A Quote by Scott Gottlieb

Biologics must be grown in living systems - fermented, for example, in large vats of bacteria cells. This makes them hard to replicate. For decades, biologics weren't subject to competition from copycat generic medicines, even once patents and exclusivities had lapsed on originals.
The higher cost of getting a generic drug approved by regulators means that many old medicines don't face competitors. It's only after substantial price hikes that these drugs offer enough revenue to offset the rising generic entry costs, and start to entice competition.
Getting a traditional pharmaceutical to the market can cost a billion dollars or more. Newer, more tailored and targeted drugs called biologics are even more complex and expensive. Simple economics dictates that companies and venture funds will invest more in products that can generate a sufficient return.
Bacteria are single-celled organisms. Bacteria are the model organisms for everything that we know in higher organisms. There are 10 times more bacterial cells in you or on you than human cells.
For the first half of geological time our ancestors were bacteria. Most creatures still are bacteria, and each one of our trillions of cells is a colony of bacteria.
We divorced ourselves from the materials of the earth, the rock, the wood, the iron ore; we looked to new materials which were cooked in vats, long complex derivatives of urine which we called plastic. They had no odor of the living, ... their touch was alien to nature. ... [They proliferated] like the matastases of cancer cells.
Plants with leaves no more efficient than today's solar cells could out-compete real plants, crowding the biosphere with an inedible foliage. Tough omnivorous bacteria could out-compete real bacteria: They could spread like blowing pollen, replicate swiftly, and reduce the biosphere to dust in a matter of days. Dangerous replicators could easily be too tough, small, and rapidly spreading to stop - at least if we make no preparation. We have trouble enough controlling viruses and fruit flies.
It's incorrect to think of bacteria as these asocial, single cells. They are individual cells, but they act in communities, exactly the way people do.
EpiPen is not unique. It falls into a category of old drugs, many of which should have long been subject to generic competition.
By weight, you are more human than bacteria, because your cells are bigger, but by numbers, it's not even close.
When the finely tuned balance among the different parts of bodies breaks down, the individual creature can die. A cancerous tumor, for example, is born when one batch of cells no longer cooperates with others. By dividing endlessly, or by failing to die properly, these cells can destroy the necessary balance that makes a living individual person. Cancers break the rules that allow cells to cooperate with one another. Like bullies who break cooperative societies, cancers behave in their own best interest until they kill their larger community, the human body.
Think about multicellularity on this Earth. Every living thing originally came from bacteria. So, who do you think made up the rules for how to perform collective behaviors? It had to be the bacteria.
Nature is flexible and resilient. Nature likes redundancy and dispersion. It is approximate and deals in gradients. All boundaries are permeable. Nature nests small systems like molecules within larger systems like cells, which in turn are nested in systems called organs, organisms, ecosystems. We grew from ancient one-celled ancestors. Nature likes mergers: we contain multitudes of other life forms within us. We stand at the crest of four billion years, bacteria molded into wondrous form, burning with a slow fire and about to take the next step.
The Three of them were beautiful, in the way all girls of that age are beautiful. It can't be helped, that sort of beauty, nor can it be conserved; it's a freshness, a plumpness of the cells, that's unearned and temporary, and that nothing can replicate. None of them was satisfied with it, however; already they were making attempts to alter themselves into some impossible, imaginary mould, plucking and pencilling away at their faces. I didn't blame them, having done the same once myself.
Like patents - which also seek to protect the little guy - unions were started for all the right reasons. But like patents, they can be twisted into something that hurts innovation, competition, and ultimately consumers and the country as a whole.
Today "aged" foods like sauerkraut, miso, and tempeh are fermented in hygienically sanitized stainless-steel vats to assure cleanliness, so we can no longer be sure they will provide us with the B12 we need. Vegans should not mess around with this issue.
Even books are nurses, medicines are nurses. But we must work to bring about the time when man shall recognise his mastery over his own body. Herbs and medicines have power over us as long as we allow them; when we become strong, these external methods are no more necessary.
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