If Mannkind has data/research of longer trials they should publish all of it so we can read it.
What drug did they try to give you?
I have had quite a few discussions with doctors who had no concern about many issues I've raised or were dismissive about them. In several cases, their lack of concern merely reflected the fact that they were ignorant about the topic they'd been asked about but being doctors not about to admit it.
I am coming to think there are two kinds of people in discussions like this. People who have been seriously harmed by bad medical advice and those who have not yet been harmed that way.
You can easily tell the difference reading any health forum.
Using the sample pack tells you nothing. I didn't get lung cancer from smoking cigarettes in high school--back in the days when ads featured doctors recommending their favorite brands and smoking was a Senior Privilege that the principal granted those of us about to go out into the wide world.
It takes a while for the problems with any drug to emerge, and all I and everyone else here is saying is that a certain amount of caution is warranted with this as with any new drug.
The FDA approved Afrezza, but they also mandated an unusually large, expensive five year safety study as part of that approval. And as mentioned before 5 years is a short time frame in which to judge the safety of a drug taken daily for decades.
Investors, who are the people leading this particular charge and who are also, from what I can see, the main group of people who are asking doctors for this drug right now, need to remember that diabetes is different from most other conditions in that people with diabetes will be taking drugs for many, many decades.
So it makes sense to be cautious. A person who starts a therapy when they are 35 years old wants to be sure that it isn't one that will cause cancer in 20 years, because they will still be quite young at 55. At my age, I'm not as concerned about the 30 year horizon, but I would prefer not to get an avoidable cancer in 20 years.
I have to say, for the benefit of the investors lurking these threads, that the more investor pumping I see the MORE cautious I am getting about this drug. It was that pumping and the many questionble statements I saw people making on investor discussion forums who claimed to be M.D.s that turned on my Caution sensors.
The company that makes this stuff is under huge pressure. The stock has been disappointing its investors for over a decade. And human nature being what it is, people with or without diabetes who have committed a large amount of money to a company are going to do what they can to get that money back, which in this case means infiltrating the diabetes community and spreading the message about their wonder-working drug.
There are plenty of discussions in the investor community right now about how to reassure people with diabetes and make sure they have the "facts"--those facts being the ones that they believe will promote the use of the drug. Anyone who suggests that the situation is more complex is accused of being in the pay of those who have bet against the stock.
Apparently investors because of how they think find it impossible to imagine that some of us PWD look at drugs in terms of how they might affect our health for decades to come and that we can hold a more nuanced opinion of a drug than those who see it as something to bet for or against.
THIS!
Very well put. Thank you Jenny for advocating on behalf of myself and many others
Well, yes, I'd be very suspicious of this pediatric pulmonologist, and probably never consult with her again.
What kind of quack it she? I encourage you to print out this entire post and take it to her.
She bases her opinion on what pediatric trials? Is it her view that the lungs of children are physiologically identical to adult lungs? What does she have to say about the IGF-1 concern articulated in some of the Afrezza study literature? Have you read it? Has she?
When pulmonologists specializing in adults express some reservation regarding the IGF-1 issue and state that it justifies carefully following patients on Afrezza to ensure there is no problem, I take note.
And I vest far more credibility in these pulmonologists, intimately involved in the approval of Afrezza, than some pediatric Pulmonologist you consulted -- who likely hasn't prescribed Afrezza yet for a single patient.
Comparing concerns over lung cancer with Afrezza to being concerned that riding a bike will cause prostate cancer is not only dismissive, it's rude and disrespectful to those legitimately concerned based on the statements of physicians involved in approval.
I truly am pleased that you are having great results with Afrezza. I'm working the system as fast as I can to get some too. I don't believe, at this point, than any cancer risk is truly there. But that's what I believe -- I do not know it, and neither does Mannkind, Sanofi, the FDA, or the panel that approved it.
Sensibly, therefore, it was raised as a low-risk possibility, and should be monitored.
Why that seems to get your panties in a bunch is completely baffling to me.
I am coming to think there are two kinds of people in discussions like this. People who have been seriously harmed by bad medical advice and those who have not yet been harmed that way.
An excellent point.
I'd point out that people in both these camps are influenced by their experiences, and have biases as a result.
I find that people who have never had a bad experience with health care, or very few, are often more sanguine about new treatments and doctor's statements than in my opinion they should be.
Similarly, I find people that have had disasterous results with medical treatment are often highly suspicious of all new treatments than in my opinion they should be.
The "truth" -- to the extent the idea applies -- lies somewhere in between. These two polar opposites will be with us forever, so its good we have both to synthesize our own conclusions from.
Investors, who are the people leading this particular charge and who are also, from what I can see, the main group of people who are asking doctors for this drug right now
This I must take issue with, Jenny, and it has that whiff of the very biases I just posted about.
What data are you drawing these conclusions from? My only data is anecdotal, from what people are doing and saying on the internet. Do you have something more substantial?
I ask this because I have a very different impression -- I see PWD, not investors, pushing, and pushing HARD. Not because there's money to be made; because they want what they're reading about from Mike, Pat, Terry, Afrezzauser, and dozens and dozens of other PWD that are using the stuff.
Yes, I'm an investor in Mannkind. I'm also a PWD. I find it ever so slightly offensive that, without knowing me at all (save a handful of posts here), nor having talked to me about my motivations, you're broad-brush disparaging my motives for jumping on the Afrezza bandwagon. And you're absolutely wrong.
I suspect you're similarly way, way off about probably every single other PWD with MNKD in their portfolio, save a handful of jerks out there than can simply be ignored. I claim, with no evidence other than my own perspective and that I've gleaned from other's meeting the PWD/MNKD/Afrezza advocate description are pushing the treatment for the same reason I am: Because we are BLOWN AWAY by the clinical results, and see this as the first treatment in our entire lives that has the promise to make diabetes a mild nuisance, rather than a constant battle.
That, for me, is just short of a cure. And that's why I'm so jazzed, and cheerleading. Making money off of MNKD's success isn't even on the radar. I suspect too that most people that have MNKD do not have a risky position -- i.e. much of a stake. If they did, they'd be foolish investors, regardless of what Afrezza is all about. MNKD at this point is no different than any very promising, money-losing, business with a promising new drug and an established market to penetrate.
Terry, corporations can not be amoral, nor have / not have a conscience. They're an abstraction.
Speaking of them in the abstract is similar folly. There are composed real human beings, with all the same virtues and failings, including sometimes being REALLY despicable, just like, well, the active membership if TuD.
So you're wrong too think that big companies are amoral, or have no conscience. The people making decisions, most certainly are moral (or immoral), and have a conscience.
And just as there are bad people in powerful positions in big companies, there are many good ones. Based on my own experience in both large and small companies, at various levels of management, I find this question to be far, far more complex than the simple nostrums tossed around in public about "Big <fill in the blank>".
Think: Al Mann.
I guarantee you that, while making money was a very big reason for Sanofi partnering with Mannkind, the genuine desire to help diabetics and make their lives better is sincerely on the minds of many, if not all, executives at Sanofi involved in the deal. For all we know one or more of them may be a PWD.
As an "insider" from time to time in large companies, it makes me very sad to see how poorly the public understand reality, and unfair and unjustified criticisms of the decision-making processes that occur in running these businesses. There are always myriad competing priorities and needs, some of which the public is too ignorant to even imagine. For example, employee impact from relocating some division or group because the new product requires it for some reason. Such things are often in the mix.
It's hardly ever "all about money/profit". In my experience, the only impact financials play is, "can we make sufficient earnings with this product?" Certainly no one expects a company to offer, make, and sell something at a loss over the life of the product. You can't stay in business that way.
So, a particular financial return that is NECESSARY to make the product viable is modeled; from there, marketing, PR, etc. plans are developed to generate that necessary revenue.
This is how it works with the vast majority of people working in corporations making decisions. They're honest, but have to make hard trade-offs sometimes, and will certainly decided differently than someone else out there who then becomes a critic.
Does this mean no corruption exists? No shenanigans take place? Of course not. Just as having police and laws doesn't mean there won't be any crime. However, the existence of criminals doesn't indict the entire human race as a bunch of immoral criminals.
The small minority of bad actors in business do not justify the outsized reputation business seems to have among some as utterly contemptible charlatans.
I'm kind of somewhere in the middle with this. The drug is so new, and really honestly we do not know the potential side effects many many years down the line. But at the same time, in order for there to be any progress in science, we have to try new drugs.. because how do we ever improve, if we don't ever try new things? (Doing a study for decades is not going to happen unfortunately.. no pharmaceutical is willing to wait that long to start a drug) That said, those willing to try are actually helping us all by testing the drug... whether or not you go for it and take the gamble, is at the end of the day, personal preference I suppose.
I am keeping a very close eye on this insulin. We want Afrezza, even if our DD would only use it for meals and snacks after dinner. If she has a snack and goes to bed with active insulin on board that could be dangerous. And, yet, as a college student, I know she will as she already eats late at night when hanging out with friends. Right now we can check her blood sugar overnight. When she goes off to college we won't be able to do so. So having an insulin that would be out of her system in two hours would be much safer than the insulin she is using, Apidra. I am stunned by the incredible results the few users who have been able to get Afrezza are reporting. After more research I became aware that there were two small cell lung cancer cases, in addition to the two other lung cancer cases from trial participants who were smokers. So we will watch and wait. But, also knowing that using the insulins she is on, because it cannot match the action of a functioning pancreas, as Afrezza does, damages her system. There are some unknown risks in trying Afrezza. There are definitely known risks staying with the status quo.
No, you are incorrect. There were FOUR cases of lung cancer in the trial participants that used Afrezza, none in the control group. I was not concerned, though with the two who had previously smoked in the past, but the two cases of small cell lung cancer are very concerning. Hoping this proves to be coincidental.
Four cases in the Afrezza users; none in the control group. Yes, it is a cause for concern. Which we must weigh against the long term effects of using the substandard insulins that do not match the action of a working pancreas. I want to be able to use this insulin. My DD would love this; it would be life-changing. But we will have to wait and watch.
Wait a minute. You keep saying TWO cases. Yes, there were two cases, both were smokers in the past. BUT there were also TWO more cases of small cell lung cancer, which is not caused by smoking. Those are the two cases that concern me. But, yes, only two cases which cause me concern. On the other hand, Afrezza will definitely help avoid the long term complications of Type 1. Which is a huge known risk. Considering a Type 1 is out of range hours after every meal, that's six to nine hours out of range every day. There are definitely risks to be weighed. By waiting, we will know more in a year or two.
Iām type 1. And rarely, rarely, out of range after meals at allā¦ Iād say maybe one out of a hundred meals causes me āmildlyā elevated levels of 140-180ā¦ I have an A1c of 5.2 Yet I think Iām the most excited person on the planet about afrezza. Be careful with generalizationsāyouāve only seen the world through one pair of eyeballs.
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Doc,
Are the following stats published correct:
Worldwide, lung cancer is the most common cancer related death, responsible for 1.56 million in 2012 alone.
80-90% of cases are due to long-term exposure to tobacco smoke. 10-15% of cases occur in people who report never smoking, with such cases usually caused by a combination of genetic factors, exposure to radon gas, asbestos, or other air pollutants including second hand smoke.
There have now been many, many people who have been using inhaled insulin for as much as a decade and testing of inhaled insulin has been going on for more than 15 years.
If a number of 40-50 year old Americans died of lung cancer while on Afrezza trials, I think the FDA would have been more concerned. But given how common the disease is, having 1-2 elderly non smokers die of lung cancer is obviously not statistically significant. Having someone from Russia, who is in their 70's die from the disease needs to be taken in context as well. We need to know more about that women since her lungs were in a formative stage while WWII was raging in her country.
You should be concerned about those cases. The fact that Afrezza has already been given a box warning not to be used in people with lung cancer or lung disease/impairment suggests to me that there is more data/info, that we don't know about, which hasn't been published/shared or at least not with the general public. But the warning is there, so that is to protect the manufacturer most likely. The package info also says there were incidents of severe bronchospasm but they don't give any details about that.