Roche Pharma | The Tamiflu Fraud
In 1999, the FDA approved Tamiflu for the treatment & prevention of Influenza. In 2020, a Federal Judge denied Roche's motion to dismiss a $1.5 Billion Fraud suit. But, Roche is at it again!
Brief Background
On October 27th, 1999 the FDA approved Roche’s new antiviral drug Tamiflu (Oseltamivir) for the ‘treatment and prevention’ of Influenza.
Based on unpublished trial results, Roche made the following claims:
Tamiflu reduces hospital admissions by 61%
Tamiflu reduces secondary complications by 67%
Tamiflu reduces the need for antibiotics (prevent pneumonia) by 55%
Recommendation: Use Tamiflu within 48 hours of flu symptom onset.
Roche had cleverly convinced European and US governments to stockpile billions of dollars worth of Tamiflu in the event of an Influenza pandemic - to “buy time for vaccine development.”
The US purchased approximately $1.5 billion of the stuff.
Cochrane
The Cochrane Collaboration, now known simply as Cochrane, is a non-profit organization started in 1993 in Oxford, UK with the intent to…
perform rigorous systematic reviews of randomized clinical trials, to ascertain what benefits and harms are associated with an intervenion
Cochrane is one of the most respected institutions in Medicine.
Cochrane is synonymous with systematic review, meta-analysis, and evidence-based medicine.
On the inquiry of a Japanese pediatrician, Cochrane attempted to track down the data that was used by Roche to buttress their claims. This did not go so well.
As it turns out, Roche left seven of their trials on Oseltamivir unpublished - submitting only the two trials which could be statistically hacked to show some benefit to regulators.
What is Tamiflu?
Although Tamiflu is marketed as an ‘antiviral,’ it is a neuraminidase inhibitor. Neuraminidases (Sialidase) are enzymes that break a bond between a sugar and another molecular group. They are found in mammals, bacteria & viruses.
For viruses, it is thought to block the enzyme (sialidase) that assists viral copies to spread from cell to cell.
Meaning, it is not supposed to prevent infection or transmission - so how in God’s name could it help in a pandemic?
Based on Roche’s published data, they were able to convince the European Medicines Agency (EMA) to approve the drug for prevention of influenza complications.
Initially, the FDA was not so warm to this product. At first, they sent Roche a letter asking them to stop claiming that Tamiflu reduces severity and incidence of infection - requiring them to add to the label:
Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian or pandemic influenza.
At the same time, GlaxoSmithKline was trying to get its own neuraminidase inhibitor, Zanamivir, onto the market. Unfortunately for them, the FDA advisory committee voted 13-4 against approving the drug.
GSK were not so happy about this and fired back at the FDA, stating:
…[the decision] is completely at odds with the will of Congress that drug development and approval proceed swiftly and surely.
The FDA then responded by overruling their committee and removing the statistician involved with Zanamivir’s analysis. The same statistician was also tasked with appraising Tamiflu’s efficacy…so he was removed from that as well.
Once the FDA overruled its own committee, and approved Zanamavir…they had no choice but to also approve Tamiflu.
FDA Approval
We now turn to the FDA approval letter of Tamiflu.
…two principal studies suggest that treatment with oseltamivir (Tamiflu) confers a modest benefit of reducing duration of uncomplicated influenza illness and that this benefit is appropriately balanced by a reasonable safety profile.
Sounds reasonable enough, right? Remember the comment on ‘safety profile.’
Let’s continue reading.
1. Estimation of magnitude of treatment effect
…in influenza-infected adults each demonstrated that treatment with oseltamivir resulted in a 1.3 day reduction in median time until symptom improvement
Remember, this is placebo-controlled.
Which means that Tamiflu improved symptoms 1.3 days faster compared to doing nothing. Not compared to Tylenol or even chicken broth.
The FDA goes on to state:
4. Outstanding questions
…this application does not contain information on the following important questions:
Safety and efficacy under 18 years of age
Efficacy over 65 years of age (the high risk group)
Prophylaxis and interruption of family transmission
Preventing complications due to influenza (pneumonia, hospitalizations or death)
To most people, including myself, this doesn’t seem like a very convincing drug. I would always chastise my superiors for insisting on giving Tamiflu to an admitted patient, and they’d always say the same thing
“But it reduces symptom duration” - whilst also giving them Tylenol & antibiotics. Embarrassing.
It took the FDA barely any time to expand its indications for Tamiflu:
Within one month of approving it for people 13 years +, they approved it for 1-year-olds.
Does this time of hurried time-frame seem familiar to anyone else? Déjà vu.
House of Cards
Tamiflu does not prevent the spread of influenza.
Tamiflu does not reduce complications, hospitalization, or mortality due to influenza.
How did Roche convince regulators to approve this rubbish?
One of the ghostwriters for their marketing campaign said:
The Tamiflu accounts had a list of key messages that you had to get in. It was run by the marketing department and you were answerable to them.
Since the 1990s, Roche & Friends sponsored and funded countless studies to show that Tamiflu was effective.
40 clinical trials, sponsored by Roche - only 2 sent to the FDA
2003 meta-analysis, sponsored by Roche
WHO funded systematic review of 74 pooled observational studies - quality of evidence was low to very low
Roche funded another meta-analysis during the H1N1 pandemic
Cochrane Review
Under pressure from the above-mentioned Japanese collaborator (Hayashi), Cochrane decided to perform a complete analysis of the clinical trial data.
From 2009 to 2013, Cochrane had corresponded with the WHO, FDA, CDC and EMA. As it turns out, none of these regulators had the complete trial data from Roche.
It wasn’t until 2014 that Roche finally revealed the data to Cochrane.
These were Cochrane’s findings:
16.8 hour faster symptom resolution in adults, 29 hours in healthy children
No benefit in patients with Asthma
No benefit for reducing pneumonia, hospitalization, or transmission
No difference in rate of hospital admission
Weird adverse effects, e.g. neuropsychiatric events, depressed mood, behavior disturbance, panic attack, suicidal ideation, delirium, convulsions, and encephalitis….
Note: No adverse events were revealed in the published trials
No adverse events were reported. The FDA was convinced by the complete lack of adverse events for a novel drug? Déjà vu.
In a fashion that became painfully obvious to us in 2021, the WHO dismissed concerns raised about management of the H1N1 flu epidemic as conspiracy theory. According to the WHO, use of Tamiflu to curb transmission whilst a vaccine is developed was the strongest reason to recommend it.
The WHO did not have complete trial data to make this assertion.
Legal Battle
A lawsuit was brought by the Cochrane collaborators in 2014. They filed in the US under a False Claims Act, alleging that Roche made false claims about Tamiflu, which led the government to spend $1.5 Billion on stockpiling the drug in the event of a pandemic.
Unfortunately for us, Roche stopped caring about what happened to Tamiflu, because its patent expired in 2016. In 2009 alone, they made $3.2 billion in revenue from Tamiflu.
New Horse in the Race
Roche have shifted their focus to their new blockbuster Influenza drug - Xofluza.
Xofluza (baloxavir marboxil) is yet another enzyme inhibitor - this time an endonuclease inhibitor. Yet again, a novel drug with a novel mechanism.
How does it compare to Tamiflu? Glad you asked…
Xofluza is a single-dose…Tamiflu is twice-daily for 5 days
Xofluza is used within 48 hours of symptoms, so is Tamiflu
Xofluza has shown reduced time to symptom resolution…just like Tamiflu
As expected, the FDA approved Xofluza in 2018 on the basis of one phase 3 trial, and one phase 2 trial - to be used on anyone 12 years of age or older.
Interesting comments from the FDA approval letter:
If influenza symptoms were severe between Days 1 - Day 22, patients were given rescue therapy - Tylenol!
Influenza-related complications were reported in 16 subjects (4%) in Xofluza arm, and 10 subjects (4%) in the placebo arm - no difference
Summary of Chicanery
Roche made false claims to the US regulatory agencies to induce approval of a novel drug. A drug which does not provide any more benefit than Tylenol or chicken soup. Roche failed to disclose adverse events to regulators. Tricked the US (and the EU) into stockpiling $1.5 billion dollars worth of this useless drug.
Is in an active lawsuit because of these actions.
What does the FDA do?
Approve an almost comically identical drug, for the exact same indication…measuring the exact same useless endpoints.
Oy, vey.
Take-away
The masses are waking up to the fraud committed by captured regulators, media, & politicians over the last 2 years.
Don’t get me wrong, this is good - it’s long overdue.
I say ‘long’ because I mean it quite literally.
Everything we have witnessed from these charlatans, they have been doing for decades.
That includes:
Pharma & Biotech
Corporate media
CDC
FDA
NIH/NIAID
WHO
This time around, they seem to have arrogantly overextended themselves - and people are catching on to the grift.
My goal is to make sure the past crimes are recognized for what they were.
The arrogance of man knows no bounds. The potential damage is likewise unlimited.
Follow me on Twitter @RemnantMD and Instagram @remnant.md
"reducing duration of uncomplicated influenza illness" if it's uncomplicated, I'll take chicken broth and a rest dayif it's complicated that drug ain't gonna help.
Excellent article! I’m saving this to share with family who still flock to drugs for supposed relief. Chicken soup for the win!