Caveat: Having read this analysis back to myself, I would give this somewhere between a 3.2 and a 3.4. I could definitely work on better integrating my own experience, perhaps dive a little deeper into the systems of research dissemination and how those integrate with the pharmaceutical companies and the FDA, and perhaps do some deeper thinking about who's really at blame for the core conundrum this system of information brings up. (Amy and class agreed: this deserved much higher than a 3.2-3.4).

A Regulator’s Dilemma

Rotem Landesman

It’s disheartening, to say the least, to read an opinion column like this one that appeared in the NYT last week about the ineffectiveness of a variety of over the counter cold medicines that contain the active ingredient phenylephrine; its doubly as disheartening, I’d argue, to read this op-ed while laying in bed with the worst flu you’ve gotten in the past decade while actively taking these over the counter medications, which your doctor assured you would cure you within the week.

So what’s a sick grad student to do? First of all calm down; at least it’s not, I told myself, one of the horrific cases of misinformation we’ve seen around popular weight loss medications like Ozempic sending patients to the hospital, or the sudden FDA withdrawal of drugs like Makena after they have been pushed to patients through an accelerated approval process.

Now the analytic brain comes in; alright, over the counter medication won’t cure this flu. So what will? And who can I trust, now that my local CVS is presumably suggesting and selling me medication that has been declared by the FDA to be a waste of time and money? Most pressing of all - how and why would such a big piece of misinformation be sold over the counter to thousands of Americans every day? Research literally says it doesn’t work.

The answer lies inside a big bureaucratic mess we fondly call the U.S government, and specifically is in the hands of the Food and Drug Association (FDA). Whenever the FDA decides to make a regulatory decision that will have an impact on consumers and private companies who will undoubtedly take a cut in profits from that decision, the process can be a lengthy and convoluted one.

If we take a look at the system through which a new drug is approved to be sold to consumers, outlined on the FDA website, we might be able to support having so many hurdles for getting new drugs on the market: preclinical tests and application processes, clinical trials and labeling restrictions, committees, lobbies and letters galore. In these cases, pharmaceutical companies are (seemingly) working incredibly hard to meet the safety standards the FDA sets; the FDA gets to control the flow of new medications onto the market, and ensure we receive items that have been rigorously tested and approved; and we as consumers can have the peace of mind required when we step into a pharmacy and need to relieve our symptoms.

But when it comes to taking drugs that may be harmful, or flat out not useful (and therefore harmful to consumers pockets) out the sleeves, the process is much murkier. Since this ingredient is on the shelves in popular items like Sudafed PE and NyQuil, the New York Times reported that “should the FDA decide that the drug “be eliminated from products, it could significantly disrupt the market for the makers of cold medicines if they do not have enough time to replace it in popular items”. Contradictory to the process we see when new medications get approved, here there’s more hesitancy than before. The pharmaceutical companies don’t always want to make the extra effort, financial and otherwise, to remove and replace popular medications from the shelves. In fact the Consumer Healthcare Products Association, which represents companies that make over-the-counter drugs, already stated last week that they have a problem with the FDA’s unanimous decision of the effectiveness of phenylephrine, and issued a statement that the ingredient was both safe and effective. The FDA might not want to ruffle feathers by making a cross cutting regulatory decision, as it may lead to lobbies and lawsuits being brought up in Congress. And the consumers? We’re left to wonder why, as you may have noticed, a majority of the resources and information we receive, like more of my sources thus far, are not from the FDA’s website itself, but rather news sources quoting the FDA committees’ decisions. It is not hidden, per say, but not advertised either; its power, then, is being swept under the rug. Why keep this information from consumers, who would then be able to make their own informed decisions about buying these generic medications over the counter with ingredients which do not work?

This story makes us question who these systems are meant to serve; the pharmaceutical companies, the government officials, or the sniffling patients waiting in line at the pharmacy to spend their money on medications they believe will have the desired effect? It seems information, in this case, is distributed based on a need to know basis. And we, the consumers whose health is on the line, apparently need to know last, need to know through op-eds in newspapers, or not at all.

This can’t be the case. When it comes to health related information,the peril lies, in large, in the failure to deliver properly and promptly to its appropriate recipients - as is happening in this case. The power that medical researchers have coincides, and unfortunately does not always trump the power that pharmaceutical companies have. It seems apparent, after this incident, that the power the FDA holds to both disseminate information regarding citizens’ health and safety is not necessarily on par with the information they intake from industry research with which they make decisions about the drugs we can and should take to protect our health.