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FDA Panel: All Thumbs Down for Amphetamine Product Meant to Deter Abuse

An FDA advisory committee voted unanimously Thursday that the risks of a novel amphetamine designed to deter abuse outweighed the benefits, concluding it may in fact be misused and could be even more dangerous than conventional stimulant medications for attention deficit-hyperactivity disorder (ADHD).

The panel also voted 19-2, with two abstentions, that drugmaker Arbor Pharmaceuticals did not adequately address the safety of AR19 (amphetamine sulfate), with many panelists noting that the drug appeared safe when administered orally, but that high levels of talc and polyethylene oxide in the drug’s composition could be toxic if taken through snorting or injection.

The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee also concluded with a 15-8 vote that Arbor did not adequately demonstrate AR19 would deter intravenous use, and voted 19-4 that it did not adequately demonstrate it would deter intranasal use.

In fact, the product’s ability to deter manipulation was “slim to nonexistent,” while the risks of the excipients were “too high and uncharacterized” to establish safety, said panel member Steven B. Meisel, PharmD, of M Health Fairview in Minneapolis.

The immediate release, pellets-in-capsule drug contains the same active ingredient as Arbor Pharmaceuticals’ currently-approved ADHD amphetamine Evekeo, but with physical and chemical barriers to deter non-oral intake.

Many panelists agreed that an abuse-deterrent amphetamine would be beneficial. But the likely impact on abuse would be relatively small, they said.

Moreover, the vast majority of amphetamine abuse occurs through the oral route, and non-oral misuse often starts with oral misuse, said Sonia Hernandez-Diaz, MD, MPH, DrPH, of the Harvard T.H. Chan School of Public Health in Boston. AR19 was not proposed to deter oral abuse.

“I think this approach would make sense if manipulation were working very well and [AR19] was the only amphetamine on the market,” Hernandez-Diaz added.

The conclusions of the panel may come as no surprise after the skeptical review FDA staff gave the product received in advance of Thursday’s meeting. Agency scientists wrote that it was feasible to extract a minimum reinforcing dose (10 mg amphetamine per mL over 1 minute) suitable for injection when using higher doses of AR19.

Arbor’s own studies aimed at determining whether manipulation could allow the drug to be snorted showed that ordinary household tools couldn’t significantly reduce particle size. But with modifications, one tool was able to crush AR19 particles down to snortable size.

Philip Posner, PhD, the panel’s patient representative from Gainesville, Florida, voted yes to both the intranasal and intravenous deference questions. He argued the evidence showed users would be far less likely to abuse AR19 compared to other stimulants on the market.

“When you compare this product with everything else that’s on the market, or that students can get elsewhere, I think they’re going to take the easy way out,” Posner said. “They’re not going to go through the excess work of emptying capsules, crushing tablets, and putting them in powder form to snort.”

That view failed to persuade Karim Anton

Parenting Was Never Meant to Be This Isolating

What this criticism fails to grasp is that throughout basically all of human history, parents have never, ever raised children in isolated nuclear units the way they have been doing for much of 2020, with little to no hands-on family or community support. Individual families being completely responsible for children “is absolutely unheard of except in total emergencies,” said Stephanie Coontz, an emeritus professor of history and family at Evergreen State College in Olympia, Wash., and the author of “The Way We Never Were: American Families and the Nostalgia Trap.”

As far back as we can go in prehistory, parents engaged in what biological anthropologists refer to as “cooperative breeding,” said Robin G. Nelson, Ph.D., an associate professor of anthropology at Santa Clara University (and an old friend of mine). That’s the idea that family and community members would help with holding, grooming and sometimes even feeding your baby. Sarah B. Hrdy, an anthropologist, called these helpers “alloparents,” and her research suggests that shared child care may have been “the secret of human evolutionary success.” Dr. Nelson called group living “part of what it means to be human.”

When you go back to the beginning of American history, the same facts hold: From colonial America through the early 20th century, there were almost no parents whose days were dedicated to just child care without support. Poorer parents worked alongside their children as young as 5 in crowded tenement sweatshops, textile mills and in the fields, while older children and other family helped care for children too young to work. And wealthier white families were not doing the child care without household workers. “Middle-class women were able to shift more time into child rearing in the 1800s only by hiring domestic help,” Coontz noted.

In fact, one parent (the mom) staying home and only spending her time on housework and child care was “a historical fluke,” for the white middle and upper classes that began in the 1940s and 50s, “based on a unique and temporary conjuncture of economic, social and political factors,” Coontz wrote in “The Way We Never Were.” As she points out, during World War II, Americans saved money at a rate that was “three times higher than in the decades before or since,” and real wages increased more in the 50s than they had in the previous 50 years.

And they were not “alone” the way many parents are during this pandemic. Middle-class mothers who stayed home with their children did so in communities of other mothers like them; the children would be pushed out to play in suburban neighborhoods. Even in the heyday of the American nuclear family, only the wealthiest white families were able to live that Donna Reed life — as Coontz points out in her book, one-third of nonimmigrant white families “could not get by on the income of the household head.”

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Some Health Workers Suffering From Addiction Steal Drugs Meant For Patients : NPR

The federal government estimates one in 10 healthcare workers experience substance use disorder. There is rising concern that medical professionals are stealing powerful opioid pain medications meant for their patients.

Kaz Fantone/NPR

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Kaz Fantone/NPR

The federal government estimates one in 10 healthcare workers experience substance use disorder. There is rising concern that medical professionals are stealing powerful opioid pain medications meant for their patients.

Kaz Fantone/NPR

When Kristin Waite-Labott, a nurse in Wisconsin, began stealing fentanyl and morphine from her hospital’s medical supply cabinets, she found it was relatively easy to cover her tracks.

Her drug inventory paperwork often didn’t add up, but she found coworkers willing to cover for her.

“They trusted me” she said. “Unfortunately I was taking advantage of that trust and that happens all the time.”

But Waite-Labott’s addiction to fentanyl quickly spiraled out of control.

“Taking it one time, I instantly craved more. It’s so powerful and deadly,” she said.

Waite-Labott eventually lost her job and spent time in jail before entering recovery and regaining her nursing license.

She works now helping other health workers who struggle with addiction and says she’s still haunted by the thought of patients she might have harmed.

“I don’t know that I made any errors,” she said. “But I can’t be certain of that because I was under the influence at work.”

NPR found a growing number of health industry experts and researchers who warn this kind of on-the-job drug theft by health workers may be increasing.

“It’s extremely common and the consequences can be very very grave,” said Kimberly New, an expert on medical drug misuse, known in the industry as diversion.

Patients in pain, patients taking contaminated medications

Harm to patients from drug diversion can be severe. In extreme cases, health workers divert so much medication, patients wind up undergoing cancer treatments or post-surgical recovery without pain relief.

“Patients will be left to linger in pain and not receive the doses that they were supposed to receive,” New said. “The diverter has progressed to the point where they’re no longer willing to share with the patients.”

Studies by the Centers for Disease Control and Prevention and the Mayo Clinic also found healthcare workers who steal drugs frequently tamper with medications, leaving them contaminated.

“I go and take a fentanyl vial, I administer the entire vial to myself and I refill the vial with water,” New said, describing a typical scenario. “Unfortunately many patients have been infected with blood-born pathogens.”

The Mayo Clinic study found as many as 28,000 hospital patients were put at risk of contracting Hepatitis C over a 10-year period because of this kind of drug theft and tampering.

Last year, physicians at a Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., reported six of their patients contracted a rare bacterial blood infection after a nurse replaced opioid medications with tap water.

“We share our experience to alert health care providers,” the doctors wrote in The New England Journal of Medicine