29th November 2018

Micro-Dosing and the Pharmaceutical Industry

Are we experiencing a role reversal of drugs within the Pharmaceutical industry? 

There has been a steady increase in the number of studies into the use of drugs such as Cannabis, Psilocybin (a psychedelic compound commonly found in mushrooms) and most recently LSD and how with micro dosing, these drugs can have a positive impact on the human body and brain.

 

What is micro- dosing?

Micro dosing is a technique used for studying how a drug behaves when administered into the human body. Doses of the administered drug are designed to be so low that they are unlikely to produce effects on the whole-body, but high enough to allow the cellular response to be studied. [i]

 

How does this impact the Pharmaceutical industry?

The Beckley Foundation, which was set up to pioneer research into mind-altering substances, and the unit it funds at Imperial College London, launched the first ever placebo-controlled trial of micro dosing LSD on Monday, 3rd September 2018.

Very recently they progressed past what is called Phase 0 (e.g., 1% or 100 micrograms of the pharmacological dose is injected into humans to evaluate pharmacokinetics and drug metabolism before a new compound enters Phase I trials)

The cost and the illegality of LSD would make a conventional study prohibitively expensive, so the decision was made to invite those who already micro dose to join a “self-blinded” study. They will take either what they usually use in a capsule or an identical dummy capsule instead, without knowing which one is which. They will complete questionnaires and tests and play cognitive games online, and only at the end will they learn whether they were happy and focused because of LSD or because they thought they were using LSD.

Balázs Szigeti, the study leader has commented that “The people who micro dose right now are not an average random set of people from the street,” he added. “They are very likely to have used psychedelics before and have preconceptions about them.”

“You are doing something novel and exciting and that you believe in – and you know you are doing it. It is absolutely no surprise that you are getting a positive effect.” [ii] However it is important to have consolidated data to understand this further.

A study by Frost & Sullivan, Strategic Analysis of Opportunities in the CRO Market – Phase 0, notes the increasing acceptance of micro dosing and suggests it may be the antidote to industry’s much-discussed problems with drug productivity.

“There is every reason to believe that the solution for faster screening of candidates and increasing pressure on costs is gaining momentum in the right direction,” said senior research analyst V. Sriram. “The compelling advantages of micro dosing present it as a potential remedy for big pharma’s maladies regarding declining returns from investments in drug development.”

Developments in micro dosing should also create new opportunities for contract research organisations (CROs), Frost & Sullivan believes. Historically, alliances between CROs in the US and Europe have been thin on the ground, it notes, putting this down to strong growth and relatively low technology demands for clinical testing.

However, consolidation among CROs has raised concerns about the quality of service and attention to detail in the sector. Companies need to ensure these elements are in place if they are to maintain their bargaining power with the pharmaceutical industry.

“CROs face the challenge of competitively aligning their services to meet customer needs in order to overcome the threat of losing their stronghold and loyalty,” Sriram commented. [iii]

 

Is Micro dosing a recent interest?

LSD has been used  on human experiments  since the 1950’s.

Project MKUltra which was also called the CIA mind control program, was a program of experiments on human subjects  and was designed and undertaken by the CIA.These human experiments were intended to identify and develop drugs and procedures to be used in interrogations in order to weaken the individual and force confessions through mind control.

They used numerous methods to manipulate people’s mental states and alter brain functions, including the surreptitious administration of drugs (especially LSD) and other chemicals, hypnosissensory deprivation, isolation, verbal and sexual abuse (including the sexual abuse of children), and other forms of torture.

The scope of Project MKUltra was broad with research undertaken at 80 institutions, including colleges and universities, hospitals, prisons, and pharmaceutical companies. The CIA operated through these institutions using front organizations, although sometimes top officials at these institutions were aware of the CIA’s involvement. In one case, they administered LSD to a mental patient in Kentucky for 174 days.

Adverse reactions often occurred, such as an operative who received the drug in his morning coffee, became psychotic and ran across Washington, seeing a monster in every car passing him. The experiments continued even after Dr. Frank Olson, an Army scientist who had not taken LSD before, went into deep depression after a surprise trip and later fell from a thirteenth story window.[iv]

 

Is Micro- dosing a therapeutic intervention or a health enhancement? [v]

The differences being:

  • A therapeutic intervention will restore normal or typical functioning with the aim of returning an unhealthy person back to a healthy state.
  • An enhancement will improve or extend the abilities or capacities of a healthy individual (who is already functioning normally) outside of this normal or typical range.

The initial benefits of micro-dosing psychedelic drugs are listed as:

  • Heightened creativity
  • Greater sense of presence
  • Heightened awareness
  • Increased productivity
  • Reduction in anxiety

Heightened creativity is one of the major factors why micro-dosing has become increasingly popular in the Silicon Valley for many within the Advertising, Artistic, Tech and Digital start- up industries as it’s been widely reported that it can enable parts of the brain that have never communicated with one other before.  Combining this creativity with the ability to still fully function within the workplace has become somewhat of a trend. [vi]

But it’s the reduction in stress and anxiety levels and how it may affect those suffering with depression that The Beckley Foundation and Imperial College London are seeking evidence-based answers on.

 

Micro dosing for breakfast

Last year the BBC aired a documentary discussing the therapeutic benefits of a select number of people. For example, in this documentary, 28-year-old male Simpa was micro dosing daily for therapeutic purposes. Living with quite severe mental health problems – “depression and anxiety as a result of childhood trauma, that led to borderline personality disorder and PTSD”, Simpa said the prescription medication he had previously been given resulted in more side-effects than benefits. He said “I’ve found that these substances, psychedelics, give me the benefits without any of those drawbacks. Me using these substances means I’ve been able to view my trauma so that it’s just an experience, a memory like any other.”

Dr James Fadiman, who has been researching psychedelics since the 1960s, runs a website on micro dosing where he asks people to report back to him about their experiences. So far, over 900 people responded.

“The most consistent result is people saying, ‘My life seems to be working better.’ [They are] more effective, their sleeping habits improve, their eating habits improve, they feel better in social situations.”

“Anna”, who lives in the UK, says she has tried micro dosing in the past, both with LSD and more recently with magic mushrooms picked from the hills near where she lives with her two children.She says the experience wasn’t very dramatic, but on the days she micro dosed she felt more productive.“It’s just like having a slightly better quality of life.”[vii]

 

We’ve seen a recent shift in the use of other previously prohibited or frowned upon drugs such as cannabis (GW Pharmaceuticals) and Psychedelics (COMPASS Pathways) being brought into the pharmaceutical industry and this is just another example. However with such an unregulated response – is this something we expect to have a real impact into the Pharmaceutical industry?

 

By Rachael Parker

Rachael joined Skills Alliance in 2016 and possesses over 6 years’ of contract and permanent recruitment experience. Having successfully setup our Healthcare Communications offering, she now leads the UK Contract Team with a specific focus on senior Commercial, Communications and Market Access appointments.

Sources:

[i] https://en.wikipedia.org/wiki/Microdosing

[ii] https://www.theguardian.com/science/2018/sep/01/first-ever-trials-on-the-effects-of-microdosing-lsd-set-to-begin

[iii] http://www.pharmatimes.com/news/microdosing_could_be_a_winwin_for_pharma,_cros_985498

[iv] https://en.wikipedia.org/wiki/Project_MKUltra

[v] http://journals.sagepub.com/doi/full/10.1177/1455072517753339#

[vi] https://artplusmarketing.com/the-cognitive-benefits-of-microdosing-psychedelics-599c5b5f7d98

[vii] https://www.bbc.co.uk/news/health-39516345

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