Bring on the Biogen lies

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Earlier this year, the developer of a promising antibody designed to slow Alzheimer’s disease strengthened a key warning given to participants in an ongoing trial of the experimental drug. Taking the antibody alongside blood clot medications, the Japanese biotech company Eisai cautioned, increases the risk of possibly fatal brain hemorrhages. That revision of its informed consent form, revealed in a 14 July version obtained by Science, appears to challenge the company’s contention that the antibody, known as lecanemab, played no role in the recently revealed deaths of two people who suffered dramatic brain bleeds while concurrently taking the drug and blood thinners.
 






Another issue mentioned in this latest Science article:

“And three key trial subgroups—people under age 65, women, and people who carry two copies of APOE4, a gene variant that raises one’s risk of developing Alzheimer’s—did not show any statistically significant benefit.”

If this is correct that there is NO statistically significant benefit on lecanemab in women then it would be UNETHICAL to put women from the CLARITY study into the ongoing open-label extension study.

Would appreciate any clarification on this.
 












anonymous said:
Another issue mentioned in this latest Science article:

“And three key trial subgroups—people under age 65, women, and people who carry two copies of APOE4, a gene variant that raises one’s risk of developing Alzheimer’s—did not show any statistically significant benefit.”

If this is correct that there is NO statistically significant benefit on lecanemab in women then it would be UNETHICAL to put women from the CLARITY study into the ongoing open-label extension study.

Would appreciate any clarification on this.
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If it gets approved, this is a niche product at best.
 






























anonymous said:
So now the fdas standard is clinically meaningless efficacy and rarely fatal. Here we go again. Money trumps the tough decisions.
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And the amyloid hypothesis is falling apart before our eyes...


New Study Challenges Previous Ideas Regarding Alzheimer’s Disease - Neuroscience News

https://neurosciencenews.com/amyloid-theory-alzheimers-22189/

Summary: The brains of older, cognitively healthy people have similar amounts of dissolvable, non-fibrilla amyloid proteins as the brains of those with Alzheimer’s disease. Findings challenge the long-standing theory that having higher levels of amyloid proteins is an underlying cause of Alzheimer’s disease.

Source: USC

A new USC Leonard Davis School of Gerontology study challenges existing ideas of how buildup of a protein called amyloid beta (Aβ) in the brain is related to Alzheimer’s disease.

While buildup of amyloid protein has been associated with Alzheimer’s-related neurodegeneration, little is known about how the protein relates to normal brain aging, said University Professor Caleb Finch, the study’s senior author and holder of the ARCO/William F. Kieschnick Chair in the Neurobiology of Aging at the USC Leonard Davis School.
 






FDA’s conditional approval for lecanemab on Friday is based on data Biogen and Eisai submitted from a Phase II, dose finding study where the primary efficacy endpoint was NOT MET. In this dose finding study, only 161 patients received the labeled, recommended lecanemab dose of 10 mg/kg every 2 weeks.

The lecanemab (Brand name, Leqembi) label clearly states the drug is only for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s. NO CLAIM of CLINICAL BENEFIT is made. This
accelerated approval of lecanemab was based only on a reduction in amyloid beta plaques (a surrogate secondary endpoint) in these patients.

How does one expect Biogen and Eisai Sales Reps to sell this drug with NO CLAIM OF CLINICAL BENEFIT and neither Medicare nor the Insurance companies willing to pay $26,500 a year for it?
 






anonymous said:
FDA’s conditional approval for lecanemab on Friday is based on data Biogen and Eisai submitted from a Phase II, dose finding study where the primary efficacy endpoint was NOT MET. In this dose finding study, only 161 patients received the labeled, recommended lecanemab dose of 10 mg/kg every 2 weeks.

The lecanemab (Brand name, Leqembi) label clearly states the drug is only for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s. NO CLAIM of CLINICAL BENEFIT is made. This
accelerated approval of lecanemab was based only on a reduction in amyloid beta plaques (a surrogate secondary endpoint) in these patients.

How does one expect Biogen and Eisai Sales Reps to sell this drug with NO CLAIM OF CLINICAL BENEFIT and neither Medicare nor the Insurance companies willing to pay $26,500 a year for it?
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Desperation is what’s driving them. Biogen and Eisai have sunk billions of dollars into these drugs. They can’t have them fail, so they’re counting on providers being willing to do virtually anything to help their ALZ patients, proven or unproven. CMS will be the death blow to lecanemab, unless Biogen and Eisai have found a way to grease the hands of enough politicians to get it through this time. If the FDA applies the same criteria as they did to Aduhelm, there will be no coverage for lecanemab. This product is dead already.
 






Is anyone surprised that Biogen is lying? What do you expect from a company and made people pay back signing bonuses for finding a new job right before they cut the whole ADU? It didn’t matter that you saved the company from paying you 3 months severance - they still wanted their $6k back. I wrote to AA, was kicked over to legal, and then told “this is just the policy. It’s out of our hands.” As if the crooks who wrote the policies can’t make exceptions to their own policies in extenuating circumstances. Working for Biogen and pushing a $56k placebo was the worst decision I ever made. Fuck you, Biogen. You’re garbage. For the sake of patients, I hope lecanamab is a massive failure. Patients deserve better than what Biogen and Eisai are trying to push on them.
 






anonymous said:
Is anyone surprised that Biogen is lying? What do you expect from a company and made people pay back signing bonuses for finding a new job right before they cut the whole ADU? It didn’t matter that you saved the company from paying you 3 months severance - they still wanted their $6k back. I wrote to AA, was kicked over to legal, and then told “this is just the policy. It’s out of our hands.” As if the crooks who wrote the policies can’t make exceptions to their own policies in extenuating circumstances. Working for Biogen and pushing a $56k placebo was the worst decision I ever made. Fuck you, Biogen. You’re garbage. For the sake of patients, I hope lecanamab is a massive failure. Patients deserve better than what Biogen and Eisai are trying to push on them.
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Filthy company, filthy people.
 












anonymous said:
Excited patients will have something that slows down this terrible disease. Sadly so many bitter ex employees can’t move on.
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No…..patients MIGHT have something (pending CMS coverage) that MIGHT marginally slow down this terrible disease that will LIKELY cause brain swelling and brain bleeding. And, I’m not sure anyone can be called “excited” about lecanemab.

And, of course I’m bitter. I gave a year and a half to a company that made mistake after mistake, lied to its employees, and then fucked people over in the end. I’ve been in this industry for 25 years and never had an experience as bad as the one I had at Biogen. But, don’t confuse bitterness with being wrong about lecanemab. We’ve seen this ugly scenario play out once before. It will happen again. You’ll see.
 






anonymous said:
Excited patients will have something that slows down this terrible disease. Sadly so many bitter ex employees can’t move on.
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Slows disease progression down by maybe a few months, has to be infused twice a month, risk of fatal brain bleeds, any benefit takes over six months to manifest, etc. Where do I sign up?
 






anonymous said:
Slows disease progression down by maybe a few months, has to be infused twice a month, risk of fatal brain bleeds, any benefit takes over six months to manifest, etc. Where do I sign up?
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Not true 25% of what can be 5-10 years with this disease is a lot more than a couple months. Risk of brain bleed low - worth the risk. Good to see patients will finally have something with more to come!!!
 












anonymous said:
Not true 25% of what can be 5-10 years with this disease is a lot more than a couple months. Risk of brain bleed low - worth the risk. Good to see patients will finally have something with more to come!!!
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Worth the risk? So says the person who’s going to profit off of prescriptions. I bet you fit in perfectly at Biogen - fuck the patient as long as you make a few bucks, right? Patients are the ones getting screwed here. You’re offering false hope coupled with a safety risk….all at what’s surely to be an exorbitant price tag. Bravo! And, yes, there’s more to come. I’m sure Biogen will come out with more ineffective therapies that can be used in combination with one another. Why not pay twice the price for the same result!!?? Biogen is morally and ethically bankrupt. I really hope lecanemab fails for the sake of ALZ patients. All it’s doing right now is getting in the way of REAL R&D that could actually benefit patients.
 






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