Eyedrops pulled by CVS, Target made by barefoot workers in India

Tainted eyedrops yanked from pharmacy shelves over fears they could cause infections and even blindness were made in a factory in India where workers walked around barefoot and safety test results were faked, according to an explosive report.

The 26 over-the-counter products — sold as store brands at retailers including CVS, Rite Aid, Walmart and Target — came from a company in Navi Mumbai called Kilitch Healthcare India Ltd., according to a Bloomberg investigation.

On Oct. 25, the Food & Drug Administration issued a recall on the more than two dozen eyedrop brands after agency investigators found unsanitary conditions at the India plant and “positive bacterial test results from environmental sampling of critical drug production areas in the facility.”

The government report, obtained by Bloomberg, said that workers were showing up to the factory barefoot or were not wearing protective gear in sterile areas while one person was observed combing their hair amidst cleaning equipment and others were forging the dates on products attesting to their sterility.

This factory in Mumbai India allegedly has ‘insanitary’ conditions that has led to contaminated eyedrops, according to an FDA inspection report seen by Bloomberg.
via Pharma Technology

The FDA did not immediately respond for comment but a spokesman told Bloomberg, “The agency proactively worked with retailers to have these products removed from the market before any known injuries arose,” Jeremy Kahn said in an email. “We urge consumers to stop using these products, as it could result in an eye infection.”

It’s the second time US authorities found problems with eyedrops made in India.

In February, health agents found that another eyedrop maker in India was linked to infections and to four deaths and 18 cases of vison loss in the US.

There has been an “alarming” rise in the number of eyedrops sold in the US that may cause health problems, according to the Dry Eye Foundation.
Jeffrey Greenberg/Universal Images Group via Getty Images

In that outbreak involving eyedrops from EzriCare LLC and Delsam Pharma LLC – that were recalled – a dangerous bacteria was found in the products, according to another investigation by Bloomberg.

Four people had their eyeballs removed to stop the spread of the bacteria while others experienced cloudy abscesses on their corneas, discharges from their eyes and migraines that lasted for months.

The contaminated eyedrops made their way to the US because of a lapse in the FDA’s supervision of over-the-counter medicines that allowed “two inexperienced entrepreneurs” in India to sell their products to distributors and pharmacists in the US, according to the report.

The FDA issued a warning in October about 26 brands of eyedrops that could cause infections or even blindness, including the Velocity brand.
Velocity Pharma

India bills itself as the “pharmacy to the world” because it is home to most of the pharmaceutical manufacturing.

However, the FDA has little power to force a drugmaker to recall its products.

But it did ban the Kilitch factory on Oct. 23 from sending more eyedrops to the US after inspecting the plant for a week, according to Bloomberg.

The agency also asked Kilitch to recall its products but it hasn’t so far, according to the outlet.

Many eyedrops are manufactured in India, which bills itself as the “pharmacy of the world.”
UCG/Universal Images Group via Getty Images

The FDA has warned consumers about 78 over-the-counter eyedrops this year, but only 13 have been recalled, according to the Dry Eye Foundation, a non-profit in Seattle. 

The group raised a warning flag back in April when it alerted the public about a “sharp rise in eye drops marketed in the US that may pose health risks to consumers.”

In August, the FDA issued a warning about a “life-threatening infection” associated with Dr. Berne’s Organic Castor Oil Eye Drops; and Dr. Berne’s MSM Mist 15% Solution.

The FDA said the contaminated eyedrops could lead to “minor to serious” infections that could potentially affect vision and even “progress to a life-threatening infection.”

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Gov’t idiocy at work, FDA’s dumb plan on smokes and other commentary

From the right: Gov’t Idiocy at Work

“Cities are rapidly inventing new job titles,” reports City Journal’s Steven Malanga, and the “hottest (pun intended)” is “chief heat officer” — whose task is to “enumerate the impact of heat on the local population” and “seek ways to mitigate it.” One popular idea among CHOs: plant trees to boost shade. And one term “you’re unlikely to hear” from them: “air conditioning,” though “warm-weather-related deaths dropped precipitously over the last century” thanks to AC. The problem: “Air conditioning demands electricity” often powered by fossil fuels or nuclear energy, “two unseemly phrases” in government circles. Yet “the biggest threat” is the loss of AC due to rising prices and outages made more likely by government climate actions. Don’t worry: “Your local CHO is coming soon to plant more trees.”

Libertarian: FDA’s Dumb Plan on Smokes

The Food and Drug Administration “wants to prevent smoking-related deaths by making cigarettes less appealing,” notes Reason’s Jacob Sullum. It “plans to ban menthol cigarettes and limit nicotine content” even as it’s “determined to make vaping products, the most promising harm-reducing alternative to cigarettes, less appealing to smokers.” Its policies contain a “condescending assumption that African Americans are helpless to resist menthol’s minty coolness” and “would spur black-market activity” while encouraging smokers “to smoke more”; its vaping stand “is hard to reconcile with its acknowledgment that vaping has great potential to reduce smoking-related disease and death.” Seems the FDA “learned nothing from the country’s unhappy experience with the war on drugs.”

Conservative: Germany Says the F-Word — Fracking

“Germany’s energy crisis is a crisis of choice, or rather a crisis of two choices, the second following directly from the first,” explains The Wall Street Journal’s Joseph C. Sternberg. The Ukraine war already has it rethinking the second choice, to rely on Russia for natural-gas imports. “But Germany is as dependent as it is on foreign fuel only because of the first decision Berlin made: not to tap the country’s substantial domestic gas reserves,” put off-limits by the 2017 ban “on dubious safety grounds” of “the fracking techniques that could reach most of Germany’s gas.” Polling shows just 27% support, though “‘only’ 56% of respondents opposed fracking outright, with the remaining 17% undecided. This after voters have been bombarded for years with antifracking messages.” In fact, Germany’s “perceived resource poverty is more a form of learned helplessness than a geological reality.”

Pundit: My Stealthy, Sexist CNN Suspension

“It came to my attention in July that I had been punished under old CNN leadership — kept off air since January,” writes Mary Katharine Ham at her MK Hammer Time Substack, “for tweeting about Jeffrey Toobin,” who’d left his webcam on while masturbating during a video call with colleagues. “I was never informed of my punishment until it was rescinded recently by new management,” and Toobin “was off air for eight months; I was off for seven. One month was the difference between punishment for” his repugnant action “versus commenting on the inadvisability of” masturbating “at work.” Oh, and: “I was also told I wasn’t informed of the network’s displeasure because I had just had a baby and someone in the old leadership thought I might be a ‘loose cannon.’”

Culture desk: Must You Tip Everyone?

“Everyone wants a tip now. Do you have to give them one?” asks Recode’s Sara Morrison. “Tipflation is everywhere,” with tips “requested at automatic car washes,” for retail purchases, “even for smoothie-making robots, usually through those touchscreen tablets a lot of businesses use.” Thanks to “social pressure” and “a pandemic that accelerated the adoption of contactless digital payment methods, those tablets have become ubiquitous, and so have the tip requests.” Research finds “just the act of asking people to leave a tip can be enough to push some people into doing so.” After all, we all want “to avoid the awkwardness and the guilt of” declining. But take it from the expert: Lizzie Post, Emily Post’s great-great-grandchild, says “there’s nothing wrong with saying no.”

— Compiled by The Post Editorial Board

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Apple Watch to Help Rune Labs Monitor Parkinson’s Patients, US FDA Gives Clearance

San Francisco-based startup Rune Labs on Monday said it received clearance from the US Food and Drug Administration to use the Apple Watch to monitor tremors and other common symptoms in patients with Parkinson’s disease.

The Rune Labs software uses motion sensors built into the Apple Watch, which can already be used to detect when a person falls. Rune Labs Chief Executive Brian Pepin said in an interview that Apple Watch data will be combined with data from other sources, including a Medtronic implant that can measure brain signals.

Rune Labs’ goal is for doctors to use the combined data to decide whether and how to fine-tune the patients’ treatment. At present, Pepin said, most doctors have to gather data on a patient’s movements by observing them during a short clinical visit, which is not ideal because Parkinson’s symptoms can vary widely over time.

Using the Apple Watch, Rune Labs’ StrivePD software platform will provide doctors a continuous stream of observations over long stretches, Pepin said.

“When you think about the process of getting someone to their optimal therapy or combination of drugs or devices, or even whether or not a patient might be a good fit for a certain clinical trial, it’s a very hard decision to make when you only have a little context,” Pepin said.

The Rune Labs FDA clearance is the first prominent use of software tools that Apple released for measuring movement disorders in 2018.

Last year, a group of scientists at Apple published a study in the journal Science Translational Medicine showing the device was effective at monitoring Parkinson’s symptoms. After contacting Apple about the tools, Pepin said, “it took about eight minutes for the team lead to get back to me and say, ‘Hey, perfect, let’s explore this.'”

Apple has partnered with a range of other companies to use the Apple Watch as a health monitoring device, including a deal with Johnson & Johnson to study whether it can be used to help lower stroke risk.

© Thomson Reuters 2022


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