USE OF THE DRUG
Thalidomide UK would like to
the drug banned for the treatment of leprosy and in countries
were the drug cannot be controlled or monitored.
We Do Not
want the drug banned in countries where the pharmaceutical
suppliers have involved European thalidomide survivors groups
with the guidelines. Thalidomide UK believes that we should work
towards licensing the drug, which would prevent it being easily
available over the internet and would stop pharmaceutical
companies supplying the drug with the side effect warnings being
displayed on a little piece of paper that includes small print.
backs return of banned
Europe's drug regulators
approved licensed for thalidomide to treat bone marrow cancer,
nearly 50 years after the medicine was withdrawn as a treatment
for morning sickness around the world because it caused
thousands of children to be born with birth defects.
The European medicines agency
granted authorisation for the medicine to be used to treat
multiple myeloma in combination with other drugs, on condition
that it was strictly controlled to avoid it being taken by
The decision follows extensive
consultation including with a number of European associations of
thalidomiders, who ultimately endorsed the approval after
agreeing to strict safeguards.
It comes at a time when hundreds
of the children born with defects caused by use of the drug are
launching a campaign to boost compensation by governments and
from Grünenthal, the German drug company that developed it in
The news marks a boost for
Pharmion, the US pharmaceutical company that has researched new
uses for the drug in recent years, and which has already won
approval in the US, Australia and other international markets.
The decision was particularly
sensitive in Europe, since the drug was developed and most
extensively marketed there.
It will be a blow to several
smaller manufacturers of the drug in Europe, which could be
legally prescribed on a case-by-case basis by doctors. Only
Pharmion will be allowed to sell it in the EU following the
The governments of a number of
EU countries with large numbers of victims, including Italy,
have always refused to offer compensation, while Germany offers
only modest monthly allowances.
Article : Jan 25, 2008
thalidomide UK warns that the
new licence for Thalidomide
in Europe must be strictly policed.
of Thalidomide UK (48,born without arms or legs) commented
on the licensing of thalidomide by the EMEA (European
Medical Evaluation Agency) today.
been working with the EMEA for more than five years to make
sure that thalidomide should only be available through an
access system the PPP (pregnancy prevention programme),
which monitors the distribution of every pill, demands that
women of childbearing age follow a strict contraception
programme and ensures that regular pregnancy test will be
Thalidomide, which is now licensed for Multiple Myeloma, is
now being used in a variety of conditions and up until today
was being distributed by many pharmaceutical companies, with
little or no precautions to prevent a thalidomide child
continued,” More than seven thalidomide groups across
Europe, plus Multiple Myeloma patient groups worked together
to achieve this result. However, our work is not finished.
We will be working hard with our sister groups across Europe
to ensure that every thalidomide pill prescribed in Europe
goes through the PPP being run by the licence holder Celgene”.
also be meeting with the regulatory authorities in each
country to make sure they police the PPP one hundred
percent. Furthermore, we will be implementing an education
programme to young doctors and pharmacists into the dangers
of thalidomide. Many of the younger generation have not
heard of Thalidomide or know it under a different name
(there were many different brand names used in different
places) or come from countries where it was never an issue.”
who is presently the only licence holder in Europe will be
responsible for the implementation of the PPP for any pills
sold by themselves. All other manufacturers and
distributors of thalidomide cannot now supply thalidomide in
any form across the EU. If they wish to do they must apply
for a licence and put in place the procedures to adhere to
Astbury has warned that Thalidomide UK would hold the
European Medicines Evaluation Agency (EMEA), each country’s
medicine control board, the medical establishment and the
pharmaceutical company that holds the licence fully
responsible if mistakes are made due to the misuse of the
Harrison, chairman of Thalidomide UK stated. “The US
started this process with its implementation of the STEPS
programme (similar to the PPP), which has now been run
successfully by Celgene for many years without a thalidomide
baby being born. Now having Europe on board we intend to
move on to other countries such as Brazil, where thalidomide
damaged babies are still being born.”
even with the programmes in place in the USA and Europe, we
recognise that we cannot eliminate the possibility of
thalidomide babies being born. What we can do is
dramatically reduce the chance of this happening.
Thalidomide UK and our sister organisations will do
everything in our power to ensure that the best possible
precautions are in place, enforced and that doctors and
pharmacists are aware of the terrible damage that we as
thalidomide people have suffered.”
ENQUIRIES TEL 0151 222 1814
Presidents Report Freddie Astbury
‘The Drug that Came Back to Haunt Us’
last five years Thalidomide UK has worked tirelessly to
reduce the chances of babies being born with missing limbs
and internal deformities.
started before Thalidomide UK was setup back in 1993 on 1st
June when a Yorkshire TV documentary ‘First Tuesday’
highlighted that the drug Thalidomide was still being used,
thirty five years after the drug was invented in West
Germany by Chemie Grunenthal. The programme confirmed that
Thalidomide babies where still being born in Brazil with
severe deformities, due to their mothers taking the drug
whilst pregnant. The women were taking the drug because it
seemed to help in the treatment of leprosy. Sadly, many
Brazilians could not read or write so even the symbol on the
medicine box was misleading.
programme also highlighted that the drug was being
prescribed for Bechit Syndrome and blood cancer at Queens
Medicines Hospital in Nottingham. The drug was prescribed on
Named Basis Only, however the UK were voluntary.
number of Thalidomide people who themselves had been damaged
by the drug in the late 50s and early 60s were shocked and
angry that the drug was still being used and unregulated.
These people born with missing limbs due to the drug started
a group named The Thalidomide Association. The group’s
original aim was to call on a ban on the use of the drug
soon got public attention through the media, which
highlighted the campaign to ban this evil drug. However the
patients who were being prescribed Thalidomide fought back,
saying the drug was a wonder drug to them. In 1994 the
campaigners were invited to appear on a chat show ‘The Time
the Place’ when one of the campaigners who herself was a
mother was asked, ‘if your child had leukaemia would you let
your child take the drug if it helped her?’. The campaigner
struggled to answer the question. The campaigners were also
introduced to a couple of young children who had cancer.
shortly afterwards ended their call for a ban on the drug
In 1993 I
founded Thalidomide UK and our aim was to campaign for
further monies for Thalidomide people who were born in the
50s and 60s.
In 2003 the
world was shocked when BBC’s Horizon ‘A Second Chance’
showed that women were still being prescribed the drug
whilst pregnant. The doctor said that he had researched the
history of the drug and found that the drug only affected
the foetus. However the doctor had failed to notice that
there was no scientific evidence to back up the research.
Thalidomide UK reported the doctor to the
Medicines and Healthcare products Regulatory Agency (MHRA),
which is the government agency who is responsible for
ensuring that medicines and medical devices work, and are
realised that we would be asked the question whether
‘Thalidomide should be used’.
wanted to be drawn into this discussion I wanted to look
back at the history of the question and to get feedback from
other Thalidomide people who were involved in the campaign.
It soon became clear that we could NOT call for a ban,
because I did not want Thalidomide UK to end up in the same
situation as our predecessors. However we did not want to
ignore the question. We were also aware that there had been
moves from an American pharmaceutical company ‘Pharmion’ to
apply for European license for the drug Thalidomide, but
this time to treat Myeloma.
We made the
decision that we would never support the use of Thalidomide
and we would force ourselves to make sure that the drug was
strictly controlled, even if we had to help with the
guidelines. We contacted the EMEA who was responsible on
whether Thalidomide should be licensed in Europe. We agreed
to have a number of meetings to discuss the issue as to
whether the proposed guidelines could be improved and also
look at the idea of setting up a working party, which would
consist of European Thalidomide and patient groups. We soon
discovered that although we knew that there was Thalidomide
groups from the UK, Germany and Sweden we did not know about
other groups throughout Europe. It was agreed with our group
and Sweden that we would research the matter.
It was as
result of Thalidomide UK and the Swedish equivalent the FfdN
that other countries were added i.e. Spain, Italy, Ireland,
Belgium, Norway. There was also others included. We then
setup a working party to improve the guidelines which were
based on the STEPS Programme in the U.S.
while I was working on the working party I discovered that
the proposed guidelines could be floored, so I personally
put them to the test.
the call centre of Pharmion and ordered Thalidomide in which
I professed to be a doctor. I then managed to purchase the
drug Thalidomide incredibly easily, which I then reported
back to the EMEA.
years we have tried to improve the previous guidelines and
although it will not stop anymore babies from being damaged,
it will reduce the chances of the drug being misused.
Thalidomide is not a cure, but may prolong life.
involved including Thalidomide UK knows that there are still
some Thalidomide people who still want the drug banned and
it is very important that we respect these thalidomide
Thalidomide UK had listened to the patients who are dying in
many cases of various types of blood cancers. We recognised
that even if we had called for a ban, we would have been
ignored this is why we followed this route, which was to
protect the unborn.
asked to be in this situation, however we have all tried to
do our best for all involved and I and Thalidomide UK will
continue to work with the EMEA, Individual European
Medicines in Europe and the license holders, which should
reduce anymore babies being damaged by the drug Thalidomide,
Revlimid and other similar medicines.
The Drug 'Thalidomide' Today
Thalidomide Is Back
made a comeback in treating illnesses and some patients even
today describe it has a wonder drug. This Page looks at all
the issues regarding the use of the drug today, including
should thalidomide be licensed in Europe. We study the
side-effects and the views of the medical world on whether
thalidomide is safe to use?
UK 'Advisory Group' Buys The
obtained the drug Pharmion have changed there procedures)
Asbury (President) 'holding the drug thalidomide'.
information regarding this subject please view The Drug
Today 'Thalidomide UK Views
[file:///N:/Thalidomide UK Consultancy Agency 2012/public/photogallery/photo00019558/real.htm]
Drug Thalidomide Is Not Ready To
Be Licensed In
& Patient Groups have told the (EMEA) European union that
the drug thalidomide should not be granted a license by
Pharmion, under its current application.
believe that the current guidelines (Pharmion Risk
Management Programme) needed to restructured.
Astbury (Thalidomide UK) said; we have much work to do to
stop anymore babies being damaged as a result of the drug
thalidomide. We are not against the from being licensed
under very strict guidelines.
EMEA could ignore the advice given by the groups and the
drug could be licensed in Europe in June or July 2004.
Agency for the Evaluation of Medicinal Products
medicines are put on the market in the EU, it has to be
evaluated on the basis of quality, safety and efficacy and
demonstrate a favourable benefit/risk profile.
Advisory Group Of Victims’ And Patients’ Organisation On
Thalidomide Group Representatives and Procedures.
various illnesses and diseases that the drug thalidomide is
used for today.
from Brazil suffers from leprosy she was prescribed
thalidomide. View the results before and after the drug
thalidomide was taken.
[file:///N:/Thalidomide UK Consultancy Agency 2012/public/photogallery/photo00023646/real.htm]
[file:///N:/Thalidomide UK Consultancy Agency 2012/public/photogallery/photo00027982/real.htm]
mother had leprosy and took the drug while she was pregnant.
The warning that came with the tablets thalidomide were in
English. This child was born with thalidomide damages born
in the 90s - The New Generation
[file:///N:/Thalidomide UK Consultancy Agency 2012/public/photogallery/photo00000481/real.htm]
In the 90s
they were many Brazilian children born with deformed limbs
as a result of their mothers taking thalidomide.
still being born with thalidomide damages? Who Knows
The views of
thalidomide and patient group do vary in the current use of
advice patients regarding the use of thalidomide and include
website links to patient groups using thalidomide. We also
give advise to patients currently using the drug.
In the case
of leprosy it is the cheapest drug to make and this is why
it’s popular in third world countries. We are all aware that
the drug must not be taken during pregnancy, because of
harming the foetus. However they is another side effect
which is often over looked ‘peripheral neuritis’, which is a
very serous side effect and cannot be detected in leprosy
treatment, because this particular disease also affects the
World Health Organisation on whether the drug thalidomide
should be used today?
'Male Patients. - New research has shown that thalidomide
does exists in semen, which was not known in the 60s.
Pharmaceutical Journal Ref: Use of Thalidomide
Orphan Product 2004
Treatment of myelodysplastic syndromes
1/29/2004 Summit NJ 07901
May Prove Beneficial for
A large clinical trial testing the
effectiveness of a new anti-cancer drug for a type of bone
marrow cancer was stopped today after an interim analysis
showed the drug provided such clear benefit that it ought to
provided to all the patients in the trial.
The trial of the drug, Revlimid® (lenalidomide) was stopped
by the trial's Independent Data Monitoring Committee (IDMC),
responsible for overseeing the safety of the clinical trial
involving 700 patients with multiple myeloma. The interim
results showed a significant increase in the time to disease
progression for patients receiving REVLIMID® plus
dexamethasone compared to patients receiving dexamethasone
The results will allow Celegene, the biotechnology company
that makes the drug, to submit it for FDA approval.
In addition to the delay in time to disease progression for
patients receiving Revlimid the results also showed that the
drug, derived from thalidomide, is safe and well tolerated
by patients. As a result, drugmaker Celgene is allowing all
patients in the study to take Revlimid if they choose.
Thalidomide was first used in the late 1950s in Europe for
the treatment of morning sickness. It was later withdrawn
from use when it was shown to produce severe,
life-threatening birth defects. March 7, 2005
lies and abusive pricing associated
AVITE, the Spanish Thalidomide Victims’ Association, has
been able once more to verify the many falsehoods and wonder
drug claims surrounding the sinister drug thalidomide.
In the US the pharmaceutical company Celgene (www.celgene.com),
are carrying out "magistral" clinical trials and are using
the drug in “palliative care” with the new drug known as
REVLIMID which they want to launch worldwide. This
Association has sufficient information to be able to say
with certainty that it too is teratogenetic and that it is a
derivative of thalidomide. Ostensibly they want to launch it
on the market to replace thalidomide
However, it is a very dangerous derivative of that drug,
which they “say” also cures myeloma (bone marrow cancer).
It is merely an inhibitor and a pain reducer.
Recently in Spain they have also been using VELCADE (BORTEZOMIB),
made by the Janssen-Cilag pharmaceutical company (www.janssen-cilag.es).
A “first line” clinical trial is being carried out with this
drug, and they are also using it in palliative care. It too
is an inhibitor and pain reducer.
It also has highly dangerous teratogenetic side-effects, and
is also used to treat myeloma. The shameless and abusive
price per patient for treatment in various cycles over 1
year is 36,144 Euros (6,000,000
pesetas) per patient, which cost is, for the time being,
being met by the Social Security system.
It must be remembered that both drugs are palliative
medicines for pain, and that, in any event, they do not
replace thalidomide, since that latter drug is still being
used in more than half the world to treat various illnesses,
with the added risk of deformed babies being born every day,
and they are still being born all over the world without
arms and without legs.
Murcia, Friday 08 April 2005
The Views of Thalidomide
UK is obviously concerned about the AVITE’S Press Release;
we are planning to meet Celgene’s scientists shortly.
that the drug lenalidomide should not be prescribed to
pregnant women and must have strict guidelines.