Big pharma's decades suffering from the patent cliff and how it led to the COVID scam

Gene therapy was last chance saloon for big pharma, and it failed miserably...

What follows is the opening of my UK Column article dated March 1st 2023, titled How Bill Gates hijacked a failing pharma system and smashed it: A tale of incompetence, deceit, greed, and an unmitigated thirst for power:

Oh, what a tangled web we weave, when first we practise to deceive!

— Marmion (1808) by Sir Walter Scott

Scroll down to hear more tangled web deception…

The Pharmaceutical Supply Chain is Broken

It began with strategic incompetence. Prior to the early 1980s, there was no such thing as Big Pharma. Pharmaceutical companies were all big in those days, because that’s what it took to develop a safe, effective, fit-for-purpose medicinal product. In the same way, there is no Big Aerospace, Big Automotive, or Big Electronics sector of those industries; small fry can't make it. A company supplying highly complex products to consumer markets must be big to get all the research and design, manufacturing, and product distribution work done.

So, where did the boutique pharmaceutical trend that gave rise to Big Pharma come from?

In the early 1980s, pharmaceutical companies that had hitherto been highly vertically integrated began casting off their physical assets, including:

• Manufacturing facilities, making the people working in them redundant

• Distribution warehouses, making the people working in them redundant

• Quality control laboratories, making the people working in them redundant

• Clinical trials units, making the people working in them redundant

• Products that patients were dependent on (out-of-patent products that weren't making them cash any more)

Today, what are referred to as Big Pharma companies merely patent molecular compounds, hand them over to third-party contractors, and market the life out of the paltry few that are approved for sale. Those same Big Pharma companies have also outsourced drug development, to small companies that are no bigger than your local supermarket in terms of employee numbers—all in the name of reducing the risk of failure.

The small companies developing medicinal products (known as drugs in the US) will have never brought any kind of drug to market. How’s that for broken?

The Key Takeaway Question

The pharmaceutical industry produces products for consumer markets and sells them. Can you think of any other industrial sector that would stay in business if it did not have a supply chain? Pretty fundamental don’t you think? Your Apple or Android phone needs a supply chain. Silicon chip manufacturers need a supply chain—remember the recent shortage in the automobile industry? That was a supply chain failure.

Can you think of any industrial sector that could exist without having at least a semblance of ownership and control of its supply chain? I couldn’t.

This resulted in the SARS-CoV-2 injections FOUR DECADES LATER!

This is the four decade downward dynamic

Not only did the now big pharma companies outsource their physical assets and people working in them, they stopped producing out of patent products to focus on blockbuster drugs. The only ‘slight’ problem was that without a supply chain, they had no control over the supply of materials for safety testing and clinical trials of the next blockbuster drug. Nearly every trial failed to gain approval to market their drugs.

That led to what investors began to term the valley of death, which then became known as the the patent cliff, where no new drugs were coming through to replace their patent expired drugs.

From the mid 1990s onward, the patent cliff became big pharma’s bogeyman, as highlighted in this 2011 article:

The patent cliff: rise of the generics

The article begins:

“The arrival of the much dreaded patent cliff, which has been haunting the global pharmaceutical for years, is finally here. Twenty drugs, including Pfizer’s cholesterol-lowering atorvastatin Lipitor, Bristol-Myers Sanofi’s blockbuster blood thinner Plavix, Eli Lilly’s atypical antipsychotic Zyprexa and Takeda’s diabetes medication Actos will become generic drugs in the years ahead.

Between 2011 and 2016, the world’s best-selling drugs, with about $255bn in global annual sales, are set to go off patent, as recent data from London-based research firm EvaluatePharma has revealed.

Once the blockbusters lose their patent protection, lower-price generics are expected to decimate as much as 90% of the sales of innovator companies.

But while consumers and companies provide health benefits could gain from the substantial slashes in costs, big pharma has to look at new ways and strategies to fill the gap; instead of relying on traditional patent blockbuster models, big industry players will have to embrace the generic market model as an increasingly important part of the overall pharmaceutical lifecycle.”

Things didn’t get any better

Ten years passed on when this article was written:

The top 15 blockbuster patent expirations coming this decade

“Looking out over the next decade, some of the biggest drugs in the industry will tumble off the patent cliff, putting pharma giants in the hot seat as investors clamor for their next blockbuster. 

The biggest names set to face generic pressure in the coming years include the top four of the industry’s best-selling drugs in 2020: Humira, Keytruda, Revlimid and Eliquis. In all, nine of the industry’s top 20 drugs by sales are set to lose exclusivity over the coming years, Moody’s analysts wrote in a recent report.” 

Desperate to keep investors happy, gene therapy injections became last chance saloon

Hopefully, the picture is beginning to emerge for subscribers. With nearly all drugs turned generic, and the failure to bring blockbuster products to market, big pharma companies were in a real fix. They had tried massive mergers and acquisitions, such as Pfizer’s acquisition of Warner Lambert in 2000, at a cool $116 Billion.

Without their own supply chain, nothing changed. Their pipelines remained seriously constipated. Then they tried a move into biologic products (made from living things) for rare diseases, orphan indications and niche cancers. The patient populations were so small that they had to charge $six figure prices for a single treatment, sometimes in the $seven figures, otherwise they would not reach blockbuster status.

That led to big pharma companies setting up market access teams through the last two decades (health economics and outcomes research—HEOR) under the banner of value-based pricing. That went down like a lead ballon with payers in the healthcare system.

This major dilemma for big pharma companies remained hidden from the majority of investors, as marketing muscle and gaming of patent law kept profits in the black for the short term.

Even now, the penny had not dropped for big pharma companies—without a working supply chain under their ownership and control, they wouldn’t get a widget to market, let alone a complex biologic with the potential to maim and kill if not produced properly.

The last chance saloon was CAR T therapy, explained in the article CAR T-cell Therapy and Its Side Effects. CAR T is in the category of a cell modified gene therapy. This means that a patient’s T-Cells are extracted, genetically modified in a curative way, and re-infused into the patients body. It is also an autologous therapy, which means it is specific to the patient. Errors in the chain of identity in the supply chain means instant death for the patient. No pressure there then!

Recently, INSIDE PHARMA, posted on a shocking development with these therapies:

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

It begins:

Is this the end for CAR-T (Gene) Therapy?

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product’s label, according to the agency’s separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication’s label.

The products involved are Bristol’s Abecma and Breyanzi, Kite’s Yescarta and Tecartus, J&J’s Legend Biotech-partnered Carvykti and Novartis’ Kymriah. The products are separately approved to treat multiple myeloma, large B-cell lymphoma, among other blood cancers.

Specifically, the U.S. agency wants the companies to include a paragraph in those boxed warnings to say, “T-cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including,” followed by the product’s name. The same language is also required as part of the “secondary malignancies” item in the less prominent “Warnings and Precautions” section of a drug’s label.

The safety issues with CAR T therapy supply chains are widely known inside the industry. The patient is in a hospital bed, and the genetic modification takes place in a production plant hundreds of miles away. The cells must be stored and transported from hospital to the plant in liquid nitrogen at -193°C. The genetic modification takes between 2 - 6 weeks, after which the cells make the reverse journey back to hospital.

This has to be the most dangerous supply chain ever invented.

We have now reached last chance saloon. The SARS-CoV-2 injections are also cell modified gene therapy, both mRNA and adenovirus versions.

It would have been a very short leap to change the name of the CAR T autologous product, for use in a single patient at c. $300,000 a treatment, to mass vaccination programs. There you have it. Pass it on…