Three Americans died from infections acquired from their eye drops. Eight more were blinded by the eye infection, four had to have the affected eye removed, and several dozen had vision-threatening eye infections or generalized infections that started with eye inflammation. The artificial tears responsible for this outbreak was a product manufactured by Global Pharma Healthcare and distributed in the U.S. under the brand name Ezricare Artificial tears by Ezricare and Delsam Pharma. The germ responsible for this outbreak was a drug-resistant strain of Pseudomonas aeruginosa never before reported in the United States. The over-the-counter eye drops were manufactured in India by Global Pharma, a manufacturer owned by Dubai Investments, for sale in the United States.
Death from eye drops is more likely to be the theme of an Agatha Christie murder mystery than the conclusion of a Food and Drug Administration (FDA) investigation. That this seemingly innocuous eye lubricant could wreak havoc on at least 68 people in 16 states is a reminder that we live in a hazardous world populated by corporations obsessed with cost-cutting and certain of their immunity from prosecution. The FDA is supposed to monitor pharmaceutical agents, but that surveillance is focused primarily on prescription medications until there is evidence that an over-the-counter (OTC/nonprescription) entity has caused a problem. The germ contaminating the artificial tears apparently got into the solution during the manufacturing process in India. Further investigations will determine if quality control measures failed to pick up the contamination or if, in fact, there were quality control measures in place at all. Investigations of this sort are not usually informative, since they rely on a paper trail that may be altered or simply fabricated.
The manufacture of healthcare products outside the United States has become fairly routine. The production costs in India or China are usually a fraction of the cost in the United States, and regulatory requirements, especially for nonprescription items, may be lax or simply nonexistent. Neither the FDA nor any other Federal agency can monitor the safety and efficacy of the innumerable healthcare products flooding the U.S. each year. Even with the more closely watched prescription medications manufactured abroad, the FDA may be challenged in its oversight by multinational companies that decide to ‘improve’ their manufacturing processes without disclosing the change to the FDA until someone notices that the color or consistency of a tablet or liquid has changed.
With multinational companies, such as Global Pharma, assigning blame for even the most egregious deviations from good practices may be difficult or ineffective. While the consequences of faulty manufacturing may be felt on the other side of the world from the plant that made the injurious item, those responsible for the plant operation or the distribution of the tainted product may be in neither location and consequently immune to sanctions. That Dubai Investments, the owner of Global Pharma Healthcare, will experience any inconvenience in connection with the artificial tears misfortune is inconceivable.
In 1984 a pesticide manufacturing plant in India accidentally released a poisonous gas, methyl isocyanate, into the town of Bhopal, India, killing thousands and injuring hundreds of thousands of the residents. The plant was owned and operated by Union Carbide, an American chemical manufacturer. Investigations after the disaster established that the plant was plagued by failed and failing systems, devoid of adequate safety procedures and devices, and operated by incompetent management and staff. It had been the site of several relatively minor toxin leaks before the major failure and had undergone no repairs or renovations to avoid the massive leak that occurred in 1984. Despite the supervisory failures and the harm caused, none of the American managers of Union Carbide faced any serious consequences. The advantages of foreign manufacturing were evident in this most awful of all circumstances.
The recent derailment in East Palestine, Ohio, of a Norfolk Southern train was an anomaly only in terms of its location. Hazardous material spills and industrial accidents on the scale of that derailment are routine and rarely noted when they occur outside the U.S. The railroad executives for Norfolk Southern testifying before Congress assured America that they would “do the right thing,” assurances that were hollow since the mishap would not have occurred if they had “done the right thing” before the accident.
The Congress makes a great show of reprimanding these transportation, manufacturing, banking, agricultural, or other special interest executives whenever there is a train wreck, building collapse, banking crisis, crop contamination, or other avoidable disaster. The irony is that an even a superficial inquiry routinely establishes that it was Congressional relaxation of government oversight at the behest of the industry lobbyists that allowed or increased the likelihood of the disaster our representatives now find so shocking. Our legislators berate these captains of industry to collect sound bites for their next election campaigns and then join them on America’s golf courses to solicit campaign donations and alternative employment opportunities.
We complain about government intrusion into business until our neighbors go blind. We are comfortable with cheap, foreign manufactures until inexpensive eye drops kill us. The executives behind the fatal flaws that cost us so dearly are secure in the knowledge that at worst they may face a few embarrassing moments before a congressional committee if their incompetence or indifference actually kills people. Warren Anderson was the Union Carbide Chief Executive Officer when the plant in Bhopal he was responsible for managing and maintaining released tons of poisonous gas because it was improperly managed and maintained. He faced no consequences for that enormous malfeasance, aside from being rushed out of India when his freedom was threatened by angry citizens. More than 3,000 people died within 3 days of the Bhopal disaster, and more than 20,000 eventually died from exposure to the poison gas. Warren Anderson lived comfortably to 92 years of age.
Dr. Lechtenberg is an Easton resident who graduated from Tufts University and Tufts Medical School in Massachusetts and subsequently trained at The Mount Sinai Hospital and Columbia-Presbyterian Medical Center in Manhattan. He worked as a neurologist at several New York Hospitals, including Kings County and The Long Island College Hospital, while maintaining a private practice, teaching at SUNY Downstate Medical School, and publishing 15 books on a variety of medical topics. He worked in drug development in the USA, as well as in England, Germany, and France.
