The FDA does not care about your health - it cares about its funding

Do not trust government agencies to look after your best interest

In 2005, the FDA issued a warning regarding an ingredient in several OTC weight loss and decongestant products: phenylpropanolamine (PPA). The warning, which can still be found on the FDA website, asserted:

Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes…

Scientists at Yale University School of Medicine conducted the study in which the researchers found an association between phenylpropanolamine use and stroke in women…

FDA believes that although the risk of hemorrhagic stroke is very low, even with phenylpropanolamine use, the conditions for which these products are used do not appear to warrant an increased risk of this serious event from using this drug.

FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE

https://www.fda.gov/drugs/information-drug-class/fda-issues-public-health-warning-phenylpropanolamine

The Yale study referenced by the FDA warning, published in Dec. 2000, states that “Since 1979, more than 30 case reports have been published that describe the occurrence of intracranial hemorrhage after the ingestion of phenylpropanolamine. Affected patients were most commonly adolescent girls or young women between the ages of 17 and 45 years who were using phenylpropanolamine-containing appetite suppressants, often for the first time.” There were 30 whole cases in 20 years; that’s a whopping 1.5 cases per year on average! The report further explains: “In addition to the published reports, between 1969 and 1991, the Food and Drug Administration (FDA) received 22 spontaneous reports of hemorrhagic stroke associated with phenylpropanolamine in appetite suppressants (in 16 cases) or cough and cold remedies (in 6 cases).” Again, an outrageous 1 case per year! How dare any company market such a product?

I could sit here and tell you how I believe the methodology of the study to be questionable, but that would likely leave you wondering what my qualifications are to say such a thing (though I was a pre-med biology major when I started college, and I have worked in different capacities in the medical field and grew quite familiar with reading studies, I did not stay the course and actually changed majors after about a year and a half). I will, however, share with you some confounding factors in the study. The authors detail some risks they found among the enrolled patients:

As compared with control subjects, patients were significantly (P<0.05) more likely to be black and to report lower levels of education, current cigarette smoking, a history of hypertension, a family history of hemorrhagic stroke, regular alcohol use (more than two drinks per day), and recent cocaine use (Table 2).

Though they claim to account for these risks as variables in their modeling, there is no way to completely account for these or then somehow determine the specific causative agent for the stroke. Even if they could account for all of these, there are other factors at play. Only 27 of the 702 patients who experienced hemorrhagic stroke had even used a product containing phenylpropanolamine (compared to 33 of the 1376 control subjects). Of the patients who had used PPA, the greatest increase in risk were among those using weight loss/appetite suppressant products. Here’s the rub - many of the weight loss supplements at the time, even if they contained PPA, contained other stimulants such as ephedra (which the FDA has since “outlawed” - let’s not get into whether the FDA constitutionally has power to legislate or make anything “illegal”). In the closing sentence of the next-to-last paragraph in the article, the authors state that “we estimate that 1 woman may have a stroke due to phenylpropanolamine for every 107,000 to 3,268,000 women who use products containing phenylpropanolamine as an appetite suppressant within a three-day window.” So, on the high side, 1 woman in every 107,000 who uses an appetite suppressant containing PPA will suffer hemorrhagic stroke. For anyone who just happens to geek out on medical studies, or if you just want to check my facts, here is a link to the full study: Phenylpropanolamine and the Risk of Hemorrhagic Stroke

This is the information upon which the FDA decided to ban what I thought was a very effective and mostly innocuous decongestant. So, why such a long rant about this particular medication?

We’re going to completely skip over the “safe and effective” mantra you’ve all suffered for the past three years. I don’t care whether you are pro-jab or against, this goes far beyond a shot for a virus. Turn on your TV (or your streaming service) at almost any time of day (and especially late at night), and you will suffer a barrage of pharmaceutical commercials. When I was a kid, you never saw such ads on TV. I was under the impression that at one time it was illegal for pharmaceutical firms to advertise their wares on TV, an article I came across (in a rather unlikely place - at least for me) while doing some additional background research informed me otherwise. I will quote just two statements from that article for you:

The United States is one of only two countries on this planet that allow the direct advertising of prescription drugs.

Drug marketing didn’t really take off until the late 1990s, when the pharmaceutical industries got a helpful “clarification” on TV rules from the FDA itself.”

(I found the article rather entertaining and informative, and if you care to, you can read it here: Pharmaceutical Ads Give Me Hives

While I feel similarly to the author of that article (not that I take meds, but about pharmaceutical commercials driving me batty), my issue goes beyond the advertising. Mine is about integrity and the government agencies that exist allegedly to “protect” you. For anyone who believes any part of the government bureaucracy exists for the purpose of, or has any interest in, keeping you safe or in any way protecting you, read my “advertisement” for the fictitious drug Opénurize™ .

Ok, these companies push their products like any others do. What makes this different? What does that have to do with the FDA’s integrity?

Perhaps most consumers do not realize that the FDA’s drug division receives 75% of its funding from pharmaceutical companies. Yes, I know a lot of what I’ve already written, and now this, makes it sound as though my brain has absorbed toxic levels of aluminum from foil-laden headwear. I assure you, this is not some outlandish theory. In 1992, Congress passed the Prescription Drug User Fee Act which levied fees on every new drug review application submitted by a pharmaceutical company. This was done in order to expedite the review process which was taking an inordinately long period of time. So the government basically instituted pay-for-play with big pharma. This information does not come from the machinations of an overactive imagination - even Forbes has written about this issue, on more than one occasion. How can a government agency be expected to legitimately regulate those from whom it receives the majority of its funding?

This is where the rant about PPA comes into play. Here are side effects of some of the medications that I have personally seen marketed as of late:

• Trintellix - bleeding, hyponatremia

• Jardiance - necrotizing fasciitis, hypoglycemia, ketoacidosis

• Vraylar - stroke, NMS, TD, hypotension, seizures, high blood sugar (that can lead to coma or death), diabetes

• Ingrezza - heart rhythm problems, abnormal movements (like Parkinson’s)

• Sotyktu - cancer, rhabdomyolysis

• Xarelto - clotting on quitting, increased bleeding

• Humira - Serious infections ([t]hese serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections), Cancer.

• Vabysmo - heart attack or stroke

• Rybelsus - pancreatitis, vision changes, hypoglycemia, kidney failure, gallbladder problems

• Rinvoq - Serious infections, cancer and immune system problems, increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, blood clots, tears in the stomach or intestines

• Verzenio - neutropenia, infections, anemia, leukopenia, vomiting, alopecia, thrombocytopenia, severe and fatal cases of Iterstitial Lund Disease/pneumonitis, venous thromboembolism, hepatotoxicity

This is a short list and does not go into detail. Something interesting about many of these is that the pharmaceutical companies admit they do not know how they work (nor if they even do - though that is implicit in the language, not explicitly stated). Let’s look at a few examples.

Trintellix:

“Although it's not fully understood, TRINTELLIX is thought to work by enhancing the activity of a neurotransmitter called serotonin in the brain by blocking serotonin reuptake.

It also has activities on some of the receptors for this brain chemical. The link between this information and therapeutic benefit is not known.”

We think it might maybe do something, but we’re not sure if it does or how that helps (if it helps).

Vraylar:

“VRAYLAR is a once-daily capsule that works with your antidepressant. VRAYLAR also works differently from your antidepressant. While the exact way VRAYLAR works is unknown, it is believed by scientists and doctors that VRAYLAR helps manage chemicals in the brain, such as serotonin and dopamine, that may control your mood.”

We don’t know how our product works, but some scientists and doctors think that managing certain chemicals in your brain (which Vraylar may do - we’re really not sure), could possibly control your mood. Don’t worry that we’re messing with your brain chemistry; trust us, we’re big pharma.

Ingrezza:

“Current research suggests that INGREZZA helps by correcting this abnormal dopamine signaling; however, how INGREZZA works to treat TD is not fully understood.”

We really don’t understand how our medication stops your muscles from uncontrollable action, but add it to your other meds since they cause uncontrollable muscle movements.

Dupixent:

“DUPIXENT is a biologic that works by targeting an underlying source of inflammation that could be a root cause of your uncontrolled moderate-to-severe eczema.”

Our medication targets a source of inflammation, and that may (or may not) be the source of your eczema. We really don’t know.

Would you be surprised to know that you can find the information for any of these drugs not just at WebMD, but at websites bearing the names of the meds themselves? Give it a try. Select any of the pharmaceuticals I listed and type its name into your browser with .com appended. Almost every one will come up (some may have slightly modified URLs bearing additional characters such as “-us”). All of the information I have presented about these meds is taken directly from those sites.

Now, back to the FDA and my rant about PPA. Compared to the side effects new meds with whose marketing we are continually bombarded, taking PPA appears akin to ingesting sugar pills. The FDA banned PPA from human meds, but they expedite approvals for pharmaceuticals with far broader, and more dangerous, lists of side effects. In case you missed it, this happened during the Covid outbreak as well. No, I’m not going to go off about the shots. Just think about ivermectin and hydroxychloroquine. I’m not talking about whether either is effective at preventing or alleviating Covid infection - I’m talking about safety. Both of these medications have been used safely for decades, yet both were demonized by the main-stream media, the medical industrial complex, and the FDA. Remdesivir, however, was pushed as the standard pharmaceutical option for treating Covid in hospitalized patients. Remdesivir very commonly causes adverse effects on the liver, kidneys, and metabolism, among other things. It is a very dangerous pharmaceutical concoction (and was never proven to have benefit in treating Covid), yet safer potential solutions such as ivermectin (dubbed “horse wormer” by critics) and hydroxychloroquine (falsely denounced as causing heart rhythm issues - https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or) were dismissed out of hand. There is only one explanation for this - money. Remdesivir brought pharmaceutical companies more money than ivermectin or hydroxychloroquine could, and that benefits the FDA as well.

This is also why they regularly try to bring natural supplement manufacturers under tighter regulation. As long as naturopathic solutions for healing and maintaining health are available, they take business away from the pharmaceutical giants, which means less money to funnel back to the FDA.

There also exists a giant revolving door between the FDA and the pharmaceutical companies. It is well known (you can easily verify this with an internet search) that many who are responsible today for approving pharmaceuticals for public use will tomorrow be found working in lucrative positions at the companies that manufacture those approved pharmaceuticals.

Bottom line: do not trust the FDA to be looking out for your health or safety as they claim. For at least two decades (likely more), they have been in the pocket of big pharma; the FDA emerging from that pocket any time soon to do what they were purportedly intended to do is highly unlikely. So, whenever you hear a government agency make claims about “it’s for your own (or ‘the common’) good,” “it’s for the public welfare,” “we’re all in this together,” “the Science™ says…,” it’s time to don your Faraday Fedora. The bureaucratic machine of the federal government does not care about the people - it is concerned solely with perpetuating its own existence.