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Thursday, Oct 14 2021

Full Issue

Some US Blood Pressure Drugs Found With Cancer-Linked Azido Impurities

Another potentially dangerous chemical has turned up during investigations into impurities in blood pressure pills: Azido impurities are linked to DNA damage and potential cancer risks. In other news, Apple is investigating how its AirPods headphones could be used as a health sensor device.

Over the past three years, millions of blood pressure pills that contain a probable carcinogen have been recalled around the world. As pharmaceutical companies have worked on finding a fix, they鈥檝e discovered an entirely new problem: Another potentially dangerous chemical is showing up in the same drugs. The new chemicals are called azido impurities and regulatory authorities say they鈥檙e mutagenic, meaning they can change someone鈥檚 DNA and potentially increase cancer risk. (Edney, 10/13)

In other pharmaceutical and biotech news 鈥

Apple Inc. is studying ways to make AirPods into a health device, including for enhancing hearing, reading body temperature and monitoring posture, according to documents reviewed by The Wall Street Journal and people familiar with the plans. The plans further demonstrate Apple鈥檚 ambition to add health and wellness features to devices beyond the Apple Watch, where most of the company鈥檚 health functions exist today. Apple is also working on technology that aims to use iPhones to help diagnose depression and cognitive decline, the Journal reported last month. (Winkler, 10/13)

In an unusual bid to address prescription drug costs, Pfizer (PFE) is promising to offer warranties for its Xalkori lung cancer treatment and will refund the entire cost to any patient and health plan if the medication fails to work within the first three months. The drug maker last June quietly began what it calls a pilot program, which runs through the end of this year, for anyone who is covered by Medicare or commercial insurance, or pays by cash. Called the Pfizer Pledge, the program has escaped notice because the company has, so far, not publicized the effort beyond describing the details on its web site. (Silverman, 10/13)

Before the pandemic, Taj Pharmaceuticals Ltd. shipped negligible amounts of ivermectin to Russia for veterinary use. But over the past year it鈥檚 become a popular product for the Indian generic drug maker: Since July 2020, Taj Pharma has sold $5 million worth of the pills for human use in India and overseas. That鈥檚 a bonanza for a small family-owned company with an annual revenue of about $66 million. Sales of the drug, which is primarily approved to treat diseases caused by parasites in livestock and humans, have surged around the world as anti-vaccine propagandists and others tout it as a Covid-19 cure. They claim it could end the pandemic if only people like Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, would open their eyes to it. 鈥淲e are working 24/7,鈥 says Shantanu Kumar Singh, Taj Pharma鈥檚 30-year-old executive director. 鈥淭he demand is huge.鈥 (Einhorn and Kay, 10/13)

Ten months into his tenure, President Biden has yet to nominate anyone to helm the Food and Drug Administration. But key new details about who鈥檚 helping to handle the interviews and which candidates have taken meetings shed some light on where the process stands. Biden himself kicked off wide speculation about who might direct the agency last week, when he told reporters that he鈥檇 weigh in on a nominee for the agency 鈥渋n a little bit.鈥 Throughout his presidency, Acting Commissioner Janet Woodcock, an agency veteran, has been at the helm. It鈥檚 not clear whether she鈥檒l be nominated to take on the role herself, but in the meantime, the White House has vetted an array of other candidates. (Florko, 10/14)

And in updates on the Theranos trial 鈥

The former chief financial officer of Walgreens took the stand for his first full day of testimony at the trial of Theranos founder Elizabeth Holmes, a key government witness in the case surrounding the failed blood-testing start-up. Wade Miquelon told prosecutors that Theranos impressed the company with its plans for in-store blood testing and technological promises surrounding its apparently state-of-the-art device that could deliver test results in 30 minutes. Company executives were so impressed that Walgreens poured $140 million in the venture 鈥 $40 million of which could be converted to equity. (Siddiqui, 10/13)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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