Tuesday, January 19, 2016

"Safe Nowhere" - An Exciting New Venture!

My latest novel Safe Nowhere, a fictional account of the clashing of a brilliant and quirky new lawyer, Katie Hornsby, with a powerful and crooked drug company and its deadly foreign generic drug, will be released near the end of February in print and e-book formats on Amazon, I-Books, Barnes and Noble and other major sellers. The story line of Safe Nowhere follows the pattern of my previous novels in presenting timely issues of safety and corporate wrongdoing within the pharmaceutical industry and the book specifically addresses the lack of quality and purity of foreign generic drugs that are currently flooding the American marketplace. Katie Hornsby faces obstacle after obstacle in her fight to help her clients.  A powerful combination of interests stack the deck against her quest.

While Safe Nowhere is a work of fiction, it is written within the context of present-day reality.  More than 83% of all U.S. prescriptions written in the United States are filled today with generic drugs. India’s generic drug industry is the source of more than forty per cent (40%) of our generic drug supply and routinely violates basic quality control standards and knowingly exports sub-par medicines. The Drug Controller General of India, G N Singh, recently offered an alarming excuse for the transgressions of India’s generic makers, “Our society and our economy are different from those in the US. If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country.” If you are taking a generic drug, it is highly probable that you are one of millions of guinea pigs being unknowingly exposed to an ongoing crap-shoot-like experiment on the safety of these foreign products. 

According to the FDA there are 526 drug manufacturing plants in India making products for the U.S. market. The agency has 10 investigators, soon to increase to only 19, to cover the entire country. China, as another example,  has 517 drug manufacturing plants making products that will end up in the U.S. market. At last count there were three investigators for the entire country.  Other countries have had problems as well. It was recently reported that, “The US Food and Drug Administration found that foreign producers of drugs were increasingly falsifying data about the quality of medicines, and  . . . issued six warning letters to companies in Mexico, Poland, the United Arab Emirates, India, and Canada about the quality of active pharmaceutical ingredients, over-the-counter solutions, and injectables.*  

Under the rubric of “transparency,” the FDA has claimed on its website in the past that “foreign drug manufacturing plants are routinely inspected for compliance with applicable regulations, including the Current Good Manufacturing Practices.” and that the “agency ensured that generic makers adhered to proper manufacturing standards and ‘the entire generic industry should not be judged by a few isolated incidents'.” This rose-colored myopia is not borne out by reality.  A more realistic assessment of the FDA’s current ability to do its job correctly is found buried deep in the FDA’s latest Global Assessment Program report  that tells the alarming truth; “Because of the vast and growing number of foreign facilities, FDA does not have—nor will it—the resources to directly inspect all the higher-priority facilities at desired frequencies.” and “Inspections still account for only a small fraction of the more than 300,000 foreign facilities manufacturing or processing FDA-regulated products for the U.S. market." The danger potential is growing geometrically. Imports of foreign-made drugs increased by nearly five-fold from 2007 to 2013 and India and China, the leaders of the pack, expect more than 400 per cent increases in their product exports by 2020. 

Just saying . . . .