INSIDE PHARMA goes from strength to strength
Time to move supply chain malfeasance centre stage
INSIDE PHARMA has been growing nicely
From its inception in January 2022, readership of INSIDE PHARMA has been moving from strength to strength. We are now approaching 7,000 subscribers, which has exceeded my original expectations by a country mile.
At the beginning, it was about winning paid subscribers, after the COVID scam took away my consultancy work at PharmaFlow. My last paid assignment in 2019 was to carry out a strategic review for a company renting out cold chain management containers for shipping temperature sensitive biologic products, including advanced therapies:
If you click on the link, you will see the range and complexity of shipping biologic products around the globe. Tower has grown exponentially since I helped them with consulting advice.
Paid Subscribers have been a lifeline
It took me a while, but eventually my paid subscriber base grew to a point where I had enough coming in to allow me to be less concerned about income. It’s still not a fortune, but it allows me to share what I know without worrying about paying the bills.
Then I had advice from another Substack writer - they will know who they are - all I can remember is the name included East of Albuquerque. The advice was to make all my posts free. Initially, when I did that, there were all kinds of comments that, to me at least, seemed off target. However, it did allow me to grow the free subscriber audience which, as I said, is now approaching 7,000, and I began to understand the questions that needed answering.
Free subscribers are valuable too - this is why
While paid subscribers are the essential bedrock, free subscribers are an incredibly rich source of information, if comments are allowed. I have learnt a lot, trust me. Some of the comments I may find hard to agree with, but that’s where the benefit comes - what can I say to help discover common ground? Free subscribers have been so powerful in shaping my understanding of what’s needed to frame the messages being sent out.
So, this is where things are today. What next?
Let’s take stock of where to go next with INSIDE PHARMA
My expertise is in the management of pharmaceutical and biopharmaceutical supply chains. Those supply chains are what produce and deliver the medicinal products (drugs) that go inside you when you take one or have one administered.
In 2011, Wiley published my book Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics.
It wasn’t cheap at the time and it’s still not cheap. This is what Edward said about in in a comment:
I'm with you Hedley! I appreciate all your unparalleled edification on Pharma Industry! In 2012, I purchased your First Edition "Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics" I'm still paying it off! :)
After nearly three years of blowing the whistle as loudly as I can, and with the truth of supply chain malfeasance continuing to emerge, it’s time to make a modest course adjustment.
A new, two-pronged approach for INSIDE PHARMA
From this week, there will be more posts with a paywall, although there will be no change to the current rate of $5/month or $40 per year. I hope subscribers will understand that additional depth and detail of what went on in the supply chain for the SARS-CoV-2 injections will be required going forward. Without basic knowledge of the drug development process, and the supply chain it creates, the smoke and mirrors will prevent you from working things out for yourself.
Conversely, with knowledge of the basics, you will be able to convince yourself, and others, of what went on, and how to call it out next time, if they tried it again.
In particular, if you work in manufacturing outside pharma, you will find out how poor quality levels are in pharma. Modern day production systems work to 6-sigma standards, which is 3.4 defects per million opportunities. Pharma achieves between 2.5 to 3 sigma, which is between 70,000 and 100,000 defects per million opportunities.
For subscribers working in engineering, systems development, or any disciple of industry outside pharma, you will have your eyes opened.
Even if you work inside pharma, such as a chemist, biochemist, pharmacist, toxicologist, etc, there will be much in there for you.
There will still be free posts, of course, with useful information for you to make sense of what has been going on. I do hope you will stay a free subscriber to keep getting the word out wider.
To finish, this is something I wrote in 2019, to accompany Taming the Big Pharma Monster by Speaking Truth to Power:
BIG PHARMA – FULSOME PLUM OR DRIED-UP PRUNE?
It’s a dried-up prune!
Truely, Big Pharma is a dried-up prune compared to the fulsome plum it used to be.
In the pre-blockbuster era, discovering and developing drugs was the exclusive domain of large, predominantly vertically integrated pharmaceutical companies. They were the ones that generated and owned all the clinical and non-clinical data, compiled the license applications, manufactured the test materials, liaised with regulatory bodies and generally exercised stewardship of the many and complex activities required to develop and market a drug. They sponsored the clinical trials and if and when a marketing authorisation (MA) was approved, they maintained in-house company structures to ensure safety, efficacy and quality of their products, under their statutory obligations as marketing authorisation holder (MAH).
In those days, people all worked for the same company, sharing the pain and sweet smell of success.
Having retrenched into opposite ends of the prescription drug life-cycle in search of blockbusters, Big Pharma has left most of the work of testing, developing, making, storing, moving, distributing and reporting issues with prescription medicines to third party service providers.
Having abandoned vertical integration and the corresponding control over drug development and supply, what is Pharma doing to stay afloat?
What is Big Pharma doing about it?
...employing a number of tactics to maintain revenues from the declining pipeline of blockbusters. Health Economics and Outcomes Research (HEOR) has become a new tool in the box. The reluctance of payers to stump up the eye watering prices has given rise to market access groups, tasked with justifying why prices are so high, based on HEOR arguments.
Also in favour is the targeting of perceived less challenging regulatory environments and patient populations—rare diseases, orphan indications and all things cancer. The unfortunate side-effect of this is that prices have to be astronomic because of the very small volumes.
Pharma, it seems, is playing the same tune on a different instrument. Only this time, the instrument is broken; all Pharma has left to play on are massive discovery research teams and sales & marketing muscle. The crucial body of the product development instrument has completely lost its puff.
With such little capability in drug development, important debilitating diseases, such as Alzheimer’s, sepsis and bacterial infections (AMR) have fallen out of favour. These are no longer the cherries that Pharma wants to pick, and the world is suffering because of it.
Service providers and generics have soared
Meanwhile, on the other side of the fence, the fledgling service providers that were, flew the nest years ago and grew into fully formed adults, soaring like eagles.
Clinical research organisations (CROs) have been and still are consolidating, becoming big, powerful providers of clinical and non-clinical services.
Massive consolidation has also taken place in the contract development and manufacture organisation (CDMO) world, and evidence suggests they are moving into additional areas of the value chain.
The specialist third party logistics companies have also been part of the consolidation, as the two main players have been acquired by giant corporations, one from inside Pharma and one from outside.
The finished product distributors of Pharma products are now mega corporations, on the back of, yes, you guessed it, consolidation. Just three share nearly 90% of the market on each side of the pond. There has been forward integration (pharmacies) and reverse integration (logistics specialists) going on for some time and also moves into broader service offerings to the industry.
The generics industry has grown enormously on the back of payer demands for cheaper drugs. Up to 90% of drugs now sold in the US and UK are generic. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiralling rises in generic drug prices. This again has been attributed to M&A activity leading to far less, bigger players on the field being able to pick and choose what they supply.
WHAT NEXT FOR PHARMA?
It should now be clear from what we have just heard that the large R&D based companies developing and selling drugs (Big Pharma) have lost contact with an industry it once dominated. As drug development business models have become increasingly virtual, isolated and lacking in physical presence, the issues have risen to boiling point, and the bubbles have reached the top.
We must therefore conclude that things have gone horribly wrong for large swathes of stakeholders in the world of prescription medicines...
...re-integration is the only way forward. Big Pharma MUST start buying back the assets necessary for the development and commercialisation of prescription medicine, otherwise the prune will shrink to a raisin and eventually disappear from view...
Hmmm, interesting timing and the specific nature of your last contract, Hedley. As you've mentioned several times, supply chain logistics takes years to set up, not weeks. When did you get that 'ah ha' feeling after plandemic and solution announced?
Moving back to doing things like development in-house makes obvious sense as traceability and accountability are under visible control. At the other extreme, was there ever any sense, or GxP sufficient traceability and accountability in the notion of a virtual company?