The Times - UK (2022-02-03)

the times | Thursday February 3 2022 2GM 5

News

beautician and contacted two compa-

nies asking to buy the product. The

companies, both based in Britain, of-

fered to sell it with no questions asked.

They included Shafaa Pharmacy

Limited. I inquired about Botulax and

asked a handler if I had to show identifi-

cation to buy it. He said that I would be

able to order it and receive it the next day.

A leading cosmetic doctor said that

to offer 22 injections in the forehead

face to face. They must ensure that the

person is suitable for treatment and un-

derstands the expected outcome. It is

difficult for experts to assess the correct

doses of substances that are unlicensed

for use in the UK and have not been

through safety checks.

Esho said that he recently saw a

woman with lumps in her forehead

after being injected with an unknown

product. He said that he had seen more

of these cases over the past five years.

The Medicines and Healthcare Prod-

ucts Regulatory Agency has begun an

investigation into our findings and said

that it would “take appropriate regula-

tory action where any non-compliance

is identified”.

Karklins and Walker did not respond

to requests for comment. Bennett said

she was not aware she had been using

unlicensed products. “I’ve done noth-

ing wrong,” she said. “I wasn’t aware

that you’re not supposed to use this.”

Shafaa Pharmacy Limited said that it

was a licensed pharmacy and had “the

right to sell Botulax”. Hugel, which

manufactures Botulax, said that the

product had undergone rigorous clini-

cal trials and was licensed for use in 28

countries but it should not be ordered

or used by practitioners in Britain.

Pharma Research Bio, which manu-

factures ReNTox, did not respond to re-

quests for comment. Medytox, which

manufactures Innotox, said it did not

sell the product where it is not licensed,

including in the UK.

Have you had botulinum toxin

injections? Share your experiences

through [email protected]

A danger to public health,

leading article, page 29

“seems excessive”. Dr Tijion Esho, who

carries out corrective work on victims

of botched treatment, said that there

were differences between botulinum

toxin brands. Calculations of how

many units might be needed varied

with how a product was diluted.

But Esho said that “22 injections in

the forehead, I would find excessive”.

To properly assess someone’s suitabili-

ty for Botox, a doctor must see a patient

Still no regulation nine

years after danger spotted

Paul Morgan-Bentley

Charlotte Wace

A review commissioned by the govern-

ment warned in 2013 that non-surgical

cosmetic treatments, such as lip fillers

and Botox injections, were “almost en-

tirely unregulated” in Britain.

Sir Bruce Keogh, the NHS medical

director at the time, led the review and

wrote of his surprise at the lack of legal

protections given the “major and irre-

versible adverse impacts on health”. He

added: “A person having a non-surgical

cosmetic intervention has no more

protection and redress than someone

buying a ballpoint pen or a toothbrush.”

Nine years later experts warn that

there is still a “complete absence of reg-

ulation”, which puts vulnerable people

at serious risk of harm.

There have been some changes, most

notably a law making it illegal to per-

form these injections on under-18s,

which came into force last year. How-

ever, as an investigation by The Times

reveals today, practitioners with no

formal medical qualifications are still

able to administer the injections, with

some using unlicensed drugs that have

not been checked for safety in Britain.

Campaigners warned of increasing

reports of botched treatments, with

some women scarred for life. “Black

market Botox” is booming because un-

licensed products can easily be ordered

online, allowing practitioners to offer

treatments on the cheap and bypass the

legal prescribing process.

It is an offence to supply, or offer to

sell or supply, an unauthorised medici-

nal product, such as the brands of un-

licensed botulinum toxin we found

being used. A person found guilty could

face up to two years in prison.

Licensed brands of botulinum toxin,

of which the best known is Botox, are

only meant to be administered after a

prescription is given by someone

licensed to do so, such as a doctor, after

a face-to-face appointment. But report-

ers found that this was not enforced.

Manufacturers of products that are

not licensed said if they appear to be on

sale in the UK the product in the vials

may well be counterfeit. It is impossible

to know what is being injected into un-

suspecting young people’s faces.

A report published last year after a

year-long inquiry into non-surgical

cosmetic treatments identified many of

the same issues found by Keogh. The

all-party parliamentary group on

beauty, aesthetics and wellbeing

announced its findings in July with a

press release titled: “MPs call on gov-

ernment to address complete absence

of regulation over botox and fillers”.

In light of our findings, Sajid Javid,

the health secretary, said officials were

investigating what changes were

needed “to ensure no one is harmed”.

with a registered

prescriber before the

treatment last

summer, in northwest

England. During the

appointment she

became concerned

because a needle was

left on a counter while

the practitioner took a

telephone call. Baby

wipes were used

instead of the sterile

wipes she had

expected. She asked

what product was used

and believed she was

initially told it was

Botulax, which is not

registered for use in

Britain, but the

practitioner later told

her it was a licensed

product.

Elizabeth, who is a

care professional and

asked not to have her

and later paid to see a

private dermatologist

who gave her stronger

medicine. There were

13 lumps initially and

two are still left. It is

hoped that her face

will heal over time but

it has damaged her

self-confidence.

“I have to go to

work, otherwise I’d

have no home,”

Elizabeth said. “But I

don’t go out

socialising. My life

revolves around either

my job, my

grandchildren or one

or two friends coming

to the house. I used to

always go out but now

I won’t. I got fed up

with people saying,

‘what did you do with

your face, it looks like

you were beaten up’.”

real name published,

said soon after the

treatment she began

experiencing pain in

her face and could feel

tiny lumps forming.

The practitioner

repeatedly advised her

to drink water.

“The lumps on my

forehead were hard,

they burst and it was

like black stuff coming

out of them”, she said.

The pain grew so bad

that Elizabeth went to

a walk-in centre where

a doctor asked if she

had been “beaten up”.

She was sent to

hospital and recalled a

nurse saying she had

never seen that type of

reaction from anti-

wrinkle treatments

before. Elizabeth was

prescribed antibiotics

News

media, no prescription required

wrinkle injections.

Medical products

that are not

prescription-only

cannot be advertised

unless a marketing

licence is in force.

But references to

unlicensed botulinum

toxin products such as

Botulax also feature

on social-media posts.

It is feared that

some practitioners

using unlicensed

products fail to state

they are doing so and

clients may not know

what is used. The

Times found instances

where unlicensed and

licensed products

were being marketed

to injectors on social

media.

An official for Meta,

Facebook’s owner,

said: “We do not allow

the sale of

pharmaceutical drugs

on Facebook and

remove this content.

“For posts

attempting to

promote or sell

cosmetic procedures,

we restrict content to

people over 18.

“We urge people to

report anything they

think doesn’t belong

on our platform, so

our teams can review

it and take action.”

They said they had

removed the page

brought to their

attention by The

Times.

Approved options

cannot compete

T

reatments

using

licensed and

unlicensed

brands of

botulinum toxin are

being freely marketed

by cosmetic

practitioners on social

media sites such as

Facebook (Charlotte

Wace writes).

Botox and other

licensed brands in the

UK are prescription-

only medicines and it

is unlawful for them

to be advertised to the

public. This extends

to social media and

websites as well as

paid-for

advertisements and

non-paid-for

marketing posts or

communications,

according to the

Medicines and

Healthcare Products

Regulatory Agency.

References in

images and hashtags

using terms such as

“botox” are also

banned. But these

rules are often

ignored and

practitioners use

hashtags with brand

names to market anti-

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