Nature, Science & Human Nature

Galenisys Newsletter : November 2026

Table of Contents

• TALES FROM FARAWAY PHARMA: Targeted measures in Venezuela
  Targeted measures in Venezuela
  By Steve Biddulph

• SEE ……… IT’S EASY!
  Algae keep it simple
  By Tony Dunford

• THE PSYCHOLOGY BEHIND THE USE OF WEIGHT LOSS PRODUCTS
  “Should I” or “Shouldn’t I” be thinking about slimming drugs.
  By Richard van Duyse

• SAFEGUARDING YOUR ALLNIGHT IBOGA SESSIONS
  Donald Trump's pals are coming for your Iboga root.
  By Tony Dunford

TALES FROM FARAWAY PHARMA: Targeted measures in Venezuela

by Steve Biddulph

Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.

Targeted measures in Venezuela

Some years my Quality Assurance responsibilities Included auditing various companies in Latin America.

In Venezuela these included the need to order audit a plant handling our active product ingredients (“APIs”), product storage and distribution, and the site's infrastructure and quality systems.

I arrived at the warehouse early in the morning and the introductions with the local staff, included some good coffee.

The agenda started with a review of how goods were received and checked. The best that can be said of this was that it was a “passive system” ie it assumed everything was OK for quantities, identity, cleanliness etc unless a note had been made in the records. I explained the need for recording all actions in the QA system to show that a review of these criteria had in fact taken place.

We then walked round the storage areas which in which there was good segregation of the different materials and batches, and protecting the of these materials by covering every pallet with a large plastic bag. Material locations were checked and found to be correct.

The stores were clean with no evidence of pest infestation. I reviewed the pest control programme, sites, and monitoring records which pleasingly showed that the third party pest control company maintained thorough records.
However, as we were finishing, I heard bird song and looking up to the roof above the 6 pallets high storage racking, I could make out a group of pigeons that had arrived.

“How did they get in?” I asked. The supervisor replied that a gap of 50cm is left between the top of the walls & the roof so that the warehouse does not overheat during the (very) hot daytime outside temperatures.

“Can’t you stop the pigeons from entering by using grills on top of the walls?” I asked. “No need” he replied, “I’ll show you what we do”. He went into his office and came out with a 0.22 carabine and started to fire at the pigeons, which departed in a cloud of feathers.

But what was it like on top of the pallets? There was nothing for it other than climb up to the top of the walks for an inspection.

Rotting pigein bodies were everywhere! And the roof was also full of holes thanks to the 0.22 bullets. It was now around 14:00 hours and the daily tropical rainfall arrived and promptly fell onto the goods stores being stored.

I suddenly understood why all the pallets were covered with large plastic bags!......... and later had no difficulty making formal recommendations.

Steve Biddulph

SEE ……… IT’S EASY!

Algae keep it simple

By Tony Dunford

If this summer you travelled to Lake Windermere in one of UK’s national parks, hoping to catch sight of Wordsworth’s “host of golden daffodils” your gaze might instead have switched to an algal bloom which had been turning the beauty spot an unwelcome green in parts.

To be sure algal bloom algal blooms crop up in many parts of the world & can grow at a remarkable rate in suitable conditions, discolouring the water, even poisoning or asphyxiating other life forms.

However, generally algae are very useful. Our industry uses agar (derived from red algae) as it's a good medium on which to grow bacteria and fungi. Alginic acid, or alginate, from brown algae, is a gelling agent used for medical dressings etc, & as a biocompatible medium for cell encapsulation, and cell immobilization.

The word algae covers a large and diverse group of organisms possessing photosynthetic machinery, and most algae are single cell organisms.

Keep it simple stupid
In the 1990s one of these single cell algae, Chlamydomonas, was being studied by a Dr Hegeman. He found it’s reaction to the way it responds to light, was faster than the equivalent response in the human eye. Our retina has a protein molecule which detects light and then indirectly triggers another known as an “ion channel”, to create an electrical signal. Dr Hegeman figured that Chlamydomonas had a simpler method.

Working out how was hard at the time, but later a team of Japanese researchers mapped the DNA of the Chlamydomonas finding it included two genes similar to those in light sensitive proteins in some other organisms.

I’ll swop you this gene for that ……
With the help of a Dr Nagel, they worked on a series of gene editing experiments and found a way of making mammal cells light sensitive. Further collaboration was with a Dr Deisseroth, who conceived the idea of putting a protein into which one of these Chlamydomonas genes had been inserted, into neurons, ie the cells whose job is the transmission of electrical signals. They showed that cultured rat neurons responded to light & could pass signals to other neurons.

“…laying the foundations of optogenetics…”
This year the three researchers were recognised with the award of the Nobel Prize for Medicine for “laying the foundations of optogenetics”. This field of research has hugely increased in importance in recent years, after other foundational research by teams at the Sloan-Kettering Cancer Centre in New York, and Stanford.

In continued research Dr Deisseroth’s lab used extremely thin optical fibres to illuminate, and so stimulate, groups of neurons, & then found that they could control certain rodent movements.

There are now 1000s of papers on optogenetics describing how it's being employed in animal research on a whole range of illnesses, depression schizophrenia, deafness, dementia, anxiety, & addiction. And there's an ambitious attempt to restore vision in people with a form of blindness called retinitis pigmentosa.

“Blooming marvellous!”

Tony Dunford

THE PSYCHOLOGY BEHIND THE USE OF WEIGHT LOSS PRODUCTS

“Should I” or “Shouldn’t I” be thinking about slimming drugs

By Richard van Duyse

Experienced international vaccine industry consultant. Specialized in project & operational management, facility design, start-ups, & technology transfers. Bachelor of Applied Science (B.Sc.).

GLP-1 (glucagon-like peptide-1) is a naturally occurring hormone that suppresses appetite, stimulates insulin, and regulates blood sugar levels. Medications that mimic this GLP-1 agonists such as Ozempic or Wegovy are used for type 2 diabetes and severe obesity. In our September Newsletter I wrote about how these drugs are reshaping the pharmaceutical industry.
This month article reflects on the patient psychology behind the use of these products.

The decision to start or to stop GLP-1 therapy (such as semaglutide or tirzepatide) is determined not only by physical factors but also by psychological ones, which often play a major role in how a person experiences eating, weight, and health. For both medical and psychological reasons, decisions on therapy should take place in consultation with a doctor.

Starting
There are good psychological reasons, and motivation for the patient to start weight loss therapy:
• To end the patient’s fatigue from years of dieting
• To lessen mental stress about food intake
• The chance to prevent weight-related illnesses
• The improvement in self-image and self-confidence
• The greater sense of personal control

Stopping

The psychological reasons for stopping after a period include:
• The feeling that the goal has been achieved
• The desire to be independent of medication
• The experience of side effects.
• The costs or hassle of treatment.
• Changed identity
• Psychological fatigue

But what happens psychologically after stopping?
Many people experience a return of appetite, more thoughts about food and the feeling that it becomes more difficult to control portion sizes, after ceasing medication.

That can be discouraging. It does not automatically mean that someone lacks willpower. After all, medication also affects the biological systems that regulate hunger and satiety. When the medication stops, those effects diminish, and old eating patterns can return more easily.

When can stopping be a good choice?
Stopping may be appropriate if:
• the treatment goals have been achieved, and the person has developed sustainable lifestyle changes
• the side effects or costs no longer outweigh the benefits
• there are medical reasons to stop
Ceasing should be done in consultation with the treating physician, preferably with a plan to continue monitoring diet, exercise, and weight.

In summary
From a psychological perspective, GLP-1 (weight loss) therapy is often more than just a means to lose weight. It can reduce the ongoing mental struggle about food and help people regain a sense of control. Quitting often occurs out of a desire for autonomy, satisfaction with the result, or for practical and medical reasons.

At the same time, it is important to realize that the biological mechanisms regulating hunger usually become more active again after stopping, meaning that long-term weight maintenance remains a challenge for many people. Therefore, it is sensible to create a plan for the period afterward together with a healthcare provider before stopping.

Richard van Duyse

SAFEGUARDING YOUR ALLNIGHT IBOGA SESSIONS

Donald Trump's pals are coming for your iboga root.

By Tony Dunford

After Venezuelan oil, and Greenland's rare earths, getting hold of enough Iboga root used in Gabon's ritual traditions should be pretty easy.

On one side of the tug of war for iboga is one of ibogaine’s most visible political champions, the former Texas Governor republican Rick Perry. Texas has granted $50m (£38m) for a multicentre trial, and on 18 April, Donald Trump signed an executive order specifically naming “ibogaine compounds” and directing federal agencies to create a treatment pathway for eligible patients. (That’s a similar sweetheart deal to that we reported in April about John F Kennedy Jnr head of US healthcare fast-tracking peptide preparations).

On the other side are those involved - nay “rooted” - in Gabonese ritual traditions. Typical is a night long candle lit session in a “temple” full of folk swallowing the bitter Iboga root bark. It comes from a slow growing Central African rainforest shrub Tabernanthe iboga that has long been cultivated & consumed in the villages. It's root bark continues to be used in several Gabonese ritual traditions. It’s sometimes gathered from wild populations.

In the “Bwiti” or “Bwété” spiritual tradition, Iboga is used in “Misoko Bwiti” concerned with healing and divination. The all-night ceremony called “Mubindu” is “a way of lifting the burden carried by relatives and friends after a death”.

A practitioner says and “Misoko is like a microscope to see clearly about details in the life of someone….” it can “restructure a person and resolve what ordinary medicine cannot”. (Difficult to include this in a clinical trial). The knowledge & practice is passed down from generation to generation verbally.

In this competition for resources there's a sharp contrast of cultures:

• Whereas Yann Guignon, an intercultural and sustainable development consultant and President of NGO “Blessings of the Forest”, records practitioners describing wild iboga as something that must be considered in relation to the whole forest, including by following animals that eat the fruit…….

• “Beond”, a clinic in Cancún, lists Ibogaine programmes costing from $13,500 to $19,500.

• On the outskirts of Gabon’s capital stands “Maman Djédjé’s” temple whose entrance is guarded by a painted mermaid. She grows iboga plants & specialises in another traditional vigil concerned with rebirth and restoration using small amounts of iboga mixed with another plant.

• In a small uncontrolled study 30 US army veterans mostly with “mild traumatic brain injury”, received ibogaine plus magnesium. Average PTSD, depression & anxiety scores were reported at least 81% less after 1 month, while disability scores improved. Pharma companies have taken a keen interest, with Ibogaine (from Iboga root) viewed as a potential API, for addiction treatment. Early observational studies report sharp reductions in opioid withdrawal and craving after a single treatment.

The “Western” and African demand for iboga has pushed up prices - “money is the root of all evil” - & too many are taking the whole shrub out - so killing it - without replanting. Small amounts of bark are normally removed without uprooting the shrub.
For an important potential API, wild iboga is “rare and poorly studied”. Local officials found evidence of severe local over-harvesting in some areas but can’t find funding for a study of distribution and genetic variation.

Ibogaine can also be made semi-synthetically from voacangine, found in the related African tree Voacanga africana. But the iboga root bark is particularly in demand for ceremonial use, and for the manufacture of extracts containing several of its alkaloids.

Gabon's government has moved to protect its cultural and financial interests, recognising iboga traditional knowledge, as national heritage. It now requires benefit-sharing in return for commercial use.

Iboga related patent applications now must disclose the product origin.
The decree creates an iboga sovereign fund, funded by royalties or benefit-sharing agreements.

And this autumn it prohibited the export of Iboga and every derivative, in any form, “…to protect the plant and the cultural knowledge attached to it”.

Tony Dunford