In the Fall of 2005, via Committee Opinion # 313, the American College of Obstetricians and Gynecologists asked its physician membership to stress to the women of America the importance of planning for pregnancy. Unfortunately, in 2006, almost half of the pregnancies which occur in our country are still unplanned. That has several ramifications, probably the most important of which is that women who have consulted with their obstetrician prior to attempting pregnancy will have been placed on prenatal vitamins/folic acid. Taking folic acid before conception will significantly reduce the potential for having a child with a neural tube defect, such as spina bifida or meningomyelocele. For those women with diabetes mellitus, achieving accurate glucose control prior to conception and during the pregnancy can decrease the potential for maternal harm during the pregnancy, as well as reducing the potential for having too large a baby, or one with birth defects unique to being a poorly controlled diabetic.

Preconception planning also allows for assessment for any medical condition that could adversely affect a pregnancy, make sure that immunizations are up to date, and inform patients in potentially hazardous occupations to limit their radiation exposure. Family histories can be reviewed, and genetic factors can be explored prior to conception.

Finally, if a patient is sexually active, not using contraception and not desirous of becoming pregnant immediately, then we can provide her with reliable contraception so she won’t be a part of that 50% of women who experience an unplanned pregnancy.

We’re happy to help you with your planning process, whatever those plans may include.

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Within the last few weeks, lay media articles have publicized a rare condition called osteonecrosis of the jaw and its association with use of the classification of drugs named bisphosphonates. These drugs are known to the public as Fosamax, Actonel, and Boniva, all of which are indicated for the treatment of osteoporosis. Osteonecrosis is a serious condition that usually results following dental surgery, such as a tooth extraction. This condition describes the non-healing socket at the extraction site, or the exposed bone which may occur, and which can progress to involve swelling, discharge, and infection. It should be emphasized that this is an extremely rare condition, occurring in less than 1 patient per 10,000 users of the bisphosphonate category of drugs. This is also a "class" effect, meaning that any of the bisphosphonates can be involved, not just one of the drugs in the group, so it makes no sense to switch from one drug to another to try to avoid this complication.

It is also important to realize that the risk of having this condition develop is significantly increased by patients undergoing dental surgery procedures who also have a diagnosis of cancer, and who have had occasion to have chemotherapy, radiation therapy, or therapy with steroids. Other risk factors which increase the potential for osteonecrosis include problems which may be associated with cancer or its treatment, including infection, clotting disorders, or anemia.

Our phone lines have been extremely busy in the last couple of weeks with calls from patients and their dentists wanting to know what we think they should do regarding continued use of bisphosphonates. A careful review of the medical literature reveals that the majority of patients who develop osteonecrosis have received their bisphosphonate drug intravenously. None of patients in our practice have received these drugs in this fashion. While taking bisphosphonates orally does not eliminate this risk, it does reduce it substantially. Further, the routine use of the drugs in an otherwise healthy patient without a cancer diagnosis seems to be extremely safe.

We are aware of the fact that the use of any drug involves risk. Our task is to help you keep that risk in perspective. In the case of the bisphosphonates, we are also aware that these drugs have revolutionized therapy for a debilitating, crippling disease that robs women of health, mobility, and even life. Some 40% of women who fall and break a hip are dead within 6 months. We think that hip fracture is a problem to be avoided if at all possible, even if its prevention involves the extremely rare risk of osteonecrosis of the jaw.

We think the media may have scared you unnecessarily about the potential risk of a very rare problem. Call us if this newsletter has not relieved your anxiety.

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Within the last several weeks, the Digene Corporation has been advertising heavily on television about the accuracy of Pap smear testing, and suggesting that the Pap smear by itself may not be enough to detect cervical abnormalities up to and including cervical cancer. The implication, of course, is that you should ask your gynecologist to perform a test (made by the Digene Corporation) to detect the presence of human papilloma virus DNA. The rationale for doing this test (according to the ads) is that the Pap smear is too imprecise to detect cervical abnormalities, and that the more precise DNA testing is now state of the art for detecting cervical cancer and/or its precursor, cervical dysplasia. Like most advertising, this one has “a grain of truth,” but pursuing that “truth” may be costly to you both financially and psychologically.

HPV (Human Papilloma Virus) is a sexually transmitted virus, and therefore cervical dysplasia and cancer of the cervix are sexually transmitted diseases. Studies of young American college students indicate that the majority of them have been infected with this virus by the time they graduate from college. For those who are infected, by the time they reach their late 20’s, the vast majority of them will no longer harbor the virus, as their intact immune system will have eradicated it from their system. Only those few women who still carry the virus are felt to be at risk for eventually developing cervical cancer.

Our laboratory will automatically do the HPV DNA testing on your Pap specimen only if it returns as an ASCUS (Atypical Squamous Cells of Undermined Significance) smear. These ASCUS paps are minimally abnormal and hence knowing the status of the HPV DNA is helpful. This means we will evaluate your condition further only if the Pap smear indicates that it needs to be done. It is not necessary, in our opinion, to test all Pap smears for HPV DNA. If we were to test everyone for this virus, and your results were positive even if you had a normal Pap, we would still have to inform you of a positive test. We would not be able to tell you if the presence of this virus alone would ever lead to any abnormal smear. We would also not be able to tell you who gave you the virus, when they gave it to you, or if you will be able to get rid of it. Since the presence of HPV DNA virus alone does not mean you are going to have an abnormal Pap, we do not feel that we should test everyone for it.

Following an abnormal Pap, we still will rely on the smear in that situation to determine how to manage your problem, because having HPV in and of itself is not an indication for therapy.

In our combined 35 years of clinical practice, we have never failed to detect a significantly abnormal Pap smear, and we have never had a patient with an abnormal smear go on to develop cervical cancer. The new TV ad campaign is, we believe, trying to scare you into doing something you do not need to do. See us annually, let us get your routine Pap smear, and trust us to do the DNA test if we feel it is necessary. Spend those DNA test dollars on something a lot more fun and exciting.

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Within the last couple of years, there has been increased publicity about an entity called “metabolic syndrome, or “syndrome X”. The current (Winter 2006) issue of the Heart Health Times from the New-York Presbyterian Preventative Cardiology Program discusses this issue in some detail, and lists 5 criteria for diagnosing this problem. They include:

1. Increased waist size (>35 inches for women; >40 inches for men)
2. High blood triglycerides (blood fat content) ( >150 mg/dl)
3. Low HDL (“good”) cholesterol (<40 mg/dL in men, <50 mg/dL in women)
4. High blood pressure (>130/85 mm Hg)
5. High fasting glucose (blood sugar) (100 mg/dL)

Having any 3 of these 5 problems are sufficient to make the diagnosis of metabolic syndrome, and having metabolic syndrome significantly increases the risk for developing heart disease and diabetes mellitus, usually well before one would expect to encounter these diseases on the basis of age.

Within the specialty of gynecology, we are especially concerned about metabolic syndrome, because it is also associated frequently with polycystic ovary syndrome, which also includes some hormonal abnormalities, and a propensity to have irregular menses, difficulty conceiving a pregnancy, increased acne and unwanted hair growth.

Metabolic syndrome can be a frustrating condition for both patient and physician, because the typical mainstays for therapy require exercise, dietary control, and weight loss. We have drugs that can help with elevated cholesterol and with polycystic ovary syndrome, but self help with reducing the size of the waist line and the number of pounds on the scale is the first line of defense.

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Within the past several years, there has been significant concern about the safety of hormone therapy for menopausal symptoms since the publication of the Women’s Health Initiative study in 2002. Patients who were in our practice at the time of the publication of that study recall receiving a letter from us elucidating our views on that study and the relative risks and benefits of hormone therapy.

Partially as a result of that study, after which it was predicted that the “snake oil salesmen” would appear in droves to capitalize on fearful women with menopausal symptoms, the concept of “bioidentical hormones” has gained increasing notoriety. In response to the claims made about these highly advertised products, the American College of Obstetricians and Gynecologists Committee on Gynecologic Practice has published a committee opinion on this topic in November, 2005.

A summary of the key points in that committee opinion:

1. BIOIDENTICAL. “There is confusion over what bioidentical implies.” These products are actually made from plant sources, and are not made from human or mammalian sources.
   
2. PURITY.“Most compounded products have not undergone rigorous clinical testing for safety or efficacy, and issues regarding purity, potency and quality are a concern.” “From 6/01 through 12/01, the FDA analyzed 29 product samples from 12 compounding pharmacies…10 of the 29 products (34%) failed one or more standard quality tests performed.” “In comparison…the analytical testing failure rate for drug therapies approved by the FDA is less than 2%.”
   
3. HORMONE TESTING. Physicians and compounding pharmacies which promote these drugs usually suggest that saliva testing be performed to check for “hormone levels”. “There is no evidence that hormonal levels in saliva are biologically meaningful.”
   
4. WARNING. Hormones which are prescribed by our practice will universally have product warnings required by the FDA describing the risks of hormone therapy. “However, because compounded products are not approved by the FDA, and have no official labeling (ie, a package insert), they are exempt from including the contraindications and warnings required by the FDA in class labeling for hormone therapy. “
   
5. COST. Compounded bioidentical hormones cost two to three times as much as prescription products which are approved by the FDA, and these bioidentical products are frequently not covered by health insurance plans

Finally, at University Ob/Gyn of Texas, we have a long standing commitment to be fiscally responsible with your health care dollars. We know there is no good reason for you to spend over twice as much for hormone therapy marketed in a fashion like fad diets and elixirs of youth, which may not be made correctly in the first place, and which is no safer or more effective than FDA approved products. Trust us--science is on our side.

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