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New Experimental Pill Offers Hope For People With Advanced Pancreatic Cancer 

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A new novel pill is reportedly helping people with advanced pancreatic cancer, one of the deadliest, live longer, according to new research recently published in the New England Journal of Medicine and presented at the American Society for Clinical Oncology (ASCO).

“While not curing the cancer, it is a very large step forward,” said Dr. Zev Wainberg of the University of California, Los Angeles, who helped lead the study. 

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The new drug is called daraxonrasib, and it works by blocking a mutated protein that fuels tumor growth in over 90% of pancreatic cancer cases. Pancreatic cancer is also known for being very deadly with very little viable treatment options. 

The pills are meant to be taken daily and have shown to nearly double one’s survival time with fewer side effects in a study that randomly assigned the experimental drug or more chemotherapy to 500 patients with metastatic cancer that have stopped responding to other treatments, according to reports from AP. 

The research showed that those who took daraxonrasib lived for an average of 13.2 months compared with 6.7 months for chemotherapy recipients. Dr. Wainberg said while this may seem like a small improvement, it marks the first drug to show a substantial advantage over chemotherapy. 

“Having treated pancreatic cancer for 16 years, I actually started crying when first seeing the study results,” Dr. Rachna Shroff of the University of Arizona Cancer Center, said at the ASCO meeting. 

“[I was struck by how] patients stayed on this treatment because it was providing a durable and meaningful benefit to them.”

The pills’ effects eventually decrease but those taking it for significantly longer than the chemotherapy group reported less pain and a better quality of life. Many continued to use the medications after the data was analyzed. Dr. Wainberg stated this means the survival gap may widen as researchers continue to track them. 

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Dr. Brian Wolpin, of the Dana-Farber Cancer Institute, presented the findings and said “the drug should become a new standard of care” for previously treated metastatic pancreatic cancer. Researchers also will explore its use earlier in the disease, including to see if tumor shrinkage might let more patients qualify for surgery,” AP reported. 

He also said the side effects most likely to impact the treatment course were a rash that can become severe and mouth sores. 

The Food and Drug Administration is planning to expedite their review of the drug because of its success. It was developed thanks to funding from Maker Revolution Medicines. The agency is granting “expanded access” to the drug for patients who meet the criteria. 

Pancreatic cancer is one of the most deadly forms due to the fact that it’s hard to detect before it starts spreading throughout the body. The American Cancer Society estimates around 67,000 new cases will be diagnosed in the US this year with more than 52,000 people dying from the disease. 

Pancreatic cancer is also harder to treat and doesn’t respond to chemotherapy the same way other cancers do. This drug is leaving a lot of experts very optimistic about the future of treating this deadly disease, as well as other cancers.

melatonin

Study Links Long-Term Melatonin Use to Higher Risk of Heart Failure

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A large-scale study reviewing health records of more than 130,000 adults with chronic insomnia has found that people who took prescribed melatonin for over a year were more likely to develop heart failure within five years than those who didn’t use the supplement, according to findings announced Monday by the American Heart Association (AHA).

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covid

Covid-19 Vaccine Accessibility: What You Need To Know About New Restrictions For Receiving Immunizations 

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The Food and Drug Administration recently announced that it has removed the emergency use authorizations for Covid-19 vaccines. Now, only certain populations in the US will have access to the new shot starting this fall.

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FDA Approves Twice-A-Year Injection For Preventing HIV 

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A drug that is currently being used to treat certain HIV infections was recently approved by the US Food and Drug Administration (FDA) to be used to prevent HIV. Lenacapavir is the name of the drug made by Gilead Sciences, which will be distributed under the brand name Yeztugo. 

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candy

FDA To Phase Out Artificial Food Dyes In US Food Supply By The End Of The Year 

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The US Food and Drug Administration announced this week that they’re planning on phasing out the use of petroleum-based synthetic dyes in food due to ongoing health concerns.

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chickens

FDA Reports Over A Dozen Cats Sick Or Dead From Bird Flu In Raw Food 

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According to the US Food and Drug Administration (FDA), bird food found in raw food has killed or infected more than a dozen house cats throughout America. 

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The FDA said in a statement to CBS that the administration was “aware of reports of death or illness associated with uncooked food in 13 domestic cats in eight households, 1 exotic cat in one household, and an unknown number of animals at two sanctuaries for large felids.”

CBS also reported that the FDA informed them that cases were found in Colorado, California, Washington, and Oregon. 

The FDA has issued a statement to cat and dog food manufacturers as well. They warned manufacturers who use uncooked or pasteurized materials from both cattle or poultry to keep the H5N1 bird flu in their food safety plans. 

The FDA explained that the bird flu virus can be transmitted to cats and dogs when they eat food products made from infected poultry or cattle. Unpasteurized milk, uncooked meat, or unpasteurized eggs are some of the biggest culprits when it comes to transmitting the virus.

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Dogs, on average, display much more mild clinical signs and symptoms and have lower mortality when infected. In cats, the virus can unfortunately lead to severe illness or death. 

The initial outbreak of the H5N1 virus in the US began last March when it was found in dairy cattle in both Texas and Kansas. 

Last year, twelve barn cats died after they drank infected raw milk and in December 20 exotic cats, including a Bengal tiger, four cougars, and four bob cats died at an animal sanctuary in Washington. 

In a study published last year in the academic journal Emerging Microbes and infections, “cat H5N1 genomes had unique mutations that could suggest potential virus adaptation. It found cats could serve as mixing vessels for reassortment of avian and mammalian influenza viruses as well as a bridge to infect other species,” according to the Guardian. 

Since the initial outbreak more than 20 million hens have died along with 134 million birds across the poultry industry being impacted, according to a report from the US Department of Agriculture.

mcdonalds

McDonald’s Resumes Selling Quarter Pounders After E. Coli Outbreak

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McDonald’s has resumed selling Quarter Pounders in all their restaurants this week after a recent E. coli outbreak was found in the burgers. 

The US Centers for Disease Control and Prevention (CDC) first issued a food safety alert the other week, warning that dozens of individuals were becoming sick after eating the Quarter Pounder sandwich at the famous fast food chain. 

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The E. coli outbreak has led to at least 75 individuals falling sick throughout 13 states, a majority of which were in Colorado. 22 individuals were hospitalized and one individual died, according to the CDC.

While a specific ingredient wasn’t confirmed to be the source of the E. coli outbreak, the US Food and Drug Administration stated that the slivered onions and/or beef patties themselves were most likely the cause of the contamination. 

“Evidence does not point to ground beef as the probable source of the E. coli outbreak,” said the US Department of Agriculture’s Food Safety and Inspection Service.

“FSIS has conducted a thorough investigation in response to this outbreak, including traceback of beef patties served on Quarter Pounders at McDonald’s,” the agency said in a statement, according to CNN. 

“FSIS used specific meal information reported by ill people to trace beef patties through the supply chain to the establishment where they were produced and did not identify a beef source.”

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The Colorado Department of Agriculture said that “McDonald’s beef patties used for the Quarter Pounder tested negative for E. coli. The department tested fresh patties from restaurants associated with the outbreak.”

“Based on the findings from that testing and after comparing CDC data with its own supply chain data, McDonald’s is confident in ruling out fresh beef patties as a source of contamination,” they in a Sunday news release.

“It’s now asking beef suppliers to produce a new supply of fresh beef patties, and the Quarter Pounder is expected to be available in all restaurants in the coming week,” the release said.

“Onion supplier Taylor Farms’ Colorado Springs facility will resume sales of Quarter Pounders without slivered onions,” the release added. 

“Those restaurants are in Colorado, Kansas, and Wyoming, as well as portions of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico, Oklahoma, and Utah,” it said.

“I know that our relationship is built on trust. You trust us to serve you safe food every time,” McDonald’s US President Joe Erlinger said in a video.

“On behalf of the McDonald’s system, I want you to hear from me: we are sorry,” Erlinger added.

“For those customers affected, you have my commitment that, led by our values, we will make this right.”

milk

FDA Says Traces Of Bird Flu Found In 1 In 5 Samples Of Pasteurized Milk 

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The Food and Drug Administration (FDA) has stated that 1 in 5 samples of retail milk contains traces of the highly contagious bird flu. They also said that these findings may not be an indicator of an infectious risk to consumers, according to reports from The Hill. 

The FDA has been publishing updates throughout the week, and just recently shared some of the biggest takeaways from their nationally representative commercial milk sampling study. 

“The agency continues to analyze this information; however, the initial results show about 1 in 5 of the retail samples tested are quantitative polymerase chain reaction (qPCR)-positive for [Highly Pathogenic Avian Influenza] viral fragments, with a greater proportion of positive results coming from milk in areas with infected herds,” the FDA stated. 

The Administration continued to state that additional testing will be required in order to determine whether or not intact pathogens of the bird flu are present in the milk and if those who consume it would be at risk of infection. 

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“To date, the retail milk studies have shown no results that would change our assessment that the commercial milk supply is safe. The pasteurization process that retail milk undergoes as well as the diverting and destroying of milk from infected cows,” the agency shared.

They also re-emphasized their long-standing warnings against drinking raw milk. Earlier this year, a worker on a dairy farm in Texas became infected with the bird flu after working closely with cows that were later found to be infected with the highly infectious H5N1 strain of the bird flu. 

According to William Schaffner, professor in the division of infectious diseases at the Vanderbilt University School of Medicine, “pasteurization should kill the virus and people generally shouldn’t be too concerned about buying milk from a grocery store.”

“A bird flu virus can pick up the capacity to spread readily from person to person. This is a rare event, every 15 years or so. There’s no indication that the current bird flu virus has picked this up but it’s out there circulating,” Schaffner told The Hill.

wegovy

US FDA Approves Weight-Loss Drug Wegovy To Be Marketed For Heart Health Benefits 

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The US Food and Drug Administration (FDA) approved an application from drugmaker Novo Nordisk that allows the weight loss drug Wegovy to add cardiovascular benefits to the medicine’s label, according to CNN. 

This marks the first weight-loss drug to be marketed to reduce the risk of heart attack, stroke, or heart-related deaths in people who are at higher risk for cardiovascular issues and/or events. 

The addition to the label may improve some insurance coverage for Wegovy; the “sister drug” to Ozempic. The drug currently costs around $1,300 per month out of pocket, and many insurers don’t cover weight loss drugs. 

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“The evidence is that they reduce risk and save lives – and so it is indefensible to deny people access, or make it difficult for people to access, medications that will directly improve their health,” Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital, said Friday. 

“The point is that these drugs are not about appearance but about health. By treating obesity, we know we can reduce cardiovascular risk, and that may be only a part of the benefits that accrue.”

The approval occurred after a study involving 17,000 patients. The study, according to reports, showed that the patients who took Wegovy had a 20% lower risk of having a cardiac event than those who took the placebo. 

Wegovy is meant to be used for individuals who are considered to be obese or overweight, meaning they have a body mass index of anything between 27 – 30, as well as have a weight-related health condition such as high blood pressure or high cholesterol. 

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” Dr. John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, said in a news release.

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“This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

The trial performed prior to this classification was done with patients with cardiovascular disease. They’ve either previously had a heart attack, stroke, or symptoms of peripheral artery disease: which is when one has clogged arteries in their arms or legs. 

Wegovy, however, has and is in a shortage currently, and drugmakers are struggling to keep up with the demand. Novo Nordisk released a statement last month that stated it would be gradually increasing the supply over this course of this year.

“The shortages are really, really bad right now,” Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, said Friday. 

“[I hoped] the expanded approval would improve insurance coverage, particularly as generic weight-loss drug alternatives can carry heart risks, but if insurance comes on board with this indication, [I have] no idea how manufacturing will ever catch up,” she said. 

Dushay added, “this might also help prioritize use of [the drugs] among those with highest-risk obesity, those who also have cardiovascular disease.”

vaping

FDA Orders Juul To Stop Selling E-Cigarette Products

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On Thursday, federal health officials from the Food and Drug Administration (FDA) ordered Juul to remove its electronic cigarettes from the U.S. market as it continues to battle against the popular and addictive products that have seen high usage amongst teen groups.

Under the ruling, Juul cannot sell its e-cigarette device, along with its four kinds of tobacco and menthol-flavored Juul pods. It’s a move that dates back to April, when the FDA gained the ability to regulate e-cigarettes and other products that utilize synthetic nicotine.

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“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf, MD, said.

“We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

The ban only affects the commercial distribution, importation, and retail sales of Juul’s products and not those currently owned and used by a consumer. Juul had previously sought approval from the FDA in regards to its device and pods.

However, the FDA noted that Juul lacked “sufficient evidence” regarding the toxicological profile of their products in order to show their marketing would be appropriate for public health. Additionally, Juul’s studies also raised questions due to conflicting data — particularly in regard to genotoxicity and potential chemicals leaking from their pods — that were not addressed.

While the FDA said it didn’t receive any information that suggests an immediate hazard associated with using Juul products, their ban shows that the lack of health data played a critical part in the regulatory process.

E-cigarettes have become a staple of the country’s current youth. According to the Center for Disease Control (CDC), a 2021 survey found that 43.6% of high school students and 17.2% of middle school students reported using e-cigarettes on 20 or more of the last 30 days. One in four high schools smoke e-cigarettes daily, while that number is one in 12 for middle schoolers.

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The study also found that 53.7% used a disposable device, while 28.7% used a prefilled or refillable pod or cartridge device. Juul was found to have been the fourth-most used brand among students at 6.8% (130,000) behind Puff Bar, Vuse, and SMOK.

It’s another blow for a company that has often been blamed for starting the e-cigarette epidemic. It’s seen its total revenue fall from $2 billion in 2019 — when it possessed 600,000 daily users under 21 — to $1.3 billion in 2021, while its market share has endured similar falls.

That decline in sales can also be attributed to the FDA, which banned flavored e-cigarettes in 2018. Altria, which purchased a 35% stake in Juul Labs for $12.8 billion in 2018, already felt the heat in the form of a 10% stock drop Wednesday. This year, Altria values that stake at $1.6 billion, just 13% of their original purchase.

Meanwhile, the FDA will continue to review and regulate other e-cigarette products, many of which have never been through the application process before. The administration previously stated it’s reviewing 6.5 million applications from 500 companies, and have already rejected over 950,000.