The First Generic EpiPen Just Received FDA Approval

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iStock

For people with severe allergies, having an EpiPen on hand could mean the difference between life and death. But that safety net comes at a high price: In the past decade, the cost of the brand-name drug has risen by more than 400 percent, with a set of two pens selling for $600. Now, CNBC reports that patients can finally get the treatment they need for a more reasonable amount of cash: The FDA has approved a generic version of Mylan's EpiPen, making it the first direct generic competitor to the brand-name medication.

Teva Pharmaceutical's versions of both the EpiPen and EpiPen Jr. will work like the originals, with an injector delivering epinephrine, a chemical that opens the airways, into the bloodstream of someone suffering an allergic reaction. Similar generics have been made commercially available in the past: In 2016, Mylan introduced a cheaper version of its own product at $300 for a two-pack, and in 2017 CVS started selling an EpiPen alternative for $110. Teva's drug is different, though. It's a direct generic copy of the EpiPen, which means pharmacists will be free to offer it to patients who have been prescribed Mylan's product. A price hasn't been announced, but Teva's EpiPen could end up being significantly cheaper than Mylan's generic EpiPen, which could in turn bring down prices of the injector drug across the board.

The exorbitant price of the EpiPen has hit patients hard in recent years. Some EMTs have even started loading epinephrine into syringes manually rather than paying for the drug-injector combo. Though the drug itself isn't protected by a patent, the design of the EpiPen device is difficult for competing pharmaceutical companies to replicate, which has allowed Mylan to charge whatever it can for the product.

In 2017, the FDA tweaked its guidelines to make it easier for generic EpiPen competitors to receive market approval, even if the design of the new injector differed slightly from the original. With the approval of Teva's auto-injector made official, more EpiPen generics could soon start appearing behind pharmacy counters.

[h/t CNBC]

The Phony Disease That Helped Researchers Identify Bach's (Purported) Body

Rischgitz/Getty Images
Rischgitz/Getty Images

Three days after Johann Sebastian Bach died from a stroke in July 1750, his body was laid in an oak coffin and hauled to a cemetery outside the city walls of Leipzig, Germany. Like many burials back then, no headstone was placed to mark Bach’s plot. Within years, the exact location of the composer’s grave had faded from memory.

Bach died a respected musician, but was by no means a superstar. That would change over the coming decades: An 1802 biography about his life—as well as a burgeoning interest in the musical works of the past—would launch him to the top of the newly formed classical music canon. Bach grew to become a source of national pride, and musical pilgrims worldwide were hungry to visit his grave to pay him homage. In 1894, a group set out to find where, exactly, he was buried.

Rumor suggested that Bach’s corpse lay six paces from the south door of St. John's Church, but nobody was certain. “The oral tradition apparently originated in 1894 from a 75-year-old man, who in turn was informed about the location 60 years earlier by a 90-year-old gardener employed at the graveyard,” write Richard H.C. Zegers and several other scholars in the Medical Journal of Australia [PDF]. That same year, Pastor F. G. Tranzschel, the vestry chairman at St. John’s, ordered an excavation based on that information.

Dr. Wilhelm His Sr., a Leipzig professor of anatomy, served as the dig’s leading egghead. As workers dug into the slop and mud of the church graveyard, His inspected the skeletons to see if the bones resembled those of a 65-year-old man. He described the scene as “heaps of bones, some in many layers lying on top of each other, some mixed in with the remains of coffins, others already smashed by the hacking of the diggers.” (To say the least, this was not history’s most scientific excavation.)

Thankfully, there was one telltale sign to look for: Most of the coffins in the cemetery were pine, but Bach’s bones were supposedly entombed in a casket of pricey oak. The crew found at least three such coffins. One contained a young woman (definitely not Bach), a second contained remains that had been smashed to splinters (hopefully not Bach), and a third contained a beautifully preserved skull (Hallelujah?). In the words of musicologist and Bach expert David Yearsley at Counterpunch, Wilhelm His believed this skeleton “belonged to a man of distinction.” He studied the cranial cavity and even attempted to reconstruct the skull's face, later claiming in a book that this "strange skull of very distinct and by no means ordinary forms" belonged to J.S. Bach. Shortly after, the skeleton was laid in a crypt below the altar of St. John's Church.

But there was always a lingering doubt that His got it wrong. In 1949, Bach’s purported skeleton was exhumed and later reburied in St. Thomas Church in downtown Leipzig (where the composer once worked as Kapellmeister, or music director). Before this celebrated second burial, researchers decided to give the bones a second look. The skeleton was re-examined by the oral surgeon Wolfgang Rosenthal, who claimed to see proof of Bach’s identity not in the skull—but in a region, well, slightly south.

Rosenthal was intrigued by abnormal bony growths, called exostoses, around the skeleton’s pelvic ring, as well as growths at sites of muscle and ligament attachment, called enthesophytes, near the arms. Both are signs of occupational stress, common in physically active people who make repetitive motions day-in and day-out.

Rosenthal wondered: Could a lifetime of organ-playing cause somebody to develop these bony growths? After all, an organist must regularly make awkward, repetitive foot and arm movements—especially if he or she practices a lot. To test his hypothesis, Rosenthal x-rayed the hips of 11 professional organists organists who, like Bach, had been playing since childhood. In a paper published more than a decade later, he claimed that all of them showed signs of the same bony growths as Bach's purported bones. Rosenthal came away convinced that not only had he re-confirmed the identity of the skeleton, he had discovered a new medical ailment: Organistenkrankheit, or organist’s disease.

Unfortunately for Rosenthal and fans of weird diseases with fun German names, the surgeon may have been mistaken. In 2007, researchers at the Academic Medical Center of Amsterdam tried to replicate Rosenthal's experiment, this time adding a control group of non-musicians. According to their report in the Medical Journal of Australia, of the 12 church organists x-rayed, only 33 percent had growths near the pelvis. Damningly, 75 percent of the non-organ-playing control group also showed an incidence of bony hip growths.

While the researchers admitted that their sample size was small, their work does appear to throw a wrench in Rosenthal's hypothesis. “Our findings do not support the existence of Orgnistenkrankheit as a condition among organists,” the research team wrote. Furthermore, they concluded that "given the uncertainties about the burial site, His's controversial facial reconstruction, and Rosenthal's irreproducible Organistenkrankheit, it is unlikely that the remains are those of Bach." Evidence, it seems, that hips really can lie.

Should You Take a Daily Aspirin to Prevent Heart Disease?

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iStock

For decades, physicians have recommended that older patients or those who have had a cardiac event like a heart attack take a low-dose aspirin daily. Acting as a blood thinner, aspirin can help prevent blood clots from forming and causing more cardiovascular issues.

This wisdom was examined in a new study published in the New England Journal of Medicine, which looked at more than 19,000 elderly people and found no measurable benefit to the practice for people aged 65 and over. Worse, aspirin may actually cause harm by increasing the risk of bleeding.

So, who should be taking aspirin as a preventative measure, and when?

The most recent study, which began in 2010 and followed subjects 65 and older with no prior cardiovascular disease taking either 100 milligrams of aspirin daily or a placebo, found that the risk of bleeding in the stomach or brain was increased in those taking aspirin (3.8 percent in the aspirin group versus 2.8 percent in the placebo group). The rate of disease-free survival among subjects was no higher among those taking aspirin compared to those on the placebo.

Aspirin has been shown to help some patient populations, however. For people who have already suffered a heart attack or stroke, aspirin can reduce the risk of a recurrence. According to the U.S. Preventative Services Task Force, adults aged 50 to 59 who have a 10 percent or greater chance of developing cardiovascular disease, typically as the result of lifestyle, genetic, and dietary factors, will likely benefit from a daily dose. As that patient population ages and risk of bleeding increases, it becomes a risk-to-benefit assessment. The task force found insufficient information for aspirin use to prevent cardiovascular disease in people under age 50.

The American Heart Association and the American Stroke Association both recommend aspirin to decrease cardiovascular events in patients with risk as low as 6 percent over a 10-year period. For adults with only average risk, no medical authority currently recommends the regimen.

As with any medical issue, it’s best to consult with your doctor about taking aspirin to prevent cardiovascular disease. Only your specific medical history can help determine whether it’s right for you. And if you're currently taking aspirin and have concerns based on the newest research, don't stop taking it until you've had a chance to discuss it with your provider.

[h/t NPR]

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