The U.S. Food and Drug Administration has announced it will end alternative summary reporting, a program that allowed medical device companies to keep reports of harm and malfunction from the public. The FDA announced the conclusion of the program a month after a Kaiser Health News investigation reported that the FDA has collected 1.1 million reports since 2016, none of which were publicly available.
In particular, makers of breast implants have been able to report adverse events and keep the malfunctions and injuries opaque, according to the report.
The fact that the FDA is keeping consumers in the dark is hardly a surprise. There have been and continue to be many conflicts of interest within the agency, with some government officials working for the very companies they are supposed to be regulating, including medical device companies, the food industry and pharmaceutical corporations.
When it comes to lapdogs, Big Pharma has no better companion than the FDA.
One of the primary roles of the FDA is to review the safety and effectiveness of new drugs before they approve the drugs and release them into the market. These reviews should be objective and unbiased, of course, but conflicts of interest have been revealed time and time again.
FDA researchers have room for “interpretation” when reviewing drugs. For example, many cancer drug studies use surrogate endpoints, which means the study may not reveal whether the drug improves survival or quality of life, but instead may evaluate a different outcome, such as tumor shrinkage. So, even though the new drug may be highly toxic with minimal benefits, if the tumor shrinks, it’s approved.
In the end, FDA-approved drugs may appear to be more beneficial than they really are. And, once approved, Medicare and Medicaid programs must cover them, and those agencies are unable to negotiate prices. The thing is, gaining consumer confidence and transparency from the FDA can sometimes be like pulling teeth.
Along that same line, for years Consumers for Dental Choice has been trying to get the FDA to warn parents about the risks dental amalgam poses to their children, since the U.S. is one of the only developed countries in the world that refuses to even warn parents about the risks of amalgam.
The FDA does have a 2009 ruling on amalgam, but still allows it — which is 50 percent mercury — to be put in children’s dental fillings in any amounts and without warnings.
On another note, although millions of people are concerned about toxins and food additives in their food, you may be surprised to find out that food additives are not automatically required to get premarket approval by the FDA.
As a result, at least 1,000 ingredients are added to our food that the FDA has no knowledge of.
How could this happen? It started with a 1958 Food Additive ruling, where any item that falls under the “generally recognized as safe” (GRAS) designation is exempt from the FDA approval process altogether. At the time, it was meant to apply to common food ingredients like vinegar and baking soda. The numerous chemical concoctions we have today did not exist then.
Unbelievably, companies are allowed, on their own, to determine whether an ingredient is GRAS. A company simply hires an industry insider to evaluate the chemical, and if that individual determines that the chemical meets federal safety standards, it can be deemed GRAS. The company doesn’t even have to tell the FDA that the ingredient is in the food.
GMOs are a prime example of this practice. Monsanto and other agribusinesses sneaked GMOs into our food supply after the FDA classified GMOs as GRAS in 1992.
The bottom line is, whether you’re talking breast implants, food, fillings in your mouth or any number of other materials or devices, since 1848, the FDA’s sole purpose has been to fight for consumer protection and public health. Yet, the irony of that purpose is not lost on a consumer-savvy public — people like you who wonder whether it’s you or Big Business the FDA is protecting.