Birth Defects: What Took The FDA So Long To Come Out In Favor Of Folic Acid?

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Birth Defects Prevented by Folic Acid

 

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

FOLIC ACID?

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

(Reprinted with the kind permission of Charlotte

Kaufman)

 

Folic acid (or folate) is frequently referred to in

the news media, so I will make some comments about it.

 

Folic acid is an artifact of chemical isolation. Folic

acid is pteroylglutamic acid. This active molecule is

a partially degraded, fully oxidized derivative of the

folates. Virtually no folic acid exists in either

plant or animal tissues. But the folates do.

 

Folic acid is an inexpensive chemical with a

vitamin-like action. One can buy at retail 250 tablets

containing 800 micrograms of good quality folic acid

for about $6.00. These tablets contain four times the

folic acid in today's RDA's (recommended daily

allowance). One tablet costs a little over two cents.

 

Who is most susceptible to general folic acid

deficiencies? Pregnant woman, fetuses, premature

infants, and elderly people. Women with a systemic

folic acid deficiency can develop in addition to other

health problems, pre-cancerous changes in the uterine

cervix. In addition. some women (users of oral

contraceptive agents or smokers) who do not have a

systemic folic acid deficiency can develop areas of

localized folic acid deficiency in the uterine cervix.

Areas of localized folic acid deficiency on the

uterine cervix also may become pre-cancerous.

Pre-cancer in both types of women, can become cancer.

However, the administration of adequate amounts of

inexpensive folic acid can effect a cure of the

precancerous areas. Then, perhaps the woman may be

able to change her diet to include foods rich in

folates and sustain such a cure. But it is often hard

for a woman to make a sustained improvement in diet.

Poor women simply cannot afford the improved diet. In

both such types of women, it would seem wise to use

inexpensive, adequate pill-a-day folic acid

maintenance therapy in addition to as good a diet as

they can afford and get themselves to eat..

 

A folate deficiency in a pregnant woman may cause a

special kind of anemia, a premature separation of the

placenta, spontaneous abortion, bleeding, an abnormal

fetus including those with a neural tube defect,

anacephaly, spina bifida and low weight babies. Not

only do these sad events cause misery to the mother,

father and family but they simultaneously cause a

large drain on medical resources as well as an

enormous economic drain on Medicaid and on other

sources for financing medical care. It would appear

that these complications of pregnancy can be largely

prevented by good nutrition and appropriate folic acid

supplementation for the entire duration of the

pregnancy from conception onward. And, this leads me

to comment on the FDA's (initial) rejection(s) of an

application for approval of the use of folic acid

therapy for the prevention of neural tube defects as

being premature.

 

The FDA is charged with making sure that the drugs

they approve for prescription use are both safe and

effective for specific therapeutic use.

 

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 partakes of alcohol

(alcohol will negate folic acid action)

 

© 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.)