Allan Coukell

@coukell

In the stew of health policy, public health, drugs, food, FDA, epidemiology, pharmacy. Also bicycles. I direct health programs at Pew, but tweets are my own.

Washington, DC
Vrijeme pridruživanja: listopad 2013.

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  1. proslijedio/la je Tweet
    3. velj

    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.

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  2. proslijedio/la je Tweet
    30. sij

    Today nearly 30 groups from across health care sent a letter to & 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 al

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  3. proslijedio/la je Tweet
    31. sij

    New from in -- Unlawful stem cell products continue to harm people as FDA deadline looms:

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  4. 31. sij

    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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  5. 31. sij

    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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  6. 31. sij

    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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  7. 31. sij

    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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  8. 31. sij

    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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  9. 31. sij

    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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  10. 31. sij

    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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  11. 31. sij

    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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  12. 31. sij

    A thread: 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.

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  13. 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 regulators

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  14. 29. sij

    I can't comment on specific campaigns, but am glad this issue is getting attention and hope every candidate will address it.

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  15. proslijedio/la je Tweet
    28. sij

    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.

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  16. 27. sij
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  17. 18. sij

    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.

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  18. 17. sij

    . chief patient experience officer recently spoke with to share why she prioritizes stewardship. She is already seeing positive effects across the health system

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  19. 17. sij

    Latest data from FDA underscores the need for better information about how and why are being used on U.S. farms.

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  20. proslijedio/la je Tweet
    16. sij

    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.

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