The Hemophilia Community is Not Prepared to Handle an Emergency

As the President and CEO of a bleeding disorder nonprofit, I need to publicly let this out. What occurred over the past couple of weeks with the recent Bayer recall is a true telltale sign that the Hemophilia community is just as vulnerable now as we were 35+ years ago. For those of you that were left in the dark, on July 19, 2019, Bayer Pharmaceuticals announced a recall on two lots of Kogenate FS. This product was mislabeled as Bayer’s other product, Jivi. If that wasn’t bad enough, the product expired in August of 2018! Bayer released 986 vials of this mislabeled and expired product into the community. Bayer’s press release indicated that the last manufactured date of lots was July 15, 2019, but the actual recall did not occur until July 19th, four days after the manufactured date.


Let’s take a step back into time for a minute. Bayer killed thousands of hemophiliacs in the late ’70s and early ’80s when they released factor that was contaminated with HIV and Hep C. Not only did Bayer know about it, instead of recalling the product and destroying it, they shipped it overseas and killed more hemophiliacs. I spent three years of my life in law school. This was willful, deliberate and premeditated. This was murder.


Now, back to the current recall, both the National Hemophilia Foundation and the Hemophilia Federation of America sent out a “joint statement” to Bayer. In this statement, both organizations expressed “concern” for the hemophilia community. Mind you, the recall happened on Friday, July 19. Both NHF and HFA didn’t send out the joint statement until Friday, July 26, the following Friday! For two bleeding disorder organizations to issue a joint statement to Bayer expressing “concern” for the community, time certainly was not of the essence. Take your time guys, no rush or anything. Just 986 vials of mislabeled and expired product were released to the Hemophilia community. Do you know why it took NHF and HFA a week to send out a joint statement? Because these two ding dongs were emailing drafts back and forth all week to each other before they reached an agreement on a final draft. Then, they mailed the letter. They did not get a response back from Bayer until July 30th, which was then 11 days after the recall! It’s almost the year 2020 and the two largest hemophilia nonprofits are mailing a letter to the pharmaceutical company. You should have just used a feather quill pen and sent the letter by Pony Express. Again, no urgency guys, just 986 vials are now being drawn into syringes and into the veins of hundreds of hemophilia patients.


I read Bayer’s response to NHF and HFA’s joint statement and it’s appalling. For example, the organizations asked Bayer nine questions and one of the questions asked Bayer whether all affected vials had been sent back to Bayer. In response, Bayer said returns are ongoing and will take several weeks. You would think Bayer, who made $39.586 billion last year, would have a system in place where they knew exactly how many vials have been returned. Additionally, another question that was asked to Bayer was whether all pharmacies had been notified of the recall. Bayer said that they notified all pharmacies but that is untrue as several specialty pharmacies who my organization partners with had no idea there was a recall.

What I think is the most concerning issue at hand here is the fact that a Mother reached out to my organization stating that her son takes Bayer’s Jivi product. She needs to mix two vials together to get the required units her son needs and one of those vials was mislabeled. Therefore, she mixed a vial of Jivi and Kogenate together and infused her son.


We obviously have serious problems in our community. There needs to be an investigation into Bayer’s manufacturing procedure and they should be fined for this recall. Furthermore, both NHF and HFA need to learn the definition of urgency. The community should not have to wait 11 days to hear back from a pharmaceutical company concerning a potentially life-threatening recall. You both need to get your shit together. Additionally, all bleeding disorder nonprofits should have a direct line to every pharmaceutical company and these lines should be open for communication at all times. The days of writing letters should be over.


If you are a patient taking a Bayer product, I highly suggest you switch to a different manufacturer. They obviously have no regard for the hemophilia community.




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