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Allan Coukell proslijedio/la je Tweet
This sounds like what you’d expect from a FFS payment system change designed with that one siloed FFS payment system’s goals in mind. But people are not defined one payment system at a time. US long term care is broken and needs a real solution.
#complexcarehttps://twitter.com/DavidCGrabowski/status/1224335856527269888 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Allan Coukell proslijedio/la je Tweet
Today nearly 30 groups from across health care sent a letter to
@SecAzar & OMB calling for the finalization of the API elements of the ONC & CMS rules without further delay. The groups include patients, providers, tech companies, app developers, public health advocates, et alpic.twitter.com/JJYR1rVTrc
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Allan Coukell proslijedio/la je Tweet
New from
@coukell in@thehill -- Unlawful stem cell products continue to harm people as FDA deadline looms:https://bit.ly/2Ofb4taHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Some, including John Rex, have proposed a hybrid: a baseline award with tiered additional sums for added value. Challenges of that include total cost of the program and the aforementioned arguments against rewarding undifferentiated drugs. /end
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Cons of big/few: many current companies won't qualify and therefore may not survive, it is hard to define and predict what drugs would qualify (since most clinical development programs do not support an FDA label for superiority or activity against resistant bugs).
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Pros of big/few: public pays only for actual clinical advances/chemical or structural novely, incentivizes harder indications, larger award may attract capital that wouldn't go after small awards.
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Cons of small/many: small awards likely won't be sufficient to get big pharma back in the space, they require the taxpayer to pay for products that have no clear advantage over what exists, and they don't incentivize trials against harder indications.
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Pros of small/many: possibly saving existing companies and creating a viable business model for biotechs, thereby retaining R&D expertise. Also it is hard to predict how resistance will emerge (ie which drugs may be useful in future). And it is just hard to find truly novel
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Most (but not all) observers of the space agree that the current market is inadequate & policy change is needed to increase/supplement revenue from sales. But how much, and to which products? Some say smaller awards to more companies; some say big awards for only the best drugs.
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But quibbles about defining QIDP point to a bigger underlying question: what is the best way to ensure a robust pipeline of antibiotics that will meet future needs?
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The original QIDP definition was fiercely contested. (For the record, I was among those who favored an "unmet need" standard and opposed including antifungals.) But even now, there are others who would broaden it further - for example to include biologics.
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A thread:
@akesselheim argues that the threshold for Qualifying Infectious Disease Product is too low. QIDP is used for GAIN Act Incentives and is proposed to set eligibility in DISARM.https://academic.oup.com/ofid/article/7/1/ofaa001/5716891 …Prikaži ovu nitHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Allan Coukell proslijedio/la je Tweet
FDA v CA Stem Cell clinics is headed to court. Outside of the context of a clinical trial, patients with cancer should avoid risky, unproven therapies. Column: U.S. judge rejects FDA bid to shut down stem cell clinics, dealing blow to regulatorshttps://www.latimes.com/business/story/2020-01-28/judge-fda-stem-cell-clinics …
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I can't comment on specific campaigns, but am glad this issue is getting attention and hope every candidate will address it.https://twitter.com/damidefelice/status/1222498867914203137 …
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Allan Coukell proslijedio/la je Tweet
Extraordinary. Practice Fusion criminally rigged its EHR software "to increase prescriptions" of opioids "at the height of the opioid crisis" in exchange for kickbacks, DOJ says.https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0 …
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At a bare minimum, the
@US_FDA should have a way to know which products are on the market -- a policy the public supports. https://www.pewtrusts.org/en/research-and-analysis/articles/2019/10/01/most-supplement-users-back-enhanced-fda-oversight-of-these-products …https://twitter.com/TamarHaspel/status/1221800665808240640 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Canada is using this to dispense hydromorphone, but it could also help address a major barrier to methadone in the US -- the need to show up daily at an OTP that may be far from the patient's home.https://twitter.com/martinsmith02/status/1218522446267068418 …
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@Intermountain chief patient experience officer@scphillipsmd recently spoke with@pewhealth to share why she prioritizes#antibiotic stewardship. She is already seeing positive effects across the@Intermountain health system https://pew.org/30xhskj@saveantibioticsHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Latest data from FDA underscores the need for better information about how and why
#antibiotics are being used on U.S. farms.https://bit.ly/371NjMuHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Allan Coukell proslijedio/la je Tweet
Even for insured people long stabilized on methadone for opioid addiction, high out of pocket costs and burdensome regulations pose persistent barriers to staying on effective treatment.https://www.vox.com/policy-and-politics/2020/1/16/21065528/methadone-treatment-opioid-epidemic-addiction-treatment-drug-rehab …
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