FYI a media report viewpoint
One wonders if we will ever see a sentence about breastfeeding that doesn't
have the words "choose not to" and lump that in with "can not" regarding
nursing. Of interest to is the stats on who is allergic to "modified cow's milk"
and would "need" soy, and that formula is needed for 8 or 9 months....
Judy LeVan Fram, PT, IBCLC, Brooklyn, USA
Israel News Jerusalem Post Internet Edition.htm
Nov. 10, 2003
Lack of B1 blamed for formula deaths
By JUDY SIEGEL-ITZKOVICH
The deaths in recent weeks of three infants from neurological
and cardiological disorders were due to them having been fed non-dairy
Remedia baby formula that completely lacked vitamin B1 (thiamine), the
Health Ministry announced on Sunday.
After lab tests confirmed the absence of the vitamin, the
ministry asked the parents of all babies fed with this line of soy-based
formula during the last two months to see their pediatricians who, if
necessary, can administer the vitamin.
Only those infants with clinical signs of beriberi (severe
thiamine deficiency) will receive infusions of the vitamin in the hospitals.
Parents whose children show symptoms should bring the Remedia
package to the hospital.
Clalit Health Services said Sunday night that the vitamin would
be given at no cost to babies who need it.
Parents should call *2700 or 1-700-707-700 for more information.
The other health funds are offering the same services to their members.
Health Ministry Food and Nutrition Service director Dr. Dorit
Nitzan-Kalusky said that Remedia – an Israel-based food distributor that
imports the special line of parve (non-dairy) formula from Germany due to
"kashrut requirements" – had not informed the ministry that the formula had
been changed in April. This change resulted in the powder being produced
without a trace of the vital vitamin, she said. Since the company did not
ask for approval, the ministry didn't make a special check of the formula,
she said.
Nitzan-Kalusky dispatched a four-member team, headed by Prof.
Yehuda Danon of Schneider Children's Medical Center for Israel, to the
Humana company in Germany to investigate the case.
In addition, the whole non-dairy line of Remedia formulas was
taken off the shelves in Israel.
Although Remedia's milk-based formulas were found to have the
proper amount of thiamine, the ministry is thinking of cancelling its Good
Manufacturing Practice (GMP) recognition and licenses for all its products,
because it violated the ministry's faith.
Ministry Director-General Boaz Lev told health reporters on
Sunday night that he had asked the State Attorney's Office to investigate
the matter, as Remedia and Humana allegedly committed a crime by claiming on
the product's label that it contained vitamin B1 when it did not. It also
marketed a product without ministry approval, Lev said.
He added that the ministry itself does not fear lawsuits as "our
supervision of foods meets the most stringent international standards.
Remedia itself received the GMP certification for its products, but it
violated this certification with this formula."
The ministry checked the formula when it was originally
registered and tested samples most recently in 2002. "We can't check
everything all the time; we depend on the GMP certification. It's like a
bank: You don't check all the time to see that your money is there," said
Lev.
He voiced praise for Nitzan-Kalusky and Schneider for finding
the common denominator quickly.
"Beriberi is very rare, found only in the third world. Few
doctors would think of it."
The Humana company has so far "not even bothered to contact the
ministry to provide an explanation," Lev said. "The importer, Remedia, has
not offered any credible explanation so far."
Although infants suffering from disquiet, followed by apathy,
vomiting, and then coma and breathing problems began to be hospitalized in
various parts of the country several months ago, no one thought to alert the
ministry, as encephalopathy and cardiopathy are symptoms that could be in
involved in a number of nervous system and cardiac disorders.
Only when three cases were admitted last week to Schneider in
Petah Tikva did pediatricians take note and alert the health authorities. So
far, two babies have died at Schneider and one at Josephthal Hospital in
Eilat during the past few months.
Four babies remain in serious condition, perhaps with
irreversible brain damage, at Schneider. All those affected were fed formula
exclusively or almost exclusively since birth.
Breast-feeding is the best food for all infants, nutrition
experts note. If new mothers can't or don't want to breast-feed, they should
use a baby formula based on modified cow's milk. But the small minority of
infants who are allergic to cow's milk should be fed with soy-based,
non-dairy formula for the first eight or nine months of life.
Prof. Ettie Granot, a veteran pediatric gastroenterologist at
Kaplan Hospital in Rehovot, said that only about 2 to 3 percent of newborns
are allergic to cow's milk. However, about 8% to 15% of babies who are not
breast-fed are fed the soy-based formula.
"There is definitely an overuse of non-dairy formula," Granot
told The Jerusalem Post. "This occurs in the secular population, but it
seems to occur more frequently in the modern Orthodox, but especially the
haredi population," she added.
But Rabbi Dr. Mordechai Halperin, a gynecologist and Jewish
medical ethics expert in Jerusalem, commented that babies have absolutely no
obligation to keep kosher. "Infants and babies are regarded by Halacha as
being 'in danger,' so these rules are not relevant to them."
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