http://www.objectivismonline.net/cgi-bin/tb.cgi/658

Quote :

"The Court of Appeals for the District of Columbia Circuit recently ruled that terminally ill patients do not have a right to take medicines that have not been approved by the FDA. "Barring individuals from choosing what medicines to take is immoral and destructive," said Dr. Yaron Brook, executive director of the Ayn Rand Institute. "The decision about what drugs to put in one's body rightfully belongs to each individual, not to FDA bureaucrats. To deny individuals this right is to impose a death sentence on those who, in the face of certain death, would rationally choose to accept the risks of an experimental treatment, but are barred from doing so until the urgently needed drug completes the FDA's onerous, years-long approval process. Indeed, this case was initiated by a group founded by the father of a girl who died after she was denied access to an experimental anti-cancer drug the FDA later approved. "

Yet another reason to get rid of the FDA.

8/10/2007 6:53:05 PM

yet another overly-simplistic analysis from the Ayn Rand Institute, put forth by yet another fresh-faced and eager acolyte ready to change the world.



look even the best plans can have unintended consequences, and yes the FDA might need some oversight or maybe even an overhaul. the anti-science agenda pushed by Bush cronies highly placed in scientific positions is downright depressing.

but the last goddamn thing we need is an unregulated industry of food and drug manufacturers peddling their latest concoctions without the force of law to keep them from using industrial toxins as cheap fillers.

have you even been paying attention to the rash of contaminated food and drug products lately?

talk about your moonbats. what makes you Ayn Rand people think deregulation will magically allow benevolent corporations and entrepreneurs to produce their products while voluntarily caring for civil rights, public health, and environmental protections? because, I suppose, corporations will always favor the long term vision and larger common good over the short-term gain?

8/10/2007 7:44:43 PM

Quote :

"have you even been paying attention to the rash of contaminated food and drug products lately? "

Is this an argument for the FDA?

Quote :

" magically allow benevolent corporations and entrepreneurs to produce their products while voluntarily caring for civil rights, public health, and environmental protections? because, I suppose, corporations will always favor the long term vision and larger common good over the short-term gain?"

If it's the only way to sell their product they will. Just because the FDA hasn't approved it shouldn't mean you can't buy or take it, but it should come clearly marked as such. But don't you think companies will still clamour for FDA approval? Imagine the money in being able to declare your product the ONLY ONE approved by the FDA?

Lack of regulation combined with privatized (or even public) testing can still lead to plenty a safe product. For an excellent example, see http://en.wikipedia.org/wiki/Underwriters_Laboratories

8/10/2007 7:59:00 PM

Quote :

"executive director of the Ayn Rand Institute."

AHAHAHAHAHAHAHAHHAHAHAHA

8/11/2007 1:51:26 AM

The purpose of the FDA is to support intellectual property based mechanisms of globalization and medical socialization by centralizing food systems and backing federal drug prohibitions while maintaining the facade that it is simply an apolitical food and drug safety regulator. The FDA is near the very center of American fascism.

It has GOT to go.

8/11/2007 9:34:21 AM

Quote :

"The FDA...The Coldest Monster, The Cruelest Slavemaster by William Norman Grigg Abigail Burroughs, died at age 21 after pleading unsuccessfully to use a promising drug called Erbitux, then in final clinical trials but not yet approved by the FDA. Months after Abigail's death, the FDA granted approval amid geysers of self-laudatory praise for making the "life-saving" drug available. Rather than tracking down and beating the tax-fattened bureaucrats who helped kill his daughter – as he was morally entitled to do – Abigail's father Frank created the Abigail Alliance for Better Access to Developmental Drugs. It's not that often that we can say with perfect confidence that a judicial ruling will lead directly to the needless agonizing deaths of innocent people. The U.S. Court of Appeals for Washington, D.C. handed down just such a ruling (.pdf) in a case brought against the FDA by the Abigail Alliance for Better Access to Developmental Drugs. Bobbing in the porridge of intellectual perversity served by the court is this particularly unpalatable morsel: "[C]reating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state, which, like drug regulation, has increased in scope as changing conditions have warranted." From this single observation we can extract the logic (if that word can be tortured into applying here) of the entire ruling: Constitutional rights are a government artifact, "created" primarily by the courts. Since "rights" are creations of the State, they can be summoned into existence, summarily abolished, or modified as the government sees fit, in order to serve the State's "compelling interests." The fact that certain freedoms have been historically exercised by Americans – such as the right to seek alternative treatments for life-threatening conditions, a right exercised by Americans without qualification for most of our nation's history (from the colonial period until 1962) – is of no consequence when the State decides to expand its own regulatory mandate. If, in defiance of the foregoing assumptions, terminally ill patients are permitted to exercise ownership over their health by seeking treatments not approved by government, then the entire rationale for the "administrative" State will be fatally undermined. It is better that we let a few innocent people die in agony, than to permit the State's regulatory powers to be undermined in any way. Not surprisingly, the court tried to buttress this argument by invoking that all-purpose exterminator of liberties, the "War on Drugs." If there is a "deeply rooted" right to experimental drugs and other treatment, the court sneers, shouldn't there likewise be a "deeply rooted" right to use marijuana and other narcotics, which weren't subject to federal regulation until 1937? For the DC Appeals Court, the default setting is "paternalistic authoritarianism," which is why sees nothing amiss in decanting lines such as this: "A prior lack of regulation suggests that we must exercise care in evaluating the untested assertions of a constitutional right to be free from new regulation." The only way this can make sense is if one assumes – contrary to the text and history of the Constitution (particularly the Ninth Amendment), the commentaries of those who drafted it, the recorded debates of those who ratified it, and the common sense invested in each of us by our Creator – that individual rights, rather than grants of government power, must be specifically enumerated. In that mental universe, it is freedom, rather than power, that must be justified. This includes the liberty of peaceful, law-abiding people who suffer terminal illnesses, acting with full knowledge of the risks, to make use of promising experimental drugs that haven't yet earned the unqualified approval of the regulatory bureaucracy. The court complains that, in essence, "the Alliance insists on a constitutional right to assume any level of risk." Well, why the hell not? If someone confronts the prospect of a lingering, painful death from a terminal disease, doesn't that person have the right to take any risk he deems appropriate in seeking to defeat the disease? According to the court, the answer is "no" – because it is the State, acting through the legislature and the regulatory apparatus, that makes "value judgments" of this sort, and the suffering individual has no "constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA's clinical testing process." The candor with which the court emits such collectivist nostrums is amazing. And undergirding them is the tacit but unmistakable understanding that from the court's perspective, the State owns each of us, and as slaves, we must defer to the State's power to do as it sees fit – no matter what needless cruelty results. "

8/11/2007 11:02:50 AM

hmm...lets not regulate drugs

let anyone make whatever kind of drug they want to

with the cheapest materials of the lowest quality (in fact, lets outsource all drugs to china where everything's cheap...not to mention has some sketchy water...)

while not taking care to pay attention to how the drugs are manufactured

without conducting clinical trials

without ensuring that they work

and then lets allow people to use them

then who's responsible when many more people die from poorly made, unregulated drugs?

drug companies would go under, there would be no drugs, people would suffer

Quote :

"Lack of regulation combined with privatized (or even public) testing can still lead to plenty a safe product. For an excellent example, see http://en.wikipedia.org/wiki/Underwriters_Laboratories"

there will never be a UL type group for pharmaceuticals...there's a big difference between the consequences of chemicals on the human body and the consequences of a piece of innovative equipment failing. If my toaster breaks and stops working one day, its not that big of a deal to throw it away and go to the store and get a new one. If a drug I'm taking makes me sick or kills me, well what am I supposed to do then?

[Edited on August 11, 2007 at 11:38 AM. Reason : asdfghj]

8/11/2007 11:26:37 AM

Quote :

"hmm...lets not regulate drugs let anyone make whatever kind of drug they want to with the cheapest materials of the lowest quality "

This assumption that all companies are cold and evil and the gov't is efficient and good is alarming.

Quote :

"If a drug I'm taking makes me sick or kills me, well what am I supposed to do then? "

If you are dying and the gov't forbids you from using an experimental drug that may save your life..what are you supposed to do then?

8/11/2007 11:43:03 AM

^^um, isn't this happening now under the rule of the current FDA ? Many of the clinical trials are jokes, data manipulation is rampant. Besides, the drugs from other countries are not all unsafe, they just break the monopoly and overpricing of the US-producers.

There are many drugs which have been sold in the US in recent history which have proven to be both unsafe and expensive, but they had FDA approval. So I'm not sure what you're arguing.

I'd certainly rather see some sort of UL-type organization or organizations which could hold companies accountable w/o putting federal politics into the mix.

What happens if the drug sold is bad? The same thing as now. We litigate the pants off that drug company.

[Edited on August 11, 2007 at 11:52 AM. Reason : .type slow]

8/11/2007 11:51:56 AM

Quote :

"This assumption that all companies are cold and evil and the gov't is efficient and good is alarming."

there is no assumption that all companies are cold and evil. drug companies wouldn't be drug companies if they didn't want to help people. but it's important that drugs be produced as safely as possible. is the government efficient, no. they're human so of course not. but regulation is absolutely necessary.

but there is the assumption that companies are out to make a profit and some companies will do whatever it takes to compete...in the long run the good companies with the best drugs that work rise to the top...but the minute some freak occurance happens (because everyone will never respond exactly the same way to the same exact drug every time), other drug companies will ride and promote that bandwagon to put down the suffering drug company by spreading rumors and misinformation...its just like anything else.

Quote :

"Besides, the drugs from other countries are not all unsafe, they just break the monopoly and overpricing of the US-producers."

these aren't toys made in taiwan

would you rather have cheap drugs or quality drugs?

do you even know how much it costs to produce some drugs? including the years of development to refine that drug?

would you rather drug companies not make a profit so they can't develop and make more drugs? or even support the need for the drugs they currently produce?

do you know that companies do make some drugs for no profit at all?

Quote :

"What happens if the drug sold is bad? The same thing as now. We litigate the pants off that drug company."

yeah, but when's the last time you saw a big drug company go under?

And you do realize FDA is made up of scientists and doctors who know what they're talking about most of the time and not just some Washington rule makers.

Quote :

"If you are dying and the gov't forbids you from using an experimental drug that may save your life..what are you supposed to do then?"

that depends...is the drug just in the approval process and a decision hasn't been made yet...or has the drug been denied? if it's been denied there's probably a good reason. if it's still in clinical trials...there's probably ways to get the drug but it'll cost you.

and drugs are used all the time (well not "all the time" but on occasion) for things they are not FDA approved for. so if there is a currently a drug that is approved for Disease A, but you have Disease B, you could be perscribed the drug for Disease B if your doctor knows how the drug works and thinks there's a chance of it helping you out.

[Edited on August 11, 2007 at 12:26 PM. Reason : cutthroat]

8/11/2007 12:18:48 PM

i kinda like the fda...i thought they made sure we get good drugs

8/11/2007 1:45:21 PM

Quote :

"drug companies wouldn't be drug companies if they didn't want to help people put profits first."

Quote :

"but regulation is absolutely necessary"

who calling for no regulation? I'm calling for regulation by more than one entity, thereby making it accountable and competitive, and therefore efficacious and resistant to fascism and politics in general.

Quote :

"the long run the good companies with the best drugs most lobbying money that work rise to the top"

Quote :

"would you rather have cheap drugs or quality drugs?"

both, actually. I shouldn't have to choose.
I'd rather have the most choices possible.
And why exactly can't I make the drugs myself?

Quote :

"do you even know how much it costs to produce some drugs? including the years of development to refine that drug?"

Why are electronics so cheap?

Quote :

"would you rather drug companies not make a profit so they can't develop and make more drugs?"

drug companies, as they currently exist, couldn't be profitable without fascism.
And why would market-based regulation preclude drug development?

Quote :

"do you know that companies do make some drugs for no profit at all?"

I would do that. I'd bet others would, too. Let's start an open source drug movement....

Quote :

"And you do realize FDA is made up of scientists and doctors who know what they're talking about most of the time and not just some Washington rule makers."

Have you read the countless testimonials of scientists and doctors that quit the FDA because it is hopelessly fascist and is completely bound by the Washington rule makers?

Quote :

"if it's been denied there's probably a good reason."

IOW, it competes with another [fascist] drug company's ability to make profits lobbyist payments.

Quote :

"there's probably ways to get the drug but it'll cost you"

break the law?

8/11/2007 3:07:33 PM

Quote :

"And why exactly can't I make the drugs myself?"

surprisingly enough, its not as easy as making kool-aid...

8/11/2007 3:13:21 PM

And why exactly can't I may I not make the drugs myself?

8/11/2007 3:16:03 PM

you can try to make them

but i'd think twice about selling and distributing them

8/11/2007 3:21:25 PM

Quote :

"there will never be a UL type group for pharmaceuticals...there's a big difference between the consequences of chemicals on the human body and the consequences of a piece of innovative equipment failing. If my toaster breaks and stops working one day, its not that big of a deal to throw it away and go to the store and get a new one. If a drug I'm taking makes me sick or kills me, well what am I supposed to do then?"

1) UL also handles safety as well. If your toaster catches fire and burns down your house, that's a big deal.

2) Why do you think a UL like group couldn't exist for drugs and food?

3) If a drug you're taking now makes you sick or kills you, what do you do now?

8/11/2007 3:33:24 PM

you can always buy a new house

its not so easy to just go out and buy a new body

8/11/2007 4:22:22 PM

Except for when you die in the fire or if you are electrocuted before the house burns.

8/11/2007 4:48:17 PM

The current system is designed to prevent accidental deaths, and it does so by killing lots of people on purpose.

To get a drug approved, you must prove that it on average produces a smaller pile of bodies than not taking it. We do this by arranging trials, where we find lots of very similar people, divide them into two groups at random; one group gets the new drug, the other group gets a fake drug. At the end of the trial, we count the bodies in the two groups. Why would someone sign up for a trial when there is only a 50/50 chance of actually getting treatment? This is where the ban comes in: it is the only way to get treatment.

This system certainly does produce safer drugs: counting bodies is scientific. However, it also produces far fewer drugs, even if some of them would have been safe. This is because trials are very expensive, patients are not allowed to pay for them, so many drugs are lost simply because the owners ran out of money.

8/11/2007 5:23:59 PM

wow

8/11/2007 5:45:45 PM

Quote :

"but regulation is absolutely necessary."

The FDA is a political organization. It's managers are political appointees. I am not particularly excited about politicians making decisions for me about what medicines I can take. Why not allow for a second opinion..your own personal physician for example? The FDA offers its opinion and your own doctor offers his..and then you decide. The FDA shouldn't own your body.

Abigail Burroughs died at 21 because the FDA wouldn't let her try a new drug because it was stuck in trials. The FDA basically told her to go and die while they get around to approving Erbitux. It was better to let her family watch her die than upset the regulatory power of the FDA.

8/11/2007 9:15:26 PM

Quote :

"Why would someone sign up for a trial when there is only a 50/50 chance of actually getting treatment?"

this is actually not true in most cases: the control group still receives the current standard therapies+placebo while the experimental group receives current standard therapies+experimental drug

8/11/2007 10:16:54 PM

But Abigail could still die with treatment, only then we would have no idea how effective the treatment really was, scientifically that is. Sure, we will still have statistics, but they will be imperfect, comparing apples to oranges. It might simply be that wealthier better fed people could afford the drug, so no doubt the drug would be statistically life extending; wealthy people live longer anyway.

I'm not saying I approve of the system, but we cannot pretend they don't have a point.

8/11/2007 10:32:18 PM

Why would Abigail be relevant to a study as to how effective the drug was, unless she was part of the trial in the first place? Nothing says the FDA (or another organization) couldn't test and rate the drug, just that people should be able to accep the risk of taking a drug even without those tests and approvals. Some folks would, others wouldn't. Some phramacies would stock non FDA approved, and others wouldn't touch it, but you would still have a choice.

8/12/2007 12:08:15 AM

You misunderstand. Without banning non-approved drugs, there would be no way to approve any drugs because there would be no way to get test subjects. Today, test subjects are desperate to participate, since it is the only way to gain access to new drugs. But without the ban, if a patient is willing to take a non-approved drug, then they will just go buy it like everyone else. What idiot signs up for a trial when only 50% of the subjects will actually get the drug? Better to buy the drug, then you have a 100% chance of actually getting the new drug.

8/13/2007 1:34:00 PM

I think a reasonable solution that would leave the FDA intact and useful would require differentiating between different "tiers" of drugs and conditions.

If a new cold medicine comes out, it has the potential to be used by a large percentage of the population, meaning that if it is defective or, worse, contaminated or harmful, it can cause a serious problem for the whole country. Cold medicine is also not something that is generally needed as quickly as possible to save lives. Thus we can, and I would argue should, afford a fair degree of regulation of such drugs. People won't die from a cold, but they could, potentially, from some hack medicine with a good marketing scheme.

The experimental drugs that get brought up as not having been available in time to save an individual's life tend, I sho uld think, to be more specific to a much smaller and needier population. The case for heavy regulation of these drugs is much less tenable, since at worst the patient basically has the choice of dying doing nothing or dying doing something.

I think that some sort of tier system is conceivable, and though it certainly wouldn't be perfect it would allow us to keep control where it is prudent and release it where it is not.

---

My biggest concern with complete deregulation would be the enormous potential for profiteering (which is distinguishable from mere profitting), which is perhaps unmatched with medicine. All it takes is a quick scare, a bird flu or monkey pox panic, and then anyone with a little money to start up the operation can start screaming that they have the cure. People would probably realize eventually that they were being duped, but market forces would be slow to punish the person, who by then might have made his money and closed up shop.

8/14/2007 12:45:35 PM

lol id like to see you try and make some of the drugs manufactured in pharm. facilities these days. these facilities dont cost billions of dollars to make because they are getting some pretty aesthetic architecture. There are ridiculously complex processes and environmental requirements to create some of these safely. Not only so the drug is safe, but so that certain reactions/part of the process are contained within cleanspace areas before the air can be filtered etc.

8/14/2007 1:10:28 PM

Who was that directed at?

8/14/2007 2:27:30 PM

oh sorry not you, 392 i think if i recall correctly now. whoever said they should be allowed to make their own drugs.

[Edited on August 14, 2007 at 2:30 PM. Reason : ]

8/14/2007 2:29:06 PM

don't ruin 392's dreams

plus its fun letting people pretend they're right and they know what they're talking

[Edited on August 14, 2007 at 7:48 PM. Reason : asdfg]

8/14/2007 7:47:05 PM

You guys are idiots.

I was referring to personal autonomy and liberty.

Didn't you see you where I said

Quote :

"why can't may I not"

I wasn't talking about someone cooking up something in their house,
but rather about businesses having autonomy from the government.

"MAY ONE", NOT "CAN ONE"

Quote :

"plus its fun letting people pretend they're right and they know what they're talking [about]"

Wow, how embarrassing it must be for you to say something like that,
when in fact I do know what I'm talking about and you are the one that can't read.



[Edited on August 14, 2007 at 8:14 PM. Reason : .....if feasible, one should be allowed to make drugs at home w\out govt knowledge/permission]

8/14/2007 8:10:09 PM

so you know how to make drugs?

[Edited on August 14, 2007 at 8:16 PM. Reason : damn you edit fast...]

8/14/2007 8:15:28 PM

^^ you know NOTHING about the pharmaceutical industry obviously. sure there are a lot of things that i suppose could be made at home sort of, but for everyone of those there are a bunch more that youd have to be a millionaire to make even if the government wasnt interfering so its pretty much a moot point.

i know you said if feasible, im just pointing out that that part of it isnt even worth arguing over really.

8/14/2007 8:26:37 PM