Genentech Now Hiding Hemlibra Death Data from the Hemophilia Community

Hemo Times has learned that Genentech will no longer publish quaterly data on hemlibra deaths. HemoAware Founder, Jesse John Francis Clark, talked about this on Episode 3 of the HemoAware Podcast.

Professor Michael Makris

We have also made a transcript of the podcast available for you below.


INTRO: Welcome to the HemoAware podcast with your host, Jesse Clark. The show to promote public awareness about rare, inherited bleeding disorders.


JESSE JOHN FRANCIS CLARK: What's up everyone. Welcome to episode three of the HemoAware podcast. Glad to have you, if this is your first time. Welcome. If it's not your first time, then welcome back. Before I get into today's episode, I just want to talk about something real quick and it's kind of concerning. If you saw the Hemo Aware account this morning, the Instagram account, you would have seen that we posted something very concerning regarding the drug Emicizumab also known as Hemlibra by its commercial name. Today Genentech announced that they will no longer give the community access to the quarterly death reports on the website. We will no longer have access to that. As it stands today, we have currently 44 fatalities with Emicizumab. Now 37 out of that 44 happened after the drug was FDA approved. Now that's kind of concerning. I have been advocating for the safety and transparency of Hemlibra since April 2019. That was the first time I took the camera, put it on a tripod hit record and let the community know that there were 10 deaths.


Okay. Now all of these other foundations, NHF HFA reported on the first five fatalities and Hemo Aware also reported on the first five. We didn't make a big deal of it. But when we got the second report, which was the next quarter stating that there were 10, I'm like, well, this is kind of concerning. Now we went from five, now we're going to 10. I need to let the community know about this. I put the camera on the tripod hit record and I made a video. Some people thought it was concerning. Some people thought I was crazy. The fact of the matter is I printed out that fatality report from their website. I just reiterated what I saw on the report. So people were fighting me over it and I'm like, I'm just trying to report this guy, and report this to you.


Don't get mad at me, but it went from 10. Then it went from like 13 and it just kept going and going and going every quarter. Now we're up to 44 and now Genentech stating that they will no longer provide the reports to us. Does that mean that there's more and they don't want to report on it because it's making it look bad? Probably. I mean if Genentech doesn't have anything to hide, then publish the damn reports. Why all of a sudden you got to stop reporting. It wasn't an issue before and now it's an issue? It's kind of concerning. If you're born with half a brain, just half of the left side, let's say you, would comprehend what the hell is going on here. They're trying to hide something, okay? Now I'm not on Hemlibra. My nurse practitioner wanted to get me on Hemlibra.


And I said, no after I did some due diligence. Because Genentech has been sued before for misrepresenting a product that led to a large settlement. I just wanted to sit back and see how this drug would do with other patients before I made a decision. After all of this, I will never take Hemlibra. You know, it was kind of concerning that the community will no longer have access to this data. I went and did the reporting and the research and everything and I published the most extensive reporting on Hemlibra to date. It's on Hemo Times, I posted it a couple months ago. If you go to the hemotimes.com, just keep scrolling down you'll see this article on Hemlibra, that I published and it took me eight hours to do this. I wanted the community to see all of this data that I have, and to make their own decision before getting on it or whatever.


But if you want to take a look at that report, you can go to a hemotimes.com and you can look at it. I just want to let people know what's going on with the Emicizumab, also known as Hemlibra. They're withholding the death reports now. So, which is very, very concerning. I wanted to let you guys know about that. Genentech did state, however that they will provide the death reporting in scientific meetings only. What constitute a scientific meeting? Does as a hemophilia conference constitute a scientific meeting. Probably not. I don't think the community will ever know any more on this fatality report. I don't think we'll ever see it again. And the startling thing, I made a video on this, I haven't posted it yet. But I seen it last week, made a quick video on it to let the community know.


Now that we're not going to have access to these reports anymore. It's kind of a moot video, but I'm still going to post it because it's still evidence of the wrong doing of Genentech here. But if you go to hemlibra.com, there's nothing on the death reporting, nothing. There's no PDFs, there's nothing. There's nothing like that. And this past week, Hemo Times posted a video. It's a leaked, a video. It's an audio recording from HFA Symposium in Cleveland on a Hemlibra presentation. Now, the reason why we posted this is so people can actually see that the representative who was paid by Genentech to put on the presentation, she was urging patients to go to hemlibra.com. If you have any questions, if you want to review information, she keeps saying, go to hemlibra.com. Well, if you go to hemlibra.com, patients will never see the death reporting on there because they've never posted on hemlibra.com.

If you want to see the death reports, you got to go to emicizumabinfo.com. Now the reason why they do this is because it's a lot harder to type in Emicizumabinfo.com than it is just to type in Hemlibra. Everyone who wants to do any research on Hemlibra is this going to type in hemlibra.com because it's easier. Genentech buries us information on emicizumabinfo.com. If you go to emicizumabinfo.com and you click on patients and caregivers, and then you click on safety then you scroll all the way down to the bottom of the page, you're going to see tiny little font. They must have told their web designer said, hey try to use the tiniest font you can. It's going to be like size 11, maybe size 12 font on the right bottom. It says fatalities, and the word fatalities this is hyperlinked.


You have to do is just click on it and then a PDF shows up of the deaths, okay? That's how you get to the death report. You have to go to emicizumabinfo.com, click on patients and caregivers, then safety, scroll all the way down to this little word that says fatalities that's hyperlinked to click on that and then the PDF shows up. You would think you would want and info on hemlibra.com. Patients can see all of the data, all the reporting so they can make a cognitive decision, but they don't. They hide the information, they buried the information. Now they're not even going to give the information to the consumer, also known as the patients taking the product or going to take the product. This is concerning now. 37 out of 44 fatalities happened after it was FDA approved, but there's been no reporting on this at all.


No independent agency has come forward to say, hey we want to do a study on this. We want to check the data, we want to make sure this is safe, but nope, nothing. We have absolutely no data. We have no fatality reporting, death reported, we have no autopsy reports on the patients. We don't know how these patients died, we don't know if it's connected to Hemlibra or not. These are the questions I want to know. I want to know the liver toxicity of patients on this product. I am just very concerned about this and my community. Before I make this all a Hemlibra podcast, I think I should stop it there. I just wanted to let you guys know what's going on. But for the community, I have made a website. I own the domain names, hemlibradeaths.com and hemlibrafatalities.com.


I've made it easier for people to get this information with the article that I've written. Also the fatality report that is on hemlibradeaths.com and also hemlibrafatalities.com. If you go to that, you'll bypass all this information that I told you to go to on emicizumabinfo.com. You don't even have to go there. Just go to hemlibradeaths.com. All of the information is there for you. It's made it easier for everybody, just wanted to let you know about that. That's kind of concerning that they're doing that. We will never know if there's any more Hemlibra fatalities. Now I do want to mention one more thing before I move on. There have been 44 deaths with patients who have taken Hemlibra, whether it was compassionate use or whatever, there have been 44 people. I have made Google ads. I've made Facebook ads trying to target the families or caregivers of the people who died on Hemlibra. I've been trying to at least talk to somebody to see what happened, and if I can get any information. I have made these ads for a long time, trying to target people, and I can't get one single person of this 44 to talk about what happened. I can't find anything online from people, from families, caregivers talking about happened nothing. It kind of tends to tell me that they have made and when I say they, I mean, Genentech has made a cash settlement to these people who have died to be quiet. It was we'll give you money because of the fatality. You sign a nondisclosure agreement and that'd be it. I think that's what happened. I may be wrong, but kind of odd that I can't get any people to talk about the fatality or anything, what happened after the death. I wanted to let you guys know about that. But I will continue to update the community, if I know anything. If I see anything, come across anything, hear anything I'm going to let you guys know right off the bat. I have always kept the community updated with the community with the reporting and the fatality's. I made videos, I've made articles and I will continue to do that. I've been the only person in this community to advocate for the safety and the transparency of Hemlibra. I will continue to do that. Without further ado, we're getting into episode three of the HemAware podcast. Today I want to go over all of the activity, all of the drama that has happened over the past two weeks in regards to my HTC, kicking me out as a patient.


For those of you who are not up to speed yet, you're going to get up to speed today. Last Tuesday I went in for my regular appointment. And for those of you who don't know I was on the BIVV001 study drug, which is through bioverativ. Bioverativ is trying to get this drug FDA approved. It's kind of backtracked because of COVID. A lot of patients who were on this study drug weren't able to get on it because of COVID. Now it has delayed the study about three to four years now. You're not going to see this FDA approved anytime soon. I think if a gene therapy product hits the market before this, this things didn't get blown out of water. They won't see the light of day. If it does, then this is going to be a very little patient's on this product, but whatever.


I was on this drug, the study drug. I would go in every week to, to get infused with this drug. They would take blood and just do whatever they needed to do in regards to the study. Last Tuesday, I went into my HTC for my regular weekly appointment. Before they even did anything, Amber Federizo, my lovely nurse, former nurse practitioner walks in and she has a clipboard with a contract. She says we know you own our domain name. And what I have in my hand is a quote unquote, behavior contract. You need to sign it, and if you don't, then we're going to give you 30 days to find a new HTC. I looked at this half-ass contract, and I did three years of law school.


I'm looking at this contract and like the first paragraph's font is bigger than the rest of it. It was quickly thrown together. It was copied and pasted. It was basically telling me, I can't say anything bad against HTC. I can't go online and read any reviews. I can't do this, I can't do that. If I violate any of the terms in this agreement, then the HTC can bring suit against me. If they win in court, I am responsible for any and all attorney's fees and court costs. I'm looking at an Amber and I said, can I have a week to look this over? See what my legal options are? She's like, Nope, you've got to sign this right now, and if you don't sign it right now then that's it.


We're going to just take you off the study drug, we'll just give you some random factor and you'll be on your way. You'll have 30 days to find someone else. Amber started talking to me about a lot of things that happened in my life and it was irrelevant. I thought it was very unprofessional. She talked about my kids and my past, and it had nothing to do with the study at all. I had just a little bit of respect for Amber. You know, I've seen her for six years I went in there, I was a nice to her. Even though I kind of felt like she wasn't very nice to me, but I was always nice to her. After what she said in that room, it was just irrelevant.


I lost all respect for her. I don't know why all of a sudden, after six years I have to sign an agreement in order to be treated. It's just not right. So I refused, I said, keep it. Then she took the contract back and then she comes in the room since I'm not going to be on the study drug anymore. Basically she's playing God, and just taking me off that study drug. Even though I'd never signed anything to be taken off, I never specifically said I wanted to be taken off this drug. She just said, okay, that's it. Then she comes in with two boxes of, I think it was a Bayer product. I think it was Kovaltry. We're going to infuse it with Kovaltry. You're going to have to come back Friday and you'll have 30 days to find someone else.

Then on the 30th day, if you come here, the police will be here. I'm like, whoa what the hell are you talking about the Police will be here? I mean, I'm just here to get factor. You act like I'm here to rob the place. Police are going to show up, it was very confrontational. I don't know how this woman expects me to come here for the next 30 days while I try to find a new HTC and come here and be in this hostile environment. How am I going to do that? Then listen to this, so she wants to put me on Kovaltry, which is a Bayer product. Now, if any of you know, I have been a big advocate against Bayer because of the whole contamination thing Back in the eighties.


I've also made a T-shirt on the HemoAware website of the Bayer logo. Instead of saying Bayer, it says murder, because that's what they did. They got away with it and I would never, if you even paid me to take a Bayer product, I wouldn't. I looked at her, I said keep it. I walked out, not even going to discuss it. I've never, ever, ever, ever, ever been treated like that as a patient ever. It was just so unprofessional what went down there. The poor nurse there, his name's JR. He was in the middle of all this and I've known JR for the past five years. Nice guy, and it just sucks that he was the poor guy in between this back and forth with me and Amber. But as Amber is yelling at me and you know, telling me all this stuff, I'm just shaking my head.


You know, I'm not a confrontational person. I'll just shake my head, I'll agree with you sometimes. I'll be like, yep. Okay. Yep. And that's what I did. I wasn't about to a stoop so low as to start arguing back and forth because that's just not going to get anywhere. I'd rather just shake my head and walk out rather than get into a confrontation. Then you just look like two idiots going back and forth, yelling at each other. So I walked out after she tried to get me on Kovaltry. The interesting thing is, is that prior to me being put on this study, I had a whole shipment of Eloctate, that was mine. My insurance company paid for it. And it was stored there at the clinic. Now I asked her where's the Eloctate that I had prior to this study?

She's like, Oh, we threw it out. It was expired, threw it out. You could at least told me you threw it out, it is my factor. You could have offered to give it to me or whatever, but you just threw it out? It was like $74,000 of factor you just threw out? Well, so it tends to lead me to believe that they took that factor because there's a pharmacy there at the clinic. They took that factor and they resold it to someone else, probably another patient who is on Eloctate. That's what they probably did with it, they didn't throw it out. If they did throw it out, they should have at least told me. They should have offered for me to have it. I mean, I'll take expired factor. Expired factor is still good. It may not be as potent, but it's still good.

I'll take it. I'll ship it to people out in Africa or Portugal or wherever, Iraq. I constantly get emails every day, messages on Instagram, from people from third world countries trying to get factor. Even if it's expired, they'll take it. Just give me anything. Nope, I don't have it. And I've always contacted the pharmaceutical company to see if we can get expired factor. They don't won't give it up. They act like this stuff is like platinum gold, like its currency. That's really what it is. They'll never give it up. I couldn't even get on Eloctate. I mean, I would have come back if they put me on Eloctate, but I don't know how they expect me to come back for the next 30 days while I'm trying to find another primary care in this hostile environment. And it was hostile.


It was a very hostile and very unprofessional. Never in my life have I encountered something like that at an HTC ever. This all stems from me having to do with their domain name. For those of you who kind of missed episode two, I bought the HTCs domain name like a year and a half ago because they never donated to Hemo Aware, they never offered to do any events with us. I've countlessly tried to get that HTC involved to do anything for the community, even if it was a hundred dollar donation. So I could give it to some, someone who needed financial assistance, something they never did anything. Then I turned around and find out that they gave $160,000 donation to the NHF Nevada chapter. It kind of pissed me off a little bit, so I bought their domain name, htcnv.com.


Now they own htcmb.org. But most people, when they type in a domain, they type in dot com because it's the most common extension. So everyone who would go to that website would be redirected to Hemo Aware, and at HTC found out and it pissed them off. Their executive director came up to me one day prior to my appointment and said hey I noticed you got ahold of htcmb.com. Do you mind forwarding that to us? At one point, some point in time, we'll take it over permanently. But for now, can you just redirect it? I'm like yeah, okay. I went home and I thought about it and I'm like, you guys never did anything for Hemo Aware, why am I going to do anything for you? So I wrote him back an email. I have his email and I said, Hey Jerry, I was thinking about the domain name and you guys never donated a Hemo Aware.


So I'm going to have to respectfully decline forwarding the domain. But if you want the domain, I went GoDaddy and I did an appraisal on a domain and it was $1,400. If you want the domain, you can pay me $1,400 or I'll have GoDaddy buy it back from me. Then you can buy it from GoDaddy. But anyways, just let me know and didn't I hear back from him. So when I went into my appointment last Tuesday, that's when Amber came in with the little clipboard, with the little fake contract and try to get me to sign that and transfer over to the domain. Can't say anything about the HTC, can't write reviews, can't do nothing. It was basically a hush contract and keep me quiet. I didn't like that, I don't like to be kept quiet.

It's my freedom of speech. You're going to restrict that over hemophilia. I don't think so. I wanted to let you guys know what happened at the clinic. What happened after me trying to get the factor a whole other ordeal, so I'm going to go into that now. After that thing all happened, I was trying to actively try to get at least an box of a Eloctate. No, I contacted Bioverativ and I told them the story that I had a falling out with my HTC. Can you send me a box just to get me through? So I have something in case I get a bleed? I'm searching for a primary care to write me a script for this?. I spent a half hour on the phone with Bioverativ 30 minutes going back and forth.


I'm talking to this rep, she's putting me on a hold, so she can talk to her supervisor to see if they can do this. Going back and forth, back, forth, putting me on hold, taking me off hold, putting me on hold. And after the 30 minutes, she's like, no, I'm sorry but we won't be able to help you. The best thing you're going to have to do is find someone to write a prescription. So even Bioverativ couldn't send me one box complimentary. After all these years of being on Eloctate, they wouldn't even send one box of Eloctate the tide you over. Can you believe that? It wouldn't surprise me but I tried and whatever. I'm like, well, if you don't give me the box of factor, then you know what? You don't give a shit about me.

I don't give a shit about you. I posted on Hemo Times, leaked all of the study documents on BIVV001, the whole thing, everything that Amber gave me, I just put it up there. Because why should I help Bioverativ keep this study drug quiet then? If you're not going to help me so forget about it. Published it to the Hemo Times said, Hey, just publish this, get it up on the website to my staff. We published it and I got some more stuff to publish on BIVV001 that's going to be going to be leaked this week, but we did it. So 24 hours after the posts of that Hemo Times on BIVV001, a Bioverativ, Sanofi owns Bioverativ, they contacted me less than 24 hours after the post and said, Hey, this is property Sanofi, can you take this down?

I'm like, well, I contacted your representative. I tried to get a box of Eloctate to tide me over because I had a falling out my HTC. And you said no, so I'm going to tell you exactly what your representative told me. And that's no, I'm not taking it off the website. Then after the whole Sanofi Bioverativ telling me they couldn't get me a box of factor. I'm going through my phone, and I'm saying, well, who do I know that can write me a prescription? I know one nurse through Hemo Aware, because in the community you get to meet people. I contacted this nurse and I knew from her Instagram that she worked with a primary care person, a doctor.


So I went to that Instagram account of that doctor and contacted her. I said, Hey, I had a falling out with my HTC. I don't have any factor. I need to get a prescription. Can you help me out? Then she did a FaceTime with me. One-on-one, spent an hour with me just going over everything. Very nice lady, and she wrote me a prescription. We had that prescription forwarded to a pharmacy here in Las Vegas that my nurse friend works directly with. They were going back and forth trying to get this all set up and trying to get the copay waived because the copay is ridiculous. I was on some assistance, co-pay assistance program with CVS earlier. CVS sucks by the way, terrible, terrible, terrible. Do not ever through Caremark or CVS specialty, terrible. Years ago I was on Eloctate and I was going through Caremark pharmacy. Every time I need a prescription, they're like, Oh, we need to get a prior off from your doctor.


Why couldn't you get the prior off, prior to me calling you to order the factor? You guys knew I needed a prior authorization you could have handled this before I called for the prescription. You know I call every month to get a prescription for Eloctate. Why can't you guys do this beforehand? The last time they did this, they were texting me back and forth. They're like yeah, we sent over the prior auth of your doctor and we're just waiting on the doctor. So I'm texting my doctor and I said, hey what's going on? CVS is saying that they're waiting for you to do this prior auth. They are like, oh we gave that back to her the two days ago. CVS Caremark here is telling me that they're waiting on my doctor, but my doctor already submitted two days ago.


It's like CVS didn't have their act together. They don't know what's going on. It was all on text, and I think I published it on the Hemo or Instagram. And somebody in the community saw it that was tied to Caremark and Caremark found out. When I try to order my next month's appointment factor, they're like, Nope, we can't contact you through text anymore, you have to call. I'm like, what the hell? I figured out, I put two and two together and I found out that they found out that I outed them and copied all their text on Hemo Aware and told the community not to use CVS Caremark anymore. That was my last interaction with them before I got on the study drug. I will never ever go back on CVS Caremark or CVS specialty, anything like that. Because they just, they don't have their shit together over there.

Anyway, I had basically a team. I had three people. I had my primary care person. I had my nurse friend and then I had the pharmacy representative, all texting we are all texting, back and forth trying to get this prescription for me. And finally 17 days after I got infused through Amber with the Hemostasis and Thrombosis Center of Nevada, also known as HTCNV, I finally got the factor. Thank you to the people who took care of me. Those of you who know who you are. I'm not going to say your name on here but I appreciate it. It took a long time to sort everything out and get the insurance and everything, but I finally got the factor.That's it, that's my story finally got the factor after 17 days. After being infused over at the Amber's HTCNV and I am done with their bullshit. I think I got to get pretty good team behind me now. Very, very caring, they worked fast on it and it's good to know people I guess, right? If you made it this far into the episode, I appreciate it. I think that does it for episode three of the Hemo Aware podcast. Thank you. Always keep you guys posted, make sure to follow the Hemo or Instagram account, or the Hemo Aware Facebook account. Make sure you check out hemotimes.com and we'll keep you posted until next time. See you.


OUTRO: Thank you for listening to the HemoAware podcast, to learn more about HemoAware or to catch up on recent bleeding disorder news, visit hemoaware.org.

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