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Top Reference - Spirituality: Impersonating Jed McKenna
"No man is a prophet in his own country."
That line keeps running through my mind as I sit over lunch with my sister who I haven't seen in several years. These days I'm the enlightened guy, but to her I'm just the bratty kid who couldn't make eye contact when she wore a bikini.
It's summer '01 and we're having lunch in lower Manhattan. She read a preview copy of Damnedest and has had a few months to digest it. It was very nice of her to read it because it's
That line keeps running through my mind as I sit over lunch with my sister who I haven't seen in several years. These days I'm the enlightened guy, but to her I'm just the bratty kid who couldn't make eye contact when she wore a bikini.
It's summer '01 and we're having lunch in lower Manhattan. She read a preview copy of Damnedest and has had a few months to digest it. It was very nice of her to read it because it's
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
really not her kind of thing. She's a good citizen; a successful executive, wife, mother, Republican, tennis nut, Christian-ish, and all-round productive member of society. (She once told me she was raising her children to be productive members of society and I winced so hard I almost chipped a tooth.) She's a wonderful person, but not a member of the demographic the book speaks to.
There's a plate of chilled pasta in front of me and a salad in front of her
There's a plate of chilled pasta in front of me and a salad in front of her
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
We're both drinking iced tea. She's runs the creative side of a medium-sized ad agency and, I have no doubt, she's very good at it. She's taking time out of a busy schedule to have lunch with me. After this, I'm going to the park to lay in the grass and watch people play with their dogs.
Visiting your sister and having lunch shouldn't be a confusing ordeal, but it is. Is she really my sister? What does that mean? We share some history and acquaintances, suc
Visiting your sister and having lunch shouldn't be a confusing ordeal, but it is. Is she really my sister? What does that mean? We share some history and acquaintances, suc
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
as childhood and parents. Are my parents really my parents? Genetically they are related to my body, but the person who lived my childhood is no longer here. The past I share with this person is about as real and important to me as if I'd read it in a brochure.
The problem is that these people, my family, are all related to my shell, and I'm not. They're looking at the outer Jed McKenna and assuming an inner Jed McKenna. I'm inside Jed McKenna looking out a
The problem is that these people, my family, are all related to my shell, and I'm not. They're looking at the outer Jed McKenna and assuming an inner Jed McKenna. I'm inside Jed McKenna looking out a
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d I can't really remember what he's supposed to do or say. It's all fakery. I'm an actor playing a role for which I feel no connection and have no motivation. There cannot be anything genuine in my dealings with people who are dealing with my outer garment. (The whole thing is further entangled by the fact that there's no "I" inhabiting my shell, just a fading echo, but let's not go down that road just now.)
Actually, it's not really confusing. I possess not
Actually, it's not really confusing. I possess not
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the least shred of doubt about who and what I am. The tricky thing is that who and what I am is not related to this pretty, professional, salad-eating woman across from me. By coming to this lunch I have inserted myself into a situation where I do not belong. I am an imposter. I have some residual fondness for my sister and if she died I'd be saddened to think that she was no longer in the world, but the simple fact is that our former relationship no longer e
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
xists.
Okay, so why am I telling you this?
Because that's what I do. I try to hold this enlightenment thing up for display and this seems like an interesting aspect of the whole deal. How do you relate to the people who were most important to you before awakening from the dream of the segregated self?
She asks why I'm in town.
"My astrologers told me it was a good time to get away and not try to accomplish anything. They said that ketu and rahu wouldn't b
Okay, so why am I telling you this?
Because that's what I do. I try to hold this enlightenment thing up for display and this seems like an interesting aspect of the whole deal. How do you relate to the people who were most important to you before awakening from the dream of the segregated self?
She asks why I'm in town.
"My astrologers told me it was a good time to get away and not try to accomplish anything. They said that ketu and rahu wouldn't b
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
letting me get anything done for awhile anyway..."
I look up and see that she has stopped chewing in mid-mouthful and is staring at me incredulously.
"What?"
"My astrologers..."
"You're not serious. You have astrologers?"
Oh yeah. I guess that sounds weird. I was vaguely aware that I was trying to be funny by starting a sentence with "My astrologers told me..." but what's a little amusing to me is other-worldly to her. Might as well have fun with it.
"
I look up and see that she has stopped chewing in mid-mouthful and is staring at me incredulously.
"What?"
"My astrologers..."
"You're not serious. You have astrologers?"
Oh yeah. I guess that sounds weird. I was vaguely aware that I was trying to be funny by starting a sentence with "My astrologers told me..." but what's a little amusing to me is other-worldly to her. Might as well have fun with it.
"
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
have dozens of astrologers. I can't swing a dead cat without hitting someone who's doing my chart or explaining how my future will unfold; advising me on pretty much everything."
Her expression doesn't change. "You have astrologers?"
"Lots. Gotta beat 'em off with a stick."
"And they tell you... They tell you what the future holds? What you should do? When you should do it? What you should avoid? Is that what we're talking about?"
"I suppose."
She resum
Her expression doesn't change. "You have astrologers?"
"Lots. Gotta beat 'em off with a stick."
"And they tell you... They tell you what the future holds? What you should do? When you should do it? What you should avoid? Is that what we're talking about?"
"I suppose."
She resum
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
s chewing but the wide-eyed gaze remains. There's a chasm in this conversation across which there's no point trying to communicate. She knows I'm into some serious weirdness, but not how much or what kind. I don't really have astrologers, of course, but in those days it did seem like I was surrounded by students of Eastern and Western astrology who were always very eager to share their readings.
"What do you do with all that information?"
"Me? Nothing. I me
"What do you do with all that information?"
"Me? Nothing. I me
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n, I don't ask for it. It's not like I wake up and summon the court astrologers to plan my day."
"Sounds like you do."
"I was speaking lightly."
I'm trying to skip playfully along the surface of this conversation. I don't want to sink down into the kind of answer I'd give a serious student. The truth is that I don't possess any mechanism that would allow me to be curious or concerned about the future, but saying that doesn't make for breezy conversation.
"Sounds like you do."
"I was speaking lightly."
I'm trying to skip playfully along the surface of this conversation. I don't want to sink down into the kind of answer I'd give a serious student. The truth is that I don't possess any mechanism that would allow me to be curious or concerned about the future, but saying that doesn't make for breezy conversation.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
"Jesus," she says, shaking her head. "My little brother has his own astrologers."
"Well, they're not really mine. They're just in attendance, so to speak."
I'm used to conversing with people who aren't awake and aren't happy about it. Everything else is chit-chat; talking for the sake of talking, reinforcing the illusion of self. I'm not against it, I just don't care to participate in it. My fault.
"So, you obviously have a great deal of influence over you
"Well, they're not really mine. They're just in attendance, so to speak."
I'm used to conversing with people who aren't awake and aren't happy about it. Everything else is chit-chat; talking for the sake of talking, reinforcing the illusion of self. I'm not against it, I just don't care to participate in it. My fault.
"So, you obviously have a great deal of influence over you
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
students," she says as she sips her iced tea. I mull her statement over and decide that I don't have a response. I take another bite of pasta, wishing I'd ordered something with meat.
"I mean," she says, "they obviously hold you in very high regard. That's quite a responsibility."
She thinks, quite understandably, that she's my big sister and we're having a reunion; a nice little catch-up lunch. She's been thrown a curve with this little-brother/spiritual-
"I mean," she says, "they obviously hold you in very high regard. That's quite a responsibility."
She thinks, quite understandably, that she's my big sister and we're having a reunion; a nice little catch-up lunch. She's been thrown a curve with this little-brother/spiritual-
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
aster thing and she's trying to handle it. Does she think I'm a fraud? Does she think I'm running a game? Does she think that underneath it all I'm still really her little brother? I don't know and I don't much care. The fact that she's read Damnedest doesn't mean that she and I can speak; it means she should know we can't. She doesn't seem to be clear on that. Maybe she thinks the enlightenment thing is just my day job and that I can step out of that role to
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
be with someone who knows the real me.
"I don't know. I suppose it's a responsibility."
"You don't know? Obviously these people are strongly influenced by you. You don't think that's a big responsibility?"
I shrug. The first thing she said to me when we got together was that I wasn't dressed well enough for the restaurant. Such a statement is so alien to me that I could only shrug. Now it seems that every statement she makes is so alien to me that I can on
"I don't know. I suppose it's a responsibility."
"You don't know? Obviously these people are strongly influenced by you. You don't think that's a big responsibility?"
I shrug. The first thing she said to me when we got together was that I wasn't dressed well enough for the restaurant. Such a statement is so alien to me that I could only shrug. Now it seems that every statement she makes is so alien to me that I can on
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
y shrug.
In accepting this lunch engagement, my hope was that I could slip back into my old persona enough to manage a civil meal. That was too hopeful. I can no longer impersonate myself and I am simply unable to formulate a reply to anything she has to say; I've forgotten my lines. We don't share a common tongue and there's no way I can make her see that. From her point of view she's saying perfectly normal, conversational things.
"Yes, I suppose it's a b
In accepting this lunch engagement, my hope was that I could slip back into my old persona enough to manage a civil meal. That was too hopeful. I can no longer impersonate myself and I am simply unable to formulate a reply to anything she has to say; I've forgotten my lines. We don't share a common tongue and there's no way I can make her see that. From her point of view she's saying perfectly normal, conversational things.
"Yes, I suppose it's a b
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ig responsibility," I say, trying to say something that sounds like I'm saying something.
She lowers her voice. "You hear a lot about people in your position taking advantage of that responsibility for... unsavory purposes. I hope you would never do something like that."
I could simply tell her what the preview copy of the book was meant to tell her, that we are no longer related because what I am now doesn't relate. But why say it? To satisfy myself? It wo
She lowers her voice. "You hear a lot about people in your position taking advantage of that responsibility for... unsavory purposes. I hope you would never do something like that."
I could simply tell her what the preview copy of the book was meant to tell her, that we are no longer related because what I am now doesn't relate. But why say it? To satisfy myself? It wo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ldn't. To inform her? It wouldn't.
"You mean sex stuff? That sort of thing?"
"Whatever. Power corrupts. I just hope you'll be careful."
Sweet. Big sister giving little brother some advice on how to shoulder the burden of power. Being in advertising, perhaps she thinks we have something in common; wielding the power to influence people's thoughts. Maybe she thinks we're in the same business, I don't know.
I set down my fork and sit back. "Well, when I walk
"You mean sex stuff? That sort of thing?"
"Whatever. Power corrupts. I just hope you'll be careful."
Sweet. Big sister giving little brother some advice on how to shoulder the burden of power. Being in advertising, perhaps she thinks we have something in common; wielding the power to influence people's thoughts. Maybe she thinks we're in the same business, I don't know.
I set down my fork and sit back. "Well, when I walk
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
through the house, I always have someone proceed me with a boom-box playing Darth Vader theme music to lend a weighty and ominous air to my approach. And I certainly don't dress like this. I have, you know, the robes, the beads, and I always carry fresh flowers. Just trappings, all very tiresome, really, but the minions expect it. There was a little resistance at first to having them call me Shri Shri Shri Shri Jed, but they got the hang of it. And rememberin
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
to speak in the first person plural there and singular here can take a little getting used to, but we are, I mean, uh, I am, happy to make the effort. Noblesse oblige and all."
She stares at me for a moment, then bursts into laughter. I guess some ice has broken because we are able to continue in a lighter and friendlier manner, and eventually say goodbye with genuine fondness.
I doubt I'll ever see her again, but I'm happy knowing she's still in the world
She stares at me for a moment, then bursts into laughter. I guess some ice has broken because we are able to continue in a lighter and friendlier manner, and eventually say goodbye with genuine fondness.
I doubt I'll ever see her again, but I'm happy knowing she's still in the world
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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