Does FDA Stand for Fundie Dominated Administration?

Earlier this year, Ron Bailey looked at the FDA's decision to ignore the recommendation of its own expert panels and delay approval of over-the-counter status for "Plan B" emergency contraception (aka "the morning after pill"). A report released today by the Government Accountability Office confirms that the process FDA followed in that case was "unusual," and "not typical of the other 67 proposed prescription-to-OTC switch decisions made by the FDA" in the preceding decade. In short, the report confirms the conclusion most observers had already reached: That the denial was a political decision that required flouting the ordinary procedure, and the ordinary medical grounds, used to make these determinations. Kerry Howley took a long look at the forces that keep drugs stuck in the prescription vault back in our August issue.

Comments

[Herrick and His Balls]

I have realized something: Government sucks ass.

(But then again so do I, but that's neither here nor there)

[joe]

Blaming "government" in the abstract is a dodge. As the report says, this is highly unusual for our government.

There is a cabal of very specific people responsible for this travesty, and they shouldn't be let off the hook.

[Serafina]

That it was a political decision is no surprise, but at least the GAO has come out and said so. If this administration really were pro-life instead of anti-choice, emergency contraception would have been readily available long ago.

[Eric the .5b]

In short, the report confirms the conclusion most observers had already reached: That the denial was a political decision that required flouting the ordinary procedure, and the ordinary medical grounds, used to make these determinations.

You can't escape the vulnerability of "non-political" decision-making to political forces in government. So, unless you really, really need the government to make a decision on something, it's best not to let it make that decision.

[R C Dean]

joe is absolutely correct that there is a small and more or less identifiable group of people who exerted the political pressure that resulted in this dumbass decision.

But the FDA is a government, which is to say a political, agency. We can hardly be shocked, SHOCKED, that it makes political decisions.

I suspect that joe's ire has a lot less to do with the FDA making decisions for political reasons, than with the FDA making decisions for political reasons that he disagrees with.

[thoreau]

I think joe's point is that this decision was unusually bad even by political standards. One can agree with that without sharing his views on other matters.

[Akira MacKenzie]

From the report:

The rationale for the Acting Director of CDER?s decision was novel and did not follow FDA?s traditional practices. The Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity. The Acting Director further concluded that because these differences in cognitive development made it inappropriate to extrapolate data from older to younger adolescents in this case, there was insufficient data on the use of Plan B among younger adolescents.

So, in other words, it was a foregone conclusion that if Plan B was avaiable OTC, teens would rutting like sex-starved minks and we shouldn't even be finding out if it's true of not?

[M1EK]

"But the FDA is a government, which is to say a political, agency. We can hardly be shocked, SHOCKED, that it makes political decisions."

Bull. The scientific decision was clear; this was an outlier, not the norm.

I have to admit, though, that I'm not at all SHOCKED to see y'all fall into your typical buckets on this one (RC Dean defending the administration; everybody else claiming that this is a problem with too much government, unlike the heady salad days of 19th century medicine).

[Herrick and His Balls]

I want to get on the FDA Panel. How do I do that? I'm just gonna let every drug through. I have an MS in Organic Chemistry, does that qualify me?

[joe]

RC,

"But the FDA is a government, which is to say a political, agency. We can hardly be shocked, SHOCKED, that it makes political decisions."

If that is the case, then why was the process behind this decision a drastic departure from the other 65 cases looked at in the 1990s? The "everybody's doing it" excuse is indefensible enough, but when, in fact, everybody is demonstrably NOT doing it, it is not just a foolish argument, but a dishonest one.

[joe]

Correction:

This completely unavoidable interjection of politics into the technical operations of the government was not drastically at odds with the previous 65 examples of FDA review, as I wrote above.

It was drastically at odds with the previous 67 examples of FDA review. My bad.

[guy in the back row]

M1EK is right.

I think wer'e at the point where someone can whip up a bot to emulate all the standard positions of regular posters on H&R. Is it time we all changed names or some oither way of shaking things up?

Familiarity breeds contempt!

[Adam]

Of course, since they changed the name from the Government Accounting Office to the Government Accountability Office, I assume they'll step right in and fix this shoddy bit of governin'. (Right after Ted Kennedy flaps his arms and flies, Rick Santorum drops a crucifix in a jar of urine, and Dennis Kucinich goes on a murderous rampage.)

[fyodor]

RC Dean,

joe's unstated implication would appear to be that the FDA would never make political decisions not supported by science under a Democratic administration. I share the skepticism you likely have for such a claim. But the best way to disprove joe's implication would be to identify an equivalent counter example.

[joe]

fyodor,

No, it's not partisan. A decent and honest Republican administration wouldn't do such things, either.

[thoreau]

It is inevitable that certain lines will eventually be crossed.

The people in charge determine when "eventually" is.

[Akira MacKenzie]

Can anyone name a drug that a Democratic administration has blocked from approval on political/religious grounds?

[Julian Sanchez]

Akira-
Ron's also argued that political pressure from the left played a role in overturning an advisory board ruling that held silicone breast implants were safe.

[mediageek]

Akira, none that I'm aware of, but the Dems tend to focus their feats of social engineering in other directions.

[Gimme Back My Dog]

Merck made more than $5M/year in political contributions at the federal level during the Clinton Administration. Apparently, they thought the FDA was influenced by politics.

[joe]

'A report released today by the Government Accountability Office confirms that the process FDA followed in that case was "unusual," and "not typical of the other 67 proposed prescription-to-OTC switch decisions made by the FDA" in the preceding decade.'

[metalgrid]

'A report released today by the Government Accountability Office confirms that the process FDA followed in that case was "unusual," and "not typical of the other 67 proposed prescription-to-OTC switch decisions made by the FDA" in the preceding decade.'
Comment by: joe at November 14, 2005 02:23 PM

So isn't the solution to replace the 'expert panel' with people who would be more in line with leaving it prescription only? That way the recommendation would be to keep it prescription only, and the FDA will then keep to the usual and typical method of listening to the expert panel. That way you can keep the current results and the consistent methodology.

[Baylen]

Does Ron mean "fundie" like "fundamentalist" or "fundie" like "that underwear for couples sold at Spencer Gifts"?

[JDM]

There are not any examples of drugs held back by the lefties, because there are no drugs that are releated to democrat concerns. Right wing politicians are going to make bad decisions on reproductive drugs, and less ideological decisions on the other 99% of drugs the FDA reviews.

There is no way to infer that Democrats make fewer ideologically motivated decisions in government as a whole from that, however, and nothing here that argues against the idea that putting decisions in the hands of government politicizes them. It should be obvious to anyone that it is prima facie evidence that it does.

[joe]

metalgrid, that didn't make any sense at all.

No, the solution to the injection of politics into technical processes is not to inject more politics into the process.

Of course, we're working from different premises here - I don't start off JUST KNOWING what the right decision for the panel is, and you do.

[Timothy]

Mentioning breast implants might bring the crazies out of the woodwork. As for Plan B, this is an onerous decision, but not all that much more onerous than keeping hormonal birth control prescription for the past 40 years when it should be OTC. The FDA has been ignoring expert opinion on that for decades.

[joe]

"There is no way to infer that Democrats make fewer ideologically motivated decisions in government as a whole from that,"

No, there is not. Partisanship and ideologues of all sorts should be kept away from technical operations.

"...and nothing here that argues against the idea that putting decisions in the hands of government politicizes them." Except for the preceding 67 cases.

If I find a case of a guy with a gun committing a violent crime, can use this logic to argue that private gun ownership "inevitably" leads to violent crime?

[Akira MacKenzie]

So isn't the solution to replace the 'expert panel' with people who would be more in line with leaving it prescription only?

How about this: If we're going to have an FDA (a concession we libertarians might have to make in the real world) then it should be stocked with people who actually approve drugs after using vigorous scientific methods rather than basing their descions on religious or ideological dogma.

[joe]

Timothy, I don't have nearly the expertise to say what the right call on OTC birth control pills should be.

However, finding that the consumption of a drug can cause physiological problems, and therefore should be overseen by a physician who knows what to look for, is not the same at all as finding, without evidence, that the availability of a drug will encourage people to behave in a manner you disapprove of.

[Daniel Montiel]

Obligatory defense-of-religion comment:
Everytime I see this stuff, I get the embarrased twinge you get when a relative does something stupid in public. Why does religion have to be used for this god-awful anti-scientific line of attack?
Oh, that's right, cause the current elected Republicans use these pseudo-scientific wedge issues to win elections.

[David]

I can criticize government in general and at the same time demand better government. Even limited government should do those limited things well. And unless you have a plausible solution for keeping drugs safe without any government intervention whatsoever an organization like the FDA must exist. So why am I supposed to just throw up my hands and say boys will be boys?

[metalgrid]

Geeze Joe/Akira, don't get your panties in a bunch over a tic comment :p

Honestly, as long as the FDA is in the business of determining whether consumers have the intelligence or whatever other qualifications are neccessary to medicate themselves, the FDA reasoning for witholding Plan B remains valid. It is a sign of a larger problem IMO, the FDA catering to the lowest common human denominator in moving drugs OTC vs. merely verifying the tests and procedures for compliance to what the pharma industry says they are for.

A friend of mine once said that 50% of the population is below average, and average is what you see on jerry springer. Leaving aside the other implications of that, you do need to be very sympathetic to the onus a drug company has to overcome in order for the FDA to approve it for OTC sale if they need to cater approval to the average population.

[JDM]

"If we're going to have an FDA (a concession we libertarians might have to make in the real world) then it should be stocked with people who actually approve drugs after using vigorous scientific methods rather than basing their descions on religious or ideological dogma. "

No one has or is going to argue against that here...

"If I find a case of a guy with a gun committing a violent crime, can use this logic to argue that private gun ownership "inevitably" leads to violent crime?"

There's no analogy there.

You can't keep taking each individual peice of evidence, day after day, claim it isn't a pattern, and just keep ignoring that you made the same argument yesterday. Well, you can, but no one is going to buy it. And if you do, you're just fooling yourself. Especially when the theoretical causal factors are well established.

[JDM]

A better ananlogy would be to say that just because 1 dangerous felon acquired a gun and used it for a crime, doesn't mean we should stop giving felons guns, all the while claiming that there is no pattern of recidivism in felons.

[Daniel Montiel]

"Honestly, as long as the FDA is in the business of determining whether consumers have the intelligence or whatever other qualifications are neccessary to medicate themselves, the FDA reasoning for witholding Plan B remains valid. It is a sign of a larger problem IMO, the FDA catering to the lowest common human denominator "
Two things:
A) But this isn't a given, is it? This is indicative of a larger problem: it's not just the lowest common denominator--it's ANY outlying data, any random person who could could theoretically exist and do something stupid that sets the bar for these things. It's similar to the sensitivity pogrom going on right now, across everything from office parties to school dances: all it takes is ONE person saying they feel offended, and 3000 people change what they are doing. When it comes to the FDA and drugs, we have a case of "some people may feel more inclination to do something some of us disapprove of, so we need to ignore all the positive and liberty issues at stake: giving freedom to all may result in non-preferred behavior from some, so we won't allow it.
B) I hate to sound like a Kossack here, but does anyone think this is really about encouraging abstinence? Isn't this more about a political group choosing a red-meat red-state issue to draw attention to themselves, establishing their bona fides with the religious voters, and reinforce the "Republicans=Christ" meme that helps maintain a GOP majority?

[Akira MacKenzie]

I hate to sound like a Kossack here, but does anyone think this is really about encouraging abstinence? Isn't this more about a political group choosing a red-meat red-state issue to draw attention to themselves, establishing their bona fides with the religious voters, and reinforce the "Republicans=Christ" meme that helps maintain a GOP majority?

Does it really matter? The damage has been done. Whether or not it was because or it was a made out of a sincere belief or cynical politcal utility is irrelevent. What matters is the results.

[Akira MacKenzie]

Edit: Whether or not it was made...

[SR]

Why does the GAO hate God?

[joe]

JDM,

'"If I find a case of a guy with a gun committing a violent crime, can use this logic to argue that private gun ownership "inevitably" leads to violent crime?"

There's no analogy there.

You can't keep taking each individual peice of evidence, day after day, claim it isn't a pattern, and just keep ignoring that you made the same argument yesterday.'

The "pattern" here is that, in 67/67 cases - not a cherrypicked sample, but every single similar question they faces, they did not allow political pressure to be so introduced into the process.

This "well established theoretical and casual factor" is contradicted by the available evidence, just as much so as the assertion that the ownership of firearms by private citizens causes violent crime.

[R C Dean]

RC Dean defending the administration

In no way am I defending the administration, M. I don't think it should be against the law to buy any damn thing you want over the counter. From my perspective, the FDA keeping a perfectly useful drug off the market isn't an outlier, its what the FDA does for hundreds of drugs every single goddamn day. One more, used to "treat" a non-lethal "condition", isn't even a blip on the radar.

Every single denial or delay imposed by the FDA is imposed for political reasons. Every single drug that was delayed or denied during the Clinton administration refutes the claim that Democrats have clean hands on this issue.

unless you have a plausible solution for keeping drugs safe without any government intervention whatsoever an organization like the FDA must exist

Typical nanny-stater dodge - Look exclusively at whatever good the state claims to be doing, and ignore entirely the thousands who die because of the delays and denials the FDA imposes.

[joe]

And what's more the letters F, D, and A don't even creat a pronounceable word! Everything done by this dastardly organization is therefore evil, and there is no purpose to be served in noting whether there was political interference, in the cause of ideology and electoral advantage, in the oppressive "FehDehAaa's" decisions.

Yeah, well I can top that. I don't think there should be any Dept of HHS at all!

Well, I don't think there should any cabinet departments. None!

What were we talking about again?

[JDM]

"The "pattern" here is that, in 67/67 cases - not a cherrypicked sample"

Yes it is cherrypicked, it's all of the FDAs OTC cases for the last 10 years, not all FDA cases, nor cases for government organs generally, and not for all of time.

It really takes a special bias to look at a case where the government has injected ideology into a decision where it doesn't belong, and claim that it's not evidence that the government injects ideology into places where it doesn't belong. No one is basing their opinions on this case alone. You do read this site everyday, right?

[joe]

Dude, if taking all cases subject to the same review for the past decade is "cherry picking," than I am totally now hiring you to work in my orchard.

It really takes a special kind of bias to look at 30,000 murders a year committed by people whith firearms, and claim that it is not evidence that people commit murders with firearms.

FDA boards don't inject politics into technical decisions about drug approvals. People inject politics into technical decisions about drug approvals.

[Serafina]

And you don't think a nonprofit licensing board set up by the insurance industry would inject ideology in places where it doesn't belong? That seems curiously naive.

"Said seal of approval is highly desirable for new drugs since no insurer will cover the cost of a drug which does not bear the seal. People are free to purchase unapproved drugs out of pocket, although few doctors will recommend them, and hardly any retailers will sell them for fear of wrongful death suits."

Since about 45 million Americans don't have health insurance and a good portion of those with insurance still pay out of pocket for prescription medication, it would open a burgeoning market unregulated medications. Without the structure of a regulating body continuing ongoing surveillance of adverse effects after they're released on the market, it could take much longer for some dangerous side effects to become apparent.

[Serafina]

(It's about 8,200 intentional homicide with firearms a year in the U.S., according to U.N. crime statistics, but it is the prefered weapon, used in 65 percent of murders.)

[JMoore]

Serafina

The insurance industry has no ideology. But, no, I do not think such a board would be perfect.

Whether a person has insurance or not would not change the fact that the seal of approval could only be displayed on "approved" drugs. Everyone, insured or not, would benefit from the group's labelling.

And ongoing surveillance for adverse effects would certainly be a major concern of such a board--they would not want to continue to endorse a dangerous drug, nor would their industry sponsors wish to continue paying for it.

[JMoore]

Brief follow-up: think of Underwriter's Laboratories; now apply that model to drugs instead of electronics.

[Daniel Montiel]

JMoore,
Isn't the maximizing of profile, minimizing liability, eliminating competition all parts of an ideology? I mean, I know this is just business, but different companies and different corporations have different levels of dedication to dealing with competition (compete versus drive out of business), intellectual property (more open to allow innovation verus patents to silo knowledge), etc. Aren't these ideologies?

[M1EK]

"How's that for a plausible solution?"

JMoore, if it were plausible, it would have happened pre-FDA, when people had even more incentive to control their own healthcare costs than they do now. It didn't, of course, because health care is about the least perfect 'market' there is.

You can say "who cares if some idiot buys a quack remedy to cure an infection - it'll only hurt his family"; but then you're stuck either letting that kid with brain damage or blindness rot or bailing him out by supporting him the rest of his life.

[Native NYer]

I don't see the insurance industry OKing new drugs that are added to their formularies, increasing their costs. They might add generics, or they might add a medication that had a dramtic effect on conditions that worsen into costly conditions in the future (like a silver bullet for diabetes), but otherwise how is it in the insurance company's interest to increase their costs when they are not required? Perhaps if they got a cut of the sales of useful drugs?

Also, I read once that there aren't any sales controls for drugs in Mexico. Is this true? If so, do they have a problem with OTC narcotics? Do they have a problem with OTC RU486? Can't we use Mexico as a living laboratory?

[JMoore]

Daniel M

I stand corrected. Yes, it would be fair to say that the insurers' ideology is, at its core, profit. Which would give me some comfort because health insurers make money from healthy people. Thus, it would be in their interests to exert pressure on manufacturers and doctors (through their research group) to keep unsafe drugs off the market.

I should note that there is a compromise position between the FDA abolishers and the FDA keepers: make the FDA itself the approvals board. That is, keep them in place to apply a "seal of approval" on new drugs (and follow up on older ones), but take away their power to ban drugs. Let the doctors and patients and their respective insurance companies decide whether to use a non-FDA-approved drug.

[JMoore]

Native NYer

Who said anything about adding it to their formularies? As now with the FDA, just because it's approved doesn't mean a company has to pay for it.

[JDM]

"FDA boards don't inject politics into technical decisions about drug approvals. People inject politics into technical decisions about drug approvals."

Thank God FDA boards aren't made up of people then...

If the governement didn't have the only say on which drugs were allowed to be sold OTC, this wouldn't be a problem. Hence it's a valid criticism of government. Pointing out that this is the first time this particular bias has effected this particular branch of government's execution of this exact power in the last 10 years does not in anyway deflate the libertarian critique of government monopoly power, or change the fact that this is an example of the problem with that power

[nmg]

Is anyone foolish enough to believe that the FDA is necessary? Does anyone believe the FDA is anything OTHER than an arm of government used for implementing political agendas such as the Drug War?

nmg

[Hakluyt]

The morning after pill was delayed in approval for use by perscription in the 1980s and early 1990s.

Of course, if anyone doesn't understand what the FDA is (a captured agency with a very cozy relationship with industry) then they clearly aren't paying attention. This is one of the many problems with well-meaning regulation. The FDA is, in other words, at its very heart political in nature. That joe and M1EK happen to differe with one aspect of those politics is more of an indication of what their policy preferences are than anything.

[Hakluyt]

JDM,

Drug-approval by itself is very politicized, if by tht we mean that industry heavily influences an outcome because the FDA has been captured by industry. The the Bush administration has politicized it for another group of patrons doesn't detract from this fact.

[JMoore]

nmg

Necessary? No, but then neither is electricity. Still, it's nice to have.

Could the FDA be better? Definitely. It's too slow, and like any institution of government, is vulnerable to politics.

Do I believe it is something other than...? Yes, overall, I think it can serve a useful function. Ideally, though, I think its power to ban should be removed. Instead, let it authorize a seal of approval; let it write administration guidelines; let it require warnings on unapproved drugs.

[JMoore]

Thanks, Hak. You're quite right of course: it is a captured agency--the great vulnerability of government regulators. In my scenario, of course, the approvals board could not be so easily captured by drug makers since it would already be owned by the people who have to pay up when drug makers go bad. (I should also mention that "my scenario" isn't really mine--it's been floated around lib circles for years--I'm not that original).

[Hakluyt]

JMoore,

Right now much of the FDA's budget comes from drug companies seeking approval of their drugs.

If it had its power to ban taken away it would be much more like the SEC and its role in dealing with registration statements.

[JMoore]

Well, this discussion has been marvellous!

Civil, but not dry.
Argumentative, but not vicious.
Passionate at times, but not nasty and insulting.

Quite a change.

Now, off to an expensive dinner at someone else's expense....

[Robert Goodman]

Book on this topic: "The Myth of Scientific Public Policy" by Robert L. Formaini.

It is also interesting to note that Congress has not left things up to FDA in all cases. The Federal Food, Drug and Cosmetic Act is riddled with mentions of particular products (not by brand name, however), specified by Congress as exceptions or to have particular rules applied to them. Congress could make an exception in the case at hand as well.

Meanwhile, some states have made arrangements that practically make emergency contraceptives OTC -- standing "prescriptions" filed by physicians at pharmacies. FDA has not objected as to the validity of such an arrangement.

[Phil]

JMoore, if it were plausible, it would have happened pre-FDA, when people had even more incentive to control their own healthcare costs than they do now.

I want to shake the hand of the person who accepts this as a valid argument, just because I always wanted to shake the hand of an anencephalic adult.

"If social security was a good idea, we would have had it before FDR, when social conditions were even worse than they were during the 1930s!"

[M1EK]

"Which would give me some comfort because health insurers make money from healthy people."

No. They make money by not having claims, which is a different thing entirely. If they can make more money off your premium by NOT filling your drug, even if your quality of life goes into the dump, they will.

Most people don't get to choose their insurance company either. So much for that way out.

[jf]

Most people don't get to choose their insurance company either. So much for that way out.

That sounds like a perfect argument for eliminating the system that allows employers to offer insurance to their employees without having to tax it. I've never understood a system that penalizes people for choosing their own insurance, but that seems to be what we live with.

I'd add that the myth of "group insurance" needs to be dealt with as well, although I'd be wary of any plan to regulate it out of existence. (Scare quotes used because the "group" depends on how big of a company you work for, instead of the insurance company recognizing that you belong to the larger "group" of all their insured customers.)

[M1EK]

"I want to shake the hand of the person who accepts this as a valid argument, just because I always wanted to shake the hand of an anencephalic adult."

And I wish you were here, so I could stick my foot up your ass, but we're going to have to settle for vivid imagery, I guess.

All sorts of useless to dangerous 'cures' were peddled before the FDA, and regular people did, in fact, buy them. What we have nowadays, warts and all, is a comparative paradise.

[M1EK]

"That sounds like a perfect argument for eliminating the system that allows employers to offer insurance to their employees without having to tax it. I've never understood a system that penalizes people for choosing their own insurance, but that seems to be what we live with."

I've never understood peoples' willingness to look at successful nationalized systems in every other industrialized country and say that it's worse than what we have here, but here we are. (In fact, at one point in my life, I was one of those guys! Although the insurance racket in this country wasn't quite as asinine in those days).

As somebody pointed out on another blog (I forget which one), health care fails most tests of a good market - you can't opt out (if you want to live), you can't negotiate price; there's very little chance the average consumer will be educated enough to make informed-enough decisions on their own; and society generally isn't willing to let people die on the streets for making poor choices.

[Ammonium]

I can no longer buy cold medicine without seeing a pharmacist and registering with my [blue] state, and I'm supposed to act surprised that the Bush administration is trying to prevent the morning after pill from going OTC?

Medicine is totally politicized, like everything the government tries to control. I guess the lefties are surprised to learn that Bush is not a saint -- he'll play politics too.

But as real orld libertarians, we agree that the problem isn't that the FDA is bad, it's just that the wrong people are running the FDA. Always.

[Eric the .5b]

I can no longer buy cold medicine without seeing a pharmacist and registering with my [blue] state, and I'm supposed to act surprised that the Bush administration is trying to prevent the morning after pill from going OTC?

Absolutely. The report makes me grin. "The one prescription-to-OTC decision in the last ten years that was politicized - was made politically! The shock! The horror!"

The point is not that most of those decisions aren't politicized and then made on a decision of the merits, it's that they can get politicized and then won't be made on the merits - and we're stuck with them.

[nmg]

All sorts of useless to dangerous 'cures' were peddled before the FDA, and regular people did, in fact, buy them.

So? Unless you advocate paternalistic authoritarianism, where the govt routinely abrogrates our freedoms for our own good, then I must assume you at least agree there should be no agency allowed to ban medicines that consumers want to use.

Test drugs and provide information and warnings?
Sure we can live with that, but an agency that actually has the power to label you a criminal for taking certain medicines? unconscionable.

nmg

[Hakluyt]

M1EK,

All sorts of useless to dangerous 'cures' were peddled before the FDA, and regular people did, in fact, buy them.

And all sorts of useless to dangerous "cures" exist today. Has the FDA changed the status quo w/regards to that? Not one iota. This of course gets us involved into a necessary and/or sufficient discussion. The point is though if the main means to judge the FDA is this one you are providing, then clearly the FDA is an abject failure.

I've never understood peoples' willingness to look at successful nationalized systems in every other industrialized country and say that it's worse than what we have here, but here we are.

Having lived in a "successful" nationalized system (your term entails question begging by itself) I perfer the one in the U.S.

nmg,

Since the FDA's decision to approve or not is so heavily dominated by industry (which is what many FDA scientists say in the open about the process) in the first place, trusting them to make the decision is rather foolish to start with.

[Hakluyt]

M1EK,

What we have nowadays, warts and all, is a comparative paradise.

What we have today is a completely different sort of drug-making regime based largely on changes wrought by enhancements in expertise, knowledge, etc. and has little to do with the FDA.

[M1EK]

"So? Unless you advocate paternalistic authoritarianism, where the govt routinely abrogrates our freedoms for our own good, then I must assume you at least agree there should be no agency allowed to ban medicines that consumers want to use."

In fact, I DO NOT AGREE. I think having the FDA ban the use of advertizing and selling antifreeze as a home remedy for the common cold, for instance, is a damn good idea, even if it infringes on your freedom to be stupid.

Then again, the FDA failed to stop the Blue Man Kook, so I suppose I understand the libertarian argument against it. If it couldn't help Your Guy not look like such an idiot, it must be useless, right?

[Hakluyt]

Another area where the whole issue of what the FDA does is politicized is regarding various "herbal remedies," etc. Of course this leads into an area which liberals just love, so they aren't going to talk about there being no regulation there.

[joe]

'"FDA boards don't inject politics into technical decisions about drug approvals. People inject politics into technical decisions about drug approvals."

Thank God FDA boards aren't made up of people then...'

People who managed to do their jobs honestly and competantly 67 out of 67 times, until one certain administration decided that having the job done honestly and competantly wasn't important. People, btw, buy and posess firearms, too. Most of them manage to do so without commiting violent felonies, and those that do are extreme outliers.

"Pointing out that this is the first time this particular bias has effected this particular branch of government's execution of this exact power in the last 10 years does not in anyway deflate the libertarian critique of government monopoly power, or change the fact that this is an example of the problem with that power." It does, however, deflate the criticism that such corruption is inevitable, and that the job cannot be done without such corruption. Just as the overwhelming number of decent, responsible gunowners deflates the criticism that private gun ownership leads inevitably to murder.

[joe]

nmg, "Is anyone foolish enough to believe that the FDA is necessary? Does anyone believe the FDA is anything OTHER than an arm of government used for implementing political agendas such as the Drug War?" Seen a lot of remedies containing mercury on the shelves at CVS lately?

Because they used to be all over the place.

[Hakluyt]

joe,

Seen a lot of remedies containing mercury on the shelves at CVS lately?

Yeah, if they sell Ayurvedic medicine you can. Many Asian "cures" and "remedies" use mercury as a component of their teas, compounds, etc.

[Hakluyt]

joe,

And you can find mercury in less exotic OTC areas as well. Including eye drops and laxatives. My wife used to work in a pharmacy, she could tell you all about all the sorts of uses mercury has in today's medicine. You are the proverbial fish in a barrel. Let me get my gun.

People who managed to do their jobs honestly and competantly 67 out of 67 times...

This assumes that the system itself is an honest one. Essentially you are complaining about one type of problem, when the problems with drug approval are endemic (again, according to FDA scientists themselves).

[bigbigslacker]

The function of the FDA does not have to be carried out by the federal government. When you go into an electronics store and see all the latest products, all bearing FCC, UL, and ETL marks, they all were tested by private labs (even the FCC testing) who then issued authorization for those marks. Reputable retailers will not sell products that do not have these "certs". The government does nothing, it doesn't even write the safety standards. That is all done by commitees made up of representatives of private corporations.

[Hakluyt]

bigbigslacker,

See, without the FDA we'd have OTC items which have mercury in them. Oh wait, we do. 🙂

[tarran]

I think that we libertarians and statists like joe are arguing at cross purposes:

Joe is arguing that the FDA mostly does a good job and that any organization regulating drugs would be subject to simmilar political pressures. Others are arguing that the FDA is an evil organization that routinely prevents good drugs from getting to market.

The problem is not that the FDA exists. Certainly there is a need for regulatory bodies that inspect and audit drugs. Prior to the existence of the FDA, this function was carried out by the A.M.A. and Consumers Union (the guys who today publish Consumer Reports).

The problem with th FDA is that its edicts have the power of law. If the FDA does nto approve of a drug, if someone tries to use, manufacture or sell the substance, people will kidnap him, steal his stuff and stick him in a cage. By comparison, should a private group, like Consumer Union, recommend against a drug or even a particular manufacturers formulation, the consumer still is free to purchase or not purchase the drug as they desire.

This is the heart of the problem with the FDA. It eliminates our control over the health of our bodies. This loss of control has deadly results. For example, my employer's flagship drug product is not approved in the US. but is approved in Europe, Canada, Australia and Japan. As such hundreds of kids in the US with a particular genetic disorder are doomed to live short lives full of agony while other children accross the border have a chance at an almost normal life. The reason for the disapproval was a serious gap in our quality systems that could have, but never did impact the quality of our product. Thus many parents who would choose to risk the drug to give their beloved children a chance to live into adulthood and a childhood free of pain are denied the freedom to make that choice.

Additionally, the FDA has perverse incentives not to view drug safety and efficacy as its primary concern. If the FDA goofs and allows anothe Massengil debacle does it suffer? Not a whit. If they make a mistake, the rules and laws will be changed, and they will be given more money and a greater bureaucracy to command. The FDA only needs to keep a few senators and representatives in a particular comitee happy and it will continue to get funding. They could do this by approving safe and efficacious drugs, or they could do it by banning drugs that a powerful senator frowns upon. They do not directly answer to the consumer.

On the other hand, let us assume a group like Consumer Union makes the mistake. Well, people will start ignroing its recommendations. Then it will have trouble raising money. Moneyed individuals who are dissatisfied with the performance of the testing will look for alternative organizations. If one is not available some critic will start this own. It is highly unlikely that it wil get this far; Underwriter Laboratories (the UL sticker on your appliances) has been certifying electrical appliances fro I think over a century now, and I can find no complaints about its performance. The insurance companies who bankroll it have found it quite beneficial in reducing their costs.

To me, the performance of the FDA is irrelevant. It is the fact that I have no recourse when I disagree with it that is the problem.

[bigbigslacker]

If FDAish lab testing were private, a good capitalist organization would step forward to issue product certification in a case where the competitors were showing their tardishness. The free market has ways of dealing with ineptitude.

(I actually spell-checked this message. MS Word says "tardishness" isn't a real word. Oh well, the free market has its flaws)

[Hakluyt]

tarran,

It eliminates our control over the health of our bodies.

joe (whatever he says on the matter of abortion) isn't interested in such individual control, choice, liberty or freedom.

[Phil]

And I wish you were here, so I could stick my foot up your ass, but we're going to have to settle for vivid imagery, I guess.

You're welcome to fly here and try any time you think you're ready, tough guy. (Boy, you sure talk big about whose asses you're going to kick. Which leads me to believe you're kind of a pussy, as most Internerd ass-kicking-talkers end up being).

All sorts of useless to dangerous 'cures' were peddled before the FDA, and regular people did, in fact, buy them. What we have nowadays, warts and all, is a comparative paradise.

Did I say I disagreed with this? Does this have any bearing on the stupidity of the argument, "If it was a good idea, someone would have done it before?" Don't bother typing, because the answer is, "No, no it does not."

[Hakluyt]

Liberal fight! A cage match between M1EK and Phil. See who is the biggest statist!

[M1EK]

'Does this have any bearing on the stupidity of the argument, "If it was a good idea, someone would have done it before?"'

Hey, retard, this country existed for a long time before the FDA came around -- and yes, in an unregulated market, I would have expected 'it' to have been done 'before', if the 'it' is a supposedly profitable enterprise which would have helped a lot of people. Otherwise why do we talk about how great leaving things up to the market is?

And your counterexample of social security really showed who might be the anencephalic adult around these parts.

Here's a clue, Sherlock: If the libertarians assert that the market would 'solve' this problem as long as the FDA weren't around, then it's quite damn reasonable to look to times when the FDA _wasn't_ around and see how well it worked.

[thoreau]

Let's see if I can reconcile joe's stance with everybody else's:

everybody else: The system is inherently prone to abuse like this.

joe: Somebody still has to say "Hey, I'm going to abuse it!"

There, bad system + bad people.

Happy?

[Hakluyt]

thoreau,

joe is arguing the old Adams line that if we have the right people in office, everything will be ok. That's a radically different approach from being skeptical of government to start with no matter who is in office.

[M1EK]

thoreau,

The problem I have with your characterization is that I think the FDA, warts and all, is still better than leaving medicine evaluation up to the market, as we did pre-FDA with catastrophically bad results.

So a more accurate description might be that the FDA is the worst system of regulating medicine, except for all the other ones.

[Hakluyt]

M1EK,

You aren't even willing to compare it to another nation's system of drug regulation? That's very odd indeed.

[thoreau]

So much for my attempt to bridge the divide.