It is an unfortunate reality that a major crisis including fires in petrochemical plants or an extensive foodborne disease outbreak such as the SE event of 2010 and the most recent disruption in the supply of infant formula serves to focus attention on a problem. Intervention by government agencies and Congress with accompanying revelations emerging from media scrutiny usually results in some form of preventive action to avert a recurrence.
In the case of the ongoing shortage of infant formula, there is a lot of blame to go around. There is no centralized reporting system for outbreaks of Cronobacter sakazakii in infants other than in Minnesota. Accordingly, mild infections may not have been diagnosed and only severe cases presenting as encephalitis were documented. In the absence of mandatory reporting and a central registry, paralleling FoodNet, problems may persist without investigation as to causation. More aggressive involvement by the Centers for Disease Control and Prevention in an earlier stage in the outbreak might have quantified the extent of the problem.
The Food and Drug Administration bears a heavy responsibility for lack of oversight of the implicated Abbott Nutrition, Sturgis, MI. plant that clearly was deficient with respect to physical facilities, equipment and above all, the inherent culture of safety and quality in the manufacturing facility. As an aside, one might question the competence of the FDA to monitor any pharmaceutical plant either in the U.S. or Asia supplying ingredients and drugs consumed by our population. The FDA is also faulted for inaction, having failed to follow up on deficiencies noted on previous inspections of the Sturgis facility. A fully documented and credible whistleblower report sent directly in October 2021 to the Director of the FDA and senior administrators including Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition did not elicit a response for three months. An inspection of the plant then revealed deficiencies characterized by Rep. Janice Schakowski (D-IL) as “disgusting”. The magnitude of problems both physical and managemental were clearly described in the FDA Complaint served on Abbott Nutrition resulting in a Consent Agreement, effectively an admission of guilt.
The major blame for the undesirable situation can be laid at the door of Abbott Laboratories extending downward to their subsidiary, Abbott Nutrition. Regrettably the Sturgis plant was responsible for a high proportion of U.S. production. Effectively, Abbott Nutrition, Gerber and Reckitt collectively manufacture ninety percent of U.S. infant formula including special products for children with exceptional needs. The FDA Complaint, based on the allegations of the whistleblower and a series of inspections of the plant in January 2022, identified numerous problems resulting in an extensive recall of product and closure of the facility. In accordance with the Consent Agreement extensive changes in the plant must be completed before resuming operation scheduled for mid-June 2022. The question of retraining personnel, introduction of appropriate production and quality control procedures and amending the culture of management from “making numbers” to a preoccupation with safety will obviously require a longer period with close surveillance by qualified and disinterested third party auditors authorized by the FDA.
The problems facing the manufacturer are exemplified by the self-exculpatory opinion published in the Washington Post by Robert Ford, Chairman of Abbott Laboratories. The article ran counter to all accepted principles of crisis control. At the outset, Ford should be referred to the action taken by James Burke, Chairman of Johnson and Johnson, following the 1982 Tylenol tampering event. The immediate response of Burke to the Tylenol toxicity that was not due to any deficiency of Johnson and Johnson is regarded as a classic in crisis control. Despite the fact that the problem was caused by malicious tampering to cover a homicide, Burke took responsibility, immediately recalled all Tylenol products, made himself available to the media on a daily basis, expressed a clear plan to resolve the issue and provided consumers with assurances and a timeline for resolution.
Ford, from his article, obviously parsed by corporate and outside counsel, has failed on all counts as measured against the Johnson and Johnson standard. His preamble dealt with the acceptance and function of diagnostic tests made by Abbott Laboratories, irrelevant to the problem of contaminated infant formula from a defective plant. He referred to the recall as a voluntary action in the interests of consumers of Similac™ formula. The recall would have been mandated so the action by Abbott was in no way virtuous. The Ford article noted, “We will not take risks when it comes to the health of children.” This is belied by the FDA Complaint detailing falsification of documents, actions to deceive FDA inspectors, tolerance with obvious deficiencies in equipment and operation and a culture in which achievement of budgeted volume and profit took precedence over the safety of product. Ford in no way communicated that, as a corporate entity, Abbott was responsible for the problem, or that long-standing deficiencies and contamination existed. Referring to the claimed safety of Abbott products on store shelves, Ford stated, “What is available has passed rigorous inspections.” This is incorrect since there is adequate evidence that microbiological testing of product was inadequate and, that in some cases, batches were consigned to retail without review of results and were even shipped with known contamination.
To complicate the issue, the culture of the Sturgis plant generated management and peer retaliation against any individual questioning inappropriate practices. The whistleblower was terminated after considerable internal pressure following expressions of concern over alleged procedures that may have contributed to contamination of product. Ford noted in his article that, “Data collected during the investigation, genetic sequencing, retained product samples and available product from the four complaints did not find any connection between our products and the four reported illnesses in children.” This is a direct denial of responsibility. The fact that Cronobacter sakazakii was present both in the plant and in samples of Abbott product constitutes res ipso loquitor. Under oath, newly appointed FDA Commissioner, Dr. Robert Califf, noted that whole genome sequencing (WSG) assays performed by FDA were in fact inconclusive. The contention that because a preliminary WSG procedure did not absolutely demonstrate a correlation is misleading and scientifically insupportable. The reliance on preliminary WSG data to create the impression that Abbott Nutrition is “off the hook” is eerily reminiscent of the denial of responsibility by the Managing Director of Enterprise Foods in the Republic of South Africa, responsible for the most extensive Listeria outbreak ever recorded. During the early stages of investigation preliminary WSG assays of plant and product isolates failed to correlate with the genetic sequence of numerous Listeria isolates from early patients. Subsequent epidemiological investigations and additional WSG assays confirmed the source of the plant and its salami product as the vehicle of widespread infection.
The Sturgis plant of Abbott Nutrition has failed to support the integrity of the Similac™ brand and the Abbott corporate image as a major pharmaceutical company. Ford has tolerated and even engendered a management culture preoccupied with production and profit to the detriment of quality and safety. One might question whether this situation exists in other Abbott facilities or for that matter, in other production units operated by major pharmaceutical companies flying under the insensitive FDA radar.
Ford did not have the courage to appear before the Subcommittee on Oversight and Investigation of the House Committee on Energy and Commerce. He dispatched a Vice-President, Christopher Calamari, to respond to questions. The grilling of this corporate officer elicited evasive, defensive and self-serving responses indicating a denial of corporate responsibility. Calamari claimed to be unaware of a problem of culture at the Sturgis plant and responded to the fact that Cronobacter was isolated within the plant as “It wasn’t in the production area” and that Cronobacter is a “naturally occurring” potential pathogen. The fact that under the Consent Decree, Abbott replaced roofs, floors and changed procedures confirms that deficiencies existed that should have been recognized and rectified as preventive measures.
Congress will have to deal with the obvious dereliction of responsibility by FDA. Clearly, deficiencies in both structure and personnel were highlighted in a recent investigative report. Abbott will now face punitive action by the FDA and also the Department of Labor for their apparently unjustified termination of the whistleblower. More importantly, the tort bar is firing up their word processors and the legal, financial and reputational consequences will be severe for corporate management, Abbott Laboratories and shareholders. The circumstances are similar to the events leading to an extensive outbreak of salmonellosis precipitated by the Peanut Corporation of America that resulted in extensive prison terms for the brothers Parnell and QC personnel.
The question remains as to how many more ticking time bombs there may be in the food and pharmaceutical industries that are currently obscured by manufacturers. The current infant formula debacle developed through the incompetence, lack of imagination and a pedestrian business-as-usual mode of operation of regulatory bodies including the FDA that is tasked and funded to maintain public health.