Counterfeit drugs: The growing threat to patients

Counterfeit medicines pose a real and growing threat to patient safety and worldwide public health. Pharmaceutical counterfeiting crosses geographic boundaries and impacts patients suffering from a variety of diseases. It is a crime that generates large profits for the counterfeiters even as it steals one of medicine's most important ingredients: trust.

In every part of the world, patients are unknowingly encountering counterfeits that look like the actual medicine — from the package to the size and color of the pill. These are dangerous imposters that may contain inactive and useless ingredients or even toxic substances. In each case, they are unreliable. In some cases, they can cause harm to patients, including death.

Drug counterfeiters have steadily expanded their reach to making illegitimate versions of lifesaving medicines, including cancer medicines, cholesterol-lowering drugs, antibiotics, hypertension medicines, hormones, steroids, and copies of many commonly used pain killers and antihistamines.

In some parts of the developing world, counterfeit medicines for the treatment of life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS are now threatening public health on a massive scale.

With so much at risk for patients, Lilly believes it's time to act on this issue for what it is: a serious problem that needs serious answers.

Lilly is actively engaged in efforts to combat counterfeiting in order to protect the health and safety of our patients. These initiatives include:

  • Securing the integrity of Lilly products throughout the supply chain
  • Deterring criminal activity
  • Partnering with government and non-government organizations and trade associations to strengthen enforcement and raise awareness

This global problem requires a sustained, long-term commitment. To stop this dangerous trend, collaboration and cooperation are critical, and Lilly is committed to working with a wide range of public and private partners.

Frequently Asked Questions

What are counterfeit medicines?

According to the World Health Organization (WHO), a counterfeit medicine is one that is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic medicines, and counterfeits may include products with the correct ingredients or the wrong ingredients, without active ingredients, with insufficient active ingredient, or with fake packaging. The bottom line: There are no safe counterfeit medicines.

Have people been harmed by counterfeit medicines?

While the exact number cannot be determined, many injuries and deaths are linked to counterfeit medicines worldwide.

  • A 58-year-old Canadian woman died from taking counterfeit medicines purchased from an online pharmacy. [1]
  • 260,000 bottles of cold medicine containing diethylene glycol, which caused many deaths, were discovered in Panama. [2]
  • 30 people died in Cambodia in 1999 after taking counterfeit antimalarials. [3]

What is the scope of the problem? How many, and where are they?

  • Every region is different. The World Health Organization (WHO) estimates that the percentage of counterfeits in the legitimate, global medicine supply network is less than 1% in developed markets, [3] 10-30% in developing markets [3], and over 50% in certain markets in Asia and Africa. [4]
  • Estimated deaths from counterfeit drugs vary from tens of thousands to more than 200,000. [5]
  • Customs agents around the world seized over two million tablets of counterfeit Lilly medicines in 2006 and 2007. [6]

What medicines are counterfeiters targeting?

Counterfeiters are increasingly targeting medicines for chronic diseases, HIV/AIDS, TB, and malaria.

Any kind of product can be and has been counterfeited: expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol-lowering drugs, hormones, steroids, and inexpensive generic versions of simple pain killers and antihistamines. In developing countries, the most disturbing issue is the common availability of counterfeit medicines for the treatment of life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS. [3]

Is it safe to buy medicines over the Internet?

If it looks too good to be true, it probably is.

  • Internet-based sales of pharmaceuticals are a major source of counterfeit medicines. [3]
  • It is estimated that 50% of medicines ordered over the Internet from sites that hide their physical address are counterfeit. [7]
  • Recently, the FDA issued warnings on Internet ordering from various Canadian websites that were selling counterfeit products. [8]

Why would people manufacture counterfeit medicines?

  • It is all about the money. For all products, it is estimated that $650 billion in global sales are lost to counterfeit goods. [9]
  • The trade in fake medicines has become big business for counterfeiters. The U.S. Department of State estimates the counterfeit pharmaceutical market totals approximately $32 billion. [10]
  • The counterfeit medicines trade in Mexico is estimated to be valued at $650 million per year. [4]
  • The market in fake drugs is estimated to be worth $130 million in Kenya. [5]
  • Unlike trafficking in narcotics, the penalties for selling counterfeit medicine remain weak.

How can patients avoid getting counterfeit medicine?

Patients should check the packaging, notice any changes in shape and color of the medicine, and buy medicine only from known and/or established sources. If patients suspect a counterfeit or tampered product, they should report it to their pharmacy, health care provider, and the manufacturer. Patients should also save the medicine so that it can be tested.

If you have additional questions or concerns about the safety of any of your Lilly medicines, please call 1-800-LillyRx.

References

  1. www.theglobeandmail.com, accessed July 10, 2007.
  2. The New York Times, May 6, 2007.
  3. World Health Organization, Counterfeit medicines, Fact Sheet No. 275, Revised November 2006, http://www.who.int/mediacentre/factsheets/fs275, accesssed January 2, 2008.
  4. Julian Morris and Philip Stevens, Counterfeit medicines in less developed countries: Problems and solutions, International Policy
  5. Network and the Campaign For Fighting Diseases, May 3, 2006, http://www.fightingdiseases.org/pdf/IPN_Counterfeits.pdf, accessed January 2, 2008.
  6. Donald G. McNeil Jr., A growing epidemic of fake medications in Asia, International Herald Tribune, February 20, 2007 http://www.iht.com/articles/2007/02/20/news/drugs.php, accessed January 2, 2008.
  7. Data on file, Eli Lilly and Company, ZYP20071130.
  8. Impact International Medical Products Anti-Counterfeiting Taskforce newsletter, http://www.who.int/impact/en/index.html, accessed January 2, 2008.
  9. FDA Bulletin P06-123, August 30, 2006, wwwfda.gov, accessed November 9, 2007.
  10. Countering Global Counterfeiting and Piracy, US Chamber of Commerce, National Chamber Foundation, Summer 2006.
  11. USINFO, U.S. Department of State, May 20, 2005.

If you have additional questions or concerns about the safety of any of your Lilly medicines, please call 1-800-LillyRx.