Hedley Rees An Expert On Pharma Supply Chain Tells Me What Is Wrong With Big Pharma

Hedley Rees is a passionate advocate of modernising the pharmaceutical industry. He founded his company Pharmaflow in 2005, specialising in clinical trials and commercial supply chains for biopharmaceuticals.

Hedley is also author of Wiley’s Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics. The go to manual on pharma supply chain.

Prior to this, Hedley held senior positions at Bayer UK, British Biotech, Vernalis, Ortho-Clinical Diagnostics and OSI Pharmaceuticals (now Astellas).

He holds a degree in production engineering from Cardiff University and an Executive MBA from Cranfield School of Management.

His latest project is Inside Pharma, (@hedleyrees.substack.com), a daily newsletter educating pharma outsiders to the internal workings of the pharmaceutical industry.

In September 2023 Hedley signed a new contract with Wiley to write a second book titled Transforming the Pharmaceutical Supply Chain, aimed at graduates, professionals and practitioners in pharmaceutical sciences.

In this conversation I talk about the normal steps in drug development, how things have gone wrong in the industry and the scandal behind the Covid Vaccine rollout.

I hope you enjoy the conversation!

0:07

Oh, supply chain management in the drug industry.

That’s it.

I knew.

I knew.

That’s the name of the book.

So I mean, look, Hedley, first of all, thank you so much for coming here.

Very welcome.

We tried this online right at the beginning when I was starting to learn about podcasting and to be honest, kind of balls it up.

0:29

But you’re here now and I really appreciate you coming a long way away.

You and I are in same kind of pickle.

We’re not earning much money these days.

So driving all the way from Wales is no mean undertaking.

You know, that’s a big, big sacrifice for you and your wife coming down here staying the night before some in.

0:48

So thank you so much.

Can you just let’s start with just introduce yourself because you’re you were in the Pharmaceutical industry?

In the supply chain, what does that actually mean?

Yeah, a good question.

1:05

It’s easy for me to assume people understand that it’s good to have the opportunity to.

Assume I know nothing.

OK, OK.

I know nothing.

Yeah.

Well, I always direct people to other supply chains, like for an iPhone or for an aircraft, or people tend to understand you have these various stages.

1:29

You have components that you start off with and to know what components to use, you have to go through a development process.

So then you have to put the various stages together, the components, the sub assemblies, the larger assemblies that they go into.

1:48

And then if it was an aircraft, you’d have final assembly.

Now typically it takes three or four years to do the development work.

You’re testing in wind tunnels and flight simulation, all that sort of thing.

Then you come up with a design that you lock into and then you build the full commercial supply chain from there.

2:11

And typically that’s a six or seven you undertake it.

So, yeah, how long have you worked in in this pharmaceutical supply chain industry?

40 years, I’m ashamed to admit that.

But forty.

Yeah, yeah, yeah.

And.

2:27

So you got a little bit of experience, just a bit, Yeah, Yeah.

And to be honest, I’m having difficulty because everyone feels that Med medicines and medicinal products are made by scientists or doctors.

2:47

Yeah, they I have no credibility whatsoever when I’m talking about the development and manufacture of drugs.

Everyone wants me to come to be a doctor and APHD doctor.

And actually the amount of science involved in developing, manufacturing and distributing drugs is very limited.

3:10

Most of it is engineering and technology.

So I qualified as a production engineer where you were taught how to make things and you know, deliver them.

It’s very focused on outputs.

And so I think in terms of systems, and I’ve just signed, just to let you know, I just signed a contract with Wiley in New Jersey to write the next book, which is going to be called transforming the Pharmaceutical Supply Chain.

3:42

Amazing.

And that it’s Wiley is an academic publisher.

So this is to educate graduates, professionals and people in pharmaceutical sciences on how you actually build, manage and improve supply chains and and that’s my next mission in in in life.

4:06

So before before COVID kicked off.

A lot of people looked at you as a kind of guru, am I right?

Because you wrote the Seminole textbook on supply chain.

Am I right?

You’re absolutely.

You’re held in high esteem.

You’re invited to conferences and meetings and asked to talk.

4:22

Tell me a little bit about that.

Yeah.

Well, once I’ve wrote the book as I said if 450 pages and explains exactly how drugs are developed, the regulations, everything about the industry you would need to know and about best practices in supply chain management in other sectors.

4:42

So we’re talking about companies like Toyota, Toyota Production System, the advanced exemplar sectors that have really sharp well designed supply chains.

And people would come to me and say well this is, you know, this is I wish we could do this, but the industry doesn’t work that way.

5:05

You know, it’s been the dark ages and the whole thing.

And I would say, well, you know don’t be pessimistic because there’s no difference between developing drug medicinal product as as to developing and manufacturing any other physical product that has to be delivered to test consumers who want to use the product.

5:29

And if you don’t keep your consumers happy, potentially you’re going to lose your business.

That is a one law of business.

You have to focus on the people and using your products.

So I so after the book launched, I joined the Advisory Board of a cold child management company called Marken, which was the top company doing cold chain management, which is you know, shipping in dry ice and all this, all the things you have to do when you move these drugs.

6:03

Cold chain.

Cold chain.

It’s your Welsh accent.

Cold chain.

Oh yeah.

Cold chain, like Coldplay, only.

Cold chain, yeah.

And so a marker.

And then was acquired by UPS Healthcare.

So I went around large parts of US and Europe, give him presentations with the head of regulatory and I sort of educated them in supply chain management in doing that.

6:35

Then when it when people realize this is actually not going to make you more profitable, it’s going to make you more sustainable in that if you do work with the best practice of supply chain management, then you’re going to build loyal customers and you’re going to have business keep coming in.

6:58

So let can we go back to pharmaceutical supply chain and drug development?

OK.

Well, yeah, with pharmaceutical there’s two types of products in the pharma industry, what they call small molecule which like aspirin, paracetamol products made by industrial chemistry, what they call chemical synthesis.

7:24

They’re fairly stable.

You know they last two to five years you you could look at the shelf life on on the pack in the pharmacy and the the whole industry was founded on small molecule products, right.

But because they’re relatively simple, it’s A1 size fits all situation as well.

7:43

So you know, other than languages there’s nothing different between aspirin in the US, Europe, Brazil or or or whatever.

So the supply chain was never challenged in any particular way in terms of temperature and the outside environment when biologics came along.

8:04

These are products made by from living things, cancer treatments like a septin which is a monoclonal antibody.

You know, they were approved and began to work suddenly that there was a big growth in biologics.

8:23

But of course with biologics they’re made from living cells or plants or whatever.

In terms of manufacture, they’re very difficult to manufacture.

They are very large molecules.

So biologics, large molecules, every process that makes what appears to be the same product, makes a different product because the living thing reacts with the vessels that is mixed in, it reacts with the tubing, the piping that it’s transferred in, and it reacts with its environment, particularly temperature.

8:58

So you can lose a biologic in the blink of an eye if it goes outside its temperature and you have to run trials to to see the temperatures that that product survives in and the temperatures it doesn’t survive in.

9:15

And typically it’s been refrigerated for a finished product +2 to plus 8 degrees centigrade.

So the the wholesalers and distributors, they’ve got fridges properly validated.

So they’ve always been able to deal with those lower temperatures of biologics.

9:35

But Even so they’re incredibly difficult to manufacture.

They’ve got these issues of of, as I said, temperatures.

They could also change potency depending on the source of the starting material.

So when we’re talking about biologics, we’re also talking about things like, you know, stem cell injections.

9:53

We’re talking about PRP injections.

We’re talking about vaccines as well.

Or vaccines.

Yeah, we’re talking about vaccines.

So the non biological ones are things like aspirin, paracetamol, you know, water tablet, diuretic tablet, all that kind of stuff.

Another biologic would be an insulin injection.

10:11

Yeah, yeah.

Instance of classic of one of the first biologics.

So let’s go back.

Let’s go back to drug development.

So when you get a drug, right, some people are in a lab somewhere in some university or something.

They’re doing some research.

There’s a problem, there’s a condition, there’s a disease, and they want to find a treatment for it.

10:30

So talk me through that.

What’s what’s going on?

Talk me through the whole stage.

What happens?

So you’ve got lab testing, research taking place.

Yeah.

This first stage is discovery, research, discovery, research.

You discover a molecular compound, typically called a compound, and the spawn molecule compound is pretty easy.

10:52

You draw the chicken diet wire diagram that chemists very often draw and you say, OK, we’ve got this compound, That’s the molecular structure.

This is the mechanism of action.

This is what we think is going to happen in the body that will allow this compound to to cure or help this particular disease, what they call an indication.

11:16

Effects change in some way, Yeah, yeah.

Effects change in some, some way, Yeah.

It is a theory.

And that is a big issue because it’s one thing coming up with a theory, it’s another thing proving.

Yeah, yeah, it works.

But it’s that you have to assume it’s an unknown substance and if someone came up to you in the street and said I’ve got this on themselves substance here, will you eat it?

11:39

Sadly, like you say, no thanks, no thanks.

Show me that, show me the data, show me the data.

So you have to go through into the development stage then.

So the R&D is basically a theory.

You have to prove by development it actually does something to the disease.

11:57

So it’s called an indication that is will you be familiar with obviously.

So the first stage is preclinical testing, either testing in animal models or you can test what they call in silico which is using computer simulation and you can test in tissue as well.

12:17

And but the preferred method of the industry is testing in animal models.

So this is the thing people miss.

You have to manufacture an amount of the compound, actually manufacture with the supply chain to then test that on on animal models by administering the compound to animals.

12:40

And then you have to write study reports, all the bloods and all the pharmacy pharmacodynamics of what was happening inside the animal.

That has to be written up scientifically and this takes months.

12:55

You know, imagine these animals are kept, you know, they have to meet certain standards called good laboratory practice.

So it’s all.

GMP this is GLP.

GLPELP, yeah.

Yeah.

So and it’s not just one study, there’s lots of different study.

13:17

And for these more advanced therapies, biologically advanced therapies you have to who studies on immunogenicity, obviously really complex toxicology studies before you go into humans and and typically even for the small molecule product that takes three years.

13:36

So even the small molecules, if you’re giving it to animals, I guess you have to, you have to make sure there’s a quality control issue and you’ve got standardization because you’re experimenting on, see, let’s say animals and batches of animals.

You want to make sure that what you’re giving administrating to these animals is consistently the same product, the same dose, the same quality, no contamination.

13:58

Because if if you’re producing something and just administrating it to these animals and it actually varies in itself, how do you know the effect you’re seeing is the effect of the drug or not just because of the variation within natural production of this small molecule agent.

So you have to have a quality control, is what you’re saying?

14:15

And then robust studies, because I guess if you’re putting this drug into an animal, you want to see, first of all, does it do anything, Is anything beneficial?

How quickly does it, the drug clear from the body, where does it go in the body?

What is this, the lowest safe limit?

14:32

What is the highest safe limit?

What’s a toxic level?

Does it have, I mean, do you do studies like reproduction studies in these animals?

Like what effect does it?

Absolutely.

I mean again the regulations will dictate things exactly, but for the more advanced therapies, again there are regulations what they call non clinical and quality regulations.

14:55

So non clinical means that it’s the combination of the supply chain and the safety of the of the compound.

So you you can’t just test 1 batch of drug and say that’s safe and assume every other batch is going to be safe.

15:13

You you you actually have to test on the drug that’s been actually physically made and prove that that process with those specifications was tested and it was proven safe.

15:30

And it’s it’s particularly for biologics and advanced therapies that’s very, very complex because it’s one thing for the small molecule working out what the drugs does, the body and the body does to the drug.

But when you go to something that’s inherently variable anyway, which is very, very difficult to manufacture consistently to the same standard, then the risks of things going wrong are really high.

16:02

So the companies that manufacture these have to be absolutely, you know, top skilled and they have to be inspected by the regulatory authorities to prove that they are working to the right standards.

16:19

Now with the, with the work in animal models, they have what they call the first batch is what they call a dirty batch.

It’s as unclean as they can possibly make it, OK.

So that if it passes safety testing in animal models, it’s only going to get cleaner and more likely to be to get approved.

16:42

So it’s a common term in the in, in in the industry when you develop in a drug.

We talk about making The Dirty batch.

Now that’s a bit terrific and it is actually actually true And once if you prove that drug is safe, you then have to manufacture to a higher standard, which is good manufacturing practice.

17:05

That’s it, yeah.

Before you go into humans.

So you cannot go into.

And that standard of manufacture is an order of magnitude higher than it is for animal models.

So yeah.

I’ve got that.

So, so we’ve done the discovery we’ve done now.

17:22

The basic animal studies and the toxicology and the bio distribution and reproduction and all that kind of stuff, yeah.

What happens next?

What kind of studies?

What?

What’s the next level of testing?

Did you?

Hear about phases phase.

Oh, yeah, yeah.

OK.

17:37

Well, phase one is the first testing in humans and you have to get approval from the regulators called the TRILO clinical trial approval.

In Europe, it’s called an Ind in the in in the investigation of New drug.

17:53

What regulator do they need approval from either European Medicines Agency, MHRA for ACTA in the US is the FDA Food and Drug.

So they know right from the beginning what’s going on.

Yeah, yeah, yeah, they, they have to insist that companies work to the regulations for supply chain.

18:13

It’s it’s there everything has to be manufactured to GMP and there’s a book two inches thick or not maybe an inch and a half thick in the in the UK from MHRA which lists all the responsibilities that these companies have for for developing the drugs.

18:30

OK so so phase one is you collect healthy volunteers normally in a building where there’s Game Boy in beds and very often the students who went to earn a few Bob, they go on there.

They’re happy to spend 2 weeks, you know in in, in the bed while they are sort of given the medications and they they tested to see what’s doing to them.

18:53

But phase one, Maloney proves safety almost invariably.

You cannot get much of A measure of the effective the drug on the indication how effective it is.

Yeah, because these are, I take it, these are healthy kids.

They don’t have a disease.

19:09

They don’t have a condition.

So if a drug is to check if it’s working or not, you need to give it to people who have actually got the condition.

So at this stage now you’re giving it to young healthy people to make sure that what, they don’t die, they don’t get sick.

Well, yeah.

Yeah.

19:25

And there happens there’s a people having very severe reactions in phase phase one because.

Yeah, but it’s a bit, it’s a bit ridiculous because I think it’s ridiculous because you have companies with a press release saying Hallelujah, our compound has got through phase one tested.

19:44

OK, so it’s it’s safe.

But Sugar’s safe.

Bombly it is safe as far as we know.

I mean, you could word it the other way around.

Hey, our drug experimental drug didn’t kill everyone.

Well, you could, yeah.

Yeah.

I mean, that’s another way of spinning it.

Yeah.

Yeah.

Like, great for you.

20:00

Good for you.

Yeah.

So the next stage then is a phase 2A.

Just just go back to that phase one.

Do these young kids know they’re taking something completely random?

It might kill them.

No, they’ve they won’t because they’re focused on the 2000 dollars or pounds they’d get for doing the the time that they have to and.

20:20

But it’s there in the small print.

Oh, I’m sure it will be.

Yeah, I’ve never I’ve.

I have to assure you, I’ve never done it.

But it will be in the small print, yeah?

OK, so you’ve not killed these young kids playing computer games in a in a in a building after two weeks.

20:35

So now phase two.

What happens there?

They said two phases, Phase 2A22 stated Phase 2A is what they call dose ranging studies.

So they give people with the indication with the disease various levels of the dose and they work out which is the most effective and that obviously that’s they use statistics and they take it all the the sort of measurements of from the blood and all all the measurements they need to take.

21:04

And at the end of a Phase 2A study and this maybe twice as many patients on that as well on the phase one study or three.

But once they know the the, the, the effective dose they want to go with and that in a sense is a bit guesswork as well to be honest.

21:24

Once they’ve got that, then they can go into a Phase 2B study where they test that dose level, the dose regimen, You know how many times you take it once a day, twice a day or whatever.

And that then gives them statistical.

21:43

They call it the end point at the end of the study, at the end.

At the end point, you work out if you’ve got a drug or not, whether it’s safe and effective and then you get press releases saying Hallelujah, this drug didn’t kill people and we think it works.

22:01

But we’ve still got a long way to go because you’ve got the phase three studies.

So phase three studies are much bigger study typically run all over the world or in large parts of the world.

And the aim there is to prove that pivotal studies that prove the drug is safe and effective and has to be made to the correct quality.

22:24

And this is where people very often don’t understand in fact the quality is part of the whole assessment of the drug.

By quality I mean chemistry manufacturing and controls.

So, so that is module three of three models that have to be submitted to get a drug approved first.

22:46

The first one is Module 3, chemistry manufacturing controls.

It’s effectively is all the companies in the supply chains, the materials, the specifications, the testing methods have to be submitted to the regulators so they can confirm that these companies are up to the job of making these drugs too good manufacturing practice.

23:06

Module 4 is safety, which is toxicology and anything to do with the patient’s safety.

And Module 5 is a clinical module and throughout all of the, I won’t go into the vaccine particularly, but you know the focus is very much if it’s very much on the clinical aspects, you’re missing out the really crucial elements which is the time taken to build the supply chain, put it in place, test the materials first to make sure it’s safe in animals, then make sure it’s safe in humans.

23:43

The time to bring a drug to market, that’s the limiting step, is the time to manufacture the poster development batches and then the full scale commercial batches.

So.

Yeah, because there’s one thing making a drug in a small quantity, and for labs, there’s another thing producing like millions and tons of something.

24:05

That, I mean, the chemical reactions must be different.

The whole process must be different.

I mean, there’s a whole big engineering thing.

So how long does it normally take for a drug to come to market from the moment it was discovered?

When it comes to market on average, what’s the normal time?

Well, the US Government Accountability Office wrote the report November 2006, which says pre clinical is 3 years, pre clinical clinical is 7 years, and it takes the regulator, FDA European messaging 1 1/2 years to assess the application.

24:42

Now that’s the key piece that the regulator needs a long, long time to look at all the data that’s been submitted and say we’ve inspected all the all the manufacturers, We’ve made sure that the materials you’re using aren’t toxic or they aren’t, you know, banned in certain countries.

25:02

We make sure that your people are properly trained to do this, and we’ll make sure all the elements of good manufacturing practice and the way you distribute the drugs have all been done to the regulations.

So that that’s about 11 and a half, 12 years.

Yeah, it is, Yeah.

Yeah.

25:18

OK.

So how many drugs that are actually researched and are being, you know, developed actually end up becoming a profitable, successful therapeutic drug, one in 250?

One in 250?

25:34

Yeah.

So all the other ones end up in a dead end.

Yeah.

No wonder the whole thing is so expensive.

Oh absolutely.

They claim $2.6 billion to develop a drug.

At least $2 billion is waste.

Wow.

So OK, so when they say a drug takes, you know, 2.7 billion, most of that was all the other 200 that didn’t get anywhere.

25:55

Yeah, that’s quite a lot.

Yeah.

And.

So now let’s let’s move to the COVID vaccines.

So you’re telling me 11-12 years it takes for something to get developed.

26:12

Discovery.

Go through all the trials.

Supply chain, quality control, toxicology.

By distribution, you name it, it goes on and on on the list.

And then the regulatory process Over a decade, what had the fact that this warp speed business happened and all these companies suddenly came out with a vaccine in 3-4 months, six months, whatever.

26:33

How did that happen?

Well, the regulators would evolve.

Or if, you know, there is no knowledge evidence based, I’ve just explained to you that that’s an evidence based explanation of how drug development works.

26:54

When it doesn’t work that way, when it happens in the time it did less than 12 months and you’ve got, you know, people in the industry saying, oh, we changed the genetic code and now we’ve got another vaccine coming out.

27:10

Well, you know, pull the other one because you know, it’s got bells on nuts.

It’s complete lies.

Has to be.

Explained that to me.

What do you mean?

Well on top of these not being small molecule drugs, they have biologics.

So the the whole if it takes 1210 to 12 years for small molecule drug they they the US Government Accountability Office data was 2006 that would have been mainly small molecule drugs These days you expect the number of failures and the issues being much more extreme with biologics and yet they’ve come to market in this less than 12 months now I.

28:01

I How’s that possible?

What?

How?

How could that have happened?

Or they must have ignored all the regulations, and I could tell you so.

Have they skipped key steps?

Oh, absolutely.

Like what?

Well, like it’s almost so ludicrous.

28:19

Tell me, well, they can’t have done any preclinical testing.

They can’t have tested in animal models because even the most basic safety testing in animal models would have taken three or four years.

28:35

So that’s a conspiracy theory and you’re fact checked because apparently there were three animal studies at least, but there were very basic animal studies from what I saw.

They they put some stuff down their lungs, they washed it around, then they gave the vaccine, then they said, oh, there’s antibodies and they killed all the animals.

28:53

And I was like, great.

So I was really confused when I read those papers.

I was like, that’s a that’s a weird study.

So you didn’t check.

Where the drug went, you didn’t say which part of the body went.

You remember they said it’s going to stay in your arm?

Oh, yes.

Yeah.

They didn’t study.

29:09

Yeah, yeah.

They didn’t tell us like where did it go in the body, What effect did it have on the on the animals, babies.

Were there any teratogenic effects or, you know, yeah, yeah, that’s right.

You know, and they didn’t tell us about safety levels of dose of the vaccine or or the maximum dose.

29:24

They didn’t say how you could reverse the vaccine or switch it off.

They didn’t do any of these animals.

They were animal studies.

They were, but they were so pathetic that I, even me a DEM orthopod was like, what the hell, This is it.

This is your, this is the animal studies.

29:41

Like, ridiculous.

So there were animal studies done, but they weren’t very good.

Yeah, I could add to that that every time you scale up the process and there will have had been multiple scale UPS.

Yeah, you have to rerun the safety studies of animals.

Of course you do.

Because the drug, the composition of the the drug could change.

30:00

You have what they call polymorphs.

It’s not just polymorphs.

Any change in the process can change the clinical performance of the drug, and it could even make a safe drug toxic at at the higher scale.

And it’s hard to believe how many scale UPS they must have gone through to get to the billions of doses that they actually delivered.

30:21

And there would have been no animal studies, safety studies run on those.

And do you know much about the original Pfizer study, the Pfizer trial, well, not the clinical, I know the supply chain because the supply chain was made by a company called Wyeth Palmer Biopharma.

30:36

The 1st 33 batches were made in the US in Andover, Wyeth, Palmer, Wyeth Biopharma Solutions and Pfizer never made the biologics in his life.

Hold on one second.

I thought, I thought this it was Pfizer Moderna that make all the drugs.

30:55

No, Oh no, no.

None of these companies have ever made the biologic drug.

Not Pfizer Moderna.

Biontech, particularly not Biontech because it’s, you know, it’s the size of our size of our corner shop.

Dude, hold on one second.

What are you talking about?

Well, I’m talking about Biontech is just a group of business people who are pulling the levers.

31:20

So they submitted that for the first applicant, they submitted the application to market the drug.

But they don’t have the skills to do all the work that I’ve said and they certainly don’t have the manufacturing facilities.

But I thought they had big shiny factories and that’s where it’s all made.

31:37

So where is it made?

If it’s not them?

Well, OK, I’ll at the start it was made by a company that Pfizer bought in 2009 called Wyeth Biopharma.

Now I’ve looked at that company and it’s R&D, it’s not capable of manufacturing to good this good manufacturing.

31:56

What’s the name of the company again?

Wyeth Biopharma.

Wyeth Wyeth biopharma.

OK, carry on.

And they’re in Andover, so I’ve looked at the website and Andover.

And Massachusetts.

All right.

OK, Wyeth.

32:12

Yeah.

And they were biologics.

But since Pfizer bought them because you know, these companies, they’ve seen the growth of biologics and they’ve bought biologic companies, but they don’t have the the sort of history of of developing biologic.

32:30

They don’t have the innate skills that are needed.

So you have to wonder how much how well were these made to good manufacturing practice.

So we know from various documents that no public domain they were leaked originally that the 1st 33 lots of the Pfizer vaccines had abnormally high levels of adverse events.

33:02

And we also know that those first 30 to 3 batches were made at Wyeth Biopharma in Andover, MA and they are not capable.

In my professional opinion, they are not capable.

They don’t have the skills to manufacture to the tight regulations of good manufacturing practice.

33:24

So it says over here, Wyeth was a pharmaceutical company until it was purchased by Pfizer in 2009.

So they might argue that there is no Wyeth biopharma, it is Pfizer.

What is what I’m saying is the facility though that they bought is not capable of making biologics to the Good Manufacturing Practice standard because it’s mainly an R&D facility.

33:48

It’s if you listed all the things they offer in terms of services, yeah, it’s mainly R&D and a site has to be exclusively GMP because you have to segregate materials to stop contamination.

You know, it’s highly controlled because R&D is more experimental.

34:09

So.

So in terms of other company, there’s a company in Germany called Renschler.

Wow.

Wow.

So I’m just reading up.

Do you know Pfizer bought Wyeth for $68 billion?

And they did it so that Pfizer could diversify into vaccines and injectable biologic medicines.

34:29

By adding Wyeth’s big selling Prevnar vaccine for childhood infections and Enbrel rheumatoid arthritis treatment.

So there are obviously, it’s one of these big companies that says I want to go into this market, let’s just gobble up another competition and consume it.

34:48

Yeah.

And the usual thing happened.

The good people at Wyeth left, because I’ve known people who worked at Wyeth, and they they were not a bad outfit and they had a site down in the South, southeast of England.

But the good people left.

35:06

And so you had the people of Pfizer and not sort of degrading them, but, you know, they hadn’t.

They didn’t have a history in biologics.

The people who had the experience probably left though, particularly over that length of time.

So you’ve got a company that doesn’t really understand biologic is actually owning the facilities that are are making them and that’s a recipe for.

35:30

So so does Pfizer make their own vaccines then?

Do they?

Do they make their own drugs?

They have.

Well, we know that.

No, they don’t.

They don’t.

And the research that’s being done, the animal testing, the clinical trials aren’t isn’t this all under the?

35:48

An umbrella of like the pharmaceutical companies or are they outsourcing that’s all fully outsourced or fully outsourced to contract if we take Madura as an example, because they don’t have any facilities at all that they’ve bought of anyone.

We know that Lanza in Switzerland manufacturers the what they call the drug substance or the active ingredient for the Madura vaccine.

36:13

Biggest contract manufacturer in the world, probably the best in biologics in terms of expertise.

But they aren’t.

They work on a fee for service basis.

What’s their name again?

Lonza.

LONZ.

36:29

A OK Lonza I’ve they’ve been a former client of mine and I’ve not.

I know quite a lot of the people involved in this, and I’m not saying they’re bad people, but I’m saying that things haven’t work to the way they normally should.

36:46

All right.

So carry on.

So Lanza Biologics, they’re the ones actually manufacturing, they’re the contract developer and they’re the ones making it for Maderna.

We don’t yet because there’s a press release to that effect to that public domain.

It’s on the Lanza website and it’s on the the website as well, I think.

37:06

OK.

And then the, the company that fills the drug substance, this is like a liquid that’s been created from animal cells lawns to send those to the next stage, which would be Cattle and Farmer Solutions initially in blue in Bloomington.

37:27

This is the initial supply chain to get to get things going.

Cattle and Farmer Solutions are the second largest contract development organization in the world.

Again a former client of mine and they had an FDA inspection 1218 months ago.

37:46

And the report there that when you get an FDA inspection, 3 or 4 inspectors go in and they go through the plan from start to finish.

And although the an FDA always put these inspections the results are what they call a form 483 and that inspection form showed mass non compliances with quality such as shipping projects before they’d been passed not recalling projects with they knew had failed but not not recalling them.

38:25

And I’ve got again this is public domain, the F all FDA 48 threes are on their website and you can you can see them and if you just have to read that and you think this was out of control, these people didn’t know what they were doing and that’s what the so and that was recorded by a well known industry journal called Fierce Pharma and the form 4H3 is there and they’ve described the comments from the the FDA inspectors which are horrible.

38:57

So Moderna is contracting to Lonza and what else?

So they don’t actually physically make the vaccine?

No, no, no.

We know that you in the UK they, I think there’s an R&D site being built for Meduna, but they know they are very, very small company.

39:17

You know, they they’ve never ever manufactured anything or developed a drug.

So Moderna has never manufactured or developed a drug prior to this or any job?

No, no.

Wasn’t there some cancer treatment they’ve done or something?

39:33

Or they’ve got a phase one study in my myeloma you know which but cancer street but but and again I’ve documented this in the sub stuck it’s they they went from the running the phase one study and we know phase one only proved safety so it was not proof of efficacy Then suddenly all these companies started to invest in Moderna about 2013 two thousand and fourteen 2015 and suddenly they they were they appeared to be a giant company but they.

40:07

Like how many people do they employ?

Oh, I I always look at the website and if all the people on there have got church ties and they look like business people, I know there’s nothing underneath.

You know what I mean?

When you sort of if you work in industry, you know that you know who you would expect to see on the site and you won’t see the manufacturing people.

40:32

So it’s the same with Beyond Tech, you look at the website and.

These companies are springing up all over the place.

You look at the website and you see about, you know you have a Chief Business Officer obviously have a Chief Executive, you have a Chief Financial Officer, you’ll have a Chief of something else and people would assume that underneath them all these sort of all these people making things, but actually it’s all outsourced and this started 40, the outsourcing started 40 years ago so.

41:06

The companies selling the drugs are not the ones who have developed them or or or making them, and that’s some.

That is the key issue here.

So it says over here.

Moderna is planning to hire about 2000 employees by 2020 threes, and they have now about 3900 employees.

41:28

What do they all do?

No, no idea.

But I know they don’t, they don’t get involved in drug development or manufacture in any meaningful way.

And I’d be happy to sort of go along to one of their sites and say I was wrong, you’ve got all these people and look, they work into good manufacturing practice and good distribution practice.

41:51

The regulator should have done that already, but I don’t know that they So all these big shiny companies are actually outsourcing everything.

All their drug development, their research, their R&D.

Wasn’t there some Brooke Jackson?

She was a whistleblower, if you’re saying.

Yeah, yeah, yeah, yeah.

42:06

Yeah.

Oh, yeah.

What broke out?

I mean, I’ve got to know Brooke over the years.

I’ve interviewed it.

So what was that all about?

Was that example of that where there was a contracted research unit and?

You know, it wasn’t just one contractor.

The main contractor was a company called Icon who took responsibility for all the clinical trials.

42:27

But Icon outsourced the the, the, the sites to another company called Ventavia.

And Ventavia were they were recruiting their own employees onto the clinic, onto the studies.

42:44

You wouldn’t believe what they were doing.

And they were using incentives to keep people to join the study.

Well, you know Brooke, she’s still in litigation, isn’t she with, with, with, with Pfizer?

But she absolutely knew her stuff.

She was a professional in clinical, clinical research.

43:02

And he two days after she was there as a senior leader there, she said.

There’s just something badly wrong here.

So you can see how divorced this company is from Pfizer who well actually Biontech submitted the application.

43:20

So and it was joint between Biontech and Pfizer.

But then the icon of doing the clinical work and another company are doing the work on getting people on to the clinical trial, recruiting them and looking after them and taking the bloods and all that sort of thing.

43:39

And they’ve got no, there’s no ownership of what’s going on because they’re all getting paid a fee for service.

All these contractors are paid a fee for service.

So they get paid whether the drug passes or fails.

So and now we’ve got private either we know that private equity have been buying up these contractors and they are investing heavily in.

44:06

The the, the service infrastructure in the industry, you know clinical services, contract manufacturing services and it’s all about return on investment.

So the industry has really focused on massive returns on investment irrespective of whether drugs are approved, whether they’re safe, well that that whole thing.

44:35

So it’s.

Really, really worrying.

So just driven by money.

Yeah, yeah, yeah.

Yeah.

So look, we need to go back.

I feel like we’ve gone off piste a bit.

So these M RNA jabs rushed through.

I’m still struggling in my head, her Pfizer Moderna with no one really behind the scenes how they came up with a vaccine so quickly.

45:01

I mean, I think the Moderna chief executive or whatever was actually even saying how they never actually had any virus.

It was all just a computer code and they just plugged it in and made this modified RNA.

It’s not, it’s not mrnas, it’s actually fake RNA.

45:20

It’s this.

They’ve replaced a a base pair pseudorididine or whatever, so it doesn’t get degraded by the body.

How how did they all just suddenly come up with this vaccine?

Like they just knew what the code was going to be and everything.

45:36

And then I don’t understand, was there some conspiracy and it was all pre planned a year or two in advance and they knew what they’re going to do?

Or was it literally just rushed out?

Well, if I can tell you what I know from my personal experience, because after not long after I wrote the book in 2011, two 1013, I was asked by someone working with the Office for Life Sciences.

46:01

To help a company based in Oxford, Oxford by America, with what they called a government Advanced Manufacturing Supply Chain Initiative, was across all industry sectors and I was told that there’d been two rounds of this funding call.

46:21

And like the life sciences companies had failed because they, the bids were framed like they were scientists, not engineers or people thinking about producing things.

So would I spend four days consultancy time finding a company to apply for this, a life sciences company.

46:40

And when I went along to the launch of round three, which Michael Fallon and was host, you know he was, he gave the opening address.

I was on the table.

With someone with the chairman of Oxford Biomedica and I knew that because he was mentioning biotech and I said, oh gosh, you know, he said, Oh yes, well, I said, well I’ve come here to find the company to apply for this.

47:01

So.

And he said, well come along and speak to us.

So I went along, talked to Biomedical in Oxford and they said, yeah, we like what you’re you you’re going to do for us.

So they took me on for six months consultancy.

47:18

I recruited the Heart of England NHS Trust into the the bid to give an end user customer perspective and Cranford University to do the modelling that that was going to be necessary and the cell and gene therapy catapult was involved as well.

47:35

I’m not I wasn’t involved with that.

They were working independently but that is AUK body funded by UK.

They funded they they they government or they funded in some way and their role is to grow gene therapy and cell therapy in the in in the UK by working with these companies.

47:57

So anyway, cut a long time short, we framed the bed it went in and it was awarded £7.1 million award to Oxford Biomedica and then after that UK Government Office for Life Sciences came along.

48:16

To the the sort of rapid meeting at the end and they were really impressed by the whole gene therapy thing and what was going on.

And I was invited a few months later to a meeting in London which was which was hosted by by a government official GSK with their challenging therapy catapult other people involved.

48:39

And I I was sort of I spoke up to say look.

I don’t think you understand how difficult this is.

You know gene therapy is not magic.

And the following month I was, you know, I was let go.

48:55

I was, I was sickly fired and you know, I didn’t know anything after that until this all started and I suddenly realized how how’s what had been going on with the MHRA with the cell and gene therapy catapult and UK government in.

49:15

Pushing gene therapies.

So when we had the what’s that?

Sorry, I’m sorry, your accent, what’s the name the the gene catapult.

What was?

It’s the cell and gene therapy, cell and cell and cell and.

Gene therapy, Catapult.

49:33

There are about 9 catapults in the UK, one for, you know, different industry sectors.

Cell and gene therapy has got a catapult.

So the the term catapult means we will help catapult companies to become successful OK cells as in like human cells.

49:51

Cell and yes, cell and gene catapult.

Gene therapy, gene therapy, catapult.

So they really want to push this, don’t they?

Yeah, the current chairman was on the Vaccine Task Force, which was chaired by Sir Richard Sykes.

50:07

Who was the CEO of Glaxo for many years, so no conflict of interest there.

No conflict and the chair previously worked for GSK as their head of supply chain.

Well, I met him in 2012, him a cabin SO and UK with MHA, with the first country in the world to approve the first jobs with the Pfizer jobs.

50:35

And every job that’s been approved has been the MHRA first, followed by a lockstep almost.

So this sounds like a conspiracy theory, but it’s absolutely true.

And if you look at the time scale that Oxford Biomedica’s manufacturing facilities were approved by MHRA without ever going there, without ever inspecting the facilities, it was like about three or four months.

51:02

Normally that would take three or four years.

So it’s horrific.

So when MHRA says it’s an enabler of this, absolutely it is.

It’s still not inspecting any sites it could inspect.

You know, there are mutual recognition agreements between all the regulators where they can share inspections.

51:23

So that FDA inspection where there’s been two bad inspections, you know when I say bad, the company’s been bad.

That immature rate could go to FDA and said, oh, we can use your inspections to say they can’t, you know they can’t sell the products manufactured then in in the UK none of that’s been happening at all.

51:46

So they’re not doing their job.

No, no, absolutely not.

They’re not doing their job of regulating and protecting the public.

No, absolutely not.

And making sure the products are safe.

They’re just going by whatever the company tells them.

Yeah, yeah.

This the sort of.

52:02

The companies and even the contractors are part of it because they have to be, because they are the ones actually making it.

So they’ve known, they’ve been breaching the regulations in a, you know, by more than five orders of magnitude.

It’s.

52:18

And why and why are they not?

And they’re just, they don’t care because they’re getting paid.

They’re getting paid a big, fat amount of money.

Yeah, is it as simple as that?

It is as simple as that.

Now, what have you heard about this bait and switch that Pfizer was producing the first lot of vaccines that they use for their clinical trials in a certain manner And then for the mass rollout, they completely changed the way they produced the vaccine.

52:39

Have you, do you know anything about that?

Well, it’s been given the name Bait and Switch, but really it’s a fancy word for they started off with the process in a pretty raw and they were.

Emergency is supplied made to get these launched as soon as possible.

52:58

It didn’t have the process right.

And what was the process?

The process is sort of like how you put the no, no, I know, But what was the process that first, the first batch?

How were they making it the vaccines?

Like what’s the difference between the two?

53:16

Now, I don’t go into, you know, the liquid Nando particles and all that sort of thing, because that is scientific.

No, no.

Wasn’t there something about E coli?

Or DNA plasmids.

Yeah, but, but, but this is don’t focus on E coli and plasmids or whatever focus on change because whenever you change something, you start off.

53:39

They started off with this process and it it wasn’t doing the job for what they wanted to do.

So they changed to this E coli thing.

But there were thousands of process changes this may have been.

So how many times did they change the process?

And created something that was toxic because scale UPS and all these different variation in manufacture, all these things could have made these drugs, you know, gone from reasonably safe.

54:10

Well, none of these were started off safe to to be honest, but I don’t know while I’m explaining this, but any change in the supply chain?

Has to go through retesting, No.

So I get it.

54:25

What you’re saying, like what you’re saying is, Ahmed, don’t get bogged down in the details and the nitty gritty of what they changed and how they did it.

That in itself actually isn’t even relevant.

What’s relevant is the fact that the fact they made a change warranted everything.

54:41

Going back to the drawing board, going through all the rigorous studies from like you go back to the first, you go back Monopoly, you go back to the first square, like you go straight back, you have to start all over again.

And the problem is, not only did they not do that, but they did these changes lots of times.

54:59

Yeah, absolutely.

Yeah.

Now you.

That’s exactly.

That’s what you’re trying to say, yeah.

Absolutely.

So that in itself is enough evidence to to call foul, yeah and say you’re not doing your job properly and the regulators aren’t holding these manufacturers to account.

55:17

You can’t be tinkering and changing the manufacturing and the content and the ingredients, because every single time you do, you need to justify and prove that it’s safe that you you’ve gone through all the steps that we’ve outlined before and they haven’t done that.

55:35

Yes, absolutely.

So what do you think of the tagline?

Safe and effective?

It’s it’s so ridiculous.

You know, It’s to me, it’s so obvious.

And I keep going back to this the myth of penicillin.

Where people believe penicillin came to market by accident.

55:55

But actually, if I’ve got time just to just to go through this, Fleming found we came back from the holidays, August 1928, and he had all these Petri dishes out, and in one of them, the compound in there appeared to be killing bacteria.

56:13

But he didn’t know what the active ingredient was.

And it took him 11 years to find someone, a group of people who could isolate the active ingredient.

And it was Oxford University and they managed to isolate the active ingredient and they could make small quantities, just gram quantities to test in animals and in the field patients.

56:34

And they proved it was actually working, but they couldn’t make it in the quantities that were required.

So they actually went to the US Department of Agriculture.

Which was the forerun into the FDA in fact and they spoke with some people there.

One of them was a guy called Andrew J Moyer who was an expert in the manufacture of moles and he devised a process using corn syrup, liquor and sucrose or some something else and suddenly the yield increased exponentially and.

57:07

He devised the process that was then given to few large companies.

Merck, I think Pfizer was one of them and they could manufacture in 10 quantities.

But Moya actually was awarded the patent or the patent for penicillin.

57:25

So you can imagine if Fleming, Oxford University, Howard Florey and others and Moya had been together at the start when.

Fleming made that initial finding.

Penicillin could have come to market in four years, but actually it took 16 years.

57:44

And what we’ve got now is this disconnected development process where you start with R&D, then you hand it to the people to develop it, but they’re not going to be selling it.

Then you handed the people to do the commercial manufacture and you know it’s so disconnected and disjointed and that’s the the big issue.

58:01

Now we’ve got an industry that is so fragmented.

Particularly in supply chain terms, but even connection with the patients because the pharma companies sold off the wholesalers, the the companies, you know, the pharmacy, the OR or the the supply chain, the distribution supply chain to patients that’s in the, you know, the healthcare system.

58:24

They sold all those companies off.

They were bought by companies like Boots Healthcare and now they these cut the pharma companies got no connection.

With the people who are buying their products, you know, it’s they’ve got no feedback, no connection at all.

58:40

They don’t really need that, do they?

All they need to do is convince the politicians to mandate their drugs and products, and then they’ve got a market.

And if you and if you have vaccines and get them on childhood schedules, that’s repeat business.

Boom, boom, boom.

58:56

Forever.

Yeah, absolutely.

Yeah.

Yeah.

So do you know about the vaccines?

What are in these mRNA jabs?

We know about the lipid nanoparticles, we know about the modified RNA.

What else Now they’re talking about DNA fragments, when you say it’s grown and living in tissue grown and what what are these things grown in?

59:20

Well, it’s what they call cell lines and these have to be kept at -193 degrees here in liquid nitrogen.

So you can imagine the first stage in the supply chain.

No, no, no.

Let’s go back to the cell lines.

Yeah.

59:35

So where do the.

These cell lines can’t be frozen.

So what?

They’re growing in cell lines.

And where are these cell lines?

I mean, because I spoke to Aaron Siri and he was talking about aborted, freshly aborted fetus tissue.

Yeah, And.

And they need, they need a regular supply of aborted tissue.

59:51

Well, I mean.

Yeah, yeah.

I’m just, I’m just a dumb supply chain guy.

I just think process.

And so I know they, I mean like even with sort of HCV in that they get their samples they may be collecting them from Alcoholics in the back streets of New York, the the donors and you know and.

1:00:13

The management of donors and your traceability of donors should all be there.

So I know that has to happen.

So there are again regulations about how you deal with and if it’s animals as well or babies.

The donors have to be properly identified and the ethics applied to it.

1:00:30

So, but I don’t get into that.

I just know that happens.

So you don’t know anything about the manufacturing and whether they use aborted feces or not, I’m sure they do because you know, how else do they go into, how else are they going to collect these things?

But you know, my focus is always the stages that it goes through.

1:00:48

I know, but you know, you’re in the manufacturing.

You know about the business of making these things, like how many like 1 aborted fetus, How much?

How many drugs will that make?

10 thousand, 1000?

Like, how many of aborted fetus tissue do they need to manufacture an upscale like this?

1:01:07

I’ve got no idea.

So I I’ve got no idea.

And if I did, I wouldn’t be running supply chains.

I’d be a scientist or or not.

Yeah, they they’d be medically qualified in some ways.

But these these biobanks, you know, like I think MHRA is building a bit of biobank at the moment.

1:01:28

So you’ve got what’s a biobank.

Biobank is these companies will just collect samples of everything human tissue, whether it’s and it could be embryos.

You know, people specialize in in having collection of all these things.

1:01:45

It’s a specialist skill.

You know, you have to know where to find these people.

You have to have links with hospitals and even sort of you know, other, you know the mortuaries and all these places where you can get animal and human tissue.

1:02:03

I used to say I know it goes on, I I don’t know the detail, but what I do know is to collect these things must be incredibly difficult and there must be shortages and you know when the shortages people make money.

1:02:23

So this must in my mind this would be another element of potential.

You know what they call price gouging?

You know, to get to get money.

No.

What does he mean by price gouging?

It’s a common term in the industry where if you charge an awful lot more like I did not remember the guy he he went to jail.

1:02:48

Martin scrawly.

He he found a drug called Daraprim and he realized only one company in the world made it.

It was in shortage and he bought the rights to the drug and he increased the price by 5000% from I forget I said, like you know, from few dollars to few $100 or even a few $1000, it’s all documented squarely.

1:03:20

Daraprim, I think he went to jail for the period, but these are people who look for the opportunity.

He found a shortage and then this comes down to farmers, right?

Because they’ve outsourced so much.

And they’ve also, they drop a drug that they’ve got, which is outside the pattern, period.

1:03:39

They drop the drug and then you get four or five generous companies jumping in making the same drug.

But now the generous companies have got so many drugs that they can dip into.

They’re being selective about what they make and what they don’t.

So they drop in drugs now that they’re not making a lot of profit on, but you’ve still got patients who are dependent, the lines potentially dependent on those drugs and no one’s bothered.

1:04:05

So the big issue with Scorelli was I forget what the condition was Daraprim was for.

That’s fine.

So, so can I ask what about I wanted, I wanted to ask you something.

So going back to these MRA jobs and whatnot, do you feel they went through their normal regulatory process?

1:04:27

Well, after what I’ve said, could you, could you imagine me saying yes?

Absolutely not.

OK.

And now every single time a booster comes out, last time I heard there was some bivalent booster came out and it was tested on just a handful of mice.

You know, how is that possible?

1:04:42

How is it?

And there weren’t even any human studies on that.

How are the regulatory bodies allowing this?

A it’s nonsense, obviously nonsense.

What I think has happened is that well I I do know this there’s a duplicate regulatory bodies been set up non non elected you know FD, AM, HRA.

1:05:04

They what they call competence authorities.

They have delegated responsibility from governments to deal with certain aspects concerned with with with drugs.

This duplicate or the the International Coalition for Medicines Regulatory Affairs was set up in 2016 by Dr. Ian Hudson who was at the time chief executive of the MHRA in the UK.

1:05:32

And so he he was doing, you know, he was working for two bosses.

Now he he set up this body which seems to be duplicate.

It’s got all the members are all the regulatory authorities around the world.

1:05:49

It was set up originally by the World Health Organization and the Billam Lander Gates Foundation, of course.

And and it seems they have hollowed out.

They’ve managed to sort of make themselves the surrogate authority global authority.

1:06:11

Ian Hudson was the first chair.

The chair now is Emma Cook.

Miss Emma Cook.

He was also the chief of the executive director of the European Medicines Agency.

So she has two jobs at the same time, one which is the official European Medicine Agency job and one is the unelected illegitimate International Coalition for Medicines Regulatory Authorities.

1:06:38

And you’ve only got to Google those initials or the full name and you will see in 2012 it was there was a meeting in Brazil with The Who and then and the the current chair executive director of European medical energy worked for The Who for the period and she also worked for a lobbying body for the Pharmaceutical industry so.

1:07:02

So there’s a revolving doors between regulatory bodies and the industry.

Yeah, yeah, some could argue, but they get expertise and and it’s only right that someone who’s got the expertise in the farm industry ends up becoming part of the regulatory body.

You know, I think that’s reasonable because they’ve got the experience and knowledge or do you see it that although they’ve got their charms still in the farm industry and they’ll do them a favour?

1:07:27

Well, that’s pretty clear, isn’t it?

Because this is a commercial industry.

And when they’re working far, if a regulator moves into a pharmaceutical company like Scotland, Gottlieb has moved from FDA as as this commissioner to Pfizer.

1:07:45

He’s not going to be able to use any of his skills at Pfizer because, you know, that’s not the role.

And if they were suddenly complying with, you know, doing things the kosher way that were, that were that we spoke about, but that isn’t the evidence.

1:08:03

So is that more like a reward?

You come on the board.

Oh, well, you’d have to say that, wouldn’t you?

I don’t.

I don’t think anyone would describe it any other way.

So OK.

Can I ask you about drugs?

Where are most drugs like the basic molecule drugs made now?

1:08:20

I keep hearing things like India is the main drug developer and maker of drugs.

Is that true or are we still making lots of drugs here?

And is there quality of drugs just as good over there as they are over here?

Well, we have to go back again tonight.

Well, I won’t go too much.

1:08:37

When the industry started to outsource its manufacture, it moved offshore what they called in those days and the move was to to Asia local, what they were calling low cost country sourcing, which of course is not low cost anymore because the China, India, other Asian countries have you know they’ve become more successful.

1:09:02

But I coach at a conference in Cincinnati which was Co sponsored by FDA and Xavier University in Cincinnati.

I Co chaired that from 2011 to 2013 and this was the big issue, outsourcing moving offshore.

1:09:21

And I think then 80% of for the US 80% of raw materials were sourced from China.

Is it just China?

And 40% of finished products were sourced from China.

You have to say China, China.

1:09:38

Like Donald Trump.

No, I, I, yeah.

So anyway and that’s not changed and really India now is outsourcing to China because India manufacture more the finished products and supply in more the Western world.

1:09:57

But the the dynamic is basically the same.

These the, The thing is the starting materials, the raw materials, those you can’t even start to make a drug unless you’ve got those.

So that puts you in a strong position of power than that.

So and so the power making drugs is in Asia and that’s the way it’s the West.

1:10:21

The West actually made it that way by going offshore in the 1st place and as such a profitable industry.

Why would you go offshore to buy your active ingredients, you know, just to shave pennies off the cost of a drug because the raw material cost is, you know, is almost negligible in what you pay for the pharmaceutical product.

1:10:42

So why would you do that?

And you know, eminent professor who I’ve got to know quite well, Professor Andrew Cox, which is he’s a guru in procurement of supply, he basically said that, you know, that outsourcing was a major strategic error that the industry is just not recovered from.

1:11:05

So why did they do all this fragmentation, outsourcing.

You know, it sounds like everything’s not under the one roof R&D development.

Is it?

Is it just literally just saving money?

Is it about you’re less accountable?

You can pass a buck and say, oh, it’s not us?

1:11:24

Those guys didn’t do their job properly.

They didn’t do the safety testing properly.

It’s their fault.

I mean, is it all of these things?

I mean, what’s the main reason for it?

OK, There was an event in in the late 70s, early 80s, a company called Smith Kline French launched a drug called Tagamet for acid indigestion.

1:11:45

I’ve heard of that.

Yeah.

And that sold really well and that became you know a high selling drug, it being a blockbuster five years later and it took 12 years to develop Tagamet and the team in place will really experience skill team.

1:12:01

Five years later Glaxo launched a drug called Zantac competitor drug and within three or four years it was out selling Tagamet 3 to one.

And it was put down to the superior sales and marketing effort that Glaxo put in to detail to doctors on the difference in side effects between Target Met and Zantac.

1:12:26

So they targeted a weakness in the competitor and Hallelujah, they had success.

So they had, they built up this big sales and marketing team and that sent a message to the whole of the industry to say oh, if you’ve got a patent and a sales and marketing team for an approved product, you can name your price.

1:12:52

And both those products became blockbusters.

They they made 10s of billions of dollars between them.

But the industry copied the Glaxo model which was patent molecules and sales and marketing.

So the patent is in the discovery research and obviously the sales and marketing is in these huge marketing teams that they’ve got now.

1:13:15

So the industry, the big pharma companies flooded themselves with sales of marketing people and molecular modellers research and you know discovery research people and thought these manufacturing plants and this distribution, we don’t need those because all we need is a patent and and sales of marketing we sell them all off and they sold them all off And we saw in the UK we saw you know they used to be planted well all all over the UK they used to, they used to got the pill plant in up in Northumberland.

1:13:55

They made the pill pill as it was a contraceptive pill in the same plant when it was owned by Pfizer.

And then Pfizer sold it to an Indian company which is now called Piramal, which became a contract manufacturer.

1:14:10

But they closed the active ingredient manufacturing element there.

So instead of it all been done on one site, it became 234 sites involved in in in the manufacturer.

So that’s how it’s that’s how the supply chain is fragmented because the contract manufacturers have worked with centres of excellence.

1:14:32

There’s a centre of excellence for active ingredient, one for drug product, one for packaging.

So you find now these develop a drug you’re having to work all over the world whereas before you could have worked on the same site.

1:14:48

Well I work for buyer 1980 to 1996 used to make Alka Seltzer and we made the whole thing from start to finish.

We bought the citric acid, the aspirin and and the sodium bicarbonate in the back door and we shipped finished products to the pharmacies around the UK and we used to ship to other bio entities in Europe and they’d have similar structure in their countries where they’d have their own transport to you know send to pharmacies.

1:15:22

And it was fully integrated, joined up and over the last 40 years since I when I joined by it was fully integrated.

The time I left it was heavily fragmented and has continued to fragment ever since.

1:15:39

Do you think it’s a health and safety issue?

Do you think there’s a risk to patients with the current model?

Oh, absolutely.

Yeah, absolutely.

Yeah.

If you could change things what would you do?

I’d I’ve written about this.

I’d change this the patent law because what what the industry has done over 40 years it’s it’s games patent law.

1:16:01

When they mentioned penicillin where Moyer got the paint patent for the process and it was the same for Targamet, the same for Zantac, it was the process that was patented.

So they knew how to make the drug before it was.

1:16:19

It went into before they got a patent.

The Americans later call it patent.

So I I tend to so but So what the industry does, it doesn’t know if it can make the drug.

1:16:34

It starts to develop it and develop it and it’s sort of like evolves, the process evolves and by the time they get to market they realize they couldn’t manufacture a safe drug in the 1st place and it fails.

That’s why 249 out of 250 development projects fail.

1:16:52

We have to go back and say look what they use.

The mechanism they use is what’s called compound claims where you can claim a molecule as yours.

So any big pharma company, if you’ve got the £60,000 or whatever it is to buy a patent, you can say look, this is the chicken wire diagram of the compound.

1:17:11

This is our theory on the mode of or the mechanism of action.

And for Alzheimer’s, it was something called amyloid beta wrapping itself around brain cells.

And we want to patent for that and they get a patent and then.

1:17:28

They have to do something with that molecule and make it work.

If it doesn’t, absolutely.

What you’re saying is instead of patenting A molecule and an idea, they should actually patent an actual end production line.

That will result in a compound that works.

1:17:45

Absolutely.

Yeah.

And what other industry does, I mean if you went in the Patent Office with with any other industry, I said I’ve got this idea on this.

I’m going to it’s got to be a commercializable that’s what the patterns around and they say, well, how are you going to commercialize this?

Well, I’ve got this idea, I’ve got this molecule.

1:18:02

What do I do with the molecule?

We don’t know yet.

You know, give us a pattern, then we’ll tell you in five years or 10 years time.

You know it’s.

It’s like different.

Yeah, this is back to front and people don’t realize that.

So that’s important, changing the patent law.

1:18:19

And what about changing the way the drug developers are working and having everything under one roof?

You think that’d be better?

So yeah, Well, I think if you if you look at changing the patent, changing it to the process, this will drive the right behaviors in anyone developing drugs.

1:18:39

This is Russell Acuff’s principle that change the rules and the system will change itself.

So the ultimate rule is the fact that you won’t get a patent for the drug until you’ve come in here and you’ve described the process and you’ve showed me data that that process is going to produce a safe, effective drug up to a certain level.

1:18:58

I mean, you know, up to a level that is used acceptable to an engineer who who is a group of engineers who, same way that’s what Smith Kline the French did.

What about?

What about things like the regulatory bodies?

1:19:15

Do they need to be changed or anything?

Do they need to be revamped?

Oh, absolutely.

Well, all these things I can say was the FDAFDA.

If we’re FDA, we go back to the days of doctor John Woodcock who’s still still there.

1:19:30

But she introduced a number of initiatives to try and get the industry to change, to think about manufacture.

And based on, you know, she wrote with Cole wrote the Critical Path initiative in 2004.

And she’s going to contribute to my next book on that on writing on why she did that.

1:19:49

But she recognized that the industry was in a bad way in terms of manufacture.

But you know, the industry becomes so profitable.

But what I’m saying is, I think there’s enough.

Core competence still in FDA at the lower levels, these two inspections I mentioned, those inspectors know their stuff when they go in there, they know what they’re looking for and they picked up all the issues.

1:20:14

So I think we’ve just got to go back to basics, to the basics of regulation and the fact that the COVID is licensing with experience evaluators, people who can do the evaluation based on safety, supply chain and clinical and also inspections, inspecting the facilities, the clinical, you know the, the, the, the clinical sites, they all have to be inspected.

1:20:41

And at the moment, they’re all doing virtual inspections using AI.

You know, Microsoft HoloLens.

That’s what the MHRA use for, for their inspection.

What’s a Microsoft HoloLens?

It’s virtual reality and machine learning.

1:20:56

Is there a Microsoft product that that habitually used?

But how can you check a facility like that?

How can you check what’s in talk to the people on the ground and that just you can’t you can’t it’s a nonsense.

It’s a nonsense.

But what happens is the people at the facility will put the camera.

1:21:15

Some of the one of the managers will put the camera on their head and they say, oh the the, the Hamish array will say what?

Show us your that machine.

We OK, you put the camera and then, but they’re only going to show you the things they want you to see.

1:21:32

And the idea about inspection is that.

You can go into any door, any door.

And any cupboard and anywhere.

Anywhere you like.

Every nook and cranny, yeah, yeah.

Oh, for God’s sake.

It just gets worse and worse.

What about the revolving doors?

Would you change the revolving doors between regulators and farmer people working?

1:21:49

Yeah, that’s that’s a given in there.

That’s a given.

Obviously it’s not God things.

And you know, I think only politicians can change.

Again, I’ve written about this until there’s a consultation on patent law.

1:22:08

This compound claims the fact that no one’s, no one’s benefiting from this.

You know, farmers, CEOs under so much pressure to deliver blockbuster profits, I don’t know how they sleep at night.

Investors expect, you know, far too much for an industry that’s going to be sustainable because only any industry is only sustainable if they’ve got loyal customers that they can satisfy in the long term.

1:22:38

What’s happened is we’re at the tipping point.

Now less and less products are coming to market because no one’s incentivized to do the manufacturing distribution because they’re all paid anyway.

There’s almost nothing coming to market and these gene therapies have been the last chance saloon to deliver blockbuster profits.

1:22:57

Do you think that’s what it’s all about?

So I just read the.

Government website and it says Moderna to open you know vaccine and research and manufacturing center in UK woo NHS patients to have access to next generation of mRNA vaccines.

I mean, this is Auk government website press release.

1:23:15

And it’s basically advertising and saying how amazing and wonderful it is.

Like, they’re so super happy.

Like why are they happy about a private company opening a research, development and manufacturing center?

You know, it’s a, it’s a private pharmaceutical company.

Why are they so happy about this?

1:23:32

Like, surely that’s just that doesn’t make sense to me.

Well, nothing people don’t.

Realize is that three years ago the government built its own VMAC Vaccine Manufacturing Innovation centre in Harwell and they sold it off to Catalan Farmer Solutions.

1:23:49

Last year a fire set this so they built the facility to manufacture vaccines 3-4 years ago, didn’t take off and they sold it off.

And now why did they even build it?

I.

Don’t know whether government is doing you.

1:24:05

Know.

I think they’ve fallen in love with genes in therapies as as the way the UK can.

Become number one in the world in life sciences and then say, look, we’ve done Brexit, we’ve left Europe and hey, in this industry, the world’s most profitable industry, we are #1, but we’re not #1 yet.

1:24:27

When I first entered the industry, GSK was #1 in the world.

It’s now #10.

It was Glaxo in the initially.

It’s now #10 and still appears to be struggling to keep in the top 10.

So, so all these mRNA vaccines and.

1:24:44

Gene therapies is it?

Are they just easy and quick to produce?

The regulatory system is less rigorous when it comes to vaccines and that’s why they just think of this as a a money maker.

Is that what it is?

Because to me it seems like a very flawed platform.

1:25:00

It doesn’t.

It’s never been proven to be effective.

It’s not safe.

There are inherent risks and dangers whether you look at the mRNA, modified RNA or.

You look at the LNP aspect, I mean, there’s some major concerns and questions there, but you’ve got something that’s, let’s just give it the benefit of the diet isn’t a finished product yet, OK?

1:25:22

That’s me being really generous by the way, but it’s being rolled out for everything, for, you know, heart disease, for cancer, for the all the they want all the vaccines and that to be this modified RNA.

What?

What the hell is that all about?

Is it literally just money?

1:25:38

Is it just see as an easy plucking?

Let’s go for it.

Oh, absolutely, absolutely.

Yeah.

Well, the other thing I should say is that the head of the FDA, the head of biologics, which includes vaccines, is a guy called Doctor Peter Marks, who next year will be talking.

1:25:58

He’ll be speaking at the Advanced Therapies Conference in London.

He spoke with it last year and he spoke virtually there the year before.

He’s basically all behind these.

He’s a doctor, he’s a, you know, he’s a qualified as a medical doctor as far as I know.

1:26:19

So you know physicians are not unless they that they are sort of have got the right background, they’re not suited to regulate because they don’t know really much very much about manufacture.

No, no, no, no.

You almost got you almost got that sentence right.

1:26:35

Doctors don’t know very much about anything.

Well, what we we have got because they’ve been sort of educated by the industry and you know a doctor knows no more about the drugs that you take that you when you get your patient information leaflet you take it told me read that that’s what the doctor knows and nothing more.

1:26:56

And it’s a shame.

It’s more than a shame.

It’s it’s criminal, really.

So yeah, do you think things are going to turn around anytime soon?

Oh, yes, yeah.

I think, as I say, I mentioned my first, that I’m working.

1:27:16

With Daniel O’Connell, who’s the CEO of Trial Site News, which is an ethical publication in the US, and he’s working with investors.

And what’s been on earth is that private equity has been hugely active in buying these contract manufacturers and squeezing them, making sure that they make a lot of money irrespective of whether they’re doing the right thing.

1:27:43

And there’s a company called Blackstone Life Sciences which is built up to further invest in these companies that are providing services to the pharma companies.

So and they need each other that they need the big pharma companies to make the profits to the revenues and the profits And then the service provider needs to charge them lots of money based on the profits they’re making and they’re all happy.

1:28:10

Thank you very much.

So but this is coming out that and and there’s a report I can give you give you a link to written by AUK organization where they’ve made this really clear.

1:28:26

I think it’s I sense people are waking up to it.

You know people in there’s been a lot of suppression a lot of censorship but you can’t keep these you know this is against nature what they’re doing.

You can’t make products that damage and kill people and it goes on forever as a profit baking opportunity.

1:28:47

It has to stop at some point.

Yeah, you would think so.

So to me it’s.

It’s funny.

I feel like Big Pharma profits from human illness and misery and they don’t want you to get better.

Because if you get better, your customer lost.

And not only do they profit from sick people.

1:29:05

Now with vaccines, you’re profiting from healthy people.

You just got a bigger market.

So like, you don’t need to focus on people who are just sick.

You sell it to all the healthy people too, you know, the children, the pregnant women, the unborn kids, the children, you know, the adults, the elderly, everybody, everybody has to take.

1:29:23

It doesn’t matter if you’re sick or not.

You need to take this product.

And that that to me is very sinister.

It’s just, you know, people have their own theories and agendas.

I think it comes down to money, money, money, money.

And they want to extract as much money.

Out of us, the cattle, the livestock as possible, regardless of whether it makes us sick or not, it’s it’s quite ridiculous.

1:29:47

But we need to be able to hold these people to account.

The governments, the officials.

I think the governments are in the pocket of these Big pharma.

They’re so profitable, so rich, your Bill Gates, all these foundations, they’ve all got an ear in the politicians they’re all choosing.

And the and the media, it’s they’re all complicit.

1:30:04

They’re all they’re all in on the party.

Everyone’s in on the party.

Everyone’s invited except us.

Yeah, absolutely.

And.

I’ll say one thing I don’t think in terms of government or I don’t think they realize how dangerous these are.

1:30:22

I think they are.

They’ve been seduced by people in the industry who’ve said this is the next advancement in the world of medicine.

And I don’t think they’ve really understood that they’ve been deceived to the extent they have.

1:30:40

You know where Bill Gates is on speed dial terms with Boris Johnson, with all these other politicians, he’s probably saying, you know, these are perfectly safely to do it and they’re believing it because I cannot believe any politician other than some of them.

1:31:00

Who would knowingly do this?

And knowing that they’re.

I don’t know, maybe I’m being naive.

My wife tells me I’m being naive sometimes.

But I think there’s been a lot of smoke and mirrors over the last 40 years in pharma industry.

1:31:16

And no one realizes now that you can make very dangerous drugs if you don’t follow very careful rules, right?

Listen, Hedley, the last question I.

Always ask.

We’ve been talking for an hour and a half, by the way.

Is Imagine you’re on your deathbed, you’ve hit a grand old age of 117, right?

1:31:33

And you’re surrounded by your family, your children, grandchildren, all that kind of stuff.

Before you pass away and meet your maker, what advice would you give to your family, health or otherwise?

Yeah, good question.

I’d say stay healthy, stay happy, Never take a pharmaceutical product or any product that has been manufactured that claims to do you good.

1:32:03

Because, you know, I can see what could happen is that people will move to more natural remedies, herbal, and they are equally dangerous if they aren’t made to the same standard.

So whatever you put in your body, unless it’s a cake that you made yourself, that you’ve, you know, you’ve tested all the raw materials, be sure that you know it’s not going to do you any any harm.

1:32:28

And I think my family know they’d say we’d expect you to say that.

OK, it’s good advice.

Amazing.

No, I like that.

I think that’s a very, very good point you make.

That you know, people are drifting into the whole Wellness world and alternative health, but don’t assume that they’ll be selling you something that’s any better, any healthier for you.

1:32:51

You know a lot of the supplements of fillers and binders and crap, Yeah, absolutely.

Yeah, you know and you know, for example, the best.

Protein bowl you can get is an egg.

Just get a nice free range organic egg, you know, just, you know, try and get to root basics, you know, just something that comes out the ground, something that eats grass and pasture and you make from scratch.

1:33:16

I mean, I made you a cup of coffee and I had to apologize.

I didn’t have sugar for you.

And also the chickens were clucking outside and I’m sure you you’re getting plenty of eggs yourself.

We’re getting terrific eggs.

They’re they’re very much loved.

Chickens have to admit, Hedley, thank you so much for coming out here.

1:33:32

It’s it’s been really nice chatting to you and it’s been kind of like depressing as well when you realize here we are in 2023 and the basics, the basics are so fundamentally wrong, you know the common sense has just been thrown out the window and the only thing.

1:33:49

That can make sense, is that there’s all this corruption and you know, problems that we’re seeing are just driven by greed and money.

And and that’s sad because you think with every passing year, you know, human beings as a species will have learned, have become wiser.

1:34:07

But we’re not.

It seems like we’re regressing.

We’re going backwards.

Yeah, everything cyclical I think in life and I I can see a return to more human values, you know the the type that we are used to and I’m just hoping it’ll come sooner rather than later.

1:34:29

On that note, we’ll end thank.

You so much, Hedley.

Everyone, thank you so much for listening.

Bye, my friend.

OK, you take care.

Bye.