Thursday, June 21, 2007
More about counterfeit medications:
(Part III of a III part Series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 19, 2007
A couple of weeks ago I wrote about a report from Dr. James Adams at the USC School of Pharmacology, detailing problems in our drug distribution chain, including the sale of counterfeit medications, which accounts for $39 billion in sales in the U.S. annually.
And while pharmaceutical drugs sold over the Internet were singled out for special consideration, the problems were not related solely to that avenue. The report stated that; "counterfeit drugs kill thousands of people world-wide every year," and that the U.S. Food and Drug Administration was keeping the problem quiet to avoid having American consumers lose confidence in the drug market.
And while there are press releases on the FDA web site, they only work if the press actually reports on them. There are not many people who check the FDA or the CDC web sites on a regular basis to find out if there are any major health risks in their area, (but it's not a bad idea.) Also, a press release by itself says very little about the scope and severity of a given event. It gives enough information to satisfy our sound-bite mass media, but fails to truly inform the average citizen.
Dr. Adams' report also states that a large part of the problem involves imported drugs or compounds used as a base in drug manufacturing. These various chemical compounds and/or finished medications "[may be contaminated, may contain the wrong amount of active agent, may be manufactured by another company in places like Russia, China, India and Pakistan; and may be packaged or labeled incorrectly."
These tainted products make their way into the U.S. pharmaceutical supply chain through large wholesalers who import nearly all of these chemicals, (think about the recent pet food poisoning tragedy that involved nearly every brand of food on the American market.) When counterfeit drugs and compounds find their way into one of the few giant wholesalers, they end up distributed throughout the system.
These wholesalers get big discounts when they buy these drugs from certain countries, so they choose profit over domestic manufacturers who would be bound by U.S. rules and regulations, and who would be much less likely to endanger the lives of American consumers. If a family member died from a drug distributed from New Jersey, but containing a contaminated chemical manufactured in China or India, the people responsible for the death are rarely identified or prosecuted.
But the victims of these phony medications are hardly limited to the United States. Examples include the following:
"Meningitis in Niger 1995 – 50,000 people were inoculated with counterfeit vaccine, resulting in 2,500 deaths."
"China in 2002 – 8% of all Over-The-Counter (OTC) drugs were counterfeit."
"Kenya 2005 – 30% of the drugs in the country were found to be counterfeit, including AIDS medications."
There are diluted or useless Malaria vaccines sent to places like Africa where 1 million children die from the disease annually.
The FDA has attempted to stop counterfeit drugs from reaching the American market using things like RFID tags, cross-border purchasing laws and regulations, a National Drug Code, (NDC,) changes to labels and packaging, and other measures.
But one huge gaping hole in this regulatory scheme is strict oversight and regulation of our domestic pharmaceutical industry. Considering the industry's tentacles have found their way into every corner and crevice of national politics, and their corruption of our political system through money and lobbying makes them nearly untouchable, I wouldn't expect any serious changes there in the near future.
(Part III of a III part Series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 19, 2007
A couple of weeks ago I wrote about a report from Dr. James Adams at the USC School of Pharmacology, detailing problems in our drug distribution chain, including the sale of counterfeit medications, which accounts for $39 billion in sales in the U.S. annually.
And while pharmaceutical drugs sold over the Internet were singled out for special consideration, the problems were not related solely to that avenue. The report stated that; "counterfeit drugs kill thousands of people world-wide every year," and that the U.S. Food and Drug Administration was keeping the problem quiet to avoid having American consumers lose confidence in the drug market.
And while there are press releases on the FDA web site, they only work if the press actually reports on them. There are not many people who check the FDA or the CDC web sites on a regular basis to find out if there are any major health risks in their area, (but it's not a bad idea.) Also, a press release by itself says very little about the scope and severity of a given event. It gives enough information to satisfy our sound-bite mass media, but fails to truly inform the average citizen.
Dr. Adams' report also states that a large part of the problem involves imported drugs or compounds used as a base in drug manufacturing. These various chemical compounds and/or finished medications "[may be contaminated, may contain the wrong amount of active agent, may be manufactured by another company in places like Russia, China, India and Pakistan; and may be packaged or labeled incorrectly."
These tainted products make their way into the U.S. pharmaceutical supply chain through large wholesalers who import nearly all of these chemicals, (think about the recent pet food poisoning tragedy that involved nearly every brand of food on the American market.) When counterfeit drugs and compounds find their way into one of the few giant wholesalers, they end up distributed throughout the system.
These wholesalers get big discounts when they buy these drugs from certain countries, so they choose profit over domestic manufacturers who would be bound by U.S. rules and regulations, and who would be much less likely to endanger the lives of American consumers. If a family member died from a drug distributed from New Jersey, but containing a contaminated chemical manufactured in China or India, the people responsible for the death are rarely identified or prosecuted.
But the victims of these phony medications are hardly limited to the United States. Examples include the following:
"Meningitis in Niger 1995 – 50,000 people were inoculated with counterfeit vaccine, resulting in 2,500 deaths."
"China in 2002 – 8% of all Over-The-Counter (OTC) drugs were counterfeit."
"Kenya 2005 – 30% of the drugs in the country were found to be counterfeit, including AIDS medications."
There are diluted or useless Malaria vaccines sent to places like Africa where 1 million children die from the disease annually.
The FDA has attempted to stop counterfeit drugs from reaching the American market using things like RFID tags, cross-border purchasing laws and regulations, a National Drug Code, (NDC,) changes to labels and packaging, and other measures.
But one huge gaping hole in this regulatory scheme is strict oversight and regulation of our domestic pharmaceutical industry. Considering the industry's tentacles have found their way into every corner and crevice of national politics, and their corruption of our political system through money and lobbying makes them nearly untouchable, I wouldn't expect any serious changes there in the near future.
# posted by Phillip T. Alden @ 7:31 PM 
