Stiffer regulations won’t kill the consumer, lack of them will
(posted by Alix)
Did you know that acetaminophen is used in an effort to control the brown snake population in Guam? All it takes is one mouse stuffed with 80mg of acetaminophen; a pretty desirable remedy in Guam where they spend upwards of 1 million to control the invasive species.
Me either.
Not until I wound up in a hospital on Friday, in Jackson, MS, caring for my father–who will soon meet his demise from acute liver failure. The source? Tylenol.
Don’t worry, that’s about as personal as this blog gets.
Now, to kill a human it takes a little bit more than 80g. In my father’s case, he was popping about 10 grams a day–or 20 pills. He was in a ton of pain from previous surgeries, on his knees and prostate.
I couldn’t imagine taking that many of anything and hopefully you can’t either. However, it doesn’t take that high of a dose to be lethal.
The suggested dose is 4 grams a day, although researchers have shown even the suggested dose raises ALT levels in the liver.
Hundreds, thousands, millions of consumers surely disregard, misinterpret, or forget the suggested dose.
There are millions of simple scenarios to demonstrate how people could easily ingest more than the healthy amount. One is Tylenol’s mistake, including a cap for measurement on its pediatric/infant pain relievers and cough syrups, instead of a dropper. Or, in simple error, after a night of drinking, someone could pop three Tylenol, sleep, wake up, and pop three more to start their day. Then let’s say that person is a woman who develops menstrual cramps in the afternoon, so she pops two, three more and proceeds to take 2 every 4 hours for the next 5 days. More than likely, she’s just consumed more than the safe amount. Perhaps she has allergies also, and it’s hay fever season. If she takes the average OTC allergy relief, that’s adding 4 more pills in a day that contain acetaminophen. I use a woman in this example because researchers have found that 73% of the patients in liver disease cases were women.
A Harris Interactive consumer poll revealed some discouraging information about OTC use (Harris Interactive 2002):
* 51 percent of responding patients read the label when using an OTC for the first time.
* Only 34 percent read the label for the active ingredients.
* Only 19 percent read the label for usage instructions.
* Only 10 percent read the label for possible adverse effects or usage warnings.
* Only 34 percent who took an OTC medication for headache pain relief could correctly identify the active ingredient, which easily leads to widespread duplication of ingredients in different products.
* One out of three surveyed used more than the recommended dose of an OTC medication.
* 69 percent took more than the recommended dose at one time.
* 63 percent took the next dose sooner than directed on the label.
* 44 percent took more per day of the medication than the label directed.
Tylenol has spent millions branding itself as safe; spending more than Coca-Cola on marketing. America’s grocery and drug stores have aisles chock full of acetaminophen products. I checked last night and found I can purchase a 250 pill quantity bottle of EXTRA-STRENGTH Tylenol, making a suicide pretty easy. It’s not just suicide cases that are the problem here.
In fact, OTC medications as a category are responsible for more than 150,000 hospitalizations every year, according to the Food and Drug Administration, and almost 1000 OTC medications have been linked to liver toxicity, which causes about 2000 deaths annually in the United States (Ford MD et al 2001).
I also checked the bottle for warnings and found the FDA warning is not as strong as it should be–considering the staggering death toll.
“Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.”
My cigarette packs at least say, although in small letters, that:
* Caution: Cigarette Smoking May be Hazardous to Your Health (1966)
* Warning: The Surgeon General Has Determined that Cigarette Smoking is Dangerous to Your Health (1970)
* SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.
* SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
* SURGEON GENERAL’S WARNING: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, And Low Birth Weight.
* SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.
Am I comparing cigarettes to Tylenol? Not necessarily. But let’s keep in mind that cigarettes don’t inflict those above damages on everyone who smokes. (Although they do contain Carbon Monoxide regardless of the person smoking them) Nor does Tylenol harm everyone who uses it–but studies are showing that abuse of Tylenol does frequently result in liver or kidney damage. Not everyone smokes habitually either, but regardless, the packages all STILL have specific warnings. And you don’t need ID to purchase Tylenol either!
Easton and Herrera make solid points:
We could go on. Our point is not that Tylenol is too dangerous to sell-Americans take billions of doses a year without suffering ill effects. The question is simply one of disclosure. Has Johnson & Johnson done all it could to publicize the hazards? Shouldn’t the label, which is full of boilerplate about consulting physicians, be more explicit?
J&J has made grudging concessions, strengthening the warning label, a little at a time. After the Keele case, J&J added to the extra strength package: “Not for use in children.” In 1994, after Benedi, it added a warning about using any pain reliever if you drink. It is planning to redo the confusingly similar packages on the two very different versions of Tylenol for young patients.
Still, J&J resists writing the kind of label that would really wake people up to the dangers of stepping over the line between permissible and impermissible doses.
Why not warn about possible liver failure? J&J says that “organ specific” warnings would confuse people. Why not talk about the risk of death? That would promote suicides, says the company: If people knew that acetaminophen was potentially deadly, they might find it a convenient means for departing this world.
So, we are considered responsible and intelligent enough to search out the facts about drug care but stupid enough to kill ourselves? The small number of people who might consider suicide by Tylenol should in no way interfere with the other millions who need good information.
In 2002 and 2005 petitions were made to include the above warnings, even though more specific language was suggested. However Tylenol previously resisted posting the known correlation between acetaminophen and liver disease–since 1977.
In 1977, the Food and Drug Administration’s (FDA’s) Advisory Review Panel recommended the following warnings for acetaminophen-containing products: “Do not exceed recommended dosage because severe liver damage may occur” and “Do not exceed recommended dosage or take for more than 10 days, because severe liver damage may occur.”
The FDA chose to ignore this wise advice.
Almost 30 years later Tylenol finally began educating the public. Our European neighbors long ago chose to limit acetaminophen availability. It is suggested that a strategy restricting but not banning over-the-counter sales of acetaminophen containing medications may be necessary to prevent accidental overdoses;
“This approach was taken in the United Kingdom in 1998, when over-the-counter sales of acetaminophen were restricted to 16 g,” he wrote. “In the four years following the change in legislation there was a 30% reduction in patients with severe acetaminophen-induced acute liver failure admitted to specialist liver units and liver transplant centers.”
In France, where only half that much acetaminophen can be bought at one time “this measure is highly effective in minimizing severe acetaminophen hepatotoxicity,” Dr. O’Grady added.
Epstein ( a consultant to Big Pharma) believes that “What’s good for pharma is good for America.”
These trends should worry us all. Pharmaceuticals are not tobacco. There is no reason to rejoice in putting pharma on the ropes if its business reversals hurt the very consumers they are trying to serve. The medical advances of the past 30 years are not just a matter of dumb luck. They are very heavily dependent on the patent law, pricing freedom, and marketing strategies that have allowed these firms to bring a wide variety of vital products to market.
First, a majority of these so called medical advances are just purely unnecessary, their very existence supports already unhealthy lifestyles and reinforce ridiculous stereotypes. These life changing technologies aren’t really life changing.The billions in production, research, marketing and lawsuit settlements of unnecessary medicines doesn’t warrant a lack of appropriate regulation on OTC’s that are known to hurt people.
Valium for stress? Eliminate some of the stress in your life by reevaluating your needs and capabilities.
Viagra to maintain a sense of youthful vitality? Doesn’t really help all the lesbians out there now does it? And face it, if your impotent you aren’t less of a man. Well, I guess in pure medical terms you would be…
Prilosec for indigestion? Stop eating all the fast food crap, eat some raw garlic and take some pro-biotics–more than likely you will see an improvement.
Fevers? In a majority of cases, that is our body’s defense. Why immediately suppress it?
Should a free market mentality really apply to pharmaceuticals? Would a free market be okay if these companies were truly supplying a safe product? The consumer has decided to purchase a product declared mostly safe, and billions are spent enforcing that idea. Is “safe for most people” really okay when the number of deaths from these products is on the rise? Where is the corporate responsibility and crisis management?
Specific groups and organizations have decided that certain substances are harmful and must remain controlled or illegal. They are assuming that a majority of citizens have no self control or intelligence to use the substances. For example; qualudes, meth amphetamines, ecstasy, LSD, and marijuana.
By those standards, how can we assume the same public are fit to handle 250 pills of a substance that creates liver failure if over consumed?
Perhaps it is the lobbyists who interfere? In 2007, the pharmaceutical industry spent a record breaking $168 million. Some of the triumphs: “getting two controversial laws extended and thwarting congressional efforts to restrict media ads for prescription drugs.”
The FDA, under the Bush Administration, has limited the state’s rights, with it’s new preemption policy.
“We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don’t have the same scientific knowledge.”
If health care should be free market does this mean my father should get a new liver just because he has the money and the need? We were told he is not a candidate for a transplant because his history of alcohol abuse indicates he didn’t value the first one enough to deserve a second. I’m only slightly paraphrasing. By the way, my father is a recovering alcoholic for the past 4 years. I’m sure if Ted Kennedy needed a new liver, he could get one tomorrow.
How much responsibility do Tylenol and other acetaminophen manufacturers owe the general public? As with so many issues, this isn’t about opposing political ideologies of the left and right, it is about what is right. That truth shouldn’t get lost in fears of big government or money laden handshakes in Congress.
October 13th, 2008 at 6:10 pm
Alix, my sympathies. My alcoholic father actually knew about this risk years ago and even tho it upsets his stomach, he went back to aspirin. He knows his liver cannot take both.
October 13th, 2008 at 10:37 pm
Mona, thanks.
I’m unable to tell how many people know about this, and how well they know the facts.
Most people seem surprised by the severe damage something like Tylenol can cause.
October 14th, 2008 at 12:45 am
Most people seem surprised by the severe damage something like Tylenol can cause.
Well, that scientist at Ft. Detrick whom the FBI very suspiciously (and with poor evidence) claimed had been responsible for the post-9/11anthrax attacks committed suicide by Tylenol overdose.
Aspirin kills about 1,000 a year. At some point a product’s danger impacts few enough people — I suppose a subjective assessment — that keeping it from everyone else or costly regulation is not justified.
October 14th, 2008 at 5:20 am
Should a free market mentality really apply to pharmaceuticals?
Absolutely, and your example actually proves it.
In a free market for pharmaceuticals, we would have effective pain relief that would drive Tylenol off the market. It’s called morphine, and it’s already available, but doctors are afraid to prescribe it because of the War on (Some) Drugs.
That by itself could be a big reason why so many people overdose on Tylenol.
October 14th, 2008 at 8:39 am
Jason,
Yeah, and there’s no way to overdose on morphine, right?
Oh, I forget. There’s no harm done by lack of regulation that can’t be undone by even more deregulation. With the help of some helpful conjecture.
Alix,
Thanks for sharing your story. I think reading it drives home the dangers of taking tylenol to excess more than a thousand fluttering warning labels. Of course, the problem is, if we have to wait to be alerted to every danger through personal stories like these, we’d probably still be blind to 90 percent of the dangers out there, and might perhaps be oversensitized to some dangers that seem very salient from personal examples but are actually not that bad.
For me, an appropriate level of regulation in pharmaceutical industry is desirable the way guard rails on dangerous curves are desirable.
October 14th, 2008 at 9:29 am
Angelica, Jason’s point probably is that the man described in this post was in severe pain for which Tylenol is not at all effective. Hence the excessive consumption.
Morphine is extremely effective in small doses.
October 14th, 2008 at 9:39 am
Of course, the problem is, if we have to wait to be alerted to every danger through personal stories like these, we’d probably still be blind to 90 percent of the dangers out there,
But we did have to be alerted to the danger by personal stories like these — precisely because the FDA put a stamp of approval on large doses of acetaminophen. Such tragedies have been increased precisely because we have centralized the warning functions in our society.
As Alix points out, there is a push for anything approved at the federal level to be approved at the state level regardless of any rules made there. Moreover, by setting up federal drug testing, we have crowded out private alternatives and diminished public skepticism of pharmaceuticals to the point where pharmacists are treated as mere stock clerks despite their highly relevant specialized knowledge.
There’s a false dichotomy here between regulation/no regulation. The real distinction is between a society where safety functions are dispersed and where they are centralized. My observation is that centralized safety functions tend to encourage people to assume that something is safe without even thinking about it. This actually increases the likelihood of tragedy.
October 14th, 2008 at 10:28 am
Tylenol, and the other jackasses, are so wrong about increasing suicides by stronger labeling.
Indicating that something causes organ damage and failure does not make a good market for an individual who wishes to depart quickly and quietly.
If I read that something was going to damage an organ that I needed to live, this would indicate a long, painful demise…a COSTLY, long and painful demise…
What’s so sexy about that when I could just drink Chlorox?
October 14th, 2008 at 10:48 am
The problem is that the FDA has gone far beyond its original function — that of making sure ingredients were labeled honestly, and that medicines didn’t make false claims like “Drink Jennifer’s Opium Cordial and it will cure cancer, restore lost manhood and make you look ten years younger” — and has instead taken for itself the power to decide whether you personally are allowed to take Jennifer’s Opium Cordial at all. (The answer is “no,” not even if you’re dying, because God forbid a man with six weeks to live becomes an opium addict, and God forbid ANYBODY take something with the potential to make them actively feel good rather than simply reduce pain by a fraction.)
Even addiction concerns are made worse by illegality. I’m sure we all know one or two “functional alcoholics” — every day they have several beers when they come home from work, and on weekends they park themselves before the TV and do nothing but drink. That’s not how I’d choose to live my life, but it works for them, and this is no problem for them or anybody else, when they can stop by a legal store whenever they please and buy an inexpensive, clean, safe dose of their drug of choice. But if Prohibition came back, this functional alcoholic would become dysfunctional, because now he has to deal with dangerous criminal dealers, and instead of safe, clean beer he might drink bathtub gin that will make him go blind or suffer organ failure.
Best to let him continue his habits legally, and if he ever decides he’d like to cut back on the drinking he can get plenty of help without fear of legal consequences.
Likewise, anyone currently addicted to morphine or anything else wouldn’t have had much of a problem 100 years ago when they could buy their daily dose from a legal drugstore, but the government now ensures their addiction will have all sorts of legal and social problems on top of that.
October 14th, 2008 at 10:51 am
“The real distinction is between a society where safety functions are dispersed and where they are centralized.”
The more I work through all this, the more I’m coming to believe that this is THE issue in regulation. Specifically, in this situation, an old fashioned pharmacist who personally knew his customer and customer’s family would be in the best possible position to regulate in conjunction with the customer’s physician. The new CVS computerized database is but a very poor substitute for the amount of knowledge contained in localized community. The only way to properly balance all the competing interests is to actually KNOW the patient. To know if their personality has changed lately. To know if they’ve suffered a severe loss. To know if they’re suffering from severe physical pain or if they’re just malingering. Will it be a perfect solution? No, obviously. But it would a massive improvement on the status quo.
All of this is impossible in a coercively atomized society. (Hope I haven’t doomed this thread to oblivion by using the “a” word). So instead, we try to write supremely detailed regulations that can’t possibly address every possibility - and we’re content to just let those outliers rot, because it is more important that we remain pragmatic, never question existing institutions, and always agitate for more power to be given to existing institutions. That’s what makes us popular in our social circle, after all.
October 14th, 2008 at 12:18 pm
The core function of pharmaceutical regulation is to provide monopoly privilege to pharmaceutical manufacturers by raising obstacles to competition and inflating the costs of many essential medications to the level where it becomes cost prohibitive for many ordinary consumers.
I’ve seen this over and over again in the business that I’m in (marketing health care related products and benefits plans). The price of a drug is marked up so high even people with insurance can’t even make the co-pay. Alternative, less expensive, sometimes arguably most effective treatments are prohibited.
One particularly shameful aspect of this is the undertreatment of persons in severe pain because the goddamned system is so worried about generating drug addicts. I knew one woman whom CPS threatened to take her kid from her because she couldn’t afford an expensive antibiotic.
I’m for an unregulated free market in drugs (both pharmaceutical and psychoactive). That doesn’t mean there wouldn’t be any quality control. Ever heard of Consumer Reports? I have one friend of mine who has some very severe health issues and she’s on something like 36 prescriptions at once. Whenever she gets a new prescription, she doesn’t just start swallowing pills. She does the research from the huge amount of medical reference material available online to see what negative side effects medications can have, “overdose” issues, dangers from mixing different drugs together, etc. It’s called personal responsiblity.
October 14th, 2008 at 2:42 pm
As far as I know, the drug approval process - and regulation generally - is more lax in Europe, on the whole. And since most here want us to be more like Europe…
Dan Klein supports the de-nationalization of drug approval here:
http://www.willwilkinson.net/flybottle/2008/10/12/drug-approval-denationalization/
Basically, if Canada or Germany or France approves a drug for its citizens, then it should be ok for Americans too. Unless the FDA has some morally legitimate reason for saying “no.” And protecting its monopoly is not morally legitimate.
October 14th, 2008 at 8:19 pm
quasibill: we’re content to just let those outliers rot, because it is more important that we remain pragmatic, never question existing institutions, and always agitate for more power to be given to existing institutions.
Yep, that’s exactly it. (As an aside, have you recently read Shaffer’s Calculated Chaos? It sure sounds like it.)
One way to start decentralizing drug approval would be to take away the FDAs ability to ban drugs. Rather, they would simply approve or disapprove of a drug, like a consumer rating agency. You could still buy an unapproved drug, if you felt the FDA was being overly careful. In addition, this would likely result in the creation of private drug approval companies to compete with the FDA (especially if they came up with a faster approval process).
October 14th, 2008 at 8:40 pm
Smally, Jennifer
I’m all for the easing up of restrictions on morphine use.
But I don’t see any conflict in doing that AND be in favor of all the light-touch regulations that Alix suggests. If the research is there to suggest acetaminophen kills a lot of Americans, slap a warning label on it. If it still kills a lot of Americans, stop making it so readily available OTC.
Quasibill,
The more I work through all this, the more I’m coming to believe that this is THE issue in regulation. Specifically, in this situation, an old fashioned pharmacist who personally knew his customer and customer’s family would be in the best possible position to regulate in conjunction with the customer’s physician. The new CVS computerized database is but a very poor substitute for the amount of knowledge contained in localized community.
I agree that it would be great to have a knowledgeable pharmacist who knows me as an individual and can advise me accordingly. But I fail to see what this has to do with the subject at hand. Stronger warning labels on tylenol will not make such a pharmcist disappear. Nor would taking away more regulation, making Oxycontin OTC, say, cause him to come into being.
we’re content to just let those outliers rot
Actually, in the case of the kind of de-atomized society you’re advocating, my biggest worry is with the outliers. Just a few incompetent pharmacists out of the pool can probably do great harm to the communities they serve if they are unaccountable to regulation.
Keith Preston,
It’s called personal responsiblity.
That’s your value judgement. A world with no safeguards in which every man is his own safety consultant in every field might appeal to you, it does not to me.
Dain,
And since most here want us to be more like Europe…
Which site do you think you’re on? This is AOTP, where the I am the big gubmint liberal. I doubt this statement highly.
October 14th, 2008 at 10:11 pm
I’m all for the easing up of restrictions on morphine use.
But I don’t see any conflict in doing that AND be in favor of all the light-touch regulations that Alix suggests
Look, it is hard to argue w/ Alix when she is watching her father die. But the fact is, he drank alcoholically until 4 yrs ago. Many if not most drugs are metabolized in the liver, and Tylenol does warn about using it if you drink a lot.
So what is the issue for the general public? MY FATHER stopped taking Tylenol years ago rather than give up his to Brandy Manhattans and a 12 pack each night.
My dad also, btw, is not long for this life; drinking as he does and weighing 350 lbs is not compatible with more than another few years.
October 14th, 2008 at 10:45 pm
That’s all well and good, IF you realize there’s a DEFINITE danger.
The point is, “may cause” (in tiny print) isn’t very threatening when you have chronic issues that DEFINITELY CAUSE pain.
I remember Tylenol commercials from the early 80’s and pregnant women talking about how safe it was. I was so branded by the ads that 20 years later,I was sure I could take them when I got pregnant. I was a kid in the 80’s; that’s smart advertising.
I’m surprised they didn’t sell it in black and orange packages as Halloween candy (which by the way, MAY cause tooth decay).
October 14th, 2008 at 10:47 pm
“Look, it is hard to argue w/ Alix when she is watching her father die. But the fact is, he drank alcoholically until 4 yrs ago.”
Not really. I wouldn’t have written an article about this if I couldn’t handle discussion. Nobody has to agree with me just because my I’m spoon feeding my father.
Per comments, sorry, I’m tied up right now…get back to them…good stuff….
And on a ironic closing note, the nurse suggested Tylenol for my Dad’s fever last night. F**king idiot.
October 15th, 2008 at 12:23 am
“But I don’t see any conflict in doing that AND be in favor of all the light-touch regulations that Alix suggests. If the research is there to suggest acetaminophen kills a lot of Americans, slap a warning label on it. If it still kills a lot of Americans, stop making it so readily available OTC.”
Warnings, maybe. Not making is available OTC is not “light touch”.
And look, the FDA regulations might save some lives, but I think the fact that it forces drug manufacturers to go through the long process of validation before they can come into the market possibly costs more lives. And I am not even going into the absurd bans on morphine etc.
In a more sensible world, the FDA would simply stick to efficient warnings, evaluations, and rating systems and not have the power to ban drugs or food items. But we don’t live in such a world.
October 15th, 2008 at 3:34 am
Warnings, maybe. Not making is available OTC is not “light touch”.
OK, agreed. Now that I’ve thought about it a bit more (especially given how onerous it is to make a trip to the docs in the US), not making something OTC is too big a step to be characterized by light touch. I’m all for warnings, and the curbing of advertising though.
October 15th, 2008 at 5:49 am
“But I fail to see what this has to do with the subject at hand.”
Well, since you’ve since qualified your position slightly, my point is somewhat less forceful, but the point is that with such a society, the manufacturer wouldn’t need to include every possible warning on every possible dosage delivery.
Since you’ve qualified your position to increased warnings and curbed advertising, I’ll admit that I have less issue with those policies. However, I still do think they are problematic, outside of actual fraud. Have you ever actually read a drug insert? A full one, not just the patient insert? The FDA already has a “fair balance” (at least that’s what the standard was 10 years ago) requirement on all advertising - and the drug companies employ teams of lawyers and writers to comply with this standard. It isn’t as simple as slapping on a new warning and being done with it. It costs a lot of money to comply with these requirements. You can see the result in those tv ads that have long-winded descriptions of “rarely occurring” side effects and complications that always end with “check with your doctor.”
And that doesn’t even address another fundamental issue - too much information can be just as bad as too little. When you receive a 7 point, two column per page, 5 page document when you’re sick - how much of it are you going to read and internalize? Especially when it’s full of jargon that you aren’t familiar with? How much is the average person going to read?
I’m not going to rail against increased warnings, but I’m also not going to sign on to them as much of an improvement, especially if all the requirement does is raise costs of already expensive drugs to turn a 5 page warning document into a 10 page warning document that even fewer people will read.
“Just a few incompetent pharmacists out of the pool can probably do great harm to the communities they serve if they are unaccountable to regulation.”
And just a few incompetent central regulators, or even competent ones who aren’t omniscient, can do great harm to even larger communities if they have no access to localized knowledge. And just because someone isn’t accountable to centralized regulation doesn’t mean that they are totally unaccountable - versus central regulators, who are generally totally unaccountable.
October 15th, 2008 at 8:32 am
“Keith Preston,
It’s called personal responsiblity.
That’s your value judgement. A world with no safeguards in which every man is his own safety consultant in every field might appeal to you, it does not to me.”
LOL! I suppose everything is a value judgement.
I agree with Ben Franklin on these kinds of matters. Those who trade liberty and independence for safety and security will get neither and deserve neither.
I could almost sympathize with an unabashed mafia state that exists to simply maintain power and makes no pretenses to the contrary. But a regime of secular nuns and busy body soccer moms I will most assuredly resist to the death. Bring on the suicide bombers. LOL!
October 15th, 2008 at 8:34 am
Angelica, Jason’s point probably is that the man described in this post was in severe pain for which Tylenol is not at all effective. Hence the excessive consumption.
Morphine is extremely effective in small doses.
Precisely. A small, safe dose of an opiate painkiller would almost certainly have controlled his pain far better than Tylenol. This is not to say that opiates are risk-free. No painkiller, and no drug, ever is. But opiates would certainly have been more effective at a much safer dose. There are also ways of preventing all but the most determined individuals from abusing opiates, including several derivatives that are administered by a transdermal patch.
But, as I said, doctors are afraid to prescribe these drugs with the frequency that they deserve. Radley Balko has done some excellent work on this question, for example here.
October 15th, 2008 at 8:43 am
Kurt,
I haven’t read Calculated Chaos yet, but it’s at the top of my list when I finish my current batch of reading (mainly “A Nation of Counterfeiters” by Stephen Mihm- raises a lot of questions about what a free market with a stable currency would actually look like).
October 15th, 2008 at 10:17 am
Angelica,
You’re right, there is no good reason to think everyone at AOTP “wants us to be like Europe.” I guess I was projecting my own inclination to want to live there…at least for a while. Berlin is the shit!
October 15th, 2008 at 10:57 am
For the most part, I would prefer that America be more like Europe. I’d rather have Sweden’s or Switzerland’s foreign policy, than US foreign policy. I’d prefer Switzerland’s political system over the US system. I’d prefer Dutch social policies over the US police state. Right now, I’d certainly prefer the euro over the dollar. I’d prefer the penal systems of many European states to the US prison-industrial complex. I certainly approve of the Swiss and Finnish positions on “the right to bear arms”. If we must have a wasteful welfare state bureaucracy, high taxes and massive public debt, I’d generally prefer lavish unemployment benefits and social security over the US military-industrial complex.
Unfortunately, where the Europeans are fucking up is on immigration (allowing the de facto Islamization of their countries) and, not coincidentally, on the entrenchment of the cultural Marxism of its elite classes.
http://www.candidlist.demon.co.uk/hampden/culture.htm
http://www.theconservativevoice.com/article/7069.html
October 15th, 2008 at 10:23 pm
Jason:
“That by itself could be a big reason why so many people overdose on Tylenol.”
Good point. I still want a simple form of federal regulation, when enough consumer experiences indicate the need to do so–as in this situation.
Kurt: There’s a false dichotomy here between regulation/no regulation.
This is an important distinction and the binary opposition makes for impossible arguments and realistic solution.
Notably, the preemption clause is nothing but a gift to Big Pharma. It is a reversal in policy as well.
Ex from the cited link in article:
“A statement saying the complete opposite was made in 1996, by the FDA’s Chief Counsel in a speech that said the FDA had a “longstanding presumption against preemption” and that “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”
Daphne:If I read that something was going to damage an organ that I needed to live, this would indicate a long, painful demise…a COSTLY, long and painful demise…
Interestingly enough, someone privately sent me an email stating that years ago they had attempted overdose with alcohol and Tylenol. Their stomach was pumped and they were informed about the possibility of liver damage. To which their response was, “damn, I wanted my suicide to be quick, not long and drawn out.”
Risk of suicide increases is a very far-fetched weak argument from the manufacturer.
Jennifer Abel
“The problem is that the FDA has gone far beyond its original function — that of making sure ingredients were labeled honestly.”
That is correct. Their approval of bio-techonology is despicable. Monsanto should never be able to own a patent on life and potentially control the world’s food supply.
“Even addiction concerns are made worse by illegality.”
Sure, good example with alcohol but what about meth. It is an ugly, toxic, highly addictive drug. What’s the proposition there?
“Wouldn’t have had much of a problem 100 years ago.” I don’t know if I long for the days when I could visit the local apocathary, grab a root beer float and some morphine.
quasibill
“So instead, we try to write supremely detailed regulations that can’t possibly address every possibility - and we’re content to just let those outliers rot, because it is more important that we remain pragmatic, never question existing institutions, and always agitate for more power to be given to existing institutions. That’s what makes us popular in our social circle, after all.”
Brilliant.
You just left out the part where we inevitably complain when it bites us in the ass.
“The new CVS computerized database is but a very poor substitute for the amount of knowledge contained in localized community. The only way to properly balance all the competing interests is to actually KNOW the patient.”
In some ways, yes its a poor substitute, in other ways it is a bonus. I move around a lot and I travel a lot–I rely on a computerized database.
“too much information can be just as bad as too little.”
Right, I usually skim that crap and read the warning on the bottle. If people can find a way to say exactly what they are doing in 160 or less words on Twitter, the FDA can find a way to put a bare bones, specific, cautionary warning on labels.
Keith, agree with most of your points.
But I’m up for warning labels to augment Consumer Reports.
“Those who trade liberty and independence for safety and security will get neither and deserve neither.”
Right, but do you feel like YOU traded? I don’t.
I feel like I’m putting up a pretty good resistance out here, holding tons of information and opinions–but many of my liberties have been taken away. The present day era seems to render that quote useless.
Appropriate:
“A government big enough to give you everything you want, is big enough to take away everything you have.” - Thomas Jefferson
Angelica
“But I don’t see any conflict in doing that AND be in favor of all the light-touch regulations that Alix suggests. If the research is there to suggest acetaminophen kills a lot of Americans, slap a warning label on it. If it still kills a lot of Americans, stop making it so readily available OTC.”
Indeed. If the FDA has suggested this warning since 1977, something should be done. If there are known, proven complications with OTC drugs, they should be required to blatantly label the bottle and banally list them in advertising, like prescription drugs must. Although, advertising should be limited. In their defense, Tylenol has detailed information about liver failure on their website. However, that acknowledgement could and should easily transfer to the bottles.
Jason, great link to Radley’s article. Do you know if Paey was ever released?
In my father’s situation, with a case history of addictive behavior, he should accept that a morphine script would be difficult to obtain. I don’t know much about the transdermal patches. I’m sure there are levels that could combat pain without stimulating a buzz. Regardless, it’s pretty hard in this era to make a case for an opiate scrip when you’ve been an alcoholic for 40 years of your life.
October 16th, 2008 at 1:24 am
Yes, it’s hard to object to warning labels much. The unmodified position was horrible, but warning labels no biggie.
I think way more medicines should be OTC. All but the very most harmful and most addictive should be. Really it’s obscene that even birth control pills are not OTC. But I’m very very thankful Tylenol is. It’s served me well in many many situations in which I would never have bothered with a doctor (I would have just lived with the pain).
October 16th, 2008 at 5:06 am
“f people can find a way to say exactly what they are doing in 160 or less words on Twitter, the FDA can find a way to put a bare bones, specific, cautionary warning on labels.”
How many people converse with their doctor through Twitter? Have you ever sat through a high level medical discussion between doctors? Jargon is necessary because the highly nuanced meanings they need to convey the ideas involved. I’m not sure that you can have meaningful discussions on the subject without resort to highly technical jargon or very long explanations in plain english.
Even if what you say is possible from a medical standpoint (which I highly doubt) - centralized regulations NEVER work that way. Centralized regulations ALWAYS generate CYA, kitchen sink thinking. It will be the one risk that you leave out that becomes a problem, and suddenly people will be agitating for *more* warnings to be added - after all, if 160 words is okay, 200, then 250, then 300, etc.
What people need is warnings that are tailored to their individual circumstances and concerns. And again, that requires actually knowing your patient.
October 16th, 2008 at 9:26 am
I agree there has just got to be a way that the government can effectively stop ignorant people from doing dumb things. Perhaps a cage for each man, woman and child in the country. We could be kept in them and three times a day govcare would stop by to administer our required nutrients and take us out for needed excercise. Yes?
October 16th, 2008 at 10:35 am
Wikipedia says Paey was pardoned in September, 2007. It’s still pretty awful what happened to him.
October 16th, 2008 at 3:46 pm
I don’t know if I long for the days when I could visit the local apocathary, grab a root beer float and some morphine.
You prefer the days when morphine is illegal and DEA agents, rather than doctors or patients, have the power to decide whether or not a person in agonizing pain should be allowed to take something that will make the pain go away?
I imagine that if Prohibition had never been rescinded, there would be modern Americans thinking in horror of the wild days when any old person could just go to the store and plunk down a few dollars in exchange for Demon Rum. Our modern system where drinkers are put in jail and/or frequently suffer blindness or organ damage from illicit bathtub gin is so much better, don’t you think? Alcohol can be quite addictive, so it’s lucky it’s been made illegal.
October 16th, 2008 at 5:03 pm
When I first wrote this article, I knew beyond a doubt that
*OTC should have better warnings
*the preemption clause is total crap–state’s rights and opinions should not be disregarded.
*people use unnecessary medications and don’t have a preventive philosophy.
Otherwise, I’m a herbalist. I’ve spent more than a decade pursuing alternative healing and I’m pretty well versed in it. It works great for me. I also don’t view my health as simply, “good until it’s not.” It has to be cultivated, which takes a fair amount of self involvement ,motivation and education.
Before this stupid crisis, I had not spent any bit of time asking myself the questions brought up in my article.
The last antibiotic I took was for Lyme’s Disease, two years ago. I should be able to get Doxycycline directly from a pharmacist without a doctor’s visit. Or birth control pills. Or amoxicillin for a sinus infection.
Very obviously the reason that we can’t is because many health care players benefit from this current arrangement, but clearly this form of regulation isn’t benefiting the consumer/patient.
Look, people are punished if they commit a crime. We know that drinking and driving is dangerous and criminal. We shouldn’t feel sorry for a person who does so. There are plenty of societal messages about the problem to both educate and discourage us.
We should have better options and I now think, yes the free market can assist.
Of course the FDA should be the agency which enforces strict label warnings when there is an overwhelming case PROVEN for side effects. States can individually decide if extra labels are needed, but the basics have to be there.
CAUTION: Exceeding recommended amounts of acetaminophen has often resulted in liver failure. If you consume alcohol, it is extremely important to reconsider putting this pill down your throat.
quasibill, that’s 159 words.
So let’s say we have Class 1 and Class 2 drugs. If you greedily abuse the opportunity to walk into your pharmacist and request Viagra, Morphine, Percocet, Xanax, etc. and you get caught, you get punished.
Otherwise, who cares? You’re 17? You take a valium and drive and wreck? Not good for you–but shouldn’t be bad for me. Basically, you could decide to do the same thing with a bag of freon from Dads AC unit.
The right amount of education and blatant PSA’s should mostly take care of that
Not everyone will turn into a raging drug addict just because they are given the opportunity to self prescribe.
The amount of addiction that someone chooses to create is ultimately lower and less insignificant than the number of people who can’t afford expensive insurance/Dr. bills/medication.
Pharmacies should carry most prescription drugs and be able to sell them to a patient. Like antibiotics, Viagras, birth control, low level pain pills. And then it’s on the consumer. If they break the law, they get punished.
The consumer must know the product; read the literature for the nuances and minor side effects. (the major ones are on the warning label)
The last antibiotic I took was for Lyme’s Disease, two years ago. I should be able to get Doxycycline directly from a pharmacist without a doctor’s visit.
I’m not asking the pharmacist to diagnose me, I’ve diagnosed myself.
Of course one could still have the opportunity to go to a Dr. but it wouldn’t be the only way to get a prescription.
Let me tell you, a massive bullseye around the tick bite is pretty straightforward.
It would be far more beneficial to our self-worth and longevity if we took personal responsibility to maintain a preventive lifestyle and a vested interest in our illness and recovery.
The “CVS” computer base comes in pretty handy, because I simply have a record of my medical allergies.
If someone doesn’t understand that it is in their best interest to consult a doctor when their skin turns yellow, or they can’t put a finger on their illness, then that should carry the same weight as a crime. Or at least a personal forfeit. Otherwise, their are millions of situations that people can resolve by self-diagnosis.
I personally am pissed that being a smoker would raise my insurance rates but the high statistics of obese McDonald/sugar/fried chicken fiends is still considered healthier. People aren’t being penalized for eating poorly, but it does affect your longevity.
My insurance rates should be lower, because I am a lesbian, which means I’m less likely to get STD’s, ovarian cancer or have a child. But that’s a far stretch. Point being, I’m sick of not being able to afford insurance, as I get older, but the only reason I want it is for care that I can’t administer myself, or for the antibiotics I can’t get without a 7 minute expensive visit to a doctor where he looks me in the eyes maybe twice.
In the above situation, the big players can’t get quite as rich, but then again, they won’t be spending so much money lobbying. The smaller guys gain far more importance and money, but the reform and adjustment of the health care process will create more competition.
Abel:
I don’t know if I long for the days when I could visit the local apocathary, grab a root beer float and some morphine……
SImply because in those days blacks didn’t have the vote, gays were punished more than they are now, there was no public transportation, internet, rice milk, or cutting edge medical techonology.
I’m not willing to trade morphine legality for those things…….
Point being, the set up you propose is binary. I don’t want to go back to, I want to move forward.
October 16th, 2008 at 5:41 pm
“quasibill, that’s 159 words”
And the next person who has a different side effect will want to add their 159 words.
Plus, what is “recommended dosage”? It’s different, for different people, and for different purposes. Hence extra-strengths and clinical strengths. Which is which? And for how long? Believe me - the pharma companies have *teams* of lawyers and writers to address this issue. As much as you would like it to be just that simple, centralized regulation NEVER works that way. As I said, CYA rules the day in these situations. It’s always easier to write more “just in case”.
Sure, it’s a nice warning, but I doubt it would change more than 0.5% of the decisions made, if that.
October 16th, 2008 at 8:11 pm
in those days blacks didn’t have the vote, gays were punished more than they are now, there was no public transportation, internet, rice milk, or cutting edge medical techonology.
I’m not willing to trade morphine legality for those things…….
Point being, the set up you propose is binary. I don’t want to go back to, I want to move forward.
What in the WORLD did I say to make you think I wanted to make a trade-off of drugs being legal in exchange for rolling back the social and technological gains of the past 150 years? I mentioned modern-day functional alcoholics who’d be much worse off if their addictive-drug-of-choice were illegal, and added that morphine addiction wasn’t such a big deal when addicts could buy a legal fix in a drugstore. But I’m quite sure I didn’t make an addendum along the lines of “Also, addicts could legally lynch a darky to take the edge off their irritation, and could get lucrative unskilled messenger jobs since there were no telephones to compete with.”
October 16th, 2008 at 8:57 pm
Abel– Sorry, it was a rather literal interpretation on my part. LOL at me.
“Likewise, anyone currently addicted to morphine or anything else wouldn’t have had much of a problem 100 years ago when they could buy their daily dose from a legal drugstore,”
October 17th, 2008 at 2:04 am
I’m very sorry about your dad, Alix. My dad died of cancer when I was a teenager, and a couple of times I thought my mom was about to die, and I know things seem pretty bleak in those circumstances.
I can’t say I’m very keen on the idea of mandatory labeling (although I’d love to see a reinvigoration of tort law for negligence in labeling). But trading that off against your proposal at 5:03 pm, for drastically blurring the prescription/OTC distinction and weakening the priestly powers of doctors and pharmacists to control access to meds, would probably be a pretty good deal for libertarians.
Last year, I had a really bad case of poison ivy where the histamine reaction ran out of control and fed on itself, and the rash just kept spreading for almost two weeks until I finally visited a clinic. The Advanced Practice Nurse prescribed a run of Prednisone (I never saw a doctor, although his presence was legally mandated at the behest of the licensing boards–apparently he kept me safe by osmosis). A month ago, the same thing happened, and I called the clinic to see if the APN would call in a scrip for me. Nope, “we have to see you to make sure it’s the same thing.” Yeah, and charge me 80 bucks plus the cost of my medicine; mighty convenient, the way all that concern for my welfare pays off in cash dollars. So I wound up ordering it from an online Canadian pharmacy, rash cleared up, no problem.
The main function of professional licensing is a way of collecting tolls on the direct transformation of our own labor into use-value. Instead, we have to earn the wages to hire the services of a licensed professional at monopoly prices.
I know some home-schooling antigovernment rightwingers who raise cattle, and they order veterinary grade pharmaceuticals from the supply houses for their families’ use.
Or I guess I could do what Kramer did, find a dog whose cough sounds like mine and take him to the vet.
October 17th, 2008 at 8:10 am
Kevin”
I never saw a doctor, although his presence was legally mandated at the behest of the licensing boards–apparently he kept me safe by osmosis.
LOL!
Yes, I offer advice to my friends and family, and the holistic approach is often successful. Although I’m sure a Dr. somewhere shrieks in disgust at my approximation of their scientiae. However, I’ve found in many cases and especially with the Lyme’s disease, that my own research was more informative than the 10 minute visit with the Dr. Lama.
Bush just successfully passed a bill intended to assist in prosecuting rogue online pharmacies.
http://www.jointogether.org/news/headlines/inthenews/2008/bush-signs-law-cracking-down.html
It’s a crappy article, by the way, but just a quick google and all that came up where slanted articles, sorry.
October 20th, 2008 at 4:15 pm
Alix wrote:
“The last antibiotic I took was for Lyme’s Disease, two years ago. I should be able to get Doxycycline directly from a pharmacist without a doctor’s visit. Or birth control pills. Or amoxicillin for a sinus infection.”
Actually, the misuse of antibiotics involves quite serious externalities that seem to me to be an excellent argument for prescription laws in their case. Not taking a full course of antibiotics helps create resistant strains of bacteria which imperil the lives of other people.
Case in point: my wife recently got a small boil on her cheek, and the infection rapidly generalized over half her face. The doctor didn’t even bother with standard antibiotics but put her immediately on sulfa. “If you’re alive,” she said, “you have resistant strains of staph (MRSA) on your skin.” And that is precisely because of antibiotic misuse in the general population, abetted by lazy doctors. I imagine it would be even worse without prescription regulations.
Another step that should be taken is banning the use of antibiotics in raising animals for consumption, for the same reason.
November 4th, 2008 at 11:05 am
My condolences to you and your family,
Thank you for enlightening me even more. I will give you my story, briefly. I have consumed up to 15000 mg of tylenol per day for the last 8 years. Tylenol with codeine, in Canada it is readily available as an over the counter product, simply ask for it. I have a substance abuse problem, poor coping skills and personal trauma have enabled me to make this regrettable decision. I take full responsibilty for my current condition, I blame no one but myself.There truly is no accountability on the dispensing side of this product in Canada.I wanted the codeine, the acetaminophen was inconsequential to me, yet it is the acetaminophen that has decimated me.
I await my liver count as I write. Education and leadership will help stop this, but the big issue here is $$$$$$$.
In the sates you cannot get T#1 without a prescription, yet cross the border here into canada and your allowed to take 50 back per year????????? All I want is to see my son graduate in 4 years. What price do you put on a human life? Apparently it is anywhere from 2.99 to 10.00 dollars. This can change, I truly believe it. The side effects from this abuse are beyond words, I have lived it for 8 years and it is real and it does kill.