Thursday, May 24, 2007

A Q&A with the co-authors of 'Is Your Body Baby Friendly?'

Among the many theories of recurrent miscarriage causes is the controversial field of reproductive immunology. The general idea of reproductive immunology is that for a subset of women who suffer recurrent pregnancy losses, the miscarriage cause is that her body is having an immune reaction against the developing baby.

Reproductive immunology is controversial because most of the peer-reviewed studies that have examined the treatments for the problems (Natural Killer Cells or HLA incompatibilities, for example) have not clinically demonstrated that the treatments have a beneficial effect over placebo.

But that’s not the end of the story on reproductive immunology. Critics allege that many of these studies did not screen patients properly – and if you scratch beneath the surface, you will find countless anecdotal stories of women who have had five, six, seven or more miscarriages who finally carried a baby to term with the help of immunological treatments. These stories are hard to wave away as being pure chance.

One pioneer in the reproductive immunology field was Dr. Alan Beer of what is now known as the Alan E. Beer Center for Reproductive Immunology and Genetics (now run by Dr. Raphael B. Stricker). Dr. Beer passed away in May 2006 after many years of treating patients who had suffered recurrent miscarriages.

A recent book called Is Your Body Baby Friendly?, cowritten by Julia Kantecki and Jane Reed, brings Dr. Beer’s experience and ideas to a larger audience. I recently interviewed Ms. Kantecki and Ms. Reed about the book and Dr. Beer’s ideas by email, and here is what they had to say.

Q: So if a woman is constantly miscarrying or is failing with IVF, or just can’t conceive at all, you say that her immune system is to blame.

KANTECKI: Once the usual problems have been ruled out, such as male factor and chromosomal errors (which do not usually occur repeatedly) then immune problems will almost certainly be the cause.

Q: How can a woman find out if she has immune system issues contributing to miscarriages?

KANTECKI: She will need to have a series of blood tests done which will show whether certain antibody levels are too high, or if she has an abnormally high natural killer cell count, or if these cells are over-active.

Q: Who carries out these tests?

KANTECKI: Under the supervision of the woman’s fertility doctor, RE or Ob/gyn, blood is taken and sent to specialist facilities in California or Chicago. As it is possible to ship the blood samples in from other countries, this treatment is available to women anywhere in the world.

Q: Is it true that some of these immune therapies are dangerous and have been banned in the United States?

KANTECKI: No. Lymphocyte immune therapy has currently been suspended in the US, but this treatment is extremely safe. It is essentially a blood product, or serum, made from the male partner’s blood. This blood is washed and screened for all kinds of diseases from hepatitis to HIV before a tiny amount is injected into the surface of the woman’s skin. It works by prompting the woman to make blocking antibodies that protect the fetus from immune attack. In an analysis involving a survey of over 3,000 patients the risks involved were shown to be negligible.

Q: Why has the treatment been suspended in the US?

KANTECKI: The FDA has based its decision largely on the negative trial outcome involving lymphocyte immune therapy – or LIT. However, as you will read in the book, this trial was seriously flawed as many doctors and professors now acknowledge. The conclusion of the many studies that have been carried out properly is that this therapy does far more good than harm.

Q: Is LIT available outside the United States?

KANTECKI: Yes. It is widely available outside the US in countries including South America, Australia, the Philippines, Middle East and Europe. 70% of Japanese teaching hospitals provide this therapy as a matter of standard practice. In Mexico, a 78% ongoing pregnancy success rate is being seen in patients with a history of miscarriage.

Q: What about treatments that suppress the immune system? Do these treatments carry dangers?

KANTECKI: Immune therapy used for reproductive failure is a temporary measure. It is designed to replicate the natural suppression of the immune system at the very beginning of a normal pregnancy. The drugs involved are taken for the least amount of time and a prescribed at the lowest doses possible. These are standard drugs that have been used for years to treat other illnesses. They are just being used in a slightly different way.

Q: You state that Dr Beer has achieved a success rate of over 85% within three natural cycles or IVF attempts.

KANTECKI: Dr Beer’s success rates are extremely high. What’s more, his patient population is probably the most difficult to treat. Having seen many specialists or failed many times with IVF, many come to Dr Beer as a last resort. The average age of the patients that visit his center is just over 36 and he often treats women in their forties.

Q: What percentage of women with recurrent losses might be having
some kind of treatable immune problem?

REED: Dr Beer has found that 70-75% of his patients with three or more miscarriages have an immune problem. This is close to the 80% figure given in a similar analysis posted by Dr Carolyn Coulam ( another well known and respected Reproductive Immunologist) See this quote from Dr Coulam's article: "As much as 40% of unexplained infertility may be the result of immune problems, as are as many as 80% of " unexplained" pregnancy losses. Unfortunately for couples with Immunological problems, their chances of recurrent loss increase with each successive pregnancy.."

(Note from editor: These quotes are referring to patients who have had multiple miscarriages and other causes have been ruled out; not that 70-75% of all women with recurrent losses have these issues.)

Q: Why do you think the use of IVIG is not more widely accepted in the obstetrical community?

REED: Here is a summary of explanations given by another well-known IVIG proponent and infertility specialist Dr Geoffrey Sher:

Q: Any cost ballpark for pursuing Dr. Beer's therapy?

REED: Total cost of immune treatment (testing, treatments and consults) can average about $10,000. Preconception diagnostic testing can run about $1,300. Physician consult costs can run about $1,000 total (initial consult + follow-up consults and physician emails). Medications and follow-up testing can total anywhere from $2,000 to $20,000. Final outlay is difficult to predict. Insurance will often cover a good portion of these costs. More cost information about costs can also be found at Dr. Beer’s website and the files at Dr Beer's support group (which I also moderate). The group requires free sign-up to view documents.

Q: Do you think there's a trend to assume as a default in older women that all miscarriages are caused by chromosomal issues? Is there any evidence that older moms might be more prone to immune problems too?

REED: Yes, you are correct. This is a wrong assumption made by many. We recommend that older patients with recurrent losses and failures get fully immune tested before making conclusions about the causes of their problems. If there is an immune problem, there may still be hope for having babies with their own eggs. Yes, immune problem increase with age. You ask a good question. This is a fact that is often misunderstood and overlooked. Studies mentioned in our book supports this.

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