Folic Acid: How the FDA Killed 12,000 Babies

The FDA has recently publicized a change in policy. It now plans to speed up the new drug approval process. This will enable giant pharmaceutical companies to sell expensive drugs with many side effects much earlier than is now possible, which will result in less careful scrutiny of the safety and efficacy of such new drugs,

Nutritional substances such as vitamins and minerals are not drugs. Folic acid is a vitamin. However, there is a section of the FDA regulations that states that any substance can be considered to be a drug if a claim is made that it can improve function or structure in an individual or prevent illness. Because of this, folic acid was legally characterized as a drug, the sponsor had to subject folic acid to the regulations governing the application of a new drug application.

The FDA (had previously) rejected a new drug applications for the use of folic acid intended to prevent neural tube defects in the fetus of a pregnant woman who had such a tragic event in a previous pregnancy. (For years) they had considered this New Drug Application to be premature. This is a way of saying that the FDA considers the data submitted in the folic acid New Drug Application was inadequate and that the sponsor must spend time, possibly years, gathering more data. (Editor’s note: This is precisely what indeed happened with folic acid.  See note below.) In the meantime, women who have had the misfortune to have had a fetus with a neural tube disorder in a previous pregnancy could not, for a long time, legally be prescribed folic acid with the view of possibly reducing her risk of having another neural tube defect fetus in future pregnancies,

ABOUT THE SAFETY OF FOLIC ACID:

Folic acid has been used for over forty years as a vitamin and has been found safe in the treatment men, non-pregnant women, and in pregnant women who have had folic acid deficiencies, Folic acid has been used to remove pre-malignant lesions on the uterine cervix and thus prevent cancer.

Even a very high daily oral dose (10 milligrams, which is 10,000 mcg) that is 50 times the present RDA (Recommended Daily Allowance) taken by 27 non-pregnant women for four months was safe and there were no adverse side effects. The much lower oral doses commonly used in treatment of folic acid deficiencies are also safe and effective.

There are no folic acid adverse side effects excepting the following:

(1) folic acid in huge doses administered to epileptic persons may block the anti-epileptic action of their drugs and cause them to have an increase in epileptic attacks (this is unlikely to occur with lower doses of folic acid);

(2) it may rarely decrease zinc absorption of zinc but this does not lower blood zinc levels because of decreased urinary excretion of zinc, and

(3) the patient have concurrent deficiency in both vitamin B 12 and folic acid, a condition that requires concomitant treatment with both vitamin B12 and folic acid. Therefore, folic acid alone cannot be effective.

Thus, folic acid is safer than most of the drugs, if not all the drugs, the FDA has approved for prescription use.

ABOUT THE PROBABLE EFFECTIVENESS OF FOLIC ACID IN THE PREVENTION OF NEURAL TUBE DEFECTS IN THE FETUS

While the FDA may (have been) bureaucratically and legally right in rejecting the application for the use of folic acid for the prevention of neural tube defects as being premature, from a humane and practical point of view it is wrong.

Neural tube defects are terrible complications of pregnancy. A mother who has had this calamity happen to her infant in a previous pregnancy is at considerable risk of having it happen again in subsequent pregnancies.

Many published reports in the medical literature indicate that giving such a woman folic acid in sufficient amounts can greatly lower the risk of recurrences of such extremely damaged fetuses. Some other medical reports disagree. A meta-analysis of all these published papers would probably show that there is enough favorable evidence to show that folic acid can reduce the risk of having a fetus damaged by neural tube defects. In view of all the circumstances, the FDA should give this application provisional approval to since folic acid is an exceedingly safe vitamin.

I am now suggesting how such provisional approval could get the FDA the additional data they want and currently not deprive women at risk of having neural tube defects infants of possible freedom from the recurrence of this calamity through the use of folic acid.

This provisional approval should be subject to the following conditions:

(a) that the non-epileptic woman who has had a previous fetus with neural tube defects start the agreed upon dose of folic acid before conception and continue it throughout her entire pregnancy

(b) that she will agree not to indulge in alcohol before conception and throughout her entire pregnancy and if she does, she will inform her physician how much and how often she partakes of alcohol (alcohol will negate folic acid action)

(c) the obstetrician or nurse midwife who delivers the infant will make a full report about the pattern of folic acid oral usage, whether or not alcohol has been indulged in during the pregnancy and the amounts and frequency of intake, and the condition of the infant on birth to the FDA.

The data on controls (women who have had neural tube defect babies in a prior pregnancy and who have become pregnant again but who did not take folic acid during the current pregnancy) should be collected under the direction of the Surgeon General of the U.S. Public Health Service, who could make it mandatory that that all hospitals which supply obstetric care in the United States compile data report the condition of every baby at birth born to a mother who had not been treated with folic acid during her pregnancy but has had a previous pregnancy ending with a neural tube defect infant. This data would give some reliable measure of how great the risk is of having subsequent neural tube defect babies when folic acid treatment was not given during the pregnancy. This information combined with the prospective information reported to the FDA on the incidence of neural tube defect babies occurring in women treated with folic acid, in turn, would make it possible to assess accurately how effective folic acid is in lowering the risk of occurrence of such tragedies.

(Editor’s note: FDA did ultimately approve folic acid as preventive for neural tube defects such as spina bifida.  It took them almost ten years to do so.  In each of those years, at least 1,200 babies were born with neural tube defects. That makes some 12,000 birth defects that FDA failed to prevent because of unwarranted caution over a substance that is vastly safer than any drug that they have ever approved.)

WHAT TOOK THE FDA SO LONG TO COME OUT IN FAVOR OF FOLIC ACID?

by William Kaufman, M.D., Ph.D.