The recall of a common blood pressure and heart condition medication by the US Food and Drug Administration (FDA) has caused a major health scare globally.
The drug contains an ingredient called valsartan, which was found to have N-nitrosodimethylamine or NDMA, a substance that is carcinogenic.
The action of the US regulator was replicated in some 30 countries including South Africa and the European Union.
A US online publication ‘‘Tech Times’’ noted that “the presence of the carcinogen was unforeseen and initial investigations suggested there were chemical reactions in the way these particular valsartan products had been manufactured.”
As such, not all medications containing valsartan were recalled. This has raised a new challenge: knowing which brands of medicines that came from the faulty manufacturers. In the US for example, the recall affected two major pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd.
The Kenyan Network of Cancer Organisations has some startling statistics, noting that globally, cancer causes more deaths than HIV, TB and Malaria combined and that 70 per cent of the global cancer burden is in low and middle income countries (LMICs) like Kenya.
This tragic reality is not by accident. Most developed countries have functional and morally obligated regulatory regimes that are buttressed by strong consumer protection groups keeping governments and manufacturers on their toes.
In contrast, our failure to take responsibility in our regulatory duties, coupled with our selfish interests, limit the capacity to fairly protect our citizens from harm. As I wrote this article, nothing has been said about valsartan ingredient in virtually all blood pressure medicines in this country. I walked into three different pharmacies and bought different medicines with valsartan ingredients. None of the pharmacists had any idea that some drugs containing this ingredient had been recalled in many countries.
Since there is no tracking and tracing of medicines in Kenya, we have no idea what is in the shelves of the many pharmacies in the country and citizens have little idea of the risks facing them.
Time and again, regulators have failed the country when it comes to consumer protection.
Several weeks after news emerged that some batches of sugar were contaminated, we still don’t know the truth about its content. Instead, politicians have politicized the matter without regard to the real risk facing consumers.
It is not just pharmaceuticals that we should worry about. Several agricultural chemicals are known to cause cancer but little is said.
A recent study at University of Nairobi links the presence of some Persistent Organic Pollutants (POPs), particularly the Organochlorine pesticides found in farmed fish to cancers. Researchers say that some of these contaminants cannot be avoided in our diet. The consumable amount is referred to as maximum allowable limit, and this means that even if they are consumed for a long time, they cannot cause immediate health effects. However, new research by Dr. Isaac Omwenga from Faculty of Medicine, University of Nairobi, shows that “irrespective of how little these substances are consumed they actually have long term effects. In science this means that these chemicals are able to cause diseases like cancer and other reproductive problems.”
Technology, however, could help reduce our exposure to harmful drugs and chemicals. In 2013, the US Congress enacted two key legislations; the Drug Quality and Security Act (DQSA) and DQSA, the Drug Supply Chain Security Act (DSCSA).
According to the FDA, the legislations outline steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the country.
This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.
Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.
Parliament therefore, should get down and draft legislation that would effectively protect citizens from harmful drugs and chemicals within the country.