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Counterfeit Drugs: A Growing Global Health Crisis

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.

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. 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 <1% of US.

-    Most counterfeit medications found in the US supply chain seem to be introduced through Internet purchases.

-    The global active pharmaceutical ingredient production was estimated at $70 billion in 2008. China and India account for 60% of production

-    70% of all generic medications are manufactured in India. It is estimated that the Indian global generic business will grow to >$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.

Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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7 thoughts on “Counterfeit Drugs: A Growing Global Health Crisis

  1. ArtK says:

    One of the ways that this is being addressed is through legal mandates for “pedigrees” for each bottle of drugs. At each step of the way, whoever has control of the drugs must certify their possession. This pedigree gets passed from the manufacturer to the distributor and finally to the pharmacy. http://www.hunton.com/files/tbl_s47Details%5CFileUpload265%5C1527%5CContractPharma_JulyAugust_2006.pdf

    There is legislation in several states mandating this, although some (like California) have delayed implementation. The feds have a standard as well. There are electronic standards for digitally signed pedigrees. http://www.epcglobalinc.org/standards/pedigree

    I work for a major software/hardware vendor, on their traceability and pedigree product.

  2. Citizen Deux says:

    In addition to counterfeit drugs, there are a plethora of “counterfeit” medical advisors on the web – each pushing their own bogus diagnosis and VERY bad science.

    Disclaimer – Your head may asplode!

    Bad explanation of pH

    —–Original Message—–
    From: BioRaynaturaldetox@yahoogroups.com [mailto:BioRaynaturaldetox@yahoogroups.com] On Behalf Of Tami Wilken
    Sent: Thursday, June 11, 2009 7:22 PM
    To: BioRaynaturaldetox@yahoogroups.com
    Subject: RE: [BioRaynaturaldetox] pH Questions

    Hi Crystal,

    I am very confused about pH and how it works…and I’m not sure if this is the appropriate place to ask but thought I would give it a try. We started my son on LiverLife about two weeks ago.

    ***This is the perfect place to ask. :-) A healthy first morning urine pH is 5.8-6.2. For someone who is going through detox, an optimal first morning urine pH is 5.5-5.8 as this increases the rate of acid excretion. The first morning urine pH represents what the body is excreting. A healthy first morning saliva pH is 6.8-7.2. The first morning saliva pH represents the current state of the body.

    Why it is important to get the pH into range:

    An acidic pH contributes to many health issues. Enzymes are required for every chemical reaction in the body and an acidic (body) pH impairs enzymatic functions. When the body (saliva) pH is too acidic the body’s response is to compensate by secreting less acidic fluids and a shortage of proper stomach acid is the result. If there is low hydrochloric acid (HCl), the gastrointestinal (GI) tract will malabsorb nutrients and will grow harmful organisms that disrupt beneficial ones. The GI becomes compromised. Partially digested food particles can leak into the blood through inflamed mucosa (leaky gut). Those undigested particles have to be filtered out by the liver. This contributes to liver congestion which is represented by an alkaline first morning urine pH. When we do not drain acids efficiently through the urine, those acids remain in the body contributing to an acidic first morning saliva pH. It is impossible to detox efficiently from yeast, bacteria, viral, heavy metal, chemicals and/or parasites if the liver is congested.

    His pH has always been very alkaline.

    ***How alkaline? What is his first morning urine and saliva pH?

    He has a very limited diet but a balance of acid and alkaline foods. I have read that most people/kids are acid but my son is very alkaline and I have no idea why? Any thoughts on this?

    *** Excess ammonia can be the result of a sluggish liver metabolism contributing to an alkaline urine pH and saliva pH. This can be misleading, masking an over acidic terrain and a depleted mineral reserve.

    How do I get him more neutral?

    ***Liver Life has an adaptogenic effect on the pH. If the first morning saliva and urine pH are too high, Liver Life will lower them. If the saliva and/or first morning urine pH are too low, it will increase them.

    In clinic, BioRay found that Liver Life restored the alkaline/acid balance in the body much more quickly and without the hard work of an alkaline forming diet. Liver Life is very effective at helping to drain acids and restore a healthy pH. For some, the pH regulates very quickly and Liver Life is all that is needed. For others, the pH takes time to regulate. And taking additional steps can assist in speeding up the process:

    * Eat more alkaline forming foods. For a list of alkaline forming and acid forming foods go to the links below:

    * http://home.bluegrass.net/~jclark/alkaline_foods.htm

    * http://www.essense-of-life.com/info/foodchart.htm

    * Watermelons and lemons are two of the most alkaline forming foods and also assist with draining acidic waste through the urine. Watermelons are a good source of glutathione while lemons also are a great way to cleanse the kidneys and assist with digestion.

    * alkaline drops: http://www.alkalinebooster.net

    * Drink alkaline water

    * Chew foods properly: Alkaline forming foods that are not chewed properly will turn acidic in the body. Chew each bite to a liquid, 30-50 times. If your child does not chew well, try making a game out of it and teach them to do so. Using digestive enzymes with every meal will help until they have this accomplished. Patients in clinic found that simply by chewing their foods to a liquid, they felt full quicker and lost excess weight very quickly.

    * Moderate exercise will help to release acidic waste through the lungs and skin. Excessive exercise will cause an increase of lactic acid build up in the body contributing to an acidic environment; common in athletes.

    Please let us know if you have any further questions.

    Tami Wilken

    BioRay, Inc.

  3. Citizen Deux says:

    A mix of nutritional information, shameless product promotion and a false connection between excretory pH and bodily ills is rampant throughout this post. What is amazing is the ability of sites like this to “dodge” FDA regulations and foster the propogation of bad information.

    There is a citation of “patients in a clinic” who were chewing their food to liquid and thus felt fuller quicker! Neverminding that the time it takes to masticate a solid to a liquid was sufficient to permit the body to register fullness.

    A brief purview of the site reveals a host of bogus experiments, dubious claims and (of course) the quack Miranda warning.

  4. bluesixer says:

    While i don’t doubt that counterfeit meds pose a serious danger in some corners of the world – i have to wonder how much of the concern in the US is being ginned up by Pharma as a hedge against reimportation of identical-but-cheaper meds from Canada & the like…

    Of course – it’s been less of an issue since the dollar tanked…

  5. Mike_Doyle says:

    I order my meds from three safe and respected sources in India. I see this scare tactic as a means of cutting me off from cheap meds and forcing me to pay more locally for the same meds from the same place. I’m submitting a new order for more meds before this nonsense goes any farther.

  6. GHIBlog says:

    It looks like the mPedigree model was not discussed at this conference? mPedigree is a startup that has figured out a mobile phone based solution to countering fake drugs overseas. We have blogged about it here:
    http://globalhealthideas.org/2009/05/ghc36-discovering-new-strategies-using-proven-mhealth-technologies/

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