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Patients and researchers often complain that the U.S. Food and Drug Administration takes too long to approve new drugs. So it might come as a surprise that a fast-tracked approval – in this case for a drug to treat Alzheimer’s disease – met pushback for being too speedy.
But that’s exactly what happened as the FDA gave a temporary green light to aducanumab following an accelerated approval process. The decision was made even though the FDA’s external advisory board urged the drug’s rejection last year because of a lack of data supporting its effectiveness. And at $56,000 a year, treatment with aducanumab will be very expensive, especially for Medicare.
To better understand the controversy surrounding the FDA’s verdict, I asked pharmacist and drug development expert C. Michael White of the University of Connecticut to break down what accelerated approval entails. He also explained the benefits for patients – and whether the drugs are worth their high cost.
Also today:
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Do the benefits of approving a drug before confirming it works outweigh the potential costs?
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C. Michael White, University of Connecticut
The FDA approved Alzheimer's disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don't yet have.
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Education
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Raphael E. Rogers, Clark University
Few issues are as difficult to deal with in the classroom as slavery in the US. Here, a professor who trains teachers on how to present the topic offers some insights.
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Science + Technology
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Emmanuel Fonseca, West Virginia University
Fast radio bursts are the focus of a young and fascinating field of astronomy. Researchers just released data on more than 500 new bursts, quadrupling the total number of detected events.
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Jerry Malayer, Oklahoma State University
Scientists get up close and personal with deadly pathogens to give doctors the tools they need to treat people sickened by germs. The key is keeping the researchers – and everyone around them – safe.
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Ethics + Religion
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Erin Bass, University of Nebraska Omaha
Wriggling out of paying taxes may be legal, but is it right? Aristotle, Immanuel Kant – and others – have their say.
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Environment + Energy
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Daniel Baldwin Hess, University at Buffalo; Jeffrey Rehler, University at Buffalo
When Buffalo, New York, changed its zoning code so that developers no longer had to provide specified amounts of parking, space was freed up for public transit and people.
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Health
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David H. Jernigan, Boston University
In the US, underage drinking accounts for a whopping $17.5 billion worth of alcohol yearly. New research shows which companies take in most of this money and how little is spent on prevention.
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Economy + Business
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Marlon Williams, University of Dayton
An experimental study found that the vast majority of women didn't support a pay policy that corrected for an advantage they received, slightly more than men in the same position.
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David Campbell, Binghamton University, State University of New York
News about how little income tax some of the richest Americans reportedly pay is adding to questions about the value to society of their massive charitable donations.
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Beverly Moran, Vanderbilt University
A new report found that America's top billionaires paid very little income tax despite tremendous gains in their wealth.
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Trending on Site
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Deborah Woodcock, Clark University; Herb Meyer, National Park Service
Using remnants of fossilized trees, scientists and an artist figured out what the forest looked like long before humans existed.
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Chris Impey, University of Arizona
In the coming decades, governments and private companies will set up permanent bases on the Moon and Mars. And at some point, the first galactic baby will be born.
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William Petri, University of Virginia
The vaccine rollout is underway, but what happens if there is a supply disruption? Would it be feasible to change strategy and give more people a first dose? An expert analyzes the data.
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