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Monday, July 15, 2024 7:17:35 PM
The European market for Vazkepa, which has no competitor, can be estimated at roughly €10 billion for secondary prevention, targeting 6 million patients with an annual cost of €1,700 per patient. Yet, Amarin is valued at a mere $300 million. This is not a normal valuation.
Why is a potent drug like Vazkepa struggling to gain traction?
Uninformed opinions have permeated prominent medical journals such as the NEJM and the BMJ, followed by articles in the physician-targeted press. The Nissen’s flawed JAMA Cardiology paper, which calls for a new trial and suggests that mineral oil is toxic, has been a catalyst for these attacks against Vazkepa. Amarin must actively challenge the undue credibility given to doubts about its efficacy, as these doubts are impeding the drug's acceptance.
I have red thoroughly this JAMA paper and it is riddled with bias which are easy to uncover. Therefore, it should be in the best interest of Amarin to formally request the retraction of the Nissen’s JAMA Cardiology article, citing its extreme bias and inadequate review. It would be a first step in the right direction and would pave the way for the medical press to recognize the drug's true potential.
Now my question is: how can we make it inevitable for Amarin to request a retraction?
I have two analyses which if published in the right media might do the trick:
• An inescapable demonstration of the inanity of Nissen’s assertion regarding mineral oil's toxicity.
• Evidence that the discussion in the Nissen’s JAMA Cardiology paper is riddled with bias, making it easy to request its retraction.
For a demonstration to be truly effective, it must be logically irrefutable. However, many analyses favoring Vazkepa's efficacy, even those from the Reduce-It investigators, rely on arguments that, while compelling, may be susceptible to counterarguments and ultimately lack definitive proof. My own analyses lead to an inescapable outcome. After a thorough investigation, I have pieced together parts of the puzzle regarding the impossibility of any plausible mechanism of action for mineral oil's alleged toxicity. Additionally, I uncovered risk rate numbers buried in the EMA assessment that definitively prove Mineral Oil cannot be toxic. This prior demonstration renders Nissen's argument—that all the Japanese trials without a comparator are not credible—irrelevant. Then demonstrating that the JAMA Cardiology paper is riddled with bias is just a piece of cake.
The challenge lies in strategically placing these analyses in a medium that will lend them credibility or enough resonance to force Amarin to react and request a retraction. Submitting these analyses directly to Amarin may not be the most effective approach, as their response may be influenced by existing relationships with the REDUCE-IT investigators, who might be hesitant to openly challenge their colleagues.
Your insights are welcome.
Recent AMRN News
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