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<p class="MsoNormal"><strong><span style="font-size: 11pt; font-family: Arial">Birth
Defects Prevented by Folic Acid</span></strong><span style="font-size: 11pt">
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<p class="MsoNormal"><span style="color: red">Birth Defects & Vitamins</span><br />
<a href="index.html">Home</a></p></td>
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<p class="MsoNormal"><strong><span style="font-size: 11pt; font-family: Arial">WHAT
TOOK THE FDA SO LONG TO COME OUT IN FAVOR OF FOLIC ACID?</span></strong><span style="font-size: 11pt"> <br />
</span><strong><span style="font-size: 11pt; font-family: Arial">by William
Kaufman, M.D., Ph.D.</span></strong><span style="font-size: 11pt"> <br />
</span><span style="font-size: 11pt; font-family: Arial">(Reprinted with the
kind permission of Charlotte Kaufman)</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">Folic acid (or folate) is
frequently referred to in the news media, so I will make some comments about
it.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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..</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">The FDA is charged with making
sure that the drugs they approve for prescription use are both safe and
effective for specific therapeutic use.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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,</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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. <em>(Editor’s
note: This is precisely what indeed happened with folic acid. See note
below.)</em> 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,</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><strong><span style="font-size: 11pt; font-family: Arial">ABOUT THE SAFETY OF
FOLIC ACID:</span></strong><span style="font-size: 11pt"> <br />
</span><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">There are no folic acid
adverse side effects excepting the following:</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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);</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">Thus, folic acid is safer
than most of the drugs, if not all the drugs, the FDA has approved for
prescription use.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><strong><span style="font-size: 11pt; font-family: Arial">ABOUT THE PROBABLE
EFFECTIVENESS OF FOLIC ACID IN THE PREVENTION OF NEURAL TUBE DEFECTS IN THE
FETUS</span></strong><span style="font-size: 11pt"> <br />
</span><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">This provisional approval
should be subject to the following conditions:</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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)</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">(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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><span style="font-size: 11pt; font-family: Arial">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.</span><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><em><span style="font-size: 11pt; font-family: Arial">(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.)</span></em><span style="font-size: 11pt">
<o:p></o:p></span></p>
<p><strong><span style="font-size: 10pt; font-family: Arial">(To order a mint-condition, hardcover copy of the rare, original 1949 edition of Dr. Kaufman’s arthritis treatment book, <em>The Common Form of Joint Dysfunction</em>
(194 pages plus references), please <a href="../../order.html">click here</a>.)</span></strong><strong><span style="font-size: 10pt">
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