Stella Daily ([info]stellavision) wrote,
@ 2005-10-04 09:23:00
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Current mood: aggravated
Current music:Toto - Love Has the Power

Sometimes I hate being a girl
Maybe I should go on Depo. Enough said.

I am going to go ahead and rant about birth control as an example of why the government shouldn't be in the business of healthcare regulation, though. See, the researchers who invented the Pill realized that women didn't NEED to have a monthly period. They simply designed the Pill that way because they figured women would feel more "normal" on this new medicine if they still had a period every month as usual.

Birth control pills have been around for, what, thirty years now? More? Which makes it totally infuriating that it was only LAST year that a pill designed for a woman to have periods every three months, instead of every month, came onto the market. Actually, such a pill was ALWAYS available -- it's just a matter of skipping the placebos in a normal pack of pills, and going straight to the next pack, taking placebos only one week out of every 13. (It's even possible to skip your period altogether by getting rid of the placebos; Wyeth is currently working on getting approval for theirs.) But the FDA wouldn't approve that use of the pill without additional clinical studies of thousands of women. Imagine the better uses the money used to fund those studies could have gone to! Maybe it could have developed a diabetes drug, or gone toward cancer research, or any number of other healthcare problems that HAVEN'T been solved as elegantly (or as redundantly; besides the Pill, women can use the patch, the Depo shot, Norplant, or quite a few other methods) as the problem of unwanted pregnancy has.

Not to mention, the supposedly "new" pill, the once-every-three-months pill, is being marketed as though it has no competitors. Because, as far as the FDA -- and thus, many third-party insurance payers -- are concerned, it doesn't. Never mind that a pack of Seasonale is no different from four packs of a generic brand of everyday Pills with the exception of its containing fewer placebos. When I go to the pharmacy and ask for the generic pills more often than once every 28 days, I get a hard time from the clerk and my insurance makes me pay full price for the "extra" pack of pills in that three-month period that I am "not supposed to be taking" according to the FDA. This means that it is actually less expensive for me to buy Seasonale (which has a co-pay of $60 per three-month pack -- $20 for each month of a formulary non-generic drug) than it is to buy a generic brand ($10 copay for each of three packs, plus about $35 for the "extra" pack), even though Seasonale is undoubtedly costing my insurer more money. And all because of silly FDA approvals.

Ah, yes, and let's talk about the prescription drug system. I think that should be abolished too. What business does the government have regulating what people put into their OWN bodies? Obviously robberies or other crimes performed in order to get a supply of drugs must be punished as the crimes they are, but as long as a person's drug use harms nobody but himself, the government has absolutely no place in forbidding it -- and even if it does harm others, the criminal acts are what should be punished, not the underlying drug use. If I want to go to the store and buy a chemotherapy drug (and can find someone willing to sell it to me) and swallow it, it's MY funeral. It's not the government's job to protect me from my own stupidity, or anyone else from theirs. If we didn't have a prescription requirement for any drug, I bet I could walk into the store and just buy a BOTTLE of birth control pills, not the carefully bubbled little packs with their printed schedules, and just take one every day in the hope of never menstruating again until such time as I am ready to have children. (I can hear the archconservatives screaming.) Damn, that would be nice.

Totally unrelated note: in typical Stella style, I am planning ahead. Next week is Objectivist karaoke night, so I've been going to the karaoke bar's web site to decide what I'm going to sing. (I'm annoyed that they don't have Chicago's "Will You Still Love Me For the Rest of My Life?" so I guess I'll have to settle for "Saturday in the Park.") They do, however, have Toto's "Hold the Line." Excellent!

I am also planning WAY ahead -- an Objectivist Christmas party. (Really, there's no Christ in THAT "Christmas" celebration.) I thought it'd be fun to throw a holiday party with a bunch of fellow atheists around this year. Would you believe I've already got two full menus (one utterly diet-unfriendly, the other a bit lighter) in mind? Well, yes, of course you would.


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[info]fuldu
2005-10-04 04:59 pm UTC (link)
>>>It's not the government's job to protect me from my own stupidity, or anyone else from theirs.

No, but what about protecting you from the malicious dishonesty of others? Finding a good doctor is difficult and knowing that you've found a good doctor is even more difficult. I am quite comfortable with allowing the government to decrease the likelihood of receiving laxatives in lieu of a cancer treatment by increasing the costs to a doctor of doing so, even as, you're right, it also decreases my ability to get exactly what I want, how I want it. FDA approval and prescription laws (along with a few other, related laws) put the responsibility for making sure I get the treatment I'm seeking on the doctor and the pharmacist. Otherwise I'm stuck with caveat emptor in a realm where I (and most people) lack the tools to make informed decisions.

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[info]stellavision
2005-10-04 05:21 pm UTC (link)
Otherwise I'm stuck with caveat emptor

I think that's a fallacy. People assume that in the absence of government regulation, there would be no quality control standards. However, just about every medical specialty, including oncology, has its own medical association, and many of these associations issue treatment guidelines that are much, much more up-to-date than FDA approvals. For example, the American Society of Clinical Oncology and the National Comprehensive Cancer Network (both private organizations) issue treatment guidelines for various types of cancer. These guidelines are not based on speculation; they are based on the latest data. Would clinical trials cease if the government stepped out of healthcare regulation? Certainly not -- because no doctor I've ever met is willing to suggest a course of action without any evidence that it will work. There are plenty of clinical trials sponsored each year by non-government organizations -- the Eastern Cooperative Oncology Group and the Southwest Oncology Group, for two. Clinical practice guidelines -- BETTER clinical practice guidelines than the FDA's hopelessly outdated product approvals -- would still exist, just as they do now. It would be no different than choosing to purchase a tube of toothpaste because it has an ADA seal of approval on it, or a UL-listed appliance. UL is not a government agency, yet its seal of approval has become almost a universal assurance of a certain level of safety in electrical appliances.

People would also still have doctors under a non-prescription system. The fool who would take such a system as license to self-diagnose everything from earaches to cancer would deserve the poor healthcare he got. The rest of us would continue to see our doctors (who, as I previously mentioned, would still have the resources to make informed decisions) for advice on issues we don't have the knowledge to handle ourselves. But you and I would be free to self-treat what we do have sufficient knowledge of -- birth control being my classic example.

No government agency can hope to be as efficient as the free market in figuring out how to treat sick people. That's why, for example, in lung cancer patients with advanced disease are often first treated with, say, docetaxel and carboplatin on a weekly schedule, because that schedule is better tolerated than giving the same drugs in larger doses every three weeks. But the FDA has not approved this schedule (indeed, carboplatin is not approved for the treatment of lung cancer at all), so pharmaceutical sales reps cannot even mention it. So we get doctors begging for current information, and we're not allowed to give it to them. Pisses me right off!

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[info]fuldu
2005-10-04 08:40 pm UTC (link)
>>>People assume that in the absence of government regulation, there would be no quality control standards.

That wasn't quite what I was assuming. My argument is more that individuals lacking the necessary expertise wouldn't (without a good deal of added effort) be able to distinguish between those doctors abiding by good standards and those not. Appealing to private associations doesn't solve the problem, it just pushes it back a step. Now I don't have to know which doctors are the reliable ones, I have to know which medical associations are the reliable ones. There are plenty of clinical studies sponsored by Philip Morris and Merck, too, and their incentives don't align with mine. But if I don't know that they've sponsored the study (and it's easy for them to hide that fact), I can't take it into account when making my decisions. In theory, laissez-faire works best with complete and free information, so in practice laissez-faire promotes the interests of those who are best able to control information about the transaction in question. And that is more likely to be the expert than the customer.

And if you need a different example of the way this actually occurs in the real world, look at the argument in favor of intellectual design. It isn't just that religious people hear what they want to hear; many of them actually believe that those are real scientists providing them with an actual scientific viewpoint. And why would we expect people not trained in science to be able to easily make that distinction?

>>>No government agency can hope to be as efficient as the free market in figuring out how to treat sick people.

Broadly, I wouldn't disagree with this, although it doesn't take into account the issues of information-gathering that I mention above. However, judging a social system solely on the basis of efficiency isn't a very meaningful assessment. Depending on the particulars of the situation, a result in which no sick people are actually treated can still be considered efficient. That doesn't make it (for me) the right outcome.

If you wanted to talk about ways in which the FDA might better serve the American public, I think your point about self-treatment is well taken. But there are alternatives to eliminating it entirely that don't demolish those benefits that I believe it does provide.

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[info]stellavision
2005-10-04 09:06 pm UTC (link)
Appealing to private associations doesn't solve the problem, it just pushes it back a step. Now I don't have to know which doctors are the reliable ones, I have to know which medical associations are the reliable ones.

Why wouldn't you also trust your doctor to evaluate them? He or she most likely already does.

And why would we expect people not trained in science to be able to easily make that distinction?

Not easily, no. But then I wouldn't expect most people to do it themselves. Again, that's what we pay doctors for. (Besides, every man's life is his own responsibility -- and just because he can't do it himself doesn't mean a coercive government agency should exist to do it for him.) Not just doctors, but also peer-reviewed journals. No respected journal will publish a paper without demanding full disclosure of any financial interest of the researchers, or how the study was funded -- and they demand an awful lot of data in order to accept a paper. Even abstracts presented at annual meetings have pretty strict requirements. Unlike your average religious fanatic, most doctors know how to tell good data from bad.

Following the FDA's guidelines is a bad, bad way to practice medicine. Private groups are MUCH better at it than FDA approvals. Why? Because the former more rapidly reflects emerging data than the latter. If you listen to the FDA, for example, carboplatin is approved only for the treatment of advanced ovarian cancer. Yet it is a tremendously useful drug in lung, breast, and other cancers. It will almost certainly never be FDA-approved for those purposes, though, despite a stack of clinical trials a mile high showing the benefits. Why? Because carboplatin is a generic drug. Nobody is marketing it, so its manufacturers don't care whether they can add "lung" or "breast" to their advertising. Manufacturers of OTHER lung cancer drugs, however, do care -- because their drugs are often used in combination with carboplatin to treat lung cancer. But we're not allowed to talk about it, because the FDA hasn't approved it. How silly is it that drug manufacturers are completely muzzled from talking about a treatment option KNOWN to work, simply because it would take a mountain of paperwork to get that option FDA-approved? Of course, many doctors (in fact, it might even be most doctors) are already treating lung cancer with carboplatin combinations -- but if they aren't, no pharmaceutical rep can tell them why they might want to consider it. (It happens to have somewhat fewer side effects than its approved counterpart, cisplatin.) If not for an alphabet agency, drug advertising could discuss the kinds of treatments actually in use these days, not the ones that were in use ten years ago when the drug was approved.

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[info]fuldu
2005-10-04 11:10 pm UTC (link)
>>>Why wouldn't you also trust your doctor to evaluate them? He or she most likely already does.

On the assumption that I trust my doctor. But I've had something like five doctors over the past ten years and while all of them were perfectly adequate for checkups and day-to-day health needs, I wouldn't have any idea which of them would be most capable of handling something more life-threatening. Besides, it's circular to suggest that I should trust the doctor recommended by a private association and that I choose a private association to rely on based on the views of my doctor.

>>>(Besides, every man's life is his own responsibility -- and just because he can't do it himself doesn't mean a coercive government agency should exist to do it for him.)

No, but the resolution of disputes requires an arbiter of last resort. In this case, the FDA (and the Dept. of Health and Human Services, and some other organizations, depending on the particular issue in question) acts in that capacity. Relying on private organizations means finding the one that maintains the highest degree of moral authority (probably the AMA) and acceding to their decisions when necessary. The problem is that while moral authority might grant an agency the clout to put pressure on doctors and other groups to follow a certain set of guidelines, legal authority allows you to wield a much stronger stick. And the existence of such a stick helps to limit the occurrence of disputes, precisely because it decreases the incentive of malfeasants to, well, malfease. Relying on private organizations would have the likely consequence of increasing the number of junk doctors and junk medical organizations, further clouding the information issue. That, in my view, is a reason for maintaining a "coercive government agency." The "coercive" has positive side effects, as well as negative ones, and on balance I think it comes out ahead.

>>>Following the FDA's guidelines is a bad, bad way to practice medicine...

All of which is an argument in favor of reforming the way in which the FDA does its job, not in favor of abolishing it. Mitigating the negative outcomes of any government agency is a difficult, but vital, piece of good politics. But looking at what private organizations do today, under the eye of the FDA, and saying that if we removed the FDA, those organizations would be even more effective ignores the fact that the existence of the FDA is part of the reason that those organizations operate in the way that they do today when there's no reason to assume that they would continue to act that way without it. With the removal of the FDA, incentives change and with it, behavior would change, as well.

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[info]louaudioguy
2005-10-05 12:51 am UTC (link)
Ah, so we're talking about the FDA. Well, I'm not an expert on birth control or the FDA, but I can tell you this much--The FDA is just another extension of Big Government. And that's bad. It's bad because the more power a government has, the more it can control your freedom.

In this case Stella is talking about a woman's freedom to choose a particuliar form of birth control. Now, I'm a guy and I don't use the pill, but that doesn't change the evidence that shows that the effects of the pill are pretty well known. It's been in use for about 40 years or so. Does the government REALLY need to test more and more? Probably not...but I bet all those testers love having to test again and again! Keeps that paycheck coming! If the government didn't need to control the situation to give it's self the power it has, it wouldn't need to do this. Can't independant groups do the same thing? Of course! They'd do it cheaper, faster, and in fantastic new ways too! Why? Profit motive. Profit motive is part of what keeps great things coming forward in the world. It's what gets creators creating...that and their love of creation. You think some guy is out there making these drugs because he cares about everyone so much? Nope. Well, maybe he/she does...I'm sure the overwhelming majority of scientists and doctors are not sadists!!! But I digress........

People need to realize that the government and it's systems of checks and balances is just made of people...just people. They aren't super heroes! We don't need the government to make decisions for us! And ya know what? When they do, they go and screw it up! Do we really need the government to do that? Nah, let someone else screw it up so they can get fired quickly...the old fashioned way!

Is someone going to tell me that we need the government to keep us from the bad drs? Yes, and you're right...but the way to do it is to make sure the bad, the evil, the mad drs are punished!

What if we had no FDA, no government to oversee what drs do? Well, for one thing we can do studies, and publications can get paid for them, and drug companies can advertise in them...and hell, even a dr could advertise in them. My point is that people can fund groups that are not government controlled and can oversee that bad things are kept to a minimum. It's possible because people can and always have been creative at getting the job done. The government isn't about getting creative...the government that we have in America today is about being big, being in control, it's about power, it's about who will the politician cater to in order to get votes. Do these people even believe what they say? Or do they just spew what they say because that is what the mob wants? Yes, give the mob it's demands and they'll chant your name! That is what we have here, the FDA is just one part of that problem. In this day and age, any company, dr or whatever that screws up and commits fraud to whatever degree...or harms people, the media will be all over you like white on rice. It's in any rational persons best interest to act within the law, do the proper testing and keep their own house in order.

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[info]stellavision
2005-10-05 02:39 am UTC (link)
Besides, it's circular to suggest that I should trust the doctor recommended by a private association and that I choose a private association to rely on based on the views of my doctor.

I didn't say that. I said the doctor should trust treatment options recommended by a private association that *s/he* trusts. You would not necessarily pick a *doctor* based on private association recommendation. In fact, there are plenty of ways to pick a doctor: you ask your friends for recommendations; nearly every city magazine publishes a list of the best doctors in that region annually; you ask the doctor if s/he is willing to refer you to other patients s/he has treated.

Now, I did not say that no government coercion should exist. I said that the FDA as a coercive government body shouldn't -- because the proper function of government is to protect man's rights to life, liberty, and property. The FDA, by stifling development of new drugs, puts the coercion in the wrong place. Where coercion is necessary is to combat actions that are properly illegal -- say, fraud. As [info]louaudioguy says, that's where the courts of law and the police come in -- because selling your snake oil as a life-saving drug is properly considered a crime, and it is the proper function of government to punish crimes. And so there IS legal authority to deal with criminals -- but remember that whole "innocent until proven guilty" idea? That's what the FDA and other agencies like it do away with. They punish businesses BEFORE a crime is committed.

What makes you think that fraudulent organizations would flourish without an FDA? Because the thing is, any crook can start a business, but reputation takes years to build -- and it is to a pharmaceutical company's advantage to carefully cultivate a good one. In the long run, crooks fall by the wayside as honest businesses flourish. And in the short run...well, it's not just a government stick that can force the rats out of their holes. The mass media can accomplish that just as well!

You can't fake reality and get away with it. Only those whose products live up to their claims can last in a free market -- fakers eventually get found out!

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[info]fuldu
2005-10-05 04:26 am UTC (link)
>>>As louaudioguy says, that's where the courts of law and the police come in -- because selling your snake oil as a life-saving drug is properly considered a crime, and it is the proper function of government to punish crimes.

I actually deleted a whole paragraph about this from the previous comment before I posted because I decided it was too patronizing sounding. But here's the short version. Relying solely on the courts to be the coercive arm of the government means presenting the courts (and probably the legislature that writes the laws the court enforces) with a great deal more power and responsibility than they presently have. Judges are not medical experts, nor in my opinion should they be expected to be. But punishing the crime of selling snake oil requires that someone is able to clearly define what constitutes snake oil. Sometimes that might be easy and other times it might not. But putting that decision in the hands of judges means that not only do they need to understand law, but now they need to understand medicine, as well (and by extension, pretty much any topic on which an "expert" might take advantage of someone). Putting the decision in the hands of the legislature is likely to create even more politicized and inefficient outcomes than are presently the case. And putting the decision in the hands of a private organization tends to make the private organization a de facto public organization (see ICANN's governance of Internet domain names for an example of a private organization quickly taking on pretty much all of the characteristics of a public bureaucracy, including abuse of its coercive power).

>>>You can't fake reality and get away with it. Only those whose products live up to their claims can last in a free market -- fakers eventually get found out!

And this is the part of that that I have the biggest problem with. It depends, as I've said, on the free and perfect flow of information, and such a thing just isn't technically feasible. But even beyond that, when you're talking about something as a) lucrative and b) important as pharmaceuticals, a short-term fraud can be worthwhile and could negatively impact, perhaps irreversibly, many patients.

Health policy in particular isn't my area of expertise, so the following facts may not be totally accurate in all regards, but they're what 20 minutes of research provided me, so if they're incorrect, that tends to bolster my point, as well, because everything I looked at to get this seemed reputable.

Phen-Fen was never approved by the FDA for use in combination, even though the consituent parts (Phen-something & Fen-something) were.
The two drugs were prescribed safely for about twenty years.
In 1984, a peer-reviewed journal (the AMA's Archives of Internal Medicine) published a study funded by two of the pharmaceutical companies hyping the combination, but the FDA still didn't allow this combination to be promoted to doctors.
In 1997, the FDA investigated the claims of heart problems in 33 women using the Phen-Fen combination, eventually documenting 24 cases.
These results were correlative and unusual, but not statistically significant.

The FDA resolved the issue by asking for the voluntary withdrawal of Fen and generic versions of it. The particulars of why this was the solution are unclear, since everything seems to suggest that the problem was with the combination of drugs, not with just one of them.

So, were the producers of these two drugs fakers? No, I don't think so, especially if the problem was with the combination of drugs rather than one or the other. But the fact that they aren't to blame doesn't mean that paying for and promoting a non-approved treatment was good behavior. And the FDA never approved the combination of drugs, so while the fact that they didn't address this earlier is frustrating, I don't think they can be blamed for it. Mostly the scenario just doesn't make me feel good about relying on peer-reviewed journals.

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[info]stellavision
2005-10-05 12:23 pm UTC (link)
I can see this debate could go on until the posts are half an inch wide and thirty-five miles long and I'm still not going to convince you.

[info]testitest is right -- I should have argued from first principles (that the rights of the individual -- to life, liberty, and the pursuit of happiness, are preeminent, and that governments properly exist ONLY to protect those rights) from the start. That the FDA does not work is merely a consequence of the fact that it shouldn't exist under first principles.

I refer you to Ayn Rand's Capitalism: The Unknown Ideal for further comment (though I reserve the right to rebut the individual points in this post some other time ;-)).

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[info]louaudioguy
2005-10-05 05:28 pm UTC (link)
I agree. Principles are most important, and therefore the only issue at hand is really---does the government have rights or do individuals or do groups of individuals? The answer is --individuals have rights. They have rights based on their nature as human beings. As human beings, they must be free to use their minds to act as they see fit to best serve their lives. Of course rights must not be contradictory. An individual's rights must be respected and must not infringe on the rights of others. This is where the government screws up. Because it constantly decides who or what is more important, and it's always at someone else's expense. If you or the government decides that taking someone's money to pay for something you feel is good or right, then you infringe on someone else's choice on how to live their life. This is the immorality of democracy. When choices are made by the majority at the expense of the minority, whether it's by 80/20 or 51/49, those in the minority have thier rights taken away.

Rights must be protected on principle, and not by majority rule. It is the only way people can decide for themselves, and that is must for a human to live their life and be happy.

------------

Here's a few Ayn Rand quotes to chew on:

"Individual rights are not subject to a public vote; a majority has no right to vote away the rights of a minority; the political function of rights is precisely to protect minorities from oppression by majorities (and the smallest minority on earth is the individual). "
Ayn Rand

"Individual rights are the means of subordinating society to moral law."
Ayn Rand

"It only stands to reason that where there's sacrifice, there's someone collecting the sacrificial offerings. Where there's service, there is someone being served. The man who speaks to you of sacrifice is speaking of slaves and masters, and intends to be the master. "
Ayn Rand

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[info]fuldu
2005-10-05 06:45 pm UTC (link)
>>>This is where the government screws up. Because it constantly decides who or what is more important, and it's always at someone else's expense.

This is done not because the government has screwed up, but because such decisions are vital to the completion of a large class of business transactions. Even the Coase Theorem, economics's greatest gift to laissez-fairists, points out that private individuals engaging in private exchanges interact infinitely more efficiently when the rights to the action in question adhere to one or the other of them. Otherwise it comes down to time-consuming haggling and/or lawsuits to resolve the dispute, both of which are bad for both parties. Government "interference" in this instance aids both parties (though I will grant it may aid one more than the other).

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[info]fuldu
2005-10-05 06:34 pm UTC (link)
You're probably right, just as I quite clearly am not going to convince you. But if it will make you feel better, you can rest assured that it's not because I'm ill-informed on the matter. I haven't read Rand (I tried several times, but her writing style has that Kantian quality of dense incomprehensibility that deterred me), but I've read a lot of Milton Friedman's works. While his motivations are slightly different, his recommendations fall into the nearby Libertarian category most of the time.

But arguing from first principles doesn't help your case any, at least not with me. For one thing, first principles are a matter of opinion and while yours are unexceptional, I hardly feel that they are the end-all be-all of political philosophy. But mostly, it's just that this particular first principle (in and of itself) strikes me as wholly untenable as the basis for a society. It relies on the premise that individuals acting in their own interests will aggregate into society acting in its own best (by whatever measure you'd like to use) interest. And it's simply not true. Theory and analysis in economics, political science, organization theory, and psychology all say that (with the exceptions of some extreme cases like dictatorship) interests don't aggregate like that. If you want to define people acting in their best interests as the only good, without regard for anything else (whether it be ends or other means), then yes, a society in which everyone was pursuing their own interests would be the best such society, tautologically. But that tends not to give the appearance of being an especially pleasant society. And even just adding in the characterization "with regard for the rights of others," makes the possibility of such a society suspect.

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[info]stellavision
2005-10-05 06:40 pm UTC (link)
first principles are a matter of opinion

Not according to Objectivism, they aren't. Objectivism holds that these principles are derived from the conditions necessary to sustain man's life, the ability to produce and trade freely being one of those conditions.

Okay, I said I was going to stop in the previous post. The end.

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[info]lunchboy
2005-10-04 05:41 pm UTC (link)
I assume objectivist karaoke features no songs like the Beach Boys' "God Only Knows" or Violent Femmes' "Jesus Walking on the Water".

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