I've Got the Pill to Drive Myself Sleepless

Teresa Nielsen Hayden is a touch miffed at Ralph Nader. To wit:

If Ralph Nader is run over by a beer truck and killed, if a very large meteorite falls on the offices of Public Citizen and vaporizes the lot of them, I won't feel sorry. Not the least little bit.

It turns out Teresa had been treating her narcolepsy with Cylert (the brand name of pemoline), a stimulant initially developed for ADHD, but also frequently prescribed off-label to narcoleptics and MS patients suffering from fatigue. Because it increases the risk of liver failure, it's typically something doctors resort to only after other medications fail. Now, under pressure from Public Citizen, the FDA has withdrawn it entirely.

The FDA's reason is that it has determined "the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug." Except, of course, that Teresa Nielsen Hayden obviously thought the benefits outweighed the risk. And, of course, there isn't really such thing as the "benefit" or "risk" of a drug in itself, but only the benefit and risk to a particular patient—not just because of physiological variation between people, but because of how we differently value the same sets of positive and negative effects. A sane FDA would give us the information and let us decide for ourselves which way the balance came out.

Comments

[Jennifer]

I also wish the FDA and the Nannies would learn to distinguish between "quality of life" and "quantity of life." Even if Teresa Hayden knows for a FACT that she will get liver damage, maybe she would prefer to live for sixty years of a normal life before dying of liver failure, rather than live eighty years but be unable to enjoy them because the poor woman can't stay awake for anything.

[Baylen Linnekin]

When I was in high school I fell asleep during a Nader talk at a local university. Death in this case seems a reasonable punishment, given that Nader may in fact be the cause of narcolepsy.

[Charles Hueter]

Great title, Julian.

Mrs. Hayden is making a bread-and-butter libertarian argument: "I've made the choice to use this drug because I think (with my medical professional) it is an excellent choice for my needs. Why should I be deprived of this drug when only a few are suffering bad reactions?" AKA, individualism over collectivism.

Little does she know that very argument applies just as equally to nearly everything the state does today. Little do I expect her or her sympathizers to try and apply it logically.

[Hakluyt]

I can see a black market in Cylert coming.

[andy]

Nor would a sane FDA require a prescription for every little drug imaginable. While in Spain, I had a nasty little infection, for which I'd been treated in the States, recur. I no longer had the medication which I'd used here and I was extremely disinclined towards paying for a doctor's visit when I was certain of the diagnosis and treatment. Imagine my surprise when an amigo told me that I didn't need a fuckin' scrip to get a simple antibiotic. It completely blew my mind.

[quasibill]

As Julian and Jennifer note - risk management and assessment is subjective. That's why you don't want to open that door for the state. Once you do, you become nothing more than a child in thrall to the nanny state.

[Randolph Carter]

Nice homage to Mike Doughty in the title

[Thomas Paine's Goiter]

This same argument can be made for the Celebrex. My great aunt's sister has begged for it to come back. It took all of her pain away and as she says "I'd much rather take the chance of dying of a heart attack than living with this much pain."

[Phil]

andy, when I spent a month in Germany a couple years ago, and had had problems getting a scrip filled here in the States before leaving, I found out to my amazement that I could get SSRIs OTC in Germany. Walked in to a pharmacy, asked for it by the generic name, and walked out with it in five minutes.

[andy]

Phil,

Interesting how in their uber-welfare state that SSRIs aren't more regulated. Did you happen to find out what other classes of drugs are OTC (that are here)?

[andy]

*are scrip only here 😛

[Russ 2000]

andy,

OTC antibiotics? Some hardcore libertarians admit to there being a benefit in government limitation of antibiotics

[Julian Sanchez]

Beat me to it... I was going to say, antibiotics are one of the few classes of drugs for which I do see a libertarian argument for restricted access.

[MP]

Some hardcore libertarians admit to there being a benefit in government limitation of antibiotics

Yes. This is for general public safety reasons, not for the protection of individuals.

[quasibill]

"Beat me to it... I was going to say, antibiotics are one of the few classes of drugs for which I do see a libertarian argument for restricted access"

Not that I necessarily disagree, but just to point out a contrarian position:

One of the reasons there are so few developed antibiotics is because there is no market for new ones - the old ones do the job well enough. So, if the old ones become less effective, a demand will develop for new ones, and they will be created.

Obviously, there are risks in that model, which is why I think that a wiser course (although one that doesn't require state intervention) would involve restricted availability of antibiotics (it wouldn't require state intervention because it would be in the producers' self-interest to keep their product effective).

[mediageek]

"If Ralph Nader is run over by a beer truck and killed, if a very large meteorite falls on the offices of Public Citizen and vaporizes the lot of them, I won't feel sorry. Not the least little bit."

What if he were to be run over by a Corvair?

[Phil]

Andy, I didn't ask -- I was in a pretty bad way, as SSRI withdrawal is kinda ugly. 🙂 Actually, it may not even be all of them, but definitely fluoxetine.

[taktix]

Hey, could you guys explain the libertarian arguement for antibiotic regualtion?

I know little about pharmocology because I personally don't ever want to become dependant on medication fed to me by the quasi-govermental medical industry.

[sulla]

If antibiotics are used incorrectly (i.e. you fail to take the full course) it increases the likelihood that resistance bugs will develop; potentially subverting the germ-killing power of the drug for everyone.

[iseek]

Argument for antibiotic regulation:

1. people often request antibiotics for non-baterial infections (i.e. flu) where they are absolutely worthless

2. putting antibiotics in your gut (where there are a lot of harmless bacteria) favors resistance to the antibiotic (note also that different species of bacteria swap resistance genes around like plug-and-play parts)

3. once resistance has evolved, it's only a matter of time before bacterial diseases are resistant and the antibiotic is useless

actually, resistance to any given antibiotic is pretty much inevitable; the only thing to do is make sure it happens slowly by not using the antibiotic correctly.

I'm not sure this is really a "libertarian" argument, but keeping you from doing something that does you no good (worthlessly taking an antibiotic) helps everone else in the long run (by avoiding bacterial resistance for as long as possible)

[Rich Ard]

hmm...so because it's bad for society, it should be controlled? Well, anything involving mold makes for a slippery slope.

[thoreau]

Rich Ard-

I think the argument is that improper use of antibiotics is akin to wandering around and leaving out bait for plague-carrying rats or malaria-carrying mosquitos. Not quite the same, of course, because you're fostering the development of new organisms rather than luring in pre-existing organisms. Still, the fact is that improper use of antibiotics carries more consequences for society than, say, voluntarily taking a drug that might damage your own liver.

I'd be thrilled if antibiotics were the only medications regulated by law.

[Amy Phillips]

Actually, it sort of makes sense that countries with socialized medicine would have deregulation of prescription drugs. If I have to go to the doctor every time I need pills, the government is paying for both the doctor and the pills. If I can just go to the pharmacy and buy the pills, the government only has to pay for the cost of the pills. Governments aren't generally great at managing money, but it's sort of a no-brainer that getting people to go to the doctor less will cost the system less.

Hmm, now I wonder if anyone has ever done a study to figure out what percentage of doctor visits in the U.S. are solely for people to get pills. The U.S. spends a higher percentage of GDP on healthcare than other industrialized countries, most of whom have less regulated drug distribution. If we didn't have to go to the doctor to get painkillers, birth control, strong cough medicine, etc., how much would we save?

[Isaac Bartram]

If we didn't have to go to the doctor to get painkillers, birth control, strong cough medicine, etc...

How would the Medicos maximize their incomes?

[Jeff P.]

And every time this fuck appears on a talk show they treat him with quaint politeness.

[Jennifer]

Amy, I can give you a personal statistic from my own my pre-insurance days.

Cost of generic prescription painkiller: $25 for a ten-day supply.

Cost of doctor visit to get prescription for generic painkiller: I don't remember exactly, but it WAS over $100.

(And that was about eight years ago. Make the proper adjustments for inflation.)

[Jennifer]

Wait a minute, I think the pills were actually $25 for a five-day supply. Still pretty cheap, though, compared to the cost of the doctor visit.

[Doc]

>A sane FDA would give us the information and let us decide for ourselves which way the balance came out

Please, this in a country where most think "intelligent design" should be taught in science classes? Or a 1/3 of people doubt we landed on the moon? Or where 21% still think Sadaam had links to 9/11?

We're a science ignorant society. Have you ever seen how crap is sold on those home shopping channels? People don't know shit and they're willing to take drugs simply because a commercial tells them 'Ask you doctor is "Drug X" is right for you!'

Pleasant dreams, Teresa! 😉

[mediageek]

We're a science-ignorant society because people can get away with being ignorant. No need to learn when someone else has already pre-packaged your thinking for you.

[Isaac Bartram]

Interesting, isn't it?

Public Citizen does not think that people with the advice of their physicians can make a sensible choice about the risks of a medication available only by prescription.

Some bunch of Christians does not think that women can make a sensible choice about the risks of the "morning after pill".

Not to mention the assorted drug warriors, smoking banners, GM food banners and on and on and on...

Hell, self-righteous busybodies as far as the eye can see.

[Bobster]

Smokers have sued the evil tobacco companies after they have been smoking for 50 years. I am sure many Cylert users will sue the evil makers of Cylert after they have been sleeping for 50 years. The company must be stopped for their own good and the good of mankind!

I love the god like commandments of the FDA!

[rafuzo]

I'll join the chorus in tipping my cap to a very coy title.

[Dave W.]

Julian's plan sounds pretty good to me, so long as you could sue the pharma co's if it were proven that their (required) risk assessments were incorrect or incomplete (and that probabilistically caused you harm). I wouldn't be so sanguine about a world with no FDA and no tort liability. That would get an awful lot of killed in a hurry.

Remember, this FDA stuf helps out a lot in tort suits. I think there would be a lot more tort suits in a world with no FDA and there probably should be. If disclosure is the name of the game, that disclosure ought to be a lot more meaningful, both informationally (eg, probabilities attached to risks) and liability-wise, than what we get now.

[Eddy]

What if he were to be run over by a Corvair?

Only if he is standing behind the Pinto it rearends.

[Nicolai V.]

Let me get this straight: In a year in which countless thousands of people have died from drug toxixities in drugs that the FDA FAILED to regulate--the year of Vioxx and the year of literally countless drug related tragedies--Julian Sanchez finds himself moved above all else by the plight of a blogger denied her narcolepsy medication?

You people are very lost. The FDA IS A GOVERNMENT organ. IT HAS FAILED DISASTROUSLY.

And this...is the thread you single out to snarkily comment on?

Are you all like...on numbing medications that they dole out at REASON?

Are dead people... dead people in a libertarian's mind, or just STUPID people?

Do you never address your class assumptions?

Who exactly do you think is "equipped" to read up on the dangers of the drugs that are sold like lifestyle dreams on TV commercials?

People like YOU? (White, middle class, snarky, know-it alls who never leave their computers?)

Are you ever responsible or do your hearts ever twinge even slightly for people who are less fortunate, more vulnerable, less ready with reading glasses, health insurance, a critical gleaming free market-loving mind?

The libertarian voice is the voice of a very shallow teenager, bordering on a sociopath.

How can you stand yourselves? I suspect you can't--which is why you all sound so angry.

[Nicolai V.]

What is the rationale for Libertarian silence on this disgusting scandal? Are forcibly experimented on foster children "free" in your free market utopia? Were they free when the state mass consented them, without guardians? Were they free when they died?

http://www.ahrp.org/infomail/05/05/04.php

[Nicolai V.]

Read this, Mr. Sanchez. Do some reporting. Pick up the PHONE. Ask some questions. This rising movement is not something you will want to be on record having sneered at and dismissed. This site contains hard data, and inside documentatoion from both FDA, NIH and pharma.

You will squirm out via some libertarian slip-knot but you will not be free of a nagging conscience...that maybe people are indeed great danger in today's pharmatopia. Adverse reactions and deaths, to be precise. On a shocking scale.

READ UP. Sit down with their loved ones and see if your arguments don't start to feel a bit uncomfortable.

I have been a libertarian for 25 years but this is where you lost me. Be ashamed. No better yet--start reading. Go to the AHRP's site and read all you can. The woman who runs it is neither right, left nor libertarian. She is a child survivor of Auschwitz. Got a quick retort for that?

http://www.ahrp.org/infomail/05/11/03.php

[tarran]

Uhmm, Nikolai,

First, I think few people question the need for auditors to monitor drug manufacturing processes and studies to examine the efficacy of the same.

However, I know of no true libertarian who accepts that the FDA in its current form is morally acceptable.

The FDA performs two functions in relation to pharmaceuticals: it forces companies to "prove" that the drug works, and it audits manufacturers to ensure that the manufacturers are manufacturing drugs properly.

The flaw in the FDA is that it has the power to prevent people from ignoring it.

If the FDA has not approved a drug, it is impossible to legally purchase it. You can be arested, and your property confiscated for attempting to do so. This has led to the absurd situation where people dying of terminal diseases are prevented from purchasing unapproved medicines, even though they are willing to take the risk.

Additionally, the FDA has no competition. Because it is funded by confiscated wealth, it has been able to muscle competitors like the AMA and Consumer Union out of the drug regulation market. Officers of the FDA do not have to do a good job; they are not personally liable for their mistakes, if they goof, they will not lose business (in fact if they goof they may get more funding!).

The FDA also makes medicines highly expensive by limiting competition in the pharmaceutical field. Currently, it takes about 7 years to bring a new drug manufacturing plant online. This means that a new facility will lose massive amounts of money before it generates any income. The net effect is to reduce the number of manufacturing capacity available, and to limit the pool of businesses in the field. In theory, the profit margins of a business are dominated by the barriers to entry. The harder it is for a new competitor to enter an industry, the higher the prices the existing players can charge for their services without having to worry about increased competition. Furthermore, the fDA attempts to introduce scarcity by limiting competition between competing drug lines. The FDA is in effect the enforcer of the cartelization of the pharmaceutical industry.

Speaking for myself, I am a huge fan of free-trade between consenting adults. If one person wishes to manufacture a medicine, and another person wishes to consume it, I have no right to stop them. I could, if I thought the choice of medicines a bad one, speak out against the transaction and seek to persuade the buyer/seller not to enter into the deal, bu I have no right to use force to stop the deal from going forward. Nor does anyone else hve such a right over me. If neither I nor anyone else has that right, we certainly cannot delegate it to others, and so the actions of a government agency that exercises such powers are inherently and on their face immoral.

The heart of libertarianism is the zero-aggression principle, which holds that it is immoral to initiate acts of force or fraud against anyone else. The FDA violates this principle.

As to your question"What is the rationale for Libertarian silence on this disgusting scandal? Are forcibly experimented on foster children "free" in your free market utopia? Were they free when the state mass consented them, without guardians? Were they free when they died?"

Obviously what has been done to those children was a violation of their rights. When government officials kidnap children from their parents to force them to be guinea pigs in medical experiments, it is, by definition not a freemarket activity.

For someone who claims to be libertarian you strike me as being pretty ignorant of what it actually is.

As to our "silence" on the issue, dude, I notice that you did not condemn, in either of your posts, the millions killed by Hitler and Stalin in their pogroms agains the people of Eastern Europe and Russia. Should I equate this "disgusting silence" on your part with tacit support for those two gentlemen?

[Dr. Nick]

Hi Everybody!

Did I hear someone asking for prescriptions again?

[dead_elvis]

If Ralph Nader is run over by a beer truck and killed, ..., I won't feel sorry. Not the least little bit.

I don't know, I mean, what if some beer is spilt?

[Phil]

Let me get this straight: In a year in which countless thousands of people have died from drug toxixities in drugs that the FDA FAILED to regulate--the year of Vioxx and the year of literally countless drug related tragedies--Julian Sanchez finds himself moved above all else by the plight of a blogger denied her narcolepsy medication?

Dear Asshat:

Learn to read.

[Nicolai V.]

What kind of juvenile writes: "Dear Asshat, Learn to Read?"

I read the links you provided and it confirmed my critique: Libertarians have taken a firmly apologist no--no-no-it-isn't-happening head-in- sand position on the multi-facated catastrophe of the medical industrial complex since the bio-tech boom and the deep penetration of pharma funding into all organs of the medica/scientific eco-system.

You have failed to detect the point at which "free markets" degenerate into cluster tyrannies. True, dependable, clean, evidence-based "science" has been all but made impossible--choked out by tighter and tighter webs of conflict.

As journalists, you have failed your readers. You honk your horns over minor infractions, cherry-pick silly, absurd cases of statist over-protection, and fail even to recognize that this is not a matter of free markets vs big brother government but of a terrible Frankenstein merger of the two into one swollen, rotten organ that says anything, can prove anything, pushes any swill down any throat in the name of the medical utopias you folks are so dazzled by.

You should be careful with the links you trumpet "Phil." All you proved is that Ron Bailey isn't even reporter enough to know that NOT EVEN THE NCI maintains that HPV "causes most cases of cervical cancer."

And he worries about some moron who is still waiting around for an HIV vaccine? HIV positives already have antibodies, but presumably Ron Bailey and friends trust that given another 22 years and maybe another $50 billion, the wizards will find a way to distingush between the good kind and the bad kind.

You REASON-ites SEEM to me unless I am totally mistaken...being that I am apparently as "asshat," to be disdainful of the very idea of vested power blocks and neurotic pseudo-market driven scientific systems injuring or killing people.

That is your perogative. As it is mine to say you're blowing it.

As for the desperado Hitler and Stalin accusation...I invoke, Godwin's Law which holds that online threads that go on past a certain point reach a 100% probability of somebody invoking Hitler. (In this case Stalin too!)

Whoever does so is generally said to have hands down lost the argument.

We weren't talking about Hitler or Stalin.

As for "zero-aggression," I once again invite you to investigate the literally countless claims, stories, reports of wrongful deaths at the hands of aforementioned free market medical machine, and tell the grieving families all about your carefully crafted, elitist libertarian principles. Tell them to their face.

As of this exchange and the painful reminder of libertarian denialism in virtually all matters pertaining to medicine and science, I will no longer identify with the belief system, so you have one less ass-hat to contend with and can now carry on with your pointless piss-matches on the fringes of reality. Don't forget the core principle that all Texans are morons.

From Austin with love, adieu--

[R C Dean]

Nicolai commits the classic error of the regulator - he

(a)focusses exclusively on the harm of a given activity - countless thousands of people have died from drug toxixities in drugs

(b)adds a gloss of exaggeration for effect (c'mon, "countless thousands"? - give me a break)

while

(c) completely ignoring the benefit side of the equation.

Did it ever occur to you, Nik, that the drugs that may have toxic side effects for some patients may have beneficial side effects for others?

Get back to us when you have done a cost/benefit analysis that includes, you know, the costs and the benefits.

[Dave W.]

Nicholai:

I think when Julian says "A sane FDA would give us the information and let us decide for ourselves which way the balance came out." he means information in a form that poor ppl without reding glasses could read and understand. I don't think he means to just give ppl raw undigested clinical data. At least I hope that's what he means -- cause I'm not paranoid like you!

[Baylen Linnekin]

The woman who runs [AHRP] is neither right, left nor libertarian. She is a child survivor of Auschwitz. Got a quick retort for that?

Nikolai, besides senselessly robbing people of their lives did Auschwitz also somehow steal their ideologies?

[Nicolai V.]

R C Dean:

I will "get back" to you precisely never. The argument you so cleverly frisbee back to me here about er, er, er, risk/benefit forces me into Godwin's Law, so now I really cannot return after this: It is in fact the "gotta break a few eggs to make an omelet" argument and it is widely credited to sociopathology in general and Josef Stalin in particular. It is a cold utopian argument that attempts to collectivise the toll of human life and reduce it to calculations.

Pharma-defenders: Nobody is against medicines or effective medicines. It is corruption, greed, rotten science, and inhumane standards of human research that we are in fact addressing. Have you not READ the voluminous documentation of the outright farce "medical science" with its purched, market driven "conclusions" about gee wiz drugs has become? The entire cast of characters, from doctor to researcher to text writer for medical journal to broadcast journalist...on profligate pharma payroll. Does it mean the data is wrong?
No.
Does it mean the data cannot be taken at face value?

Not necessarily.

But countless examples have proven this to be the case.

Back to the favored risk/benefit fig leaf, the gotta-break-a-few-eggs muscular rationalism of REASON and friends:

The populations on whom today's drugs are tested include minority orphans, foster children, and Third World illiterates. They are the eggs.

If you don't believe this I suggest a thorough reading of the documentation of our radical departure in the pharma age from Nurenberg/Helsinki codes of human research protection listed at the website of the Alliance For Human Research Protection (www.AHRP.org)

This small outfit is apolitical, and I dare say humane and probabaly in your terms "paranoid."

If, ("Dave W") "paranoia" includes the capacity to react and respond as a human being to stomach turning injuctice then count me in.

The FDA used to protect against both human research abuses and wanton drug dangers and one of the things it used to rely on was TIME. Prior to the 1980s, they generally took 10 years to approve drugs because they placed a premium on safety. Safety above and before all and that includes efficacy. Safety must come BEFORE efficacy. Efficacy cannot be conflated with safety. This is what Phase 1, 11, and 111 drug testing is (used to be)about.

Today's drugs are approved in as little as six weeks. (Yes.)Their "safety" is tested in powerless, voiceless populations, (animals and prisoners are among the BETTER protected) and also in the general population, where in fact, your values are in place, so you oughtta be happy. They crank the drugs out, make a killing, settle lawsuits with gags, and so it goes. Until Vioxx, which of course you guys all choked on, because obviously the jurors were too Texan and dumb to understand the data. What they DID understand and did communicate in their verdict was a punitive amount calibrated on the amount of time Merck had consciously suppressed the ominous data due to now well known marketing plans. Do you people think that all the governmental and pharmaceutical whistleblowers such as David Graham and others are delusional, PR seeking paranoiacs?

That is a very lazy and comfortable interpretation. It suggests that libertarians have lost the line between market/state freedom and Thoreau-ian humanistic consciousness.

You are proving yourselves more Lysenkoist than the left, and more craving of social acceptance (as measured by a chronic need to assert that critics and alarmists are stupid and "whacko,") than the right. You have become the new middle--the center, the blind spot.

Off you go. There may be some blogger who is furious over some minor infraction at the pharmacy. Nothing like getting your priorities straight.

We have here a total gridlock of perspectives so I won't waste any more of my time or yours locking horns with ya.

Go ahead and crow over what as asshat, tin foil, crazy, wrong, unreasonable, irrational, paranoic I am, but DO try to come up with new and better words than "whacko," or "whackjob."

I am a sentient human being and I can, in fact, read. Better yet, I can cry.

[an adolescent]

>Better yet, I can cry.

I don't steal and I don't lie--
But I can feel
And I can cry
A fact I bet you never knew

But to cry in front of you...
That's the worst thing I could do...

[Dave W.]

http://www.reason.com/hitandrun/2005/08/merck_jerked.shtml

disclosure: I was the poster with Dep't in my names.

[mediageek]

"How can you stand yourselves? I suspect you can't--which is why you all sound so angry."

No, fuckwaffle. We're so snarky and angry because self-righteous, quarter-witted, do-gooding assholes like you have made it your life's mission to tell everyone else how to live their lives.

And then you motherfuckers have the unmitigated gall to get indignant when anyone, anyone deigns to point out that your idiotic, statistopian ideas (which are funded by the public essentially at gunpoint) don't work.

Moron.

[mediageek]

"I am a sentient human being and I can, in fact, read. Better yet, I can cry."

(Snarky, angry libertarian mode)

You can cry?

Jesus Christ, you pansy.

It's truly unfortunate that a bleeding heart isn't a fatal affliction.

[Angry Snarky Bastard]

Nicolai has just cost me a bunch of money and an afternoon I should spend working as I now have to head out to the rifle range.

[johnl]

Wow. We landed a whale with this one.

It really is too bad about the narcolepts. I hope their doctors are able to find replacement strategies.

I have my own sob story about a decongestant. Somethinghydromine, or something. It worked better than pseudofed for me and did not keep me awake like pseudofed does. But some anorexic girls got heart attacks and it was taken off the market. And now the government doesn't like pseudofed either. It's like the FDA is out to make me stuffed up.

[vabs]

>And now the government doesn't like pseudofed either. It's like the FDA is out to make me stuffed up.

Sweetie, you should ask about nasal steroid sprays to decrease your sensitivity to allergens and irritants. Course, you will have to get a prescription for them, even though they have none of the side effects associated with topical or oral steroids, at least in most people.

(It angers me to no end that I can't just buy 'em when I need 'em. I have my diagnosis and I know under what circumstances I need to use them.)