Unbiased Analysis of Today's Healthcare Issues

Off-label prescribing

How frequently are pharmaceuticals used off label?  Perhaps more than you think.  Although these figures are a bit dated, Tabarrok (2000) details the extent of off-label prescribing in the U.S. as follows: According to a study by the U.S. General Accounting Office, 56 percent of cancer patients have been given non-FDA-approved prescriptions, and 33 percent […]

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The Voice of the Patient

Did you ever wonder what is is like having lung cancer?  Or narcolepsy?    What factors are most important to patients when receiving treatment for these diseases? The FDA is working to collect these answers to help guide their drug approval process.  The FDA’s “Voice of the Patient” aims to “…more systematically gather patients’ perspectives […]

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Drug approval and reimbursement when clinical trials use surrogate endpoints

An interesting paper from some of my colleagues at Precision Health Economics: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of […]

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How we should pay for cures, according to economics

I have an article up at the Washington Post‘s In Theory blog titled How we should pay for cures, according to economics. Imagine a major medical breakthrough: a cure for Alzheimer’s. Imagine that cure not only would improve the cognitive abilities of the more than 5 million Americans living with Alzheimer’s but also would give these patients […]

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FDA to Consider Patient Preferences

Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information […]

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Narrow Networks

One of the ways health plans in the health insurance exchanges have been able to keep premiums down is through offering beneficiaries very narrow networks. By steering patients towards “efficient” doctors, premiums stay low. However, patients may worry that these “low cost” doctors are lower quality than those outside of the network. The tradeoff between […]

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Does your FitBit need to be FDA approved?

Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology.  This guidance  says it will not regulate “general wellness” products like the FitBit. However, if the wearable cites health benefits for […]

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Regulatory Tsunami?

Medicare is working hard to make sure that doctors are efficiently providing high-quality care. Programs such as the Physician Quality Reporting System (PRQS) and the Value-Based Payment Modifier all are aimed to improve quality and lower cost. The downside of such programs, however, is that the impose reporting burdens on physicians. For instance, Medicare can […]

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Residency Hour Restrictions and Patient Outcomes

Residency has been a right of passage for physicians. Long 36-hour shifts mix with the excitement of new learning. However, recent regulations have now capped residency weekly hours at 80. Although patient medical care in the short-run may improve (because physicians are less tired), in the long run, are physicians exposed to as wide a […]

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Too much or too little regulation

Getting Obamacare subsidies may be too easy or too hard depending on your perspective. From MSN: In May 970,000 people had citizenship data errors in their Obamacare applications. As of August, 450,000 of those cases have been resolved, 210,000 are in progress and 60,000 new documents arrive every day. The 310,000 remaining applicants will receive […]

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