Fertility Drugs and Birth Defects

If you can’t trust the FDA, then who can you trust? After all, it’s part of the Federal Government and the designated watchdog to protect the consuming public from dangerous and ineffective drugs. It also sits in a position of impartiality, is loaded to the gills with expertise, and even has unlimited access to some of the foremost experts in the country, if not the world. Thus, when the FDA puts its stamp of approval on the language of the product labeling that accompanies a drug, it is something that every prescribing doctor can rely upon.

Or can they?

The official language for a drug is contained within a document referred to as a package insert. It accompanies the package of pharmaceutical products that are delivered to your local pharmacy, and contains everything a prescribing physician would want to know about a drug, including its chemical composition, pharmacology (how it works), indications (what it is intended to treat), contraindications (when it shouldn’t be given), warnings, precautions, adverse reactions (side effects) and dosage. Although it is printed by the manufacturer of the drug, by law its language must be first approved by the FDA. Most prescribing physicians rely upon what is stated about a drug within the package insert, or by referring to the Physician’s Desk Reference (PDR), an annual publication which incorporates the same approved language contained within the insert.

Consider that on November 30, 1983, the FDA approved an updated draft of the package insert for Clomid (clomiphene citrate), one of the most popular fertility drugs in the world. On that date it requested the manufacturer (Merrell Dow Pharmaceuticals, Inc.) to prepare final print labeling that included the following new warnings, which it had earlier required:

· “Some Clomid and/or its metabolites…may, therefore, remain in the body during early pregnancy in every woman who conceives in the menstrual cycle of Clomid treatment.”

· “The physician should counsel the patient with special regard to the following potential adverse reactions that may be encountered. …Pregnancy Wastage and Birth Anomalies.”

· “Among the birth anomalies spontaneously reported as individual cases since commercial availability of Clomid, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by Clomid….”

· “Population-based reports have been published on possible elevation of risk of Down’s Syndrome in ovulation induction cases and of increase in trisomy defects among spontaneously aborted fetuses from subfertile women receiving ovulation inducing drugs (no women with Clomid alone and without additional inducing drug).”

The FDA had also requested deletion of the following statement, previously included in earlier editions of the package insert: “No causative evidence of a deleterious effect of Clomid therapy on the human fetus has been seen….”

The FDA was justified in ordering these changes because: (a) Clomid has a long half-life (5 days), and studies had shown that the drug and/or its metabolites had been found in feces as long as 6 weeks after it had been ingested; (b) case reports of birth defects voluntarily submitted to the FDA by the medical profession revealed that about 25% of all reported cases involved neural tube defects (spina bifida and anencephaly); and (c) published studies had shown an increased risk in Down syndrome and abnormal chromosomes in spontaneous abortions following the use of fertility drugs, including Clomid. Such studies also represented “causative evidence of a deleterious effect of Clomid therapy on the human fetus.”

On March 5, 1987, the FDA wanted the drug company to add a further warning:

· “Clomid is contraindicated in pregnant women. Clomid may cause fetal harm when administered to pregnant women. Since there is a reasonable likelihood of the patient becoming pregnant while receiving Clomid, the patient should be apprised of the potential hazard to the fetus.”

Yet to this very day, none of these justified warnings have ever been included in the Clomid package insert. And the above statement that was requested to be deleted was never removed until 1995, when it was replaced with: “No causative evidence of a deleterious effect of Clomid therapy on the human fetus has been established….” The change is an apparent acknowledgement that such evidence had by then been “seen,” but had not reached the level of establishing a causal relationship.

But it gets worse.

The current Clomid package insert represents to every prescribing doctor:

· “The overall incidence of reported birth anomalies from pregnancies associated with maternal CLOMID ingestion during the investigational studies was within the range of that reported in published references for the general population.”

So, what is wrong with this statement? The pre-market investigational studies referred to were never designed to assess the risk of birth defects. This acknowledgement has been made under oath by the drug company’s employee who oversaw the studies. In other words, no one knows how many birth defects occurred during these studies. This is due in part because the vast majority of the clinical investigators were fertility specialists who did not deliver any of the babies. After conception was achieved, the pregnancies were delivered in other clinics by doctors who had no obligation to report the outcome. There is also evidence that some documented birth defects and spontaneous abortions from the investigational studies were not reported by the drug company to the FDA. These, and many other deficiencies, have been reported to the FDA on several occasions, including as early as July 1975.

The tragedy is that every physician who relies upon the Clomid package insert before prescribing the drug is being deceived into believing that there is absolutely no risk of the drug causing birth defects – and that every Clomid patient is being similarly deceived and denied the right to make a true informed choice. Whether or not a woman might choose to roll the dice and encounter the risk, she has every right to know what that risk is; not only what the percentages are, but the type of birth defects she might be faced with should the dice come up “snake eyes.”

But what if there was a means to substantially reduce or even eliminate that risk? What if it involved nothing more than taking a small dietary supplement during the first 8 weeks of pregnancy? Being denied such an opportunity would be the greatest tragedy of all, especially if the Clomid mother came home with a malformed baby in her arms.

The above documented facts are just a small sample of the wealth of information available on my website and in my book, THE PRICE OF OVULATION: the Truth about Fertility Drugs and Birth Defects – and a Solution to the Problem. The “solution” is explored in depth in the book, including all of the scientific studies which back up the conclusion, and which can potentially save tens of thousands of babies from severe and catastrophic congenital anomalies – even those occurring in natural pregnancies.