Rebecca Adams
The Washington Post
1150 15th Street, NW
Washington, D.C. 20071

Dear Ms. Adams:

Thank you for yesterday’s article spotlighting the current controversy over
FDA actions against domperidone.  Please continue to keep the FDA under
scrutiny and encourage other reporters to do so.  There is much more to the
backlash you wrote about than has so far been reported.

Please let me draw your attention to the incongruity of the FDA taking
action against domperidone at this time in particular.   Many breastfeeding
experts are incredulous and dismayed that the FDA would be doing this at the
same time that its parent department, Health and Human Services, is
initiating major campaigns against obesity and for breastfeeding.

If you do a combined search of  “metabolic syndrome” and “PCOS”, you’ll find
articles about the women who represent a considerable portion of the women
your article focuses on, a considerable portion of the women lactation
experts deal with, and a considerable portion of the people the HHS
initiatives are aimed at.  Polycystic ovary syndrome and metabolic syndrome
are often involved in at least three of the indications for domperidone use
that I am aware of:  adoption (due to infertility), prematurity (due to
pregnancy complications), and primary lactogenesis insufficiency (due
problems with glandular development).

These are women who have been dealing with chronic health problems and
especially want to prevent such problems in their children.  No wonder Web
sites for mothers have been inundated with protests!  A major tool in
enabling them to breastfeed their children and help prevent the perpetuation
of their health problems to the next generation is threatened.  It is
difficult to design conclusive studies, but it doesn’t take much maternal
intuition to feel confident that an infant fed milk with components designed
for human rather than bovine or soybean metabolism is more likely to be free
of metabolic problems.  Also, an infant fed at mother’s breast, which always
provides milk fresh and at the right temperature, in the quantity desired,
learns to eat when he’s hungry and stop eating when he’s full – a lost skill
in the United States!

At least as important as their child’s short and long-term health, to
mothers dealing with complicated breastfeeding situations, are the benefits
of normal family physiological function.  Viagra, for example, has given
many husbands new hope for normal marital relations.  I have seen many
testimonies from mothers that domperidone has made a significant difference
in their ability to lactate for their infants, whatever the cause of their
milk supply problems.  To tell these mothers that formula will do just fine
trivializes their resolve to have a normal maternal relationship with and to
provide nature’s best for their infants.

I have been in contact with a couple of the compounding pharmacies that have
been warned by the FDA. They hope for a groundswell of support for their
continuing to provide domperidone to American consumers.  They are
particularly distressed for the many patients, including those undergoing
chemotherapy, who need domperidone for gastric disorders, because the
alternatives for their treatment are also substantially less safe and/or
effective.  I should note that domperidone is in use in some countries for
gastric disorders in infants, and the dose an infant gets from mother’s milk
is much lower than the dose an infant gets for such treatment.

The manufacturer of domperidone, Janssen-Cilag, has so far decided not to
pursue the expensive process of FDA approval based on the bottom line.
Meanwhile, domperidone use has spread (do a search on “Motilium”!), and has
even been approved by the American Academy of Pediatrics, based on its
safety and efficacy.  I can’t presume to know what has motivated the recent
FDA action against domperidone, but it is ill timed and scientifically
unfounded.

Here are some websites for your reference:

The Adoptive Breastfeeding Resource Website:

http://fourfriends.com/abrw/

A site about breastfeeding premature infants:

http://www.parentingweb.com/lounge/premature.htm

The BreastFeeding After Reduction website:

http://www.bfar.org/

The page at the BFAR website with a physician’s letter to an FDA ombudsman
with a clear analysis of the benefits of domperidone and the lack of
scientific merit in the FDA action:

http://www.bfar.org/domperidone-smillie.shtml

The page at the BFAR website with a well-researched letter to the FDA by a
mother in Garland, Texas:

http://www.bfar.org/domperidone-fisher.shtml

A.H. Robins’ prescribing information sheet about metoclopramide (Reglan),
giving a list of dangerous side effects, in addition to the lactogenesis
side effect desirable to new mothers:

http://www.fda.gov/cder/foi/label/2001/18821s20lbl.pdf

An attorney web page for those who have suffered harm from Reglan:

http://www.reglan-lawsuit.com/

Please don’t hesitate to contact me by email or by phone if you have any
questions or want any help contacting others who are concerned about this.

Earnestly,

Ruth Piatak, B.A., M.S., mother of four

Cc:
Lactnet lactation professionals’ email list
Dallas Morning News
Warren Rumble, CDER Ombudsman, US FDA
The Honorable Tommy G. Thompson, Secretary, Health and Human Services
Gene Ragazzo, R.Ph., Hopewell Pharmacy
Ray Solano, R.Ph., Peoples Pharmacy, Austin, TX
Michael A. Chappell, Director, Dallas District, FDA
Doreen Fisher
Barbara Latterner
Martin & Jones, Trial Lawyers

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