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Business Dump - Evangelical Skepticism: Pursuing Your Right To Be Wrong
Michael Shermer speaks with the energy and passion of an evangelist, so it's not too surprising to learn that he used to be one. What is surprising is that he has made a 180-degree turn in his approach to belief. As a college student at Pepperdine University, he knocked on do
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
ors to spread the word of the gospel to anyone who would listen. Now he preaches the power of skepticism in the true sense of the word.
Like a war hero who becomes an anti-war activist, this turnaround is both curious and inspiring. His story underscores the complexity of th
Like a war hero who becomes an anti-war activist, this turnaround is both curious and inspiring. His story underscores the complexity of th
; 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
concept of belief and our need to hold on to some form of validation.
Shermer is the publisher of Skeptic Magazine. He is quick to point out that what many people think of as skepticism is really cynicism. Being skeptical has nothing to do with being a grumpy curmudgeon who
Shermer is the publisher of Skeptic Magazine. He is quick to point out that what many people think of as skepticism is really cynicism. Being skeptical has nothing to do with being a grumpy curmudgeon who
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
discounts any idea that disrupts his world view. It is less a position and more an approach using science and reason.
Skeptics are open to looking into anything and everything, but are reluctant to latch on to theories without sufficient evidence to back them up. Skeptics d
Skeptics are open to looking into anything and everything, but are reluctant to latch on to theories without sufficient evidence to back them up. Skeptics d
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n't sit around trashing the ideas of others--that would be a waste of thinking time. Instead, they luxuriate in the opportunity to further explore interesting notions.
The motto of the Skeptics Society and Skeptic Magazine is a statement made by the 17th-century Dutch philos
The motto of the Skeptics Society and Skeptic Magazine is a statement made by the 17th-century Dutch philos
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
pher Baruch Spinoza: "I have made a ceaseless effort not to ridicule, not to bewail, not to scorn human actions, but to understand them."
This is a fabulous approach to life, even though it may require more patience than most of us can muster. If we can't count on any absolu
This is a fabulous approach to life, even though it may require more patience than most of us can muster. If we can't count on any absolu
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
te truths and we don't want to get bogged down by the muddy thinking of relativism, we've got to do our best to establish what Shermer calls "provisional" truths. He uses the word "provisional" a lot to refer to those pretty good truths and almost universal ideas we tend to t
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
ink of as fairly consistent. Is infanticide bad? Yes, almost always. There could be, in some cultures and in some specific circumstances, ethical reasons to justify infanticide, but we recognize that those are few and far between. Provisional ethics allows for continued discu
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ssion and exploration in a way that a black and white view never will.
Shermer was in town recently to talk about the third book in his trilogy on the power of belief: The Science of Good and Evil: Why People Cheat, Gossip, Share, Care and Follow the Golden Rule. He offered
Shermer was in town recently to talk about the third book in his trilogy on the power of belief: The Science of Good and Evil: Why People Cheat, Gossip, Share, Care and Follow the Golden Rule. He offered
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
ompelling theories and groundbreaking scientific results regarding the evolution of human ethics. Thanks to magnetic resonance imaging, we can now see what's going on in the brain while we perform certain tasks. It turns out that the pleasure centers of our brain "light up" w
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
en we engage in activities that are cooperative- sharing, being generous, helping others. Just as though we were eating our favorite comfort foods, getting a massage, or making love, our brains register this activity as highly pleasurable. There is (some) reason to believe th
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
at cooperation has evolved as a highly prized survival skill, and thus we are "rewarded" by feeling good about it.
Engaging in competitive activities--trying to beat a rival, striving to gain control--shows up in an entirely different area of the brain. Of course, this is al
Engaging in competitive activities--trying to beat a rival, striving to gain control--shows up in an entirely different area of the brain. Of course, this is al
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
o a very important survival skill, but it tends to come with its own tangible rewards--more food, more wealth, the mate of your choice, etc.
I'm still waiting for research on highly competitive individuals. Do their brains light up in the pleasure zone when they win? Is ther
I'm still waiting for research on highly competitive individuals. Do their brains light up in the pleasure zone when they win? Is ther
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
e some sort of shift that happens? What about sociopaths? Do their pleasure centers flare when they lie, cheat, steal, or harm someone?
There's just no end to thinking when you view the world with a healthy dose of skepticism. Socrates observed that the only thing he knew fo
There's just no end to thinking when you view the world with a healthy dose of skepticism. Socrates observed that the only thing he knew fo
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
sure is that he knew nothing. Sticklers are all too happy to point out that this, in fact, suggests that he knows that nothing exists, knows that he knows this, knows that he knows that he knows this, ad nauseum. By the same token, if you are skeptical about everything, you
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
ust be skeptical of your own skepticism! Just when you think you've got something figured out, it's time to be skeptical again.
This isn't the mainstream approach to thinking. We tend to like having ideas we can hang on to. We choose a couple of stable concepts, tie up a ham
This isn't the mainstream approach to thinking. We tend to like having ideas we can hang on to. We choose a couple of stable concepts, tie up a ham
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
mock and swing there contentedly.
That's one way to live.
Another way is to hang that hammock on a couple of sturdy ideas, sway there a bit, and then go off and find another place to swing. It's a lot more work, but you cover a lot more territory in the process. Your intell
That's one way to live.
Another way is to hang that hammock on a couple of sturdy ideas, sway there a bit, and then go off and find another place to swing. It's a lot more work, but you cover a lot more territory in the process. Your intell
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ctual journey may be arduous but infinitely rewarding.
Because there are limitations in scientific investigation and plenty of mysteries remaining, the Skeptics keep in mind the words of Albert Einstein: "All our science, measured against reality, is primitive and childlike-
Because there are limitations in scientific investigation and plenty of mysteries remaining, the Skeptics keep in mind the words of Albert Einstein: "All our science, measured against reality, is primitive and childlike-
.
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
-and yet it is the most precious thing we have."
Einstein believed in the power of the unknown and reveled in the right to figure things out as best we can. He valued imagination over knowledge, but persisted in searching for evidence that what we dream can be described and
Einstein believed in the power of the unknown and reveled in the right to figure things out as best we can. He valued imagination over knowledge, but persisted in searching for evidence that what we dream can be described and
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
eported scientifically.
Skeptics are cautious believers. They hope for magnificence, they dream of infinite truths and they doggedly pursue their right to be wrong. They are forever moving their hammocks and testing untried trees.
And they are downright evangelical about it
Skeptics are cautious believers. They hope for magnificence, they dream of infinite truths and they doggedly pursue their right to be wrong. They are forever moving their hammocks and testing untried trees.
And they are downright evangelical about it
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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