Synthroid: Not FDA Approved

I'll bet you thought the Food and Drug Administration (FDA) was there to protect you, didn't you? Your physicians would never prescribe a drug for you that hadn't been tested properly, would they?

I'll bet you thought the Food and Drug Administration (FDA) was there to protect you, didn't you?

Your physicians would never prescribe a drug for you that hadn't been tested properly, would they? Surprisingly, there are many untested and unapproved medications. Synthroid for hypothyroidism and Ritalin for attention-deficit disorder in children are two examples. This is surprising mostly for those who place blind trust in the medical establishment and imagine that there are some who will not take herbal or nutritional products because they aren't FDA approved.

In the case of Synthroid, developed in 1955 to treat the symptoms of hypothyroidism (fatigue and weakness, weight gain, dry skin, cold intolerance, muscle cramps and pain, carpal tunnel constipation), it has become the third-most prescribed drug in America, behind Lipitor for high cholesterol and Premarin for menopause.

Synthroid has been constantly surrounded by controversy. Due to a powerful marketing campaign by its manufacturer — Knoll Pharmaceuticals, recently purchased by Abbott Laboratories — it is prescribed by mainstream physicians almost exclusively for hypothyroidism. This marketing campaign has led to class action lawsuits that resulted from an investigation, begun in 1996, that alleged Knoll was violating consumer protection laws by attempting to prevent publication of the results of a research study showing that generic and competitive brand names were equivalent to the Synthroid brand.

The case was decided against the manufacturer, and the proceeds from an escrow account — approximately $100 million plus interest — will be paid to consumers who agree to release all claims against Knoll.

Remember Synthroid hasn't been approved for use in hypothyroid patients, and Knoll recently applied for a waiver of requirements for "adequate and controlled studies." But that's not the worst. It's ineffective. Maybe that's why there are no adequate and controlled studies.

There are more effective natural therapies. You might be comforted to know that Abbott Labs finally submitted a new drug application on Aug. 1.

To understand why Synthroid doesn't work, a simple explanation is needed. There are two glands involved, the anterior pituitary and the thyroid; and three hormones, thyroid-stimulating hormone and T3 and T4. Though the human body is very complex, some processes are very simple.

Think of it this way: When a hormone is released, instructions are communicated to another part of the body to perform another function. With that in mind, the anterior pituitary, which also monitors blood levels of many hormones, releases thyroid-stimulating hormone, stimulating the thyroid to secrete T3 and T4 for use in other parts of the body. T4 is converted into T3 in healthy people, and T3 is the main hormone needed to overcome the symptoms associated with hypothyroidism.

Unfortunately, Synthroid contains only T4, and not everyone is healthy enough to make the conversion into T3. A simple lack of selenium, the most deficient mineral in our diets, is only one of many possible deficiencies that will make you "unhealthy" enough to prevent this conversion.

The reason Synthroid contains only T4 is because T4 signals the anterior pituitary to produce "normal" levels of thyroid-stimulating hormone, and the traditional medical establishment, in its infinite wisdom, believes "normal" thyroid-stimulating hormone levels define a healthy patient.

Wouldn't it be more effective to take a medication that contains T3 in proper amounts and T4 in smaller amounts or none at all? Thyroid-stimulating hormone would not be artificially normalized to suggest an inaccurate picture of health, and T3 would be present to help overcome the symptoms of hypothyroidism.

Along with dietary changes and proper nutritional supplementation, there still remains an outside chance for restoration of proper thyroid function using none of these medications, depending on many circumstances.

Hypothyroidism might also be missed as a diagnosis in many patients. Lab results from traditional laboratories are not sensitive enough to differentiate between T3 and rT3. Suffice it to say rT3 is not used by the human body and should not be counted in the overall amount for T3.

Traditional medicine doesn't make this very important distinction, leaving many patients unaware that they have deficient levels of T3 and therefore have hypothyroidism.

Once again, don't take for granted that you are receiving the best care available; ask questions. Always ask an alternative physician. You might be surprised what you'll learn. Your health might depend on it.

contact DAVID DAHLMAN: [email protected]

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