| In what can only be described as the drug industries' | | | | Yet, in spite of this knowledge, the FDA took no |
| version of the shell game, over the past three | | | | steps to insure that the users of fertility drugs and |
| decades the manufacturers of fertility drugs have | | | | their doctors were aware of these studies. To the |
| demonstrated with exquisite skill that what you don't | | | | contrary, between 1967 and 1995, the Clomid |
| see may as well not exist. | | | | package insert assured prescribing physicians that "no |
| In 1972 it was reported in a scientific journal that in a | | | | causative evidence of a deleterious effect of Clomid |
| combined study involving Clomid (clomiphene citrate) | | | | therapy on the human fetus (had) been seen." |
| and Pergonal (human menopausal gonadotropin/hMG), | | | | During the mid-1990s it was determined that NTDs |
| there was twice the expected frequency of Down | | | | and other specific congenital anomalies can occur |
| syndrome in the offspring of women using those | | | | when the early embryo is denied an adequate supply |
| drugs. The subject birth defect, which is usually | | | | of cholesterol. In addition to being an important |
| caused by an abnormal chromosome (trisomy 21) in | | | | constituent of the human cell, it has been discovered |
| older women, could not be attributed to the average | | | | that a gene (Sonic hedgehog/Shh), which dictates |
| age of the study populations. The following year, | | | | how certain organs are to form during early |
| another published study concluded that there was an | | | | pregnancy, must bind with cholesterol to properly |
| increased incidence of abnormal chromosomes in first | | | | function. Absent a sufficient level of cholesterol, Shh |
| trimester spontaneous abortions (miscarriages) in | | | | cannot effectively communicate and malformations |
| women conceiving with fertility drugs, including | | | | occur. |
| clomiphene and hMG, when compared to the general | | | | The discovery about the importance of cholesterol in |
| population and women who naturally conceived two | | | | the development of embryonic organs was a major |
| or more cycles after using drugs to induce ovulation. | | | | breakthrough toward understanding how fertility |
| In yet another published paper during the same year | | | | drugs can malform a human embryo. Although not |
| (1973), scientists described a study establishing that | | | | widely known, clomiphene citrate is a cholesterol |
| clomiphene was capable of causing abnormal | | | | inhibiting drug -- it inhibits the function of an enzyme |
| chromosomes in the endometrium (lining of the | | | | in the body that normally converts desmosterol to |
| uterus) of women using the drug. | | | | cholesterol. The suppression of cholesterol during the |
| Yet, even though this evidence was presented to | | | | critical first few weeks of pregnancy can also occur |
| the FDA over 3 decades earlier, the current labeling | | | | as a consequence of another function of fertility |
| (package inserts) for these drugs make absolutely no | | | | drugs; namely, their demonstrated ability to |
| reference to these studies. | | | | significantly elevate normal levels of estrogen. It has |
| But it doesn't stop there. In 1983, a scientific article | | | | been established that there is an inverse correlation |
| appearing in the International Journal of Epidemiology, | | | | between the level of estrogen and the level of |
| reported on a study in which they found a significant | | | | cholesterol: the higher the estrogen, the lower the |
| increase in the incidence of limb reduction defects | | | | cholesterol. |
| (absence of limbs) following the use of fertility drugs, | | | | A recent published study (January 2008) |
| including clomiphene citrate. And beginning in late 1987, | | | | demonstrated this very subject. The researchers |
| a series of published scientific studies began | | | | found that when women, who did not develop |
| appearing in medical journals in which the researchers | | | | ovarian follicular cysts, were exposed to clomiphene |
| reported on an increased incidence of neural tube | | | | during the first 2 months of pregnancy, they had a |
| defects (NTDs) following use of fertility drugs, | | | | 350 percent increased risk of having a baby with a |
| including their use during in vitro fertilization (IVF). An | | | | neural tube defect. However, if the fertility drug also |
| NTD results when the neural tube fails to fully close | | | | caused the development of ovarian cysts -- which |
| during the 4th week of pregnancy, leaving an open | | | | contain high levels of estrogen -- the incidence of |
| cranium (anencephaly) and/or spinal column (spina | | | | NTDs shot even higher to a 540 percent increased |
| bifida). One scientist, after combining the results of 3 | | | | risk. The authors concluded that when accompanied |
| of these studies in a meta-analysis, stated that "the | | | | by follicular cysts, the "treatment with clomiphene |
| three studies, when combined, do indicate that the | | | | may have a role in the genesis of NTD." Although |
| association between ovulation induction and NTD is | | | | administered prior to conception, clomiphene can be |
| real." He calculated that the odds of the combined | | | | biologically active up to 54 days after ingestion, and is |
| statistics (a 194 percent increased risk) occurring by | | | | thus present during early pregnancy in every woman |
| chance was only 4 in a thousand (P = 0.004). In still | | | | who conceives during a treatment cycle. |
| another NTD study published in 1991, the authors | | | | The real tragedy about withholding this information |
| commented that "these data (a 136 percent | | | | from users of fertility drugs and their doctors is that |
| increased risk), combined with those previously | | | | there currently exists a simple means to substantially |
| published, indicate an association between stimulation | | | | reduce or eliminate the risk of birth defects while |
| of ovulation and increased rate of NTD." | | | | continuing to take these drugs. |