FDA slams EpiPen maker for doing nothing while hundreds failed, people died


The manufacturer of EpiPen devices failed to address known malfunctions in its epinephrine auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths, according to the Food and Drug Administration.

The damning allegations came to light today when the FDA posted a warning letter it sent September 5 to the manufacturer, Meridian Medical Technologies, Inc. The company (which is owned by Pfizer) produces EpiPens for Mylan, which owns the devices and is notorious for dramatically raising prices by more than 400 percent in recent years.

The auto-injectors are designed to be used during life-threatening allergic reactions to provide a quick shot of epinephrine. If they fail to fire, people experiencing a reaction can die or suffer serious illnesses. According to the FDA, that’s exactly what happened for hundreds of customers.

In the letter, the agency wrote:

In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.

The agency goes on to lambast Meridian Medical for failing to investigate problems with the devices, recall bad batches, and follow-up on problems found. For instance, a customer made a complaint in April 2016 that an EpiPen failed. When Meridian disassembled the device, it found a deformed component that led to the problem—the exact same defect it had found in February when another unit failed.

The FDA wrote:

Nonetheless, on June 3, 2016, you concluded that the defect was infrequent, even though you had not examined all of your reserve samples to determine the extent of the defect within the same lot of finished products, nor did you expand your investigation to other lots... You closed your investigation and determined that “no market action would be taken.”


A momentum shift against assisted suicide

https://goo.gl/iyMkgq

Momentum is finally shifting against the legalization and expansion of assisted suicide. Twenty-three states have rejected bills attempting to legalize assisted suicide since the beginning of 2017, and these bills are now considered dead for the remainder of the year.

Why such unusual bipartisan consensus? In our profit-driven healthcare system, where care is expensive and assisted suicide is cheap, patients with terminal illnesses, people with disabilities, the elderly, and the poor are in grave danger of being pushed towards a death-too-soon. Assisted suicide policy injects government bodies and insurance companies with financial incentives into every single person's end of life decisions.

The states that defeated these bills to legalize or expand assisted suicide run the gamut politicalls, from New York and Rhode Island to Utah and Indiana. Such bills were defeated by votes in the legislature, died from inaction, stalled in committee or were completely withdrawn. A circuit court in Hawaii dismissed a lawsuit which asked the court to resolve that the criminal laws in the state should not apply to assisted suicide.

And there are four additional states — Pennsylvania, Wisconsin, Minnesota and Michigan – that are unlikely to act on similar measures this fall. Another indication that momentum is shifting in opposition to the expansion of this practice is states like Alabama and Ohio recently enacted laws to strengthen prohibition of assisted suicide. And a congressional committee passed an amendment to their appropriations bill to repeal the new DC law legalizing assisted suicide.


Who deserves a liver? Officials try to make organ transplants fairer.

Systems for choosing who gets transplants are the 21st century equivalent of eugenics....
https://goo.gl/vz5okX

His belly swollen, his energy flagging, 45-year-old Jorge Perez Remache waits in his Queens apartment for the word that his turn has come to receive a life-saving liver transplant. Though he has suffered from cirrhosis for 10 years, the chance of that happening is virtually zero.

A thousand miles south in tiny Morven, Ga., Katryna Grisson— equally sick, just three years older and, like Perez Remache, on Medicaid — awaits the same miracle. Her odds, however, are substantially better, because the ratio of available livers to people who need them is more favorable in the southeast.

“Basically, it’s not fair that my dad has to wait until he gets sicker and sicker,” said Alex Perez, Perez Remache’s 22-year-old son. “What’s the point of getting [a liver] when you’re sicker? Before they find a liver, he’s dead already.”

Under a recently proposed plan, that could change. The people who control transplants in the United States are preparing to consider a way to address the decades-old geographic disparity in liver allocation. The plan would alter how the precious organs are distributed and could shift hundreds of livers across state and regional borders.

How to distribute organs is the ultimate life-or-death decision, one that has divided the liver transplant world into feuding camps for 15 years: those who favor the current system and those who claim it costs lives. The conflict has sparked accusations of ma­nipu­la­tion of rules, led to lobbying in Congress and prompted more than 60 proposals, all of which have been abandoned.


You Can Now Download Information From Every Congressional Session Since 1973

https://goo.gl/en9geu

Since 2009, developers have been able to use the ProPublica Congress API (first developed by The New York Times) to retrieve data about the thousands of bills introduced during every two-year session in the House of Representatives. Until now though, you had to download each piece of information separately, and you needed to know how to write API calls.

For example, if you wanted to discover who sponsored a bill and also how members of Congress voted on it, you would need to download those pieces of data individually, and know how to call for them in the software code.

That's no longer the case. Wednesday, ProPublica announced that you can now download all the information about all of the bills in each legislative session using its new bulk bill data set. You can get all of the data for free in the ProPublica data store. There's also a data dictionary that can be used to decipher the bills here, and you can download them in either JSON or XML formats.

Two times a day, ProPublica will generate a single zip file containing metadata for every bill introduced in the current congress. That way, if you're interested in learning about legislation currently being considered, you'll be able to get info about it quickly.


Trump Administration Cuts $$$ for Health Insurance Outreach

https://goo.gl/NGCjyR 

The Trump administration is drastically cutting the money being spent on encouraging people to sign up for the Affordable Care Act's insurance exchanges, the Centers for Medicare & Medicaid Services (CMS) announced Thursday.

CMS will spend $10 million on "educational activities in order to meet the needs of new and returning enrollees," the agency said in a press release. "CMS will target its advertising and outreach activities to educate consumers on the new dates of the Open Enrollment Period through digital media, email, and text messages. These outreach methodologies have proven the most effective in reaching existing and new enrollees. Outreach will also be targeted based on specific demographic and geographic data."

In the last Open Enrollment period, CMS spent $100 million on education and outreach activities, according to a Department of Health and Human Services (HHS) spokesperson; that amount was double the outreach budget for 2015 - $51.2 million – when enrollment was higher.

The agency is also changing the way it awards funds to the Navigator organizations that help people sign up for coverage. Money for the Navigators -- which comes from fees paid by insurers -- amounted to $62.5 million last year; the administration expects to spend $36.8 million this year, the spokesperson said in an email.

"For the upcoming enrollment period, Navigator grantees will receive funding based on their ability to meet their enrollment goals during the previous year," CMS said. "For example, a grantee that achieved 100% of its enrollment goal for the plan year 2017 will receive the same level of funding as last year, while a grantee that enrolled only 70% of its enrollment goal would receive 70% of its previous year funding level, a reduction of 30%. The new funding formula will ensure accountability within the Navigator program."