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THALIDOMIDE
UK WEBSITE
This website is dedicated to the history of the drug
'thalidomide' and we explore the various disabilities that the
drug caused to babies worldwide.
Since Thalidomide UK founded in 1993, against all odds, Diageo
have put additional monies into the trust on three separate
occasions. Payments are being made to provide some facilities
(adaptation of properties/wheelchairs/cars, etc) to alleviate
the problems.
The thalidomide disabilities was a man-made by a drug, which
could have been
so easily avoided if the manufactures and
suppliers had carried out the adequate testing on the drug.
Those who were responsible for the marketing of the drug did not
have a care for human life.
.......................................
Freddie Astbury -
HEAD CONSULTANT
(Medicines 'Teratogenic' Regulatory Consultant)
Thalidomide Agency UK website provides information the use of thalidomide and
similar drugs.
In 1985 when the world discovered that the drug thalidomide was
being used in the treatment of leprosy and that babies were
still being born in countries like Brazil, our immediate
response was to call for the drug to be banned.
Over the years, most thalidomiders
have come to accept that if it can help people who suffer
from number of illnesses then it must be used but only under the
strictest guidelines such as a risk Management Programme.
In our ideal world, thalidomide would be banned, but we have to
accept that we live in the real world. We believe that the best
way forward is to work on Risk Management Programme like the
European Pregnancy Prevention
Programme and the STEPS Programme
in the USA, with the manufactures and suppliers that would
reduce the chances of more babies being damaged by the drug.
.......................................
What
Is Thalidomide?
The drug ‘Thalidomide’ was
mainly prescribed to pregnant women for morning sickness in the
late 50s and early 60s. Instead, the drug caused severe
deformities in babies with missing limbs.
Some thalidomide people where
also born with internal deformities. It is estimated that over
3,500 babies died before their first birthday. Thalidomide was
invented in 1954 at the Grünenthal Labs in Germany by the
inventors Dr. W. Kunz (chemical synthesis) and Dr. H. Keller
pharmacological description of sedative properties).
.......................................
THALIDOMIDE AWARENESS VIDEO
(UK VERSION)
(PLEASE CLICK
ON THE VIDEO BELOW)
WARNING
- SOME PEOPLE MAY
FIND THIS DVD
UPSETTING
.......................................
2008: EU
backs return of banned
drug
Europe's drug
regulators yesterday recommended approval of 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 pregnant women.
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 1957.
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 regulatory approval.
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 Financial Times
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Pomalidomide
(another thalidomide analog)
Pomalidomide (originally CC-4047), is a
derivative of
thalidomide that is anti-angiogenic and acts
as an
immunomodulator. It was discovered in 2001[citation
needed] by the lab of Dr. Robert D'Amato at
Harvard Medical School to inhibit both the tumor cell and
vascular compartments of tumors in animals[1].
It is more potent than thalidomide and can be taken orally.
Pomalidomide has been granted
orphan
drug status for the treatment of
multiple myeloma by the
European Medicines Agency.[2]
Clinical trials
Phase I trial results showed
neutropenia was a frequent side effect.
Phase II clinical trials for multiple myeloma and
myelofibrosis have reported 'promising
results'.
It has been submitted to the FDA for approval.
Mechanism
The immunomodulatory effect is probably due to
inhibition of
TNF-alpha with an
IC50
of 1 μM.
In
vitro it affects
erythropoeisis[7]
and enhances
antibody-dependent cellular cytotoxicity
(ADCC).[8]
Lenalidomide,
another thalidomide analog.
Discovery and
development of thalidomide and its analogs
References
EMEA grants orphan
drug status for pomalidomide for multiple myeloma
Alternate day
pomalidomide retains anti-myeloma effect with reduced adverse
events and evidence of in vivo immunomodulation,
BJH Apr 2008
Promising Results From 2 Trials Highlighting Pomalidomide,
Presented At ASH
Promising results
from 2 trials highlighting pomalidomide presented at ASH" Dec
2008
Pomalidomide Therapy
in Anemic Patients with Myelofibrosis: Results from a Phase-2
Randomized Multicenter Study
Pomalidomide and
lenalidomide regulate erythropoiesis and fetal hemoglobin
production in human CD34+ cells
^
Lenalidomide and pomalidomide strongly enhance tumor cell
killing in vitro during antibody-dependent cellular cytotoxicity
(ADCC) mediated by trastuzumab, cetuximab and rituximab
.......................................
History of Human Teratology:
Environmental Causes of Birth
Defects"
(Please click on
symbol below to view video)
UCSD Department of Pediatrics & the
Skaggs School of Pharmacy and Pharmaceutical Sciences bring
together world-renowned experts in the field of Human Teratology
in a new series providing clinicians an update on the
environmental causes of birth defects. In this program, Paul
Lancaster, M.D., University of Sydney, discusses Identification
of Human Teratogens through Recognition of a Pattern of
Malformation. Series: "Human Teratology: Environmental Causes of
Birth Defects" [2/2007] [Health and Medicine] [Professional
Medical Education]
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GRUNENTHAL
APOLOGY
Speech on the occasion of the inauguration of
Thalidomide-Memorial
Translation of the German speech by Harald F.
Stock, PhD., Chief Executive Officer of the Grünenthal Group, on
the occasion of the Thalidomide-Memorial inauguration upon
invitation by the City of Stolberg on 31st August
2012 in Stolberg/Rhineland
In numerous talks with those affected, but also
for example with the Ministry of Health, Equalities, Care and
Ageing of North Rhine-Westphalia – especially in the last few
months, we learned how much it is publicly desired that we
express our deep regrets to those affected by Thalidomide, and
in particular to their mothers.
We are aware of our responsibility and will
continue to fulfil it in demand-oriented projects and
initiatives.
The fact that I can stand here today and address
a few words to you is nevertheless not a matter of course.
We also apologize for the fact that we have not
found the way to you from person to person for almost 50 years.
Instead, we have been silent and we are very sorry for that.
We ask that you regard our long silence as a sign
of the silent shock that your fate has caused us. We have
learned how important it is that we engage in an open dialogue
with those affected and to talk and to listen to them. We have
begun to mutually develop and implement projects with them, to
improve their living situation and assist in hardship situations
easily and efficiently. We will continue to pursue this path in
the future.
Grunenthal
Full Statement
Apology
Freddie Astbury
(Head Medicines Consultant of
Thalidomide Agency UK) Official Statement
We have studied Grünenthal’s speech
made by Harald Stock and recognise words that Grunenthal have
apologised
for the fact that they have not found the way to
you from person to person for almost 50 years. Instead, they
have been silent and we are very sorry for that.
We also acknowledge that they have begun to
mutually develop and implement projects with them, to improve
their living situation and assist in hardship situations easily
and efficiently. We will continue to pursue this path in the
future.
There
are currently 469 registered thalidomide survivors UK through
who desperately needs help in making their lives easier as their
health has deteriorated dramatically over last number of years
and sadly thalidomide survivors will only get worse, because of
the severe of their disabilities
We therefore will be contacting Grunenthal
shortly with the chance of opening discussions.
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THALIDOMIDE:
HOW
TO
CLAIM
The Thalidomide UK is not
responsible for the content of external Internet sites and
remain Impartial to any legal challengers.
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Nichola
Marshall, Solicitor assisting Martyn Day
Leigh Day & Co.
Priory House, 25 St John's Lane, London EC1M 4LB
Tel secretary: 020
7650 1234, Direct Dial, 0207 650 1324 Fax: 020 7253 4433
DX 53326 Clerkenwell |
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THALIDOMIDE IS licensed in
the eu FOR MYELOMA
WHAT IS MYELOMA?
Diagnostic tests make inroads in
market
Cell biologist Mark Ross prepares samples of brain tumour stem
cells to look for cancer biomarkers at Stemina Biomarker
Discovery Inc., a young Madison company.
Madison company Stemina's product
can predict toxicity
When
thalidomide came to market in the 1950s as a morning
sickness treatment, no one imagined the many cases of birth
defects that would result from use of the drug.
More than 50
years later, a small Madison-based stem cell company is
selling a research product that could have prevented what
some have called one of the biggest medical tragedies of
modern times.
Stemina
Biomarker Discovery Inc. uses a proprietary stem cell
technology that allows it to predict with a high degree of
accuracy whether a drug or a compound is going to be toxic.
"If
thalidomide would have gone through Stemina's screening, it
would have been so easy for them to say 'this isn't going to
work,' " said Tom Shannon, principal at private investment
group Shamrock Partners and an investor in Stemina. "But
instead, they used rat models that resulted in terrible
outcomes for thousands, if not tens of thousands of
children."
Stemina,
founded in 2006, has the potential to have a big impact on
the identification of toxicity not just in drugs that are
being developed, but also in agricultural products,
cosmetics and other areas, said Shannon, who previously
headed Prodesse Inc., a Waukesha biotech company bought by
Gen-Probe Inc. of San Diego in late 2009.
Stemina raised
$3 million of funding last year in a round led by Shamrock
Partners. That brought to $4.6 million the total amount of
investor money the company has pulled in, said Beth Donley,
co-founder and chief executive officer. It also has raised
about $3 million of federal and state grants and other
incentives, Donley said.
Stemina has
one product already on the market. Called DevTox, it is an
alternative to animal testing and uses embryonic stem cells
to screen the potential toxicity of drugs and chemical
compounds and the impact they might have on human
development.
The company
had its first profitable quarter in the third quarter of
2011 and now has 12 employees - 30% more than a year ago,
Donley said. In July, it doubled the amount of space it
occupies to 6,000 square feet, she said.
Stemina also
has forged partnerships to help develop new products,
including one with Children's Hospital of Orange County,
Calif., to develop a newborn screen to diagnose autism.
"Right now the
average age of diagnosis is more than 30 months old because
they rely on behaviors - and we know early intervention
makes a difference," Donley said.
Donley has the
type of strategic plan for her company that can lead to
great success, said Ken Johnson, managing director of
Kegonsa Capital Partners LLC of Fitchburg.
"She hasn't
got a lot of money invested in her company, and she's
developed some things where a $30 million or $40 million
exit will give her a very good return," said Johnson, who is
not an investor in Stemina.
Stemina is one
of 102, or nearly 77%, of past finalists in the Wisconsin
Governor's Business Plan Contest that is still in operation,
said Tom Still, president of the Wisconsin Technology
Council, which sponsors the contest.
Like many of
the contest alumni, Stemina got a great head start with a
well-developed business plan, Still said. It made a solid
business decision to focus on developing a diagnostic
product rather than a therapeutic product, which would
require much more funding and a longer timeline.
By
Kathleen Gallagher of the
Journal
Sentinel
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Accutane
or Roaccutane
(generic name isotretinoin)
Hundreds of drugs still pose the risk of birth
abnormalities. It is a
retinoid,
meaning it derives from
vitamin A
and is found in small quantities naturally in the body.
Accutane,
or Roaccutane (generic name isotretinoin)
Amnesteem are members of a family of drugs called retinoids
which are known to cause a number of
very
serious birth defects,
and has been implicated as a possible cause of cleft lip and
cleft palate. Isotretinoin is derived from vitamin A.
Oral isotretinoin is marketed under various trade
names, most commonly Accutane (Roche),
Amnesteem (Mylan),
Claravis (Barr),
Decutan (Actavis),
Isotane (Pacific
Pharmaceuticals),
Sotret (Ranbaxy),
Oratane (Genepharm Australasia) or Roaccutane (Roche),
Izotek (BlauFarma);
while topical isotretinoin is most commonly marketed under the
trade names Isotrex or Isotrexin (Stiefel).
What is even more terrifying is that the drugs are aimed at
teenagers for the treatment of ACNE.
Accutane
and Roaccutane This drug is NOT manufactured by
Celgene the suppliers of Thalidomide or Revlimid, but the
pharmaceutical giants Roche.
Celgene,
however is the owner of the business process patents on
components which will be essential elements of the new
isotretinoin RiskMAP. Celgene is not involved in the
strengthened isotretinoin RiskMAP aside from the patent
negotiations.
In
US the
U.S. Food and Drug Administration 'FDA or USFDA'
(an
agency of the
United States Department of
Health and Human Services and is responsible for
regulating and supervising the safety of
foods,
dietary supplements,
drugs,
vaccines,
biological medical products,
blood products,
medical devices,
radiation-emitting
devices, veterinary products, and
cosmetics) has
insisted that the drug has a stronger Risk Management Programme
than used in the past.
The new
Risk Management Programme is called iPLEDGE.
The iPLEDGE program is a mandatory
distribution program in the United States for
isotretinoin
(commonly sold under the trade names Accutane,
Amnesteem, Claravis or Sotret), intended to
prevent the use of the drug during pregnancy due to the high
risk of
birth defects.
iPLEDGE
VIDEO
(Please click on
symbol below to view video)
iPLEDGE
(Risk Management Programme)
Revised October 28, 2005: The implementation dates of the
iPLEDGE program have been revised. The date by which wholesalers
and pharmacies must be registered /activated in IPLEDGE has been
changed from November 1, 2005 to December 30, 2005. By March 1,
2006, only prescribers registered and activated in iPLEDGE can
prescribe isotretinoin and only patients registered and
qualified in iPLEDGE can be dispensed isotretinoin. Patients can
begin registering and qualifying on December 30, 2005.
FDA has developed stronger requirements to prevent fetal
exposure to the drug Accutane (isotretinoin) along with its
generic equivalents, such as Amnesteem, Sotret and Claravis.
Isotretinoin is used to treat severe, recalcitrant, nodular
acne, but it can cause serious birth defects if taken by
pregnant women.
These requirements are now going into effect in a new program
called iPLEDGE. Under this program, wholesalers, prescribers,
pharmacies and patients, both men and women, must register.
Also, women who are capable of becoming pregnant must have two
negative pregnancy tests before isotretinoin can be dispensed to
them. They also must have a negative pregnancy test each month
while taking the drug.
Isotretinoin is now a restricted distribution drug. This means
that wholesalers won't be able to distribute the drug,
pharmacists won't be able to dispense it, physicians won't be
able to prescribe it, and patients won't be able to receive it
unless they register. Doctors, patients, and pharmacies can
obtain program information and register with iPLEDGE either
online or by telephone at 1-866-495-0654.
There is also a possible link between taking this drug and
depression, Suicidal, and psychosis. And for that reason, FDA
has strengthened the labelling to help practitioners and
patients identify and manage these risks.
Any patient being treated with this drug should be carefully
monitored for symptoms of depression, or Suicidal or psychosis.
Patients should be told to stop the drug and contact their
health professional if they experience any of these symptoms.
Stopping the drug by itself, however, may not be sufficient.
Psychiatric evaluation and intervention
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