Asymmetrical Information

No scientist here, as you know, but I do recall some serious discussion about why albuterol should not be OTC.

1) The effectiveness of EC is substantially diminished and finally destroyed by the passage of very little time. If you can't get your BC pill on a Saturday, big deal, you can just buy some condoms. Plus, birth control pills are something that you KNOW in advance that you will need and you buy them in month-packs, so you have 28days notice before running out. Most people do not expect to need EC.

For that matter why not add question 5: Why can anyone over 21 buy alcohol, which can very easily kill you, but not a little albuterol inhaler?

Your point 3 is well taken, unfortunately. Acetominophen-linked liver damage is far too common, generally in combination with alcohol. It's certainly not an awful drug, but it does indeed have side effects, which kick it at (by modern standards) unacceptably low multiples of the therapeutic dose.

The reason you can still buy it is that it's sort of grandfathered into the safety regulations, even though it would never reach the market today. And there aren't any big individual targets to sue, either - never forget that part.

If I'm not mistaken the albuterol inhaler works only if one actually has asthma, not being useful for other pulmonary conditions. I suppose the risk of making inhalers available OTC is that people who *think* they have asthma might buy the inhalers when they should be seeing physicians to find out what's really wrong and what they should be using.

As for Plan B, one interesting side effect is that using it may cause a woman to test positive for steroids, which can be quite a problem for a female athlete subject to random testing.

1) Taking one whacking great dose of hormones is not going to cause the blood pressure/blood clotting problems that taking hormones every day indefinitely can potentially cause. (Whether the risk of blood clots is high enough to justify making it prescription only is another question--AFAIK, it is mostly only a problem for smokers.)

Ok, time to hijack this thread with a digression. If, as Peter says, a side effect of Plan B "is that using it may cause a woman to test positive for steroids," if someone got themself a steady supply of Plan B (by buying OTC, maybe at a different store each time), would that actually work like steroids? And going back to Jane's point 1), could you cut up the Plan B pill(s), and create your own OTC birth control pill supply?

Tylenol is called paracetemol in Britain, and we are allowed to buy only 32 (I think) tablets at a time OTC. The explanation of the restriction was that it was to inhibit suicide. Very rum.

With respect to Sudafed (and Claritin D, etc.), as you imply it's not merely checking ID, I believe the store tracks the purchase by name and address. They're tracking how many purchases, not so much because you might be starting a meth lab, but that you would be one of dozens of purchasers to buy the drugs for someone else. Of course, if there are enough purchasers, no one purchaser will buy so much as to trigger anything suspicious -- unless, of course, they're all buying at one store during a time when allergies are not that bad, causing a suspicious amount of increased sales generally.

Interestingly, at Duane Reade in downtown New York, I don't have to show an ID, and the drugs are on open display racks. At Target in Jersey City, I need to go to the pharmacy counter during pharmacy hours to purchase, and take down my drivers licence number and everything.

MB

2) Because kids use the inhalers to get high, but nobody gets high on Tylenol. I don't know if there are any other health risks involved, but I have known kids who would actually do this. If I recall correctly, it involves modifying the inhaler to take a massively higher dose than it's intended to dish out, and it wasn't very hard to do.

Regarding my last comment, for the record, I'm not saying that it's a good reason, either. Just that it happens to be the reason.

Well, I'm not a pro-prohibition wonk, but I can certainly imagine one answering the Extra Credit question with "while I think meth should be prohibited, I also think requiring ID to buy a 12 pack of Sudafed is just government be-seen-to-be-doing-something grandstanding essentially unrelated to the goal I support, since, as you say, it has no real effect on the ability to produce or acquire methamphetamine, most of which is imported anyway".

(On that topic, either now or Very Soon, due to incredibly stupid state law, I'll need to not show my ID, but have a god-damn prescription to get anything with pseudo-ephedrine in it.

I should say right now that I hate everyone in the Oregon legislature that voted for that particular bit of immense stupidity.)

Remember, the Drug War is not about going after dangerous people. It is about going after disobedient people.

In this case, the State has declared that it will decide the reasons for which we may take drugs, and for which reasons we may not.

If the Drug War really was based on getting dangerous people off of the streets, the laws would let people take what they want, but come down like a ton of bricks on anyone whose drug use led them to wrongdoing. Since this end would be accomplished by slight extension of the same laws that cover alcohol-related impairment, such a stance would drastically reduce DEA funding levels.

Instead, the government goes after disobedient people. They ban meth, and ban anything that assists the manufacture of meth, and then ban anything that assists the assistance of the manufacture of meth, and so on. The result is that the circle of banned and restricted behaviors grows over time, the cost of fighting the Drug War grows with it, but the numbers of dangerous people on the streets is not effectively minimized.

The focus on disobedient vs. dangerous people is a common misdirection of effort that happens when the government sees itself as primary and the people as secondary. Dangerous people are a threat to the citizens; disobedient people are a threat to the government. By spending more and more time and energy on the latter, the government tells us where its real priorities lie.

The tail is wagging the dog.

I also think requiring ID to buy a 12 pack of Sudafed is just government be-seen-to-be-doing-something grandstanding essentially unrelated to the goal I support, since, as you say, it has no real effect on the ability to produce or acquire methamphetamine, most of which is imported anyway".

Citation, please. There have been numerous meth lab busts in the Denver metro area, so evidently some quantity is produced locally, and that requires sourcing the raw materials.

Worse still, regardless of where meth is coming from by volume, are the peripheral effects of a local operation; the chemical pollution from an illicit meth lab can mini-Superfund an entire residence, requiring (in the worst case) that a HazMat-type team remove and destroy pretty much anything resembling a textile, and scrub all permanant surfaces. If this isn't known and done, innocent parties living in the residence later may become inexplicably ill from the residues.

EPHEDRA works nicely on asthma. It can be found at truck stops and the body building section of health food stores. The FDA banned its use in diet pills but not for asthma.

1) You should be able to buy Birth Control Pills OTC

2) You should be able to buy an albuterol inhaler over the counter as well as a whacking big supply of hormones.

3) You should be able to buy an albuterol inhaler over the counter as well as Tylenol.

So the basic answer to all your questions...beats the hell out of me?

Why do you need ID to buy Sudafed, which only comes in little packages, but you can buy a case of kitchen matches OTC. You need kitchen matches too.

How come if it's legal to buy booze when you turn 21, depending on the state the seller has to card you no matter how old you are?

Why is OTC hydrocortizone cream limited to .10%?

As far as Sudafed, note that Sudafed has recently produced a non-psuedephredine version because of states which don't let you buy it without ID.

Also, psuedephredrine like Sudafed is completely illegal in Japan, as a stimulant, under their drug policy.

Another point is that in general the FDA is way too overregulating of OTC mediations (unless it's known to do nothing, a la many herbal remedies). Any hypocrisy partially comes in because many of the feminist organizations which are big about Plan B are also liberal Democrats and support FDA regulations for safety in general-- except when it comes to Plan B. Reverse accusations can be easily aimed at Republicans, no doubt. But the FDA's actions are overwhelmingly far too popular, sadly.

I'll take a stab at the extra-credit question.

You may not be able to start a meth lab with a pack of Sudafed, but a meth lab operator may require you bring him a pack or two of Sudofed as part of the payment so that he doesn't have to buy as much himself.

How will producing ID stop this? Well you got me on that one. I'm not sure what they do with the information when they get it, if anything.

John,

Thank you for providing your clear thinking:

"The focus on disobedient vs. dangerous people is a common misdirection of effort that happens when the government sees itself as primary and the people as secondary. Dangerous people are a threat to the citizens; disobedient people are a threat to the government. By spending more and more time and energy on the latter, the government tells us where its real priorities lie."

The laws, and their purported rationales, that drive the activities that Jane is questioning are, as above, are a mis-direction.

John's whole post, further above, lucidly explains the paradign in operation.

We, all of us, myself included, need to start thinking more clearly, while we are still able.

Forget: "Questions that need Answering", Remember: "Answers that need Questioning."

Extra credit: for pro-prohibition drug policy wonks only (Mark Kleiman, I'm looking at you)--why do I have to show a photo ID to get a 12-pack of Sudafed? Is it really likely that I will be able to use 12 Sudafed tablets to start my own home Meth lab?

That's easy enough. No, but if you ... and a few friends ... buy a 72 pack ... each ... at five stores ... three times a day ... every day, you can certainly operate a meth lab.

Certainly it's possible to accumulate a large quantity of Sudafed by buying it one box at a time, but is there any evidence that this actually happens with non-trivial frequency?

"Worse still, regardless of where meth is coming from by volume, are the peripheral effects of a local operation; the chemical pollution from an illicit meth lab can mini-Superfund an entire residence"

anony-mouse, you are blaming the drug for what is actually the effect of government regulation of the drug. It's like the often contaminated "bathtub gin" of the Prohibition era. No one who could just buy meth at a store would find it easier or cheaper to cook their own.

"No one who could just buy meth at a store would find it easier or cheaper to cook their own."

But if they took too much meth, they might think otherwise...

Do not waste your time, or even the ten calories it takes to type a short blog post, searching for consistency in the regulation of drugs and medical devices. There is none, either within the United States or among intelligent countries with sensible regulation. All these decisions are political.

Why, for example, is ritalin controlled more tightly than antibiotics? It seems to me that the misuse and overuse of antibiotics is much more troubling from a public health perspective than ritalin, but our bizarre national obsession with purpose in the prescribing of drugs drives greater regulation of a fundamentally harmless stimulant than antibiotics, which defend our population against vastly higher mortality rates. Makes no sense at all.

I was in Australia in December, and learned that acetomeniphen cannot be purchased there. One can get ibuprophren only after listening to the cashier in the pharmacy read a long statement of the risks and contraindications. Not something you want to suffer through when you have a splitting headache.

Economics plays a big part of this. Pharmaceutical companies do not want to see ethical drugs authorized for OTC too early in their product cycle, because the margins are so much lower. Why? Your insurance does not cover OTC drugs. Politics, too. It is far harder to get a device approved for aesthetic surgery than for medical applications. That's why silicone breast implants were long available in the United States for "reconstruction" but not enhancement. They were not any safer in the abstract for the first indication than for the second, but there were *cough* political objections -- phrased in high-sounding scientific terms, of course -- to approval for the latter. (Indeed, one can't help but wonder whether the same people who are decrying the politicization of Plan B were behind the politicization of the breast implant debate. Category: Swords, living by, dying by.)

Also, health care providers often win and lose depending on the status of a drug or a device. New medical devices will shift business from one practice specialty to another. Cardiologists and cardiac surgeons have been fighting over the same pool of heart patients a year, the fortunes of their specialties rising and falling with the introduction of new technology. You can treat epilepsy with drugs or surgery, and you can bet that neurologists and neurosurgeons have a different point of view on that topic. The same will soon be true of depression, obesity, and lots of other pathologies. Politics will drive a great deal of this.

In the case of Plan B (which I believe *should* be available OTC), there are even competing public health considerations. I know gynecologists who will use the birth control prescription as leverage to get their patients in for a routine pelvic exam or even a physical. If Plan B takes away that leverage, will sexually active women avoid going to the doctor when they should? Maybe, maybe not. But there's a reason that gynecologists control -- or at least steer -- something like 30% of the healthcare dollars in this country.

On the domestic vs. imported issue, I found this article which claims that cracking down on meth labs only increases the market share for Mexican importers of meth. This was news to me--I was expecting googling "Missouri meth production" to lead me to an article proving that most meth is produced in homes in America's Heartland, because I'd remembered reading the stat about meth lab busts in Missouri.

***

"Clearly, [the law's] not going to solve the addiction problem that exists," says Jack Riley, assistant special agent in charge for the DEA in St. Louis. "[Mexican cartels] have a target audience or customer base in Missouri. So the harder we make it for the mom-and-pop labs, in many cases we may be opening up some of these customers to the Mexican organizations."

http://www.riverfronttimes.com/Issues/2005-07-06/news/news.html

anony-mouse, you are blaming the drug for what is actually the effect of government regulation of the drug. It's like the often contaminated "bathtub gin" of the Prohibition era. No one who could just buy meth at a store would find it easier or cheaper to cook their own.

You could also wipe out the market for home-brew fertilizer bombs by allowing open-sale of TNT in Wal-Mart's home improvement section, but that doesn't mean that it's a good idea, or will lead to better results than the current spaghetti-code of regulations that cover possession and use of explosives.

Stated another way, it is within human nature to find ways around limitations, and no less so when those limitations are imposed legally; but that doesn't mean the situation would automatically be better in the absence of that limitation.

The obsession with "government regulation" as an automatic root of all evil (even if it sometimes is) strikes me as unhealthy at best. Since it was your analogy -- can you show that the recreational use of methemphetamines would have no more serious quantity and quality effects than the recreational use of alcohol? I'm not convinced that thread of argument works with any consistency on many/most presently-illicit narcotics, with the obvious exception of marijuana.

anony-mouse wrote:

"Worse still, regardless of where meth is coming from by volume, are the peripheral effects of a local operation; the chemical pollution from an illicit meth lab can mini-Superfund an entire residence, requiring (in the worst case) that a HazMat-type team remove and destroy pretty much anything resembling a textile, and scrub all permanant surfaces. If this isn't known and done, innocent parties living in the residence later may become inexplicably ill from the residues."

So say drug ennforcement officials, but look closely at what they say.

One most common assertion, reproduced in the press and all over the web:

"The production of methamphetamine has skyrocketed in the United States since the early 1990s. The chemicals used in the making of the drug include lye, red phosphorus, hydriodic acid, and iodine. One pound of finished methamphetamine results in five to six pounds of hazardous waste byproducts. These chemicals are often dumped into the ground near a laboratory, contaminating the local water."

Source:
http://www.justthinktwice.com/costs/DamagetoEnvironment.cfm

Now think about that with the aid of a first course in high school or college chemistry.

Dump lye and hydrochloric acid together, the result will be water, table salt and lots of heat for a few minutes. Dump them separately, as millions of ordinary people do every time they use drain cleaner or some kinds of concrete surface cleaners, and they react rapidly with most common organic things like wood, leaves and the like to form water or salt and other innocuous reaction produces. Their real danger is before they are "dumped", because they are highly reactive.

Red Phosphorus? How many tons of ordinary household matches are "dumped" into the enviroment every day by ordinary use? Iodine? It's still used medically as an antiseptic, and it's certainly required in human nutrition. You wouldn't want to ingest too much of either element at a sitting, but they are both a part of human enterprise and human nutrition and abundantly occur in nature.

Ammonia? Farmers put it on cropland by the thousands of tons daily at least.

So, a few pounds of any of these "dangerous pollutants" from a "meth lab" dumped in one place may make an unsightly and stinking mess when the initial chemical reaction occurs. It will kill the plants it's dumped on. But so will emptying your ice cream freezer salt water in your garden. The latter hardly creates a grave long term environmental danger requiring some kind of "superfund cleanup". Why should the former?

A typical "homebrew meth lab" involves at most a few pounds, say 100 pounds, of any of these "dangerous chemical pollutants". Yet ordinary human enterprise dumps them all over the face of the planet by the thousands of tons daily, and we're better off for the enterprise.

The environmental destruction aspect of "home meth labs" is questionable at best. At worst it is a canard by rentseeking prohibition enforcers to scare up support and tax money from ignorant "environmentalists".

When I was stationed in Idaho (Mountain Home AFB), we were briefed that there was a meth problem in the area. There are parts of Idaho which have maybe ten households per square mile. Running a meth lab there doesn't bother the neighbors.

Anyhoo, we were told that the meth users in California thought that the Idaho meth was the best.

Not that the judgment of a meth user is anything to go by...

Nobody:

Your analysis would carry water if you had first noted two things: (1) my use of "can [do]", as opposed to the universal "always [does]" (which I did not use); and (2) paid an observance to the real-world situations in which these chemicals might be introduced into a home through somebody's adult chemistry set, as opposed to making vacuous generalizations.

Couple hints: Some of the source ingredients are not good things to have open or heated in a primary living area, and trace amounts of anhydrous ammonia in the curtains or HVAC ducts have no comparative relevance to a properly-applied fertilizer.

IMO, most of your analysis strongly suggests that you are out of your depth here.

anony-mouse wrote:

"Couple hints: Some of the source ingredients are not good things to have open or heated in a primary living area, .."

I addressed the government and press claims about hazardous residue and dumping issues, not whether having NaOH or liquified NH3 in open containers in the kitchen is a good idea.

However, many generations have grown up home canning with concentrated and boiling NaOH solutions in the kitchen to skin fruits and vegetables. Reasonable care is necessary to avoid removing one's own skin as well as that of the fruits, but a HazMat team isn't needed to clean the kitchen afterward.

anony-mouse continued:

".. and trace amounts of anhydrous ammonia in the curtains or HVAC ducts have no comparative relevance to a properly-applied fertilizer.

IMO, most of your analysis strongly suggests that you are out of your depth here."

Condescention demonstrates only atttitude, not relevant facts. If my facts are incorrect, you can enlighten me. I'm not making extraordinary claims, nor did I attack you. I do think the facts you quote from the press and government are incorrect or exaggerated by the press and government. It's not the first time that either have lied or exaggerated, and it won't be the last.

So, enlighten me: How long will "trace amounts of anhydrous ammonia in the curtains" remain anhydrous when exposed to air of ordinary humidity?

How are those "trace amounts" more dangerous than the trace amounts of residue from fertilizer application, or from using a commercial oven cleaner containing anhydrous NH3? Note that neither of these activities requires government HazMat intervention.

Nobody:

Well, you certainly get points for one thing: You pulled a first-class bait-and-switch, and I fell for it, and only just now realized it. Let's review what I wrote, again:

Worse still, regardless of where meth is coming from by volume, are the peripheral effects of a local operation; the chemical pollution from an illicit meth lab can mini-Superfund an entire residence, requiring (in the worst case) that a HazMat-type team remove and destroy pretty much anything resembling a textile, and scrub all permanant surfaces. If this isn't known and done, innocent parties living in the residence later may become inexplicably ill from the residues.

Your next response, after quoting the above, was this:

So say drug ennforcement officials, but look closely at what they say. One most common assertion, reproduced in the press and all over the web...

And then you proceeded to discuss someone throwing byproducts into the soil, following that up in your next post by declaring it evidence that government and press may be lying, or some such. So far, I fail to see how any of this really had relevance to my particular example, let alone breaking into the accuracy of your claims about what those chemicals represent once disposed-of in the natural environment, in concentrated volumes.

At any rate, funny you should mention caustic lye as a canning agent -- the stuff is almost impossible to find in the canning aisle these days, with the closest substitute being a food-safe "pickling crisp" additive. Anyone who really wants lye must fetch a large bag from the gardening center.

Second, the fact that something has been used "for generations" is not really a compelling argument. Many generations didn't have anything better, or in other cases, didn't fully appreciate the dangers (or both). And so people played with mercury in science classes, and used it in household thermometers up into the 1980s; and as recently as the 1950s, nerve-agent derivatives were sold in glass vials as household poisons and stocked on the shelves of grocery stores in concentrations sufficient to kill a man with just one small splash on the skin. Refrigerant-12 was a popular open-air cleaning agent in the electronics industry up until the Montreal Protocol. And so forth.

Third, I hope we can make a distinction between responsible people using a known-dangerous chemical in a careful way, and fly-by-night drug-labbers hastily brewing up an illegal compound in the kitchen of a rental unit. On average, I think it's safe to assume the latter group will be less careful, and thus more likely to pollute the place.

Fourth, I don't think you appreciate what prolonged exposure can do to a human, as compared to a limited exposure in an environment where the chemical is otherwise appropriate. Whether sound pressure levels, light intensity, chemical exposure, radiation, or anything else, the human body is remarkably good (within reasonable maximums) at recovering from a short, extreme exposure -- but is often harmed more seriously and/or permanently by a prolonged exposure, in some cases even at noteably lower intensities.

No doubt we're talking at cross purposes. I said, and I stand by it, that government and the press have either lied about or exaggerated the greater environmental effects of various chemicals in the typical quantities dumped or left as residue by illegal meth labs. I find this not surprising, though I certainly don't support it.

I made no "bait and switch". You made assertions about a specific chemical, NH3 in "trace" concentrations. I asked for specific technical reasons why that represented the degree of human health threat that you suggested. You didn't answer the question. So, we have no conversation on that issue.

I will, however, point out one most obvious difference in our understandings of how things work. Perhaps such differences underlie our difference of opinion on the other matters.

anony-mouse wrote:

"At any rate, funny you should mention caustic lye as a canning agent -- the stuff is almost impossible to find in the canning aisle these days, with the closest substitute being a food-safe "pickling crisp" additive. Anyone who really wants lye must fetch a large bag from the gardening center."

"Pickling crisp" is typically CaCl. I've never heard of it being remotely close either in use or effect to caustic lye, NaOH.

As I understand it, NaOH is used to strip fruit skins. It is then washed away with the skin residue, and the concentrated NaOH bath in which the fruits were dipped is poured down the drain or dumped in the soil. NaOH certainly does not end up in the finished product, although no doubt some reaction products do, such as table salt, NaCl.

As I understand it, CaCl is in fact present in significant quantities in the pickled vegetable product. It's purpose is to make pickles more crisp.

This conversation has enlightened me. But I think our views of how things work are sufficiently different that further discussion is not likely to be, um, fruitful.

You made assertions about a specific chemical, NH3 in "trace" concentrations.

In my second post on the topic, yes. The first post was a general observation that the types of chemicals that can go into a drug lab operation, and then disperse into textiles and living surfaces, are not healthy things to accidentally breathe or ingest.

I asked for specific technical reasons why that represented the degree of human health threat that you suggested. You didn't answer the question. So, we have no conversation on that issue.

We probably don't. Ammonia is a known eye and respiratory irritant, and in the context of a residence, there is the possibility of secondary complications (such as asthma) making matters even worse. That's roughly where my specific interest in the topic ends, although there are plenty of studies available, such as this:

http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=141398

The odor threshold of ammonia is something like 5ppm, so emnations as high as those researched in the study ought to be noticeable in a residence, but this study doesn't address lesser concentrations, and the perceptibility at threshold assumes the place is clean and free from other significant odors. Also, perception of ammonia is subject to habituation.

"Pickling crisp" is typically CaCl. I've never heard of it being remotely close either in use or effect to caustic lye, NaOH.

You have never enjoyed sweet lye pickles? They're a pain and a half to make, mainly because the pickles have to be washed several times to remove the lye. Worth it, though, and they really ehance a relish tray.

As I understand it, NaOH is used to strip fruit skins. It is then washed away with the skin residue, and the concentrated NaOH bath in which the fruits were dipped is poured down the drain or dumped in the soil. NaOH certainly does not end up in the finished product, although no doubt some reaction products do, such as table salt, NaCl.

Sodium hydroxide is sometimes used in wastewater treatment processes, so the 'down the drain' approach probably doesn't cause too many problems. "On the ground" may have the effect of sterilizing the soil if it isn't moderately acidic, but if it is, well...that's why the stuff is sold in the gardening center.

I believe you can get in trouble for knowingly dumping it into any natural waterway or reservoir, though.

This conversation has enlightened me. But I think our views of how things work are sufficiently different that further discussion is not likely to be, um, fruitful.

That sounds fair.

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