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Antibiotic Regulation

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There are a lot of papers that promote regulation of antibiotics. This is an example of the argument that a lot of them make:

Because the misuse of antibiotics promotes the spread of bacterial resistance, the use of antibiotics must be regulated.

Here is an example of such an article:

http://www.physics.ohio-state.edu/~wilkins...ntibiotics.html

I was not able to apply Objectivism to solve the problem of increased bacterial resistance and it would be very helpful if you guys could answer some of these questions in order to help me.

1.) Are there any Objectivist arguments against government regulation of antibiotics?

2.) Is there an alternative to government regulation of antibiotics?

3.) In theory, how would a society of Objectivists approach development, production, distribution, regulation, exports/imports of antibiotics?

4.) (I know that this is a stretch) If country A is using antibiotics in a way that endangers the lives of people in country B, can country B use force to stop them (assuming that diplomacy failed)?

I know that I'm asking a lot. Thank you in advance.

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Because the misuse of antibiotics promotes the spread of bacterial resistance, the use of antibiotics must be regulated.

I whole heartedly agree. A class of antibiotics, like all medicine, is more often than not patented technology, that belongs to the person owning the patent, and its use must not only be regulated by, but absolutely under the control of its owner.

If the owner of a particular class of antibiotics, the entity without which the medicine wouldn't even exist in the first place, so desires, all samples should be flushed down the toilet and never used once, all prospects burned and technology creating it destroyed. Or, if his desire is to distribute it to everyone who wants to eat it for breakfast, thus rendering it useless quickly, then that should be what happens.

Or, if the owner's smart (as someone who just came up with a new class of antibiotics inevitably will be), and he will only distribute it for a price high enough that those who don't need it aren't likely to pay for it, thus maximizing his long term profits, that's what should happen. In a LFC society, at least some antibiotics would in fact be saved for serious illnesses, because pharmaceutical companies would be allowed to set their own prices.

The reason why that is impossible now is because if the company that first patented Cipro for instance (a German company called Bayer A.G.), were to charge a large enough sum of money for it to both maximize its profits and make sure only those who are really sick will ever buy it, the government would bear down on them with all its might, in the name of altruism. The other reason why that's impossible is that Cipro has been (legally) stolen from its owner and is now available in generic form, in many parts of the world.

4.) (I know that this is a stretch) If country A is using antibiotics in a way that endangers the lives of people in country B, can country B use force to stop them (assuming that diplomacy failed)?

If use of a drug neutralizes its effects over time, then that action should be either legal or illegal, depending on whether the owner of the medicine is the one selling it. If it isn't, and this thief of intellectual property is in another country, then the use of force is justified.

But note that the reason why force is justified is the violation of private property. Using an antibiotic in fact cannot actively harm anyone, it can only neutralize he effects of that antibiotic, making it useless. A person, or a group of people (including a state) may only lay claim to that antibiotic if it is their property, because they purchased its patent or invented the thing themselves. If it isn't, they should be grateful they got to benefit from it for as long as they have, they certainly have no right to make any claim for something they didn't come up with, as some kind of insurance for the future, at the expense of other nations or individuals.

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It was not state-mandated regulation that discovered the issue of sub-optimal-dose-mediated antibiotic resistance, it was clinical experience and early studies showing the mechanisms by which gram-positive bacteria mutated to become less susceptible to penecillin. The process of modifying penG to ampicillin, amoxicillin, etc., led to more observations and more knowledge of how such resistance occurred and led to changes in prescription, dose, frequency, and duration. It was when drugs like streptomycin and tetracycline proved ineffective on strains never exposed to it that the realization that some of these nature-derived drugs had nature-derived antidotes furnished to bacteria on plasmids passed by conjugation that things got scary and many were predicting the end of antibiotics and a new "dark age" of infectious disease.

There was abuse of these drugs early on due to ignorance of doctors and hospitals and hospitals themselves became the biggest repositories of multiply-resistant bacteria. I was at UC Irvine Medical Center when the doctors there began to test an extremely conservative strategy, including multi-antibiotic treatment to reduce the possibility of acquisition of resistance, preceded and followed by petri culture to determine the organism and the success of the treatment and the incidence of resistant strains went way down. Many of these steps were and are left out because they are expensive and time-consuming, but that work and the procedures established there and elsewhere have led to better life-spans for such weapons against disease.

It is in the interest of no doctor, no hospital, and no drug company to push bad administration of drug therapies. The sooner the intended target becomes resistant, the sooner the doctor loses a tool, the hospital loses immunodepressed patients (and, hence, their rating and certification), and drug companies lose a valuable product.

No government regulation is necessary. In fact, as with every other form of regulation, it's generally outdated, simple-minded, restrictive of intelligent treatment, and destructive at every level of disease management and interaction. Let the people who stand to profit or lose directly from their behavior do their job. There will, of course, always be bad doctors and crooks, but they will soon be known and tagged as such. It's government intervention, through restrictions in prescription (e.g. off-label use lags well behind discovery of such use and leads to patients seeking inferior and suspect sources of foreign treatment, etc.), or mindless sanctions, that causes far more problems than it intends to solve.

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Daedalus, your post mixes up two issues which are not primarily related:

(1) Patents to protect intellectual property, and

(2) The question of whether the improper unnecessary use of antibiotics, which can increase resistance in contagious bacteria, ought to be regulated.

If the owner of a particular class of antibiotics, the entity without which the medicine wouldn't even exist in the first place, so desires, all samples should be flushed down the toilet and never used once, all prospects burned and technology creating it destroyed

Even though these actions go far beyond what a patent holder ought to be allowed to demand? Patents cover such acts as "making, using, selling, or distributing the patented invention" (Wikipedia*), and not necessarily all technology that went into it. Furthermore, once a unit of an invention is built and owned, the patent holder cannot necessarily demand the owner to destroy it, and especially not destroy information about it, lawfully possessed.

(*Yes, I know, with the disclaimer of "with what Wikipedia is worth", but this excerpt is consistent with my limited knowledge of patents, so I am relying on it for the purposes of this argument.)

The patentability of medicine does not imply that government should regulate the medical field. Patent law, to the extent possible and practical, should be uniform across all categories of inventions. Differences in the nature of different categories of inventions may imply some differences in patent law applied to different categories (such as, for example, longer patent terms on medicine and shorter patent terms on software, because of the inherent differences in research and time-to-market in these fields), but these differences should be legislated in a uniform manner according to basic principles of intellectual property.

If use of a drug neutralizes its effects over time, then that action should be either legal or illegal, depending on whether the owner of the medicine is the one selling it. If it isn't, and this thief of intellectual property is in another country, then the use of force is justified.

This is not an intellectual property issue, but a question of whether improper use of an antibiotic, by supposedly causing resistance, violates rights. For example, what if one antibiotic, which happens to be patented, causes bacteria to develop resistance to a much wider class of antibiotics, some of which are patented and owned by different owners?

Using an antibiotic in fact cannot actively harm anyone, it can only neutralize he effects of that antibiotic, making it useless.

This claim involves questions of science which cannot be deduced from principles of intellectual property.

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This is not an intellectual property issue, but a question of whether improper use of an antibiotic, by supposedly causing resistance, violates rights. For example, what if one antibiotic, which happens to be patented, causes bacteria to develop resistance to a much wider class of antibiotics, some of which are patented and owned by different owners?

This is how Understood the question in the first place. Regulation could be justified on grounds of harm to individuals in your example. That of course would have to be objectively proved by science.

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This is how Understood the question in the first place. Regulation could be justified on grounds of harm to individuals in your example. That of course would have to be objectively proved by science.

The purpose of my example was to show how the issue of patents is unrelated and doesn't resolve the question of antibiotic resistance (on which I don't have a full opinion with certainty, at the immediate moment, but is one of a class of issues I've been thinking about recently).

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I'm following this thread with interest, as I have always wondered the Objectivist position on common goods (I probably do not need to explain the Tragedy of the Commons principle to you). Here we have negative effects which impact not the drug producer (at least not immediately) but the "general population" (however much I loathe this term).

For example, forcing people to be vaccinated against deadly but common diseases can be justified, since it takes a minimum level of immunity in a population (over 90%, I am sure Alann can be more precise) in order for diseases to be eradicated. Whilst it's in your best interest to be vaccinated, it takes a small proportion of irrational individuals who fail to see the risk/reward of the vaccine to jeopardize the health effort to eradicate certain diseases. But how do you justify "forcing" people to vaccinate their children, for example at school (or making them go private for the privilege), without resorting to "it's what's best for society"?

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Even though these actions go far beyond what a patent holder ought to be allowed to demand?

No. But then again, you are begging the question there, of course what ought to be allowed is what ought to be allowed.

This is not an intellectual property issue, but a question of whether improper use of an antibiotic, by supposedly causing resistance, violates rights. For example, what if one antibiotic, which happens to be patented, causes bacteria to develop resistance to a much wider class of antibiotics, some of which are patented and owned by different owners?

I have seen no hard evidence of that actually happening, with actual humans. It is theoretically possible, but in practice, as far as I know, the phenomenon is limited to specific types to cause resistance to themselves, even hat only temporarily, and only with massive use.

I find it very unlikely that that problem would ever need addressing, in Court. If it does, we'll cross that bridge when we get there.

Using an antibiotic in fact cannot actively harm anyone, it can only neutralize he effects of that antibiotic, making it useless.

This claim involves questions of science which cannot be deduced from principles of intellectual property.

I know, I deduced it from empirical evidence, not property rights. You're welcome to disprove it, with counter examples of actual people being actually harmed by someone else's sale and use of an antibiotic they own.

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I'm following this thread with interest, as I have always wondered the Objectivist position on common goods (I probably do not need to explain the Tragedy of the Commons principle to you). Here we have negative effects which impact not the drug producer (at least not immediately) but the "general population" (however much I loathe this term).

That's why you should replace it with the term "other individuals". If someone can't prove that a single individual was harmed, in their rights, by my sale and use of an antibiotic I invented myself, then the bigger claim remains unproven as well.

As of yet, no one in the thread presented evidence of anyone getting hurt. The link raises the possibility of a risk, in theory, but does not prove actual damage, to anyone. I have no reason to search for a legal solution to something that isn't a problem, but I'm sure a Court would find one, if it became a problem. (any arbitration should favor the company "first on the scene", meaning if the antibiotic being neutralized by another strain was invented and used first, they would have a valid claim to limit the use of the newcomer, through a Court order. Otherwise, if an antibiotic already in use affects a new invention, that new invention's owner wouldn't have a legal claim (he would have to hammer out a compromise with the owner of the older antibiotic: if his new strain is more useful, there's no reason why they couldn't come to a mutually beneficial agreement)

For example, forcing people to be vaccinated against deadly but common diseases can be justified, since it takes a minimum level of immunity in a population (over 90%, I am sure Alann can be more precise) in order for diseases to be eradicated. Whilst it's in your best interest to be vaccinated, it takes a small proportion of irrational individuals who fail to see the risk/reward of the vaccine to jeopardize the health effort to eradicate certain diseases. But how do you justify "forcing" people to vaccinate their children, for example at school (or making them go private for the privilege), without resorting to "it's what's best for society"?

I wouldn't. Force is only justified in the face of actual threats. The possibility that maybe, on a long shot, a child might contract a disease in the future, and transmit it to others, does not justify the use of force against that child. Actually having a deadly disease would justify quarantine, or forced treatment, but the mere possibility of future infection does not.

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I wouldn't. Force is only justified in the face of actual threats. The possibility that maybe, on a long shot, a child might contract a disease in the future, and transmit it to others, does not justify the use of force against that child. Actually having a deadly disease would justify quarantine, or forced treatment, but the mere possibility of future infection does not.

It's more than a possibility. The eradication of diseases such as rabies (which is incurable past the very early stages, and used to kill thousands), polio, cholera and other diseases which used to kill millions is definitely more than a small chance of catching a disease in the future. That's the issue - the gain is definitely very high - the complete eradication of a killer disease that costs individuals hundreds of millions, and their lives, on a routine basis, for the small cost of inconveniencing school children by taking ten minutes of their time to jab their arm.

It is easier to be against it for "superfluous" vaccinations such as that for influenza (I've never been vaccinated, and never caught it despite it being very frequent in Western Europe).

I might be biased - I took a cholera vaccine course before heading out to work in India, and it saved my life later on when I did catch the disease by making it only as unpleasant as a course of very bad food poisoning.

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I'm undecided about this issue, but I do have a few cents to chip in.

It's more than a possibility. The eradication of diseases such as rabies (which is incurable past the very early stages, and used to kill thousands), polio, cholera and other diseases which used to kill millions is definitely more than a small chance of catching a disease in the future.
It's not "more than a possibility". A possibility refers to something that is not guaranteed to happen, but could happen -- which is clearly the case of contracting polio, cholera, and other diseases sans a vaccine in modern, first world countries.

To add more information to the discussion, it's not just people refusing the vaccine could contract the later disease -- certain people with certain health problems aren't given vaccines and rely on "herd immunity", as well as the fact that vaccines do not work 100% of the time -- some are around 90%, for instance. So it is legitimately innocent people that are harmed -- otherwise there would be, of course, no justification for protecting people from themselves.

As a sidenote, the general population is not given the rabies vaccine, which is why it's critical that you get to a doctor right away when you may be compromised, because the vaccine may be administered after transmission and still be effective.

On the topic of antibiotics, it would be wrong to tell an inventor that he can't sell his product to much because it may become less effective over time. Without him, there wouldn't have been any benefit to begin with! The issue gets somewhat fuzzier for me when the drugs become genericized, though :D. I wonder if Miss Rand ever discussed this -- I'm sure she could clear it up for me.

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It's more than a possibility. The eradication of diseases such as rabies (which is incurable past the very early stages, and used to kill thousands), polio, cholera and other diseases which used to kill millions is definitely more than a small chance of catching a disease in the future. That's the issue - the gain is definitely very high - the complete eradication of a killer disease that costs individuals hundreds of millions, and their lives, on a routine basis, for the small cost of inconveniencing school children by taking ten minutes of their time to jab their arm.

The cost of allowing the government to initiate force is not small. You make an excellent case for vaccination, and have the personal drive and conviction to get that across to people. So why would you resort to force, instead of placing some trust in your fellow human beings, and allowing them the freedom to be convinced and make the right choice themselves?

No to mention that it is precisely the use of force that makes people tune out even the soundest arguments, and stubbornly resist those who try to force the "greater good" on them. People like the infamous Dr. Wakefield draw their influence directly from the feeling that government coercion is malicious, and cannot be trusted. So not only is the use of force immoral, it is also counter productive and pretty difficult to accomplish consistently enough, if more than ten percent of people decide to try and evade mandatory vaccination.

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The issue gets somewhat fuzzier for me when the drugs become genericized, though

I don't know. That seems like pretty crystal clear theft to me.

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...

No government regulation is necessary. In fact, as with every other form of regulation, it's generally outdated, simple-minded, restrictive of intelligent treatment, and destructive at every level of disease management and interaction. Let the people who stand to profit or lose directly from their behavior do their job. There will, of course, always be bad doctors and crooks, but they will soon be known and tagged as such. It's government intervention, through restrictions in prescription (e.g. off-label use lags well behind discovery of such use and leads to patients seeking inferior and suspect sources of foreign treatment, etc.), or mindless sanctions, that causes far more problems than it intends to solve.

This is excellent. I couldn't have said it better.

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The issue gets somewhat fuzzier for me when the drugs become genericized, though

I don't know. That seems like pretty crystal clear theft to me.

You don't agree with patent time limits?

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You don't agree with patent time limits?

It's complicated. I do agree that patents cannot be held forever, because the act of cataloging and enforcing patents is a costly endeavor, and because at some point a patented invention stops being beneficial to producers, and the patent becomes a hindrance their unrelated technology has trouble working around, legally (it holds back legitimate, creative technological progress).

However, when those particular arguments don't apply (because the patented invention is still extremely valuable and worth the effort of the gov. keeping track of whom it belongs to and who's attempting to steal it, and because the invention does in fact have essentially the same role, in the market, as it had when it was first patented - for instance a drug invented twelve years ago), then the government's decision to no longer enforce a patent should be called what it is: legalized theft.

What is happening is not what happens to a two century old invention which:

- has at best unclear origins,

- with similar inventions created God knows how (meaning a hundred years ago maybe some guy stole the idea, maybe he came up with a similar idea himself),

- that have been incorporated into various areas of activity, etc.,

- and where some long lost descendant has the idea to bother everyone with lawsuits, hoping for a payday.

Then, obviously, two hundred year old patents would quickly become a burden on government, and a tool for scam artists to leach off productive people.

But this is nothing like it. We are talking about drugs that have been developed twelve years ago, and maybe are only used on a large scale once every two decades, during a major epidemic, and which play essentially the same role in the market they played on day one: they are the unmatched solution to a specific disease. Having such a patent nullified after twelve years is not the same as applying the sound principle of leaving patents to expire, when their enforcement no longer serves its purpose: the protection of property rights.

This is theft, plain and simple. I can't think of a single drug, invented in the past 50 years, that should have had its patent annulled. And I can't think of any reason why, when the time comes to legitimately end the enforcement of a patent, on a drug, such action would still be relevant to the issue of this thread, the effect of some other, modern antibiotic's use on the drug that became generic.

P.S. The twelve years I'm referencing is from the latest legislation regulating the field, the so called "Obamacare". It allows the sale of generic drugs in the US, after only twelve years of patent protection for their owner.

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The problem I have with patents is that I believe - much like Rearden - that industry secrets are a much, much better way of protecting technology (ask Rolls-Royce and their wide-chord fan blades, which gain them business over GE night and day despite an engine which is overall less efficient outside the blades).

This obviously does not apply to drugs. I have many friends who could probably replicate the drugs within days if not hours. I could outsource it to India. The patent system is vital to innovation in the medical sciences.

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