A few weeks ago I happened to catch an episode of the radio show This American Life, which focused on the how the U.S. Food and Drug Administration (FDA) dealt with problems related to acetaminophen, also know as Tylenol.
In a nutshell, it took the FDA over 30 years to let us know that taking too much of this medication can cause severe liver disease and death. Historically, Tylenol was thought to be the safe pain reliever and one that we should "trust." Truth be told, taking just two extra strength Tylenol tablets over the maximum daily dose of eight can cause liver failure.
Why did it take the FDA so long to inform the public of the health risks associated with Tylenol? According to a review of the FDA process, a lack of financial resources and a heavy workload caused the delay.
Ironically, days before I listened to this episode, I was thinking about a few other perplexing FDA positions. While their tagline is "protecting and promoting your health," there are many instances where their actions are anything but. Here are four such examples.
1. Food Additives
A recent study published in the Journal of the American Medical Association Internal Medicine (JAMA Intern Med) found that between 1997 and 2012 all of the members on panels to determine if a food additive was safe had ties to the industry that created them, either as an employee or consultant. One has to wonder, with such an infiltration of industry in the decision-making process, if these additives are truly safe to consume.
Additionally, the FDA allowed companies that created food products to determine whether or not a food additive was generally recognized as safe, also known as GRAS. In some cases, these companies did not even notify the FDA of this determination!
Food politics guru Marion Nestle, Ph.D., wrote the commentary for the article. Not one to mince words, she says: "How is it possible that the FDA permits manufacturers to decide for themselves whether their food additives are safe?"
How indeed.
She also says:
... financial ties with food and beverage companies are now recognized as influences on federal dietary guidelines, opinions of nutrition professionals, and the interpretation of nutrition studies.
The article concludes with the authors urging the FDA to address the lack of independent review and the ubiquitous financial conflicts of interest in GRAS determinations. Let's hope the FDA follows this advice.
2. Fecal Implants
Fecal implants, also known as fecal microbiota therapy (FMT), are a procedure whereby stool from a healthy donor is inserted into the colon of another. Yes, fecal implants sound really gross. But they save lives and are actually more effective for curing difficult cases of Clostridium difficile (C. diff) -- which can cause diarrhea, cramping, colitis, and death -- than really expensive antibiotic pills. They have also been found to be helpful, or in some cases cure, other gastrointestinal conditions, such as ulcerative colitis, a debilitating condition that causes inflammation of the colon and bloody, frequent diarrhea.
However, in April 2013 the FDA decided if feces were preventing, treating, or curing a disease, then feces should be classified as a drug. The FDA did not approve fecal implants for therapeutic uses. Any doctor who wanted to use them would have to fill out an investigational new drug application. In response, many doctors stopped doing fecal implants, even though they were found to be 90 percent effective for C. diff.
Just a few months later the FDA changed their mind, due to strong push back from the American Gastroenterology Association. They allowed fecal implants for use in people with C. diff who were not responding to standard antibiotic treatment.
I find it interesting that the FDA wants a lot of regulation for feces, a substance that appears to be helping many people, yet they are lax about so many other things. Of course, precautions need to be taken such as screening for HIV, hepatitis, and parasites. However, at a time of diminishing returns with drugs for many gastrointestinal diseases and no chance of an actual cure, why not allow fecal implants, especially when they have the potential to help so many people who are suffering?
3. Antibiotics in Animal Feed
Meanwhile back at the ranch, the FDA is still dragging its feet to ban the use of antibiotics in factory farming. A recent FDA report reveals that 80 percent of antibiotics are given to industrial farm animals. Why give these animals low doses of antibiotics? So they will get fatter faster and to prevent health problems caused by the extreme confinement and filthy conditions they are forced to endure.
Although there is a clear-cut link between the use of antibiotics in farm animals and antibiotic resistance, the FDA continues to allow their use. Instead of banning the practice, the FDA has called for industry to voluntarily stop the practice. According to Marion Nestle, the problem has only gotten worse. The Centers for Disease Control states that 2 million people are sickened each year by drug-resistant bacteria, and 23,000 of them die. Since part of the problem is the use of antibiotics in animal feed, it seems like a no-brainer to stop this practice. The FDA has had over 30 years to take action on this, but has not as of yet.
Apparently, banning the hundreds of antibiotics used in factory farming would be "lengthy and cumbersome," so a volunteer approach was the option chosen by the FDA.
One would think that 23,000 Americans dying each year would trump industry desires and long appeals.
4. Genetically-Modified Organisms (GMOs)
I have written before about the fact that the FDA does not do its own safety assessments or studies on GMOs before they are approved for use. Instead, the companies that create the crops do their own safety assessments, which the FDA only reviews. In other words, it is the opinion of companies such as Monsanto, Dupont Pioneer, Bayer CropScience, Dow Agrosciences, or Syngenta that are driving the approvals. This is a win-win for companies that stand to make a buck on GMOs but is a lose-lose situation for us, the very people the FDA is supposed to be "protecting."
The FDA is worried about poop, a basically free substance that can cure C. diff and potentially other inflammatory bowel diseases, but is fine with adding food additives, antibiotics, and GMOs to our food supply without adequate testing or conflict-of-interest-free determinations.
What is wrong with this picture? A lot. And it is the American people who will be paying the price.
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