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Post by mannmade on Mar 2, 2015 8:50:53 GMT -5
www.thestreet.com/story/13062927/1/mannkinds-afrezza-earns-lackluster-review-from-independent-drug-arbiter.html?puc=stocktwits&cm_ven=STOCKTWITS&utm_source=dlvr.it&utm_medium=organic&utm_campaign=stocktwits MannKind's Afrezza Earns Lackluster Review from Independent Drug Arbiter ADAM FEUERSTEIN Follow Mar 2, 2015 8:15 AM EST Afrezza is "modestly effective" at reducing blood glucose and its long-term safety is unknown, according to a review of the inhaled insulin published this week by The Medical Letter, an independent, non-profit organization which evaluates prescription drugs. MannKind (MNKD) developed Afrezza and secured U.S. approval last June. The rapid-acting inhaled insulin, intended for use during mealtime by Type 1 and Type 2 diabetics, was launched commercially one month ago by MannKind's marketing partner Sanofi (SNY). The Medical Letter is influential with doctors and other healthcare professionals because the organization doesn't accept industry money and publishes drug information that aims to be an "unbiased consensus of scientific experts." The two-page review of Afrezza in the March 2 issue of The Medical Letter, available only to subscribers, describes the efficacy and safety data from the clinical trials included in the product's FDA-approved label and places Afrezza in the context of other rapid-acting mealtime insulins, all of which require injections. The review concludes: "Afrezza, the only inhaled formulation of insulin currently available in the US, appears to be only modestly effective in reducing HBA1c. Cough is a common side effect and the long-term pulmonary safety of inhaling insulin is unknown." The Medical Letter's review also includes a pricing chart showing Afrezza to be more expensive than the competing injectable insulins marketed by Novo Nordisk (NVO) (Novolog), Eli Lilly (LLY) (Humalog) and Sanofi (Apidra.) Doctors have written 290 prescriptions for Afrezza during the first four weeks of the launch, according to Symphony Health.
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Post by mnholdem on Mar 2, 2015 9:06:40 GMT -5
Adam lays down his daily "cover fire". Looks like it's getting tougher for him to find bullets. Don't worry, as he still has plenty of spitballs (disgusting but don't do any harm).
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Post by esstan2001 on Mar 2, 2015 9:11:01 GMT -5
If you search on the Mar 2 issue of the Medical Letter, the link to the Afrezza article requires subscriber login, but there is an option for a free trial where you have to list your personal info and medical specialty... any docs want to try, and see what they really say if you get both sides of the story?
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Post by spiro on Mar 2, 2015 9:30:53 GMT -5
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Post by ezrasfund on Mar 2, 2015 9:58:20 GMT -5
I doubt he needed to cherry pick the article. Many of these article in medical publications just restate the information that the FDA has approved. That data was produced using the existing RAA protocols and did not show all of the benefits of Afrezza, as we know. For instance,lower incidence of hypoglycemia is a benefit that diabetics are now seeing in real life, but one that MNKD and SNY cannot state. It could be in an article like this, but they generally restrict themselves to FDA approved statements.
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Post by liane on Mar 2, 2015 10:01:45 GMT -5
Well, I signed on. I can't c/p due to copyright. The conclusion is this:
Afrezza, the only inhaled insulin currently available in the US, appears only modestly effective in reducing HbA1c. Cough - a common side effect and the long-term pulmonary safety of inhaling insulin is unknown.
They also compared cost as such:
Afrezza $278 1pkg of 60 8 unit + 30 4 unit
Novolog, Apidra, Humalog 2pens $157
I'm not sure how long a pen lasts.
I will say AF's using "lackluster" in the title of his article is deceptive; The Medical Record article is just stating facts, and no where does it mention "lackluster".
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Post by joeypotsandpans on Mar 2, 2015 10:13:25 GMT -5
You mean like purposely omitting select most important things like pharmacokinetics like the following:(Source: The Medical Letter) Serum concentrations peaked earlier with Afrezza, but the onset of action was similar with both drugs. The maximum effect occurred about 50 minutes after administration of Afrezza and about 120 minutes after injection of insulin lispro. Inhaled insulin had a shorter duration of action than insulin lispro (~3 vs. ~4 hours).The "article" in the letter is essentially a repost of the "flawed" FDA imposed/requested trial results. When the "Afrezzauser" trial results are discovered worldwide AF will most likely be helping to produce license plates with some buddies somewhere IMO  |
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Post by Deleted on Mar 2, 2015 10:20:30 GMT -5
Well, I signed on. I can't c/p due to copyright. The conclusion is this: Afrezza, the only inhaled insulin currently available in the US, appears only modestly effective in reducing HbA1c. Cough - a common side effect and the long-term pulmonary safety of inhaling insulin is unknown. They also compared cost as such: Afrezza $278 1pkg of 60 8 unit + 30 4 unit Novolog, Apidra, Humalog 2pens $157 I'm not sure how long a pen lasts. I will say AF's using "lackluster" in the title of his article is deceptive; The Medical Record article is just stating facts, and no where does it mention "lackluster". 2 pens = 600 units of Insulin Afrezza = 600 units of Insulin So they did a complete BS comparison with equal insulin units but failed to account for zero loss due to priming. So shady. |
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Post by spiro on Mar 2, 2015 10:24:49 GMT -5
Liane, thanks for taking one for the team. Now, we will never know if Baba would have done it. BTW, had you ever heard of that publication prior to today?
Thanks again,
Spiro
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Post by liane on Mar 2, 2015 10:29:49 GMT -5
Liane, thanks for taking one for the team. Now, we will never know if Baba would have done it. BTW, had you ever heard of that publication prior to today? Thanks again, Spiro Oh, absolutely I've heard of them. They are quite respected and factual. As mentioned above, they did miss the nuance of pen priming. Their article is fine; it's AF's slant of "lackluster" that is incredibly deceptive. BTW - what specialty would baba have made up???  |
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Post by spiro on Mar 2, 2015 10:51:49 GMT -5
Baba, for sure GYN.
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Post by liane on Mar 2, 2015 10:59:16 GMT -5
I was thinking proctology.
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Post by ezrasfund on Mar 2, 2015 11:51:40 GMT -5
The story is told again in Afrezzauser's latest tweet (see the photos) of his CGM summaries on Novolog and Afrezza.
Glucose Average High Target Low
Novolog 183mg/dL 58% 42% 0%
Afrezza 99mg/dL 6% 93% 1%
This data clearly shows that Afrezza causes more hypos than Novolog LOL
This data also shows why such conclusions are a total fantasy, and it shows that the FDA protocols and conclusions were less than perfect.
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Post by mnholdem on Mar 2, 2015 12:39:48 GMT -5
FDA's refusal to factor in Afrezza's speed is what led to poor trial protocols. It's as if FDA officials wanted it to fail.
Another subject I've been wondering and keep forgetting to ask regarding the trials - maybe some of you know the answers to some of these questions:
Sam said he used a CGM during the trials. Did all trial participants get a CGM? If that were the case, they had the potential to record an incredible amount of information. Were the only data points recorded those that the FDA deemed worthy? Were the rest of the measurements collected by CGM's thrown out or not collected at all? It seems that Sam is trying to prove to the world something he discovered about Afrezza during the trials.
Wasn't the trial physician (Dr. Edelman or something like that?) recently was quoted as saying that the FDA spent so much time disputing the data that they missed its importance? |
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Post by savzak on Mar 2, 2015 12:50:40 GMT -5
Wasn't the trial physician (Dr. Edelman or something like that?) recently was quoted as saying that the FDA spent so much time disputing the data that they missed its importance? I've never heard this before. If it's accurate, I'd like to see the quote, hopefully in a broader context. |
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