In 2005, the reclassification of pseudoephedrine to behind-the-counter status led to widespread use of oral phenylephrine in OTC decongestants, despite evidence of its ineffectiveness. Randy Hatton, a clinical professor in the College of Pharmacy at the University of Florida, and his colleague worked to bring this issue to the FDA’s attention, revealing loopholes in the regulatory process for older OTC drugs. Hatton writes in an opinion piece for Scientific American: Before the FDA required that drugs had to be proven effective, it determined whether OTC drugs were effective through expert panels that reviewed existing data. These OTC monographs establish what older OTC ingredients can be marketed without FDA approval. The oral decongestant monograph panel reviewed a few published studies and multiple unpublished studies for phenylephrine. Of the unpublished studies, only four studies showed oral phenylephrine was effective, while seven showed it was no better than placebo. We requested copies of all evidence used by the nasal decongestant review panel via a Freedom of Information Act request and performed a systematic review and meta-analysis ourselves. […]

The FDA has multiple regulatory processes for different types of medicinal compounds. People are perhaps most familiar with the New Drug Application process, which leads to clinical trials for prescription drug approvals. However, many OTC or nonprescription drugs are regulated differently. In fact, a law passed in 1951, the Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act, created the categories of prescription and nonprescription drugs. In 1962, the act was amended again so that drugs had to be shown to be effective, hence the requirement for well-done clinical trials. But what about the drugs that were approved before 1962? This is the loophole that some OTC drugs fall through. For prescription drugs, FDA tried to address pre-1962 approvals through a review of over 3,000 prescription drugs. Most of those drugs have now been reviewed and addressed, but there are still unapproved prescription drugs on the market today, such as an extended-release form of oral nitroglycerin. For nonprescription drugs, FDA established the OTC monograph process 10 years after the 1962 amendment to the Food, Drug, and Cosmetic Act, which required products not proven effective to be reconsidered. FDA formed advisory panels grouping hundreds of ingredients into 26 categories based on the products’ uses. After gathering all available information, both published and unpublished, from manufacturers, the advisory panels issued final reports to FDA about whether these ingredients were GRASE (generally recognized as safe and effective), not GRASE, or inconclusive. GRASE ingredients can be used in nonprescription drugs without FDA approval if the use matches the monograph. “The oral phenylephrine example shows that FDA needs more funding to look at these old drugs,” concludes Hatton. “We need public funds to support independent researchers who want to examine these products objectively. The government should be able to spend millions to save consumers billions on ineffective products. Companies that market these products have no incentive to prove they don’t work. Nonprescription drugs must be effective — not just safe.”

Read more of this story at Slashdot.

Source: Slashdot – How Two Pharmacists Figured Out That Decongestants Don’t Work

An anonymous reader quotes a report from the Los Angeles Times: It was the late 1980s when Gary Mund felt his pinky tremble. At first it seemed like a random occurrence, but pretty quickly he realized something was seriously wrong. Within two years, Mund — a crew worker with the Eastern Municipal Water District in Riverside County — was diagnosed with Parkinson’s disease. The illness would eventually consume much of his life, clouding his speech, zapping most of his motor skills and taking away his ability to work and drive. “It sucks,” said Mund, 69. He speaks tersely, because every word is a hard-won battle. “I was told the herbicide wouldn’t hurt you.”

The herbicide is paraquat, an extremely powerful weed killer that Mund sprayed on vegetation as part of his job from about 1980 to 1985. Mund contends the product is responsible for his disease, but the manufacturer denies there is a causal link between the chemical and Parkinson’s. Paraquat is manufactured by Syngenta, a Swiss-based company owned by the Chinese government. The chemical is banned in at least 58 countries — including China and Switzerland — due to its toxicity, yet it continues to be a popular herbicide in California and other parts of the United States. But research suggests the chemical may cross the blood-brain barrier in a manner that triggers Parkinson’s disease, a progressive, neurodegenerative disorder that affects movement. Now, Mund is among thousands of workers suing Syngenta seeking damages and hoping to see the chemical banned.

Since 2017, more than 3,600 lawsuits have been filed in state and federal courts seeking damages from exposure to paraquat products, according to Syngenta’s 2022 financial report (PDF). […] Paraquat is 28 times more toxic than another controversial herbicide, Roundup, according to a report from the Pesticide Action Network. (Roundup has been banned in several parts of California, including a 2019 moratorium by the Los Angeles County Board of Supervisors forbidding its use by county departments.) Paraquat also has other known health effects. It is listed as “highly toxic” on the U.S. Environmental Protection Agency’s website, which says that “one small sip can be fatal and there is no antidote.” The EPA is currently reviewing paraquat’s approval status. However, both the EPA and Syngenta cited a 2020 U.S. government Agricultural Health Study that found there is no clear link between paraquat exposure and Parkinson’s disease. A 2021 review of reviews similarly found that there is no causal relationship.

Read more of this story at Slashdot.

Source: Slashdot – California Workers Say Herbicide Is Giving Them Parkinson’s

Remy Tumin reports via the New York Times: It was supposed to be what a fan described as a “loving homage” to his hero, the author J.R.R. Tolkien, and to “The Lord of the Rings,” which he called “one of the most defining experiences of his life.” A judge in California had another view. The fan, Demetrious Polychron of Santa Monica, Calif., violated copyright protections this year when he wrote and published a sequel to the epic “Rings” series, U.S. District Judge Stephen V. Wilson of the Central District of California ruled last week. In a summary judgment, Judge Wilson found “direct evidence of copying” and barred Polychron from further distributing the book or any others in a planned series. He also ordered Polychron to destroy all electronic and physical copies of the published work, “The Fellowship of the King,” by Sunday. As of Wednesday, Amazon and Barnes & Noble were no longer listing the book for sale online. Steven Maier, a lawyer for the Tolkien estate, said the injunction was “an important success” for protecting Tolkien’s work. “This case involved a serious infringement of The Lord of the Rings copyright, undertaken on a commercial basis,” he said. “The estate hopes that the award of a permanent injunction and attorneys’ fees will be sufficient to dissuade others who may have similar intentions.”

Read more of this story at Slashdot.

Source: Slashdot – Tolkien Estate Wins Court Order To Destroy Fan’s ‘Lord of the Rings’ Sequel