Fact Check ALS

One disease, one team, one #ALS community. No personal attacks, no smears, no obfuscating. DM with tips. #ALSfactcheck #endALS

[Fact Check ALS @factcheckals]

Another trial is needed to confirm efficacy. No payday before proof.

[ALS Advocacy @alsadvocacy]

@LLarry689 Do they have the data that show the magic characteristics of the responders?
If so, why not do another trial and get moving?
If not, then let's learn not to do trials like that ever again. 4/end

[Fact Check ALS @factcheckals]

💯

[ALS Advocacy @alsadvocacy]

@LLarry689 Nurown is a different situation imo since it didn't hit endpoints. I think they have to offer FDA more in order for the FDA to get to maybe. No doubt in my mind that it helps some people, but the trial Brainstorm designed didn't reflect efficacy. 2/

[Fact Check ALS @factcheckals]

Thread

[Fact Check ALS @factcheckals]

@Robdback @US_FDA The manuscript was submitted months and months ago, they should publish now and unblind patients. That’s an excuse for them to delay

[Fact Check ALS @factcheckals]

The evidence of absence on #NurOwn is deafening. Most #ALS researchers cower in labs hoping it will blow over, but it won’t until they stick out their necks & tell us how it is: is more evidence needed? The onus is on researchers to counter pharma TPs & preserve @US_FDA integrity

[Fact Check ALS @factcheckals]

@Zionisthumanist @jwf_jr @als_now @Michell62614519 @sandymorris333 @BrainstormCell It’s not possible to prove a negative, but the evidence of absence is deafening: most ALS researchers & NurOwn PIs have been silent. ALS researchers are afraid to publicly come out against #NurOwn since ppl are running interference for pharma with the power to eviscerate careers.

[Fact Check ALS @factcheckals]

@Robdback @als_now @jwf_jr @Michell62614519 @sandymorris333 @BrainstormCell They’re not doing what they’re supposed to be doing, which is unblinding & publishing the journal months ago, & applying for BLA if they believe in NurOwn. Instead they’re staying silent & letting folks like you run interference to lower standards. Response ≠ helpful effect

[Fact Check ALS @factcheckals]

@als_now @jwf_jr @Michell62614519 @sandymorris333 @BrainstormCell They cherry picked like 12 ppl for EA that are most likely to respond from the trial. Hardly a consolation for the thousands of others, and not nearly enough to cut through the noise of any data that will produce to support any kind of external validation.

[Fact Check ALS @factcheckals]

@Zionisthumanist @jwf_jr @als_now @Michell62614519 @sandymorris333 @BrainstormCell It’s not possible to prove a negative, but the evidence of absence is deafening: most ALS researchers & NurOwn PIs have been silent. ALS researchers are afraid to publicly come out against #NurOwn since ppl are running interference for pharma with the power to eviscerate careers.

[Fact Check ALS @factcheckals]

@jwf_jr @als_now @Michell62614519 @sandymorris333 @BrainstormCell The P3 data NurOwn for approval is not published, so you’re also conflating the importance of P2 data.

Who can afford to pay for an experimental drug we don’t know works? You think insurance will? Of course not.

@BrainstormCell has obligation to prove and pay til approval.

[Fact Check ALS @factcheckals]

@iamalsorg Has @iamalsorg joined to become a member of @ALSMNDAlliance yet?

[Reshma Ramachandran @reshmagar]

So many issues with this piece in @JAMAInternalMed from @US_FDA officials (Dunn, Stein, & Cavazzoni) attempting to justify their poor choice in approving #aducanumab - don't bother reading it unless you want your blood to boil. I'll summarize instead: https://t.co/ddQ8EmDvoD 1/

[Fact Check ALS @factcheckals]

@nadia_sethi Would it be possible to pass a bill that made the Registry collect this info? Or is that something they already do?

[Fact Check ALS @factcheckals]

@als_now @BrainstormCell @bsw5020 @sabrevaya I don’t know what you’re talking about, but regardless it seems to be a red herring to change the conversation. Unblind #nurown #amx #tofersen and publish the NurOwn data NOW

[Fact Check ALS @factcheckals]

@LorriCav @AuntJ14 @BrainstormCell @Cylebo @BrainstormCell is same old pharma, they all care about $ more than people. Just because Aduhelm got approved on shakey data doesn’t mean #ALS drugs should be. BS is being investigated by the SEC, so might take that under consideration talking about trust

https://t.co/6LnCC0Fi42

[Fact Check ALS @factcheckals]

What @FinishALS said

[EndALS @FinishALS]

When can we expect publication and unblinding of data?

[Fact Check ALS @factcheckals]

Kewl.

You have no legitimacy to dictate how your own agency is investigated. You signed off 🖊

[Dr. Janet Woodcock @DrWoodcockFDA]

Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.

[Fact Check ALS @factcheckals]

@nadia_sethi 🙌🙌🙌

[Fact Check ALS @factcheckals]

@Zionisthumanist @BrainstormCell @als_now As for ALSA, who cares about them (or any nonprofit) right now? They have NOTHING to do with either of these things applying to get approved. Stop running interference and using pharma talking points.

[Fact Check ALS @factcheckals]

.@BrainstormCell unblind now, show us the full data/ journal, apply for BLA if you think it works (or start another trial now on responders with EA, which you’ll be told to do regardless), but for gods sake stop letting #ALS patients die angry!

[Brian Wallach @bsw5020]

A thread on #NurOwn:

I have seen first hand a number of friends receive NurOwn in the EAP and through RTT.

Seen it slow or stop their progression.

As an ALS patient this makes me scream for access for all of us who are dying due to rampant systemic paternalism. /1

[Fact Check ALS @factcheckals]

@Zionisthumanist @BrainstormCell Okay Chaim. Rather than having @als_now run interference for you to try lowering approval standards, why don’t you stop hiding behind that lazy excuse and tell dying patients whether they were on NurOwn or placebo, tell us the results NOW (even FDA broke tradition), and APPLY