Health Ministry backs its five indicted employees, praising their "professionalism and work according to guidelines."
By JUDY SIEGEL-ITZKOVICHremedia 224.88(photo credit: Channel 2)
Prosecutors on Tuesday filed a 52-page indictment against eight suspects in the Remedia formula affair, which led to the deaths of three infants and severe or potentially severe injury of more than 20 others from malnutrition in 2003.
According to the indictment, the harm to the children was caused because the German Milchwerke Westfalen EG (Humana GmbH) company, which supplied the formula to Remedia in Israel, did not include vitamin B1 (thiamine) in a new vegetarian formula it began manufacturing in 2003.
Although senior officials in Remedia knew that Humana had decided to stop adding vitamin B1, it did nothing about it. Furthermore, it retained the old list of ingredients on the label of each tin of new formula. This list falsely stated that the new formula included 385 micrograms of vitamin B1 for each 100 grams of formula.
Furthermore, five Health Ministry officials - four inspectors responsible for releasing food imports from quarantine at the Haifa and Ashdod ports and the then - head of the ministry's National Food Service failed to properly check the documents and contents of the baby formula before it was released for distribution, the indictment said.
The Health Ministry has given its five indicted employees its "full backing," praising their "professionalism and work according to guidelines."
The defendants working for Remedia are Frederick Black, who was in charge of quality control and research and development; Gideon Landsberger, its general-manager; and Moshe Miller, the owner of the company. The Health Ministry defendants are Dr. Dorit Nitzan-Kaluski, an experienced pediatrician who was head of the ministry's Food Service Division at the time the scandal broke in November 2003, and the four inspectors, Nasreen Khouri, Yosef Haskel, Berta Shvum and Raisa Parvarov.
According to the indictment, Remedia issued a declaration in 2003 saying its "products include only ingredients whose safety has been proven and they fulfill all the strictest international and Israeli standards. We operate quality control laboratories in which every product is examined so that it will meet the high standard set for it."
However, according to the indictment, it did not conduct any analysis of its products' contents to see that they met the proper specifications.
Before 2000, Remedia prepared two formulas for non-dairy formula based on soy protein. In November 2002, the company decided to replace the old soy-based formulas with two new ones. The company also prepared labels with new graphics for the new products.
Soon afterward, Humana decided not to add vitamin B1 in the new product, and notified Remedia of this decision.
Nevertheless, "Black and Landsberger did nothing about the matter and did not even ask, at the very least, for analyses to prove that there was sufficient natural thiamine in the soy protein itself."
Furthermore, to save money, the company decided to import the new product as if it were the old one, rather than ask for a new import permit. In doing so, "the consumption by babies of Remedia's new non-dairy formula created certain danger that the illness caused by the lack of thiamine would spread among them and a clear and immediate danger that they would suffer severe health problems including death," according to the indictment.
Large shipments of the new formula arrived in Israel in April, May, June and August 2003. The indictment said the four inspectors released the shipments without carefully checking the product. The state accused them of various acts of negligence including not carefully checking the identity of the importer and not attributing sufficient importance to the examination of the product, especially considering the fact that it was baby food.
At the same time, the state accused Nitzan-Kaluski of improperly supervising the work of the inspectors, and failing to inform them of the guidelines and regulations and to point out the particular health sensitivity of baby food. She allegedly also issued orders reducing the amount of supervision required for imported food, including baby food.
In sum, the indictment continued, "Nitzan-Kaluski did not supervise and did not examine how her new instructions were being implemented and whether these orders were carried out in such a way as to safeguard the safety of the imported food and public health. Because of her actions, an atmosphere was created in which minimal examinations, if any, were carried out by the inspectors at the ports."
The state also charged Landsberger and Miller with obstructing justice by paying off company employees who were questioned by police. One of those they tried to pay off was Black. As a result, he allegedly changed his testimony to protect his employers.
The State Attorney's Office said in the indictments that the Health Ministry officials should have prevented the soy-based mother's milk substitute from reaching the market. The formula powder was made specially for Israel with strict kashrut specifications from soy because some haredim prefer non-dairy baby formula so it won't "clash" with meat meals, and also because other infants are allergic to dairy products.
The missing vitamin B1 is vital in the development of infants, and when they are fed solely with formula lacking it, they can suffer severe neurological problems and even die.
Spokeswoman Einav Shimon-Greenboim said the ministry was sorry about the decision to prosecute its officials and hoped that their "innocence would be proven beyond a doubt. The spokeswoman said the ministry was among the first (after nurses and doctors in hospitals who received the infants) to suspect that the cause of the babies' hospitalization was the lack of the vitamin. The ministry "continues to follow up the health" of the surviving children, Shimon-Greenboim said.
The state attorney's indictment "is liable to have serious implications for the ministry's regulation and supervision processes," she said. After the affair broke, then-health minister Dan Naveh decided that baby food would treated with a higher level of supervision, like that for pharmaceuticals.
Not long after the scandal erupted, Nitzan-Kaluski accepted a job as representative of the World Health Organization in Serbia and Montenegro. She continues to live there.
Nitzan-Kaluski said through a public relations adviser that "the great pain of the affected families remains with me all the time, since September 6, 2003. Every night I see the faces of the babies and the thousands of babies exposed to disease. As a mother and grandmother, a pediatrician specializing in gastroenterology and child nutrition with years of experience in Israel and the world.... My sorrow is great and even more stinging."
On that day in 2003, she said, she spoke to the parents of all the affected babies fed solely on the non-dairy Remedia formula and asked Remedia company director Lansberger if the components of the formula had changed. "He claimed the only change was in the amount of fat," Nitzan-Kaluski recalled.
But she concluded that the symptoms were those of beri-beri, a disease of malnutrition normally found in the Third World. Within 24 hours, the Food Service Division chief ordered Remedia's soy formula powder removed from store shelves. After affected babies improved when given thiamine, the ministry quickly informed the public that they must stop using it immediately.
Nitzan-Kaluski maintained that even though the ministry had given approval for the formula's import, Remedia had not informed her that the ingredients had been changed, thus "turning it into a new product. It is impossible," she concluded, "to examine thousands of products for all their constituents."
Parents of the Remedia children - who received significant financial compensation from the manufacturer and importer - welcomed the decision to prosecute and said the case had been delayed long enough.
Both Health Ministry director-general Prof. Avi Yisraeli (who did not work for the ministry in 2003) and associate director-general Dr. Boaz Lev (who was then director-general) declined to be interviewed by The Jerusalem Post about the case.
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