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Post by cretin11 on Jul 12, 2019 11:55:52 GMT -5
Is there as effective an alternate rescue medication available for ashtma in this case? If there is no other good option, you have to use what is available. plytle , I saw your post just after I posted above - the point is spot on.
mnkdfann , the point was not whether there were options available, but rather rtmd implied it would be a malpractice risk to prescribe an inhaled medication for "an ailment whose hallmarks are airway constriction and difficulty breathing." Care guidelines for asthma illustrate the silliness of that claim. I agree, there is no medical malpractice concern for any doctor prescribing a inhaled form of epi that's FDA approved.
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Post by rtmd on Jul 12, 2019 12:12:59 GMT -5
I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing? rtmd , are you kidding me Have you never heard of an asthma inhaler??? Asthma is not the same as anaphylaxis. The airway constriction in anaphylaxis can be very rapid and very severe. You prescribe an inhaled medication rather than an epipen to somebody for anaphylaxis and they die because they weren't able to inhale the drug, you can bet that malpractice lawyers will line up at the victim's families door.
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Post by rtmd on Jul 12, 2019 12:15:27 GMT -5
plytle , I saw your post just after I posted above - the point is spot on.
mnkdfann , the point was not whether there were options available, but rather rtmd implied it would be a malpractice risk to prescribe an inhaled medication for "an ailment whose hallmarks are airway constriction and difficulty breathing." Care guidelines for asthma illustrate the silliness of that claim. I agree, there is no medical malpractice concern for any doctor prescribing a inhaled form of epi that's FDA approved. Did Mannkind ever explain why they didn't move forward after the FDA meeting regarding epinephrine? Might it have been because they saw little likelihood they could get it approved for anaphylaxis?
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Post by awesomo on Jul 12, 2019 12:15:49 GMT -5
Another PR that initially sounds nice, but doesn't really have any actual substance to it. Shareholders are left to conjecture what any of this means, some positive, some negative. Maybe if they released a PR with concrete details the market might give a crap.
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Post by mnkdfann on Jul 12, 2019 12:37:22 GMT -5
Is there as effective an alternate rescue medication available for ashtma in this case? If there is no other good option, you have to use what is available. plytle , I saw your post just after I posted above - the point is spot on.
mnkdfann , the point was not whether there were options available, but rather rtmd implied it would be a malpractice risk to prescribe an inhaled medication for "an ailment whose hallmarks are airway constriction and difficulty breathing." Care guidelines for asthma illustrate the silliness of that claim. I was making a different point. My point was as to whether other rescue medications were available for ashtma. If not, plytle's argument can't be applied to the Epi situation.
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Post by hellodolly on Jul 12, 2019 14:00:14 GMT -5
"We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind." Could this be more than UTHR when it's in plural form? Are the hinting or slipping, that they are pursuing partners who are interested in the process for other drugs to be manufactured using this process, besides MNKD? here is what caught my eye. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.
I am amazed at how many mABs commercials I see. Treating everything. arthritis, I saw eczema being treated with mABs commercial this morning. mABs used in oncology. Subcutaneous Administration of Monoclonal Antibodies in Oncology Technosphere and the dreamboat a Route of Administration. www.ncbi.nlm.nih.gov/pmc/articles/PMC4078128/dMAB Technology is out there, too. Those are synthetic DNA encoded MAbs.
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Post by stevil on Jul 12, 2019 14:25:03 GMT -5
Is there as effective an alternate rescue medication available for ashtma in this case? If there is no other good option, you have to use what is available. plytle , I saw your post just after I posted above - the point is spot on.
mnkdfann , the point was not whether there were options available, but rather rtmd implied it would be a malpractice risk to prescribe an inhaled medication for "an ailment whose hallmarks are airway constriction and difficulty breathing." Care guidelines for asthma illustrate the silliness of that claim. Litigation is chock-full of silly claims. If I would ever consider prescribing inhaled epinephrine, I would only do so with an accompanying epipen script. It's up to the patient at that point which or both they want to fill, but at least I'll be able to document to cover myself that I offered an injected version to my patients. You have to remember that judges do not have medical knowledge and lawyers are able to exploit any loophole and make it look like a highway tunnel. All I will add to this is be careful about how much of a "no brainer" this is. I think it was mentioned before, the same was thought of Afrezza. I would also want to see that outcomes were as good or better than an injected epinephrine before considering a script. I'm not sure inducing anaphylaxis would be ethical, although I'm not an expert. I am way more weary of prescribing epinephrine than I would be for insulin because the margin for error is much wider with a chronic disease than one that can kill you within minutes. Just my opinion. Take it for what it's worth. Edit: To illustrate my point of how silly lawsuits can be, I'll share a story from a GI doctor I rotated with. He was treating a woman with diabetes who had gastroparesis. There aren't a lot of good options for it. About the only thing that is FDA approved is Reglan. So he prescribed her Reglan. A serious side effect of Reglan is tardive dyskinesia. It can be reversible if you stop Reglan soon after initial symptoms present themselves. He told her to stop taking the medication. He even documented that he told her to stop taking it. The problem was that he gave her a year's prescription of it right before she started showing signs of TD, and she kept taking it. The story doesn't make a lot of sense to me when you consider why she waited 10 years after he saw her to sue him, but that's supposedly what happened. Well, you're allowed to shred medical records after 6 years and that's what he did. So there went his proof that he told her to stop taking her medication and he ended up losing the case. So she developed a well-known side effect from the drug but the doctor lost a lawsuit because it's our responsibility to make sure the drug isn't harming our patients. There was proof that his treatment plan harmed her and no proof that he did his job to protect her. No patient's convenience is worth a lost lawsuit.
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Post by liane on Jul 12, 2019 14:46:48 GMT -5
The study for this would not be inducing anaphylaxis. Rather, it would occur in an ER. Patients coming in with anaphylaxis would be randomly assigned to either the EpiPen group or the inhaled epi group. Should any treatment fail, you have the full capacity of the ER to follow up with other means of resuscitation.
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Post by goyocafe on Jul 12, 2019 15:04:09 GMT -5
The study for this would not be inducing anaphylaxis. Rather, it would occur in an ER. Patients coming in with anaphylaxis would be randomly assigned to either the EpiPen group or the inhaled epi group. Should any treatment fail, you have the full capacity of the ER to follow up with other means of resuscitation. I thought I read that they don’t study these types of drugs in the midst of an event, but rather measure serum levels for drug concentrations in healthy patients, given the drug is already well understood. That’s why the insulin testing the FDA dragged Mannkind through for the change in inhalers was so ridiculous.
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Post by stevil on Jul 12, 2019 15:12:23 GMT -5
I won't pretend to play expert here because I am not.
However, a few things that immediately jump out to me.
1. They'd have to get patient consent. I'm not sure taking the time to explain the differences between the two as well as the risks involved, then get a signature would be a good use of time in this kind of scenario. I did have an EM rotation at one of the busiest emergency centers in the nation so maybe my understanding of the process is jaded, but stuff did not get done that quickly. The staff certainly would not take the time to do this, but maybe it would work at slower centers. Then again, how much anaphylaxis would they see at a slower center?
2. It's likely that they'll already have a needle stick for IV access by the paramedics. At that point, what's the benefit to the patient to receive the medication orally? Especially when it's not proven? I wouldn't choose to participate in that study nor would I encourage a loved one or friend to.
3. I'm sure you're well aware there are varying degrees of anaphylaxis ranging from mild to shock. How do you tease those out? Can you reliably say that taken within x amount of minutes that it would be just as effective as injected? Different people have different immune systems and have more severe reactions than others. You obviously cannot give it to patients with severe reactions if they have to wait that long to get it (as they will be unconscious), so the results will be skewed. So maybe you could make the case for mild anaphylaxis, but then that leaves the door open to litigation because it's a subjective call based on potentially immeasurable quantities (unless they get lucky enough to have as good of results if they can still reliably inhale and that be the proper metric for indication). However, I wouldn't even want to put myself in that position as a patient or physician of having to distinguish when I can or when I can't when I already have an option I know I can reliably trust regardless.
Maybe that's what the BluHale is for. Maybe it will come in the box with the epinephrine and will tell if it's appropriate to inhale. If they can inhale at a certain force that they'd have enough ability to get it into their lungs... just a thought....
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Post by stevil on Jul 12, 2019 15:13:27 GMT -5
The study for this would not be inducing anaphylaxis. Rather, it would occur in an ER. Patients coming in with anaphylaxis would be randomly assigned to either the EpiPen group or the inhaled epi group. Should any treatment fail, you have the full capacity of the ER to follow up with other means of resuscitation. I thought I read that they don’t study these types of drugs in the midst of an event, but rather measure serum levels for drug concentrations in healthy patients, given the drug is already well understood. That’s why the insulin testing the FDA dragged Mannkind through for the change in inhalers was so ridiculous. This would be impossible to test without knowing how much of the medication reaches the bloodstream when an airway is closing or closed. The only way to do that would be to test it under conditions of anaphylaxis. In other words, it's not the efficacy of the compound they'd be testing, it'd be the route of administration. They already know what certain blood levels of epinephrine will accomplish. They don't know how much an obstructed airway would affect the ability of the epinephrine to get to its target without conducting real world scenario tests.
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Post by rtmd on Jul 12, 2019 15:19:12 GMT -5
The study for this would not be inducing anaphylaxis. Rather, it would occur in an ER. Patients coming in with anaphylaxis would be randomly assigned to either the EpiPen group or the inhaled epi group. Should any treatment fail, you have the full capacity of the ER to follow up with other means of resuscitation. I suspect there have never been trials involving anaphylaxis per se. From Mylan: "Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis,the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine." Nevertheless, there is a phase 1 trial for a nasal spray: snacksafely.com/2017/12/phase-i-trial-of-epinephrine-nasal-spray-for-anaphylaxis-begins/ "This Phase I clinical trial is designed to establish whether intranasal administration of epinephrine is bioequivalent to the standard method of delivering the drug via intramuscular injection." However, they are using patients with seasonal allergies and exposing them to the relevant allergens.
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Post by wgreystone on Jul 12, 2019 17:06:28 GMT -5
Another PR that initially sounds nice, but doesn't really have any actual substance to it. Shareholders are left to conjecture what any of this means, some positive, some negative. Maybe if they released a PR with concrete details the market might give a crap. Currently, the market doesn't even give a crap about a signed license deal of TreT.
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Post by awesomo on Jul 12, 2019 17:17:29 GMT -5
Another PR that initially sounds nice, but doesn't really have any actual substance to it. Shareholders are left to conjecture what any of this means, some positive, some negative. Maybe if they released a PR with concrete details the market might give a crap. Currently, the market doesn't even give a crap about a signed license deal of TreT. They did when it was initially announced, the PPS went from around here to over 2 in a few days. Then came the December dilution, the stagnant Afrezza growth after blowing millions on a weak TV campaign, and a whole lot of fluff and nothingness from management.
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Post by lifebreath on Jul 12, 2019 18:10:26 GMT -5
Currently, the market doesn't even give a crap about a signed license deal of TreT. They did when it was initially announced, the PPS went from around here to over 2 in a few days. Then came the December dilution, the stagnant Afrezza growth after blowing millions on a weak TV campaign, and a whole lot of fluff and nothingness from management. The lack of experience of young MC. Will haunt this company for years
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