Two International Board Certified Lactation Consultants, strengthened the case against Wyeth by providing the Philippine Bureau of Food and Drugs (BFAD) a complete list of the affected brands of contaminated milk and the outlets where they were delivered and sold to the unknowing public. The document came from sources within Wyeth that was provided to them through email exchanges. There is a great discrepancy between this document and the list that Wyeth released in June in major newspapers, showing an attempt to cover-up the magnitude of the risks to which children were exposed.
Elvira L. Henares-Esguerra, MD and Nona D. Andaya-Castillo alerted the Department of Health (DOH) and BFAD in May. It took the BFAD a few more weeks to verify the authenticity of the documents before issuing an order to Wyeth to recall the affected products of at least 4.5 million cans. Ms. Andaya-Castillo, the director of Nurturers of the Earth, Inc., got the information from sources within Wyeth itself, who have been in touch with her by e-mail since April. "BFAD had to issue a recall order, Wyeth had no plans of informing the public that milk contamination occurred," the IBCLCs pointed out.
Why did Wyeth deliberately withhold information from the BFAD on a potentially dangerous situation where the life and health of infants may be at stake? "One must remember, that a year ago, milk companies including Wyeth were able to get the Supreme Court to impose a Temporary Restraining Order (TRO) against the implementation of a new DOH revised implementing rules and regulations (RIRR). The RIRR is designed to curb the abuse of milk companies who were undermining the Breastfeeding Policy of the national government," Ms Andaya-Castillo said. "One could understand why Wyeth would avoid a scandal of monstrous proportions like this that may prejudice its case before the Supreme Court."
Wyeth publicly violated the procedure on product recall last year by not reporting the discovery of contaminated milk at the time it occurred. This is a good example of a situation that the new RIRR seeks to prevent. The RIRR also enforces sanctions on perpetrators of violations from milk companies AND government officials who allowed the violations to materialize. Other companies have experienced the same predicament but faithfully followed BFAD's recall procedure. In 2002, Abbott Laboratories headed by Edwin Feist reported to the BFAD the possible contamination of microscopic steel flakes and industrial oil in its Gain product (Advisory BA 2002-01),. In 2004, Novartis reported possible contamination of arsenic poison in its Gerber baby food (Advisory BA 2004-02) - a product line that was recently purchased by Nestle. Both reported to BFAD and were allowed to issue a public warning, and to withdraw such products from the shelves. (Source: http://www.bfad.gov.ph /advisory). Wyeth did not follow that procedure, more concerned as it was, on "damage control" over its image and its case before the Supreme Court.
According to Ms. Castillo and her sources within the Wyeth, sometime during the rainy season of 2006, a year ago, some infant formula products were exposed to the elements in the Wyeth warehouse and developed "leaks, molds, rust, discoloration and staining," a sign that microbes might have already invaded the stock. Unfortunately, Wyeth discovered it only after releasing millions of pesos worth of such products to the distributors and the buying public. Instead of informing the BFAD and issuing a public warning, Wyeth deliberately withheld information and tried to retrieve the products from their distributors as quietly and as secretively as possible.
According to the sources, Wyeth's Supply Chain Director, Mr. Luis Achacoso, issued a secret "Communication Handling" memo, which Ms. Castillo provided to BFAD.
1. There was no mention of Wyeth in the memo, indicating an attempt of Wyeth to avoid responsibility for the problem. However, the file's properties traced it to a computer of American Home Products (AHP), Wyeth's old name.
2. There was no mention of the seriousness of the problem, only that they are making a "quality check due to the rainy season." What was odd though was that they were checking for infant formula milk manufactured as far back as May, 2006, a full four months before the "communication handling" was issued in September 2006. Rainy season usually peaks in July, so why the delay in reaction time?
3. Even the "lead time of 24 hours" in the memo is suspicious. Task forces were even created to hasten the process. If indeed this were a regular checkup, why the hurry to get the report back in 24 hours. Usually regular checkups are done with a lead time of a few weeks, sufficient time to make a good assessment of the problem.
4. No microbiological assay was conducted to determine the presence of bacteria (Salmonella, E. sakazakii), a requirement that should be submitted to the BFAD. Certainly, problems of "molds, rust, discoloration and staining" may have caused the proliferation of harmful organisms that should be confirmed through laboratory tests rather than just simply looking for "visual signs," as instructed by Mr. Achacoso's "communication handling" memo.
5. Obviously, Wyeth, after being paralyzed by the enormity of the problem, and acting a few months too late, was in a great hurry to find where the "affected brands" were. One would not even suspect that something was terribly wrong, until the IBCLCs had secured computer-generated lists of an enormous quantity of "LOT NUMBERS OF AFFECTED BRANDS," copies of which Ms. Castillo also submitted to the BFAD. Even more alarming is the existence of only a few that were left in shelves and warehouses, indicating that most of the "affected brands" were already sold to the public for the consumption of babies.
6. The delay in reaction time can also be explained by the necessity of informing the mother company Wyeth Global, and getting its instructions on how to cope with the problem and its authorization to proceed with damage control.
7. By any definition, the "communication handling" is a secretly initiated selective recall. In the memo of Luis Achacoso, which is unusual because it did not show the corporate logo, his instruction was to make "visual identification of lot numbers vs. published lot numbers of affected brands, HOLD, SEGREGATE and SEND BACK TO WPI (Wyeth)." Damaged stocks should be replaced as the memo instructed. If that is not a recall order, what should we call that?
8. This affair has been marked by a series of terminations/resignations of personnel, including that of Mr. Ike Avenido (officer-in-charge of the warehouse) who with Luis Achacoso and Brenda Cielo are the best persons to shed light on what really happened. From the time this violation became public, Ms. Castillo has received feelers from other sources who offer even more information.
9. The affair has also been marked by a high incidence of destroyed stocks during the same period, that eventually have to be reported to the BIR for tax purposes.
10. Dr. Nerissa Calimon, Wyeth's Company Medical Director, is in charge of handling any BFAD concern. With the knowledge that she has, was she being truthful in her oath being a doctor? With most of the damaged goods already sold and in the hands of consumers, what samples were submitted for BFAD testing? Based on the "communication handling" memo, Ms. Brenda Cielo was responsible for collating the reports from the field. What did Cielo report to BFAD? That all the damaged goods have already been retrieved? Obviously, when BFAD actually found that there were other damaged goods that were not reported, BFAD issued its recall order, an automatic act that had to be done, even if after a full year the damaged goods are no longer available for retrieval.
11. The issue here is not that a tragedy occurred or a potential tragedy was likely to occur but rather that the consuming public and the retail outlets were kept in the dark on the risk that they were exposed to . No efforts were made by Wyeth to inform the public, the supermarkets, the drugstores, nor the prescribing doctors. Wyeth did not see it fit to provide the rest of the people a warning that our children might ingest "contaminated milk" due to their own negligence and greed for profit. Its course of action upon learning of the grave threat was not to protect the public interest, but rather to minimize the impact of the threat to their image as a company, and the status of its case before the Supreme Court. Instead of informing the public, they managed the crisis by resorting to secret "communication handling."
12. If this Wyeth fiasco resulted to illnesses and deaths, mothers or caregivers would automatically be blamed due to "improper or unsanitary" preparation. The truth is, even if they were prepared under sanitary conditions, the milk itself may not be safe or sterile.
13. When Wyeth had an inkling that their violation may be made public, two days later on March 29, 2007, all their salesmen were called to Manila for a "communication handling" briefing. We can check the airlines for their travel details on that day. A high ranking official of the company resigned as well on April 2.
14. Another way to verify the secret selective recall is to contact the 25 distributors to whom Wyeth delivered the damaged goods. With the mere 4% mark-up they earn, they will not be disposed to lie about the fact that most of the damaged goods have already been sold.
15. On TV, damaged cans were shown with rust on the top rim, but the contamination started at the bottom of the cans on top of the pallet. Wyeth did not show the real damaged cans.
It is rather amusing to recall that sometime in February this year, Mr. Andrew Santos, Wyeth's Vice President of Sales & Marketing, publicly stated that Wyeth products undergo 1,000 quality tests before being released to the market. The sources in Wyeth say that either he has a short memory or is just a plain liar. He knew at that time that there were already some products in the suspected list that could not be retrieved anymore because they were already in the supermarkets or have been bought by consumers.
BFAD Circular No. 8-2001 states that "A firm may decide on its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is mandated to notify immediately the BFAD." The question here is that did they notify BFAD, as did Abbott and Novartis in the past? Did Wyeth FULLY disclose the total amount of affected products, especially those already in the supermarkets and in the hands of the consumers? Was it reported at the time it was discovered? If it was, the BFAD would have issued a public health alert at least, and demanded an immediate recall of all the products and NOT a full year later, when the damaged goods are assumed to have already been sold and consumed.
The sources within Wyeth are well aware that those responsible for the fiasco - Luis Achacoso (Supply Chain Director), Brenda Cielo (Trade Marketing Department)), even Ike Avenido (Officer-in-charge of the Wyeth warehouse), as well as Ms. Castillo's Wyeth sources, are bound by an oath of secrecy that they were asked to sign before being employed by Wyeth. These Wyeth employees live under the threat of being blackballed by the entire American industry here and abroad if they tell the truth. They may lie with impunity because never in the history of Philippine jurisprudence is perjury ever punished by imprisonment. Castillo's sources have the computer print-outs, the backup disks, and the information that can ferret out the truth and provide the prima facie evidence to accuse Wyeth of malfeasance. It is far better for the Senate with its awesome power to cite for contempt under the glare of publicity, to COMPEL all witnesses to tell the truth, in an investigation conducted in aid of legislation.
"Parents should be warned of the tremendous hazards of formula-feeding. It is high time that the DOH RIRR is institutionalized and incorporated into a new law, like the bill introduced by Congresswoman Anna York Bondoc in the Lower House. At the same time, the Senate should ratify every Treaty and Covenant of WHO and Unicef, dealing with breastfeeding and formula milk," said Andaya-Castillo.
The Breastfeeding Clinic:
Your Partner from Pregnancy to Parenting
(Managed by two International Board Certified Lactation Consultants)
Nona D. Andaya-Castillo, IBCLC
Elvira L. Henares-Esguerra, MD, FPDS, RPh, IBCLC
Telefax: 632-889-1105 Mobile: 63-919-839-5555
Children for Breastfeeding: Mobilizing children to promote earth-friendly parenting
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