How Big Pharma Companies Learnt to Flog Drugs

Find It, File It, Flog It

Two very self-satisfied scientists admiring their ‘Find’, dreaming of retiring to a life in the sun:

Excerpt from FIND IT, FILE IT, FLOG IT: Pharma’s Crippling Addiction loopand How to Cure It, Hedley Rees, Amazon CreateSpace, 2015 - see review by Amazon’s recommended book reviewer, Kirkus, here.

Rich pickings begin

Pickings began to get rich starting in the mid-1970s, mostly from the battle of the stomach ulcer drugs Tagamet (Smith Kline & French) and Zantac (Glaxo). Even though Tagamet was the first to market (1976), Zantac overtook Tagamet soon after its launch in 1981 with what was reported to be a superior marketing effort. This seems to have been the birth of the blockbuster era.

By the early 1980s, industry players learned that a patented compound—new molecular entity—with an important license to sell could use nimble marketing to make huge profits under the shelter of patent protection. The industry focused increasingly on patenting as many compounds as seemed reasonable, selected the most promising for development, and then marketed the bones out of them once approved.

Below is a tongue-in-cheek description of the approach. Figure 1 shows a gifted scientist who has found a compound from the patent library that is showing some promise in the test tube. He’s having an ‘eureka’ moment.

Figure 1. The reigning paradigm of drug development (image courtesy Graham Cox)

We see that our eager scientist phones his boss, who is under pressure from above to move compounds into development, and he is more than happy to hear the news that the finding has potential. The race is now on to get the magic powder into trials by making larger quantities to test on animals. Figure 2 shows the scientist’s baby hastily passed along the development conveyor belt as the patent clock ticks.

Figure 2. The patent clock is ticking (image courtesy Graham Cox)

The scientist moves on to find further medical breakthroughs—or not, as the case may be. Other scientists take over the baton and head toward the finish line. The next step is proving that this compound is safe for clinical trials to begin and has some scientific rationale as to why it is going to work.

In the name of conserving remaining patent life, the industry puts things on fast-forward. The patent fairy (or is it a wicked witch?) is omnipresent, and every pause for thought must be met with a poke of her broom handle or a whack with the bristles.

To recap in the real world, this “lifestyle” approach involved finding a promising patented compound (Find It), placing it into a development pipeline intended for regulatory approval to market (File It), and then marketing the approved product with the utmost verve and vigor (Flog It). In mathematical terms, we have:

F1 + F2 + F3 = $$$.

Where:

F1 = Drug discovery (Find it)

F2 = Regulatory review and approval (File it)

F3 = Marketing (Flog it)

$$$ = Megabucks

This is the equation that has driven the industry ever since—with devastating outcomes. From here on, we will refer to this approach of drug development and commercialization as Triple F, as we continue our exploration of the pharmaceutical industry.

The race to the clinic begins

We now dig more deeply into the “File It” stage, where Pharma companies must prove their compounds are fit to be marketed. We pick up where “Find It” is completed, where a fresh team of scientists takes over from our discovery friends above. They will be conscious of the wicked witch’s presence from years of conditioning. A day lost in development is a day’s patent life and, more important, lots of money in lost sales if it’s a blockbuster. Minds are concentrated appropriately. It’s time to get cracking with pre-clinical testing.

The basics of drug development

Now is the time to shine a light on the basics of drug development.

Drugs (new molecular entities) selected as candidates for market have to be proved safe to test in humans. This is what is known as pre-clinical testing. It involves proving that the drug is tolerated sufficiently well in animals to give a high level of assurance that it can be tested in healthy human volunteers without causing undue or irreversible harm. There is also an attempt to gather evidence that the drug could be effective in the particular disease state under investigation, but animals are much different from humans, so this is always sketchy at best and useless at worst. There is normally a requirement, though, for scientific rationale as to why the drug should work in theory (Mechanism of Action).

The development, production and distribution activities are a vital component of the whole system because it is physically what will be doing the magic work during clinical trials and when the drug hits the market. The drug to be fed to animals is less pure than subsequent manufacture of the active ingredient for humans. This is known in the jargon as a “dirty batch.” The logic is clear: as development proceeds, each subsequent batch becomes increasingly pure. The dirty batch is the “worst case,” and if the regulators are happy for a company to use it for initial testing, the process will be easier.

If the pre-clinical phase gets approval, the company receives a licence to run clinical trials in humans. This is known as a clinical trial application (CTA) in the European Union and an investigational new drug (IND) in the United States.

Phase I is testing in healthy volunteers. All the data necessary are collected and the results assessed. Every clinical study must have an end point that determines whether the study achieves what it has set out to prove. If it meets its end point, then it can progress to the next stage.

Phase II is sometimes split into an A and a B run in patients with the condition. Information is collected and, again, the company judges, through statistical analysis of the results, whether the study has met its end point. If it has, Phase III testing begins with a mission to gain approval from the regulators to market. If the regulators give approval, then it is hats in the air, yachts on order, and succulent sausages all around!

This was how Tagamet, Zantac, and other blockbusters emerged on the market.

This created another mathematical formula for Big Pharma companies to adopt:

S1 + S2 + S3 = $$$

Where:

S1 = Safe sausage (pre-clinical testing)

S2 = Sample sausage (clinical trials)

S3 = Succulent sausage (marketing approval)

$$$ = Megabucks

As the years rolled on, increasing numbers of Big Pharma companies had success applying this formula. They became known as R&D-based Pharma companies or Big Pharma for short. This is the name we will use from here on.

The formula is still the basis for the drug development paradigm of today, only it doesnt work because big pharma companies sold all their supply chaingn assets in the 1980s and 1990s.

Read more on this fascinating topic here, or here if you are in the US, or your local Amazon store.

It will lend power to your elbow when critically thinking about medical freedom and mandated vaccines!

Hedley :O)