The less publicized matter stems from how these patients and their family were also completely blindsided and bombarded by products and therapies with no proof of efficacy and/or safety. Desperate for cures, parents took their children in the hundreds to opportunistic men and women in search of cures. People with absolutely zero understanding of or experience with human physiological function became the arbiter of health for the desperate. Of course these were in most cases pointless exercises as these charlatans were out for their own gains with no fear for consequence, which is unfortunately typical.
The entirety of this circumstance gives rise to many questions and shows the result of having an ineffective system in place; from clinical trial ethics to product marketing regulations. Although these incidents happened fourteen years ago, it will be very short sighted to believe regulations to forestall any repetition has caught up. Despite growth in regulatory activism and general regulatory development, there are still loop holes that “encourage” poor health product development process including clinical trials and marketing. This means the Government should put time and effort in updating regulatory mandates and recommendations while effectively executing what is currently on the books.
There should be stronger language in defining “drugs” in order to prevent fraudulent products from entering the market. There should be greater emphasis on regulations governing ethical practices, with a strict enforceable penalty for any ethics violators. A more stringent approval process for treatment therapies should be established including stronger GLP, GMP and GCP requirements. The regulatory agency should be given the responsibility of protecting the health of the people and given the authority and resource to ensure that marketed products are genuine and tested for safety and efficacy (unfortunately, the current system puts the onus for determining genuineness on consumers who are typically naïve on what constitute genuine). Resource should be available to educate the public on the differences between genuine and fraudulent products. This also means, more openness on the drug review process (including acceptance and rejection criteria). Most importantly, the regulatory agency should be giving the authority to persecute violations of established standards and mandates. I believe these as well as other regulatory developments will help to ensure greater product safety and will also promote better health quality. An alternate benefit includes an increase in competitiveness for the country in the global pharmaceutical market.
Particularly in this current global era, calling for better regulation on drug products and therapies cannot be overstated. Presently, an estimated 50,000 clinical trials are being run worldwide and in excess of 40 percent of these new studies are taking place in nontraditional research areas (countries with little share in the world’s pharmaceutical market yet as a result of declining health resources are experiencing epidemiological changes). Interestingly enough, the bulk of these trials ranging from gene therapy studies for rare diseases to studies for treatments for more common disorders; from studies of compounds imitating existing drugs to studies in search of secondary uses for them are commercially sponsored. This current trend in globalization makes it necessary for the Nigerian government to act to ensure that the incident of 1996 will remain history; otherwise, this time around the resulting disaster might be unimaginable in scale.