The FDA Fast-Tracks Another COVID-19 Booster While Preparing to Take Away Your Favorite Cold Medicine

The FDA does not use the same “safe and effective” standard on all its decisions, and the stench of political influence is hard to ignore.

As a medical doctor, I prescribed drugs, lots of drugs. I was taught (now I know indoctrinated) to view the Food and Drug Administration (FDA) as the gold standard of what medications were approved. They used objective science and were above politics and industry influence. I no longer believe this. I am not an anti-vaccine proponent and had my Pfizer vaccines in 2021 and every booster since.

Two FDA decisions have convinced me they play favorites and use different standards to evaluate drugs and vaccines. Recent declarations highlight the absurd and contradictory guidelines plaguing its approval process.

The New COVID-19 Booster

The latest booster was approved for everyone over six months of age, regardless of their vaccination status. Here is what their website said. “The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.”

Moderna boosters for this year’s anticipated most virulent strain of coronavirus, XBB.1.5, were tested in only 50 patients. Pfizer’s booster was tested in mice alone. “No serious reactions” occurred in this small number of Moderna study patients. I couldn’t find any published data about the Pfizer mice. However, the Moderna subject patients were over twelve. Yet, the booster is being recommended for children older than six months. I could not find anything about the age of Pfzier’s mice.

The FDA based its approval on CDC data. The CDC relied heavily upon the shot’s ability to neutralize (kill) the virus in a test tube. It is a leap of faith to say it will perform the same in live people. The reality is that the pandemic is over. Yes, COVID-19 infections are not gone and may have increased recently. But hospitalizations from (because of) the virus, as opposed to with the virus, are no longer a public health emergency. The FDA is acting like nothing has changed from 2020–2022.

Everything has changed. People have had more vaccines and more natural immunity from infections. Since the Delta strain, the new viral mutations have become increasingly less deadly. Vaccines, therefore, have become less effective as well.

There is even talk of more mask mandates that have always been unpopular and of questionable value. And there is evidence that widespread masking made our immune system more vulnerable. Serious illnesses and deaths have always been tiny in children, yet the vaccine continues to be pushed, with little proof of safety and efficacy in babies and toddlers.

This newest vaccine has been proven “safe or effective” by conclusions in mice, test tubes, and inferences to the “success” of prior shots. They tweaked older vaccines to try and give immunity to a new strain. Using prior flu vaccines as a comparison, we can guess this will be not much more than 50% effective. Contrast that with other FDA news this week.

Popular Cold Medications Now Found to Be Ineffective

At the same time the news of the new coronavirus boosters was approved, an FDA advisory committee determined that a popular decongestant, phenylephrine, was no longer effective. This drug has been around for over 100 years, and they are only now telling us it doesn’t work. I smell something fishy with the timing.

A committee recommendation does not mean the FDA will follow its recommendations, but it usually does. There is agreement about 80% of the time. And if the FDA agrees, this drug could be pulled from the pharmacy and store shelves—billions of dollars in medications like NyQuil, DayQuil, Mucinex, and Sudafed PE would have to be reformulated.

All over-the-counter medications are “generally recognized as safe and effective” by the FDA. Still, clinical trials have found that oral phenylephrine, or PE, does not improve nasal congestion any more than a placebo at the dosage marked for over-the-counter use.

I agree with this, but what about the higher dosages? Will those still be available.? No one knows. For example, Motrin (Ibuprofen) is only available for over-the-counter purchase in the 200 mg strength. The recommended dosage is 2 tablets or 400 mg. Yet, for pain and arthritis, 600–800 mg is often necessary. You can, of course, take three of four tablets as I sometimes do.

This is not an option with cold medicines because the decongestant dose is fixed along with the other ingredients. This is one big problem with combination, or polypill, meds. You can buy stronger dosages of a pure decongestant, but because drug dealers can cook up meth from it (I know this from watching “Breaking Bad”), sales of stronger dosages must be purchased from behind the pharmacy counter, and you must submit an ID.

Thus, the FDA says that tiny doses of PE, like 5–10 milligrams, are ineffective, but 60, 120, and 240 milligrams are likely still effective. This is not surprising. A useful analogy would be taking one-half to one tablet of Tylenol (acetaminophen) and expecting your pain or headache to disappear.

But few people will understand this important nuance. Most will be left to think that, in general, cold medicines and, in particular, pseudoephedrine (a cousin to phenylephrine) don’t work. There is no evidence that pseudoephedrine, at higher doses, is ineffective.

The same FDA committee suggested the anti-histamine component of these cold meds, like Benadryl (Diphenhydramine), was also ineffective for colds. With this, I do agree. Anti-histamines do nothing to help a cold. They are designed to treat allergy symptoms. They were originally placed inside cold pills and medications since sleep is one of their side effects. Decongestants tend to amp us up and cause insomnia, hence the attempt to balance out side effects.

Here is a list of some cold medications that contain phenylephrine or pseudoephedrine.

• Colrex Compound
• Colrex
• Tylenol Cold and Flu Severe Day & Night
• Codral Cold and Flu + Cough Day and Night
• Alka-Seltzer Plus Severe Cold & Flu Formula Effervescent Tablets
• XL-3 Cold Medicine
• Robitussin Peak Cold Nighttime Nasal Relief
• Tylenol Sinus Congestion & Pain Nighttime
• Norel SR
• Trital SR
• Vicks Sinex
• Benadryl Allergy Plus Congestion
• Mucinex products
• Advil Allergy and Congestion Relief
• Vicks Nyquil Severe Cold and Flu

Try Afrin (oxymetazoline) nasal spray if you want pure decongestant relief to unstuff your nose and sinuses. This may cause dependence and rebound if stopped, however.

Design or Coincidence

It is possible that the news release of these two decisions (new boosters and “ineffective” cold medicines) was a coincidence. I am skeptical. It could be a coincidence if I get hit by a drunk driver. But I am not buying this explanation. It’s not like any of this data is new. Studies questioning the effectiveness of combination cold medicines were published in 2007, 2009, 2015, and 2016. So why only now to try and remove them from the shelves?

I am not usually prone to conspiracies, but the latest shenanigans of the FBI, Department of Justice, CDC, FDA, WHO, SEC, and other former institutions of trust and respect have been tarnished to the point of deserved suspicion and distrust.

Standard adult dosages of pseudoephedrine are 60, 120 and 240 mg. There is no placebo-controlled data to show these dosages do not produce a reduction in nasal congestion. You can become dependent upon them and suffer “rebound” symptoms (as with Afrin nasal spray) if you stop them abruptly. However, that is a separate issue.

It is no secret that the public has become increasingly suspicious of the federal government-Big Pharma connections. With each new vaccine or iteration of COVID-19 booster, fewer people opt for it. It is not a big stretch of the imagination that the news about popular cold medicine being ineffective was purposely released on September 12, and then approval of the boosters on September 13.

In summary, the FDA suggests that a long-standing treatment for colds, sinus, and ear infections is ineffective on Tuesday. The tiny dosages, not the drug itself, don’t work. But this is not what the headlines reported. Then, on Wednesday, the FDA approved a new COVID-19 booster that has neither been proven safe nor effective.

Is this a coincidence or a head-fake distraction? You decide. Part of my training as a physician was to assume nothing. And this latest timing has done nothing to allay my suspicions.

I am a retired MD passionate about culture, health, science, medicine, sports, and food.

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