Australian Doctor Australian Doctor 3rd November 2017 | Page 3

RACHEL WORSLEY
STEM cell researchers have
welcomed the TGA’s closure
of a regulatory loophole
that allows private clinics
to offer unproven stem cell
therapies.
From 2018, the TGA will
extend regulations to cover
treatments based on the use
of autologous stem cell ther-
apies.
Scores of private clinics
have been offering expen-
sive and unproven stem cell
injections for conditions
such as arthritis, as well as
for cosmetic use.
Until now, the procedures
have fallen outside of TGA
regulation because use of a
patient’s own cells is histori-
cally considered an exten-
sion of medical practice.
However,
after
two
rounds of public consulta-
tion, the TGA has opted to
implement the more strin-
gent of five suggested regu-
latory options.
This means regulations
will be introduced to govern
Instagram
Stem cell cowboy clinics to be reigned in
Israeli model Bar Rafaeli
undergoing a so-called
‘vampire facial’. Autologous
stem cell therapies are used
for this beauty treatment.
the use of autologous cell
and tissue products used by
doctors outside of a hospital.
Stem cells will be regu-
lated under the Biologicals
Regulatory Framework, but
use in accredited hospitals
will be exempt from regula-
tion.
The new measures also
include a ban on direct
advertising to patients for
autologous stem-cell proce-
dures.
Associate
Professor
Megan Munsie (PhD), who
heads Stem Cell Australia’s
education, ethics, law and
community awareness unit,
says she is hopeful the new
regulations will rein in the
Doctors urged to drop the jargon In Brief
MICHAEL WOODHEAD Staff writers
IF you’re telling patients you
can ‘alleviate’ pain or correct
their ‘deficiency’, you’re
using the wrong terminology,
according to a new campaign.
These are just a few of
the words on the Drop the
Jargon blacklist, which aims
to encourage the use of plain
English in healthcare settings.
Sixty per cent of patients
have poor health literacy,
according to the campaign,
run by a consortium of health
organisations in Victoria, which
DON’T SAY DO SAY
Progressive Get worse/better
Detrimental Harmful, damaging
Comply with Keep to
Notify Tell us
Option Choice
Attributable to Due to/caused by
is why it is urging doctors to
use simpler words.
These include replacing
‘alleviate’ with ‘ease’, ‘lack’
instead of ‘deficiency’ and
‘keep to’ instead of ‘comply’.
“When we use jargon,
technical terms or acronyms,
it is hard for people with low
health literacy to understand
and use information. Make
it easy for people with low
health literacy to get better
information and outcomes
from services they use,” the
campaign web page says.
Hundreds of doctors and
other healthcare staff pledged
to modify (change) their
behaviour and cease (stop)
their use of jargon on the latest
Drop the Jargon day of 24
October.
Many also volunteered their
own examples of jargon that
they would like to see retired
from general use in healthcare
settings.
Type 3 diabetes common, but often
misdiagnosed after chronic pancreatitis
RADA ROUSE
DIABETES secondary to
exocrine pancreas disease
such as chronic pancreatitis
is common and frequently
misdiagnosed as type 2
diabetes, a UK study shows.
Previously known as type
3c diabetes, pancreatogenic
diabetes has a higher
incidence in adults than
type 1 diabetes (1.8% vs
1.1%), according to the
study.
Pancreatogenic diabetes
was also associated with
poor glycaemic control
and more urgent need for
insulin, the study of 31,789
cases of incident adult-
onset diabetes found.
Only 3% of the 559 cases
of pancreatogenic diabetes
were correctly diagnosed,
with 88% classified as
type 2 diabetes and a

clinics that appear legitimate
but spruik unproven treat-
ments.
“With more than 70 Aus-
tralian clinics promoting
their ‘stem cell’ treatments
online, it is certainly time for
small proportion as type 1
diabetes.
Patients showed a
sevenfold increase in insulin
requirement within five
years, by which time 46%
were using insulin.
The more severe clinical
course of pancreatogenic
diabetes showed the need
to recognise it early, the
authors of the study said.
“Clinicians should elicit
whether a patient has any
history of pancreatic disease
when they first present with
diabetes and consider the
diagnosis of diabetes of the
exocrine pancreas,” they
suggested.
Doctors should also be
aware that incretins and
gliptins were contraindicated
in pancreatic damage, they
added.
“Diabetes of the
exocrine pancreas must be
appropriately recognised to
tailor management, including
choice of antihyperglycaemic
therapy, and consideration
of malabsorption requiring
pancreatic enzyme and
vitamin D prescription,” they
said.
a re-think on how this area is
regulated,” she told Austral-
ian Doctor.
The regulations should
encourage clinics to partici-
pate in clinical trials rather
than use experimental stem
cell treatments for commer-
cial benefit, she said.
“There needs to be appro-
priate safeguards in place to
protect patients from harm
and to ensure genuine efforts
to translate promising stem
cell research into clinical
benefit are supported,” said
Professor Munsie, a stem-
cell scientist at Melbourne
University.
Professor Melissa Little,
program leader of Stem Cells
Australia, said the group was
pleased to see the changes
announced by the TGA.
“This will bring our indus-
try in line with regulations in
place in many international
jurisdictions and safeguard
the vulnerable patient groups
from unproven and poten-
tially unsafe practices,” she
said.
GP banned from court
after 14 appeals
A FORMER GP has been
declared a vexatious litigant and
banned from the courts after
launching 14 separate appeals
against his deregistration. The
doctor, known as Dr Q, was
originally struck off in 2015 for
professional misconduct. His numerous battles against the
ruling were brought to an end by the Supreme Court of NSW
last week, when it ruled he should not be allowed to continue
any further legal action without special permission. The original
tribunal hearing into his conduct found he had a narcissistic
personality disorder and could not practise safely.
Paramedics come on board
with AHPRA
THE first Paramedicine Board of
Australia has been announced
as AHPRA prepares to start
registering paramedics from
late 2018. Paramedics will have
to register with the regulator in
order to practise and the term
‘paramedic’ will become a so-
called ‘protected title’, like doctor or pharmacist. Paramedics
Australia, the peak body representing the profession, has
supported the move to register Australia’s 13,000-plus
paramedics. The inaugural chair of the paramedicine board
will be Stephen Gough, assistant commissioner of the
Queensland Ambulance Service.
TGA tightens up rules on pelvic mesh
THE TGA will phase in more stringent rules for transvaginal
mesh products as part of a
wide-ranging overhaul in regulation of surgical mesh and
implantable medical devices. Minister for Health Greg Hunt
has signed off on a new regulatory framework that will require
all new surgical mesh devices, including urogynaecological
mesh devices, to meet the higher evidentiary standards of
a Class III medical device from December 2018 . The up-
classification rules apply to products already on the market,
which will be given a transition period of up to December 2020
for urogynaecological and 2021 for surgical mesh devices to
apply for re-classification.
Diabetes Care 2017; online.
www.australiandoctor.com.au
3 November 2017 | Australian Doctor |
3