and her colleagues describe a step-by-step strategy for rolling out testing in health emergencies, in response to mistakes made obvious by covid. But in this bird flu outbreak, the U.S. is weeks behind that playbook.

Ample testing is critical for two reasons. First, people need to know if they’re infected so that they can be quickly treated, Nuzzo said. Over the past two decades, roughly half of about 900 people around the globe known to have gotten the bird flu died from it.

Although the three farmworkers diagnosed with the disease this year in the United States had only mild symptoms, like a runny nose and inflamed eyes, others may not be so lucky. The flu treatment Tamiflu works only when given soon after symptoms start.

The CDC and local health departments have tried to boost bird flu testing among farmworkers, asking them to be tested if they feel sick. Farmworker advocates list several reasons why their outreach efforts are failing. The outreach might not be in the languages the farmworkers speak, for example, or address such concerns as a loss of employment.

If people who live and work around farms simply see a doctor when they or their children fall ill, those cases could be missed if the doctors send samples to their usual clinical laboratories. The CDC has asked doctors to send samples from people with flu symptoms who have exposure to livestock or poultry to public health labs. “If you work on a farm with an outbreak and you’re worried about your welfare, you can get tested,” Shah said. But sending samples to public health departments requires knowledge, time, and effort.

“I really worry about a testing scheme in which busy clinicians need to figure this out,” Nuzzo said.

The other reason to involve clinical laboratories is so the nation can ramp up testing if the bird flu is suddenly detected among people who didn’t catch it from cattle. There’s no evidence the virus has started to spread among people, but that could change in coming months as it evolves.

The fastest way to get clinical labs involved, Greninger said, is to allow them to use a test the FDA has already authorized: the CDC’s bird flu test. On April 16 the CDC opened up that possibility by offering royalty-free licenses for components of its bird flu tests to accredited labs.

Several commercial labs asked for licenses. “We want to get prepared before things get crazy,” said Shyam Saladi, chief executive officer of the diagnostics company Neelyx Labs, which offered covid and mpox tests during shortages in those outbreaks. His experience over the past two months reveals the types of barriers that prevent labs from moving swiftly.

In email exchanges with the CDC, shared with KFF Health News, Saladi specifies the labs’ desire for licenses relevant to the CDC’s test, as well as a “right to reference” the CDC’s data in its application for FDA authorization.

That “right to reference” makes it easier for one company to use a test developed by another. It allows the new group to skip certain analyses conducted by the original maker, by telling the FDA to look at data in the original FDA application. This was commonplace with covid tests at the peak of the pandemic.

At first, the CDC appeared eager to cooperate. “A right of reference to the data should be available,” Jonathan Motley, a patent specialist at the CDC, wrote in an email to Saladi on April 24. Over the next few weeks, the CDC sent him information about transferring its licenses to the company, and about the test, which prompted Neelyx’s researchers to buy testing components and try out the CDC’s process on their equipment.

But Saladi grew increasingly anxious about the ability to reference the CDC’s data in the company’s FDA application. “Do you have an update with respect to the right of reference?” he asked the CDC on May 13. “If there are any potential sticking points with respect to this, would you mind letting us know please?”

He asked several more times in the following weeks, as the number of herds infected with the bird flu ticked upward and more cases among farmworkers were announced. “Given that it is May 24 and the outbreak has only expanded, can CDC provide a date by which it plans to respond?” Saladi wrote.

The CDC eventually signed a licensing agreement with Neelyx but informed Saladi that it would not, in fact, provide the reference. Without that, Saladi said, he could not move forward with the CDC’s test — at least not without more material from the agency. “It’s really frustrating,” he said. “We thought they really intended to support the development of these tests in case they are needed.”

Shah, from the CDC, said test manufacturers should generate their own data to prove that they’re using the CDC’s test correctly. “We don’t have a shortage such that we need to cut corners,” he said. “Quality reigns supreme.”

The CDC has given seven companies, including Neelyx, licenses for its tests — although none have been cleared to use them by the FDA. Only one of those companies asked for the right of reference, Shah said. The labs may be assisted by additional material that the agency is developing now, to allow them to complete the analyses — even without the reference.

“This should have happened sooner,” Saladi told KFF Health News when he was told about the CDC’s pending additional material. “There’s been no communication about this.”

Greninger said the delays and confusion are reminiscent of the early months of covid, when federal agencies prioritized caution over speed. Test accuracy is important, he said, but excessive vetting can cause harm in a fast-moving outbreak like this one. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he said. “I fall on the side of allowing labs to get ready — that’s a no-brainer.”

Clinical laboratories have also begun to develop their own tests from scratch. But researchers said they’re moving cautiously because of a recent FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said the rule’s enforcement will occur gradually.

However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It’s slowing things down because it’s adding to the confusion about what is allowable.”

Creating tests for the bird flu is already a risky bet, because demand is uncertain. It’s not clear whether this outbreak in cattle will trigger an epidemic or fizzle out. In addition to issues with the CDC and FDA, clinical laboratories are trying to figure out whether health insurers or the government will pay for bird flu tests.

These wrinkles will be smoothed eventually. Until then, the vanishingly slim numbers of people tested, along with the lack of testing in cattle, may draw criticism from other parts of the world.

“Think about our judgment of China’s transparency at the start of covid,” Nuzzo said. “The current situation undermines America’s standing in the world.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The symptoms can be classic respiratory problems, conjunctivitis, or less obvious gastrointestinal issues and the CDC says laboratories are ready to help with testing. Medscape Medical News

Santo Domingo.- The Minister of Public Health (MSP), Víctor Atallah, announced that the country currently lacks COVID-19 vaccines due to the perception that the disease had “disappeared.”

“COVID-19 seemed to have disappeared, and the influx to vaccination centers was almost zero. We vaccinated nearly 100% of the population, which was a record. A second outbreak was not anticipated,” said Minister Atallah during the presentation of the new edition of the National Epidemiological Bulletin.

Atallah mentioned that vaccines for adults are expected to arrive next week, and information on the distribution centers will be provided. Additionally, he confirmed that vaccines for children, who were pending vaccination, have arrived to prevent a spike in cases among this group.

No Intensive Care Patients or Intubations

Minister Atallah highlighted that there are currently no COVID-19 patients in intensive care or on ventilators. He noted that the number of cases has decreased, with no reported deaths. “Only 300 new cases have been registered, showing a reduction compared to last week,” he emphasized.

He also mentioned that approximately 2,500 hospital beds have been made available, and there has been no overcrowding in health centers. He stressed the importance of wearing masks to prevent the virus’s spread and assured that pharmacies are being supplied to avoid a shortage of medicines. “We continue to monitor to anticipate possible outbreaks,” he concluded.

Launch of the Modernized National Epidemiological Bulletin

On Tuesday, the MSP unveiled a modern version of its National Epidemiological Bulletin in digital format. The updated bulletin features changes in format, design, and content, with a focus on a main theme in each publication.

The primary objective of the new bulletin is to “inform in an easy and accurate manner” about health events in the country, targeting both epidemiologists and the interested public.

During the launch event, Minister Atallah highlighted that the new updates make the epidemiological document more accessible, with an index and chapters navigable through tabs. The bulletin uses Artificial Intelligence (AI) on its cover and includes a QR code for accessing the repository of previously published bulletins, which are available for download.

Weekly Updates and Central Topics

The new bulletin will be updated every Thursday at noon and will be available on the Epidemiology Directorate’s website, https://digepi.gob.do. Each edition will feature a central current topic, described and analyzed in detail within its local, regional, and global contexts, along with surveillance methods and prevention or control recommendations.

Minister Atallah explained that the format of the National Epidemiological Bulletin had not been updated for over 15 years. The new version aims to provide a more modern, readable, and instructive tool that facilitates quicker access and understanding of the document.

The updated bulletin will present mandatory notification events by time, place, and person, along with a summary table of confirmed cases for the week and the most relevant events. It will also feature a relevant scientific article for the ongoing education of epidemiologists and other readers.

This statistical document covers notifiable health events, showing the behavior of diseases such as dengue, malaria, leptospirosis, cholera, respiratory diseases, and rabies. It also includes the incidence of maternal and infant deaths, disaggregated by sex, age, and other indicators.

IN CANCER care, different types of doctors, including medical oncologists, surgeons, and radiation oncologists, often work together to create an overall treatment plan that may combine different types of treatments to treat the cancer. This is...

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West Indian Cherries are great to help reduce sickness and diseases that men are susceptible to such as heart disease, cancers and depression, and helps in fitness and endurance

View the full post West Indian Cherries and men’s health on NOW Grenada.

The prohibition on smoking medicinal cannabis in Barbados is sparking mixed reactions among patients and doctors, according to Chief Executive Officer of the Barbados Medicinal Cannabis Licensing Authority (BMLA), Shanika Roberts-Odle. 

At present, medicinal cannabis is mostly administered topically through dermal sprays, gels and creams. 

Appearing on a recent radio programme, Roberts-Odle, highlighted the divergent opinions on this policy, its implications and alternatives.

Her comments come amid an ongoing national dialogue around appropriate medicinal cannabis policies. Since legalising medicinal cannabis in November 2019, authorities have taken a cautious approach, prohibiting smoking as a method of administration, while focusing on the growth of an export industry.

“There are significant amounts of persons who I have met who have indicated that for them, there’s a certain level of hypocrisy involved in that particular position,” Roberts-Odle told the programme.

“Doctors that I’ve spoken with have said smoking anything, in their position, is not recommended. Others have said if there is someone for whom that is their preferred method of use, then, as long as they know that their patient is getting what they need and the patient is aware of the risk that they’re taking, they are fine with that.”

This regulatory stance has drawn criticism from some patients who prefer the rapid onset provided by smoking over other delivery methods like topical applications or oral consumption. 

Some medical experts have voiced concerns about the potential health risks of inhaling cannabis smoke. Critics counter that smoking for palliative care provides relief that far exceeds risk to a terminally ill patient. They argue that a paternalistic approach undercuts patient autonomy and the medical benefits that smoking can provide for certain conditions.

Despite the current prohibition, Roberts-Odle noted that many patients, particularly those in palliative care, prefer smoking as a method of administration, sharing that they are “disappointed that they’re not allowed that avenue at this point in time”.

Anaesthesiologist Dr Adrian Waterman acknowledged the appeal of smoking cannabis due to its quick onset of action, crucial for those seeking immediate relief. But he raised concerns about potential lung damage from tar and other particulates in smoke.

“I can understand why some patients will like that route of administration because, especially in the past, it was a much easier route because the plant, basically the raw product, was [involved]…. People would say that it was a faster route of administration and they liked that,” he said.

“Today, with therapeutic development, they have found ways to administer the chemicals in cannabis, whereby we don’t have to use the inhalation route as much to get a faster onset of action.

“Doctors will tell you, especially in the pulmonary field, that they are very concerned when people smoke and that travels into the lungs.”

Roberts-Odle countered by distinguishing between recreational and medicinal cannabis usage, noting that medicinal cannabis typically does not contain additives like “fanta” used in recreational smoking.

“Generally, the tar comes from the additional things that you put in it,” she said. “For medicinal cannabis, what is actually being smoked is just the cannabis… you don’t add ‘fanta’ and those kinds of things.” 

She also addressed the risk of public smoking and secondhand exposure, stating that if legal, there would need to be restrictions on where medicinal cannabis could be smoked to prevent exposure to non-users.

Pharmacist David Workman, another guest, suggested an alternative rapid-relief method without smoking risks: “Drops or a spray under the tongue where there is a rich blood vessel supply and allows for rapid absorption. I can’t say it’s going to be as fast, but it’s going to be fairly quick.”

Roberts-Odle shed light on patient-specific treatment plans, noting that legislation does not restrict what doctors can prescribe medicinal cannabis for, as “its usage continues to grow and your doctor knows you.”

“They’re able to make an informed decision on whether this is good for you and so we have not restricted the kinds of things that they can prescribe you medicinal cannabis for,” she added.

So far, the BMCLA chief revealed, the drug has treated patients with epilepsy, pain, muscle spasms and anxiety. Underscoring responsible usage, she said: “The same way we have to be responsible with any kind of other medicine that we’re using, medicinal cannabis would have to be under those kinds of context as well… everything in moderation and in the correct usage patterns.” (SM)

The post Debate flares over smoking medicinal cannabis appeared first on Barbados Today.

FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

"The prevalence of IBD continues to increase, and many people living with ulcerative colitis and Crohn's disease do not respond to current therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "AbbVie's mission to raise the standard of care includes the pursuit of transformative therapies that help more patients living with autoimmune diseases achieve remission. We look forward to our collaboration with FutureGen in advancing development of FG-M701 for the treatment of IBD."

"We are very pleased to partner with AbbVie, a world-leader in the development and commercialization of innovative inflammation and autoimmune therapies," said Zhaoyu Jin, Ph.D., founder and chief executive officer, FutureGen Biopharmaceutical (Beijing) Co., Ltd. "We believe that AbbVie is a great partner, with the ability to apply their expertise and global scale to realizing FG-M701's therapeutic potential and rapidly advancing this therapy for patients suffering from IBD. The collaboration with AbbVie also highlights FutureGen's ability to generate potential best-in-class product candidates with our proprietary Structure-based Targeted Evolution Platform (STEP) technology platform."

Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments and will be eligible to receive up to an additional $1.56 billion in clinical development, regulatory and commercial milestones, as well as tiered royalties up to low-double digits on net sales.

FutureGen has developed the proprietary STEP by integrating structural biology, advanced antibody engineering, and AI technologies to enable highly efficient, rapid and high-throughput drug screening and optimization. FutureGen has utilized STEP to develop CLDN18.2 antibody-dependent cellular cytotoxicity (ADCC) enhanced antibody (FG-M108), a potential best-in-class product with excellent efficacy and superior safety in the first-line treatment of advanced G/GEJ and pancreatic cancer, currently in Phase 3. Additionally, FutureGen possesses several innovative multi-specific antibodies and antibody-drug conjugates (ADC) for immuno-oncology therapy, including a CD40-PDL1 bi-specific antibody in clinical stage. 

Read also: AbbVie concludes acquisition of Landos Biopharma

St James will be the only parish visited this week when the Ministry of Health and Wellness continues its fogging programme.

On Monday when the team from the Vector Control Unit makes its first stop, Lancaster, Endeavour with Avenues, Apes Hill Development, and environs will be sprayed.

A return to that parish on Tuesday will see fogging at Wanstead Terrace 1 to 11 Avenues, Oxnards, Oxnards Heights, and surrounding areas.

The following day, Wednesday, fogging will occur at Oxnards Heights, Desert Rose Ridge, Wanstead Gardens Heights, Rose Drive, Lily Drive, Alamanda Drive, Carnation Drive, Begonia, Daisy Drive, and environs.

On Thursday the Unit will visit Independence Drive, Trident Avenue, Sugar Cane Avenue, Pelican Avenue, and neighbouring districts.

The exercise culminates on Friday in Blue Bell Drive, Croton Drive, Orchid Drive, and environs.

Fogging of districts will run from 4:30 p.m. to 8:30 p.m., each day. Householders are asked to assist in the control of the Aedes aegypti mosquito by opening all windows and doors to allow the fog to enter. Persons with respiratory problems are asked to protect themselves from inhaling the fog.

Pedestrians and motorists should proceed with caution when encountering fogging operations on the street and parents are instructed to prohibit children from playing in the fog or running behind the fogging machine.

Members of the public are advised that the completion of scheduled fogging activities may be affected by events beyond the Unit’s control. In such circumstances, the Unit will return to affected communities as soon as possible. (PR)

The post Fogging in St James this week appeared first on Barbados Today.