What Does Idursulfase (Cost: $567K/yr per patient) Have in Common With Covid Jabs? (FDA Series Part 4)

FAERS = Fraudulent Adverse Events Reporting System

Who has ever heard about Idursulfase, one of the most expensive drugs ever produced? Who’s has heard of Hunter Syndrome?

It’s not possible to query FDA’s FAERS native Mickey Mouse Dashboard to show all Idursulfase cases where Covid jabs are considered a concomitant drug, but you can now using vaersaware.com.

Let’s start by getting the specs on Idursulfase (Elaprase) as per Grok:

Idursulfase Overview:

• Brand Name: Elaprase (manufactured by Takeda).

• Use: Idursulfase is an enzyme replacement therapy (ERT) used to treat Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. This is a rare, X-linked lysosomal storage disorder caused by a deficiency of the iduronate-2-sulfatase (I2S) enzyme, leading to the accumulation of glycosaminoglycans (GAGs) like dermatan sulfate and heparan sulfate.

• Mechanism: It’s a purified form of the human iduronate-2-sulfatase enzyme, produced via recombinant DNA technology in a human cell line (HT-1080 fibrosarcoma). It replaces the deficient enzyme to reduce GAG accumulation, improving somatic symptoms such as joint mobility, liver and spleen size, and pulmonary function.

• Administration: Administered weekly via intravenous (IV) infusion at 0.5 mg/kg over 1–3 hours. An intrathecal formulation (idursulfase-IT) is under investigation for neurological symptoms, as IV idursulfase doesn’t cross the blood-brain barrier effectively.

• Efficacy: Clinical trials (e.g., a phase II/III study with 96 patients) showed weekly infusions reduced liver volume by ~25%, improved forced vital capacity, and increased the 6-minute walk test distance by 44 meters compared to placebo. However, it has limited impact on cognitive decline due to poor central nervous system penetration.

• Safety: Generally well-tolerated, but infusion-associated reactions (IARs) like headaches, rashes, or anaphylaxis can occur. Premedication or slower infusion rates may help. Long-term studies (e.g., Hunter Outcome Survey) monitor safety and effectiveness, noting reduced urinary GAG levels and stable growth parameters.

• Cost: One of the most expensive drugs, costing approximately $567,412 per patient annually.

• Alternative: Idursulfase beta (Hunterase, by GC Biopharma) is another ERT option available in some regions, like Malaysia, with similar efficacy.

Additional Notes:

• MPS II has an incidence of 0.6–1.3 per 100,000 live male births, making it rare. About two-thirds of patients experience progressive neurological involvement.

• Intrathecal idursulfase-IT studies (e.g., NCT02055118) showed a 72% reduction in cerebrospinal fluid GAG levels but didn’t meet primary cognitive endpoints in some trials, though benefits were noted in younger patients with missense IDS gene variants.

• You previously asked about brand names for other drugs like adalimumab, so if you’re interested in alternative names for idursulfase, the primary brand is Elaprase, with Hunterase as the beta variant in certain markets.

The average life expectancy for someone with Hunter syndrome (mucopolysaccharidosis type II) varies depending on the severity of the condition. There are two main forms: severe (neuropathic) and mild (attenuated or non-neuropathic).

• Severe form: Individuals typically have a life expectancy of 10–20 years, often passing away in their teenage years due to complications like respiratory failure, cardiac issues, or neurological decline. Data from the Hunter Outcome Survey indicates a median age at death of about 11.7 years for those with cognitive impairment.

• Mild form: People with the attenuated form, which does not involve significant cognitive impairment, can live into adulthood, often reaching their 20s to 50s, with some surviving into their 60s. Studies suggest an average life expectancy around the fifth decade for this group, with causes of death similar to the severe form, primarily cardiorespiratory complications.

Early diagnosis and treatments like enzyme replacement therapy (ERT) can improve quality of life and potentially extend lifespan, especially in milder cases, but they do not cure the condition.

According to the FAERS - 3,653 cases with 617 deaths:

These Safety and Efficacy blurbs per Grok certainly do not match up to what FAERS is saying? However I’ll use this example to to demonstrate how this CDC/FDA RICO level pharmacovigilance scam gets worse!

There is only 3 reports in all of VAERS that mention Idursulfase or Elaprase and it seems there should be many more reports in VAERS and not just covid vaccines combos. As it stands there are 34 reports I’ve found so far in FAERS (Excluding 2021 data) that are Idursulfase/Covid jabs comingled combo cases.

I never stopped to think nor ever heard of any discussion regarding what obligations FDA has to make sure FAERS/VAERS are in sync? My opinion and layman thinking would tell me they should have some sort of obligation and mechanism to make sure report are crosswalked to VAERS where applicable. The HHS Secretary should instruct Susan Monarez and Marty Makary to make sure a bi-directional transmission line is open to crosswalk reports to each other and make sure both pharmacovigilance systems are in sync. Hopefully my friend Alix Mayer of FreeNow Foundation can whisper this idea into Bobby’s ear.

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Now The Brass Tacks:

Let’s look at this 22 year old Canadian male in VAERS & FAERS:

I have a confirmed match. Notice how FDA says this is a serious case, however the outcome is Other Outcomes? I’d like to pause for a second and show how disingenuous the FDA is by showing the public the ambiguous simplified definition “Other Outcomes” while internally the complete definition also includes the phrase “Important Medical Event”:

Pro-vaxx pundits would argue the report should NOT have been submitted to VAERS because AstraZeneca in not even obligated to VAERS because it’s not considered an American company and the victim was not even vaxxed in America? And why did Pfizer crosswalk this report into VAERS? Where the heck does Pfizer get involved?

I had to put my Pink Panther thinking cap on to figure this one out, and it turns out two of the three reports in VAERS/Idursulfase is this same 22 year old Canadian. This guy had a couple follow-up reports and the AstraZeneca depop shot was a follow-up to apparently his initial Pfizer jabs.

FDA also follows a disingenuous naming convention by obfuscating the Pfizer jab and calling it a Covid-19 Vaccine NOS (Not Otherwise Specified).

Somebody please tell Marty Makary and Bobby you don’t need AI to fix this willful obfuscation, rather you need to incarcerate whoever oversees and administrates this FAERS/VAERS scam.

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Conclusion:

Here I showed you over 30 reports that we should be seeing in VAERS, along with the purposeful obfuscations in FAERS and that is just with the Idursulfase/Covid jab combo. If I wanted to calibrate the dashboard to reveal the other Idursulfase/Vaccines combos there will definitely be many many more reports that should be in VAERS or somehow getting crosswalked into VAERS by the FDA or the manufacturer?

I will show you in the next article all the covid jabs they are saying are concomitant to something else and basically not in VAERS, and not being counted toward Covid jabs injury (primary product) in FAERS.

With a little financial backing, coordination, and motivation we could be reconciling these two databases (FAERS/VAERS) and calling out the obfuscation where applicable. A little Python, a little server, and more RAM is what I need for the bare bones. Hire a real Tableau Expert for a little dashboard building project that wouldn’t take long and we could watchdog VAERS, FAERS, V-SAFE to death.

Please be very discerning when listening to the puppets reading the teleprompter saying the pharmacovigilance systems isn’t working and we got Silicon Valley people and AI coming to fix things and gather more data. We need just a few honest people who are not going to bow at the alter of Baal. I hope Bobby is very selective in who he is listening to. God Bless

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