DOH exec: Wyeth should have told public about milk defects

(Updated 7:43 p.m.) The Health Department on Wednesday afternoon warned that the two million infant formula cans up for market recall posed potential health risks despite claims of manufacturer Wyeth Philippines that its products were safe yet "minutely" tarnished. Health Undersecretary Alex Padilla stood pat behind the recall order issued by the Bureau of Food and Drugs (BFAD), even chiding Wyeth for allegedly failing to properly inform the government and the public about the matter. Padilla denied that the safety issue ended with the rust spots that Wyeth confessed to be present on its can lids. "We're not only talking of kalawang or ordinary rust. If it were just rust, it would not have been such a major concern," Padilla said in a phone interview. He noted that the presence of molds in some milk cans should be seen as an issue that went beyond the products' appearance. Wyeth did not mention molds in its two statements issued Wednesday afternoon. The pharmaceutical giant said "no sickness or injury had been reported" on the milk products manufactured from May 23 to July 26 last year, which are now subject of the BFAD order. It claimed to have detected "minute rust specks on the outer rim" of some cans. However, it said that, "tests conducted by Wyeth showed that the milk powder inside the affected cans was not compromised and the integrity of the milk powder was maintained." However, Padilla said the claims do not mean that Wyeth was cleared of its shortcomings. "The point is whether it was minute rust, one can or a million cans, Wyeth had the obligation to report it to the public," he added. BFAD learned of the problem from the Internet after online discussions circulated about alleged product defects. Padilla said the government then conducted a deeper investigation, and eventually a non-government organization provided the Department of Health with information from a Wyeth "insider." "Then we referred the matter to BFAD, it turned out to be positive ... Wyeth tried to clean this up on its own without telling the public or the BFAD," he said. Wyeth's milk brands included in the order carry the brand names Bonna Infant Formula, Bonamil Milk Supplement Stage 2, Bonakid Growing Up Milk Stage 3, Promil Stage 2, Promil Kid Stage 1, Progress Gold and Promil Gold. Up to 4.3 million units, meaning cans or cartons, were actually affected when super typhoon Milenyo lashed the country and damaged Wyeth's warehouse in Canlubang, Laguna. Earlier reports, however, said Wyeth pulled out only two million milk units prior to Tuesday's issuance of the recall order. Wyeth said BFAD was properly notified about the defects after a routine quality inspection at the warehouse on July 26 last year and tests on products pulled out from the market for "cosmetic reasons." It claimed that BFAD scrutinized its manufacturing facility and records on April and May 2007, and that the agency subsequently found "there was no specific health risk that was identified at that time." Deafening silence However, BFAD Deputy Director Joshua Ramos said in an interview Tuesday that the milk units should be withdrawn from the market until such time that their contents are proven to be safe. Wyeth said it would comply with the recall order and that it would "accept" products covered by the order and "replace these." It did not elaborate, however, how many milk units would be taken of grocery shelves nor how it would proceed with this given BFAD's 15-day deadline. Asked whether or not Wyeth has been fully cooperating with the government on the matter, Padilla said that, "If there was 100 percent cooperation, then it wouldn't have gone to that extent to merit a BFAD order." He added that the product pullout, which resulted after "several months of investigation," was arrived at because the "safety of the public" was potentially "compromised." Health risk BFAD, in its order dated June 19, ordered Wyeth to "immediately cease and desist from further distributing, selling and offering for sale" the firm's milk products affected during the height of super typhoon Milenyo last year. Citing "risk of illness or injury," BFAD told Wyeth to initiate a product recall within 15 days upon receipt of the order. Wyeth said it got the order today (Wednesday). The bureau said the affected stocks were "rejected due to molds and rust on the cans because of damp palletes and the typhoon Milenyo incident, which have possible serious adverse health consequences." It also ordered Wyeth to submit a recall strategy, periodic recall status reports at three days interval from the date of recall operation including records and stocks inventory, and coordinate with the bureau on the product pull out. - GMANews.TV