On Tuesday afternoon at a press conference in Berlin, Humana,
manufacturer of the soy-based infant formula distributed in
Israel by Remedia, admitted that the product it sent to
Israel had only a tenth of the B1 that it was claimed to
have, and accepted full responsibility. The company stressed
that this was a one-time mistake, and promised to cooperate
fully with Israeli authorities.
Israeli police had launched a criminal investigation into
Remedia, whose product is suspected of causing the death of
three babies. Police have questioned several Remedia senior
managers. An emergency Health Ministry task force landed in
Germany, to find out about the product's manufacture.
The Israeli Health Ministry announced that the infant non-
dairy (soy based) formula sold by Remedia in Israel lacked
vitamin B1 (thiamine) and therefore caused beriberi in
infants who ate it exclusively or mainly.
On Tuesday, the lawyer representing Remedia claimed that
Humana removed vitamin B1 from the formula, on the assumption
that the soy-based formula already contained a sufficient
quantity of the vitamin from the soy. Remedia said that the
manufacturer did not notify it of the change. Humana's later
announcement said that it was human error that caused the
problem.
The danger to any children seems safely passed, and the
various parties are now maneuvering to try to ward off or
minimize any lawsuits or criminal prosecution. Those at risk
now include the Israeli Remedia company, Humana the German
manufacturer, the Israeli Ministry of Health, and possible
the America H.J. Heinz company that is said to have a
significant stake in Remedia. At this point the facts and
responsibility are far from clear. After Humana's dramatic
admission, it seems that Remedia is largely off the hook, but
it is not yet clear what the responsibility of the Ministry
of Health is.
The dramatic chain of events burst into the chareidi
community last Friday night-leil Shabbos. At around
10:30 p.m. in Israel, ZAKA trucks with loudspeakers and
driven by non-Jewish drivers circulated through all chareidi
neighborhoods warning parents not to feed their children
Remedia non-dairy formula.
The urgency was the result of a finding on the part of the
Health Ministry Food and Nutrition Service director Dr. Dorit
Nitzan-Kalusky last Friday night, after Shabbos began, that
the Remedia product was the common denominator behind two
babies who died at Schneider Children's Hospital in Petach
Tikva and one at Josephthal Hospital in Eilat in recent
weeks. 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. Three more babies were admitted to hospitals on Sunday
night, but two of them were already sent home and the third
remains under observation.
The babies were all admitted to the hospital suffering from
disquiet, followed by apathy, vomiting, and then coma and
breathing problems, indicating some nervous system disorder.
Infants with these problems began to be hospitalized in
various parts of the country several months ago, but no one
thought there was a pattern, as encephalopathy and
cardiopathy are symptoms that could be in involved in a
number of nervous system and cardiac disorders.
Altogether the Health Ministry now says that 17 babies are
thought to have been hospitalized over recent months as a
result of the same problem, not including the three admitted
on Sunday.
Only when three cases were admitted last week to Schneider in
Petach Tikva did pediatricians take note and alert the health
authorities. At that time doctors could not be certain about
the cause -- they assumed it was a virus -- but the evidence
seemed to point to the non-dairy Remedia product. It was
after Shabbos began that the Ministry of Health decided pull
the product off the shelves and warn the public against using
it.
After consulting with the rabbonim, members of the chareidi
voluntary organizations Hatzoloh, Ezer Mizion and ZAKA spread
the word. Rav Chananya Cholek, head of Ezer Mizion, told
Yated that he had been contacted on Shabbos by the
Ministry of Health to spread the news urgently. Rav Cholek
made the recording that was played over the loudspeakers so
that those who recognized his voice would rely on the
information.
Rabbi Mordechai Barzilay, head of the Israel national
Hatzoloh, said that MDA had sent them the news over their
beepers and, after consulting with poskim, they spread
the vital news.
In the United States as well, according to Kosher
Today a warning was distributed in synagogues through
flyers and sound trucks circulated in several of New York's
Jewish neighborhood on Shabbos in reaction to news that the
Israel- based Remedia infant formula should not be used.
Lack Of B1 Blamed
On Monday the Health Ministry announced that the neurological
and cardiological disorders in the infants were due to the
baby formula completely lacking vitamin B1 (thiamine).
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 an injection
of the vitamin.
Only those infants with clinical signs of beriberi (severe
thiamine deficiency) were to be brought to hospitals. Health
funds are offering to give the vitamin at no cost to their
infant members who need it.
Health Ministry Food and Nutrition Service director Dr. Dorit
Nitzan-Kalusky said that Remedia, an Israel-based food
distributor, had not informed the ministry when the formula
was changed in April. This change resulted in the powder
being produced without a trace of the vital vitamin. Since
the company did not ask for approval, the ministry didn't
make a special check of the formula, she said.
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, the German
manufacturer, apparently 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.
A Ministry of Health investigation found that Remedia
received a two-year license to import a non-dairy soy formula
in November 2001. However, the company changed the formula
six months ago without notifying the ministry.
Remedia Marketing CEO Gideon Landsberger said in response
that the non-dairy formula had been launched years ago. The
company made minor changes to the formula five months ago, to
adapt it to recent scientific developments. He said the non-
dairy formula was manufactured according to EU standards for
baby formula, while Israel has no such standard.
The Ministry of Health sent a special team to visit the
Humana plant near Hanover, Germany, where the special
production line for the Israeli formula is.
A Business Data Israel (BDI) survey commissioned by "Globes"
found that Israel's non-dairy market totaled NIS 350-370
million a year, and was growing by 4-8 percent a year. The
Materna brand had 40-42 percent of the market; followed by
Remedia with 30-35 percent; and Similac, with 26-28 percent.
The Health Ministry believes that some 5,000 children have
consumed the Remedia product during recent months.
Now, 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.
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 (see sidebar).
Prof. Ettie Granot, a veteran pediatric gastroenterologist at
Kaplan Hospital in Rechovot, said that only about 2 to 3
percent of newborns are allergic to cow's milk. However,
about 8 percent to 15 percent of babies who are not breast-
fed are fed the soy-based formula.
Remedia spokesman Ran Rahav said that the company does not
export any of the formula, but he said it could have been
sent by Israelis to relatives in North America and Europe or
taken out of Israel by visitors.
Health Ministry associate director-general Dr. Yitzhak
Berlovich told the Jerusalem Post of reports he
received about a few Jewish babies in New York having been
hospitalized for symptoms of beriberi and of a baby from
Boston who reached Israel and who was hospitalized here.
These reports were not confirmed by New York health
authorities. All of them, he said, reportedly were fed the
Remedia formula.
"We have informed the US Food and Drug Administration and
Centers for Disease Control and Prevention about the problem,
and they are responsible for protecting the health of their
residents," he said.
In New York, the city's Department of Health and Mental
Hygiene Commissioner Thomas Frieden issued an official
warning to the Orthodox community against using Remedia. Over
the weekend, warnings were made in synagogues and over
Hatzolah ambulance loudspeakers in predominantly Orthodox
neighborhoods including Williamsburg and Borough Park, he
said.
Over NIS 1 billion shekels worth of class-action and
individual lawsuits have already been filed in Israel against
Remedia, Humana, and others involved in the death and
hospitalization of infants. Some legal experts said that it
was early, since the facts are not yet clear.
The Remedia spokesman said that Humana, one of the largest
and most veteran baby food companies in Germany, insisted its
line of soy-based formula made especially for the Israeli
market was shown by its own tests to have the required amount
of vitamin B1.
The spokesman added that the company is working "in full
cooperation" with the Health Ministry. All other Remedia
products remain on the market. He added that the formula is
manufactured "according to the European community standards
for baby foods."
According to the company only "minor changes" were made in
the powder formula in April, and that these were "too
insignificant" to require a new application for a ministry
license. But the ministry said any change requires a new
application.
Remedia's phone line is 1-800-66-66-60.
