Generic Drugs: The Same, but Not
The law requires them to be the same as brand-name drugs in all ways that matter. But what science considers important is a moving target. An Object Lesson.
I have a migraine. My son has strep throat. A patient presents to my clinic with signs of pneumonia.
These are all common enough occurrences. When I have a migraine, a good cup of coffee and a few tablets of ibuprofen go a long way towards soothing my throbbing head and general malaise. But not all cups of coffee are equally effective against migraines. I prefer the handcrafted pour-over from my local barista to the Styrofoam cupful that’s been sitting on a warming plate at my local gas station for a few hours; I think it makes me feel better faster. Nor are all pills of ibuprofen the same. I prefer the original Advil brand to generic ibuprofen because, like a well-sourced cup of coffee, it works better at making my headaches go away. Yes, I know that both pills contain the same active pharmaceutical ingredient in the same amount, and I’m a sucker for my neighborhood café. But the particular experience of consuming Advil—its lentil shape, its candy coating—is somehow more soothing than swallowing the slightly acrid, oblong generic versions. In ibuprofen, as in coffee, the materiality of my drug of choice matters.
Migraines are irritating and potentially disabling, but not life-threatening. Untreated strep throat, on the other hand, can lead to kidney failure or cardiovascular complications. Pneumonia can lead to overwhelming sepsis, shock, and untimely death. Yet I don’t give a second thought to spooning generic amoxicillin into my son’s mouth (as long as he gets to pick the flavor), or prescribing generic levofloxacin to my patients if their lung symptoms are accompanied by a chest X-ray that suggests pneumonia. I know that over the past half century the United States Food and Drug Administration has elaborated a complex system for ensuring that the efficacy, safety, purity, and quality of generic amoxicillin and levofloxacin is equivalent to the original brand-name versions. As a patient, parent, and physician, I find myself more comfortable using generic drugs in life-or-death situations and more comfortable expressing my preferences for brand names in more trivial forms of treatment.
Generic drugs may seem humdrum, banal objects. After all, who is going to win a Nobel Prize for creating a generic drug? Yet within each of these plainly wrapped commodities lies an ideological debate that cuts to the core of modern medical practice and consumer culture. For more than 50 years, research-based pharmaceutical manufacturers have tried to convince physicians and patients that generic copies are not as good as the original brand-name drugs. On one hand, the task of differentiating one brand of products from otherwise similar competitors has been the central task of marketing for more than a century. Consider how much effort the Coca-Cola Company continues to expend on differentiating its flagship product from Pepsi (and vice versa), let alone the variety of generic colas available at local supermarkets. But even conceding that the Pepsi Challenge might count as a form of experimental evidence, neither Coke nor Pepsi ever had to fill out an application to the FDA to approve their product or submit a sequence of randomized controlled trials proving their efficacy at quenching thirst. Manufacturers of generic cola do not need to prove in advance that their cola is cola in order to market it as cola. But in order to market a new drug, a manufacturer needs to provide thousands of pages of clinical-trial data proving it to be safe and effective at doing what it claims to do. And in order to market a generic version, a pharmaceutical manufacturer needs to prove that its product is the same as the original version in terms of all important physical, chemical, and biological characteristics, including identity, purity, quality, dosage, and absorption into the bloodstream.
Continue reading this HERE.
“As good as this bar is,” said the Scotsman, “I still prefer
the pubs back home In Glasgow , there’s a wee place
called McTavish’s…. The landlord goes out of his way
for the locals. When you buy four drinks,
he’ll buy the fifth drink.”
“Well, Angus,” said the Englishman, “At my local in
London , the Red Lion, the barman will buy you your
third drink after you buy the first two.”
“Ahhh, dat’s nothin’,” said Paddy Sheehan, the Irishman.
“Back home in me favorite pub in Galway , the moment
you set foot in the place, they’ll buy you a drink, then
another, all the drinks you like, actually. Then, when
you’ve had enough drinks, they’ll take you upstairs and
see dat you get laid, all on the house!”
The Englishman and Scotsman were suspicious of the
claims. “Did this actually happen to you?”
“Not meself, personally, no,” admitted the Irishman,
“but it did happen to me sister quite a few times.”
Reynolds: You are probably breaking the law right now
When lawmakers don’t even know how many laws exist, how can citizens be expected to follow them?
Ignorance of the law, we are often told, is no excuse. “Every man is presumed to know the law,” says a long-established legal aphorism. And if you are charged with a crime, you would be well advised to rely on some other defense than “I had no idea that was illegal.”
But not everybody favors this state of affairs. While a century or two ago nearly all crime was traditional common-law crime — rape, murder, theft and other things that pretty much everyone should know are bad — nowadays we face all sorts of “regulatory crimes” in which intuitions of right and wrong play no role, but for which the penalties are high.
If you walk down the sidewalk, pick up a pretty feather, and take it home, you could be a felon — if it happens to be a bald eagle feather. Bald eagles are plentiful now, and were taken off the endangered species list years ago, but the federal law making possession of them a crime for most people is still on the books, and federal agents are even infiltrating some Native-American powwows in order to find and arrest people. (And feathers from lesser-known birds, like the red-tailed hawk are also covered). Other examples abound, from getting lost in a storm and snowmobiling on the wrong bit of federal land, to diverting storm sewer water around a building.
Much more to read HERE.
This Duck Drone Could Spy on Enemy Subs
But building a flying-and-swimming robot is harder than nature makes it look.
Nature, which has no need for devices that spy on enemy submarines from the air and underwater, may nevertheless have invented their form: flying fish, for example, or ducks that can zoom over the water’s surface and dive beneath to feed. But the Navy Research Lab, or NRL, which is working on a new drone that can both fly and swim, is learning that combining robots for two different purposes is not as easy as nature makes it look.
Why does the Navy need duck drones? Simply put: flying is faster than swimming, largely because water is 1,000 times denser than air. Consider that the common MK 46 torpedo makes at best 50 mph, while sea-skimming missiles can do five times that speed.
While nature has found a way to accommodate the variety of physical forces that can act upon complex swimming and flying systems, humans have yet to figure this out. Submersible undersea drones, made thick-skinned to withstand water pressures, are generally heavy or equipped with complicated ballast systems. Aerial drones, conversely, are as light as possible, and rarely designed to crash into water.
Much more to read found HERE.
Optimism about a nuclear deal with Iran is pushing down oil prices.
Tuesday is the deadline for an agreement over Tehran’s nuclear program. If the Western powers agree to lift sanctions it would allow Iran to pump more oil into the world market, and prices could fall by as much as $5, according to an analyst at Societe Generale. Some reports say the negotiations have taken a sour turn.