Friday, April 21, 2006

The FDA's ridiculous argument against pot

While I wouldn't say there isn't an argument against allowing marijuana to be used for medical purposes, the FDA's arguments in its release (read the whole thing here), are ridiculous.

The FDA's fundamental argument is over whether marijuana is "safe and effective medication": marijuana "has a lack of accepted safety for use under medical supervision" and there is "sound evidence that smoked marijuana is harmful."

Gee, I guess if you're dying of AIDS--or cancer! you really need to worry about the harm a joint might do to your health!

As for the "effective" argument, I repeat: if a sick person says it helps, IT HELPS! If a nauseous person says a joint makes him feel better, that is, by my definition, "effective" -- regardless of what any large-scale study might find. Even if marijuana advocates' claims are grandiose, which for all I know they may be, the basic claim -- that marijuana can alleviate discomfort -- is valid if real, suffering people say it helps.

"But it has a placebo effect--they only think they feel better!" OK -- and your point is? Because my point is, "feeling better" IS THE POINT.

18 comments:

Mike the Geek said...

When my niece (now in 5+ years remission) was taking chemo for Hodgkin's Disease in San Fran, she was constantly being pushed ("hounded" would not be inappropriate) to use medical marijuana. She didn't want it, and could function sufficiently with the standard anti-nausea medications, but the "angels of mercy" wouldn't leave her alone.

If there are medically useful ingredients in MaryJane, they can be extracted, objectively tested, approved, and distributed. They can be purified, modified, combined, and provided in consistent doses like other medications. The primary push for "medical marijuana" is the legalized ability to get high, with hopes that it will then go "over the counter." If it's so great, then why not really make medicines out of it instead of trying to NORMLize it (sorry for the pun)?

Father Martin Fox said...

Mike:

I'm glad your niece is doing well.

I understand your point; I am not advocating for "angels of mercy," as you describe them, and I am not one of them: I don't smoke pot, don't approve of it. (But call me whatever, I don't think it's the same threat that many other drugs are, something I think we all understand, don't we? And the Drug War has negative consequences, too.)

In any case, my understanding is that they do make drugs out of ingredients in marijuana; and some of these are available.

My question remains, however: if a patient has tried those, and says, "I've heard pot might help; let's try it" -- I don't see any intrinsic moral problem with that; and if the patient does find that it helps, then it helps!

As it is, serious pot-users have little problem getting all the mary jane they want; and my impression -- correct me if I'm wrong -- is that the casual user of marijuana isn't punished very severely.

I have no doubt that others, interested in making a buck, are supportive of "medical marijuana"; that, to my view, isn't terribly meaningful either way -- because my focus, all through this, is on the rights of the patient.

If patients don't want it, then the law is not an issue; if patients do want it, the fact that someone will make a buck providing it is pretty hard to avoid; in fact, impossible.

Father Martin Fox said...

Mike:

As I pointed out in my original post on this thread, the FDA is arguing against allowing dying people to smoke pot is "unsafe" and questions how effective it would be.

I repeat: it's ludicrous to worry that smoking pot might be "unsafe" for a dying person; and as to effective, if the patient says it helps, it helps, "period," as far as I'm concerned.

Dave Oatney said...

I can think of quite a few drugs that the FDA has allowed to be put on the market that could be described as very likely "unsafe."

Darwin said...

I take your point, but in a sense it could be made against a lot of FDA practices.

Actual pain killing drugs have been denied or pulled from the market because of negative health effects in less than 1% of users -- despite the fact that many of these are used pretty exclusively by terminal patients.

So I suppose they are at least consistent...

Father Martin Fox said...

Darwin:

I wouldn't object if you used my comments to support a broader attack on the FDA, or government power in general.

Anna said...

Mike the Geek,

One question, how can we know which compounds in marijuana smoke are the active ones? We can only test them, and even getting the stuff to test under good condtions might be illegal.

How do we know that it is not the combination of compounds that work rather than just one or two. (Look at calcium and Vitamin D, both are necessary for good bone strength. One without the other doesn't work as well.)

Also, as I said in the other thread on this topic, delivering the dose via smoke inhalation could be very different than the same drugs going through the digestive system. A number of drugs cannot be made into pills because of they are neutralized in either the stomach or the intestines.

And if a person has severe glacoma (where pot is known to reduce pressure inside the eye where other drugs are unable to) or nausea where they are unable to eat, let them smoke marijauna and see if it helps. If it makes they high, lets deal with that later.

FYI, even though morphine can be seriously addicting, the people who have used it for severe pain, never became addicted to it. It would be interesting to see if the same thing held true for pot.

Father Martin Fox said...

Anna:

I don't disagree, but I would keep it simpler: I think the individual should not have to wrestle Big Brother over this.

I am on the side of the individual sick person who says, I want to try some pot to help me feel better. I reject the idea that someone has to "prove," first, that a joint will "work" -- because if the sick person says it makes him feel better, then it works!

In the case of addition: even if morphine did induce addiction in those in pain (which I think it has, historically, but anyway), that doesn't matter.

Morally, the good of relieving pain justifies providing the morphine; the addiction is an unavoidable consequence you live with, or you deal with after the fact. Practically, when people are dying, addiction doesn't matter.

That's why I found the FDA's news release so moronic, both in execution and in its attitude toward us, the people: to talk about "safety" around marijuana use, by AIDS and cancer patients! What, are they worried someone smoking a joint in bed will burn down the house? Gimme a break!

joeh said...

The argument for legalizing for medical reasons will become the legalization of this drug for all. Kind of like not being able to deny abortion if it impacts the "health" of the mother allows even partial birth abortion. You cannot look at things from a point of view of logic, but must look at legal precident and rights. If Jack can smoke dope because he has cancer, I can smoke it if my toenail needs to be cut or you are infringing on my rights. If you can smoke dope with cancer, then why can't I inject dope in my viens and if he can inject it with cancer, why can't I inject it with long toenails. You have to always remember the ACLU is lurking nearby ready to jump out of the shadows. Look at the entire state of pornography and how it started. The slipperly slope is real.

Father Martin Fox said...

Joe:

There's a fundamental difference between pornography and abortion, and marijuana or -- for that matter -- other drugs. Pornography and abortion are intrinsically evil; that cannot be said about marijuana, or for that matter, heroin and other drugs. (I suppose there might be a drug that is intrinsically evil, but I can't think of one just now; but the point is, most drugs that are illegal, are not intrinsically evil.)

There are legitimate reasons for them to be controlled; but the fact remains, they are not intrinsically evil. Which means, there are legitimate uses for them.

The simple matter is that people who are suffering, indeed, dying, say that marijuana helps. I am in no position to contradict them! If marijuana helps them, they are entitled to have it; and laws that impede that are, in my judgment, unjust to that extent.

Anna said...

I don't even know what I think any more about the FDA, other than I don't like them.

When I see scientific decisions being made more because of political decisions, that is wrong. Compare the number of deaths that some drugs such as Vioxx has caused (and has been yanked from the shelves) vs the deaths that chemical abortion has caused (in the mothers) and it is still available.

I also know how easily data presented to the FDA can be manipulated to give the results desired.

Wild idea. For new drugs that have a reasonable distance between theraputic doses and toxic doses, lets have a sliding scale of how widely they can be prescribed. At first, under fairly strict control and then as more and more people use them without serious problems loosen the controls. That will allow problem groups etc. to show up that might not show up in the initial testing. It would also allow for doctors to fine tune who gets what.

CW said...

Father-

There is one objection to your arguement that I'd like to raise. If we're saying that effecacy is the critereon for wether or not a substance should be used in the case of terminally ill what is to say what drugs should and should not be used and when. It's easy to say, in the abstract, that terminally ill people should be allowed to use whatever they can to ease pain, and Catholic moral teaching would say that we should try to limit pain but the first statement offers no guidlines.

It's one thing for a doctor to give out drugs with perscribed dosages and metered amount, it's another thing etirely to open up a person's medical care to some stuff that some people say seems to help.

Under a strict efficacy arguement what is to stop harder drugs? If a person reported that they found cocaine to be helping should we get them that? What about tobacco? Take any substance possible and we could justify it with the efficacy critereon.

Furthermore, what defines illness when this is acceptable and when it isn't? Marijuna and other drugs have health effects that just now we're starting to gt a handle on. If a young child is suffering should something that could cause long term brain damage down the road acceptable? Doctors and other health care advocates will point out that they get survival times wrong all the time. Someone isn't expected to live 6 months and they're around years later.

As someone who teaches future doctors one of the first things that they are supposed to look at is wehter or not any drug is actually helping. Patients are really bad at determining this. The FDA study reflects this, people say that it helps but nothing is detected. The fact that there were large study shows that they were looking for a subtle effect. That they didn't find it suggests that it's not there.

Does that mena all the anecdotal evidence is wrong? No, it means that the anecdotal evidence is probably the placebo effect. This isn't to say that a placebo can't relieve symptoms, the more we learn about the placebo the more remarkable it is. But doctors shouldn't be in the practice of perscribing placebos that are harmful, like marijuana, just so that a person is reassured that they have something.

Why is it that THC is often used by doctors and not smoked marijuana? Simple. What amount of THC gets into your bloodstream from one joint? What other chemicals do to and in what concentrations? What are the effects of all of these combined? These are questions that can have a major impact on how other medicine is affecting the body. With THC at least it's a limited chemical subtance being added for treatment in a known concentration, with studied properties about it's staying in the system. Also, it's easier to get higher levels of the chemical, which are needed for the drug to be effective, into the system.

In short all the FDA is doing is noting that marijuana is a class 1 drug now, and that's where it's going to stay. It has all of the harmful elements to make it a class 1, and no demonstrated benefits to want to move it out of there. Your efficacy arguement while worthwile, and sympathetic, does nothing to change that.

Changing the arguement to simple efficacy also means that any other drug, regardless of class, that a patient believes would help should be tried. This is poor medicine as any claims that a patient wants to try marijuana is based, wholely, on anecdotes who's claims fail in all cases where it is tested. No other substance is treated like this, why should marijuana?

Father Martin Fox said...

CW:

Perhaps I'm misunderstanding you, or vice versa . . .

The reason I'm focusing on efficacy is because we're talking about comfort, not curing the underlying disease. And I was talking about situations in which the underlying disease is not going to be cured. So it's hard to see why the putative "harm" caused by something that provides comfort.

Example: morphine is a legal, proper painkiller; is it not true that when a patient takes a dose of it, it depresses breathing? Heavy dosing of morphine is having the effect of bringing death nearer.

Yet Catholic moral teaching is clear on this: so long as the intention is pain relief, it is moral to administer those doses; it becomes immoral when the intention becomes to induce death.

So why doesn't the same apply to marijuana, and, yes, cocaine or heroin etc.?

And, yes, I am saying that it would be moral to use cocaine or heroin, if you couldn't meet the need -- in this case, for pain-relief -- with other drugs.

As it is, legal drugs do seem to do the trick for pain relief. But let us suppose, for sake of argument, legal, and standard pain relief meds were unavailable. Then non-standard methods would be appropriate, particularly where the patient is dying anyway! "You're going to die in the next day or so; but, no heroin, it could be bad for you!" Does that make any sense to you?

Now, in the case of marijuana, it's not for pain relief, as I understand it, but for relief of nausea. Can you tell me just what harm marijuana is going to do a terminal cancer patient?

Perhaps you thought I was advocating marijuana for non-terminal cases; not so. And I would be fine with having doctors handle it; I object to the federal government preventing patients from having it.

You mention tobacco. If someone is dying, and there is no reasonable hope of reversing that, what is the point of that person not having tobacco?

Again, rather than have the burden of proof on the individual, I believe the government should bear that burden. It's one thing to say, we need to control these drugs, for the sake of the whole society; it's another thing to say a dying patient getting grass is a threat to society. I don't see that! After all, morphine is controlled in just that fashion; it's legal for a medical use, but illegal for general use.

You use the "slippery slope" argument -- if marijuana, then why not anything else?

The answer is, because we are a society of reasonable people, and we make reasoned judgments all the time like this. They don't have to be infallible. We already treat marijuana different from other illegal drugs; the penalty for using marijuana is generally milder than for "harder" drugs -- why, even our terminology of "hard" drugs shows we see a difference. President Clinton admitted smoking pot; no big deal. What if he had admitted snorting coke, or injecting heroin?

So I don't buy the argment that if we allow medical marijuana, the floodgates will open.

Also, it's not as though the law, once relaxed, couldn't be tightened again. Our drug laws have gone back and forth over the years.

Father Martin Fox said...

CW:

I wanted to say, you do make some good points; as I said in my original post, it's not that there might not be an argument against marijuana for medical purposes; but I argued that the FDA is being absurd when it hammers on the "safe and effective" line, in the case of comfort care for terminal patients -- particularly the "safe" part.

I still feel that way, your very sound points about methodology notwithstanding.

joeh said...

Father, your argument that the slippery slope does not apply and that we can use logic flies in the face of everything we have seen in our courts over the last 50 years. Logical people open doors that lawyers through open wide to things we would not have considered possible. My point about abortion leading to partial birth abortion on "health" grounds is clearly a case in point. If you open the door to medical pot for terminal patients, you are then allowing one American to have something that another is denied. This is discrimination and the courts have long ruled in favor of opening wide the doors congress laws have cracked open for one. Before we OK help to restricted use of this drug, I think it would be wise to have a clear court ruling on the impact if approved. I think you will find logic plays very little role in court rulings.

CW said...

Father-

This will be long, but I feel that you deserve the best answer I can give.

You make excellent points and they are well thought out, but I think that the FDA still has a case that this is the right thing to do and I think that they’re correct in doing it. We’re talking of an issue of comfort and there is no medical evidence that comfort is being provided other than that of a placebo.

There are plenty of cases where things that are harmful are used morally, like your example of morphine. Furthermore, nobody should really argue with you giving a main in extreme pain heroin would be an immoral act if other drugs are not available.

But there’s a critical distinction between giving heroin out and the use of marijuana that you describe. Morphine is a opiate which are known to provide pain relief, marijuana has no medical use as it is currently understood. That is why it is a class 1 drug.

Are there people that say that it helps, sure. Are they lying? Nope, they used it and felt better. But there’s no evidence that it’s anything other than the placebo effect.

Also, I acknowledge that I am using a slippery slope, but I think you and I are talking cross purposes on what that slope is.

You’re correct in saying that we treat different drugs differently, and we should. Laws change, studies change what we think about drugs, all of that is fine. But what doesn’t change is that drugs are prescribed that have clear benefits and don’t do unreasonable harms.

Marijuana is a class 1 drug because there are no benefits shown and only harms. The slippery slope is that why should we allow patients to decide on a course of action for their treatment that has no benefit shown? I don’t see justification for allowing patients to start prescribing themselves a medical treatment simply on anecdotal evidence. No other drug that is treated like that and I see no reason why marijuana should be the first.

If it is, then why should we stop there? Why not allow patients to prescribe themselves anything that they think might help? The moral argument is the same. We have doctors to decide on a legitimate course of medical action for everything else, why should this be different.

Your objection about the terminal care of cancer patients is valid, but a straw man. Nobody is intentionally keeping drugs that would comfort terminal cancer patients from them.

In the event that any study showed that marijuana would help these people then give it to them. Nothing has shown that, the studies have been large and no effect has been found. In the event that something had been found it wouldn’t be a class 1 drug.

To some degree you and I are arguing cross purposes, I think. If I misstate your argument I apologize, but I think that you are arguing that any drug that can provide comfort to a dying person is justified in being used. On that you and I and the FDA would agree.

The FDA is saying that it has no benefit, and looking at the studies, I agree with that argument and that’s my objection to your argument. All of the arguments for the “legitimate medical use” of marijuana seem to boil down to, “It will help people and if you say that it shouldn’t be used you want people to suffer.” I don’t want suffering and neither does the FDA. If this, or any other drug, has some benefit it isn’t be class one.

Here’s one solution to the issue. Give the patient a different placebo that doesn’t cause harm. Sugar water injections, water injections, saline injections, whatever. That should relieve suffering just the same without causing any harm.

We could keep listing placebos all day (vitamin pills, gelatin, etc.) and if one of them doesn’t work switch to another. None would cause harms, all could provide the same documented medical relief as marijuana, that is to say, none. The placebo effect would still be there, and with no harms this seems to be the more correct decision.

Oddly enough, nobody argues for this placebo course of action preferring to push a recreational drug as a legitimate medical option even though the documented benefits are the same.

If you object to that on a basis that I’m denying someone a drug that could help them then prove that it does. Nobody has yet. If you object based on the fact that I’m giving people things that don’t actually do anything to help and that is wrong, then how is that any different than marijuana?

I look forward to you answer father, you’re a brilliant man, and may God bless you for entering, and staying, in the priesthood.

Father Martin Fox said...

CW:

I enjoyed your response!

My response is as follows:

First, I'd ask a factual question about the studies you mention: did they have people actually smoking marijuana? I'd wonder, because how do you do a double-blind test on that (perhaps there's a way, who knows)? And if not, I'd wonder, is it possible that their tests were insufficient to verify, or falsify, what is reported anecdotally?

But, setting that aside, I'd have to say I think you've out-argued me, and I hate to admit that, but there it is! (So I am not so brilliant as you say.)

That said, I am rather more skeptical about the FDA than perhaps you are; no, I don't think its made up of ogres; but it is what it is -- a government agency, and its decisions are subject to group dynamic, not to mention politics.

But your rejoinder would be, the FDA had no basis for permitting medical marijuana, simply because of the lack of demonstrated efficacy. And there you have your argument, and its eminently reasonable.

That leaves me with one reply: I don't care! Or at least, not enough.

Maybe I'm too libertarian, but I don't get too bothered by cancer patients smoking pot. Perhaps it's because I'm skeptical about the entire "Drug War." I do toy with the idea that we'd be better off fighting drugs without most of the criminal sanctions.

So with all that, in the instant case: I wonder if there isn't some way we can live with a certain amount of ambiguity?

I.e., you have pinned me with your argument for why we don't want to give any official approval to "medical marijuana"; fair enough. But how about if we just look the other way when a husband runs out and buys a baggie of pot for his dying wife?

This may shock someone -- a priest advocating law-breaking!

But this is really how law works, it has to: official policy simply can't anticipate every situation; and for reasons you give, you don't want "official" recognition.

This may, in fact, be the status quo, I concede; but in that case, this discussion still has value in highlighting the difference between the moral law that must be upheld, and the civil laws that sometimes are bent, technically "broken," in furtherance of the moral law. And that may be a shocking idea to some, but I believe it happens to be true. This may be one instance.

CW said...

Father:

I’ve enjoyed this immensely, and not just because you say I’ve out-argued you.

Most the tests that I’ve seen have tried isolating chemicals and others have relied upon double blind studies of one sort or another though it’s hard to say how many. You can have one person smoke one thing and a different one smoke another or have one dose at one time be pot and another time be inert and see if there’s any difference in symptoms between the two. I have a friend who did studies with it about migraines so I know that the studies can be done. Are they all double-blind, probably not, too expensive. But if they thing they’ve found something they’d move to double-blind, so far nothing.

Hard to know how many studies have been done and what all the results are. Nobody really writes much up about negative results, unfortunately.

Though there’s always active research going on for this, it’s very trendy. (Yes, research dollars do follow trends rather than strict science) If effectiveness is found then my argument falls and it should be handed out as fast as possible to people it would help. Since nothing new has come up I think the church might not want to take the pro-pot plank up yet.

I’m not a huge FDA fan either, but in this case I would have to say that they do have a point. No studies, done by other people in the field, have shown any benefit. I could tell horror stories about getting anything through the FDA, but the secret is that the government never does any studies whatsoever. Other people do studies and the FDA oversees and data mines based on what doctors report from either studies or actual cases once a drug is released. That’s why, when a drug first is on the market, it’s often talked about as a “Phase IV trial.”

I think that you do have a point though with ambiguity and I think that you could point out, quite successfully, that no jury in the world would convict that man for buying any drug whatsoever for his dying wife.

Would we “officially” be looking the other way, heavens no. The law is still on the books, but the prosecutor is a government employee who’s main goal is convictions. He knows he’d never get one if there’s a decent argument by the defense, that is almost guaranteed to sway at least one juror away from voting for conviction. Why? Because as much as we talk about how you can’t legislate morality jurors decide law morally. The whole case would revolve around whether the man was acting in good faith.

If the prosecutor thinks that the man was acting in good faith, breaking a law, for a morally just purpose he wouldn’t prosecute the case. He’d probably cut a deal with the lawyer for a minor ticket and drop the charge. If the prosecutor thought that the man wasn’t acting in good faith but was looking for an excuse to move any sort of drug he’d send it to a jury. If the jury thought the prosecutor was overzealous they wouldn’t vote to convict and the guy would walk free. If they thought DA wasn’t overzealous, they’d convict the man. If the judge who sentences the man thinks that both the jury and prosecutor were wrong the punishment would be a slap on the wrist and probably suspended; if not, punishment. The law should not have ambiguity, how it’s applied, mercifully, does have ambiguity. (Really father, you should be watching more “Law and Order”)

Honestly, if a man seemed to act in good faith and I was on the jury, I don’t think I’d vote to convict. Why? The man did something that he thought was right morally, though wrong legally. In that case, I really don’t care enough either.

If you want to say that we should look the other way, morally, I agree with you. The issue that you always have to look for in law, and medicine, though is the potential for abuse. If a man is doing for his sick wife who has months to live, fine. But it’s nice to have the law there if you have the man who’s wife had the flu 12 years ago and is still going strong who seems to be taking advantage of the system.

If you want to say that allowing the man to give his wife marijuana, or anything else, is right medically, now you’ve just opened up a whole new kettle of fish. Trying to claim that by fiat is, essentially, the first step to getting the OTC use Mike talked about way up there.

I don’t really see why the advocating of law breaking by a priest should be that shocking. Shouldn’t we always obey the moral laws at the expense of the civil law? While at the same time noting that the state is just in punishing us for violation of its laws? I recall apostle Paul seemed to spend a good bit of time in jail for just that sort of thing.

Arguing about whether the “Drug War” is good or bad is another topic that we could probably trade a gallon or two of ink over, so we can save that for another day.

Father, this has been a great pleasure and I think that you’re far to modest. I may be right via evidence, but you’d win the TKO in the moral realm. I’ll drop you an e-mail and if you’re ever out my direction dinner’s on me along with all the homebrewed beer you can drink. You can even call my priest as a character witness first. Best wishes and may God continue to bless you.