Updated: Aug 12, 2020
All information below was researched and written by Jesse John Francis Clark.
This is Dr. Robert Sidonio, Jr currently hailing out of Children’s Healthcare of Atlanta. He is an avid supporter of a deadly and questionable hemophilia product called emicizumab. (Hemlibra)
For those of you who are not familiar with Hemlibra, it’s a bispecific antibody that brings Factor 9 and Factor 10 together to activate coagulation. The manufacturer of emicizumab (Hemlibra) is Genentech. The product was brought to market at blistering speed. Genentech knew that they needed to get this product out before gene therapy or they would risk losing a sizable share of the market. Hemlibra was approved by the FDA for patients with inhibitors in 2017 and then later approved for patients with or without inhibitors on October 4, 2018. For a little background info on Dr. Robert F. Sidonio, he received a BS in Biology at Troy University in 1998. Dr. Sidonio then went on and received his Doctor of Medicine in 2004 from the University of Alabama at Birmingham Dr. Sidonio then completed a pediatric residency at the University of Louisville from 2004 to 2007 and went on to receive a Master of Science Degree from the University of Pittsburg School of Medicine in 2010.
I’d like to refer to Dr. Sidonio as Doctor Mustache in this article but, for SEO purposes, I will refer to him by his legal name. I am shining the spotlight on Dr. Sidonio as he is very active in the community and is friends on Facebook with a number of hemophiliacs and caregivers. It was brought to my attention that Dr. Robert Sidonio, Jr made a comment on Facebook about me and the organization I founded, HemoAware.
As some of you might already know, HemoAware was founded to build a community of support to enhance the lives of those with inherited bleeding disorders through advocacy, education, and technology. I am very active with advocacy in the bleeding disorder community. I intentionally push buttons and make people question what is going in the community in regards to products and organizations because no one else in the community will do it. I grew up being an introvert. As a kid, I would run to my room when the telephone would ring. I didn’t want my mom to tell me to pick up the phone and answer it. I was extremely shy. Well, after thirty-six years on this planet, I am no longer that shy little boy. I found that life takes advantage of quiet people. Dr. Sidonio’s comment on Facebook is a two-part comment:
HemoAware puts out disinformation on Hemlibra
HemoAware is taking down NHF
I am going to start with the first part of the comment. On April 22, 2019, I produced a video with my staff on the second issued Hemlibra fatalities report released by Genentech. I downloaded the fatalities report and I just reiterated it on camera that there we now 10 fatalities. Honestly, If I didn’t make that video, the majority of the bleeding disorders community wouldn’t even know about it. Thet video now has over 2,480 views on it. Genentech quietly uploaded that report to its website and I decided to make the video to inform the community. I’d like to mention that the fatalities report does not appear on the patient’s side of Genentech’s website. It only appears on the physician side of the site. Here is the link to the Hemlibra product website for patients. Tell me if you see the fatalities report. You can’t because it doesn’t exist. It’s deceptive to the bleeding disorders community and it’s not right. Now, as a reasonably prudent parent, I want all of the information, not just a generic list of possible side effects.
How is it that I am spreading disinformation, Dr. Sidonio? I am reporting directly from the Hemlibra fatalities report and raising concerns on behalf of my community. I even mailed a letter to Genentech in regards to why the fatalities report doesn’t appear on the Hemlibra website.
Do you know what Genentech said in response to my letter? Nothing. I never got a response. I’m not even a patient on the damn product and I wrote a letter to a Pharma company trying to get answers on behalf of my community. Now, if I was a parent trying to get answers because my kid is on the product, I’d be pissed and would immediately pull my kid off the product because it sends a message that Genentech isn’t concerned about the health and safety of the patients.
Genentech publishes an updated fatalities report every quarter. For those of you who do not know what that means, the report is uploaded every three months. So, we get 4 updated fatalities reports per year. I monitor the site quarterly and post the updated reports to HemoAware’s website as soon as Genentech uploaded it.
I will go on further and state that the fatalities report is very vague. We do not know the full nature of each death. We can’t see an extensive autopsy report on each patient. I don’t even know if Genentech is reporting all of the fatalities. They could be suppressing that data for all I know. Not all patient fatalities get reported. Per Genentech’s fatalities report, it states: “Due to the voluntary nature of post-marketing spontaneous adverse event reports, information may be missing or incomplete” See that word “voluntary.” It’s up the the physican, parent or caregiver to report the fatality. We do not have complete data.
Another problem that we have with Hemlibra is that there is conflicting data on the deaths. Genentech’s report says we currently have 44 fatalities but on the FDA’s website, they report only 19.
“we have insufficient information on the deaths to judge whether emicizumab could have played a role. Although we understand the need to protect privacy, we feel that the current listing of the deaths at www.emicizumabinfo.com without details about the causes or a least the circumstances is of suboptimal utility, and we recommend the manufacturer to explore options to expland the information provided to include, as a minimum, the cause of death and the patient’s inhibitor status.”
I can’t agree more with this statement from Professor Makris. We need answers. We needed them back in 2019.
Furthermore, Hemlibra is only licensed for patients with congenital Hemophilia A with and without inhibitors. Hemlibra is NOT licensed for patients with acquired hemophilia. For some of you who do not know what acquired hemophilia is, I will certainly get you up to speed. Acquired hemophilia is an autoimmune disease where the immune system attacks blood clotting factor VIII and inhibits its function, leading to excessive bleeding. The disease affects males and females equally but usually develops later in life.
So far, 9 patients with acquired Hemophilia A died while taking Hemlibra. This is concerning because Hemlibra is not licensed for patients with acquired hemophilia. This is medical malpractice and Hemlibra should not be used on patients with acquired hemophilia outside of a clinical trial.
Also, on November 7, 2019, the New England Journal of Medicine published a letter to the editor from Doctor Louis M. Aledort from the Icahn School of Medicine at Mount Sinai expressing his concern over the patient fatalities and that he is “concerned that we may be seeing the beginning of a serious health issue.”
As of June 2020, more than 7,200 patients with Hemophilia A with and without FVIII inhibitors have received emicizumab (Hemlibra) globally through clinical trials, expanded access, compassionate use and in the post-marketing setting. I want to mention that 37 out of the 44 currently reported fatalities by Genentech occurred in the post-marketing setting. The post-marketing setting means after FDA has approved the product for marking. If this doesn’t make you just a little bit concerned then you have a serious problem. As a side note, the average monthly cost for Hemlibra is $45,000. So if there are currently 7,200 patients on Hemlibra, Genentech is making $3,888,000,000 annually from this product. (That’s over 3.8 billion dollars if you got lost after the first decimal)
I was in Dallas for a meeting with other hemophiliacs and I spoke to someone who is on Hemlibra. He stated that he has experienced a few bleeds while on the product. His physician makes him keep factor at home so he can infuse in case he gets a bleed. My argument here is that Hemlibra obviously doesn’t work for everyone. I thought about this for a while and came to the conclusion that maybe, just maybe, some of those fatalities were because the patient got a bleed and then decided to inject more Hemlibra in hopes that it would stop the bleed. I don’t know and it doesn't help when Genentech doesn’t release any info on the fatalities. It’s very troubling to see a post on Facebook, of all places, from Dr. Robert F. Sidonio, a licensed physician from Atlanta, stating that a bleeding disorder non-profit is spreading disinformation about Hemlibra. Dr. Sidonio, I would like to inform you that we are the ONLY non-profit reporting on Hemlibra and all of our reporting has been for the health and safety of our community members. Furthermore, it’s troubling that Dr. Sidonio isn’t raising these concerns on his own and that a community member with severe hemophilia, who isn’t even on the product nonetheless, is raising these concerns on behalf of the community. It’s also concerning that Dr. Sidonio deals primarily with pediatrics. How many children on Hemlibra is he currently treating that he has written scripts for? I did a find a video of Dr. Sidonio online praising Hemlibra but there is NOTHING from Dr. Sidonio raising the questions that I have raised in this article. Why is that? Is he getting a kickback from Genentech/Roche for every patient he puts on Hemlibra? Perhaps.
Before moving onto the second part of Dr. Sidonio’s Facebook post, I would like to mention that Genentech (the manufacturer of Hemlibra) has been subject to several lawsuits. Genentech paid $67 million in a settlement over allegations that they made misleading claims about a drug used to treat lung cancer. A former employee over at Genentech blew the whistle on this. I did three years of law school and I can tell you that you do not settle a lawsuit unless you know you are going to lose. Did Genentech make misleading claims, they sure did. Are they doing it with Hemlibra? I’ll leave that up to you to decide. Per Attorney Jeffrey Newman’s post:
"As a result of today’s $67 million settlement, the federal government will receive $62.6 million and state Medicaid programs will receive $4.4 million. The Medicaid program is funded jointly by the state and federal governments. The settlement resolves allegations filed in a lawsuit by former Genentech employee Brian Shields, in federal court in San Francisco. The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. Shields will receive approximately $10 million."
Ok, now let’s get to the second part of Dr. Sidonio’s Facebook post. Is HemoAware taking down NHF leadership? You bet your ass we are. Why is that you ask? Well, because The National Hemophilia Foundation is heavily funded by all of the Pharma companies that manufacturer the very product in which we inject into our bodies to stay alive. How can NHF be there for the community when something goes wrong with a product, such as a recall or other major catastrophe. (cough, cough tainted blood scandal, cough cough) These Pharma manufacturers pay NHF so they can get in front of the bleeding disorder community to sell their products. NHF has a multi-million dollar annual payroll and a 17,000sf NYC office all paid for by Pharma. Now, how can you effectively let your community know that something is wrong with a product when you are funded by the very same company that manufacturers the product. If NHF came out and said that Hemlibra is a potentially dangerous product, Genetech would pull all funding from NHF.
On March 27, 2018, the National Hemophilia Foundation informed the community of the first 5 Hemlibra fatalities but casually brushed it off and stated that the deaths were “unrelated.” A real organization, with some balls, would ask some questions like “how do we know that the deaths were unrelated, do you have a detail autopsy report from each patient?” That was the last NHF would ever mention anything about the Hemlibra fatalities. We are now up to 44 fatalities and not a word from NHF. Not. A. Single. Word.
Furthermore, as I am hammering a nail into NHF’s coffin, last year, on July 19, 2019, Bayer issued 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. 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.
So what did NHF do about this recall from Bayer? Well, both NHF and the Hemophilia Federation of America (HFA) 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.
I’m sorry but as a patient and community member, I have absolutely zero faith in NHF and/or HFA. I’m not waiting a week for these two idiots to get together to draft up a god-damn letter to mail to a pharma company. Bayer responded to that letter 11 days after the recall. So, yes Dr. Sidonio, I am taking NHF down. It’s for the best interest of the bleeding disorders community. I care deeply for this community even though a lot of the community members disrespect me because they have a biased opinion about me. I would to if I read something from the media whose only intention is to post clickbait articles intended to create an emotional response. I am still a hemophiliac regardless and people shouldn’t look at me any differently. I do not like fighting with my community members. I would like peace but they need to accept me. I am the only ding-dong out here raising concerns within the community. There are those who don’t believe anything I report from HemoAware. When I posted about the Hemlibra fatalities report, people didn’t believe me and it’s the same report off of Genentech’s website. When I recently posted about NHF receiving a federal loan it didn’t need, they didn’t believe me, even though I provided the federal website where they can look up the loan for themselves. I could exhume and dangle the corpse of Ryan White in front of their face and they still wouldn’t believe me. I don’t know what else I have to do. No matter how much evidence I provide to some people, they will still fight me on it. Not because it’s wrong but because it contradicts everything they thought. This is called Cognitive Dissonance. Then there are people who love and appreciate what I do. That’s why I am still here. I could have shut down HemoAware a long time ago and walked away but that is not going to do any good when there is no one else out there challenging NHF, HFA, and Big Pharma.
Dr. Sidonio, I am not here to bash you or fight with you. I am looking for peace and transparency in the bleeding disorders community. I’m looking for people to step up to the plate and ask questions when questions need to be asked. You are an educated man like me. I know you are not stupid. I don’t know how to close this article out but I will say this: I’m tired of pharmaceutical greed. One month’s worth of Hemlibra (4 vials at 60mg/0.4 ml of liquid) shouldn’t cost the same as a Tesla Model 3. I’m tired of having to report Hemlibra fatalities to my community. I’m tired of infusing. I’m tired of joint pain and, most importantly, I’m tired of being a slave to a product. I speak for myself, my daughters who are carriers and for the rest of the bleeding disorders community. I was disappointed to hear that you declined to speak at our first annual bleeding disorders conference, Dr. Sidonio. I think we could have had an engaging fireside chat.