Prohibited medical treatments and procedures in the US

I started to put this in GQ, but there’s not a specific answer and I decided I wanted some examples.

My father and I got in to a discussion (read: “argument”) about doctors and medical care in the US. AS an example, my parents’ neighbor had cancer several years ago. He was an MD and was presumably more informed (or able to be more informed) and discovered a treatment which had a 90% cure rate for his particular type of cancer. This treatment was not available in the US (My dad says the AMA won’t allow it) The neighbor could afford to travel and stay in Japan for 9 months to receive this treatment and did so. He died anyway.

My father’s position is that if the treatment were available in the US he could have gotten it sooner and he would have had a much better chance of recovery and thus had a 90% chance of survival. Except that the AMA (or whatever agency determines these things) didn’t allow that treatment and thus was responsible for his neighbor’s death. I have no idea what the type of cancer was or what the treatment was, but my question is, for what types of reasons are procedures and treatments disallowed in the states? And what the heck can I tell my father (who has issues with doctors and hospitals and such that go back almost 50 years)? Can I have examples of treatments that are not allowed? That were eventually allowed?

Thanks.

The AMA (American Medical Association) is a professional organization. It has no power to legally ban treatments in the United States. The Food and Drug Administration regulates medicines.

As for why a particular treatment is not allowed in the United States, if it’s a drug the simple answer is that the FDA hasn’t approved the drug. There may be questions of efficacy or of safety.

Though not a cancer treatment, the classic example is Thalidomide a tranquilizer that was given to pregnant women to help ease morning sickness.

Although it had been approved in many European countries, an FDA commissioner blocked the approval of Thalidomide in the U.S., asking for more study. While approval was blocked, some 15,000 babies were born with birth defects to women who had taken the drug while pregnant.

Laetrile has been touted as a cure for cancer for more than 50 years, and was even the subject of a Congressional hearing back in the 1970s, although no clinical study has ever shown it to be effective.

I’d like to add that this defect was not found in any animal studies, and that typically new drugs are - at least these days - studied only very rarely and carefully on pregnant women.

The FDA is flawed in a number of ways, but it’s often damned if it does, damned if it doesn’t. When drugs like Celebrex or antidepressants come up with previously extremely rare side effects turning out to potentially be more common, the FDA gets screamed at for approving “dangerous” drugs. When treatments approved in other countries aren’t used here, they get screamed at for “holding up” approval - mind you, that’s assuming it’s the FDA’s fault here. Sometimes foreign drug companies don’t find it cost-effective to try to go through the clinical trial process here, for instance.

I was hoping to hear less about drugs and more about treatments or procedures. I understand that the treatment my parent’s friend received was more than one drug. Is the FDA also responsible for approving such things?

The FDA is also responsible for medical devices.

As a side note, the icky thing about Thalidomide is that it acts as an angioinhibitor, which leads to limb reduction deficits in developing embryos exposed to it. Thalidomide and other meds in the angioinhibition class are now being investigated for use as cancer therapeutics.

The FDA has analogs in other countries, and, at least in other first-world places, the randomised, double-masked clinical trial is the basic standard for showing effectiveness and safety in regulatory circles. Similar designs are employed in the evaluation of devices and procedures, but in most cases, pregnant women, women of reproductive age and children are generally excluded from clinical trials. Which makes for crappy safety data. But efforts are on to include children and non-pregnant women in trials, and in some cases there are clinical trials that use pregnant women, albeit rarely.

As part of a modernisation act, the US FDA created a high stakes fast track for the treatments of high-stakes diseases and syndromes like AIDS and Cancer, which go more quickly and tolerate more in the way of toxicity and adverese events. A number of new AIDS and Cancer meds have been cleared in this way.

I can’t believe that any little-known treatment for cancer would have a cure rate of 90%. Who told you that? Was it your father? Have you considered the possibility that your father doesn’t get his stories straight?

You’re really going to need to provide more detail to get any kind of answer. All you’ve told us so far is that there’s some cancer treatment, somewhere, that’s 90% effective, and has been banned by The Man. All I can tell you from that is that my Quackometer is pinging like MAD. If you really want some information as to why it’s banned (assuming that turns out to be correct), we need some idea of what the treatment IS.

First of all, thalidomide was never studied in pregnant women at all.

Second, thalidomide does affect rats… but the end result is different. In humans, you get a baby with deficient limbs. In rats, the offspring that are born are typically normal - but the litter size is reduced. It’s believed the defective rat fetuses tend to be reabsorbed by the mother’s body, so only the normal ones are left to be born. It’s a subtle change, and not noted until the initial research was revisited.

Nowadays, researchers pay attention to litter size as well as the quality of offspring produced, and medicine is very skittery about giving medications of any sort to pregnant women, even when they appear safe for everyone else.

Unfortunately, I don’t have much detail and finding out more will mean asking my dad and getting into another argument. And I certainly believe that my father point of view is seen through a filter that mjust might color fact a bit. And our neighr was a doctor himself, so I can’t imagine that the treatment was some kind of tribal medicine man or anything so whacky.

But I think I’ll just have to let it go.

Thanks for the trouble.

I can’t add much to this discussion except the observation that in my field of medicine, EVERY drug or procedure that’s was a cure-all when not available in the US turned out to be “meh” when it became actually legal.

Off the top of my head, I can think of 3 mediciations used in equine medicine that were available in Canada or Europe before they came to the states. When they were not available they were all the rage - folks smuggled them in over the border. In two cases, owners payed extremely high prices and went to the shadey vet.s who could get their hands on them.

In the third case owners and vet.s were willing to give their horses a potentially toxic drug I.V. that was only labeled for use in poultry drinking water.

Now all three are legally on the market. Two have taken their place on the pharmacy shelves and have proved to be no worse but not much better than other treatments. The third is hardly used because it doesn’t work very well at all.

So what happened back when the useless drug was unavailable and everyone swore by because the animals were all cured? No doubt it was placebo effect (which in veterinary medicine could probably be better termed wishful thinking on the owner’s part) and the fact that the disease being treated tend to wax and wane of its own accord and the times horses randomly improved the drug got the credit.
Which is a really long way to say - you were right OP. The chances that there is some better cure “out there” is slim to none.

While the AMA doesn’t have literal legal power to approve or ban a procedure, they have a heck of a lot of professional and lobbiest influence over both individual doctors and state legislatures. The AMA does have lots of “recommendations”, which, if not followed by a doc, could open him up to huge malpractice lawsuits if he doesn’t follow. The AMA recommendations are often equated in courtrooms with “standard of practice” - deviate from that, and you’re asking for trouble.

Seems to me the exception is AIDS meds - they were legal in Mexico before approved by the FDA and have been a lifesaving boon. But I’ll admit that I’m not up on AIDS medication or history, this may be heresay and poor recollection - and my Google-foo and patience are, honestly, not up to the search (I’d probably do better searching the Dope, where I suspect we did a debate or two on this). I do seem to recall that the cocktail people were getting internationally is not the commonly used one now - but it was better than what U.S. doctors could perscribe.

Starchild Abraham Cherrix wants to try Hoxsey therapy - after his first round of chemotherapy & radiation was ineffective. Social workers were involved - and the VA courts charged his parents with medical neglect.

Oddly enough, thalidomide has been found to help with AIDS. I don’t think this use is approved in the USA.

Are you perhaps thinking of a medication that was derived from eggs? There was some med (can’t remember the name of it; two letters followed by three numbers, like AX-271 or something) that if I’m remembering rightly was OTC in Mexico but illegal here. People would organize underground med caravans to buy up the stuff in Mexico and smuggle it back to the States, and there was even a recipe circulating for how you could make your own in the kitchen, out of eggs. Somewhere in at least five different books in my library there are essays that talk about the drug but I can’t find any of them. Grr. Anyway, if that’s what you were thinking of, that particular drug was completely discredited.

An excellent example would be Dicletin, given to pregnant women to prevent morning sickness (worked like a charm for me) but not allowed in the US.

I suspect that is what I’m thinking of - the caravans to Mexico sound familiar. I may be confusing several alternative AIDS therapies not in use in the U.S. during those times before there was effective AIDS therapy - (AZT something, something?)

IIRC, thalidomide wasn’t fully studied - they didn’t do the tests that were supposed to determine if it crossed through the placenta. They also didn’t study it in rabbits (in which it does cause birth defects, unlike rats).

But I think the OP was more concerned about cases not involving pregnant women, where only one life is in the balance. If you’re suffering from an incurable, fatal disease, you have to wonder who is being “protected” if you make an informed chioice to try this drug or procedure, yet it’s banned.

As a related case, what about things like tyhe case in Lorenzo’s Oil, where the boy lacks the ability to assimilate necessary chemicals from food? I realize that the film is not a documentary, and things may be very slanted, but they give the impression that it was virtually certain that he could look forward to a future of severely diminished capacity. Once again, who is served by denying him this experimental oil? (assuming the film was pretty straight about it) If he and his parents knew what they were getting into, why is it a Bad Thing for them to take the chance of amelioration against a virtual certainty of a degraded quality of life?

Cite for that? Most “standard of practice” recommendations come from academic alliances of specialists who study the area. Such as the American Academy of Asthma, Allergy, and Immunology with their asthma guidelines, or the US Preventive Service Task Force, for their recommendations about a wide variety of treatments, procedures, and screening tests. http://www.ahrq.gov/clinic/uspstf/standard.htm

To name but a few.