The FDA Has Failed (Again) To Protect America

Corporate America and Its Insatiable Greed For More

Pharmaceutical greed

It’s like a slow roll, this deception-for-profit thing big corporations do with the government; specifically, the US Food and Drug Administration (FDA).

For decades, large corporations and pharmaceutical companies have repeatedly misled, lied to, or unduly influenced the FDA to get their products to market.

In allowing it, the FDA has become a collaborator and betrayed the trust bestowed upon it by the American public.

Each time the truth comes out and a company gets caught, they practically never:

  • Get charged with a crime
  • Admit to any wrongdoing
  • Lose the ability to sell their products in the United States, or
  • Lose the ability to get FDA approval on future products

They don’t even have to apologize.

They just pay a comparatively small financial settlement out of their massive profits and then get in line to do it again.

Dysfunctional Gatekeeper

The FDA is the government agency responsible for reviewing, approving, and regulating, among other things food and medical products including pharmaceutical drugs and medical devices.

They are supposed to be the gatekeeper that keeps companies in check and prevents them from releasing products without fully disclosing how harmful, addictive, or fatal they can be.

In short, the FDA’s primary responsibility is to protect the public.

“A Science investigation shows that FDA oversight of clinical trials is lax, slow-moving, and secretive—and that enforcement is declining.”
~ Science.org

The reality, however, is that there are a number of fatal flaws with the way the FDA reviews and approves new products that leave the public vulnerable to exploitation.

These flaws provide loopholes that companies have used, and will continue to use, to release dangerous products onto an unsuspecting public without informing them of the dangers.

Leaving The Fox To Guard The Chickens

The first fatal flaw is so egregious that, quite frankly, it defies both logic and believability, but here it is.

The FDA’s product review process runs primarily on the honor system.

Yep, you read that right. The honor system.

In other words, the FDA’s entire review and approval process relies on the flawed assumption that multi-billion dollar companies will police themselves and all do 3 things consistently:

  1. Always be completely truthful and 100% forthcoming
  2. Always behave ethically and responsibly
  3. Always act in the public’s best interest

But what if they don’t?

What if they decide to “fudge the numbers”, conceal or omit critical data, or just flat-out lie?

The FDA’s review process isn’t configured to think about that.

It also ignores the fact that huge corporations have hundreds of billions of dollars worth of incentive to NOT tell the whole, unvarnished truth about the dangers of their products.

Despite decades of flagrant abuse by Big Pharma and Corporate America, the FDA’s reliance on the honor system continues unabated.

Paying To Play

As bad as the honor system is, the second flaw is even more astounding.

The FDA’s review process routinely overlooks flagrant conflicts of interest.

Chief among them is a jaw-dropper referred to as “pay-later conflicts of interest” or “after-the-fact” compensation.

“In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 [drugs] between 2008 and 2014, Science found widespread after-the-fact payments or research support to the panel members. The agency’s safeguards against potential conflicts of interest are not designed to prevent such future financial ties .”
~ Science.org

In plain English, it is perfectly okay with the FDA for a company with a multi-billion dollar product pending FDA approval to promise high-paying jobs, lucrative compensation, and a promise to fund millions of dollars in research projects for any, or all, of the doctors on the review panel.

In addition to practically guaranteed approval by the FDA, there’s another enormous benefit that companies can rely on by financially influencing panel members.

After-the-fact compensation is an easy way to block a competitor’s better or cheaper product from ever receiving FDA approval.

“By day’s end, the panel voted seven to one to approve. FDA, as usual, later signed off.
The drug, ticagrelor, marketed under the name Brilinta, sold rapidly, emerging as a billion-dollar blockbuster. It cuts the risk of death from vascular causes, heart attacks, and strokes modestly more than its chief competitor—and currently costs 25 times as much.
~ Science.org

Preferential treatment isn’t just limited to drug companies either. In September 2021, the FDA banned over a million vaping products offered by small and medium-sized companies.

To protect public health because vaping is dangerous and minors are especially vulnerable, right?

Wrong.

The FDA didn’t issue a single ban or product restriction against any of the vaping industry’s largest players. Not one.

“Zero product authorizations, over a million banned products, and many more products left in limbo by the agency’s failure to do their job. That is the end result of the FDA’s multi-year campaign to destroy the vaping industry and hand the remains over to large tobacco companies.”
~ Gregory Conley, president of the American Vaping Association

Now, any reasonably intelligent person would agree that it’s a terrible idea to let huge corporations pay hundreds of thousands or even millions of dollars to influence the very doctors who will decide whether a new product, either theirs or one of their competitors, receives FDA approval or not.

The FDA clearly doesn’t see it that way.

A Vote of No Confidence

In 2015, only about half of Americans thought the FDA was doing a good job of protecting the public.

Given the FDA’s botched handling of recent events such as the COVID pandemic, the Roundup lawsuit, vaping, and the opioid epidemic, it’s a fair bet that number has fallen considerably since 2015.

When Greed Ought To Be Illegal

When TriMark started in business way back in 2003, the then-current FDA debacle was a drug called Vioxx. It was manufactured by Merck.

Interestingly, Vioxx was the harbinger of the current opioid epidemic. Although almost no one knew it at the time, it was a sign of things to come and it should have been a wake-up call for the FDA.

Vioxx was a non-addictive prescription pain medication; a nonsteroidal anti-inflammatory drug (NSAID), similar in many respects to other NSAIDs such as ibuprofen and naproxen.

To gain FDA approval to sell the drug, Merck scientists simply didn’t tell the FDA about their internal studies which proved that Vioxx increased the risk of heart attack by 400 percent.

The FDA approved Vioxx for sale in 1999. Merck went on to make tens of billions of dollars in profits aggressively selling Vioxx until it was recalled in September 2004.

But by then, the damage was done.

Facing nearly 60,000 personal injury lawsuits, Merck ‘voluntarily’ withdrew Vioxx.

They subsequently agreed to a paltry $4.85 billion settlement and didn’t even have to reveal how many tens of billions of dollars they earned selling Vioxx.

One thing is for sure though. The settlement represents only a small fraction of the profit Merck received from selling Vioxx.

Merck looks at it as nothing more than “the cost of doing business”.

It was later determined that Vioxx may have caused as many as 140,000 heart attacks and about 60,000 deaths. An outcome Merck knew could happen before they ever approached the FDA.

Where’s The Justice?

Merck emerged unscathed.

If a person did what Merck did, they would be charged with criminal negligence and criminal homicide.

But not one person at Merck was charged or jailed for knowingly killing almost 60,000 people.

And the company continues bringing new drugs to the FDA with impunity.

How is that NOT illegal?

More importantly, how is it that Merck, with that degree of willful, reckless, negligent disregard for human safety, is still allowed to operate in the US pharmaceutical industry?

Simple answer? The FDA.

The Lesson Not Learned

In stunning testimony at a US Senate hearing, Dr. David Graham, one of the FDA’s own researchers, said “The approval of rofecoxib (Vioxx) by the US Food and Drug Administration has led to the “single greatest drug safety catastrophe in the history of this country or the history of the world”.

At that same hearing, Senator Chuck Grassley said that the FDA “has lost its way when it comes to making sure drugs are safe”. He went on to say that the FDA’s relationship with drug companies was “too cozy.”

Dr. Graham agreed and said that sweeping changes were needed.

He also gave an ominous warning; “I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx.”

A government drug safety reviewer also told the same congressional committee that the American public is “virtually defenseless” if another medication such as Vioxx proves to be unsafe after it is approved for sale.

Congress, of course, did nothing meaningful to punish or reform the FDA.

The FDA, in turn, ignored Dr. Graham’s dire prediction and did nothing.

As a result, the door was left wide open for abuse, misconduct, deception, and even larger drug catastrophes in the future.

Prophecy Fulfilled

The future drug safety catastrophe Dr. Graham warned Congress about in 2004 turned out to be a powerful, highly addictive opioid called Oxycodone.

Oxycodone, found in Percocet and Oxycontin, is an extremely potent painkiller that is twice as powerful as Morphine.

Studies have shown that regular users can develop a tolerance to the drug, which then requires higher and higher dosages to deliver the same level of pain relief.

Purdue Pharmaceuticals, the manufacturer of Oxycontin, used an extensive array of false and deceptive narratives and documentation to gain FDA approval for the drug in 1996.

One of Purdue’s most insidious lies was their claim that “less than 1%” of Oxycontin users become addicted.

In truth, Oxycodone is highly addictive and is one of the most commonly abused prescription drugs in the country.

“Opioid use disorder and opioid addiction remain at epidemic levels in the US and worldwide. Three million US citizens and 16 million individuals worldwide have had or currently suffer from opioid use disorder (OUD). More than 500,000 in the United States are dependent on heroin.”
~ National Center for Biotechnology Information

Purdue marketed Oxycontin heavily, aggressively, and at times illegally and created what is now the single largest drug safety catastrophe in the history of the world.

Seeing The Signs

As Dr. Graham warned in 2004, the opioid crisis easily dwarfed the Vioxx case.

In 2019, nearly 50,000 people died from opioid-involved overdoses and by that same year, more than 16 million people worldwide have fallen prey to Opioid Use Disorder (OUD).

In 2020, 69,055 people died from opioid overdoses, according to the Centers for Disease Control.

And it’s still business-as-usual at the FDA, which has still refused to make any meaningful changes.

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