jm + fda   3

'Looping' Created an Underground Insulin-Pump Market - The Atlantic
By 2014, the hardware components of a DIY artificial pancreas—a small insulin pump that attaches via thin disposable tubing to the body and a continuous sensor for glucose, or sugar, that slips just under the skin—were available, but it was impossible to connect the two. That’s where the security flaw came in. The hackers realized they could use it to override old Medtronic pumps with their own algorithm that automatically calculates insulin doses based on real-time glucose data. It closed the feedback loop.

They shared this code online as OpenAPS, and “looping,” as it’s called, began to catch on. Instead of micromanaging their blood sugar, people with diabetes could offload that work to an algorithm. In addition to OpenAPS, another system called Loop is now available. Dozens, then hundreds, and now thousands of people are experimenting with DIY artificial-pancreas systems—none of which the Food and Drug Administration has officially approved. And they’ve had to track down discontinued Medtronic pumps. It can sometimes take months to find one.

Obviously, you can’t just call up Medtronic to order a discontinued pump with a security flaw. “It’s eBay, Craigslist, Facebook. It’s like this underground market for these pumps,”
looping  insulin  diabetes  health  hardware  open-hardware  medtronic  glucose  medicine  fda  black-market 
23 days ago by jm
Novartis CAR-T immunotherapy strongly endorsed by FDA advisory panel
This is very exciting stuff, cytokine release syndrome risks notwithstanding.
The new treatment is known as CAR-T cell immunotherapy. It works by removing key immune system cells known as T cells from the patient so scientists can genetically modify them to seek out and attack only cancer cells. That's why some scientists refer to this as a "living drug."

Doctors then infuse millions of the genetically modified T cells back into the patient's body so they can try to obliterate the cancer cells and hopefully leave healthy tissue unscathed.

"It's truly a paradigm shift," said Dr. David Lebwohl, who heads the CAR-T Franchise Global Program at the drug company Novartis, which is seeking the FDA's approval for the treatment. "It represents a new hope for patients."

The drug endorsed by the advisory panel is known as CTL019 or tisagenlecleucel. It was developed to treat children and young adults ages 3 to 25 who have relapsed after undergoing standard treatment for B cell acute lymphoblastic leukemia, which is the most common childhood cancer in the United States.

While this blood cell cancer can be highly curable, some patients fail to respond to standard treatments; and a significant proportion of patients experience relapses that don't respond to follow-up therapies.
"There is a major unmet medical need for treatment options" for these patients, Dr. Stephen Hunger, who helped study at the Children's Hospital of Philadelphia, told the committee.

In the main study that the company submitted as evidence in seeking FDA approval, doctors at 25 sites in 11 countries administered the treatment to 88 patients. The patients, ages 3 to 23, had failed standard treatment or experienced relapses and failed to respond to follow-up standard treatment. CTL019 produced remissions in 83 percent of patients, the company told the committee.
car-t  immunotherapy  cancer  novartis  trials  fda  drugs  t-cells  immune-system  medicine  leukemia  ctl019 
july 2017 by jm
Drug Company Chairman to America: Go Fuck Yourself
'Mr. Coury [chairman of Mylan, makers of the EpiPen] replied that he was untroubled [by critics of 10x price-gouging price hikes]. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.'
mylan  gfy  fda  us-politics  healthcare  medicine  epipen  nytimes 
june 2017 by jm

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