Archive for the ‘fda’ Category

US gov’t growing a record 2-ton cannabis crop—but still won’t let others grow

July 12th, 2019
Marijuana plants grow in a greenhouse in Colorado, not for research.

Enlarge / Marijuana plants grow in a greenhouse in Colorado, not for research. (credit: Getty | Bloomberg)

With the recent explosion of cannabis access and CBD products, federally funded scientists are craving more research on the potential risks and benefits. But if any researchers were hoping for more varied sources of cannabis—sources that could better reflect what patients have access to, for instance—they may be left holding their breath.

Three years after saying it wanted more suppliers of cannabis for research, the US government continues to hold a monopoly on growing the crop. While more than two dozen entities have submitted applications to the Drug Enforcement Administration to become growers, the government has dragged its feet in processing the paperwork and is instead stepping up its own crop; its exclusive supplier, the University of Mississippi, is growing 2 tons this year, the largest crop in five years, according to a report by the Associated Press.

Orthopedics researcher Emily Lindley at the University of Colorado and other researchers are not happy with the situation, according to the AP. Lindley, who is studying whether cannabis with high THC levels could be an alternative to addictive opioids for chronic back pain, says she wants more suppliers than just Ole Miss, which has had limited strain varieties and product availability. “We want to study what our patients are using,” she said.

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Posted in cannabinoids, cbd, DEA, fda, Marijuana, marijuana research, nida, Policy, pot, science | Comments (0)

Big Dairy is trying to get teens hooked on lattes to boost milk sales

July 2nd, 2019
Will coffee-flavored milk save the dairy industry?

Enlarge / Will coffee-flavored milk save the dairy industry? (credit: Getty | Bloomberg)

Amid decades-long souring of milk sales in the United States, big dairy groups have now turned to sponsoring coffee bars in high schools to help skim profits from the trendy—and milk-heavy—latte drinks popular with teens, according to a report by the Associated Press.

A $5,000 dairy grant to a high school in North Dakota helped buy an espresso machine that makes 150-calorie latte drinks containing 8 ounces of milk, for instance. The school went through 530 gallons of milk just for the lattes this school year, according to the food-service director for the school district.

Likewise, a Florida dairy group offers schools grants worth $6,000 to outfit their coffee bars. The campaign is called “moo-lah for schools,” which refers to lattes as “moo brew.” The group says the coffee bars are an opportunity to “serve 8 oz. of milk with 2 oz. of coffee and added flavorings that fit into your school wellness policy.” One of the explicit goals of the grant program is to get students who “might not normally select milk with their school meals to consume milk.”

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Posted in caffeine, coffee, diary, fda, food regulation, latte, milk, nutrition, science | Comments (0)

Horrified researchers want out of “infomercial” for shady stem-cell clinics

June 18th, 2019
A man in surgical garb inspects a cutting-edge computer display.

Enlarge / Cheesy graphic from stem-cell documentary "The Healthcare Revolution." (credit: Healthcare Revolution)

Around a dozen prominent stem-cell experts said this week that they have been duped into appearing in a documentary series some described as an infomercial for the unproven and dangerous stem-cell treatments peddled by clinics now facing federal charges.

The researchers said they had originally agreed to do interviews for the project believing it was for a sober, educational documentary on legitimate stem-cell research—which holds medical potential but is still largely unproven to benefit patients. Just days before the documentary’s intended release of June 17, however, researchers say they were horrified to learn that the 10-part series, titled The Healthcare Revolution, hypes dubious stem-cell treatments as miracle cures and gives false hope to desperate patients. The revelation was first reported by the San Francisco Chronicle.

The researchers soon after discovered that the series was partially funded by the Cell Surgical Network, a for-profit chain of clinics currently facing federal charges for selling stem-cell treatments without approval from the Food and Drug Administration and failing to adhere to safety regulations. Hundreds of such questionable clinics have popped up around the country in recent years.

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Posted in documentary, fda, regenerative medicine, science, stem cell research, stem cells | Comments (0)

Killer poop: Fecal transplant patient’s death prompts FDA to push out warning

June 14th, 2019
The Food and Drug Administration headquarters in White Oak, Md.

Enlarge / The Food and Drug Administration headquarters in White Oak, Md. (credit: Getty | Congressional Quarterly)

One patient has died and another became seriously ill after fecal transplants inadvertently seeded their innards with a multi-drug resistant bacterial infection, the Food and Drug Administration warned Thursday.

The cases highlight the grave risks of what some consider a relatively safe procedure. They also flush out the mucky issues of federal oversight for the experimental transplants, which the FDA has strained to regulate. In its warning Thursday, the agency announced new protections for trials and experimental uses of the procedure.

The FDA shared minimal details from the deadly transplants. Its warning only noted that the cases involved two patients who were immunocompromised prior to the experimental transplants and received stool from the same donor. Subsequent to the transplant, the patients developed invasive infections from an E. coli strain that was resistant to a wide variety of antibiotics in the penicillin and cephalosporin groups. The E. coli strain carried a drug-defeating enzyme called an extended-spectrum beta-lactamase (ESBL), which generally cleaves a ring common to all the chemical structures of those antibiotics.. When unnamed researchers who administered the transplant looked back at the donor stool, they found that the stool contained an identical ESBL-producing E. coli.

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Posted in drug approval, drug delivery, fda, fecal transplant, microbiome, poop, science | Comments (0)

FDA safety scandal: 50K hidden reports of heart device malfunctioning

May 21st, 2019
The Food and Drug Administration headquarters in White Oak, Md.

Enlarge / The Food and Drug Administration headquarters in White Oak, Md. (credit: Getty | Congressional Quarterly)

The Food and Drug Administration allowed the maker of a faulty implantable heart device to secretly log 50,000 malfunction incidents, according to a series of investigations by Kaiser Health News.

The device—the Sprint Fidelis, made by Medtronic—consists of a pair of wires and a defibrillator to jolt the heart into a regular rhythm. But doctors found that it was giving patients random, harmful zaps and sometimes failed during actual cardiac emergencies.

Medtronic recalled the device in 2007 but only after it was implanted in around 268,000 patients. Many of those patients have since faced the ghastly choice of learning to live with the faulty device or undergoing an invasive, risky—sometimes deadly—surgery to remove it. According to the KHN investigation, they’ve been making that choice without information from the 50,000 incident reports.

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Posted in fda, medical devices, regulation, safety, science | Comments (0)

“Biohacker” who tried to alter his DNA probed for illegally practicing medicine

May 16th, 2019
Closeup photograph of hypodermic needle against black background.

Enlarge / Zayner is best known for injecting himself with CRISPR. (credit: Andrew Matthews / Getty Images)

Prominent genetic "biohacker" Josiah Zayner is under investigation by California state officials for practicing medicine without a license.

Zayner has a background in biophysics and runs a company called The Odin, which sells do-it-yourself genetic engineering kits and other lab equipment intended for use outside of scientific laboratories. The kits and tools are intended to allow lay users to genetically modify bacteria, yeast, animals, and even humans.

The human that Zayner's products are best known for trying to modify is Zayner himself. In fact, the brazen CEO has a long history of self-experimentation. In 2016, he attempted a stomach-churning DIY fecal transplant in an airport hotel, then moved on to trying to genetically engineer his skin.

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Posted in biohacking, CRISPR, fda, gene editing, genetic engineering, science | Comments (0)

“Natural” bottled water has natural arsenic contamination, testing finds

April 21st, 2019
Water can pick up arsenic from geological, agricultural, or industrial sources.

Enlarge / Water can pick up arsenic from geological, agricultural, or industrial sources. (credit: Getty | Nurphoto)

Several brands of bottled water contain concerning levels of arsenic contamination, according to an investigation by Consumer Reports.

The worst offenders in the report were Starkey, a brand owned by Whole Foods and marketed as water in its “natural state,” and Peñafiel, owned by Keurig Dr Pepper and imported from Mexico.

Samples of Peñafiel tested by CR had arsenic levels that averaged 18.1 parts per billion, well above the federal allowable limit of 10ppb set by the Food and Drug Administration. Testing of Whole Foods’ Starkey Water revealed levels at or just a smidge below federal limits, with results ranging from 9.48 ppb to 10.1 ppb.

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Posted in arsenic, bottled water, CDC, contamination, fda, science, whole foods | Comments (0)

FDA slams homeopaths for uncontrolled snake venom, germs in kids’ products

April 2nd, 2019
An Eastern diamondback rattlesnake milked for venom.

Enlarge / An Eastern diamondback rattlesnake milked for venom. (credit: Getty | Bloomberg)

In an ongoing crackdown on dubious homeopathic products, the US Food and Drug Administration posted warning letters on Monday to four homeopathic companies the agency said committed violations that put consumers at risk, including lacking quality controls for products containing snake venom as well as skipping safety testing for products intended for children.

“We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues,” FDA Commissioner Scott Gottlieb said in a statement.

One of the chided companies, Red Mountain Incorporated, based in Florida, was found to lack all quality controls for its homeopathic product said to contain components of snake venom. “Without an adequate QU [Quality Unit], you lack the ability to ensure the safety, identity, strength, quality, and purity of your drug product,” the agency wrote in its letter.

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Posted in belladonna, Drug Safety, fda, homeopathy, salt, science, snake venom | Comments (0)

After pushing addictive OxyContin, Purdue now pursuing overdose antidote

March 15th, 2019
If approved, Purdue's new drug would compete with opioid overdose antidote, naloxone.

Enlarge / If approved, Purdue's new drug would compete with opioid overdose antidote, naloxone. (credit: Getty | Steve Russell)

Notorious OxyContin-maker Purdue Pharma—which has been widely criticized for deceptively marketing its highly addictive painkiller and for its role in spurring the current nationwide epidemic of opioid abuse and overdose deaths—is moving ahead with a new, potent drug, one said to be an antidote to opioid overdoses.

The company announced this week that the US Food and Drug Administration has granted fast-track status to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency treatment intended to rescue people suspected of having an opioid overdose. Purdue suggests that nalmefene HCl’s effects last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes nalmefene HCl will out-compete naloxone at reversing overdoses from the most highly potent opioid, namely fentanyl, which is currently driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track status will speed the development and regulatory review of the drug.

“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose,” John Renger, Purdue’s head of Research & Development and Regulatory Affairs, said in a statement. “However, because of the increasing number of deaths due to fentanyl and its even more potent analogues, we are focusing on a potentially more potent and longer-lasting rescue option specifically intended to work in those overdose situations.”

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Posted in addiction, drug abuse, drug development, fda, opioid, overdose, purdue, science | Comments (0)

Citing parental freedom, Arizona lawmakers move ahead with anti-vaccine bills

February 25th, 2019
 A single dose of MMR (for Measles, Mumps, and Rubella) at Kaiser Permanente East Medical offices in Denver.

Enlarge / A single dose of MMR (for Measles, Mumps, and Rubella) at Kaiser Permanente East Medical offices in Denver. (credit: Getty | Joe Amon)

Lawmakers in Arizona are moving forward with three bills that will make it easier for parents to opt out of getting life-saving vaccinations for their children—and may even encourage them to do so, according to a report in The Arizona Republic.

The brazen legislative move comes as the country grapples with six outbreaks of measles, an extremely contagious, vaccine-preventable disease that can be disabling and even fatal to young children. One of those outbreaks is occurring in Washington state's Clark County, where rampant anti-vaccine views and similarly lax vaccination laws fueled the spread of disease. Since the start of the year, officials have tallied 65 cases, mostly in children under the age of 10 (47 of the 65 cases) and nearly all unvaccinated (57 cases of the 65 cases, with six others cases unverified, and two cases with only one out of the recommended two vaccine doses).

Hoping to prevent future outbreaks, Washington state lawmakers are now advancing legislation that would eliminate vaccination exemptions on personal and philosophical grounds. But Arizona lawmakers seem to have taken no heed of the efforts of their Washington counterparts, even as public health experts condemned Arizona's proposed legislation.

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Posted in Arizona, fda, Infectious disease, measles anti-vaccine, science, vaccine, vaccine exemptions | Comments (0)