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:

  1. Is it safe?
  2. Does it work better than placebo?
  3. Does it offer some advantage (increased efficacy, improved safety, etc.) over the medications currently on the market?
  4. 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:

  1. Not as safe
  2. Much more expensive
  3. 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
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  1. Blondie Thatcher
    Blondie
    @Blondie

    I had a patient Thursday whose daughter is a certified nursing assistant and phlebotomist in NY state. To get her license in N.C. she has to take another test (meaning pay the ridiculous fee) for the CNA and pass some other test for phlebotomy. My patient asked me if people in N.C. had different veins than people in NY. It’s not just a federal level thing. I’m with you 100%, Doc. 

    On the subject of drugs, when my mom was going through chemo for breast cancer, her oncologist said there was a great drug for her specific kind of cancer available in one of the Scandinavian countries (don’t remember which one), but thanks to the FDA he could not get his hands on it here in the US. Thankfully she is 15 years cancer free, but still irks me. 

    • #1
  2. Stad Coolidge
    Stad
    @Stad

    I love our drug industry.  The meds I take allow me to live a normal life, one I couldn’t do without those guys.

    I find Trump’s attacks on regulations refreshing.  Even regs that made sense 5, 10, 15 years or more ago might have made sense then, but they might not now.

    Hey liberals, here’s a quote for you:

    “If you think the Constitution is considered a living document that can be changed by the whim of a judge, why can’t the Code of Federal Regulations be considered a living document that can be changed by the whim of a President?”

    • #2
  3. Kozak Member
    Kozak
    @Kozak

    So recently had a young woman who was suffering from hemorrhoids .  I know not exactly life threatening, but trust me if you have them you can really suffer.

    So I wrote her a Rx for Anusol HC suppositories until she could see the surgeon.  She said ” this won’t be expensive will it, I don’t have insurance”. I said “naw, they are generic and have been around for ever”.

    We get a call from the pharmacy a little while latter. ” She can’t afford it”….

    24 suppositories were 435 dollars.

    2 years ago they were 30 dollars.

    • #3
  4. Blondie Thatcher
    Blondie
    @Blondie

    @kozak, what in the world! It truly has gotten insane. 

    • #4
  5. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Kozak (View Comment):

    So recently had a young woman who was suffering from hemorrhoids . I know not exactly life threatening, but trust me if you have them you can really suffer.

    So I wrote her a Rx for Anusol HC suppositories until she could see the surgeon. She said ” this won’t be expensive will it, I don’t have insurance”. I said “naw, they are generic and have been around for ever”.

    We get a call from the pharmacy a little while latter. ” She can’t afford it”….

    24 suppositories were 435 dollars.

    2 years ago they were 30 dollars.

    The price of the average genetic medicine has increased by over 600% since Obamacare was enacted.  Have production costs increased by that much?  

    Of course not. 

    Again, this is not an accident. 

    “Vote for me, and I’ll protect you against the system that I’ve created…”

    • #5
  6. Kozak Member
    Kozak
    @Kozak

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    So recently had a young woman who was suffering from hemorrhoids . I know not exactly life threatening, but trust me if you have them you can really suffer.

    So I wrote her a Rx for Anusol HC suppositories until she could see the surgeon. She said ” this won’t be expensive will it, I don’t have insurance”. I said “naw, they are generic and have been around for ever”.

    We get a call from the pharmacy a little while latter. ” She can’t afford it”….

    24 suppositories were 435 dollars.

    2 years ago they were 30 dollars.

    The price of the average genetic medicine has increased by over 600% since Obamacare was enacted. Have production costs increased by that much?

    Of course not.

    Again, this is not an accident.

    “Vote for me, and I’ll protect you against the system that I’ve created…”

    It’s damn ingenious because if the drug companies keep it up we will end up with socialized  medicine.

    • #6
  7. PHCheese Inactive
    PHCheese
    @PHCheese

    Have commented before that I use a  asthma inhaler that cots $360 here. I bought it for $66 in Costa Rica at a Walmart. I now buy in Canada 3 for $270. It’s shipped from England. Go figure. Exact same ingredients just a different label.

    • #7
  8. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    So recently had a young woman who was suffering from hemorrhoids . I know not exactly life threatening, but trust me if you have them you can really suffer.

    So I wrote her a Rx for Anusol HC suppositories until she could see the surgeon. She said ” this won’t be expensive will it, I don’t have insurance”. I said “naw, they are generic and have been around for ever”.

    We get a call from the pharmacy a little while latter. ” She can’t afford it”….

    24 suppositories were 435 dollars.

    2 years ago they were 30 dollars.

    The price of the average genetic medicine has increased by over 600% since Obamacare was enacted. Have production costs increased by that much?

    Of course not.

    Again, this is not an accident.

    “Vote for me, and I’ll protect you against the system that I’ve created…”

    It’s damn ingenious because if the drug companies keep it up we will end up with socialized medicine.

    It’s not the drug companies.  They’re just doing business, in the market as it exists.  Under different rules, they’ll behave differently. 

    • #8
  9. Blondie Thatcher
    Blondie
    @Blondie

    PHCheese (View Comment):

    Have commented before that I use a asthma inhaler that cots $360 here. I bought it for $66 in Costa Rica at a Walmart. I now buy in Canada 3 for $270. It’s shipped from England. Go figure. Exact same ingredients just a different label.

    That’s thanks to the EPA, I believe, as much as the FDA.

    • #9
  10. Kozak Member
    Kozak
    @Kozak

    Dr. Bastiat (View Comment):
    It’s not the drug companies. They’re just doing business, in the market as it exists. Under different rules, they’ll behave differently. 

    I don’t know what the reason is, but whatever it is it’s got to stop.

    • #10
  11. Mark Camp Member
    Mark Camp
    @MarkCamp

    You succinctly made a correct and important point that has escaped the public’s attention.  You did that in the second, in the third, and in essentially every subsequent sentence of this article.

    The experience of reading such an article isn’t pleasant after the first few moments.  By the end it is sheer torment.

    Perhaps I bring up a problem without offering a solution, but there it is.

    OK, here’s a try.  When you feel another one of these essays coming on, you could make a plan to dilute the content with some chat about other, more anodyne subjects, maybe US Olympic curling prospects or my favorite: theoretical economics.

    Note: For part of my career the US public paid me, by one channel or another, more than 500.00  USD/hr. (2018) for being a mostly unwitting part of this foolhardy, venal, metastatic FDA-regulated Industries complex.  Like you, I know whereof I speaketh.

    • #11
  12. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Mark Camp (View Comment):
    The experience of reading such an article isn’t pleasant after the first few moments. By the end it is sheer torment.

    Thank you for your positive feedback!

    • #12
  13. Mark Camp Member
    Mark Camp
    @MarkCamp

    Dr. Bastiat (View Comment):

    Mark Camp (View Comment):
    The experience of reading such an article isn’t pleasant after the first few moments. By the end it is sheer torment.

    Thank you for your positive feedback!

    Positivity. It’s what I do.  Back-handedly when possible.

    • #13
  14. Fritz Coolidge
    Fritz
    @Fritz

    In addition to heavy regulation, prescription drug prices soared in the wake of W’s legislation that added prescription drug coverage to Medicare, just as we boomers started to reach Medicare age.

    Consider too how the fees for ordinary dental care increased mightily after dental insurance became a common thing. Even veterinary charges have responded to the availability of private “pet insurance.”

    Once there is insurance involved, the cost of covered things skyrocket.

    • #14
  15. Arahant Member
    Arahant
    @Arahant

    Dr. Bastiat: 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.

    Isn’t it viewed as a pejorative because it is bad? Because even in its mildest form, it causes people to die needlessly?

    • #15
  16. Arahant Member
    Arahant
    @Arahant

    Fritz (View Comment):

    In addition to heavy regulation, prescription drug prices soared in the wake of W’s legislation that added prescription drug coverage to Medicare, just as we boomers started to reach Medicare age.

    Consider too how the fees for ordinary dental care increased mightily after dental insurance became a common thing. Even veterinary charges have responded to the availability of private “pet insurance.”

    Once there is insurance involved, the cost of covered things skyrocket.

    Because insurance companies, and especially governments, require a lot of paperwork and overhead for them to get payment.

    • #16
  17. PHCheese Inactive
    PHCheese
    @PHCheese

    Blondie (View Comment):

    PHCheese (View Comment):

    Have commented before that I use a asthma inhaler that cots $360 here. I bought it for $66 in Costa Rica at a Walmart. I now buy in Canada 3 for $270. It’s shipped from England. Go figure. Exact same ingredients just a different label.

    That’s thanks to the EPA, I believe, as much as the FDA.

    I don’t understand why EPA? Could you explain?

    • #17
  18. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    PHCheese (View Comment):

    Blondie (View Comment):

    PHCheese (View Comment):

    Have commented before that I use a asthma inhaler that cots $360 here. I bought it for $66 in Costa Rica at a Walmart. I now buy in Canada 3 for $270. It’s shipped from England. Go figure. Exact same ingredients just a different label.

    That’s thanks to the EPA, I believe, as much as the FDA.

    I don’t understand why EPA? Could you explain?

     I’ll give you one example that I am aware of.  There are many others. Albuterol is a drug that is used to treat emphysema and Asthma. It’s an inhaler. The propellant in that inhaler was determined to contribute to the hole in the ozone layer, so they banned Albuterol. We later found out that albuterol had nothing to do with the ozone hole, but no politician could overturn that regulation, without seeming to be insensitive to environmental concerns. Albuterol was quickly quickly reinstated, but with HEAVY regulatory issues, which makes it extremely expensive. Due to people who have only the best of intentions. The Environmental Protection Agency made it very expensive to have asthma. Again, with only the best of intentions.

    AND if you disagree, you hate the environment.  Or something. 

    • #18
  19. Boss Mongo Member
    Boss Mongo
    @BossMongo

    Thanks, Doc.

    • #19
  20. jeannebodine Member
    jeannebodine
    @jeannebodine

    Colchicine is an ancient drug that is commonly used to treat gout. My mother had such severe gout that an attack could cripple her for weeks.

    I  picked up my mom’s prescriptions at the local  CVS every month. Her co-pay for generic colchicine with the Medicare Drug Plan  was $2-3. I can’t remember the exact year, it was 2009-2010, I think, I went to CVS and found that the cost of the Colchicine was between $60 – $80! The pharmacist told me that the FDA had removed all the generics and the only colchicine available was the name brand drug, Colcrys, which was very costly.

    I was mad as hops! It seems that the FDA had withdrawn the ability of generics’ manufacturers to use the Colcrys’ patent. In order to get approval to make generics, the companies would have to go through all the FDA tests, trials, etc. (as they were in 2009-2010) which would be prohibitively expensive for a drug with such a small profit margin. 

    I then contacted the Colcrys manufacturer. After some heated discussions, they provided me with a discount card to get the brand drug for $6.00/month. I tried to get some press attention on the story since it was so indicative of the FDA/pharma problem in this country but the media’s  messiah was president so nada. Since then, I believe the FDA has approved a generic colchicine.

    • #20
  21. jeannebodine Member
    jeannebodine
    @jeannebodine

    Ask me about my migraine medication!

    • #21
  22. Boss Mongo Member
    Boss Mongo
    @BossMongo

    jeannebodine (View Comment):

    Ask me about my migraine medication!

    Uh, okay.  How’s your migraine medication?

    • #22
  23. jeannebodine Member
    jeannebodine
    @jeannebodine

    @bossmongo

    jeannebodine (View Comment):

    Ask me about my migraine medication!

    Uh, okay. How’s your migraine medication?

    I have to go to sleep now, I have a migraine. Ask me tomorrow! Nighty night.

     

    • #23
  24. Arahant Member
    Arahant
    @Arahant

    It looks as if the conversation starter has been blown up.

    • #24
  25. RushBabe49 Thatcher
    RushBabe49
    @RushBabe49

    One of the big reasons for high US drug prices resides in Europe.  Most European countries have socialized medicine, and those government systems have price caps on most medications, especially brand-name medicines.  Most drug companies are international, but based in the US.  Drug discovery is very expensive, and the only way a drug company can recover its research costs is to charge a lot of money for their drug while it is under patent.  However, that cannot happen in Europe, where they cannot charge enough (governments are paying) to recover their costs.  Basically, the only place drug companies can charge enough to recover their costs is the US, which does not yet have completely socialized medicine.  So we in the US are paying the costs of drug discovery all alone.

    That is why pharmaceutical companies have apoplexy when lawmakers and political candidates talk about “allowing Medicare to directly negotiate drug prices”.  If that ever happened, it would represent the end of the last market where the companies can charge enough to recover their costs.  They have squawked loudly that, if Medicare directly can negotiate lower prices, those companies might get out of the business entirely.  Highly unlikely, but it is something to consider.

    • #25
  26. OmegaPaladin Moderator
    OmegaPaladin
    @OmegaPaladin

    Let’s not blow it all up.

    The FDA should have a role in at least certifying studies for effectiveness.  I do not trust drug manufacturers to actually deliver what they claim is inside the pill.  We already know they regularly try to massage data.

    My tests would be simple:

    1. Does the pill contain what is says on the label?
    2. Does the medication actually treat a disease? (Be broad – an antibiotic is cleared for any bacteria that it can kill, anticholinergic medication is useful whenever blocking the parasympathetic nervous system is required, etc.  Focus on function.)
    3. Does it have a reasonable side effect profile for its target? (Lots of harsh side effects are acceptable when treating life-threatening cancer, not when treating baldness)
    4. Give it a restriction if it is an addictive medication or could encourage resistance.  (No feeding antibiotics to cows or giving them out like candy)

    That’s it.  I would also allow people to take certain medications on a waiver of risk.  I have heard of cases where people would love to take a risky medication to alleviate horrible symptoms.

    @drbastiat – I thought quinine has significant side effects?  I recall reading about arrythmia in my pharmacology books  Is really safe for leg cramps?  I will defer to your opinion as this is literally your area of expertise, but I didn’t know if it had slipped your mind.

    • #26
  27. dnewlander Inactive
    dnewlander
    @dnewlander

    Kozak (View Comment):

    Dr. Bastiat (View Comment):

    Kozak (View Comment):

    So recently had a young woman who was suffering from hemorrhoids . I know not exactly life threatening, but trust me if you have them you can really suffer.

    So I wrote her a Rx for Anusol HC suppositories until she could see the surgeon. She said ” this won’t be expensive will it, I don’t have insurance”. I said “naw, they are generic and have been around for ever”.

    We get a call from the pharmacy a little while latter. ” She can’t afford it”….

    24 suppositories were 435 dollars.

    2 years ago they were 30 dollars.

    The price of the average genetic medicine has increased by over 600% since Obamacare was enacted. Have production costs increased by that much?

    Of course not.

    Again, this is not an accident.

    “Vote for me, and I’ll protect you against the system that I’ve created…”

    It’s damn ingenious because if the drug companies keep it up we will end up with socialized medicine.

    A feature, not a bug. Repeal it.

    • #27
  28. dnewlander Inactive
    dnewlander
    @dnewlander

    RushBabe49 (View Comment):

    One of the big reasons for high US drug prices resides in Europe. Most European countries have socialized medicine, and those government systems have price caps on most medications, especially brand-name medicines. Most drug companies are international, but based in the US. Drug discovery is very expensive, and the only way a drug company can recover its research costs is to charge a lot of money for their drug while it is under patent. However, that cannot happen in Europe, where they cannot charge enough (governments are paying) to recover their costs. Basically, the only place drug companies can charge enough to recover their costs is the US, which does not yet have completely socialized medicine. So we in the US are paying the costs of drug discovery all alone.

    That is why pharmaceutical companies have apoplexy when lawmakers and political candidates talk about “allowing Medicare to directly negotiate drug prices”. If that ever happened, it would represent the end of the last market where the companies can charge enough to recover their costs. They have squawked loudly that, if Medicare directly can negotiate lower prices, those companies might get out of the business entirely. Highly unlikely, but it is something to consider.

    Completely true. Like defense, Americans  subsidize the rest of the freaking world.

    I love Europeans posting online, stating “you pay much more for [insert the blank here] than we do. We’re so great!”.

    My response is always, “Because we pay for the actual costs, jerk.” Drives me crazy.”

    [Note: does not apply for cell phones and internet cost, which are totally driven by their population density.]

    • #28
  29. American Abroad Thatcher
    American Abroad
    @AmericanAbroad

    This is a super post.  Disheartening and enraging, of course, but top-notch stuff.  The story about quinine is one that I will tell to my lefty friends who vehemently defend government bureaucracy.  Also, Dr. Bastiat, thanks for encouraging my habit of a gin-and-tonic nightcap–I wouldn’t want to cramp up at night!

    • #29
  30. I Walton Member
    I Walton
    @IWalton

    OmegaPaladin (View Comment):
    The FDA should have a role in at least certifying studies for effectiveness. I do not trust drug manufacturers to actually deliver what they claim is inside the pill. We already know they regularly try to massage data.

    You trust the government?  It is a self serving monopoly with no incentive to be honest because it is remote and non accountable, it enjoys no real information advantage, cannot self correct and once it makes a mistake will not correct that mistake because interests build up around it.   The point about any private sector produced outcome is that if it doesn’t work or does harm the company will be damaged and the drug won’t remain on the market.  Market outcomes with time move products toward what works and sells.  While there are always firms that will sell bogus products, do phony studies and make false claims these are easily researched and are driven more by the perverse incentives created by the obscene costs imposed by FDA requirements.     Would you buy a cheap generic or knock off Chinese drug  were the US product not priced several thousand percent higher?   The FDA could be replaced by an independent private public funded entity that reviews evidence and reports on findings, explores claims and reports on findings that has no authority to grant or withhold approval.  The biggest asset a large pharmaceutical firm has, or should have,  is its brand name.   It’s biggest threat is, or should be,  tort.  Instead it’s the FDA.  That’s crazy on the surface.

    • #30
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