Monday, September 13, 2010

The Counterfeit Counterfeit Drug Count

Have you ever wondered about the statement that "10% of all drugs worldwide are counterfeit"?

The 10% figure has been cited by the World Health Organization (WHO), which has become the de facto source for the statistic. Just about every technology vendor involved in pharmaceutical supply chain security still touts the 10% figure as often as possible.

Alas, it turns out that the 10% figure has no factual basis in reality. Carl Bialik, the Wall Street Journal's Numbers Guy, published a fantastic piece of journalism this weekend entitled Counterfeit Drug Count Is Tough to Swallow. You should also read Dubious Origins for Drugs, and Stats About Them from The Number Guy's blog for some additional background.

The lesson? Always check the references. And don't believe everything you hear from technology vendors.

Here is a the key section from Mr. Bialik's article:
"The 10% figure appears to have surfaced initially in a 2002 editorial in the British Medical Journal, which reported that 'the World Health Organization estimates that 10% of global pharmaceutical commerce is in fakes.' The article attributed the WHO estimate to a study published in 1999 on counterfeit drugs in Myanmar and Vietnam. For the study, WHO researchers tested samples of 500 drugs, specifically selected because they were considered particularly susceptible to counterfeiting. A little over one in 10 didn't contain the labeled amount of active ingredient. But the paper made no claim about the overall counterfeiting rate in those countries, let alone world-wide...His 2002 editorial was picked up by several major news organizations, and soon 10% became a commonly accepted figure, attributed to WHO. The health agency itself included the estimate in several statements and fact sheets. The FDA, meanwhile, cited the 10% figure in a 2004 report, attributing it to WHO. Spokeswomen for both organizations say the origin of the figure is unclear.
Amazing. IBM is running a new ad stating unequivocally that "10% of the world's medicine is counterfeit, affecting over a billion people a year." Yikes! An executive at another technology vendor published an article in August claiming that the WHO estimate was "conservative." I guess scare tactics still work.

Thankfully, counterfeit drugs are still extremely rare in the United States even as the global problem seems to be growing. But the potent mix of greed and diversion still creates potential problems as I note recently regarding products stolen from GlaxoSmithKline and Shire.

My philosophy in writing this blog can be summed up with a quote from the late Senator Patrick Moniyhan: “Everyone is entitled to his own opinion, but not his own facts.” I am opposed to unsupported accusations, overwrought hyperbole, or just plain misrepresentation. Careful readers will notice that I always try to include links to source materials so that you can make up your own. Never uncritically accept any statistic...even if you read it on Drug Channels!

9 comments:

  1. Dr. Fein,

    You are correct in asserting that the 10% WHO figure is not accurate. However, counterfeit drugs are a genuine problem in many parts of the world. I direct you to this article from the Washington Post: "India becomes a hub for fake medicines" (http://www.washingtonpost.com/wp-dyn/content/article/2010/09/10/AR2010091006700.html)

    Just because we can not measure the full scope of the problem does not mean we should not give it our full attention.

    Thank you.

    ReplyDelete
  2. Well said. However, I do not believe that we should rely on misleading or outright false data, no matter how worthy the cause.

    Here's a clickable link to the article mentioned in the comment above:

    India becomes a hub for fake medicines

    Adam

    P.S. FYI, anyone can include a clickable link in a comment with a little HTML.

    ReplyDelete
  3. Thank you for alluding to the pitfalls of "commonly accepted statistics". The Long Term Care industry is facing some significant challenged in the coming years due to a technology vendor playing the numbers game with a health care "reform" committee.

    Given the rampant innumeracy apparent throughout our society, it is frightening to hear a statistic quoted.

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  4. Your report on the hyperbole about counterfeit drugs is well done. The last thing our industry needs is an unwarranted panic about bad drugs in the USA. It also should serve as a cautionary tale about consumers buying drugs from internet sites, especially those that represent themselves as Canadian, but in reality are operating from sites in poorly or unregulated countries.

    While those of us in the industry know that the FDA is substantially dysfunctional, it does a very good job of protecting Americans from counterfeit drugs distributed legitimately in the US.

    Myron D. Winkelman, R.Ph.

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  5. Looks like the weekend was all about counterfeit drugs in the national media. A reader just pointed out this new article from The USA Today: Growing problem of fake drugs hurting patients, companies.

    Jon: I can't even count the number of innumerate people! ;-)

    Adam

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  6. Adam,
    Thanks to you and the WSJ for exposing the 10% guess (it shouldn't be called an estimate). The supply chains in certain countries have a major problem with counterfeits, but any estimate/guess of a worldwide percentage is meaningless and serves only to blow smoke into the discussion of solutions to the problems.

    Here's another "guess" that distorts the problem in the U.S. supply chain: The WHO estimates that less than 1% of drugs sold in developed countries are counterfeit. Anytime you see "less than 1%" of anything, what they are really saying is that the precentage is too small to measure. They could have said that the percentage of drugs sold in developed countries that are counterfeit is so small that it cannnot be measured or estimated.

    Dirk Rodgers
    www.RxTrace.com

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  7. Adam,

    Facts? Retail PH industry doing simply swell? Most independents and chains are thriving?.

    Pharmacy values are down. Dollar AND percent margins have dropped. RP salaries have not just come to a halt, but in many regions we are seeing paycuts...(or having RP's reapply for positions).

    Those are your facts.

    And yep, I actually do love my job as a druggist!

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  8. Adam,
    Great Post. Here is a story that is playing out in the goog old USA.


    http://www.forbes.com/feeds/ap/2010/09/03/business-health-care-us-counterfeit-drugs-
    wisconsin_7901993.html

    PS. I don't know HTML....see you @ NCPA

    Mayer Maltz
    mmaltz@gmail.com

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  9. As an experienced pharmaceutical professional from India, the so called experts claiming that 10% of world wide trade of medicines is fake, has no basis but a general perception. There are no hard facts on the estimate of counterfeit medicines since no scientific measurement of counterfeit medicines is possible since it is not a legal industry.
    If India are to global hub for the manufacture of counterfeit medicines, to the fanciful claim of 10 & 20 %, there will be deaths and misery in the Hospitals & on every roads in Mumbai, Chennai, Delhi, Kolkatta and Bangaluru. I can assure you I do not find such scenerio in India, however much the developed countries & WHO would like every body in the world to believe. The estimate of 10% is irrational and a figment of imagination, like Sadam Hussain's weapons of mass destruction. S.Ramesh, Associated Capsules Group, Mumbai, India

    ReplyDelete