VP Pence: FDA approving 'off label' use for Chloroquine, no barrier to access
Dr. Oz asks Vice President Mike Pence what the U.S. is doing to accelerate clinical coronavirus trials and if the administration plans to approve 'off label' use of Chloroquine medication
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A 42-year-old woman from the Los Angeles area who’s diagnosed with lupus said her health care provider stopped filling her prescription for chloroquine – and sent her a message thanking her for her “sacrifice” to help treat those seriously ill with the coronavirus.
The woman identified only by her first name Dale said she received a message from Kaiser Permanente, a major health care provider based in Oakland, Calif., on Tuesday informing her that the company was reserving its current supply of plaquenil/hydroxychloroquine. The drug would be used to treat those "critically ill with COVID-19" amid shortages caused by the global pandemic, it said.
"The fact that they thanked me for my 'sacrifice' is disturbing," Dale told BuzzFeed News. "I never agreed to sacrifice my health and possibly my life, and cannot believe that I am being forced to do so."
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A laboratory technician prepares COVID-19 patient samples for semi-automatic testing at Northwell Health Labs, Wednesday, March 11, 2020, in Lake Success, N.Y. The U.S. Food and Drug Administration has approved faster testing protocols as the viral outbreak continues to spread worldwide. (AP Photo/John Minchillo)
Dale said she’s taken the drug for 10 years, since she was diagnosed with lupus, which is a long-term autoimmune disease that occurs when the immune system attacks normal, healthy tissue.
"I am already immunocompromised, and not taking this medication likely put me into a lupus flare, making serious complications from COVID more likely," she said.
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In its emailed message, Kaiser Permanente said “hydroxychloroquine does build up a level in the system that stays in the body for an average of 40 days even after the last dose is taken.
"Thank you for the sacrifice you will be making for the sake of those that are critically ill; your sacrifice may actually save lives," the message said.
“We are working hard every day to continue to do everything we can to find ways to replenish the medication as soon as possible. During this time, you should continue to take the remaining pills you have on schedule unless otherwise instructed by your prescribing physician.
“Please do not contact your physician about an exception process to get a refill, as prescriptions will not be filled even if written by your physician,” it continued. “If you do run out of medication and feel that your condition is significantly worsening, please contact your doctor to discuss alternative treatments.”
Anna Valdez, Ph.D., RN, a medical professional also diagnosed with lupus, said she couldn't refill her prescription for hydroxychloroquine either due to shortages amid the coronavirus outbreak. It is unclear who her health care provider is.
“Please do not misuse hydroxychloroquine. This med is critical for people who have SLE, like me,” she tweeted on Saturday. “I was told today that my prescription cannot be filled because the suppliers are completely out. Now I do not have the meds I actually need for an incurable disease I actually have.”
There are no alternatives to the medications for many with the disease, the Lupus Foundation of America said in a press release Monday addressing shortages.
“Hydroxychloroquine or chloroquine are the only methods of preventing inflammation and disease activity that can lead to pain, disability, organ damage, and other serious illness.”
In a statement to BuzzFeed News, Nancy Gin, regional medical director of Quality and Clinical Analysis at Kaiser Permanente, Southern California, said the company is working to ensure both COVID-19 patients and those diagnosed with severe, acute lupus have access to the drug amid shortages.
"As we face the real possibility of running out of the drug for everybody if we don’t take steps to mitigate the shortage, Kaiser Permanente, like other health care organizations across the country, has had to take steps to control the outflow of the medication to ensure access to severely sick patients, including both COVID-19 and those with acute lupus," she said.
“Extensive experience and research show that hydroxychloroquine builds up in the body and continues to work for an average of 40 days even after the last dose is taken,” she continued. “By then, we expect the drug manufacturers to have ramped up production to meet the increased demand. Until then, we are no longer refilling routine prescriptions to ensure we have adequate supply to care for our sickest patients."
Pharmacist Michael Witte wears heavy gloves as he opens a frozen package of the potential vaccine for COVID-19, the disease caused by the new coronavirus, on the first day of a first-stage safety study clinical trial, Monday, at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)
Last week, four volunteers at the Kaiser Permanente Research Institute in Seattle were given the first round of Moderna Therapeutics' vaccine -- the start of the first clinical trial since the outbreak began.
Researchers around the globe have worked since Jan. 10, when Chinese officials first published the genetic sequence of the novel coronavirus, to develop vaccines, diagnostic tests and treatments for COVID-19. A vaccine is not expected to be made available to the general public for at least 18 months.
President Trump announced the Food and Drug Administration (FDA) was making several experimental drugs, including chloroquine, which is a drug designed to fight malaria, available to test whether it helps patients recover from coronavirus. In studies published by South Korea and China, the drug showed promise for treating COVID-19 patients.
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An Arizona man died – and his wife was in critical condition – after self-medicating to prevent them from contracting the coronavirus. Both ingested a fish tank cleaner including the drug chloroquine phosphate, which is used as an additive in aquariums to kill microorganisms that could harm fish and other aquatic life. Banner Health later issued a stern warning against bootleg COVID-19 treatments.
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