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When You Wear Sunscreen, You’re Taking Part in a Safety Study

July 24, 2019

The FDA almost never tests products itself. But in May, JAMA published the results of a randomized trial, conducted by FDA researchers, to determine whether the chemicals in four commercially available sunscreens are absorbed through the skin into the bloodstream

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When You Wear Sunscreen, You’re Taking Part in a Safety Study

Wednesday, July 24th, 2019

The Food and Drug Administration almost never tests products itself. But in May, the Journal of the American Medical Association published the results of a randomized trial, conducted by F.D.A. researchers, to determine whether the chemicals in four commercially available sunscreens are absorbed through the skin into the bloodstream. Four times daily, subjects were coated in one of the formulas in an amount determined to be the maximum a person might use: two milligrams per square centimeter of skin over 75 percent of the body. Later, blood samples were drawn and analyzed. All of the sunscreen chemicals were detected in concentrations that exceeded an F.D.A. threshold past which manufacturers are required to do further toxicology tests. “People who use sunscreens very reasonably presume they have been tested and are safe and effective,” says Kanade Shinkai, a dermatologist at the University of California, San Francisco, and an author of an editorial accompanying the JAMA study. “And we don’t really have that evidence.”

Legally, the U.S. regards sunscreen as a drug, meaning a substance “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” — in this case, sunburn and skin cancer — and/or one that affects “the structure or any function of the body.” Until 1962, drugs could be sold in the U.S. without any data to support claims of their efficacy. But that year, reports that a sedative called thalidomide had caused severe birth defects in thousands of babies in Western Europe led to the Kefauver-Harris Amendment to the Federal Food, Drug and Cosmetic Act, which requires drug makers to satisfy the F.D.A. that their products are safe and effective before they go on sale.

…continue reading ‘When You Wear Sunscreen, You’re Taking Part in a Safety Study’

Thumb image via NYTimes, illustration by Ori Toor

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New York Times

People Are Clamoring to Buy Old Insulin Pumps

April 29, 2019

How an obsolete medical device with a security flaw became a must-have for some patients with type 1 diabetes. In 2014, a few hackers realized that the security flaw in certain Medtronic pumps could be exploited for a DIY revolution.

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Prominent ‘Right-To-Try’ Advocate Is Getting Treatment Under New Law

February 6, 2019

One of the namesakes of the federal “right-to-try” law confirmed Tuesday that he gained access to an experimental treatment thanks to the new law

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Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

February 6, 2019

A version of the club drug is expected to be approved for depression in March. Researchers think it could help treat suicidal thinking

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Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

Wednesday, February 6th, 2019

Joe Wright has no doubt that ketamine saved his life. A 34-year-old high school teacher who writes poetry every day on a typewriter, Wright was plagued by suicidal impulses for years. The thoughts started coming on when he was a high schooler himself, on Staten Island, N.Y., and intensified during his first year of college. “It was an internal monologue, emphatic on how pointless it is to exist,” he says. “It’s like being ambushed by your own brain.”

He first tried to kill himself by swallowing a bottle of sleeping pills the summer after his sophomore year. Years of treatment with Prozac, Zoloft, Wellbutrin, and other antidepressants followed, but the desire for an end was never fully resolved. He started cutting himself on his arms and legs with a pencil-sharpener blade. Sometimes he’d burn himself with cigarettes. He remembers few details about his second and third suicide attempts. They were halfhearted; he drank himself into a stupor and once added Xanax into the mix.

Wright decided to try again in 2016, this time using a cocktail of drugs he’d ground into a powder. As he tells the story now, he was preparing to mix the powder into water and drink it when his dog jumped onto his lap. Suddenly he had a moment of clarity that shocked him into action. He started doing research and came upon a Columbia University study of a pharmaceutical treatment for severe depression and suicidality. It involved an infusion of ketamine, a decades-old anesthetic that’s also an infamous party drug. He immediately volunteered. …

…continue reading ‘Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate’

Thumbimage: De Coaster420 – Asia, Dominio público, https://commons.wikimedia.org/w/index.php?curid=5313268

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Bloomberg

If the Shutdown Drags on at FDA, It Will Put Anticipated New Treatments in Jeopardy

January 15, 2019

The government shutdown could soon jeopardize highly anticipated new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to a STAT analysis of upcoming regulatory decision dates

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Despite Warnings, FDA Approves Potent New Opioid Painkiller

November 2, 2018

The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic

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FDA Says It Will Consider Approval of First Dengue Vaccine, Despite Controversy

October 31, 2018

The Food and Drug Administration has agreed to consider Sanofi Pasteur’s application for Dengvaxia, the world’s first licensed vaccine that protects against dengue but one that brings with it considerable controversy and concern

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As Massive Zika Vaccine Trial Struggles, Researchers Revive Plan to Intentionally Infect Humans

September 13, 2018

In 2016, as the mosquito-borne Zika virus spread through the Americas and cases of infected women having brain-damaged babies mounted, investigators raced to develop a vaccine. Now, a $110 million vaccine trial is underway at 17 sites in nine countries, but it faces an unexpected, and ironic, challenge

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As Massive Zika Vaccine Trial Struggles, Researchers Revive Plan to Intentionally Infect Humans

Thursday, September 13th, 2018

Cases of Zika have plummeted to levels so low that most people vaccinated in the trial likely will never be exposed to the virus, which could make it impossible to tell whether the vaccine works.

“Right now, there are no infections, and certainly not enough to even think about an efficacy signal at this point,” says Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, which launched the trial. Human trials of other Zika vaccine candidates at earlier stages are also in limbo, and last year one large vaccinemaker pulled the plug on development of its candidate. But NIAID and others are pressing ahead, saying a vaccine might someday be needed. To make up for the lack of new cases, other investigators are turning to an unusual, and ethically complex, strategy. Starting next year, Science has learned, they plan to test a vaccine by deliberately infecting people with Zika.

Launched in March 2017, NIAID’s placebo-controlled vaccine trial includes two sites in Brazil, where Zika hit hardest and where the brain damage known as microcephaly first surfaced. From the beginning of the outbreak in 2015 until the start of this year, Brazil had about half of all 800,000 suspected and confirmed Zika cases in the Americas, according to the Pan American Health Organization in Washington, D.C. But from January through June, Brazil’s Ministry of Health reported fewer than 7000 probable cases, in a nation of 200 million people. “It’s a good dilemma because we don’t have Zika anymore,” says Esper Kallás of the University of São Paulo in São Paulo, Brazil, principal investigator for the local NIAID site. “But it’s a dilemma. Everybody is concerned about it. It’s a lot of investment.”

…continue reading ‘As massive Zika vaccine trial struggles, researchers revive plan to intentionally infect humans’

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Science

When You Wear Sunscreen, You’re Taking Part in a Safety Study

People Are Clamoring to Buy Old Insulin Pumps

People Are Clamoring to Buy Old Insulin Pumps

Prominent ‘Right-To-Try’ Advocate Is Getting Treatment Under New Law

Prominent ‘Right-To-Try’ Advocate Is Getting Treatment Under New Law

Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

If the Shutdown Drags on at FDA, It Will Put Anticipated New Treatments in Jeopardy

If the Shutdown Drags on at FDA, It Will Put Anticipated New Treatments in Jeopardy

Despite Warnings, FDA Approves Potent New Opioid Painkiller

Despite Warnings, FDA Approves Potent New Opioid Painkiller

FDA Says It Will Consider Approval of First Dengue Vaccine, Despite Controversy

FDA Says It Will Consider Approval of First Dengue Vaccine, Despite Controversy

As Massive Zika Vaccine Trial Struggles, Researchers Revive Plan to Intentionally Infect Humans

As Massive Zika Vaccine Trial Struggles, Researchers Revive Plan to Intentionally Infect Humans

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