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Monday, October 09, 2006

IVIg and the Reproductive Immunology Controversy (Somewhat?) Explained

You come to the computer, filled with deep thoughts about medical controversies and medical discrepancies and differing opinions. And then you stare at the screen for a while and finally decide to type in what you read from Preventing Miscarriage.

First off, though I had initially been a little put-off with the opening of the book (it had a tinge of manic cheerleader: you can have a baby, you will have a baby, go team!), perhaps because I don't like people to make promises that they can't keep to all readers. But I grew to love this book when the river of information began flowing. Mostly because reproductive technology changes minute by minute and even books written two years ago seem outdated in light of new discoveries.

The only drawback with this book is that the "interview" stories comes from his patient base. And all but one person interviewed was ultimately successful in carrying to term. Therefore, take their glowing reviews of the author with a grain of salt. Then again, since the author practices in New York and seems to have many tricks up his sleeve, he may be someone who you'd want to schedule a consult with if you have recurrent loss or recurrent unsuccessful IVF cycles.

When I broached the topic of clotting and immunology disorders with my OB, I had no idea about this can of worms. I was confused by his reaction, but after hearing your stories and reading a few books, I'm beginning to understand that there are whole layers of in-fighting (sometimes connected to off-label use) within the medical community. Sort of like the Sharks and the Jets. And like the Sharks and the Jets, anyone who cavorts with a member of the opposite side is in danger of...a sound rejection and mocking (which doesn't sound dangerous, perhaps, but try having someone mock you when you are strung out on hormones and grasping at anything that is going to get you--and keep you--knocked up. Not a pretty picture).

This is from the book: "IVIG has been used by doctors for over 28 years to treat autoimmune diseases such as multiple sclerosis, but it is new in the treatment of miscarriage and IVF failure. This is an 'off-label' use for the drug--a new use for an already approved drug...(p. 187)"

Which is what made me pause. I had thought that IVIG was a new treatment--and it's not. It's an off-label use. And more on the politics of this in a moment.

One of his patients stated this: "I admire the doctors who are prepared to stand up for the immunology treatment. If no one was prepared to fight the conservative ways of medicine, we'd never get any changes accepted. It seems to me that it's become quite a political issue. Some doctors refuse to treat women immunologically, even after several failed IVFs. So the women have to go secretly to get the treatment. I've heard doctors say IVIG is like witchcraft. One screamed at his patient and told her to get out of his office, then he slammed the door behind her. But women talk to each other or search on related Internet sites."

Not being a doctor, I don't really understand the controversy that surrounds off-label use of accepted treatments. And what goes into establishing a drug's usage in the first place. I can understand doctors rejecting non-approved medications--especially if taken in conjunction with treatment prescribed by your doctor (though, with a situation like Domperidone, which is approved in other countries, I'm betting that some of the decision-making comes from pressure from the drug industry lobbyists). With doctors, I understand the desire to have control over a situation you are being asked to control.

But I've seen this before when the lactation consultant recommended Reglan (don't do it, don't do it) in order to increase milk production (instead of doing something like...oh, I don't know...checking my prolactin levels and making sure that I still produce prolactin and it wasn't wiped out by...oh...fertility treatments or something). Reglan is actually a reflux medication, but it has the added benefit of increasing milk production (if you produce a normal amount of prolactin in the first place). An extra use, let's say, to an already established medication. The OB waved the whole thing away at first, but later gave in with a "if it's what you want to do" (can we note, for a moment, the fact that he too didn't offer to run some simple blood work when I told him that my milk still hadn't arrived after three weeks? It wasn't until months later that I saw the endocrinologist when my new OB sent me).

And perhaps it's just my perspective, but the controversies over off-label use seem to pop up quite often when it comes to women's reproductive health. Which goes hand-in-hand with the lack of desire to be agressive and treat a problem. Or search for the root. Again, my experience is limited to matters of women's reproductive health. But I would love a study done that looks at off-label usage of medications and see how quickly they're established as commonplace, accepted treatments when they're outside vs. inside women's reproductive health.

9 comments:

Hopeful Mother said...

Very interesting post. I'd love to hear more about IVIg from ladies who have gone through it.

Interestingly, I think Lupron is used "off-label" in IVF- it is not the official use for the drug either...

statia said...

There are some women who find the thought of IVIg and other immunology treatments very proactive, but then it doesn't stop at just IVIg, etc.

I was told that I needed IVIg. I did my research and found that it wasn't for me. I didn't believe in it as it's not proven and there's too much controversy and with it it being unproven, I didn't want to dump medication in my body that has a risk of cancer. I ended up firing my doctor shortly after our first failed cycle, because of the fact that he chastised me for not taking his advice on doing IVIg. Both my primary care and my OB had my back and said that I absolutely made the right decision.

I went through an FET with a different doctor that felt that all of these immunology treatments was over the top and that he just didn't feel as if I needed them. He wasn't rude about the other doctors doing these protocols, he just didn't feel that it added to success rates. I got pregnant with him and am now 18 weeks. No IVIg, no heparin, no other immunology treatments.

Bottom line is this. Women have to do what's right for them, but I just give a word of caution. I'm not one to shun away from modern medicine by any means, but all of these medications aren't totally known what the long term side effects are. Just something to think about. Not only that, but it gives more hokey doctors a way to make a quick buck off of women suffering. It makes the doctors that are legitimately trying to fix these issues look bad.

The Town Criers said...

Statia--

A good point about the fact that one treatment does not fit all and that what might be worth the risk/worth the pain/worth the cost to one person isn't right for another.

But whether or not one agrees with IVIg (because it is controversial, and who knows what we'll find out about ANY of these drugs in the long run. Truly, I may have just caused numerous problems for my children just by doing what are commonplace fertility drugs), the larger point is that once you get down to it, there is no fertility treatment that is 100% effective. Things that work for one person for whatever reason don't work for another who has the exact same problem. And I question rejecting anything (rejecting it in the grander medical community sense of the word, not a personal rejection of the treatment) that has had an effect on a problem. I think there's a lot that can be gained by off-label treatments that are done cautiously.

I like that there are numerous paths out there, with options open if one wishes to try. Truly no offense is meant in this response--I just think it makes an interesting debate.

squarepeg said...

It is an interesting question. Another commonplace example of a fertility drug that didn't start out as one is Femara. While REs still prescribe it, the manufacturer's have disavowed it's use in ovulation induction. My RE won't prescribe it - not becuase he doesn't think it's safe and effective - but becuase he is afraid of getting himself and the clinic thrown to the wolves if a negative result comes from use of an "off label" treatment regimen. Unfortunately, for an off label treatment to become "on" label so to speak, the drug's manufacturer would have to shell out for new clinical trials, starting at a fairly early phase (2? I think?). This is very costly, and the number of patients who could end up being future customers for the new use usually makes it not worth their while.

Murray said...

I don't quite understand why immunology treatments are so controversial. Are they super high risk? Pardon my ignorance.

Anonymous said...

One word - malpractice.

Like squarepeg said.

If you use the drug for it's labelled purposes, and you run into complications, you have the backing of an entire pharma co. and all its lawyers, scientists, money, etc etc. Your complication may be well-documented, and just one of those unfortunate things for the patient. If it's a new complication, the drug itself comes under scrutiny. Either way, you have a big, powerful friend on your side.

When you use a drug off-label, you stake your entire career on that script. This may sound dramatic, but if something goes wrong, that's what's at stake.

A lot of drugs are widely used "off-label" so if you get caught you can turn around and say, "But all the other kids are doing it..." and the courts will make allowances in light of the fact that this is "accepted practice".

If the area is controversial (ie not "accepted practice"), you are using a drug off-label, and something goes wrong... well.

And keep in mind this is a career that takes a lot to build - time, money, effort. Not something you can just toss aside lightly and start anew.

Using a drug off-label and prescribing treatments that are controversial is either the height of bravery or incredibly gung-ho, depending on whether it worked for you or not.

Bea

Anonymous said...

Oh, and I'd like to hear more about immunology, too - when you get the time.

Bea

The Town Criers said...

I knew you chickies would know the answer about off-label use. So now the question is--is it just my perception, or does there seem to be more people up-in-arms and rejecting the new use when it applies to female reproductive health? Where is the support for additional studies? Is it that infertility is not "life-threatening" (note my quotes) and therefore not worth the time and money of pharmacutical companies?

statia said...

It's a very interesting debate. And I definitely agree that it's everyones personal decision. And it's definitely not for everyone. But there are people that are taking it so far to the extreme that it's scary. Downright frightening. From doctors to patients. There are some great doctors out there that are being completely responsible when it comes to treating someone for immunology, but it seems to me like, I'm finding more, who are just out to make a quick buck at the expense of someone's personal tragedy and that just pisses me off.

That said, there's a lot of regular doctors out there that are like that too.

I think you pegged it when it comes to research on infertility. It's by and large an elective practice. It's a huge money maker for doctors in this line of practice. If they know something works with their success rates, they're not going to want to take time to try something new that might not work to the advantage of their stats. It's sad that it's this way, but it is. The only way this would probably change is if it was more regulated by the government. Why would they spend money on research when it could be better spent on a new Mercedes?

Me? Bitter? :oP