Monday, October 4, 2010

American Enterprise Institute: How Safe Are Your Medicines?

A counterfeit drug has been described as the perfect murder weapon as it is very difficult to detect.

Roger Bate, the Legatum Fellow in Global Prosperity at the American Enterprise Institute and leading expert on the counterfeit drugs writes another outstanding piece on bogus medications and the deadly global problem it has become.

How Safe Are Your Medicines?, is jammed with relevant global information and statistics and is a necessary read for anyone who is part of the pharmaceutical supply chain.

Mr. Bate is a particular favorite of Secure Pharma Chain in that he clearly articulates and connects all of the many facets of this insidious criminal act and its consequences.

Here are but a few of the highlights of this first rate article published by the American Interprise Institute:

A recent Pew poll shows that 54 percent of Americans distrust drugs made in India and 70 percent distrust drugs from China. With more and more medicines or their ingredients sourced from countries with inconsistent regulatory environments and significant levels of corruption, better-informed patients around the world are asking themselves how much they trust foreign drugs. This should be of concern to any exporting drug producer.

A counterfeit drug has been described as the perfect murder weapon as it is very difficult to detect. Essentially a fake is a product pretending to be something it isn’t—a labeling fraud. By some estimates, perhaps hundreds of thousands of people are killed a year from fake drugs, especially in the poorest parts of Asia and much of Africa.

Most pills do not kill as poisons, they simply do not treat the conditions and diseases they were taken to control or cure. Entities from Interpol to the World Health Organization to large pharmaceutical companies are fighting this menace. Inadequate criminal legislation means that intellectual property law sometimes offers the only remedy to such potentially lethal activities.

A less well-known but perhaps more pernicious problem exists with substandard medicines, which are legal, often made by politically connected local companies, but do not work properly. A patient who falls victim (or his survivors, if he succumbs) may be offered no recourse, even if someone suspects something. Finding somebody to blame is notoriously difficult.

• Political ramifications are rife—a few examples from Latin America will suffice. Take the case of the Cuban doctors servicing President Hugo Chavez’s health system in Venezuela. They are bringing drugs with them from Cuba, which are suspected to be of uncertain efficacy. Stories have leaked out of patients not responding to treatments, but no one knows for sure whether medical personnel have made mistakes, or—as seems more likely—drug quality is the cause. Patient have little recourse, especially since even an investigation would imply that a key ally of President Chavez might be at fault.

• In 2003, Brazil's drug regulatory authority, ANVISA, decided to phase out the very lightly regulated class of medicines known as “similars.” These products are made by legitimate manufacturers, but they only have to show basic chemical stability. They do not have to show that they are bioavailable (they work the same way in the body) as generic drugs. Brazil’s move began when a survey found that most substandard medicines on the market were from this class. However, similars are wildly popular with the general public, which believes these are nearly as good as branded versions, just cheaper because they don't have fancy packaging. So the Brazilian government revised its plan and allowed producers a grace period—until 2014—before they would have to conform to safety standards. Argentina allows similars and has no plans to phase them out. My ongoing analysis of these medicines leads me to believe that similars have far greater variability than proven generics. In other words it is not that the manufacturers cannot make good quality products, it is just that they do not do so consistently.

• A tragic case under investigation in Peru demonstrates some of the pitfalls. Dr. Raul Cordero of the national cancer institute administered a drug to five children suffering from lymphatic leukemia, which caused an adverse effect to the central nervous system and induced coma. Four of the children died.

• Not only are these drugs a danger for the patient, they contribute to an increasing distrust of the entire healthcare system. Patients not being treated effectively may look to bogus remedies or seek “better” treatment overseas, something only the rich can afford to do.

Competition in the drug market, as in any market, is generally a good thing. It lowers prices and enables more patients to be treated. But this is only the case where the competitors trade in products of equal efficacy and safety, and unfortunately that is increasingly not the case in many parts of the world.

As this issue continues to grow and proliferate around the globe, it is vital that all members of the pharmaceutical supply chain take measures to protect their commercial brand, inventories and most importantly the health care consumer.

The issue of substandard, adulterated, fraudulent and counterfeit medications is a problem that will only grow and will only subside until the global supply chain utilizes technology and supply chain solutions to eradicate it.

To read all of Roger Bate’s American Enterprise Institute article, visit:

To learn more about technologies for the detection of counterfeit medications, visit:

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