Silver Spring, MDOf all defective products you can have, the worst are the ones that you put in your mouth and ingest. Unlike something you swear at when it doesn't work properly, tainted foods and medicines do the damage silently, on the inside. By the time the situation reveals itself, it is often too late.
Throughout the last several months there have been dozens of reports over the quality of produced goods, or raw materials coming in from China: tainted wheat gluten, which was at the heart of the Menu Foods recall; tainted tooth paste, which was primarily marketed to the Dominican, but wound up in the United States after all.
And now comes word of a more damning discovery, with implications that could affect the entire pharmaceutical industry.
The question: Just what is IN the medicine you take? The suggestion has been made that you may never, ever conclusively know.
In a front-page report in the New York Times today (June 17th 2007), it has been revealed that in 1995, 284 barrels of a chemical identified as glycerine arrived on a container ship in New York. Glycerine is a pharmaceutical-grade liquid commonly used as the base ingredient in everything from cough syrup to tooth paste and is graded according to purity. While this particular batch of glycerine was not intended for use with drugs, it was labelled as 98 per cent pure glycerine.
However, when a client lodged a complaint, the importer, Dastech International of Great Neck, NY investigated more closely and discovered that the so-called 98 per cent pure glycerine contained sugar compounds - and worse - diethylene glycol.
Diethylene glycol, a less-expensive chemical cousin to pharmaceutical glycerine, is an ingredient used in anti-freeze. The latter was found in the lots of tainted toothpaste that were discovered, and recalled back in May.
The U.S. Food and Drug Administration (FDA) is well aware of the problem, and has been conducting numerous investigations into defective glycerine. But finding the source, or the paper trail, is anything but routine and in most instances, impossible.
Ten years ago, dozens of Haitian children were felled by what was determined to be poison - diethylene glycol - mixed in with fever medicine. Traced back to China, the FDA launched an investigation to find the source, but was frustrated every step of the way by state officials who wouldn't co-operate, records that wouldn't yield useful data, and investigative trails that would go mysteriously cold.
From a humanitarian standpoint, the FDA was attempting to get to the bottom of the Haitian poisonings in an effort to spare the further suffering of innocent children and their families from preventable poisoning. But from a purely jurisdictional standpoint, the FDA was equally, if not more concerned about the levels of glycerine imported into the U.S. as a raw ingredient for the production of pharmaceuticals.
Sadly, the Haitian deaths were repeated almost a decade later - this time, in Panama. And similar to the tainted syrup which showed up in Haiti, the Panama poisonings were finally traced back to a manufacturer in China not licensed to make pharmaceutical products.
What complicates the problem, according to the article in the New York Times, is that defective glycerine passes through so many hands in a global economy, that by the time it arrives at its final destination, the original paperwork from the factory is either lost or altered.
The tainted glycerine that played a role in the Panama poisonings passed through five brokers, while the Haitian glycerine was handled by six different entities. At the end of the day, the original documentation attesting to the chemical make-up of the glycerine at the factory did not accompany the shipment. Officials for the Centre for Disease Control and Prevention in Atlanta point to the fact that a globalized economy, and the participation of developing countries without a proper system of checks and balances in place, combines to a recipe for fraud and misrepresentation.
In the Haitian case, virtually all children who were given fever syrup containing tainted glycerine went into renal failure and died in hospital. There were 88 deaths, with half under the age of two. The FDA, fearful that the bad stuff might wind up in the United States, started to check around. Amidst a complicated relationship between brokers, importers and exporters, an FDA investigator found 72 barrels of the bad fever syrup in a warehouse belonging to a Dutch company, Vos B.V., which in turn was to sell the syrup to Haiti in a deal arranged by a broker, Chemical Trading and Consulting, which is based in Germany.
However, along with those 72 barrels of tainted syrup, the FDA investigator also found 66 barrels of chemical labelled 'glycerine' but containing lethal amounts of diethylene glycol, the anti-freeze ingredient. Thankfully, part of the shipment already sold went to an industrial user - but the revelation did not make the FDA feel any better.
They attempted to find the manufacturer of the bad glycerine through Sinochem International Chemicals Company, a large exporter in Beijing owned by the Chinese government.
After weeks of stonewalling, Sinochem finally divulged the identity of the manufacturing plant responsible for the tainted glycerine: Tianhong Fine Chemicals Factory, located in Dalain, northeast China. There again, the FDA was stonewalled in its attempts to contact, or converse with any representatives of the plant. By the time an FDA investigator finally managed to tour the Tianhong factory, the plant had been shut down, and Tianhong officials claimed that glycerine was no longer manufactured there.
A year-and-a-half had passed between the start of the investigation, and the visit to the plant. In the end, according to the FDA inspector now retired, the plant was cleared of any wrongdoing, as there was no evidence.
Troubling, is the fact that the Haitian and Panamanian poisonings are old news. The fact that the media is awash with current reports of tainted and defective products inbound from China suggests the problem is only getting worse.
It behoves the makers of drugs and pharmaceuticals to be aware, beyond any doubt, of the origins and quality of raw materials imported from other countries--especially something that we ingest, or give to our kids. Dr. Mohammed Hanif, a prominent physician based in Dhaka Bangladesh, states that foreign suppliers of diethylene glycol were never prosecuted over the deaths of thousands of children in the period 1982 to 1992. Dr. Hanif writes that he is still tormented by those suffering children, many of whom died in agony.
Importing glycerine from afar may make good business sense - but at what risk?
And the appearance of tainted toothpaste, manufactured in China and containing lethal diethylene glycol in the U.S. this past spring, shows that it's beginning to happen here.