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Thinking straight about orphan drugs, Part 2 Print E-mail
Written by Nicholas Bagley | The Incidental Economist   
Wednesday, 24 August 2016 00:00

As I said in my first post in this series, the Orphan Drug Act of 1983 sure seems like it worked. Over the past few decades, and in the last five years in particular, more and more orphan drugs have come on-line. Today, they account for one in three drugs approved for sale in the United States.

In general, the growing numbers of orphan drugs is taken to mean that "orphan drug legislation remains a critical part of the drug development process." The assumption is natural. After all, we all know that the patent system will yield too few orphan drugs because of the restricted market for those drugs, right? That's the premise behind the adoption of the Orphan Drug Act, and it's one that holds sway today.

Notice, though, the premise is flawed.

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Second Zika Zone in Florida Prompts CDC Travel Warning Print E-mail
Written by FHI's Week in Review   
Monday, 22 August 2016 18:44

An 8.19.16 CDC post states: 

The Florida Department of Health has identified two areas of Miami-Dade County where Zika is being spread by mosquitoes. In addition to the previously identified area in the Wynwood neighborhood, there is now mosquito-borne spread of Zika virus in a section of Miami Beach.

This guidance is for people who live in or traveled to the identified area of Miami Beach any time after July 14. This guidance also still applies for those who live in or traveled to the previously identified Wynwood area any time after June 15. These timeframes are based on the earliest time symptoms can start and the maximum 2-week incubation period for Zika virus.
 
Guidance from the CDC includes...

Read more in the current issue of Week in Review>>

Last Updated on Tuesday, 13 September 2016 15:19
 
FDA allows marketing of first-of-kind computerized tests to help assess cognitive skills after head injury Print E-mail
Written by FDA   
Monday, 22 August 2016 00:00

The U.S. Food and Drug Administration today <8.22.16> permitted marketing of two new devices to assess a patient's cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. The results are compared to an age-matched control database or to a patient's pre-injury baseline scores, if available.

"These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game," said Carlos Peña, PhD, MS, Director of the Division of Neurological and Physical Medicine Devices at the FDA's Center for Devices and Radiological Health.

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Aetna CEO Threatened Obamacare Pullout if Feds Opposed Humana Merger Print E-mail
Written by Jeffrey Herschler   
Wednesday, 17 August 2016 00:00
aetna ceo threatens
Jonathan Cohn and Jeffrey Young, in an August 17, 2016 Huffington Post article, give us a rare glimpse of the power plays going on behind the scenes among business executives and government officials.

"Finally, based on our analysis to date, we believe it is very likely that we would need to leave the public exchange business entirely and plan for additional business efficiencies should our deal ultimately be blocked. By contrast, if the deal proceeds without the diverted time and energy associated with litigation, we would explore how to devote a portion of the additional synergies...to supporting even more public exchange coverage over the next few years.
- Mark T. Bertolini, Chairman and CEO, Aetna

Read the article here>>

View the letter penned by Aetna's CEO here>>

See related story: Aetna to Quit Most Obamacare Markets, Joins Major Insurers

Last Updated on Tuesday, 06 September 2016 17:11
 
Hospitals are throwing out organs and denying transplants to meet federal standards Print E-mail
Written by Casey Ross | STAT   
Tuesday, 16 August 2016 00:00

Hospitals across the United States are throwing away less-than-perfect organs and denying the sickest people lifesaving transplants out of fear that poor surgical outcomes will result in a federal crackdown.

As a result, thousands of patients are losing the chance at surgeries that could significantly prolong their lives, and the altruism of organ donation is being wasted.

"It's gut-wrenching and mind-boggling," said Dr. Adel Bozorgzadeh, a transplant surgeon at UMass Memorial Medical Center in Worcester, Mass.

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