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FDA to Regulate Internet Drug Sales 266

ThatGuyAZ writes "The Clinton Administration today announced that it'll be seeking to license all internet drug sales. This seems to be the first step in sweeping the power to regulate these transactions from the states to the federal government. (States currently license pharmacists.) I know the /. libertarians want no regulation at all (right up until they receive a bad prescription themselves), but is giving this problem to the federal government really a solution? Will this soon be happening with state-based licensing of lawyers, doctors, etc.? " Very interesting application of the inter-state commerce clause, although my unschooled opinion is that it's a defensible application of said clause.
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FDA to Regulate Internet Drug Sales

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  • by Anonymous Coward
    "The Clinton Administration today announced that it'll be seeking to license all internet drug sales. " I presume you mean , all *US* drug sales. Being in the uk , it would be quite scary otherwise :) How will this work internationally?
  • by Anonymous Coward
    I can agree 100% that antibiotics should be carefully controlled for public health reasons. However when you get to 'drugs of abuse', stop the nonsence NOW!
  • by Anonymous Coward
    > Pharmacists know a hell of alot more than the
    > average joe about what you should and should
    > not take.

    You don't need laws regulating the sale of medicine and requiring prescriptions in order to walk up to your pharmacist and ask him a few questions. Just open your mouth and ask. I myself always listen carefully to what the pharmacist tells me about a medicine, and read over any printed material accompanying the medicine.

  • by Anonymous Coward
    > I know the /. libertarians want no regulation
    > at all (right up until they receive a bad
    > prescription themselves)

    Gee, that's nice of you to assume that people who don't agree with you must be hypocrites who will discard their principles at the first inconvenience.

    As a libertarian, I don't want any *governmental* regulation, because I find it thoroughly immoral to apply or threaten violence against a person just because they bought or sold something without your approval.

    But government isn't the only effective source of regulation. For example, the safety of most appliances you buy isn't assured by the government, but by Underwriters Laboratory, a private group. That little "UL" symbol you often see certifies that the appliance in question has passed UL's testing. Companies seek UL certification both because of consumer pressure and (perhaps more importantly) because insurers demand it.

    I find third-party certification much more useful in finding quality products and services than government regulation. I recently bought a kerosene heater for emergency heating. What do I know about evaluating the safety of kersone heaters? Nothing. But Underwriters Laboratory knows a lot about the subject, so I made sure that I bought a heater with a solid UL rating. Similarly, when I need an auto mechanic I look for AAA approval and ASE certification.

    > Very interesting application of the
    > inter-state commerce clause, although my
    > unschooled opinion is that it's a defensible
    > application of said clause.

    Have you ever heard of the separation of powers? Are you aware that the US Constitution explicitly gives Congress the sole power to make laws? Clinton has repeatedly usurped the legislative powers of Congress, but apparently those 900 illegal FBI files contain enough dirty secrets to keep them from squawking. The US used to be a republic, with separate executive, legislative, and judicial branches. It seems that the US is now an empire, with an emperor who can simply impose new laws by decree.
  • If you walk into the lobby of the FDA there is a large portrait of the comissioner who refused to approve thalidomide for sale in the US despite it being approved in Canada and Europe.

    Requireing safety and efficacy studies before approving a drug for sale is a very different issue. The issue here is weather or not I have the right to buy and use a drug that has allready passed those studies without a doctor's permission. Weather or not it is SMART to do that is another matter as well.

  • Various drugs should indeed be restricted to prescriptions. If every time we got a sniffle and grabbed anti-biotics, whether they are needed or not (i.e. a virus) then we just encourage antibiotic-resistent bacteria (which are very nasty, as my sister just had surgery since antibiotics no longer work).

    I agree that that's a problem, however, it seems that the prescription laws didn't exactly prevent the problem. Many doctors have (and some still do) prescribe antibiotics for a virus just to make their patient happy. Why they don't prescribe placibos (sp?) I don't know.

    OTOH, since that is a public health issue rather than simply an individual issue, perhaps it is justifiable to seperate it from other prescription drug issues.

  • For that matter, is the average person going to understand the gobbligook that is written about a medical trial and treatment?

    I have read some of that 'gobbligook', and it has mostly made me wonder why some drugs are EVER prescribed. Apparently many doctors are willing to have me take something that I would NEVER decide to take.

    As for the lawsuit issue, that's one for tort reform, not the FDA.

  • where common sense should have played a role.

    But common sense SHOULD have played a role here. Common sense should have told the guy:

    Researching drugs and their faults is something best left for specialists.

    Even with prescription laws, common sense has to play a part lest someone get a prescription for Viagra and decide that if one is good, 5 would be better (people do that with prescription drugs all the time, others take all 4 doses in the morning so they don't forget etc...).

  • The short answer is NO, because your taking any old drug can in fact affect others in a lot of different ways.

    No more so than any other activity. Examples include watching TV while driving, leaving the potato salad for the company picnic out over night, wireing the 'deadman' and the self propel lever back on my lawnmower (I've actually seen someone do that, the results in that case were merely comical, but could have been worse) etc...

    When the FDA says something ok to market, it means that in some clinical trial it looks like the benefits of the drug outweigh the risks. NOT that it is 'safe'. There is no such thing as a 'safe' drug.

    Agreed, that's why I won't take many drugs at all, including many that doctors hand out like candy. I don't want to find out that I'm the 1% with serious complications from a stupid allergy medication.

    Your wise or unwise use of drugs affects no only yourself, but can effect your decendents because of genetic effects when misused. Some drugs are showing effects on third and fourth generations.

    In spite of current prescription laws.

    Some drugs are such potent teratogens that just traces of the drug in the male sperm are suspected of being able to cause severe birth defects.

    I am aware of that. What are they doing on the market? We have laws that cover the case of alcohol (it's considered child abuse), they would equally cover other drugs.

    Not only that, but who decides what drugs your children get? We already have too many tragic cases of kids harmed by simple overdoses of liquid Tylenol. I shudder to think what would happen when parents have the ability to buy stronger drugs freely and give them to their children.

    I will. There are and allways have been dumb parents, and they often manage to harm their kids through stupidity. All the laws in the world won't stop that.

    n addition, things like overuse of antibiotics lead to spread of resistant bacteria. Many countries outside the US have VERY severe problems with this becasue they do not regulate the sale of antibiotics.

    We have a problem with that in the US as well. Mostly from doctors who should know better prescribing antibiotics for the flu (at patients' request) and people failing to take the full prescribed course of antibiotics. Actually, that argument is the best argument I have heard yet in favor of prescription laws. I will concede that perhaps antibiotics (at least the ones that are known effective against resistant strains) belong in a special category.

    IN ADDITION, a lot of people resent the FDA controlling drugs at all. They take off to Mexico or wherever to take whatever some quack can talk them into. The same libertarian philosophy that rejects the concept of prescriptions also rejects the idea that ANY drugs, be it marijuana, heroin, LSD or thalidomide should be controlled.

    Thalidomide actually does have valid medical use (leprosy). It like many other things should have a strong warning label. As for recreational drugs, I do, in fact, advocate legalisation (even though I don't advocate their use)

    I do NOT want to be saddled with the taxes to support a brain damaged kid with flippers where his arms should have been, or having to worry about my kid getting a antibiotic resistant form of TB just because you felt you had an overriding right to take any drug you wanted.

    Nobody does, but it happens all the time with or without prescription laws. For every problem due to lack of prescription laws, there is likely a problem of someone who might have avoided serious illness with early treatment had a doctor visit not been required (not everyone can afford a doctor visit, but many antibiotics are quite inexpensive).

  • by sjames ( 1099 ) on Tuesday December 28, 1999 @11:29AM (#1438908) Homepage Journal

    With these facts in hand, one can make an informed decision instead of just swallowing pills and hoping that the right combination makes you fell better.

    Removing prescription laws wouldn't prevent you or anyone else from doing the right thing and having a doctor prescribe your medication. It also wouldn't remove the manufacturers' responsability to make medical grade products, and to label them properly. It wouldn't remove the pharmacists' responsability to dispense what you ask for.

    A doctor would still be responsable for what is prescribed to you. Just as he would be if he told you to drink a gallon of (non-prescription) antifreeze and call in the morning.

    What prescription laws really are is an assumption that most of us are darwin award cantidates [darwinawards.com] and the foolish notion that we idiots won't 'find' another way to win the award. The same people who would die without prescription laws probably take their prescription sleeping pills with a pint of vodka (because they'll be more effective that way) and operate a blow drier in the bathtub (saves 5 whole minutes in the morning).

    If the prescription awards are necessary, perhaps we should also card people (for an electrician's license) before selling them light bulbs, wall switches, or any tool that can be used to work on electrical equipment. Perhaps a mechanic's license to buy auto parts (people DO die regularly from improperly secured cars slipping off the jack).

    Or we could save a ton of money and just require warning labels on what are now prescription drugs.

  • by Fastolfe ( 1470 )
    that education in most cases is favorable to education

    Naturally, I meant "favorable to regulation."
  • Letting any Joe Bloe in the country pick up whatever prescription drugs he wants is not only stupid, it's negligent. The article states that the legislation is aimed at curbing illegal sales of prescription drugs. What better way to sell something illegally than over the Internet? The legislation only gives the FDA power to verify the quality of online pharmacies and to ensure that they are getting the required authorization before filling any orders for prescription drugs.

    With respects to the whole concept of prescribing drugs, the average citizen is an idiot. This is why we have smart people who are licensed to make certain decisions for us, like doctors. If you have a medical problem that can be treated with prescription drugs, you have to get a doctor to make that diagnosis and decision. The doctor writes out a prescription, so that the pharmacy knows you've gotten a doctor's consent before they go handing out potentially lethal drugs. Would you really rather live in a country where anyone can buy any sort of drug and use it as he desires? What happens when that drug, or perhaps a certain mixture, causes sterility? Heart failure? Death? "Oh shucks, he should have known better." ? There are perfectly sane, legitimate reasons we license and prescribe drugs in this country.
  • Agreed, but another important provision in this law is the power of the FDA to investigate the quality and set standards for online pharmacies. If an online pharmacy consistently mis-fills 10% of its drugs, or skimps out on a few pills out of each prescription, the FDA could then pull the pharmacy's license until they shape up. If the pharmacy continues to operate, the fines are quite severe.

    This also makes investigating online pharmacies the explicit responsibility of the FDA. Without this legislation, that responsibility is ambiguous, and would generally require a state or a person to file a lawsuit.
  • I don't think this legislation has anything to do with international orders.

    Of course I'd have to actually read it or have someone give a better summary than what was provided in the article, but it seems to only apply to domestic pharmacies.

    It would be kind of hard to require every 'Net pharmacy in the world to get a US license, and if they didn't comply, how is the US going to enforce a fine or penalty?
  • No, I don't think this law does much in the way of international pharmaceutical orders. In those cases, I would simply hope that the host country would have similar laws (and most, if not all, do) regarding what types of drugs can be sold and how those drugs are sold and transported.

    Who do you think is going to be "pushed" out of the US as a result of this legislation (assuming it passes)? The legal, legitimate, quality pharmacies? Really doubtful. The burdons placed on them as a result of this legislation are probably going to be very trivial. Certainly less than the costs of moving their operation to another country. Think of it as a business license. They already have to get one sort of license (or more) for the state they're doing business. What's one more?

    So who's left? The illegal pharmacies, for one. Oh damn. Guess they'll have to move their illegal drug operation to another country, or maybe they can just try to hide their web site a little better. Then there's the pharmacies that don't seem to have any sort of quality control. If a pharmacy is consistently mis-filling prescriptions and acting really negligently, I would expect the FDA would pull their license. So I suppose there's a possibility there that they would move to another country. Again, good riddance.

    If I'm ordering a prescription from an online pharmacy in the US, I would take much comfort in the fact that we had an oversight body in place licensing and monitoring these pharmacies.

    If your entire business consists of 2 72" racks in a datacenter, and a local sysadmin, it's pretty easy to move your company to any country about as fast as you can propagate a DNS change.

    Apparently you're forgetting the nature of the business. Pharmacies require taking in stock of drugs, filling personalized prescriptions for specific dosages of those drugs, and shipping them out. We don't care where the web site is; we care where they're doing their business. It takes a bit more effort to move this type of operation to another country than simply relocating data and making a DNS change.

    Most countries have their own import/export laws with respects to controlled drugs. If it were so easy to get these things shipped out via standard mail, why aren't more people sending heroin, cocaine and marijuana via the USPS?

    Think about it. Somebody else already has.
  • What if it is sent by a private mail carrier, like DHL?

    I may be wrong, but I think private carriers might possibly share some liability here. It's probably quite illegal to ship controlled drugs from one country to another (where it may be illegal in either one). If a carrier is getting lots of international orders from a shifty-looking online pharmacy, an investigation might be performed. Carriers (at least in the US), I believe, have the right to open and inspect any package you put in their custody without a warrant.
  • This legislation only applies to companies selling *across* state boundaries (thus bringing it into the federal domain). The vast, vast majority of pharmacies sell in a physical store, so they're only subject to the individual state's laws.
  • I don't necessarily disagree that education in most cases is favorable to education, but really, it's unrealistic.

    Perhaps a thousand years ago it was certainly possible for one person to learn the sum of all human knowledge. A hundred years ago one could probably be pretty fluent in most subjects, but today, it's not possible for someone to educate themselves regarding everything that affects his life.

    "He should have known better," is something I tend to say pretty frequently, but only when dealing with things where common sense should have played a role. Researching drugs and their faults is something best left for specialists.

    Doctors are *trained* to know what types of drugs are best for what situations, when certain drugs shouldn't be used, and what existing medical conditions could make the use of such drugs harmful, or when the risk is acceptable. Further, they may know of a drug that performs the same thing but with a different set of side effects and problems that would be preferable.

    Sure, I could probably go to some medical web site, look up my symptoms, find an ailment that causes those symptoms, find a common drug treatment, and do all sorts of research on that drug to make sure there aren't any problems, but who's to say my work is complete or accurate? Perhaps that ailment wasn't really the problem, and taking that drug only exacerbated the situation and caused my untimely death?

    The average person is not qualified to make these types of decisions with *controlled substances* that have harmful and fatal side effects when not used correctly or in the correct situations. Nor is the average person qualified to have enough background knowledge in medicine to even attempt a thorough amount of research into their own ailments and what drugs they should take to cure them.
  • Sure...if noone is anywhere nearby that could
    possibly be hit. Otherwise you are endangering
    others.


    So by this I assume that you do not support statutes for things like "disturbing the peace"? If my neighbor started shooting all sorts of firearms in the air while my baby girl was trying to sleep, you can bet I'd be a bit angry, and there are laws on the books that makes this type of behavior illegal (at least in most cities).

    One could argue that allowing a pharmacy to operate negligently or illegally is, in fact, "endangering others."

    Why is it any of your buisness if they run a
    brothel?


    So I guess then that you are also opposed to anti-prostitution legislation, and various zoning laws about where businesses and industries can be built? I personally love the fact that my neighbor can't tear down his house and replace it with a coal-burning factory that produces foul-smelling tires. Not to mention the fact that if my neighbor started up a brothel, the value of my home would probably drop quite a lot, but then that's why we have homeowners associations, yes? Or are you against them also?

    Why not? Why is it you are so interested in what
    your neibor does in the privacy of his own home?
    Do you keep track of what he does...make sure he
    isn't having sex outside of marriage too?


    I can't really tell if you're trying to have a legitimate argument here or if you're just trying to be annoying. It sounds like you're against all sorts of laws that are already in the books (in this case, laws against the production of illegal drugs)...

    If you really have such a beef about these laws, perhaps you should try writing to your local legislature. I sincerely doubt these things will ever be legalized, so maybe it would be in your best interests to move to a lesser-developed country that doesn't have these laws. It sounds like you'd be happier there.
  • All we need is the ability to stay fully informed about those risks

    Bingo.

    So let's say we eliminate most all laws that are set up to protect ourselves from our own ignorance and stupidity.

    How would you keep people fully informed about decisions they're about to make? How would you counter misleading advertising? It's obvious to a doctor that drug X, despite being marketed on TV commercials as *the* cure for some ailment, is significantly more dangerous and less effective than drug Y. Does that not matter? How can you get information that the consumer will trust into those consumers' hands?

    What happens when that information is faulty? If a doctor is negligent, we can blame him, but if there's a typo or incorrect cross-reference in some online information source that causes a naive reader to make a poor decision ending in his death, who's liable? Anyone?

    What you seem to be advocating is a fundamental change in one of the major charges of government: to protect its citizens. That protection has tended to include protection from one's self.

    I do not feel that a person of average (or even above-average) intelligence is capable of making fully informed, trustworthy decisions about *all* aspects of their life. It seems that you put more faith in the average person than I do.
  • So should I be denied direct access to medication just because my next door neighbours are idiots? I think not.

    Who said anything about denying you access to medication? If you can't seem to find a doctor willing to prescribe some medication for you, I think it's a safe bet to say that a) you don't need that medication; or b) it would be dangerous or lethal for you to use it.

    You seem to have this horrible animosity towards doctors. I promise you doctors are in the business to keep you alive and healthy. If you disagree with that, that's your problem. If medical training and licensing requirements are really so terrible where you live, perhaps you should move.
  • I was kind of
    thinking off alone in the middle of a feild
    where noone is around.


    And as far as I know, this is perfectly legal. I think the original poster was thinking from my frame of reference, in a quiet neighborhood.

    Should we require prescriptions
    for those too? perhaps ban the sale of them?


    How about require the makers of these items to disclose all known health risks and to put serious restrictions on their methods of advertising. And while we're at it, limit the purchases of these things to people that are 18 or 21 years old, so we can be sure they're old enough to make an informed decision on their own.

    I suppose we could do exactly the same thing for all prescription drugs, but the resources required to not only put this into effect, but to monitor and ensure full disclosure and compliance on the parts of the makers of prescription drugs would be prohibitive. As prescription drugs tend to be individually things the average person knows little about (unlike alcohol and tobacco, which are quite common), it makes more sense to entrust a certain class of people with the tasks of learning the details about when certain drugs should be used, how they're used, how they're not to be used, and acceptable, less-risky alternatives, and require that class of people to give their consent before these items are given to the general public.

    I see nothing wrong with
    a brothel. As long as they keep quiet, why not?


    OK, aside from the fact that we'd have to get rid of most commercial zoning laws as well as laws banning prostitution (each independently having merits outside of this situation), your argument is that what one does in the privacy of his own home is acceptable. So when does a building cease to become a home and start to become a place of business? Or does it matter? In my opinion, by opening up his doors to customers looking for sex, that place ceases to become simply a private home. While I don't entirely disagree with your point of view here, I would rather not see my neighbor's house turn into a brothel simply because it would attract all sorts of unsavory people and attention to my neighborhood and generally cause me headaches. I'd say let's make this more of a community law/ordinance, but I think for the most part, it already is.

    I am firmly against the idea
    that the government should have any say in what
    people can or can not do in the privacy of
    their own home, or with other consenting
    adults (ie using drugs, paying for sex).


    This is moving out off of the topic at hand, but let me ask you this:

    Let's say I invent a drug X that, given a single dose, mimics the effects of alcohol while having an extremely addicting effect on the taker. So addicting, in fact, that one dose is sufficient to addict an adult in such a way that 99% of the people that take it begin taking it regularly. This drug is "marketed" as a quick, safe high by the dealers and quickly spreads.

    So you think a substance like this should be allowed to be created and sold? All of the people that end up taking this drug, whether or not they know about its addictive effects, deserve to be hooked on it? And when prices go up tenfold, they deserve to have their bank accounts drained paying for a steady supply? Or do you think they should just "suck it up," "bite the bullet" and check into rehab? Overcoming a drug addiction of a severe magnitude is not a pretty or painless thing. Did they have it coming?

    Now, I'm not saying that all illegal drugs have these types of effects, but there are plenty that do. It all boils down to the fact that people today have a need to be protected from their own ignorance and stupidity. To suggest that everyone is capable of making educated, informed decisions about everything that will affect their life is naive.

    Now I'm a firm believer in Darwinian natural selection. I do not feel we need to spend so much money and time keeping the stupid people in our country alive and healthy. I do not, however, wish to see pharmaceutical companies marketing their prescription drugs like it were laundry detergent, and things are starting to move in this direction. I am pleased that we have doctors that are trained to know what drugs are required for specific situations and when those drugs can not and should not be used. If we eliminate this requirement, for doctors to give prescriptions for certain drugs, I shudder to think how many people will, incorrectly and sometimes fatally, turn to prescription drugs when they don't need them.

    To be honest, it sounds like your beef is more with illegal drugs and how you feel drugs should be legalized entirely than with legislation of online prescription drug pharmacies, and this is out of the scope of this thread.
  • If a drug company lies about their products, they are guilty of fraud and will eventually be facing a huge class-action suit.

    Who said anything about lying? All they have to do is down-play certain side effects, like, say, a 10% incidence of heart failure. You think people always read the fine print? What if there were no requirement for the fine print at all?

    Since you believe government should be protecting us from ourselves, shall I assume you support bans on tobacco, alcohol, fried foods, and skiing?

    I think that our current regulations on tobacco and alcohol are sufficient. The places where these regulations are weak can be made up by strong parenting.

    The remainder of your examples are not remotely in the same class and unworthy of a response.

    If people are incompetent to run their own lives, how can they be competent to elect leaders to run their lives for them?

    There's a bit of difference between electing leaders and getting a doctor's advice regarding prescription medication.

    Continuing with your analogy, though, how many people do you know honestly do any research into the candidates up for office? How many simply vote with the party?

    If we had no prescription requirements, we would have as many prescription drug commercials as we have beer commercials. People would be watching the commercials, saying to themselves, "Hey, I have that problem," and flocking to their nearest drug store to pump themselves full of medication. Do people really read the warning labels on a pack of cigarettes or a bottle of beer? Do you think they're going to read the warnings on the box of medication? How many of these people are going to die because they didn't know drug X had a strong reaction with drug Y?

    How can you possibly guarantee that people are going to be *able* to have enough information to make an informed decision about what drugs are safe to take and which are not? It's not like alcohol and tobacco here, where we have two distinct items that are quite heavily regulated and impressions firmly stamped in every American's brain about the effects. The variety of prescription drugs and the endless ways that these drugs interact and behave make it impossible to regulate them like we do alcohol and tobacco.

    Should it be the user's fault that he's killed because he only did 2 minute's worth of research on a drug instead of 3, where he'd have discovered that the drug causes instant death in people that only have one kidney?

    Few people are stupid about all things. Even fewer are smart about all things. Most everyone is smart about certain things, and not-so-smart about everything else. Doctors are smart about the human body and the drugs we put into it, thus it's only logical to trust them with these decisions. We're not talking about wristwatch preferences here. A very trivial mistake with a prescription drug can easily spell death.

    And remember that there *is* such a thing as an over-the-counter drug. These are drugs that are either of low potency or deemed to have few if any ill-effects. If a drug is classified as a prescription drug, it's been classified that way for a reason. If you think the FDA is full of idiots, perhaps it's time you wrote some letters and got them all fired. I mean it's not like any of them have degrees or doctorates in any of this stuff. Maybe they'll be kind enough to hire you in their place. I'm sure we'll all be better off.
  • Whoever committed fraud by claiming that it was a safe drug, and by marketing something so dangerous without adequate warnings, would be mostly to blame

    Wow, you're right. Those damn drug dealers. Let's put them in jail!

    But the people who took it without bothering to look up any information on the drug are also to blame for their own recklessness.

    Right-o. Those kids hooked on crack deserved what they got. Let 'em sit in misery for the rest of their life. But gods, no, let's not blame the drug or the maker.

    I hope you're not saying that any real drug, illegal or legal, is nearly that addictive.

    It's all about scale. There are *plenty* of OTC and prescription drugs that are addictive in nature, but *how* addictive is one factor in many in determining how a drug should be classified. Drugs with a high-degree of addictibility tend to be made illegal, sometimes regardless of their medicinal value.

    If people are incapable of making decisions for themselves, it's because of two reasons.

    Perhaps. Without these laws, however, how many more people would be addicted to narcotics? Cigarettes? How many people would -- due entirely to their own mistake -- die or become severely ill due to an improperly researched drug purchase?

    Is it worth it for people to be permitted to purchase recreational drugs (which is what they would be -- after all, this whole thing is about getting drugs a doctor won't prescribe for you, right?) if it means a substantial increase in death and illness for people that either don't have the time nor the money to do research?
  • It's easy to generalize a story, thus making pretty much any topic that fits in that generalization "on-topic."

    The story is about legislation giving the US federal government jurisdiction over the licensing and monitoring of Internet pharmacies. It is not about whether all drugs should be made free and legal. I'm not here to debate this with you, but I think it's safe to say the vast, vast majority of Americans disagrees with this standpoint, so it's highly unlikely you will live to see your views realized. Of course, I'm not saying you shouldn't continue with your protests. By all means, continue. I'll just be dropping out of the discussion now.
  • The scenereo was specifically of a drug that was fraudulently marketed.

    ...as are crack, cocaine, and other narcotics. There'll always be people out to make a quick buck by not disclosing all of the truth, or outright lying. I was pointing out that, despite laws forbidding this, drug dealers are still out on the streets selling drugs to people that may or may not know the risks. Should we be placing the blame on the users, the dealers, the manufacturers? A combination of both? Or is there no blame at all?

    People still have a responsibility to check if what they're about to ingest is safe.

    What would you consider a 'responsible check'? How much research must one do before they cease to be irresponsible and become responsible?

    Now realize that if we move to a free market, where anyone can pick up any drug they wanted, those that make and sell dangerous drugs are probably going to want to hide a few things here and there, or downplay some risks. That may make it a bit more difficult for someone doing a cursory check on the risks associated with a drug to come up with something that changes their mind. If the company is good at obfuscating the risks, the average person is neither going to understand or recognize the significance of what their research has turned up.

    Now who's to blame? The user for not being in the top tenth percentile of educated people, or the manufacturer for listening more to their marketing people than their scientists?

    Since both are readily available, I don't see your point.

    Just because a law is 90% effective does not mean it's a useless law. Stamping out the law will allow a sort of equilibreum to be established, between the makers and sellers of harmful substances and the users of those substances, each with varying degrees of education about the risks of those substances.

    The idea is to prevent people that don't know any better from using something known to be harmful and addicting.

    It costs nothing to go to a public library.

    Are you really suggesting that everyone go to the public library every time they feel a desire to go out and get some prescription drug for some random ailment they've just noticed?

    How many people are going to do that? I'll probably round my estimates to the nearest whole number and say zero.

    In a world where people were free to choose what drugs they take, pharmacists would probably want to keep a good amount of information on hand in order to serve their customers

    They'll probably only do so if/when it helps them to earn money. I imagine "hole-in-the-wall" type online pharmacies would have plenty of business without wanting or needing to set up information centers for people to research the drugs they're wanting to buy. I'd say the majority of prescription drug purchases are for refills or drugs that the person is probably going to be taking for the rest of their life. Why go to a pricey pharmacy when you can find one that doesn't have to spend money on education, training and offering research material and can get you a much better deal?

    So now that we've established that these places will exist, why would a mother on welfare supporting 5 kids want to even start her drug shopping at a classy place to begin with? Chances are, one of her friends has told her she needs to give her kid drug X and Y to clear up two symptoms, so she does goes to Cheap-Ass Pharmacy and orders those drugs. As Cheap-Ass Pharmacy has no reference material (not that she'd take the time to read it anyways), she does not know that drugs X and Y are mutually exclusive and will cause certain death if mixed. Oh damn. Is it her own fault then? Does her kid deserve what he got? What if it's something more benign.. let's say the kid has some kidney disorder that would make drug X potentially lethal, but the mother of course doesn't know this. A doctor would be able to check for this disorder before prescribing drug X. Is it the mother's fault for not knowing this?

    government does not need to protect people from themselves. I realize that some people won't be able to handle that.

    You're right, because it's been shown time and time again that people are NOT smart enough to be able to survive in this world without some laws designed to protect them from their own stupidity. Look in your home, on the backs of appliances, on the tags on your furniture, on the very plastic bags that these things were shipped in. How many different and distinct warning labels do you see? Every one of those warning labels was brought about because somebody was too stupid to care for himself.

    I agree in that I'd like to see the government regulating less than it currently is, but I firmly believe that existing laws regarding the need for prescriptions before drugs can be given are quite necessary and inconsequential. I've probably been prescribed drugs 2 or 3 times in my life, and every time it's been the result of me going to see a doctor. If people are so adament that they be allowed to get potentially dangerous drugs without needing a prescription, what exactly do they need these drugs for? Common sense says to get a doctor to investigate your latest ailment, not to try and diagnose it on your own, yet that seems to be what people are shooting for here, and I don't quite understand why. Under what circumstances would you ever need a prescription drug (versus an OTC drug) without going to see a doctor?
  • X-rays and drug-hunting devices and dogs are pretty common, I'd wager.
  • If people are going to take a drug without either professional advice or the information to make their own decision, that is their own responsibility.

    What I'm trying to say is that people WILL be taking drugs without adequate information on the risks. There is no possible way someone is going to be able to do all of the research necessary to be sure that a given drug will not affect them adversely, either in concert with another drug they're taking or an ailment, disease or other defect. In fact, people are going to be MORE likely to be influenced by marketing and word-of-mouth than by any degree of research they will be able to do, which (as I'm sure you'll agree) is not the safest way to do your prescription drug shopping.

    The only way someone can be relatively sure that they a) need a prescription drug at all and b) know that the drug they need will be safe for them to use (or get an alternative), will be to either consult a doctor, or to utilize some yet-to-be invented computer system that can diagnose illnesses and predict risks imparted by taking a drug or a series of drugs. Sounds like a robotic doctor to me.

    I guarantee you that if legislation were dropped requiring a doctor's prescription that there would be a tremendous buying frenzy of prescription drugs that people do not need. There will also be a *significant* increase in the number of ailments, overdoses and deaths that will be a direct result of people purchasing prescription drugs without adequate knowledge or research as to how these drugs are to be used.

    It's not a simple matter of convenience here. It sounds like some of you don't want prescriptions simply because you want to get access to drugs that a doctor will not prescribe for you. Chances are, he has a VERY good reason for not prescribing those drugs for you.

    I guess we're just going to have to agree to disagree on this. I do see where you're coming from, and in an ideal world, yes, I would imagine everyone would have the means and opportunity to do their own research on drugs and have the maturity and faith in their own bodies to know when they do and do not need to use those drugs, but this is far from an ideal world. People's lives are regularly being destroyed as the result of addictive drugs, and removing the requirement for safeguards such as the current prescription drug system will only serve to hurt people.
  • Not having massive regulatory bodies does not mean that companies can get away with selling dangerous products.

    This is precisely what prescription drugs are, though. They've been deemed dangerous and are not permitted to be sold unless you have the written permission of a doctor. They've been classified this way because the FDA has determined that the average citizen is neither responsible nor resourceful enough to make a determination as to the safety of this drug with respects to their own unique situation.

    With respects to my views on marijuana, I really don't have much of an opinion. If it were up to me, tobacco would be banned right along with it, but that's not going to happen, so I wouldn't have much of a problem decriminilzing marijuana use for consistency if nothing else.

    A huge number of people die of heart disease every year, many of whom could probably have been saved

    Better diets and exercise are fundamental changes in a person's lifestyle. Prohibiting the use of certain drugs or mandating alternatives doesn't quite seem in the same ball park to me as requiring all everyone to have an hour of exercise a day.

    My point is that once you start passing "for your own good" laws how do you decide where to stop?

    I believe we already have. Laws requiring prescriptions aren't exactly new things. This article is about legislation setting federal standards that are already in sync with existing state laws. We're not passing any more "for your own good" laws, we're just making it possible for the FDA to step in in inter-state drug sales and set guidelines as to quality and keep the pharmacies honest and legal.

    If some idiot is going to randomly combine 17 prescriptions...

    It doesn't take 17. All it takes is 1 or 2 slightly ill-researched prescriptions to cause significant harm. If people were really confident in their abilities to research their own drug purchases, why are these drugs being classified as prescription drugs in the first place? Why are they not "over the counter"? The FDA has concluded (quite logically and fairly, in my opinion) that most people cannot or will not be able to do their own research on drugs that meet this level of risk.

    I'm not trying to say everyone is going to go out and start buying prescription drugs at will. I'm thinking instead of the lower-class or undereducated families that can not necessarily afford to see a doctor. If drugs were freely available without a prescription, these people are significantly less likely to even try to see a doctor, and will instead rely on word of mouth for their prescription drug choices. This can't be good. In order to survive like this, one would have to become an expert in prescription drugs, which few people are going to do.




  • Bingo! You've hit the real reason for this legislation. National pharmacy chains want to close the door on smaller pharmacies.

    Of course, the other problem with this is that many drugs are not controlled substances and are legal to ship into and out of the US (of course, many others ARE controlled substances and are illegal to ship across the border).

    It is (or was) perfectly legal to drive from the US into a store in Mexico and buy a bottle of, say amoxycillin with no prescription then take it with you back to the states. It should be legal to order the same bottle from a store in Mexico and have it sent via overnight delivery.

    Not that I'd want to with that paticular antibiotic, as once it is mixed it really needs to be refridgerated, but you get the idea (substitute, say, predisone tablets, of which I need to keep a supply around all the time).
  • We deal with dangerous things all the time in our normal daily lives. Sharp knives. Power tools. Motor cars. Hang-gliding. SCUBA diving. Football. Large dogs. Fire. Swimming after lunch.


    Be careful. There are already busybodies who want to make sure people can't injure themselves with sharp knives, power tools, motor cars, etc.

    They are called Consumer's Union (Consumer's Reports) and have some of the worst of this ilk in their employ. As an example, when reviewing a power saw (paraphrased): "This saw is capable of cutting through any pliable material, including its own cord. We recommend shortening the cord to a length that would prevent the operator from being able to cut the cord and possily suffering elotruction."

    Well, duh! Six inch cords are of course going to be into an extension cord, which same idiot user can still cut through, and now the idiot dippy enough to do this might plug a quarter-horse power saw into a light duty extension cord (since he has to in order to use the saw) and create a fire hazard . . .

    Way to improve safety...

    Sorry for the rant, I just really love that example, especially now that all my freaking power tools have six-inch cords. Thanks CU/CR!
  • I found it quite amusing that so many Libertarians were outraged by this. Let's assume for a second that not everyone is as 'intelligent' as you, and, believe it or not, they could possibly make a mistake. Of all the things sold on the internet, drugs are probably the riskiest. It's unlikely that reading too much of that book from amazon will kill you, nor will listening to track 1 on repeat from a cd do too much damage, however, taking as little as 50% more of the medication you've been prescribed can.
    It's all well and good to believe that we deserve certain freedoms; I do too, but keep in mind that not everyone has the requisite knowledge to make use of freedoms.
    To put it another way, a lot of people *think* they can handle firearms, maybe some of them do, but the number of accidental shootings in the US is ridiculous. Obviously, people have trouble dealing with too much freedom on occaison.
  • IMHO, this regulation is defensible under current interstate trade law. IANAL, however...

    My concern is that continued application of such law to the Internet will begin a trend of Internet-related regulations which will result in new legislation. The first thing that comes to mind is Internet taxation. It has been proposed (and defeated) before, but if the US Government can regulate aspects of Internet trade, I see the attitude toward Internet taxation relaxing a bit.

    I think it's important, if you share my concern, to take an opportunity like this to write your Congressperson and express your concern over such controls. Make your opinion clear, complete, and concise -- staffers read such letters, and will get bored with them quickly if they are too long-winded.

    What does everyone else think? Could decisions like this soften the attitude toward Internet regulation and lead to taxation of Internet commerce?

    -- Never underestimate the power of very stupid people in large groups

  • One common response that I have been reading a lot has to do with the stupid consumer scenario.

    I don't remember anyone mentioning the common Libertarian response of the regulation encouraging the stupid consumer. By having the regulations, consumers become accustomed to being less vigilant over the purchases they make.

    On the other hand, if it's something important, we do indeed pay a certain amount of vigilance in how we buy things. Between a website selling prescription medications whose page layout dates from the Mosaic days, and one that is sophisticated and complex, chances are people would take the nicer looking one. The nicer looking one implies that money and time was put into site creation, and therefore that use of resources further implies that the company intends to be around for some time.

    That is of course an irrational way of doing things, the nastier looking site may be just as legitimate, and they may proudly note that the savings in site creation were passed on to you. On the other hand, out of desperation for viagara, people may be willing to buy from any site.

    I am not debating the point that prescription medications are unsafe (heck, nearly 110,000 people die yearly from prescription medications, whereas less than 5,000 die from illegal drugs. Admittedly, it doesn't take long to see what's up with that statistic.) I am willing to say that some form of *certification* is necessary.

    But there are some important footnotes here:

    *Certain types of widely used prescriptions have been thoroughly tested, and need to be. Antibiotics for example, will be more or less taken by everyone, and many times the ailments for which they are being taken aren't life threatening. On the other hand, the FDA runs all medications through the same testing process, which is rather absurd. Hodgekin's disease and AIDS sufferers have much less to lose, and in cases where they need the drugs more desperately, the testing processes should not be as drawn out.

    *Related to the complex testing processes, those medications are terribly expensive because of the testing used. For people who are near death or suffering severely anyway, the testing is difficult to justify.

    *The FDA has police powers. Not only can they stop you from buying something, they can raid drugstores and warehouses. In fact, other than ATF, the FDA is one of the better armed federal regulatory bodies.

    *Testing, as it has been pointed out, doesn't guarantee much at all. It used to be that the companies, by undergoing the testing, didn't have so much liability, but changes in federal law have guaranteed liability no matter the testing. This is one area, like aviation regulations, where the companies have little reason to cheat and sell a dangerous product. The punitive damages are pretty severe. Thalidomide has not occurred again not so much because of regulations, but because liability damages are uncapped. (Toxic Shock causing Rely Tampons were approved, but removed by Procter and Gamble for fear of killing the clients.) There are of course fly by night companies which would be difficult to sue, but a consumer needs to weigh the consequences of flying JimBobJoe airlines, or taking a drug from JimBobJoe pharmaceuticals, as opposed to United Airlines and Ciby-Geigy.

    *Is it proper for a government to interfer with a contract between two people? Regulation is there indeed to "protect" you but when that regulation actually threatens your life, or severely restrains your liberty, like in this egregious example [bbc.co.uk] then the presence of the regulation is questionable.

    Libertarians often cite underwriter laboratories as an good example of private regulation (although perhaps it's disingenous to compare drugs which work biochemically on the body to lamps, which cause understood effects.)

    Certifications can be granted by such trusted groups to phamaraceuticals, pharmaceutical companies, and doctors. You can of course go to an uncertified doctor or pharmaceutical reseller, but that is the case today, otherwise you wouldn't be able to explain the huge marijuana market. It is simply irrational to expect that the presence of the regulation means that people won't have access to the drug. If that's the case, who is the regulation helping anyway?

  • Two comments.

    One, the swipe at Libertarians in the summary of this story is irresponsible, and would be moderated down as flame-bait if I could moderate comments.

    Two, even *were* I to receive a "bad prescription", I would still oppose this silly regulation. Too many of you are saying "without this, it's too easy for Joe Blow to get into trouble with dangerous drug interactions and hurt/kill himself", yadda spew.

    Maybe. It is not, it simply is not, the business of the federal government to protect people from their own ignorance and stupidity, though. If you go out and recklessly order and mix drugs, without doing your research, you probably get unpleasant results. But this does not mean it is the role of our Favorite Uncle to "protect" us.

    Freedom means responsibility.

    I'm going to stop reading this thread now, because it's going to piss me off too much. Don't tell me how to live *my* life, and I won't presume to rule yours, ok?
  • The Federal Government is the largest it's been ever. But I think the real problem is not the government, but the complacent Americans who sit and let it happen while getting really worked up watching NASCAR and Ally McBeal. We currently are at the highest tax level we've been at since World War II, and Americans are freaking out about ... having to pay ATM fees?

    Those of us who belive in freedom and individual responsibility must evangelize. Nowadays I like Linux and Libertarianism for the same reasons: for me, both mean that I am smart enough to make my own choices and I do not need any other person, government, or corportaion to make my choices for me.
  • I believe you're confused. Democrats are, at least on the political scale, closer to socialists/communists (government for the total good of the people) than fascists/nazis (government for the regulation and repression of the people), whom the Republicans are closer to. Of course, in reality, both Democrats and Republicans are pretty moderate, and middle-of-the-road compared to their extremist counterparts. True Libertarians are orthoganal on the social/political scale to both true Democrats and true Republicans. In addition, since the Libertarian party is so new, most of its constituents are still in the enthusiastic stage before they've found the inevitable collapse towards moderate.

    By the way, I appreciate some of the sentiments of Libertarians (personal freedoms with assumed responsibility and the like), but unfortunately, the vast number of people in the United States aren't responsible or intelligent enough for a Libertarian system to work on a large scale.
    ---
    "'Is not a quine' is not a quine" is a quine.

  • I believe you are confused yourself. Communists are a government for the total good of the people??? As in North Korea, for example?

    No, North Korea is what happens to communism over time - they degenerate into fascism. Read "Animal Farm" someday, and then look at what has happened to every single communist nation. True, Marxist communism is simply the ultimate in socialism; however, it relies too heavily on the altruism of its constituents.
    ---
    "'Is not a quine' is not a quine" is a quine.

  • by Pascal Q. Porcupine ( 4467 ) on Tuesday December 28, 1999 @09:01AM (#1438937) Homepage
    What about a US citizen ordering medication from a pharmacy in, say, New Zealand? There are many legitimate reasons to take advantage of the regulations regarding imported medicines (a three-month supply for one person is actually protected under US Customs laws); for example, some medicines are vastly cheaper when ordered abroad (for example, certain hormones are $45 for a three-month supply ordered from New Zealand instead of $200+ for a one-month supply purchased in the USA), and some are difficult or impossible to get a prescription for in the USA (many "smart" drugs, for example, or hormones taken for various purposes which the medical community frowns upon - not everyone wants to fit neatly into the XY-male/XX-female sex stereotype which they were born into). Also, in the case of ordering from New Zealand, it's not as though they're a third-world nation where any product you order will be incredibly shoddy; usually it's the exact same stuff as produced in the United States or in England.

    Does this only apply to prescriptions ordered online from US pharmacies? They're already regulated, at least at the state level. If it applies to international pharmacies as well, that means they're hoping to override a very convenient, useful, and oftentimes necessary loophole purposefully left in the US Customs laws. I just don't really see what this attempt at regulation is trying to help; certainly not consumers.
    ---
    "'Is not a quine' is not a quine" is a quine.

  • The announcement that the Federal Government wants to regulate prescription sales over the Internet is hardly uprising. One of the unholiest and most monopolistic industries, and one of biggest lobbies in Washington has finally started to flex it's political muscle. Considering the track record of the American Pharmaceutic industry, I doubt there is anything the common man can do about the upcoming regulation of prescription drug sales over the net in the US.

    The Pharmaceutical business, as it is composed today, has 3 basic branches. There is the manufacturing branch, the dispensing branch, and the third party payment branch. I spent large parts of my career in all three branches. On proper inspection of the workings of the drug business in the US, most people can see that it's one of the most corrupt businesses in the US. They abuse of patents in a way which makes the computer business seem soft in comparison.

    Drug Regulation in the US started in 1906 with the Federal Pure Food and Drug Act in response to the growing problem, as rightfully recognized by Teddy Roservelt administration, of problems with food purity and and medical quackery. In these early years, a number of small pharmacist, mostly around the NYC area, started to bring industrial production to the compounding and creation of Pharmaceutical products. Among these small businesses emerged some of the biggest world-wide corporations today, including familiar names like Merk on Canal street, Pfizer and Squib in Brooklyn.

    In 1938, several people died do to an antibiotic being distributed using what amounts to anti-freeze being used as a suspending agent. So the government responded by increasing safety regulation. All new drugs in industrial production needed to be submitted to the Food and Drug Authority for approval. Generally, this has been a good thing. But the Federal Government had not yet mandated a prescription for drug sales. Of course, the new regulations did not end the deaths that are secondary to bring new drugs to market on global scales, and again the Law was strengthened after the Thalidomide deaths in the 1960's. The new law was called the Harris-Kefauver amendment. It required efficacy studies as part of the New Drug Application. And even this did not end the potentential for deaths do to new drugs as Eli Lilly killed off a few folks with a release of a standard Aspirin like drug, not long after.

    While this assortment of regulation was being applied to the manufacturing and marketing of drug, increasing regulation was also being brought to bare on the dispensing end of the business. 2 aspects of drug dispensing was coming under regulation. First, the dispensing of habit forming and addicting drugs started to become regulated with the implementation of Controlled substances (like Morphine, Cocaine and THC). These laws have accumulated to the Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Act of the same year. They essentially established a schedule of drugs C ontrol 1 through Control V and are under the jusidiction of the Drug Enforcement Agency. These controlled substances are either illegal to distribute, like Heromin, or highly regulated and inventoried from raw material to distribution to the patient.

    What was most important was the general dispensing of a non controlled drug to the patient. Up until 1951, it was legal for a Pharmacist to dispense a drug upon request as they saw fit. But with the decline in Pharmaceutical compound and the threat of drug sales going completely over the counter by the growing presence of supermarkets and such, Humphrey, who had a relative who was a pharmacist, decided it was in the best interest of the Pharmacy professional to have a law prohibiting the dispensing of most drugs accept upon the presentation of a prescription of a doctor. This is the law which prevents you from walking into Kmart and buying Viagra.

    The problem that has occurred in the industry is two fold. First of all, American Pharmaceutic Companies have badly abused their patents. There was for a time a gentlemen agreement among the Pharmaceutical manufacturers to not compete with each other by producing a drug developed by one another company. They artificially inflated the cost of drugs whose patents expired decades ago. Eventually, there was a consumer backlash, which finally brought about the creation of todays generic drug industry. But years of monopolistic activity (sound familiar) left these companies very wealthy and they lobbied repeatedly for extension of patents on drugs which really have passed their 17 year patent. For example, Park Davis had a drug called Lopid which was brought to market to treat live threatening conditions which involved high triglyceride counts. Park Davis did not do extensive research into the agents other benefits. It didn't sell well. But then Merk came out with a drug a new drug to fight cholesterol called Mevacor. It was huge sellers, despite it's potential side effects, and interest grew in the Park Davis drug, Lopid. The problem for Park Davis was that their patent was expiring. They spend millions of dollars petitioning the government to extend it's patents.

    And this is not an isolated case. Pharmaceutical manufactures hold huge sway in Washington. Drug prices have gone through the roof and no one cares because the insurance companies are picking up the bill. Drug companies waste billions of dollars a year bring useless agents to market to replace drugs going out of their exclussive domain. Merk even had the nerve to fire 3000 workers in response to the Clinton's administrations threat to bring prices under control with regulation in the early 1990's. A week after the announced layoffs, Hilary kept Drug Price controls out of her healthcare bill. The Clinton's heard the threat loud and clear.

    As a result of all this, the manufactures have developed a 2 tier price structure. A drug may cost your local pharmacist 100 dollars for 30 tables. They then make a deal with the insurance company to give them a 30% rebate. But the cash customer pays full price. On top of this, the insurance companies discover the poor pharmacist is completely helpless to effect pricing. So that drug which cost the Pharmacy $100 dead net, he has to sell to HIP for $101.50, and then HIP get's a rebate. Then, the majority of the repeat drug business, like heart and blood pressure medicine, is farmed out to Mail Order prescription services. These huge houses reduce the profession of Pharmacy, which is a Doctoral degree in the US today, to standing at the end of an assembly line checking prefilled prescriptions, 400 or more a day. And yet, drug errors increasingly plague the medical system as everyone is trying to fill as many drug orders as possible in the littlest time possible, mail prescriptions to patients they never see of get to consult with.

    This current system is no better or worse than selling drugs through the Internet. Merk went out and brought the largest mail order prescription house in the US. Companies like Retailed want to prevent small pharmacies from dispensing drugs over the Internet because it's a cheap and effective way for small professionals to get back in the game. And the Feds are looking for a test case to regulate the Internet. Don't be fooled. This is bad news for everyone. Drugs already cost 3 times more in the US than overseas and most countries don't even require a prescription for dispensing. All that medical knowledge by your pharmacist is being wasted and not leveraged for the patients benefit.

  • My girlfriend [thesync.com] and co-founder of The Sync [thesync.com] acquired gastroparesis [endowsec.com] from eating tainted food. She has been unresponsive to all prokinetic medicines available in the US by prescription.

    One medicine which has not been approved by the FDA is Domperidone [theannals.com]. Her gastroenterologist revealed to us recently that despite the drug being available in many countries around the world (Japan, South Africa, UK, etc.) it was not available for prescription in the US. Evdiently the costs of trials to get US FDA approval turned out to be prohibitive.

    Severe gastroparesis is a disease that works havoc on your quality of life, limiting your diet, and often making sleep impossible for days on end.

    Fortunately, she knew a doctor in El Salvador who was willing to ship the drug into the United States. There, all medicines are over-the-counter. Her US gastroenterologist could not even legally contact the drug company to check on side effects, or give her a prescription for needed blood tests to check how the drug was affecting her liver. Thanks, US government!

    I'm certainly a ranting libertarian, but I'm willing to compromise on this issue. Let's say the FDA is an "advisory" body rather than a regulatory body. If you want the FDA "stamp of approval" on your medicine, you run the huge, expensive trials. Perhaps the FDA should also be in charge of purity of ingrediants in medicine. However doctors should be free to prescribe the drugs that people need, regardless of FDA status.

    Given the strong tort system of the United States (w.r.t. breast implants and Phen-Fen, both of which got a bum rap in the courts), and the lucrative field of malpractice suits, the FDA is not needed today as the ultimate regulator of drugs.
  • ...Is because of Viagra. In our un-ending desire for more and better sex, Viagra is turning out to be a major "culprit" in this arena. While listening to the radio this morning, it was noted that recently a man who had a _diagnosed_ heart condition was able to snag some of those blue pills on the 'net and ended up having a massive heart attack and died because of it. Whoops. Hope he died a happy man...
    I can see why we need to regulate this. People will do anything to get a fix - whether it be Viagra or painkillers. Why should it be any different than the CVS store down the street? We're not talking about eToys here.
  • That doesn't mean you should be able to purchase it just because you want it. Your doc can still prescribe it. But you and I both know better that if a drug like Viagra were to be freely available, we'd have millions of guys walking around with hard-ons, seeing blue, and many of them dropping dead because they ignored the warning about side effects.
  • True, they do have that right, but does the government? The obvious answer is yes, if they think there are drugs or other controlled substances. But, how would the government know? Would they search all packages? DHL is not responsible for tracking who is shipping what, they operate under a "common carrier"-esque type law (IANAL). As far as I know, if they know something is illegal, they can and do stop it, but they are not required to try and find out.
  • Without seriously sitting down and thinking about it, I have to say this does not look like a bad thing. Currently similar regulations exist to make sure brick-and-morter drug stores do this, why should online drug stores be any different? I think the perscription system works quite well, or at least is better than the alternatives.

    My question is: what about international drug retailers? What is to prevent a company from setting up shop in Outer Mongolia and sending all sorts of drugs (perhaps even `medicinal' pot) without a perscription? Does this already happen? For example, there are several abortion pills that a legal in places like France, but still illegal here. What is to stop me (or, rather, my girlfriend) from just ordering them from a French online pharmacy?

    The only way I can see the US `solving' this is actually opening packages and doing chemical samples, and thats a pretty scary thought! What if it is sent by a private mail carrier, like DHL? It gets pretty thorny pretty fast!
  • First of all, I don't really see myself buying any kind of drugs on the Internet. BUT, if I did (and I'm sure there are plenty of people out there), I would want the same scrutiny and rules and whatnot applied to online pharmacies (in effect what they are) as is applied to traditional brick-and-mortar pharmacies.

    I can understand the cries of "less government" and the like when it comes to some things, but when it comes to the legitimate protection of citizens, those cries seem nothing more to me than ignorant babble. Come on people, use your heads on this one.
  • I completely agree with this. What we need is control, not regulation. And control means education. Because there will always be "it's just a pill, let's try it" people. If the drugs are legal to use and the educations educates truth (which is by no mean ,,just one time and you're addict'' considering most of the drugs). I just can't agree with government's "war on drugs". It causes just more people, who die by using hard drugs (because of Semmelweis effect). -------------------------------------------------- Greetings to Timothy Leary !
  • Exactly. That's the reason why my country (Slovak Republic) won't take any smart drugs legislation. Because the pressure won't allow us to trade and to become part of international structures (such as EU and NATO). Remember the Wassenaar agreement and the letter of Janet Reno to government of Germany ? I prefer legalisation, but if US government would stand on his old-and-not-working-option on drug war, more people will die (of hard drugs).
  • Remember that if you decide to do something dumb and wreck your car because you worked on it yourself, your insurance company is going to have to pay for your resulting (possibly quite large) medical bills. That results in high insurance costs for me. So when you do that, you don't just affect yourself, you affect everyone else - the 911 response staff who have to come pick you up instead of someone who may be having a heart attack, the doctors in the emergency room, your insurance company, etc. Unless, of course, you want people to pay for their own mistakes which brings up a whole other set of moral/ethical issues that will only result in different regulation.

    Can an auto mechanic make a mistake that ends up with the same result as your mistake? Sure. They are human. But I'd wager that an auto mechanic is going to make a lot fewer mistakes fixing my brakes for me than I would if I did it myself.

    So why do we continue to allow these auto parts pushers to operate, selling parts to unlicenced mechanics? While it's true that very few deaths are attributed to unlicenced auto repair, it's only a matter of time. We need to stop this practice before innocent lives are lost. After all, if you're too stupid to work on your car, isn't your neighbor?

  • The power to license doctors and regulate the distribution of medicines is absolutely the realm of the Federal government.

    Umm, no, it's not. The 10th amendment:

    The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

    The licensing of doctors is a state power - my Dad's license is from the Wisconsin Medical Board. The Federal government does not have the power to step in here, and I'm certain the current Supreme Court would affirm that. It's only when things start to cross State lines (sometimes the Fed's idea of "crossing State lines" is pretty laughable) that the Federal Government steps in.

  • They are only legitimate because they are written in law. But they are not justice. No-one has the right to tell me what I can and can't put in my body. It's *my* fucking body.

    Have you considered that your taking drugs can affect others? A poster on another article suggested that Russia's prisons are currently acting as resistant TB farms. In Australia, there have been quite a few cases of totally-drug-resistant "Golden Staph" after operations in hospitals. Both of these are caused by the uncontrolled use of prescription medicines. I don't really care if *you* want to screw up your health by taking random drugs, but every time you take an antibiotic you potentially contribute to the pool of resistant bacteria. I want you doing so under the advice of a doctor, who is at least qualified to know whether antibiotics are justified and can advise how to take them in a non-resistance-promoting manner.

  • You can go on-line and buy as much pot from Amsterdam as you want, and they will sell you. The snag is that as soon as you and the seller agree to ship the product into the US, you are an internation drug smuggling conspiracy, and that is illegal, at least for you, in the U.S. (I don't know about the other end.)
  • If you can't seem to find a doctor willing to prescribe some medication for you, I think it's a safe bet to say that a) you don't need that medication; or b) it would be dangerous or lethal for you to use it.

    Ha! You are the very embodiment of the problem. Don't you get it? It's not for you to say whether I need medication or not.

    You seem to have this horrible animosity towards doctors

    Only what's justified by experience.

    I promise you doctors are in the business to keep you alive and healthy

    You clearly don't understand; it looks like you need an example. I once strained my wrist badly. The merest deflection of my wrist caused by something touching my forearm or hand, caused paralysing pain even though I'd immobilised it as best I could (I'd rolled up a Computer Weekly around it, secured with a rubber belt).

    I went my doctor to get it seen to because I was pretty much unable to do anything physical at all while it was like that. Apart from the constant pain. He referred me to the hospital, some distance away.

    By the time I was seen at the hospital several hours had elapsed since my arrival at the doctor's surgery. but because there was no visible damage to the bones on the X-ray, they wouldn't treat it. I asked for a plaster cast, which would have helped a lot. They refused. I asked for string pain killers. They refused.

    This is a most prosaic example. I only had to undergo two days of unnecessary pain because of the hospital's rules which are obviously geared towards withholding treatment whenever possible. But the same system causes much more severe consequences when the stakes are higher.

    Doctors are not the last word. They get things wrong, and they have different priorities (profit, budget, triage, bureaucratic rules) than I have with regard to my well-being. I've often been in situations when I know my doctor didn't have a clue, but *I* did, by virtue of this being *my* body, and these being *my* symptoms. No-one but me can be the ultimate authority on that particular subject, no matter what certificates they have hanging on their wall.

    If you disagree with that, that's your problem.

    If medical training and licensing requirements are really so terrible where you live, perhaps you should move.

    The UK isn't generally thought to be a backwater, medically speaking. These problems exist whenever the dispensation of treatment is controlled by a privileged priesthood operating within a "closed shop". So where would I go?

    I'm glad that there are standards vis-a-vis training and licensing; we need to know that when we *do* want a doctor's advice we're not getting a fraudulent quack instead. It would benefit the public if those standards were even higher than they are now. But we should not be forced to depend upon the judgment of someone else in order to get treatment when treatment may be desperately needed and that person's judgement may be wrong.

    Consciousness is not what it thinks it is
    Thought exists only as an abstraction
  • Spot on! That's just what I was going to say. Public health has to be taken into account; you can't be allowed to endanger others. I'd also include some restrictions on narcotics and other addictive drugs for all the usual reasons, it's generally agreed for example that heroin abuse causes social problems.

    If over-use of antibiotics is such a problem, I wonder if doctors are aware of it, or even care. In my experience, an antibiotic is frequently the first thing they try.

    True. Doctors frequently prescribe antibiotics for viral infections like heavy colds, just to relieve trivial symptoms arising from secondary bacterial ENT and bronchial infections. This has become a big enough problem that the UK government this year had to send out an advisory to GPs telling them to stop doing it.


    Consciousness is not what it thinks it is
    Thought exists only as an abstraction
  • by ralphclark ( 11346 ) on Tuesday December 28, 1999 @11:49AM (#1438953) Journal
    This is all sanctimonous, patronizing bullshit.

    With respects to the whole concept of prescribing drugs, the average citizen is an idiot.

    So should I be denied direct access to medication just because my next door neighbours are idiots? I think not.

    This is why we have smart people who are licensed to make certain decisions for us, like doctors.

    What are you talking about? Most doctors are idiots as well. Six years of gruelling study at medical school doesn't prove that you are infallible, smart or even responsible, it just proves that you can withstand six years of gruelling study at medical school. There have been more than enough scandals about incompetence, negligence and sexual assault to make this obvious.

    If you have a medical problem that can be treated with prescription drugs, you have to get a doctor to make that diagnosis and decision.

    For those who have to pay to see a doctor, they are victims of an extortion racket. For those whose treatment is paid for by the state, they get to wait...and wait...and wait, just for an appointment. then they have to go and wait and wait etc. in a waiting room full of sick people who are much more likely to be infecting you with something contagious than would be the case anywhere else.

    The doctor writes out a prescription, so that the pharmacy knows you've gotten a doctor's consent before they go handing out potentially lethal drugs

    You hope. What if the doctor doesn't know what drugs to prescribe? What if he/she prescribes drugs that are dangerous? This happens all the time. If any General Practitioner has to prescribe a medication that they are not familiar with, what do they do? They look it up in a book. In the case of British doctors, the same book I have in my study actually. They often don't even bother to check the appendix listing contra-indications. When confronted with this on more than one occasion I've had to tell the doctor "No, you can't prescribe that, because I'm already taking XYZ".

    Many GPs I've dealt with seem to have rested on their laurels ever since graduation. There is very little pressure on them to keep up by reading medical journals etc. The only ongoing education most of them get is the spiel and the promotional literature from the pharmaceutical sales rep. In what way are they providing an expertise that we can't provide for themselves?

    Would you really rather live in a country where anyone can buy any sort of drug and use it as he desires?

    Yes, within reason.

    What happens when that drug, or perhaps a certain mixture, causes sterility? Heart failure? Death? "Oh shucks, he should have known better."?

    We deal with dangerous things all the time in our normal daily lives. Sharp knives. Power tools. Motor cars. Hang-gliding. SCUBA diving. Football. Large dogs. Fire. Swimming after lunch.

    And *if* you're American, what about the American obsession with guns?

    It has always been like this, it's called *life*. To attempt to protect everybody from hurting themselves is not only impractical, it's undesirable. We have the right to make our own choices and take our own risks. All we need is the ability to stay fully informed about those risks.

    There are perfectly sane, legitimate reasons we license and prescribe drugs in this country.

    They are only legitimate because they are written in law. But they are not justice. No-one has the right to tell me what I can and can't put in my body. It's *my* fucking body.

    Consciousness is not what it thinks it is
    Thought exists only as an abstraction
  • It's a little late to be replying I guess. I agree with you completely that regulatory oversight of medication and its distribution is in general a necessary and even good thing. I only wished to point out that:

    (1) Just because regulation at first glance looks like a good thing doesn't necessarilly mean it is, either in practice or in theory (when looked at more closely).

    (2) Any regulation, no matter how useful or necessary, carries with it a significant price tag which all too often is not even considered, much less taken into account. With respect to regulating medicine (and food quality, for that matter) our society has (IMHO correctly) decided that that price is well worth paying.
  • by FreeUser ( 11483 ) on Tuesday December 28, 1999 @08:33AM (#1438955)
    I vehemently oppose regulation of speech, etc., but I fail to see the terrible harm that would come of safeguarding against bad medicines.

    Consider the folowing scenerio:

    Tribal lore in an undisclosed State, on an undisclosed Indian Reservation, has managed to preserve a remarkably effective treatment for [insert your favorite ailment here] in the face of several hundred years of seige to their culture by European settler's.

    A large pharmaceutical company "discover's" the tribes technique, finds it to be useful, and co-opts the idea. Perhaps they are granted a patent, or perhaps merely FDA approval. Either way, the regulartory apparatus of our government will always work in favor of the drug pusher^H^H^H^H^H^H company and against the folk doctors in question. The result? It will probably be unlawful for the tribe to continue practicing medicine in the way they have for thousands of years, while the drug company will likely get exclusive rights to market their treatment, probably at a much inflated price.

    This is an example where "safeguarding against bad medicines" does indeed do immediate and ongoing harm.

    Real world examples? Synthetic THC vs. Marijuana for glaucoma and nausea treatment, for one. Numerous other examples exist -- check out some of the patents granted to the pharmeceutical industry recently, based on folk-cures from Indonesia to Brazil which have (had?) been in use for thousands of years, and are now the sole intellectual property of various drug companies, who will let you use it, for a monopolistically high price.

    Regulation can be a good thing and is sometimes necessary, but it has a side which grows ever uglier the greater corporate influence comes to dominate the regulating institution, namely our state and federal governments, and (even when justified and necessary) regulation always carries a heavy price.

  • But the internet isn't the only problem with the perscription drug system. Even if all doctors are honest, I can:

    1. Attempt to impersonate a nurse calling in a perscription.

    2. Take a perscription form and write what I want down on it.

    One of my relatives is a pharmacist. She is quite good at detecting bogus prescriptions. The typical case is an individual who walks into the pharmacy, looking like a junky, with a badly forged prescription for a highly abusable drug. They usually disappear as soon as she picks up the telephone. Certain drugs must be prescribed on special, numbered prescription forms. If anything is questionable, the pharmacist calls the doctor to verify the prescription. A more common problem is old doctors who will write prescriptions for a fee. They don't care if they lose their license since they were going to retire anyway.

  • If my auto mechanic screws up, I might get stranded when the car dies. A pain in the neck, but not a major disaster.

    If my aircraft mechanic screws up, there is a good chance that my passengers and I will be killed or seriously injured, not to mention the danger to people on the ground.

    I like having the FAA around to certify aircraft mechanics and to make sure that aircraft replacement parts meet the aircraft manufacturer's specifications. Even with the FAA, there have been problems with counterfeit parts getting into the supply chain.

  • That would certainly be feasible, but it wouldn't be desirable. Whichever states had the weakest regulation would be the states that all the drug sellers would move to, and one thing that certainly needs to be regulated consistently is medicine. I vehemently oppose regulation of speech, etc., but I fail to see the terrible harm that would come of safeguarding against bad medicines.
  • Comment removed based on user account deletion
  • by winterstorm ( 13189 ) on Tuesday December 28, 1999 @08:31AM (#1438962)
    A clear problem with this legislation is that it ignores the possibility that neighborhood pharmacies might use the Internet/WWW to serve their local customers. We often get carried away with the Internet's ability to "globalize" and forget that it is a suitable tool for servering local needs as well.

    A neighborhood pharmacy might, for instance, setup a website so that regular customers can place perscription orders on-line and recieve email notification or instant messages when the perscription is ready to be picked up. They might also make arrangements with the local clinic or doctors.

    This legistation would require website that provide strictly "local" service (local to a single neighborhood) to be federally regulated. This seems to largely tip the scales in favor of large national providers of drugs.

  • My cubicle-mate is on blood pressure medication. He has to take this stuff every day and has been taking it for years. If he can just get it delivered to his house every month a few days before he runs out of medicine, that makes a lot of sense for him, doesn't it?

    Yeah, ok, that makes sense... sure. I never said I didn't agree with people getting meds online. My point is that this legislation merely puts the online med retailers on level ground with all the Eckard's, CVSs, Wal-Mart's, etc. out there. Of course, it is government regulation, so a great many people will fuss about it for that reason alone.

    Eric

  • by EricWright ( 16803 ) on Tuesday December 28, 1999 @08:27AM (#1438969) Journal
    Now, I'm sure all the states'-righters out there will have problems with this, but in my opinion, there is nothing wrong with this legislation. I don't have widespread knowledge of the workings of other states, but here in NC, it is illegal to purchase perscription drugs without a perscription from a licensed medical practitioner (for the most part, read doctor).

    As stated, the purpose of this legislation is to force online medicine retailers to obtain a valid prescription before selling the drug to the customer. This is the way all drug stores (as opposed to e-drug-stores [this e- crap gets ridiculous sometimes:) ]) work. If they violate this practice, and get caught, they are in deep doo.

    In my opinion, this legislation simply requires that online sellers play by the same rules. On the other hand, I'm not sure how they plan to verify a patient's prescription. Do you have to mail them a copy of the paper-prescription? What happens if it is lost in the mail? Do you allow scanned/faxed copies? How do you prevent forgery in those cases?

    Personally, if I get a prescription for medicine, I assume my doctor wants me on it as soon as possible. I'm not going to wait for a prescription to get to the retailer in Outer Mongolia (or wherever ;->), wait for verification (if that indeed is part of the procedure), wait for Bubba to go to the warehouse, search for the medicine (you don't expect them to pay licensed/trained pharmicists do you?) and ship it to you. I'll pay a few extra bucks to get it filled in the store in about 15 minutes.

    In short, I think this is a good idea, but as is the case with all good ideas, it need a good implementation plan for it to be universally accepted.

    Eric
  • It turns out that there is already a business model out there for this. There are many mail-order pharmacies in business which will ship you drugs from out of state. They are quite successful (although limited in number) and offer a modest discount over most hospital or drug store pharmacies. I know about this because when I got my new employee orientation at work they reccommended the use of mail-order pharmacies because it decreases costs both to me and to the insurance company.

    Your point about there being a significant time lag is quite correct - you don't want to do this for your first filling of the prescription. On the other hand, if you're on a long-term medication program it can add up to a big savings. It's also possible to get just enough doses from your local pharmacy to carry you through until your mail-order prescription arrives. I've been assured that the people filling the prescriptions at these mail-order houses really are full-time pharmacists (ie. with degrees in the appropriate field); I tend to accept that pretty easily considering that we're talking about people reccommended by an insurance company.

    The bottom line is that the business model is there. I don't have all of the specific details here in front of me (I'd have to go home for that), but I can post them later if someone's REALLY interested in doing a BBB search on the individual houses. Porting this business model to the web wouldn't take a lot of work, and would potentially speed up the responses time.
  • I can, with my limited knowlege of medicine and prescriptions, intimate from the press announcement *exactly* what harms it addresses. One, bad drugs from disreputable e-commerce firms can kill. Buy a book or toy or computer part from a shady e-commerce firm and the worst you get is ripped off. Buy your high blood pressure medication from a shady firm, and you could die. Big difference.

    Second, I heard all manner of stories about Viagra being sold on the web to people who claimed prescriptions they did not have, or just plain didn't have to provide one at all. Viagra is a medication that has all kinds of warnings about it's use with heart medications and such, and even the megaconglomerate drug stores that are reputable keep a cross-reference of your other scripts to ensure that you don't take two scripts that are contra-indicated.

    Finally, control over the distribution method just like they have in brick-and-mortar operations. Don't kid yourself, the DEA already spends plenty of resources keeping errant doctors and pharmacists in line. I know, my cousin is one of them. While pharmacies may be state regulated, they still need a DEA number to operate and are subject to DEA inspections and investigations. This has always been the case, it's not one of the Fed taking on new ground, just adapting to new technology.

    My liberatarian background tends to shun fed involvement in state matters, but control of deadly substances is not one of them.
  • I think that the target customers for online pharmacies are people with recurring prescriptions - heart or allergy medications, where the patient is on the medication for a long time (preferably permanently) and can predict their usage. So, the need for speed isn't so acute.

    I can't help wondering, though, whether this legislation is a handout to large HMOs, which often operate (or are in partnership with) mail-order prescription networks. These provide a similar service, at a discount compared with just running up to your local pharmacy - but are still quite profitable. The online pharmacies would certainly undercut them if left to their own devices.
  • The issue here is weather or not I have the right to buy and use a drug that has all ready passed those studies without a doctor's permission

    The short answer is NO, because your taking any old drug can in fact affect others in a lot of different ways.

    When the FDA says something ok to market, it means that in some clinical trial it looks like the benefits of the drug outweigh the risks. NOT that it is 'safe'. There is no such thing as a 'safe' drug.

    Right now there is a lot of concern because death rates from prescription drugs are rising rapidly - a lot of new powerful drugs are coming on the market. While these are a great boon, their power also increases the risks.

    Your wise or unwise use of drugs affects no only yourself, but can effect your decendents because of genetic effects when misused. Some drugs are showing effects on third and fourth generations.

    Even simple drugs like alcohol have bad effects on the fetus. Some drugs are such potent teratogens that just traces of the drug in the male sperm are suspected of being able to cause severe birth defects.

    Not only that, but who decides what drugs your children get? We already have too many tragic cases of kids harmed by simple overdoses of liquid Tylenol. I shudder to think what would happen when parents have the ability to buy stronger drugs freely and give them to their children.

    In addition, things like overuse of antibiotics lead to spread of resistant bacteria. Many countries outside the US have VERY severe problems with this becasue they do not regulate the sale of antibiotics.

    IN ADDITION, a lot of people resent the FDA controlling drugs at all. They take off to Mexico or wherever to take whatever some quack can talk them into. The same libertarian philosophy that rejects the concept of prescriptions also rejects the idea that ANY drugs, be it marijuana, heroin, LSD or thalidomide should be controlled.

    I couldn't give a shit if you, as a mature adult go to hell in a handbasket. But you are NOT operating in a vacuum when it comes to drugs.

    I do NOT want to be saddled with the taxes to support a brain damaged kid with flippers where his arms should have been, or having to worry about my kid getting a antibiotic resistant form of TB just because you felt you had an overriding right to take any drug you wanted.

    Removing prescription controls would unleash a night of horrors on our society. To suggest such is the height of irresponsibility.



  • by FascDot Killed My Pr ( 24021 ) on Tuesday December 28, 1999 @08:52AM (#1438985)
    I don't see how my chances of getting the wrong drug are any greater just because some verification is made that I have a prescription.

    Because if you have a prescription presumably a doctor gave it to you. Assumption: A doctor is more likely to know what drug you need (if any) than a randomly selected person.

    The reason this measure is necessary is that there are a lot of idiots out there who want to self-prescribe Prozac or Ridlin or Viagra or something. I think a BETTER measure would be to give the USERS licenses. Here's the kind of scheme I envision:

    Person A is born and has no licenses. At age 8 he is given a test.
    Tester:"Johnny, pour this hot coffee in your lap".
    Johnny: "No."
    Johnny then receives a "Can Eat At McDonald's" license.

    The applicable test in this case would be given around age 12/13:
    Tester: "Janey, take this pill."
    Janey: "What does it do?"
    Tester: "Cures your condition."
    Janey: "What condition? And how?"
    Tester: "Just take the pill."
    Janey: "No."
    Janey now has the "Can Purchase Prescription Drugs Without Body Cavity Search For Perscription" license.

    Other licenses include:
    "Can View Uncensored Internet" (test involves knowing the difference between instructions for making a bomb and a bomb itself)
    "Can Play Violent Videogames" (test involves knowing the difference between fantasy and reality)
    "Can Make Right Turn On Red" (test involves being able to recognize oncoming traffic)
    ---
  • I guarantee that if the average US Citizen was worried about living to see the next day, we wouldn't be having this discussion at all.

    I can't fault you're logic; unfortunately, the average US Citizen can very quickly become addicted to a substance without even knowing it. What happens when some online company convinces people that their herb (actually cocain) is good for what ails them. The first 10 doses are cheap, but then the price skyrockets due to 'supply problems' (you know, snowstorms in Canada and such). The poor schmuck ends up sending his/her rent money to get the miracle drug.

    Who gets hurt? If it were just the schmuck, I'd say "fuck 'em, he/she gets what he/she deserves. Let 'em die and clean out the gene pool." But it isn't just the schmuck. It's his/her children who have their childhood ruined. It's the average taxpayer who must pay for social services to raise the child once the parent is completely incapacitated by the drug. It's the parent who must watch their child shrivel and die under the effects of the poison. It's the schmucks neighbor who must buy a new stereo after it's stolen to buy more drugs. It's not the schmuck we care about, it's the collateral damage they cause once they're hooked.

    The FDA needs to regulate online drug dealers, just like the brick and mortar ones both to protect us from unscrupulous drug dealers and ourselves.
  • by Shotgun ( 30919 ) on Tuesday December 28, 1999 @09:17AM (#1438990)
    I almost hate myself for saying this, but I believe we need to enforce restrictions on controlled substances in this country and around the world (OUCH! That hurt.)

    I was a security guard at Ciba-Geigy, a pharma^H^H^H^H^H^Hdrug company, among other chemicals. The place I worked actually concentrated on dyes. Anyway, we would often get calls at the guard desk from people who needed 'emergency supplies' of one drug or another that had certain 'side-effects'. These callers usually got 'irrate' when we tried to explain that we had no way of helping them (usually by saying that they needed to see their doctor).

    My brother-in-law just spent Christmas Eve driving around town to various crack houses looking for his adolescent neices father. When the dirty bastard showed up, he had spent every penny he had (which was given to him to buy the child a present) on crack. I can't believe this would happen without the addictive nature of the drug. I enjoy a cigar now and again, but I wouldn't trade the Christmas morning look on my boys' face for one. Drugs like crack can't be handle by normal humans and the government has a responsibility to protect.

    I detest government regulation, but in this case I see the collateral damage of a free drug society being worse than federal intrusion. The FDA should have the power to watch over the online drug stores to insure that they don't become online drug pushers.
  • First the usual caveats: I'm not a physician or pharmacist, but I've spent a fair portion of my career as a healthcare IT consultant, so I do know a little about this.

    This is probably both needed and not needed. (Remember, though, that Bill and Hillary have not given up on socializing medicine in the US, and will take any incremental steps they can that will interpose government control between you and any healthcare resource. It should go without saying that such control is a bad thing.)

    Pharmacies and physicians are registered with the FDA today. Every doc (and presumably every pharmacist) has an "FDA number" that they must use to identify themselves with certain classes of prescriptions, particularly narcotics. (In fact, many of the better medical web sites on the web require an FDA number to get at the "good stuff", which is presumably not safe for viewing by the riff-raff (that's us.))

    Based on my consulting experience, it seems that state laws are the primary governing factor in regulating prescriptions, and that the variations from state to state complicate things for providers that operate in more than one state. In particular, only a few states allow electronic prescriptions and/or signatures - most require a written prescription because they are far more traceable, immune to tampering, and tamper evident (very important) than their electronic counterparts.

    I'm talking reality, not theory here - I think electronic prescriptions would be a very bad thing: this industry can barely handle its paper, and pays seriously substandard wages to its professionals from CIOs on down. Their chance of doing this well as an industry is near-nil. Doing this right is not a trivial problem: It involves the best cryptographic systems available and must provide all the usual crypto benefits: privacy, authentication, non-repudiation, and a serious audit trail as well. Pluggable authentication was about to make this happen a few years ago, but now that we can't do that, there will have to be an entire infrastructure built on a single crypto technology which will then leave everything vulnerable and slow to react in the event it's ever cracked. The government is more than part of the problem here, so I find their desire to help kind of ludicrous.

    While it might be nice to streamline the prescription process across states, it's clearly an area where the states have control today (and are granted that control under the tenth amendment.) Still, it wouldn't surprise me to see an FDA number required on all prescriptions in the near future as an attempt to normalize the process across the states. Unfortunately, that will remove the abilty of some states to continue to use their own, more effective regulations.

    Now, whether the FDA should exist at all is an entirely different (and quite valid) discussion topic. (Let's just say the FDA's record is far from sterling, and places it among the very worst Federal violators of the constitution.)
  • You make some valid points, but it's quite unfair to paint pharmacists as just "pill counters".

    Actually, I trust the pharmacists knowledge of drugs, their uses (indications), interactions, and situations to avoid (contraindications) far more than I trust the doctor's knowledge of the same. Although the compounding chemist of the old days is sadly becoming extinct, many of the newer drugs require active and knowledgeable management by the pharmacist.

    This is particularly true with the new classes of drugs called "kinetics", which are custom mixed in response to events in the patient's own body chemistry and require close cooperation between the lab, pharmacist and clinical staff. True, kinetics are mostly used in hospitals, but they are beginning to be used in more outpatient settings, and in any case, pharmacology is one of the most rapidly changing areas of medicine today.

    These folks know a lot, and often know it better than the docs, who have enough trouble just keeping up with new treatments without trying to keep up with all the drug innovations, too.
  • The rapid rise of antibiotic resistant bacteria in the past few years is truly scary. Sure the docs are somewhat to blame for continuing to prescribe antibiotics when the patient appears to have a cold just to "give them the appearance of doing something". (This is probably THE major problem in medicine - the refusal to admit that there's nothing medicine can do about a lot of things.)

    At the same time, they're our first line of defense at containing antibiotic resistance, so controlled access to these drugs is critical.

    Do a web search on VISA and VRSA to get an idea of what's at stake here. (VRSA is Vancomycin Resistant Staphlococcus Aureus, VISA is Immune. Staph Aureus is the most common Staph bacterium, and infests most hospitals. Vancomycin is generally regarded as "the antibiotic of last resort", so VISA is very bad news, indeed.)

    FYI, if you are interested in these things, you can read much of The Lancet online (the British medical journal) with registration at www.thelancet.com. As an interested party with no real medical background, I think this is a great deal - I could never justify subscribing (it's relatively expensive), but this lets me learn a lot about current research and findings without the cost or hassle of visiting a medical library, which I'd never bother to do - it's just not that important. I started out there doing research on prions, which are even scarier than VISA and a very good reason to wonder if you really want to ever go to the dentist again...
  • by AaronW ( 33736 ) on Tuesday December 28, 1999 @08:40AM (#1438995) Homepage
    Various drugs should indeed be restricted to prescriptions. If every time we got a sniffle and grabbed anti-biotics, whether they are needed or not (i.e. a virus) then we just encourage antibiotic-resistent bacteria (which are very nasty, as my sister just had surgery since antibiotics no longer work).

    I'm sorry, but for my own health I don't want my cube neighbor going down to the local pharmacy and buying antibiotics for the flu. There are specified doses of various drugs which vary based on age, weight, and family history. If drugs were unregulated we'd have a nightmare on our hands. There'd be lots of ODs and other problems.

    As for antibiotic resistant bacteria, they are becoming more and more common, especially in countries that overprescribe antibiotics.
  • by poopie ( 35416 ) on Tuesday December 28, 1999 @09:06AM (#1438999) Journal
    There's a fundamental problem here... what about every website that's run OUTSIDE OF THE USA?

    I predict we'll see more and more of this internet regulation as government agencies slowly realize that they are unable to control or collect revenue from online business under the traditional, over-complicated, time-consuming, labor-intesive process.

    How can you impose import restrictions, trade bans, tarrifs, sales tax, etc when you're dealing with encrypted transactions over the internet.

    Most online business today chooses to voluntarily comply with various regulations, like what products ebay chooses to not auction, but if ebay chose to allow others to auction prescription or illegal drugs *and* it were located outside the US, what could be done?

    Governments can make the rules, but can the rules REALLY be inforced? I bet that once governments start trying to enforce these rules, you'll see businesses move to small countries with the most free business environments.

    If your entire business consists of 2 72" racks in a datacenter, and a local sysadmin, it's pretty easy to move your company to any country about as fast as you can propagate a DNS change.

    The cold hard reality is that online businesses can use encryption and change location faster than government can figure out how to deciper what's going on and find a way to collect money or regulate.

    Attempts to tax and regulate the internet will only end up driving out businesses from opressive countries. The interesting thing is that your company HQ can be anywhere, and your employees can be anywhere else.

    Laws and regulations will divide into two types: those that are enforcable in the physical world, and those that are enforcable in the online world.
  • "However what about above-average joe? How about
    someone who has done personal research, read
    reports, etc and decided that a drug is right
    for them? What gives you or anyone else the right
    to tell him that he shouldn't be able to decide
    for himself? Is it not his body?"

    I do agree with you that doctors and pharmicists are not unreproachable holy people. Both make mistakes, sometimes stupid ones. I also think that an individual is capable of doing research and finding appropriate treatments for themselves. For instance, a lot of people use homeopathic or holistic remedies, or so-called "quack" medicine like chiropracty and acupuncture (which yields amazing results for being such "quacks").

    However I think that responsibility should be limited to those who can live up to it. Under your libertarian scheme, could I "prescribe" a few crates of morphine for myself, and then sell it out of the back of my car? The privelage of prescribing drugs is withheld for pharmacists because having gone through pharmacological school they, ostensibly, can live up to a higher responsibility.

    Logically you can say that people should be able to use whatever foods and chemicals (illegal "drugs" included) they want, because it is /their/ body. And when we wake up one day and find everybody is coked/tripped out, insane, poisoned, etc., we can say "oh, well, it was their choice, they're stupid"...but shit - we'll be out one country.

    If you concede that it is part of the government's responsibility to protect its populace (hell, we have a military don't we?), then it is natural this would extend to health care. Whether or not one even concedes that is another issue. I for one wouldn't mind money being shifted from weapons that kill people, to feeding and educating people.

    Jazilla.org - the Java Mozilla [sourceforge.net]
  • If a drug company lies about their products, they are guilty of fraud and will eventually be facing a huge class-action suit.

    Since you believe government should be protecting us from ourselves, shall I assume you support bans on tobacco, alcohol, fried foods, and skiing? How about a government-mandated exercise period of 30 minutes every day?

    If people are incompetent to run their own lives, how can they be competent to elect leaders to run their lives for them?

  • Who said anything about lying? All they have to do is down-play certain side effects, like, say, a 10% incidence of heart failure. You think people always read the fine print? What if there were no requirement for the fine print at all?
    Then you move from fraud to criminal negligence. Not having massive regulatory bodies does not mean that companies can get away with selling dangerous products.
    I think that our current regulations on tobacco and alcohol are sufficient. The places where these regulations are weak can be made up by strong parenting.
    In that case you should also support the immediate decriminalization of marijuana, since every unbiased study shows it to be substantially less harmful then alcohol. (No, I don't use pot. Nor drink.)
    The remainder of your examples are not remotely in the same class and unworthy of a response.
    Really? A huge number of people die of heart disease every year, many of whom probably could have been saved by better diets and/or exercise. My point is that once you start passing "for your own good" laws how do you decide where to stop?
    Continuing with your analogy, though, how many people do you know honestly do any research into the candidates up for office? How many simply vote with the party?
    Exactly my point. Why should I believe that a politician whose only qualification was that he fooled enough people into voting for him can run my life better than I can?
    Do you think they're going to read the warnings on the box of medication? How many of these people are going to die because they didn't know drug X had a strong reaction with drug Y?
    Yes, I do. In fact I think a large majority would continue to get their medications through their doctors. If some idiot is going to randomly combine 17 prescriptions from Bob's House of Amphetamines then we have another candidate for the Darwin Awards. Fools are always going to find ways to injure themsevles; they're clever that way.
    Few people are stupid about all things. Even fewer are smart about all things. Most everyone is smart about certain things, and not-so-smart about everything else. Doctors are smart about the human body and the drugs we put into it, thus it's only logical to trust them with these decisions. We're not talking about wristwatch preferences here. A very trivial mistake with a prescription drug can easily spell death.
    We are not in disagreement here. Taking drugs whose effects you are unaware of without the advice of a doctor is very stupid. But there is a difference between saying "X is stupid" and "anyone who does X should be imprisoned".
    If a drug is classified as a prescription drug, it's been classified that way for a reason. If you think the FDA is full of idiots, perhaps it's time you wrote some letters and got them all fired. I mean it's not like any of them have degrees or doctorates in any of this stuff. Maybe they'll be kind enough to hire you in their place. I'm sure we'll all be better off.
    Good grief, I never remotely implied that the FDA is full of idiots. (Although they're not perfect either; why is medical marijuana illegal despite numerous studies proving its value?) You seem to be operating under the theory that not having medications tightly controlled by the government is equivalent to encouraging everyone to self-medicate at will.
  • by konstant ( 63560 ) on Tuesday December 28, 1999 @08:58AM (#1439017)
    The power to license doctors and regulate the distribution of medicines is absolutely the realm of the Federal government. Moreover, only the Federal government can reglate this area effectively and without bias.

    Let's look at the alternatives:

    THE CONSUMERS: which is to say, the marketing divisions of the drug companies that stand behind these products. Whatever confidence I may have had in the wisdom of the Average Joe, is now lost in the haze of happy-feely "all natural" and "herbal" labels I see on potent chemicals like St John's Wort and various binge pills^H^H^H^H^H^H^Hweight loss supplements. It's clear that the noble consumer can be won over by smooth talk and obfuscation, all of which is fostered by large corporations that consider 10 or 20 deaths acceptable in the name of profits. "After all, nearly 90% of EZ-Thin Herbal All-Natual Weight Loss Dietary SupplementTM live for five years or more after taking our pill with only minor complications!!!! Proven at the University of Nairobi to make you smarter and more attractive!!!!!! All Natural!!!*"

    *(some test subjects experienced heart failure and testicular shrinkage)

    THE PHARMACEUTICALS: Don't make me laugh. History is replete with examples of powerful companies that will ignore or downplay the lethal or detrimental effects of their products in the quest for that extra $1M.

    THE STATES: Essentially this is the pharmaceuticals all over again. Congressional representatives are effectively owned by Big Money, and there are few institutions with more of that than the pharmaceuticals. Why would a representative prevent a drug manufacturer, that brings perhaps hundreds of jobs to the state, from producing a dangerous drug that might not even have a very large market in the host state? The wonderful thing about the internet is that you can base your operations in Kansas and sell primarily to people in Idaho, or Washington, or vice versa.

    With regards to the contention that will undoubtedly be made by some righteous libertarian or other, the Federal government enjoys this power because it is a matter of interstate commerce. Offering products for sale on the internet constitutes a nation-wide purchasing opportunity, unless the host company is unwilling to ship out of state. But in the case of prescription drugs, which carry a high profit margin, I don't think that will be the case.

    Now, I do lament the loss of personal discretion that comes with the Feds assuming power in this matter. Informed individuals should have the right to choose. The trouble is that many people believe they are informed when in reality they are sadly, or even dangerously misinformed. That kills people. And it's why we have an FDA to begin with.


    -konstant
    Yes! We are all individuals! I'm not!
  • My grandmother came to this country from a country where drugs were not regulated (at the time). One of the consequences of that is that she had to be more informed about what drugs she was prescribed or prescribed for herself.

    Since she's been in the U.S. of A., this knowledge has saved her life no less than 20 times in the last ca.25 years. How? Because while spending time in hospitals (she's old) she has been brought drugs that would have killed her. She is still alive today.

    Another consequence is that this knowledge or an interest in it tends to be passed down through generations (like cooking recipes). Never in my household are any drugs taken without consulting a PDR (Physicians Desk Reference) and usually a few other sources. A similar culture can be seen by contrasting cultures that consume alcohol responsibly from an early age and most U.S. cultures, where we are restricted by law from consuming alcoholic beverages before the age of 21yrs.

    Incidently, the rabid regulation of drugs in the U.S. prevents the use of less expensive and more effective drugs. Cocaine and paregoric are just two that come to mind. (Check WordNet, btw).
  • My brother-in-law just spent Christmas Eve driving around town to various crack houses looking for his adolescent neices father. When the dirty bastard showed up, he had spent every penny he had (which was given to him to buy the child a present) on crack. I can't believe this would happen without the addictive nature of the drug. I enjoy a cigar now and again, but I wouldn't trade the Christmas morning look on my boys' face for one. Drugs like crack can't be handle by normal humans and the government has a responsibility to protect.

    I promised myself I wouldn't get on a rant. Let's see if I can manage to avoid that. The government is more concerned about protecting the pharmaceutical companies, breweries, distilleries, tabacco companies, and anyone else that contributes tons of money to the war on drugs.

    They did not "protect" your brother-in-law(-in-law) from crack. The crack houses are still there, here, and everywhere. Drugs are everywhere, and if you fit the right demographic they'll come to you without any effort. I really feel the overall effect of the drug war is that illicit drugs are more dangerous (in every way), more interesting (to some), and more profitable (for criminals and lawyers.)

    I hurt everytime I talk to someone that I know is good at heart, has potential, and is throwing it all away on drugs. Hearing politicians talk about protecting us from drugs does nothing to ease that pain. In fact it infuriates me.

    The government doesn't/can't/will never protect any of us from drug abuse and it's side effects. I know a lot of people here understand because they've seen first-hand what I am talking about...the underground drug network is as uncontrollable as the Internet.

    I'd make crack unavailable if I could. But it's just not going to happen. If the government wants to help they can sponsor scientific research on drugs that are illegal and provide us with a clear picture of their effects instead of FUD. Efforts that could be made to lessen the problem are turned into efforts designed to protect and maximize the profit of those that contribute to the war on drugs. It's hard enough as it is making the right choices while growing up--it only makes it harder when the truth is being clouded intentionally.

    A little closer to the original topic: Anything that stands in the way of people getting drugs that they need is a problem as far as I'm concerned. Anything that stands in the way of big business collecting money in the process will be a problem as far as they're concerned. The government will step in to resolve this conflict of interests. They will not be impartial.

    numb
  • I'm really shocked to see the crack at Libertarians in the story. Especially when it doesn't have anything to do with the issue at hand.

    I don't think any of the online pharmacies have been accused of messing up orders. (Though it wouldn't surprise me - real pharmacies do it all the time, and sometimes it kills people). The issue is that they're selling people prescription drugs when they don't really have a prescription. This perpetuates the dangerous idea that the people have any right to determine what they put into their own bodies, so of course the government must put a stop to it. I suppose also at issue is fewer people being forced to go to a doctor just to get a cursory examination, the prescription they knew they needed, and a $75 bill for the office visit.

    I don't see how my chances of getting the wrong drug are any greater just because some verification is made that I have a prescription.
  • What about drug interactions, both with other drugs and any physical conditions/ailments you may have? What about overdoses?

    Drug interactions and dosages are information that is readily available to anyone, whether or not they are a doctor. An individual doing research for themself can do a much more thorough job than a doctor, who is probably not going to take the time to do any research at all. A doctor could easily forget something, or not be aware of new information.

    For that matter, is the average person going to understand the gobbligook that is written about a medical trial and treatment?

    I can understand it, and I have no medical training or education. I have to look up new words frequently, but I'm able to tell that I havn't seen that word before and I need to look it up. It's not like I'm not understanding it and not realizing. If someone knows they're not able to read medical literature, then they can consult a doctor. I don't think anyone is arguing against seeing doctors. Just that people who don't want to should have that right.

  • Since mention was made of what hte libertarians would say about this, I thought I'd give what libertarians would generally agree on in this area. Licensing serves two purposes main purposes -- to provide information to the consumer about whether they can rely on someone, which libertarians would support (but see below), and to prevent consumers from doing business with people the government doesn't approve of.

    If I were ordering drugs online, I would like to see that the pharmacy is licensed by someone who I believe is qualified to evaluate a pharmacy, like a state board. I don't particularly care whether it is california's (where i live) board of health that has licensed them. I just want to know that they aren't selling rat poison as aspirin. I don't need a federal law requiring licensing for drug sales over the internet, I just need a federal law that makes fraud a crime, so that no one can say they are licensed by whoever unless they are really licensed by them. You don't need to force people to go for this kind of licensing. People won't buy anything from people who aren't licensed. A better term would be "certified". It's like being UL Listed. In this scenario, my chances of getting a bad prescription are very low.

    The other purpose of licensing is similar to the charters governments used to grant. It isn't to protect the consumer, it's to make sure that some industry is in fact controlled by the government. The government wants to keep an eye on drug companies and licensing is the easiest way to do it (why track them down when you can just require them to register). This doesn't have a damn thing to do with my getting a bad prescription, but it does mean that I can't get a bottle of decent painkillers to carry for emergencies when going on off road motorcycle trips without having to worry about whether the federal government approves of what I'm doing.

    This is the argument libertarians would give about why this licensing is a bad idea. In fact, we really want to avoid the licensing because we want people to be able to buy their heroin online cheaply so that they don't have to rob us for drug money, or lurk in alleyways and bring down property values.

    --Kevin
  • If you want to know what the Commerce Clause means, it might be wise to consider what the man who was the principal author of the Constitution had to say on the subject. He discussed the matter with great clarity in a letter to Congress, in which letter he explained why he was vetoing a bill (he was President at the time) in spite of the fact that a) he agreed that the project funded by the bill was a worthy cause, and b) it had been argued that the Commerce Clause gave Congress the power to spend the money as the bill proposed to do:

    Veto of federal public works bill

    March 3, 1817

    To the House of Representatives of the United States:

    Having considered the bill this day presented to me entitled "An act to set apart and pledge certain funds for internal improvements," and which sets apart and pledges funds "for constructing roads and canals, and improving the navigation of water courses, in order to facilitate, promote, and give security to internal commerce among the several States, and to render more easy and less expensive the means and provisions for the common defense," I am constrained by the insuperable difficulty I feel in reconciling the bill with the Constitution of the United States to return it with that objection to the House of Representatives, in which it originated.

    The legislative powers vested in Congress are specified and enumerated in the eighth section of the first article of the Constitution, and it does not appear that the power proposed to be exercised by the bill is among the enumerated powers, or that it falls by any just interpretation with the power to make laws necessary and proper for carrying into execution those or other powers vested by the Constitution in the Government of the United States.

    "The power to regulate commerce among the several States" can not include a power to construct roads and canals, and to improve the navigation of water courses in order to facilitate, promote, and secure such commerce with a latitude of construction departing from the ordinary import of the terms strengthened by the known inconveniences which doubtless led to the grant of this remedial power to Congress.

    To refer the power in question to the clause "to provide for common defense and general welfare" would be contrary to the established and consistent rules of interpretation, as rendering the special and careful enumeration of powers which follow the clause nugatory and improper. Such a view of the Constitution would have the effect of giving to Congress a general power of legislation instead of the defined and limited one hitherto understood to belong to them, the terms "common defense and general welfare" embracing every object and act within the purview of a legislative trust. It would have the effect of subjecting both the Constitution and laws of the several States in all cases not specifically exempted to be superseded by laws of Congress, it being expressly declared "that the Constitution of the United States and laws made in pursuance thereof shall be the supreme law of the land, and the judges of every state shall be bound thereby, anything in the constitution or laws of any State to the contrary notwithstanding." Such a view of the Constitution, finally, would have the effect of excluding the judicial authority of the United States from its participation in guarding the boundary between the legislative powers of the General and the State Governments, inasmuch as questions relating to the general welfare, being questions of policy and expediency, are unsusceptible of judicial cognizance and decision.

    A restriction of the power "to provide for the common defense and general welfare" to cases which are to be provided for by the expenditure of money would still leave within the legislative power of Congress all the great and most important measures of Government, money being the ordinary and necessary means of carrying them into execution.

    If a general power to construct roads and canals, and to improve the navigation of water courses, with the train of powers incident thereto, be not possessed by Congress, the assent of the States in the mode provided in the bill can not confer the power. The only cases in which the consent and cession of particular States can extend the power of Congress are those specified and provided for in the Constitution.

    I am not unaware of the great importance of roads and canals and the improved navigation of water courses, and that a power in the National Legislature to provide for them might be exercised with signal advantage to the general prosperity. But seeing that such a power is not expressly given by the Constitution, and believing that it can not be deduced from any part of it without an inadmissible latitude of construction and reliance on insufficient precedents; believing also that the permanent success of the Constitution depends on a definite partition of powers between the General and the State Governments, and that no adequate landmarks would be left by the constructive extension of the powers of Congress as proposed in the bill, I have no option but to withhold my signature from it, and to cherishing the hope that its beneficial objects may be attained by a resort for the necessary powers to the same wisdom and virtue in the nation which established the Constitution in its actual form and providently marked out in the instrument itself a safe and practicable mode of improving it as experience might suggest.

    James Madison,

    President of the United States

    There is no greater authority on the meaning of the Constitution than James Madison.

  • While the Federal government may have justification to move into the area of prescriptions now that segments of the industry are involved in inter-state comerce, I think the real question is should me have a system of Prescription Drugs at all. Are we all truely better off because we have to go to a doctor in order to recieve a drug to treat an ailment. In this age of information where I can research my symptoms through medical web sites and books why can I not also choose to treat myself with the medication I require. Prescriptions are simply a way to force more people to contribute money to the medical establishment. Sure going to a doctor is normally a good thing to require, but I don't feel the state should be in the postion of a nanny. Medical Care should be a option, yes you can, and often should go get the advise of a Doctor before taking a drug, but requiring such a thing resticts my right to choose how exactly I wish to treat my own body.
  • To answer your questions:

    > Should I be allowed to fire my gun in the air
    > randomly?

    Sure...if noone is anywhere nearby that could
    possibly be hit. Otherwise you are endangering
    others.

    > should your neighber be allowed to run a brothel
    > in his house?

    Why is it any of your buisness if they run a
    brothel? Oh god no...someone might get paid money
    for Sex! Shit! that would just be wrong.

    > or a drug lab?

    Why not? Why is it you are so interested in what
    your neibor does in the privacy of his own home?
    Do you keep track of what he does...make sure he
    isn't having sex outside of marriage too?

    > I've seen anarchy in action, it aint pretty.

    No you have seen chaos...anarchy is not chaos.
    Anarchy involves mutual voluntary cooperation
    not chaos and destruction.

  • > I think there are two kinds of free-market
    > worshippers.

    Just to clarify...I am not a free market
    worshiper (anymore). I believe in freedom
    definitly...but not capitalism. I think
    Capitalism breeds inequality of opertunity, and
    makes for a system where the rich live lives
    of privilidge off the backs of the workers.
    (not to mention that it rewards the dishonest...
    it doesn't matter how bad it is or how poorly
    its made...if you can market it well you get
    rewarded with profit...doesn't exactly encourage
    moral action)

    Anyway...back to the topic....

    Yes it is infeasable to just educate everyone.
    What I advocate is make the information available.
    Make sure everyone who wants it can get it.

    Then let it loose. People will not listen. They
    may die. However, their deaths will educate others
    to the dangers of not doing research. In the end
    people will be more educated.

    MOST people will still goto Doctors and get
    advice that way. I think that in absence of
    prescription REQUIREMENTS, the vast majority will
    still goto a doctor first.

    The best solution, in my opionion, is to not
    use an economic system that favors people who
    cheat and lie. However, thats not happening very
    quickly....and is another topic completely.
  • > Seriously, why the fsck can't someone be opposed
    > to government cartel protection and still
    > recongnize that experts are still required.

    Its good to hear the voice of reason.

    I would like to state for the record...I do know
    a good deal more about drugs than "Average Joe
    Citizen", I have some access (due to previous
    employment and friends related to medical
    institutions) to informtation not everyone has
    at their fingertips.

    I am against prescriptions (as I previously said).
    When I get sick...I go see my fsck'n doctor
    if my treatment doesn't clear it up or at least
    show major improvement in 3 days. (or if the
    symptoms are inconsistant with things I am
    fammilair with)

    I have no problem with getting expert advice. I
    love the idea that its there. However...even
    then...
    Doctor gives me a script? I check it out no matter
    what it is. I look up the contraindications and
    side effects myself before I start taking it.

    > If I lie and say that I don't have a heart
    > problem because I want Viagra, it's my own damn
    > fault when I die.

    Exactly. Just as it would be the pharmacies fault
    if they lied about what the drug was. Look at it
    this way...pharmacies WANT buisness. If they
    tell you that a drug is dangerous for you...they
    could save your life. They LIKE that.

    Think about it...if you die...your not going to be
    a repeat customer. However if they warn you that
    it could be deadly because of your condition...
    well...you may just be greatful enough that next
    time you need medication, you go to them.

    I think that if you lie...or refuse to heed the
    warnings, then you deserve what you get.
  • > So by this I assume that you do not support
    > statutes for things like "disturbing the peace"?

    Well...ok disturbing the peace. I was kind of
    thinking off alone in the middle of a feild
    where noone is around.

    > One could argue that allowing a pharmacy to
    > operate negligently or illegally is, in fact,
    > "endangering others."

    Yes one could argue that. Howevr that same
    argument could be applied to sales of tobbacco
    or even alcohol. Should we require prescriptions
    for those too? perhaps ban the sale of them?

    >>Why is it any of your buisness if they run a
    >>brothel?
    > So I guess then that you are also opposed to
    > anti-prostitution legislation, and various
    > zoning laws

    Yes I am. Granted I agree that they should not be
    able to build a coal processing plant next door
    to a residental area, I see nothing wrong with
    a brothel. As long as they keep quiet, why not?
    Its been shown that crime and other problems
    associated with prostitution are more a product
    of the fact it is illegal and not a legitimate
    buisness than anything else.

    > I can't really tell if you're trying to have a
    > legitimate argument here or if you're just
    > trying to be annoying.

    A little of both. I am firmly against the idea
    that the government should have any say in what
    people can or can not do in the privacy of
    their own home, or with other consenting
    adults (ie using drugs, paying for sex).

    > If you really have such a beef about these laws,
    > perhaps you should try writing to your local
    > legislature. I sincerely doubt these things will
    > ever be legalized,

    I have written them. Also...why not have them
    legalized? They have not been illegal very long.
    The "War on Drugs" has been killing this country
    for years.

    When alcohol was made illegal, men like Al Capone
    ruled. They made their money off alcohol and branched into illegal gambling and other things.
    Now that other drugs are illegal...almost all
    of the same things happend. Drug lords got
    rich, ganges like the bloods formed. Murder rate
    skyrocketed.

    Prohibition decreases supply. Demand stays the
    same. Prices skyrocket. Thus profit for selling
    goes up. In this way prohibition FUELS the
    black market.

    In the end all you have is that people who want
    to peacefully use drugs in the privacy of their
    own homes need to spend alot more money to do it,
    and risk being arrested. All for a peacefull
    consensual act.

    Land of the Free indeed.
  • > My brother-in-law just spent Christmas Eve
    > driving around town to various crack houses
    > looking for his adolescent neices father.

    My deepest condolences. that is a horrible
    way to spend the holidays but...

    have you ever thought that prohibition might just
    be part of the problem?

    Studies have been done (not in the US, it would
    NEVER be allowed) where drug addicts were given
    a safe and REASONABLY PRICED supply of drugs.

    What happend?

    They started living and functioning as ordinary
    human beings. They still were addicts. They still
    used their drugs. However, they started to live
    normal lives.

    Thats not to say there is no problem. Hell
    Alcohol is legal and I know people who do the
    SAME thing as your relative do, but with bottles
    of booze. However, can you imagine what the
    life of an alcoholic would be if the cheapest
    bottle of booze was $150? or it was $15/shot?

    Prohibition drives up prices. Not only that but
    with hugely inflated profits, and users having
    no real recource for redress og grievences,
    most drugs sold are adulturated with other
    chemicals (cocaine users are regularly exposed
    to levels of benzene...mostly thanks to US
    efforts to limit export of the proper solvents
    that should be used to countries like columbia)

    Prohibition also brings in the criminal element.
    Drugs don't "breed crime". Look at alcohol. As
    soon as it was made illegal in the early part of
    this century, many of the problems we see today
    with drug prohibition arose.

    You can't get drugs without being in contact with
    some criminal element, just like in the 20s.
    It is how men like Al Capone got rich. The murder
    rate in 1930 was so large...that after prohibition
    ended...it wasn't till the height of drug
    prohibition in the 1980s that it peaked that
    high again.

    food for thought.
  • > It's easy to generalize a story, thus making
    > pretty much any topic that fits in that
    > generalization "on-topic."

    Very true...and topics tend to wander in
    these types of discussion.

    However.,..as was stated...its the same system.
    I am against this move by the FDA not because
    it is the internet but simply because the
    "Controlled Substances Act" (which is what all
    prescriptions are based on) is horribly
    flawed IMO and that it needs to be gotten rid
    of completely not extended.
  • > It's true that people should take responsibility
    > for their actions. However, there's a limit
    > to how much self-education you can expect
    > someone to do.

    Perhaps you don't understand our argument?

    Noone has argued that doctors and pharmacists
    are not needed. The argument is that we, as human
    beings, should be allowed to legally obtain and
    consume any chemical we wish to consume.

    This is not to say that EVERY person SHOULD do so.
    It is simply to say that those who wish to do so
    should be allowed to do so.

    Even if the prescription system were gone, most
    people would still go to doctors, they will still
    get some recomendation for a certain drug.

    The only change we are asking for, is that those
    who believe they are qualified to not go that
    route, be allowed to not go that route.

    > The FDA, IIRC, is made up of appointed
    > officials, not elected ones, making it
    > a bit harder to corrupt with money.

    Not true. How does being apointed make a person
    less greedy? Its true it makes them possibly
    more suited to the job (having been selected
    not by popularity contest but by selection based
    on qualifications) but...once there... them
    dead green presidents look mighty sweet no
    matter how you got your job.
  • >> No, North Korea is what happens to communism
    >> over time

    > Er, no. Communist countries start out this way.
    > Russia post-1917 was a very ugly place.


    Well there are lots of differnt types of
    communism and socialism. I have yet to see
    a large scale "Communist" country that actually
    espouses communist ideals in any way shape or
    form (beyond paying lip service to them)

    In truth...Lennin and Stalin were much more close
    to fascists than Communists. They just called
    themselves communist because it was popular at
    the time (and perhaps at one point they even
    believed it)

    As a socialist, and possibly a communist (I am
    not that far philosophically developed to
    call myself a communist...I am certainly an
    anarcho-socialist) I am apaulled at the
    misconceptions about socialism and communism
    that I see going around. Much of it is the
    fault of people like Stalin who were major
    world leaders and called themselves communist...
    but were not.

    Communism calls for an end to separation of
    classes (actually socialism in general tends to)
    however Lennin and Stalin, and all communist
    leaders that I have seen follow them, have
    created even worst class division than before.
    They created a working class that was basically
    everyone...then a small elite "ruling class"
    that sat above everyone.

    Hardly communist if you ask me.
  • >> The scenereo was specifically of a drug that
    >> was fraudulently marketed.

    > ..as are crack, cocaine, and other narcotics.

    Well its a nitpick but cocaine (which is what
    crack actually is) is NOT a narcotic. Neither
    is marijuana, or methamphetamine. The only street
    drug that fits the label of narcotic is heroin.
    Basically opiates are the major class of narcotic.
    Cocaine is more of a stimulent.

    > There'll always be people out to make a quick
    > buck by not disclosing all of the truth, or
    > outright lying. I was pointing out that, despite
    > laws forbidding this, drug dealers are still
    > out on the streets selling drugs to people that
    > may or may not know the risks. Should we be
    > placing the blame on the users, the dealers, the
    > manufacturers? A combination of both? Or is
    > there no blame at all?

    Well yes. People will "lie to make a buck". Its
    nothing new. If anything I would blame the
    capitalist system which ENCOURAGES dishonesty.

    However, have you thought even once that if these
    drugs were legal, perhaps things might be
    differnt?

    Think simple economics. There IS a demand for
    these drugs in the country. Since they exist, that
    means there is a market. Prohibition makes
    production illegal, and thus more dangerous.
    Supply goes down. What happens next?
    Yes. Price goes up. Since cost of manafacture is
    the same, that also means profit goes up with
    price.

    Prohibition FUELS the black market. Now who runs
    the black market? Organized crime of one sort or
    another. Remember Al Capone? He never would have
    been more than a two bit thug if it wasn't for
    prohibition.

    Now if its legal...you can require quality
    manafacturing. Illegal labs can't compete
    with Proctor and Gamble. Then the legal "dealers"
    are subject to fraud regulations. They can be
    required to disclose the truth. Black Markets are
    truely free markets, capitalism at its worst.

    Now what I really mean to ask. You favor this
    FDA regulating prescriptions and all. I have
    said I am dead set against it, because I am
    against the Controlled Substances Act alltogether
    and want to see the whole system done away with.
    (so obviously I am against extending it at the
    federal level)

    Do you think, that if a person takes a drug that
    a doctor has not said is ok, that men with guns
    should forcibly enter his home and drag him away?

    That is the necissary part of control. Do you
    believe that when I go home and load up my pipe
    and take a few hits of sweet mary jane, that
    police should break my door down and drag me
    away to jail? (which would prevent me from going
    to work and cause me to lose my job etc)
    How about when I eat a sugar cube or two (ie use
    LSD for the drug naive)? Perhaps when I crack open
    my bottle of GHB when I have a bout of insomnia?

    DO I deserve to have my door broken down and to be
    dragged away and jailed for these horrible crimes?
    GHB is not only illegal in this state, but I am
    self-medicating without talking to a doctor (of
    course I am open with my docotor about all of
    these things, however he doesn't recomend them...
    course he has never expressed disaproval either)

    The system that you are arguing in favor of, even
    in favor of extending the power of, says that
    I DO deserve to be dragged away and put in jail.
    Never mind that I am a programmer. Never mind that
    I am an otherwise normal, productive member of
    society. According to the system that you espouse,
    I deserve to be locked away as a dangerous
    criminal.

    Now to be reasonable. I am all in favor of the
    prescription system, as long as it leaves people
    like myself a way to go around it. As long as
    capitalism is in place, I realise that we can't
    trust coompanies to act responsibly in the
    marketing of drugs. I am all for regulation.
    However, internet sales?

    Internet sales are much harder than walking to
    the drug store. It takes days for them to arrive.
    That knocks most idiots right out of the picture.
    Hell I would even go further. Don't allow pill
    sales, but allow anything to be bought by a
    chemical supplier USP grade powder. I am competent
    in meauring my own dose with a scale.

    You can stop idiots without restricting those who
    are determined and know what they are doing. Its
    a much better solution if you ask me.

    Of course, all these regulations can be done away
    with once you institute a socialist system that
    doesn't reward lieing.
  • by TheCarp ( 96830 ) <sjc@NospAM.carpanet.net> on Tuesday December 28, 1999 @08:49AM (#1439068) Homepage
    hmmm so people lik myself want no regulation
    until we get a bad prescription ourselves? Hmmm
    how does regulation prevent bad prescriptions?

    Even without Licenceing etc all the drugs they
    sell still need to be made in a manner that they
    are safe to consume...if not then they are selling
    dangerous product. In fact...most of the time the
    drugs are made by the same manafacturer as the
    normal pharmacies buy from.

    Pharmacies are basically glorified pill counters
    these days. Licencing doesn't prevent them from
    fucking up and counting wrong. It doesn't
    prevent them from picking up the wrong bottle
    and giving you the wrong pills.

    An online pharmacy that sold anything except what
    they are advertising is still in trouble for
    breaking existing laws...like say fraud.

    In truth this regulation is all about control. It
    is about the belief of people in the federal
    government that they have the right to control
    every aspect of our lives. The entire concept of
    prescription drugs is founded on the idea that
    citizens do not own their own bodies and do not
    have the right to self medicate beyond what
    Big Brother has Aproved.

    Its funny how anti-drug propagandists always talk
    about the "Message it sends". I don't know
    about you...but I don't like the message that
    these control measures send.
  • > Pharmacists know a hell of alot more than the
    > average joe about what you should and should not
    > take.

    Yes they do...which is why the "Average Joe"
    should consult his doctor and pharmasist before
    he even considers using any drug.

    However what about above-average joe? How about
    someone who has done personal research, read
    reports, etc and decided that a drug is right
    for them? What gives you or anyone else the right
    to tell him that he shouldn't be able to decide
    for himself? Is it not his body?

    > Tell your evangelization shit to the family of
    > the man who died because he bought viagra over
    > the internet

    How about people who took tylanol and died? Lots
    of them every year. How about someone who took
    a bit more nyquil then they should have and found
    out the hard way that they are one of the 1%-3%
    of caucasions who are missing the enzyme that
    metabolizes Dextromethorphan.

    The simple fact is that if you don't consult a
    doctor, then its "Buyer Beware". Buying a drug
    on your own means that YOU take responsibility
    for making sure its not contraindicated.

    Noone is to blame for the fuckup but the man
    himself. He could have easily done a little
    research and found out that information.

    > Sure, it's his responsibility to know that, but
    > not everybody is as smart as you say you are

    Glad you realize that. Its why we have Darwin
    Awards. If a person dies because of their own
    irresponsibility, I have little pity (perhaps
    for the fammily but not for him).

    If you want to help out, forget regulation. Go
    for Education. People SHOULD know more than they
    do. Over the counter drugs account for many deaths
    every year.

    Believe it or not, regulation ENCOURAGES
    irresponsibility. It breeds the attitude that
    "Well other drugs are controlled by doctors and
    pharmacists, so these must be safe if I can buy
    them" so people buy them and start popping away.

  • Since the U.S. Government (what? We're not the entire world?) is only dealing with Internet sales, I don't see the state governments getting in an uproar. Your local supplier won't change.

    On the other hand, this simply gives the FDA [fda.gov] some new powers. Since traditionally, the FDA doesn't do a lot, it really doesn't change much. For example, anything your local GNC probably sells, the FDA can't and won't investigate. (It's not a medicine or a food.) For example, here's their stance on homeopathic medicines: "FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength. Homeopathic drugs in solid oral dosage form must have an imprint that identifies the manufacturer and indicates that the drug is homeopathic. The imprint on conventional products, unless specifically exempt, must identify the active ingredient and dosage strength as well as the manufacturer."

    In short, they don't care unless it's a food, cosmetic, or medicine.
    Now personally, when I order a few grams of coke, I want coke, not baking soda. At least now I have the FDA to complain to!

    (Think about it. If they sent you Premarin [premarin.com] instead of antibiotics you'd want someone to complain to.)

  • I think this law may be either a good or bad...Like many things, it depends on the implementation.

    I am currently working for one of the major online pharmacies, and I think there are some misconceptions out there:

    All *legitimate* e-pharmacies currently require a verfified prescription in order to ship any type of controlled medication.

    This verification can take several forms - an original prescription mailed in (not advisable if you are currently suffering some sort of acute condition), having your doctor call it it, or electronic transmission from your doctor's office.

    This law will probably not affect the major players - CVS.COM, PlanetRX, etc., because they already comply with these types of regulation.

    It may add another layer of bureaucracy, it's hard to say just yet.

"No matter where you go, there you are..." -- Buckaroo Banzai

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