If you have a bad cold and are congested, you, like millions of others, may run to the drug store to get some medicine to help alleviate your symptoms. You trust that the medicine you are taking has been tested, and proven, to be both safe and effective. Well… on September 12th, an FDA advisory committee agreed unanimously that phenylephrine, the decongestant that is found in many over-the-counter cold and cough medications, doesn’t work.
What? You mean that this decongestant that has been, and still is, being sold to millions of Americans, and generates nearly $2 billion dollars in sales each year, does nothing??? Yep!
So, how does this happen, you might (and should) ask? The short answer is… another case of fraud, greed, pharmaceutical slight of hand, and manipulation of studies and data.
Phenylephrine has been available in pill form since the 1930’s. Before the 1930’s, you did not have to show that drugs were safe. In 1938, the Food and Drug Act was passed, which did require drugs be proven safe. While drugs were required to be proven safe, they were not required to be proven effective until the 1960’s. Yes… you read that correctly… you could have a drug on the market that did not work prior to the 1960’s. Crazy, right?
In an effort to get more drugs on the market quicker, Congress passed an “accelerated approval” mechanism which allowed drugs to be approved if there was preliminary data showing a clinically meaningful benefit. A follow-up trial would later have to at least support the meaningful benefit. A big problem is that many drugs have been on the market based on those preliminary (and likely manipulated) studies, and have not had the follow-up studies that are supposed to happen. According to an article on vox.com, “A 2022 report from the Office of the Inspector General found that 104 of 278 drugs approved under the accelerated approval mechanism haven’t yet had their effectiveness confirmed by a trial.” So, we really don’t even know if all these drugs work. This is nuts!
And now we know that at least one of these drugs, phenylephrine, has been useless and does not work.
Studies showing phenylephrine’s ineffectiveness have been published by scientists since the 1970’s. That’s 50 years ago!!! This drug was approved using outdated measures and was approved prior to the FDA’s updated, current efficacy standards. These points and more were brought to the attention of the FDA by University of Florida back in 2007. That was over a decade and a half ago!!! Good to know we can count on the FDA to look out for the wellbeing of consumers.
We now know that phenylephrine is “no better than placebo.” And according to the New York Times, “The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others.”
As if this isn’t crazy enough, the New York Times article quoted an industry representative warning that if we remove the drug from store shelves, “the burdens created from decreased choice and availability of these products would be placed directly onto consumers.” Others say removing the drug would be “confusing” to the public. Let that sink in… many think we should keep a drug that has been proven to have NO benefit on the market, selling it as a drug to treat something that it clearly does not treat, simply because removing it would give us less choices and might confuse us.
The confusing thing should be that we have many drugs still on the market that likely do not do what we have been told they do. They are ineffective, likely dangerous, yet remain on the shelves. By now, we have to realize that the pharmaceutical companies, the FDA, the CDC, and even many of the doctors, have failed to protect us.
What drugs are you taking now that might be found to be ineffective? What adverse effects are going to be shown to be caused by these drugs down the road? The answers to your health problems will NEVER be found in a pill or a shot. The moment you realize that is the moment you stand a chance to truly regain your health and achieve true health and wellness. This recent news about phenylephrine should rock you. It needs to be a wake-up call about everything that is wrong with our healthcare system. To know that a drug has been taken by so many people, and so much money has been made by these drug companies, on something that has now been shown to have no benefit is appalling.