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Let’s Blow It Up
In a recent comment, Ricochet member @DonG wrote, “The drug industry in the US is a giant racket enabled by a corrupted regulatory system.” After over 20 years of working in medicine, and doing occasional part-time work for pharmaceutical companies in the cardiovascular field, I find that statement to be precise and accurate. Fascism is an explosive word, almost like Nazi. But this is, precisely, fascism. It’s not socialism. Our government does not want to own the means of production; it just wants to control it. Regulate the heck out of it, get private industry to do what you want, then tax the crap out of it to fund a welfare state huge enough to buy sufficient votes to get you re-elected. It’s simple, really. It’s too bad that the term “fascism” is widely viewed as a pejorative because it’s a perfect description of much of our government.
To get back to Don’s point regarding the pharmaceutical industry: This is what excessive regulation creates. You destroy everybody, except for the few corporations enormous or well-connected (usually the same thing) enough that they can withstand the regulatory pressure with top-flight, very expensive legal departments. Then you control and profit from those few. You can’t control 1,000 drug companies, but you can control six of them; maybe eight. Note that this type of evolutionary pressure selects out those who are good at government, not those who are good at creating new drugs. As is true in every industry.
Take a new drug that costs $100 per month. How much of that do you think was used, directly or indirectly, as protection money against government regulators? I would suggest that it must be more than half; probably a lot more than half.
And then when people pick up their prescriptions at Walgreens and they’re expensive, they walk out of the store swearing under their breath. And who are they swearing at? Government? Politicians? No, pharmaceutical companies. Those very people, who can’t afford their medications, will then eagerly go vote for politicians who will protect them from those evil pharmaceutical companies by regulating them a bit more intensely. The increased regulation requires more expensive legal departments and lobbying firms, so drugs get more expensive to pay for all this.
And on and on it goes.
This would be horrifying if it were a mistake. But it’s more horrifying because it’s not.
This is intentional.
So how do we fix it? Here’s my suggestion:
First, the FDA is out of control, because its job is so huge it’s impractical. For example, when a drug company develops a new drug, it has to prove a few things to the FDA about their new drug:
- Is it safe?
- Does it work better than placebo?
- Does it offer some advantage (increased efficacy, improved safety, etc.) over the medications currently on the market?
- Is there a need for this medication on the American market?
In my view, the only possible purpose of the FDA should be #1 – safety. Once a drug company proves that a product is safe, then they should be allowed to sell it. Then it becomes their job to prove to doctors that there is a reason to use their new medication. The other points are, first, none of the FDA’s business, and second, impossible for a government agency to answer with any certainty.
To illustrate my point, let’s talk about quinine. It’s an old malaria drug, which doctors happened to notice works great for nocturnal leg cramps. We have no idea why. The FDA removed it from the American market, because a) there is no malaria in the United States, and b) there have been no large, multi-center, placebo-controlled, double-blinded studies to establish the safety and efficacy of quinine for treatment of leg cramps. You can see their point, I guess, if you think like a bureaucrat and not a human being. The problem is, there never will be such a study, because, by the time we figured out this interesting little fact about quinine, it was already generic. Nobody is going to do an FDA-level study (involving untold millions of dollars) to try to get a new government indication for a drug that costs five cents a pill.
So it has been banned from the US market, because the FDA can’t find a need for the medication (it’s only government-approved indication is to treat malaria), safety data (it has plenty of safety data, but not when it’s being used to treat leg cramps), or efficacy (again, nobody will ever do that study).
So, since we can’t get quinine anymore, now we use drugs like Requip that are:
- Not as safe
- Much more expensive
- Not nearly as effective
Every time I write that prescription, I thank the FDA for their guidance (using bad words).
Right now, about 80% of prescriptions in the United States are written off-label. That means that the prescription is written for a purpose that the drug has not been approved for. Why is this? Because the FDA makes the studies so expensive. The FDA has made it much more difficult to determine which drugs are safe and effective, because of its overwhelming impact on research.
For example, let’s suppose that Amoxicillin is approved for bronchitis. If you write it for sinusitis, that would make sense, because it’s the same type of bacteria. But that would be an off-label prescription because there have been no large, multi-center, placebo-controlled, double-blinded studies to establish its government approval for sinusitis. This is a hypothetical example. I think it’s indicated for one but not the other, but I’m too lazy to go look it up; and I don’t care, because I know how to treat a sinus infection.
Which leads me to the next problem with this system: I no longer care what the FDA says, because they’ve spent decades working day and night to establish their reputation as ridiculous and irrelevant.
These are people’s lives we’re talking about. I just mentioned drugs for leg cramps and sinus infections, but imagine this in the cardiovascular or cancer realm; it’s much worse than what I’ve described. It’s also more complicated; that’s why I used these examples, and that is also how the FDA gets away with this. Most people don’t understand what is going on, because they don’t understand subendothelial pathophysiology any more than they understand government regulations. The latter is much more difficult to understand than the former, but they’re both complex. It doesn’t fit into a soundbite or a two-minute piece for the evening news; so they can do whatever they want.
This is not silly government goof-ups: This is using the power of government maliciously, hurting people that you don’t care about, to gain money and power. This is vicious. This is not funny.
One really cool thing about being a doctor is that I spend all day talking to people in different lines of work, and I learn a lot. Just in the past couple of months, I’ve talked to people who work in restaurants, concrete, landscaping, roofing, transport, kitchen remodeling, and many other fields. When I ask them about their jobs, they don’t talk about concrete or kitchens – they talk about working around government to attempt to get some actual work done. It’s not just pharmaceuticals – this affects everything that happens in the United States. Everything.
This problem is so huge it’s difficult to comprehend. It’s amazing that our economy works at all.
Imagine what would happen if the government would just…stop. Start over. Try to figure out what its proper role is. How much are we really willing to spend in regulatory costs to be sure that our mattress label is sufficiently safe?
It’s so ubiquitous that we don’t even see it anymore; that’s the idea. That’s just the way things are.
You might wonder why things are this way. It’s because we’ve voted for it, ever since Woodrow Wilson.
Trump’s attacks on regulation are critical. There may be no more important issue in American politics. Many Americans in this day and age would trust Angie’s list more than they would trust the FDA. And the problem is, they have a point. We built this system in the early 1900’s and have expanded it ever since. It’s no longer helpful. If it ever was.
Heck with it. Blow it up. Let’s start over. Or at least try to move in that direction. What we’ve been doing is not working, unless you’re a CEO or a congressman.
I’m not. So let’s blow it up. Rebuilding from rubble would be easier than working in the framework we’ve built. It feels very odd for a conservative such as myself to talk this way.
But let’s blow it up. Please.
Published in Healthcare
Got it. However I use a power and Albuterol is not on the label. I don’t believe a propellant is used.
I’m not trying to suggest that this regulatory system makes any sense.
Although I’m concerned by your obvious hatred of the environment.
My fear is that with the insidious influence of the Left, it would be even worse if we blew it up. They’d get their hands on the re-make and put even more restrictions in. And we wouldn’t even realize what they were doing it until it was too late. Sigh.
You may be right. But I don’t think so.
Hard to say, of course. You never know what might happen when you take drastic steps.
But we’ve been playing nice, working within the system, allowing incremental gains for the left in an effort to make deals, and so on for over 100 years. I’m not sure if starting over would work, but I KNOW this isn’t working.
I’ve read the history books and I’ve read the newspapers. I know how this movie ends, and I have no interest in watching the 174th sequel in the action franchise “We’re From the Government and We’re Here to Help.” It’s no fun to watch a movie when you know how it ends.
I understand your point of view, Susan, and I share your concern about uncertain outcomes.
But certain outcomes are not desirable if that outcome is awful. In that situation, uncertain good is better than certain bad.
Let’s blow it up.
I’m with you. I just think we need to something about the people who will rebuild and watch them every step!
The left’s influence is exercised through these institutions, by mob rule which the media feeds off the artificial demands, and centralized interests created by them. If blown up they’d be weakened and if we don’t respond to mob hysteria, they’d be radically diminished. I think we have to blow it all up.
How do you implement this? It will take legislation, will it not?
My wife’s Doctor recommended Tonic Water ( the mixer) for her leg cramps. No perscription. It worked, but my wife couldn’t handle the taste. I suggested she cut it with Gin or Vodka, but she still didn’t like it.
I would suggest we pass a Constitutional amendment which states:
“The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”
That should fix it. Piece of cake.
There is significent controversy in Australia over the use of statins.
This YouTube lecture by an Academic at the University of Sydney (OZ’ oldest university and – ahem – my alma mater) is startling to say the least.
In short, statins are projected to be one TRILLION in sales by 2020. All this when there are serious scientific questioning as to the efficacy. e.g. why do some people with ‘normal’ cholesteral levels have heart attacks? (Industry answer = lower the definition of ‘normal’. Result? More statin sales to a larger target audience.)
This is worth devoting 20 minutes of your time to watch. Comments from the Ricochetti docs welcome.
https://youtu.be/BzTjPuikhQEx
Sorry. That came across as a little snarkier than I intended.
My point is that we don’t need to pass any laws or amendments. We just need to follow the laws that we already have.
We have a perfectly good Constitution, if we would just follow it. Every politician takes an oath upon taking office the he/she/it will protect and defend the Constitution, but it’s been many decades since anyone has. It drives me crazy.
STOP PASSING LAWS! That’s the point.
I think it was PJ O’Rourke who said that it’s no mystery how government works. The trick is getting it to stop.
If only. We are a system of 4 levels of law, however: constitutional, legislative, administrative and case. You will have to get through all four, won’t you?
The two branches of government which are the most powerful, and will be the most difficult to control, are the media and the un-elected bureaucrats. The wield enormous power, they answer to no one, and they have absolutely no reason to shrink the size or power of the government that supports them. I don’t see how that can be overcome.
As to the FDA part, Jonah Goldberg wrote an OpEd a few years ago about Gun Control but he used as an example of his point a story about an FDA employee (in charge of approving drugs in some area of medicine) that had not approved a single drug during his tenure. His standard was 100% safe and none met his standard. Interesting. The guys name was Nestor and “Nestoring” has become a verb describing that kind of activity and mind set. Pretty illustrative of the government in general (give a bunch of power to unelected, unaccountable bureaucrats) and the FDA in particular (and the EPA – I still haven’t forgiven them for taking Primatene Mist off the market because of the propellant – ugh!!!).
I get a lot of cramps especially at night in my feet and legs. Normally I am not much of a fan of as seen on TV but my wife ordered me Theraworx cramp relief. It really works. You can use it to prevent cramps but I only use it once they happen. I know sounds crazy but I don’t like to over use stuff like this. If I get a cramp I rub it on and the cramp goes away in about a minute and the best part it doesn’t come back the rest of the night. No prescription needed. Available on Amazon for $ 20.00. Enough for months for me.
I recommend this EconTalk episode on how drug companies game the system.
I’ll add a story. I take generic omeprasole (a PPI for reflux). It costs about $5 per 90 days. One day my doctor recommends I try an improved version called “Zegarid”. That prescription cost $1300 for 30 days. What is the great innovation for $15K/year ? They added a pinch of baking soda. Yep, just like your grandma does with pancakes. Some drug company combined a generic medication with a some chemical found in kitchen pantries for 200+ years and charged a fortune. I could not tell the difference. My doctor had no idea what the cost was.
So, after we blow up the FDA, let’s work on price transparency and making most meds available over-the-counter.
Yes I have been known to sometimes exhale CO2 when no one is looking. Can’t seem to quit much to the chagrin of my ex-wife.
You can’t raise your price by $1,300 in an open market. That cannot be done without government involvement.
Once there is true competition, we won’t need transparency. The various companies will be competing for customers, not government favors. That problem just magically disappears.
Tonic Water is also known as Quinine Water, I believe.
If your doctor learned about it from a pharma rep, I bet the rep knew what the cost was. And Zegarid probably paid for shelf space and glitzy display space in the pharmacy.
Once upon a time, the premiere American medical journal was the Journal of the American Medical Association. The only drug ads JAMA permitted were sober little announcements. A “tombstone ad,” a type still used in the financial industry. In the 19th century medical context, it included the name of the drug, plant or chemical but excluded mention of any purported benefits of the stuff. The ads were
That sort of thing.
Following the Civil War, drug companies began to produce more chemical drugs not made of or from plants, and also chemically modified extracts of plants. Not just paregoric (opium gum dissolved in camphorated (camphor is also a plant product) alcohol,) but morphine sulfate.
In addition, there were patent medicines, which were widely and floridly advertised; JAMA did not accept ads for such products. Drug companies wanted in on the action, and wanted to tout their wares to physicians.
A new idea was floated. The AMA would form a committee. A manufacturer would submit its secret or patented formula to the AMA for approval; if this was granted, an ad could appear in JAMA. Manufacturers that did this were called makers of “ethical drugs,” a term which persists today.
At about the same time, the AMA decided to allow ads touting features and benefits of drugs. How this decision was reached is unfortunately lost to history; the AMA’s headquarters burned in the late 1890s and its archives were destroyed. Such advertising in JAMA became tremendously lucrative and funded the rise of the AMA as a political power.
Yes. Originally used, though with a higher quinine content, as malaria prophylaxis. The prophylactic dose of quinine is often ototoxic, which is why in old or well researched fiction you’ll see descriptions of “taking quinine until your ears sing” or some such. Some people are particularly sensitive to this effect and develop it from today’s tonic water; it’s probably more likely with high end brands which contain more quinine than Schweppes does today.
How does the requirement to be safe balance with the fact that some medication can cause a person to be unsafe while operating heavy machinery? Or might cause itches or headaches?
Yes, and after media campaigns and legislative build up showing the population why they are the problem. Almost certainly however, some of the FDA’s power comes from non legislative decisions and regulatory creep which can be unwound without major fan fare. Has Epstein weighed in on the FDA here? I’d look to guys like him to lay out a strategy because he can actually get his brain around some of the complexity of undoing deep regulatory build up.
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Oh the safety deficiencies are much more than getting drowsy or having an itch. There is a long and troubling history of diabetes medications actually increasing the likelihood of heart failure, in spite of some of some of their advertised claims that their drug will lower your risk. Every time I see a Jardiance commercial I think “How do they get away with lying like that”? Oh, that’s right. Because the FDA has given them permission to!
Maybe not exactly blow it up, but repeal the 1962 amendments to the 1938 Food, Drug, and Cosmetic Act requiring drug companies to prove that their drug is effective as to their claims for it. Those amendments were pushed through during the thalidomide scare using the old statist playbook of using public horror to grab more power. When the demagogues inevitably bring out the pictures of kids with flippers, the answer is that the tragedy was caused by government bureaucrats once again not doing their job in keeping the public safe using laws already on the books. The current tragedy of wildly overpriced medicine and unnecessarily restricted access to some medicines is caused by the Federal government trying to choose medicines for patients. We already have highly trained, licensed professionals who do that- they are doctors and pharmacists.
A – freakin’ – men
And for those here who might call your experience anecdotal, or for those here who might start the litany chant of “free market” I looked into one company’s development of a breast cancer treatment. The Fed government offered up some 300 million dollars as a grant to help this Big Pharma company help women. When everything was done and over, the Pharma conglomerate started charging huge amounts to the breast cancer patients who could afford it. Then if not finding success in Year One, the breast cancer patient could continue the treatment for Year Two. If they had not reached their insurer’s $ 100,000 drug limitation.
Oh but not to be accused of being “anti-free market” let me point out that the drug company did benevolently bestow on our Fed government a 30 million dollar amount. Which I guess is all they could afford on their 6 billion dollars worth of profit.
Yep, piece of cake. providing a person doesn’t live in California.
The beauty of federalism. Leave.