Uh, Doc?
“Yes, Donsqyuishy”
“I’m no doctor, so I’m not sure of the answer to this question but, Is my son supposed to have 3 arms growing out of his ass?”
It’s completely normal now a days. You see Donsqyuishyi, the government has deregulated just about everything and allowed harmful chemicals to be used in just about everything. Corporations now know what is best for you and are fully aware of the health risks when the test new products for you to use and enjoy. You see Donviti, in a free market society, we don’t need regulation and if a company creates a product that causes your son to have 17 eyes, well eventually that company will just go out of business and that will teach the rest of the competition a big, big, ginormous lesson not to ever, ever do that again or they could be poor, broke, down and out on the streets without a home to live
So, Unfortunately for you, it is your kid that has 3 arms growning out his ass. But, that’s the price we have to pay for deregulation.”
“Oh, ok, thanks Doc, as long as my son dies and it is for a good reason. Here’s my $50 copay!”
“Can I sue them?”
“Well, you can try but the repubs have limited maximum damages to $250,000. And the company has already factored those damages into its pricing. You’d probably get $100,000 after legal fees but if you lose you’ll owe $150,000 to your lawyers. Lawyers aren’t taking these case on contingency anymore since tort reform.”
aka tort reform. that’ll show those greedy lawyers trying to stick it to those greedy corporations
Hef–I’m having a little trouble following this post, and the terms regulation and deregulation use. Redirect me if necessary.
Maybe it would help if you went on-line and bought the “lil mutant”, what prescription was ordered, from your country of choice at the best price? That way, you can feel better that no one chumped you for paying too much for the needed prescriptions, and that next day delivery service sure beats the heck out of a $50 co-pay. Great milk just flows from a milk carton–nothin’ behind that. So I bet all drugs are the same from all over. No testing needed, no studies, no trials, no waiting periods…so give it to me now, and at a great price, because I just know EVERYONE in pharmaceutical land has candy dishes of pills, and homes made from gold ingots. They just lock up those drugs for so long–like Walt Disney putting Sleeping Beauty back in the vault–to make me pay more than what it should cost–and claim regulation.
Daddyviti–this is a tough industry, in the way you present. Could you pick on the phone service,or electric company instead? Anybody else?
“Hon, why can’t we get Dad those blood pressure medications and that new cancer treatment that’s been approved for use in France for the past five years?”
“Well, dear, it’s because the FDA doesn’t give any credence to the drug-testing done in other industrialized nations. That’s why, during the 1980s-1990s, thousands of Americans suffered and died from conditions that were being successfully treated in England, Germany, France, Italy, and Japan. You see, the drug approval process in the United States takes twice as long as it does in Europe.”
“Well, isn’t that to protect us from those industry groups that would like the FDA just to approve their drugs without adequate testing–like Vioxx?”
“You’d think so, except that there were mortality-related Vioxx studies available in France and Italy three years before the US even began to investigate those deaths.”
This isn’t a libertarian or liberal issue. The FDA has been fucked up in both directions since the early 1960s when drug adoption protocols were first adopted under LBJ that tripled the study length for drugs and forbid the FDA from looking at information generated by other governments’ agencies. Then, in the 1980s the organization was gutted of staff and budget. Following that, in the mid-1990s and the failure of Clinton’s health care initiative, the Prez signed legislation passed by the GOP congress (with virtually NO Dem opposition) allowing the FDA to rely on industry studies while still not allowing it to use overseas studies.
The result: drugs that shouldn’t be approved get approved. And people die. Drugs that should be fast-tracked, aren’t. And people die.
The FDA is and has been a national disgrace for over five decades under virtually every administration.
Hahaaaa.
All DV’s kid got was three arms growing in the wrong spot.
Bum luck…..Lord knows that DNA strain could use a little mutation help elsewhere!
If he’s got three arms growing out of his ass he can change his own damn diaper.
It would make him inherently more useful (or dangerous!) than his father.
He could walk around with two thumbs up his butt and still have the ability to screw up other stuff in a hands-on approach.
At least he’ll have his eye on the ball.
The biggest reason why the FDA was told to stop using other countries’ data is called Thalidomide. The then FDA head did not approve it for use in the US, but there were many dispensed as part of a trial.
And certainly at the time, the FDA was interested in efficacy of drugs and the testing and test protocols for that were wildly variant across Europe. Test protocols are more uniform (but not exact) now, but in the early 60’s they were anything but.
anon and JC…awesome!
cassandra
I understand Thalidomide; I remember the babies.
That was a legitimate reason to question other countries’ data, except for three things
1) As you say, the FDA had not approved it, and even in Britain and Germany it was not approved for use on pregnant women; doctors did so despite multiple warnings
2) Even if you assume wildly varying standards (and that’s a pretty debatable issue), that only justifies not immediately accepting medications and looking at the European/Asian data, not forbidding the FDA to consider them
3) That certainly does not explain why the practice didn’t change in the following four decades despite the recommendations of multiple high-level FDA officials…..
I reiterate my point: the FDA has been a national disgrace for decades, regardless of what party or ideology you adhere to….
1. Thalidomide was specifically developed and targeted for use on pregnant women. It was supposed to relieve morning sickness.
2. More than 40 years ago, testing for efficacy and side effects was almost revolutionary. Right about the time of the thalidomide decision, the FDA was asking pharmaceutical companies to go back to previously approved medications to conduct the new tests for efficacy. Not considering other countires’ data was a question of being able to compare apples to apples, which would have been tough to do with multiple agencies with varying mandates and standards.
3) There may have been a time when most agencies charged with review of these drugs had largely been on the same page, but apparently now it is the US that is producing the dodgy data re: both efficacy and side effects of drugs.
Steve,
You’re wrong. The United States has led the world in developing new, innovative, effective, and SAFE medicines for all types of diseases. Part of the credit for this goes to the FDA, which has worked hard to ensure drugs are safe and efficacious and manufactured correctly. Europe and Japan are not even close.
The FDA had been an excellent science-driven government regulatory body for years until Bush and the repubs took over (surprise). Has it been perfect? No. Best in the world? Yes. Developed regulatory and approval processes that have been the model for other countries? Yes.
To say the “FDA has been a national disgrace for decades” is absurd. Most people in this country don’t think twice about whether or not the drug they are taking is the right dose, safe, and effective. That is because of the FDA, not voluntary industry regulation.
Bravo, Steve N. I think we need real reform in the FDA and also the USDA and we certainly don’t need less regulation. We also need to look at what’s coming over from other countries because we’ve seen the problems with melamine in food, for example. It’s also crazy that we don’t work with other countries, especially ones with good regulatory systems, to open up importation.
I’ve done this before in depth so you can go read it or not
http://delawarelibertarian.blogspot.com/2008/05/basic-failures-of-government.html
anonone
We’ll just have to disagree on this one; there is tremendous evidence that both the FDA and USDA have been regulatory failures–from beta blockers to Vioxx, meat inspection to food tracking.
I won’t argue that Dubya didn’t gut the FDA; I will argue that it wasn’t doing such a bang-up job in the first place. Tens of thousands of Americans have arguably died over our ridiculous lags in testing major drugs. You can’t sweep that part under the rug.
Steve,
What is your benchmark? What countries are have done better in drug development than the US?
I am willing to be shown some evidence that another country has a better drug development process.