This year's worldwide recall of defective EpiPens has put people with severe allergies on alert. And now allergy sufferers have even more reasons to worry. Faulty EpiPens have been cited in the deaths of at least seven Americans so far this year, according to FDA reports that have only been made public this week.
Mylan CEO and noted liar Heather Bresch testifying on Capitol Hill before the House Oversight Committee hearing on EpiPen price increases in September 2016 (AP Photo/Pablo Martinez Monsivais, File)
Bloomberg News recently submitted a Freedom of Information Act (FOIA) request with the FDA for information about deaths associated in any way with the defective EpiPens. The cases at the FDA are self-reported by patients and doctors, which means that it's a conservative estimate that probably under-counts the problem.
Bloomberg obtained data of EpiPen failures generally (with and without deaths), and the trend isn't good. While there were just four failures of EpiPens reported in 2012, those numbers jumped to 12 failures in 2013 and 67 failures in 2014. As of mid-September, the FDA has received a whopping 228 reports of EpiPens failing to work as intended in 2017. Of the 228 EpiPen failures in the US so far this year, 35 people were hospitalised and seven people died.
Mylan, the maker of the EpiPen, would prefer not to take any substantial portion of the blame. The notoriously confrontational drug company has said that it's "confident in the quality, safety and efficacy of EpiPens", but seemed to have a tough-luck attitude about the news that people are dying while trying to use the product.
"One needs to keep in mind that an anaphylaxis event can be deadly and, sadly, even an appropriately administered dose of epinephrine from a fully functional device may not prevent a patient from dying," Mylan told Bloomberg News in a statement. "We have not identified any causal connection between any reported patient deaths and Mylan's epinephrine auto injector products."
Yeah, that sounds like the Mylan we all know and loathe.
The problem with the FDA reports obtained by Bloomberg is that they don't specify precisely how the EpiPens failed, nor do they directly say that the failure of the EpiPens to work was the direct cause of death. Strangely, this leaves consumers without any information about what they can do to protect themselves.
Did the people who died use the EpiPen incorrectly? Is there anything that consumers can do to make sure that their EpiPens work when they're needed most? Gizmodo reached out to both the FDA and Mylan for comment.
The FDA's response wasn't exactly encouraging:
The FDA recommends you contact the company directly for that information or submit a Freedom of Information Act request. The FDA tracks adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA in a database called the FDA Adverse Event Reporting System (FAERS). However, reporting of adverse events by health care professionals and consumers is voluntary in the United States (learn more about FAERS reporting here). As such, there are limitations associated with the FAERS data, and these limitations are listed on the disclaimer page of the database, as well as here: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
So, yeah, best of luck.
Here's Mylan's statement, which curiously acknowledges that the company has made no changes to its product since 2009. Funny how they thought jacking up the price was justified if that was the case.
Mylan closely follows all reports of adverse events related to our epinephrine auto-injector products. All adverse event reports received are investigated by Pfizer and Mylan and reported to FDA. We have not identified any causal connection between reported patient deaths and device failure related to Mylan's epinephrine auto-injector products.
Further, given the increased attention to these products due to Pfizer's voluntary recall in March (as also commented on by the FDA in the Bloomberg article) and an increase in prescriptions, the rise in reports received is not unexpected, and such rises do not necessarily mean more product failures are occurring. Additionally, it's important to note that no changes have been made to the EpiPen device since 2009, ensuring patients have had a consistent user experience since that time. Mylan and Pfizer take each adverse event report seriously and fully review and analyse all reported events.
We are concerned that misleading publicity on this issue could unnecessarily discourage patients from carrying appropriate treatment for a potentially life-threatening reaction. Consistent with the FDA's guidance, we encourage patients to carry and use their prescribed epinephrine auto-injectors. Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Since 2014, we are aware of at least 2,000 incidents in schools where an EpiPen device, donated by Mylan as part of our EpiPen4Schools program, was administered, potentially saving a child's life. These represent only a subset of the potential lives impacted thanks to this product.
Patient safety is Mylan's primary concern, and we are confident in the quality, safety and efficacy of our EpiPen® products.
Mylan has had one scandal after another over the past few years. First, the company jacked up the price of the product from $US57 ($75) in 2007 to roughly $US600 ($784) in 2016 and had to testify in front of US Congress about why the company was participating in price gouging. Then the CEO lied to Congress about how much profit the company was making on each EpiPen. Then the company was exposed for over-charging the US government by $US1.27 billion ($1.7 billion). Then Mylan had to issue a worldwide recall for the EpiPen in March because the product wasn't working as intended.
And Mylan's response to consumers and the government about its price gouging has quite literally been to tell them to go screw themselves. America's regulatory agencies are clearly broken and drug companies like Mylan can do whatever the hell they want and only get slapped with a fine here or there.
I wish I had better advice for people with serious allergies who are worried about whether their EpiPen will work, but both the FDA and the drug companies seem to have just three words for you: Good luck, sucker.