Month: October 2022

On Wednesday, advisory panel to the Food and Drug Administration recommended taking Makena, a drug for preventing premature births, off the market due to doubts about the drug’s effectiveness. Makena was fast-tracked 11 years ago to cut the risk of preterm birth, a leading cause of infant mortality.

The 14-1 vote by the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee was taken after a hearing to determine  whether the drug was effective, whether trial data support its approval and whether the drug should remain available on the market.  Peter Stein, the director of the FDA’s Office of New Drugs at the Center For Drug Evaluation and Research said in closing remarks at the hearing: “Hope is a reason to keep looking for options that are effective, whether we find them here or elsewhere … Hope is not a reason to take a drug that is not shown to be effective, or keep it on the market.”

A 2003 study cited by CovisPharma, the maker of Makena, showed Black newborns are more than twice as likely to die as White newborns when born before 37 weeks. Covis argued that pulling the drug from the market would hurt Black women. In a statement earlier this year about the drug, Covis Pharma said it wanted to work with the FDA to do more research on Makena.

Formally taking Makena off the market will be left to the FDA, which could make its decision within a few months. If FDA follows the advisory committee’s advice, it would be the first time in a decade that a fast-tracked drug would be pulled from the market.

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The North American Aerospace Defense Command said in a statement that the U.S. Air Force dispatched two F-16 fighter jets to intercept a pair of Russian bombers that flew close to Alaska on Monday.  The two Russian Tu-95 Bear-H bombers did not enter American or Canadian sovereign airspace, however, NORAD said that it “detected, tracked, positively identified and intercepted” the aircraft as they were “entering and operating within the Alaskan Air Defense Identification Zone.”  NORAD, a combined air defense organization of the United States and Canada, said the Russian activity was “not seen as a threat nor is the activity seen as provocative.” According to the Federal Aviation Administration, Air Defense Identification Zones are areas of airspace that require all aircraft to be identified, located and have their flight plan controlled “in the interest of national security.”

Tensions between the United States and Russian are high since Russia invaded Ukraine, which the U.S. has supported with humanitarian and military aid while slamming Moscow with economic sanctions.  Russians escaping the partial draft have arrived on the shores of Alaska on at least one boat, and Russian officials have also made veiled threats toward the state. Vyacheslav Volodin, the chairman of the state Duma, said that the U.S. should remember that Alaska was once part of Russia and that it could be forced “to give back” territory.  He noted that his deputy, Pyotr Tolstoy, had previously proposed holding a referendum in Alaska.

NORAD emphasized in a statement the numerous protections it maintained for Alaska and the U.S., which include “a layered defense network of satellites, ground-based radars, airborne radar and fighter aircraft to track and identify aircraft and inform appropriate actions … We remain ready to employ a number of response options in defense of North America and Arctic sovereignty.”

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Police confirmed that a Virginia man was arrested Tuesday on murder and weapons charges in the killings of four of his housemates.  The suspect, 24-year-old David Maine, faces four counts of murder and two counts of use of a firearm in the commission of a felony stemming from the quadruple homicide that took place in the Washington DC suburb of Woodbridge on Monday.  Maine is being held in jail without bail.

The Prince Williams County Police Department responded to a report of a shooting at a home at around 4:30 p.m.  Officers found the doors unlocked and entered the home, where they discovered four lifeless bodies in different parts of the residence. Three of the victims were family members who were identified Tuesday as Miguel Flores, 44, his wife, Kelly Sotelo, 42, and their daughter, 19-year-old Karrie Sotelo. The fourth victim, 36-year-old Richard Revollar Corrales, was a tenant who was renting the basement at the home.  Authorities said three of the victims were shot, while the death of the fourth remains undetermined. Maine, who also lived at the home, knew all of the victims.

Prince William County Police Chief Peter Newsham said at a press conference on Tuesday that Flores and Kelly Sotelo had recently gotten married.  He did not reveal what may have prompted Maine to allegedly kill his housemates, saying: “We’re still trying to nail down the motive in the case but the only word I can use to describe this is senseless. Absolutely senseless that anyone would take four lives the way that they did.”

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Okmulgee Police Department in Oklahoma have confirmed that four dismembered bodies recovered from a river on Friday belonged to a group of missing men.  Authorities say they are searching for a person of interest following their murders.

On Monday police Chief Joe Prentice confirmed the bodies of four men pulled from the Deep Fork River, Southwest of the city of Okmulgee, on Friday belonged to Mark Chastain, 32; Billy Chastain, 30; Alex Stephens, 29; and Mike Sparks, 32, who were reported missing overnight last Monday. The cause of death for the men is still pending, but police confirmed all four had gunshot wounds and their bodies were dismembered before they were dumped into the river. Prentice could not specify when exactly the bodies were placed in the river but guessed somewhere between late Sunday night or early Monday morning.

The four men were close friends, and were believed to have left Billy Chastain’s home in Okmulgee Sunday night by bicycel. Investigators believe that the men planned to commit some kind of criminal act when they left a residence, but added they do not know where or what the men planned to d.  Investigators found evidence of a “violent event” on an adjoining property to a salvage yard the police had initially searched.  While police have not named a suspect, they said Joe Kennedy, owner of two salvage yards, is considered a person of interest. Kennedy was reported missing Saturday night and may be suicidal. He is believed to be driving a Chrysler with Oklahoma license plate number LSA245.  Police chief Prentice said that no charges have been filed against Kennedy but “investigators would like to speak with him again.”

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Hearing aids can now be purchased without a prescription or medical exam from Walgreens, CVS, Walmart and Best Buy. The Food and Drug Administration issued a rule in August that allowed over-the-counter sales of hearing aids for adults ages 18 and older with mild to moderate hearing loss. People with severe hearing loss and children still need prescriptions for the devices. President Joe Biden issued an executive order in 2021 directing the Health and Human Services Department and the FDA to develop a rule allowing over-the-counter sales of hearing aids.

On Monday, Walgreens started selling over-the-counter hearing aids online and at its stores nationwide for $799 a pair. By comparison, the average cost of prescription hearing aids can range between $2,000 and $8,000. CVS is selling over-the-counter devices on its website with prices ranging from $199 to $999, and will also start offering them at select pharmacy locations beginning in November.

Walmart is selling over-the-counter hearing aids online and in stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee and Texas; according to the company, the devices will be available at additional locations nationwide with prices range from $199 to $999 depending on the device. Best Buy is selling 20 different over-the-counter hearing aids online with prices ranging from $200 to $3,000; the electronics retailer will offer the devices in 300 stores across the country later this month.

According to the FDA, an estimated 30 million people in the U.S. have hearing loss, but only about one-fifth of these individuals have hearing aids. Many people who could benefit from the devices cannot access them due to cost.

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