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Counterfeit Drugs: A Growing Global Health Crisis

Jun 21, 2009 - 4 comments
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Counterfeit Drugs

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antibiotics



    "A resistant strain of bacteria –created by partially effective counterfeit antibiotics – doesn’t need a VISA and passport to get to the U.S."

-    Paul Orhii, National Agency for Food and Drug Administration and Control, Nigeria

I attended a conference in DC yesterday called, “The Global Impact of Fake Medicine.” Although I had initially wondered if homeopathy and the supplement industry would be the subjects of discussion, I quickly realized that there was another world of medical fraud that I hadn’t previously considered: counterfeit pharmaceuticals.

Just as designer goods have low-cost knock-offs, so too do pharmaceuticals and medical devices. Unfortunately, counterfeit medical products are a higher risk proposition – perhaps causing the death of hundreds of thousands of people worldwide each year (http://www.aei.org/book/930).

It is difficult to quantify the international morbidity and mortality toll of counterfeit drugs – there have been no comprehensive global studies to determine the prevalence and collateral damage of the problem.  But I found these data points of interest (they were in the slide decks presented at the conference):

-    Pfizer Global Security raids resulted in seizure of 11.1 million counterfeit tablets, capsules and vials in 42 countries in 2008. Pfizer seizure of counterfeit drugs in 2008 were up 28.9% over 2007.

-    Within a 7 day period, 250 different Internet-based Viagra purchases were seized in a single mail center. After chemical testing, it was determined that 100% of the tablets were counterfeit.

-    Anti-malarial counterfeit tablets are common in East Asia and Africa, threatening to derail the US goal of decreasing malaria mortality by 50% in 15 countries (http://www.usaid.gov/our_work/global_health/id/malaria/index.html). Chemical testing in Africa revealed that 20-67% of chloroquine failed content quality checks, and 75-100% of sulfadoxine-pyrimethamine tablets (for pregnant women) was not absorbable. Tests conducted in Cambodia in 2003 demonstrated that 27% of anti-malarials were counterfeit with quinine being 77% counterfeit and tetracycline 20% counterfeit.

-    Some “Canadian” mail order pharmaceutical prescriptions have very circuitous routes of manufacture, packaging, and delivery. One batch was manufactured in China transported to Dubai, then to London, then filled in Bahamas, sent to the UK, and then mailed to the US.

-    Counterfeit drugs are estimated to make up 30% of Kenya’s total pharmaceutical products, 20% of India’s, 10% of Russia’s, and $70 billion by 2009. India and China have much less stringent safety and regulatory standards, which provides fertile soil for counterfeiters.

-    25 years ago, most counterfeit medications were placebos. Today’s counterfeits have some active ingredients because sophisticated counterfeiters are looking for repeat business.

This conference provided a sobering account of the counterfeit pharmaceutical industry, tracking its exponential growth over the past two decades. That growth appears to be fueled by the outsourcing of pharmaceutical manufacturing plants to countries with limited regulatory oversight, and the sale of medications via the Internet.  So far, poor quality and contaminated prescription drugs are rarely found in US pharmacies – but that could certainly change. The FDA, US Department of Commerce, and US Agency for International Development are calling for an international public-private partnership to stem the tide of counterfeit drug manufacturing. But with little to lose (fines for counterfeit drug manufacturing are notoriously light) and much to gain (a slice of a multi-billion dollar industry), it’s unlikely that the counterfeiters are going anywhere anytime soon.

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by scottso, Jun 22, 2009
This is quite alarming!  I am very concerned that these "poor quality and contaminated prescription drugs" will find their ways into our pharmacies due to companies looking for cheaper outs and possibly cutting corners under which they would not normally.  I hope the FDA will be able to keep up and continue or even amplify their inspections/investigations to keep our systems safe.

Great article!

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by Karen99, Jun 23, 2009
Thank you for posting what you learned at the conference.  It is nearly impossible for our government to track these counterfeit drugs.  A good portion of these drugs are coming through the mail and are near impossible to trace back the source of origin.  The example:

-    Some “Canadian” mail order pharmaceutical prescriptions have very circuitous routes of manufacture, packaging, and delivery. One batch was manufactured in China transported to Dubai, then to London, then filled in Bahamas, sent to the UK, and then mailed to the US.

We might trust a true Canadian pharmacy.  How many of us trust China to manufacture safe medications.  Very few I would say.  I no longer purchase ANYTHING from China that is "edible" or used for serving food.  Or toys for children.  Heck I don't trust the dye used in clothing from China.  

I hope a lot of people read this and become more aware that bad medications are making their way into mainstream pharmacies.  I know people who get their Tamoxifen by overseas mail order.  This could have tragic consequences.  

Often, the only deterrent in producing a bad product is initiating a lawsuit. The almighty dollar speaks.  Who can be sued in the example shown above where these meds are changing hands multiple times before they reach the customer.  China?  Good luck with that one.




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by Tammy2009, Jun 24, 2009
What about cheaper pharmacys?  Like walmart or superstore?  Their drugs are cheaper than getting them at a grocery store, is the quality of the drugs the same?  I know other things there like clothes and pet products (I work in a pet store and have compared the real brands to the walmart knock offs) are of lower quality in walmart.  

Otherwise how do they sell the same drugs at such a lower price?

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by Midrelle, Jul 15, 2009
Many other countries do not have adequate regulations concerning food and drugs. Even WE are allowing things like melamine into our food supply. How do we know that the " wheat" that we import and use in flours that are sold to all kinds of companies does not contain melamine as a filler. Why don't we use our own farmer grown wheat? Knock-off drugs are rampant and fake flavorings are rampant. although I was never suspicious of the food and drug supply in the US I am now very suspicious of everything I buy. One of my pet peeves is that no canned food has country of origin, but only says "distributed by" so and so. The FDA says no-one wanted to know. I can't believe that is true. Much of this is a prelude to Codex Alimentarius implementation and food and drug rules on a global basis. While it might seem to be  and is purported to be for "our own good" to standardize food and drug rules on a global basis it just leaves the door open for global companies to take advantage and deprive us of our rights to choose, say, a natural product instead of a drug. I see the day coming when we will no longer be allowed to grow tomatoes on our patio.

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