The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.
FDA Approves Novartis’ CAR-T
In what is being considered a historic and pioneering decision, the FDA approved CAR-T therapy for leukemia treatment in children and young adults. The treatment uses the patient’s own white blood cells and reprograms them to target cancer cells in the body.
Marketed as Kymriah, the treatment will cost $475,000, well below the $750,000 some analysts were expecting and the $700,00 price tag the UK is considering. Novartis also stated they will not charge for the treatment if a patient does not respond well to it within a month. Some, however, are critical of this approach citing that one month is not accurate measure and advocating for a period closer to 18 months.
The treatment had success in clinical trials, leaving 83% of patients cancer-free after a three-month cycle of the drug, but still had a relapse rate of 25% around the six month mark.
Harvey Causes Public Health Crisis in Houston
Hurricane Harvey captured the nation’s attention this past week as it devastated the Gulf Coast and left thousands displaced. Among the damages is Houston’s renowned Texas Medical Center, including the MD Anderson Cancer Treatment Center, which was forced to cancel treatments due to flooding.
Several other facilities had to work around the storm by transferring patients to other hospitals and having staff stay on-site to care for remaining patients.
If you would like to donate to help the Hurricane Harvey relief efforts, please click here.
An Unusual Origin Story
The backstory of drug discoveries are sometimes a dull affair: hours in a lab, a hardworking team, blah blah blah. But that’s hardly the case for warfarin sodium. Believe it or not, the drug found its beginning in cows that became sick from eating moldy hay.
The cows were dying from internal bleeding, their blood wasn’t clotting properly. After several experiments, scientists eventually found that the fungus was reacting with a substance in the hay to form dicoumarol, a blood thinner.
FDA Moves to Stricter Management of Stem Cell Clinics
The FDA seized vaccine vials from a San Diego clinic this week to prevent using them in a treatment, citing that it was “potentially dangerous and unproven.”
The vials were full of Vaccinia Virus Vaccine, which is designated for those at high risk for smallpox. The vaccine was to be mixed with cells from patients and injected directly into malignant tumors. The treatment was marketed as stem cell therapy, but not approved as such. The FDA is now launching an investigation into several clinics including the US Stem Cell Clinic.
Hacking the Heart
In even more FDA news, the organization put out a recall notice for a variety of pacemakers over concern they were vulnerable to hacking. Fortunately, patients affected by the recall will not need to get their pacemaker removed, they merely need to update its firmware.
In a release from device manufacturer Abbott Medical, executive vice president of Medical Devices Robert Ford stated “All industries need to be constantly vigilant against unauthorized access … we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”
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