Before the U.S. Food and Drug Administration (FDA) approves a new drug, pharmaceutical companies have to demonstrate through drug trials on humans that their drugs are, supposedly, safe. Unfortunately, many of these tested-on-human-guinea-pigs medications turn out to have serious side effects that aren’t discovered until countless people have taken these meds for many years after FDA approval. Even more worrisome is deliberate and illegal covering-up of potentially deadly side effects of prescription drugs.
These issues aren’t slowing down the push for more drugs and more drug testing, however. In fact, in a commentary just published in the Journal of Pediatrics, Henry Akinibi, MD, and his colleagues from Cincinnati Children’s Hospital Medical Center and the University of Cincinnati are calling for Big Pharma to work with academics to conduct more human drug tests on a special group — newborn babies.
Dr. Akinibi argues that children, especially neonates, are an “underrepresented population” when it comes to drug experiments. Out of more than 120,000 studies at the National Institutes of Health (NIH) clinical trials repository, only 0.6 percent involve neonates; in total, only 3.4 percent of all registered pediatric studies involve newborns. He puts the blame on many factors, such as extra regulations required to experiment on children, no adult equivalents of many newborn health problems to give researchers a starting point for trying various drugs, the unique physiology of newborns and, of course, not enough financial incentives for pharmaceutical companies.
The result, Akinibi and his team write, is that many physicians prescribe adult-approved drugs for children in off-label and unapproved uses and without any clinical trials at all. The safety of this practice is often unknown and could obviously be placing newborns at risk for unknown side effects and other dangers. So, the authors of The Journal of Pediatrics commentary write, the answer is for the drug industry to work with academics to come up with study designs for newborns and for more funds to test more drugs on these babies.
While no one wants sick or otherwise fragile newborns to not receive medical care and help, increasing the number of drug tests on babies is worrisome for many reasons. One important concern is the discovery of bogus drug trial results that have been used to push dangerous drugs. No one knows for sure how often this happens because we only hear about instances where Big Pharma is caught and prosecuted.
A case in point: last summer the U.S. Justice Department fined drug giant GlaxoSmithKline $3 billion to resolve federal criminal and civil inquiries arising from the company’s illegal promotion of some of its products and failure to report safety issues — including the hidden fact that the diabetes drug Avandia increases the risk of congestive heart failure and heart attack. What’s more, as Natural News recently reported, a study in the journal Nature documented an epidemic of phony research data and fraudulent research , fueled in part by greed for grant money, which also throws the whole accuracy of drug safety into question.
About the author:
Sherry Baker is a widely published writer whose work has appeared in Newsweek, Health, the Atlanta Journal and Constitution, Yoga Journal, Optometry, Atlanta, Arthritis Today, Natural Healing Newsletter, OMNI, UCLA’s “Healthy Years” newsletter, Mount Sinai School of Medicine’s “Focus on Health Aging” newsletter, the Cleveland Clinic’s “Men’s Health Advisor” newsletter and many others.