Under a recent law, the National Institutes of Health will begin spending about $25 million to enroll patients in compassionate use — also called open access — programs of unapproved drugs.
When patients with a deadly diagnosis and few treatment options have tried to get unapproved, experimental drugs, they have long faced a dilemma: Who will pay?
Only patients who can’t get into conventional drug trials are eligible for the program. And their progress must be tracked to gather data about the treatment and their underlying disease, amyotrophic lateral sclerosis, or ALS. Up to 90% of ALS patients are ineligible for traditional clinical trials, according to researchers, typically because their disease has progressed too far to show major treatment benefits. Even eligible patients must compete for access. One recent analysis counted 2,000 trial openings in the U.S. for 25,000 people living with ALS.
The NIH spends the vast majority of its $45 billion budget on early-stage research focused on identifying the root causes, treatments and potential cures for diseases. “I’m five years in so I can’t qualify for any clinical trials,” said Brian Wallach, who launched I AM ALS with his wife after being diagnosed in 2017. “I hope to be eligible for the expanded access pathway.”
The legislation grew out of patients’ deep frustration with access to experimental therapies, including a stem cell treatment from the tiny drugmaker Brainstorm Cell Therapeutics.
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NIH to fund unproven ALS drugs under patient-backed lawThe U.S. government will soon spend $25 million to help patients access experimental drugs for the incurable illness known as Lou Gehrig's disease
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NIH to fund unproven ALS drugs under patient-backed lawWASHINGTON (AP) — When patients with a deadly diagnosis and few treatment options have tried to get unapproved, experimental drugs, they have long faced a dilemma: Who will pay? Responsibility for funding so-called compassionate use has always fallen to drugmakers, though many are unwilling or unable to make their drugs available for free to dying patients.
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NIH to fund unproven ALS drugs under patient-backed lawWhen patients with a deadly diagnosis and few treatment options have tried to get unapproved, experimental drugs, they have long faced a dilemma: Who will pay? Responsibility for funding so-called compassionate use has always fallen to drugmakers, though many are unwilling or unable to make their drugs available for free to dying patients. After years of lobbying Congress, patients with the debilitating illness known as Lou Gehrig’s disease have found an unprecedented solution: make the federal government pay.
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NIH to Fund Unproven ALS Drugs Under Patient-Backed LawThe U.S. government will soon spend $25 million to help patients access experimental drugs for the incurable illness known as Lou Gehrig’s disease.
続きを読む »
NIH to fund unproven ALS drugs under patient-backed lawThe U.S. government will soon spend $25 million to help patients access experimental drugs for the incurable illness known as Lou Gehrig's disease.
続きを読む »
NIH to fund unproven ALS drugs under patient-backed lawThe U.S. government will soon spend $25 million to help patients access experimental drugs for the incurable illness known as Lou Gehrig's disease
続きを読む »