Once again, doctors and pharmacists were instructed to market barbiturates as a safer alternative to their predecessor—heroin. Once again, the risks were downplayed.

The 1930s, marked by the Great Depression, saw an explosion in barbiturate use. Millions of Americans turned to buy these over the counter sedatives to “take the edge off.” Though barbiturates weren’t derived from opium, they worked similarly—depressing the central nervous system to reduce brain activity.

By the time the U.S. entered World War II, Americans were consuming over one billion barbiturates per year. But unlike morphine, heroin, or opium, barbiturates had an alarmingly narrow margin between a therapeutic dose and a lethal dose. In fact, around one in ten overdoses resulted in death, a number that skyrocketed when mixed with alcohol.

Legendary musician Jimi Hendrix was a victim to this tragic combination. Famous artist Elvis Presley died from it. Anna Nicole Smith, Judy Garland, Marilyn Monroe and many, many more. The thin line between therapeutic and lethal doses of barbiturates is so pronounced, it may surprise you to know that pentothal, a common barbiturate, was later selected as the primary drug used in lethal injections for the death penalty—a practice that actually continues today.

By 1951, Congress intervened, making barbiturates prescription-only. But by then the pharmaceutical industry already had a new replacement in the last stages of development.

In 1955, Leo Sternbach of Hoffmann-La Roche synthesized a new class of drugs—benzodiazepines. These compounds worked on the same neurotransmitter system as barbiturates, suppressing the central nervous system in nearly the same way. And was sold as the safer and nonaddictive alternative to barbiturates.

Pharmaceutical companies wasted no time in pushing the narrative for the new drug “Librium”.

Benzodiazepines were marketed primarily as sedatives and tranquilizers, emphasizing their superiority over barbiturates due to fewer risks of overdose and addiction compared to barbiturates.

Posters would often state:

“Safer than barbiturates. Non-addictive. Low risk.”

Sound familiar? But within a decade, the truth became clear: benzodiazepines carried the same addictive and similar fatal potential as their predecessors. Undeterred, Hoffmann-La Roche created a stronger benzodiazepine and repackaged the drug. Their new flagship product? Diazepam, better known as Valium.

Advertisements emphasized their safety, efficacy, and versatility, targeting both physicians and the general public. Thanks to heavy marketing pushed partially orchestrated by the infamous Sackler Family, Valium’s prescriptions and sales soared. And before ultimately being recognized as a high-risk tranquilizer, the industry had already moved on to the next iterations—Klonopin (clonazepam) and Ativan (lorazepam).

Though chemically similar to Valium, pharmaceutical companies cleverly began rebranding these drugs as “anxiolytics” rather than tranquilizers, distancing them from barbiturates and opioids.

Marketing campaigns assured the public they were safer, faster-acting, and less risky than other anxiety relieving drugs on the market —despite the fact that just 1mg of Klonopin was equivalent to 20mg of Valium. This sleight of hand dramatically increased overdose potential but the public being lost in a bundle of medical jargon, was widely unaware.

Then came the poster child of benzodiazepines: Xanax.

Xanax was marketed as a powerful and effective medication for anxiety and panic disorders when used as prescribed. However, Xanax quickly developed a reputation in pop culture, especially in hip-hop music and social media, where it was often referenced as a recreational drug. This contributed to increased illicit use, particularly among young adults and teenagers.

I grew up during this time, and it was not uncommon for high schoolers to acquire and use these drugs in the party scene. It was not uncommon to hear on Monday mornings of 1 or 2 classmates who overdosed on them and ended up in the Emergency Room.

Despite growing concerns, Xanax continues to be one of the most prescribed and widely recognized anti-anxiety benzodiazepines in the world.

Despite the growing risk of abuse and addiction numbers growing, the pharmaceutical industry learned something amazing from Xanax and Valium. It was when benzodiazepines were categorized under new more specific categories often as “short term treatment”. The history of addictive and dangerously abusive potential usually did not follow the new classification of a new category.

Business-wise, this made sense because a company could then release a benzodiazepine as a specific treatment protocol and start with essentially a blank slate. Often times it was even downplayed that the drug was a benzodiazepine at all, and was instead marketed as a new and emerging drug specifically for the specific treatments.

Examples are:

• Anxiolytics (anti-anxiety drugs) – e.g., diazepam (Valium), alprazolam (Xanax)
• Hypnotics (sleep aids) – e.g., temazepam, triazolam
• Muscle relaxants – e.g., diazepam
• Anticonvulsants – e.g., clonazepam, diazepam
• Pre-anesthetic agents – e.g., midazolam

Man in a black suit and eyeglasses leaning against the window, his head propped on his fist

As of 2024, over 100 million benzodiazepine prescriptions are filled in the U.S. alone—roughly one for every three Americans. According to the National Institute on Drug Abuse, over 30% of opioid overdose deaths are directly linked to benzodiazepines. (1)

This is the cycle. The same blueprint. Again and again.

A dangerous drug emerges.

A “safer” alternative replaces it.

The truth is concealed.

The consequences are devastating.

A “safer” alternative replaces it again, the pharmaceutical industry profits at every step and the cycle continues. Are you seeing the pattern yet?

"If we doctors threw all our medicines into the sea, it would be that much better for our patients and that much worse for the fishes."   –Supreme Court Justice Oliver Wendel Holmes, MD

Now this obviously is not the pattern for all synthetic compounds. Some things are genuinely amazing feats of engineering. Antivirals, Antibiotics, Immunosuppressants, Monoclonal Antibodies. Metformin, Antiaging drugs like GLP-1, NAD, nicotinamide adenine dinucleotide and many many more.

So what does this all have to do with kava? Now let’s go back twenty years to the re-introduction of this fascinating root.

Well, in an unprecedented move, during analysis of the trials, BfArM decided to implement a new set of standards and rules in how they specifically assessed the category of kava, and how kava’s benefit/risk ratio will be calculated. This is not normal behavior and I don’t think this actually has ever been done before.

These new rules stated that kava in particular, must qualify under new guidelines for testing to prove efficacy of a positive benefit. Usually older clinical trials are considered to be still valid, but BfArM decided they would enforce this new rule across everything in the present, as well as in the past. Which meant every single clinical trial the companies had completed previously before this new rule was implemented, were now invalid.

So, since no studies on kava researched elsewhere around the world were considered relevant, no previous clinical trials in the country itself were allowed, and no clinical trials by the companies were considered valid, there was then not a single piece of research that now qualified to show kava being an effective therapeutic. This meant, at the end of BfArMs assessment, kava was given a negative benefit-risk ratio and marketing authorization was then pulled in 2002. Keep in mind, pulling marketing authorization is the ultimate last resort. Usually you slap a warning label on the side for potential risks or you limit dosage amounts or something.  

"Well then run some new clinical trials under the new guidelines, you might say!" Well, yes that’s true, although it would be expensive as clinical trials are commonly in the millions, this was totally doable.

But that wasn't the end of it.

Because of this new classification, this meant any company selling kava or interested in selling kava, now had to run a complete set of preclinical data BEFORE they could re-run clinical trials with humans. This meant pharmacodynamics testing (what the drug does to the body), Pharmacokinetics (what the body does to the drug), and can include absorption testing, distribution testing, metabolism testing, excretion testing, along with both invivo and in vitro testing for drug toxicity.

It would be great to piggy back some data from research institutions on some of these tests which were already done, but this new rule stated not only did they have to do this testing on their own. EACH company had to do it on their own. No company could share with another. That’s tens of millions of dollars of testing there.

It turns out, even though this new massive pack of testing was now mandatory, the steps and criteria to the application and approval process were actually hidden from the public, and was never explicitly released to the manufacturers and/or researchers. So not only did everyone have to start over, no one had the list of trials and research that was now mandatory to get done.

A couple other rules were instated, one being the new research would have to be audited and conducted under GLP standards or “Good Laboratory Practices”. A standard the majority of studies in all industries, to this day do not meet, nor are they required to meet. Even if the producers could react, the damage was already done. The result of these unprecedented regulatory actions and refusal for transparency ended in a seemingly well-orchestrated worldwide panic.

In the following months of the initial de-authorization from the most influential drug approval agency in Europe, many countries followed suit and banned kava importation entirely. This completely devastated the industry and drove under thousands of family kava farms in the South Pacific. Many countries still have kava imports banned to this day.(11)

Mathias Schmidt, a PhD researcher and herbal specialist who worked on the cases stated how at this point, it was no longer about kava. This same mechanism for denying marketing authorization could be applied to ANY other herbal or medicinal product under a simple claim of hypothetical risk. One could outright ban ginger based off completely hypothetical risk of injury

(Mathias Schmidt, PhD, studied pharmacy at the University of Tuebingen in Germany. He works as a freelance specialist for herbal medicines, with emphasis on quality issues of medicinal plants, including kava.)

Not only had they completely collapsed the entire kava market, they also included a formal recommendation to every medical professional, to substitute a certain synthetic anti-anxiety compound to kava, (which we may or may not have spoke about earlier), to monopolize the market.

But why didn’t the companies fight these bans in court, as others have in similar situations?

In Germany, decisions made by regulatory agencies like BfArM, cannot actually be legally contested until they are finalized. BfArM delayed finalizing its decision on kava for ten whole years— and only doing so after facing mounting individual legal threats for ignoring all correspondence on the matter. They were unable to act upon the category for a decade.

BfArm finalized its decision on Kava in 2014, the kava companies who were left holding marketing authorizations took BfArM to court. They laid out a mountain of evidence of a seemingly intentional effort to remove kava from Germany’s medicinal market.

After years of delays and hearings, on June 10, 2014, the court ruled in favor of the kava companies. The verdict stated:

• New regulations could not be retroactively applied to established products.

• Mere suspicion about a product’s safety was not sufficient grounds for a negative benefit-risk assessment or a marketing ban.

• Claims of kava’s liver toxicity were based on assumptions, not hard data, and the actual risk was deemed “very rare.”

• The proposed alternatives—benzodiazepines—were not equivalent substitutes, as they posed a far greater risk to patients.

At the time of the ruling, benzodiazepine-related deaths in the U.S. alone were estimated at 7,500 per year. By 2021, that number had risen to 12,500 deaths annually—and that’s just in the U.S. Meanwhile, kava, a non-addictive, natural remedy, had been removed from the market under false pretenses.

Let’s take a moment to meditate on this number as It’s almost impossible to truly grasp the loss of 12,500 lives. When we see numbers like these, they often feel distant—just statistics on a page. But each one was a living, breathing human being with dreams, ambitions, and the potential to change the world in ways we will now never know.

20 days later after the courts ruled on behalf of the kava companies, on June 30th, 2014 BfArM Germany’s regulatory government agency, appealed the court decision and extended the legal battle. An update as of 2019, BfArM has again pulled marketing authorizations for kava in Germany.

So what happened here?

Well, no one is actually sure. BfArM is not talking about the reasons for making it their highest priority to have all kava companies currently approved for use in the country, be pulled from the market. No one knows why BfArM made it their highest priority to pull all marketing authorization for kava.

No one knows why BfArM did not tell the companies how they could be re-authorized.

No one knows why BfArM began enforcing more rigorous testing requirements specifically for the category of kava and nothing else.

No one knows why BfArM disqualified any and all research spanning decades of kava’s positive benefits.

No one knows why BfArM decided to no longer accept any previous clinical data on kava

And No one knows why they were suggesting benzodiazepines as a safer alternative to kava,

Benzodiazepines, as we covered earlier, have a long, well-documented history of dangerous side effects, severe addiction, and patient deaths—yet kava remains the one to this day, burdened with entire country bans and cautionary labels.

Even in the United States today, we are required to place liver risk warnings on anything related to kava, a consequence of outdated cases from Germany’s BfArM.

Absurd, right? But is it?