British Government
The government granted distillers a UK product License for the drug thalidomide. The government have never paid any compensation for licensing the drug, however they have donated some monies first in 1974 £5million, which was to offset the tax then £7million in June 1996 - no clear reason was ever given for this donation.
£20m and an apology for Britain's 'thalidomiders'
Thursday, 14, Jan 2010 12:00
Health minister Mike O'Brien has expressed the government's "sincere regret and deep sympathy" for victims of the drug thalidomide.
It comes four decades after expectant mothers suffering from morning sickness took the drug between 1958 and 1961. Thousands of their offspring suffered from physical disabilities as a result.
Of them, 466 members of the Thalidomide Trust remain. The government has announced a £20 million three-year pilot scheme which will meet survivors' needs "in a more personalised way".
Mr O'Brien told MPs: "The government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961.
"We acknowledge both the physical hardship and the emotional difficulties that have faced both the children affected and their families as a result of this drug, and the challenges that many continue to endure, often on a daily basis."
The new funding for 'thalidomiders' will prioritise looking after their health needs for the long-term.
After the drug's negative side-effects were first realised the government launched a major review of the machinery for marketing, testing and regulating drugs, which resulted in the Medicines Act 1968.
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Thalidomide victims gain £3.4m to fight
disability
Published Date: 26 February 2010
By Angus Howarth - The Guardian
VICTIMS of the thalidomide scandal will be given
extra help through a £3.4 million fund announced
by the Scottish Government yesterday. The money
will be spent over three years to alter homes
and buy specialist equipment. Pregnant women
were prescribed the drug between 1958 and 1961
as a treatment for morning sickness or insomnia.
It was withdrawn from sale after babies were
born with limb deformities and other
disabilities. There are 55 known thalidomide
survivors in Scotland who can benefit from the
money pledged by ministers. The health
secretary, Nicola Sturgeon, said yesterday:
"Half a century later, the survivors of
thalidomide are still battling against the
disabilities the prescribing of the drug
caused."
Liz Buckle, 49, a thalidomide victim who lives
on the island of Lismore, near Oban, said: "As a
Scottish thalidomider, I very much welcome the
positive response from our government. They have
acted with integrity."I look forward to working
together with the Scottish Government to the
benefit of thalidomiders and others."
The UK health minister, Mike O'Brien, announced
a £20m fund last month, when he apologised for
the scandal surrounding the drug's history.
£1.9m for thalidomide survivors in Wales
26/2/2010
First Minister Carwyn Jones will today announce
£1.9million for the Thalidomide Trust to improve
the care and support for thalidomide survivors
in Wales.
The funding which will be available from April
will be distributed amongst survivors to help
meet their health needs and minimise any further
deterioration of their condition.
This funding will be in addition to £20million
announced by the Department of Health last month
for the Thalidomide Trust for a pilot scheme to
support thalidomiders, as they refer to
themselves.
Between 1958 and 1961, the drug, thalidomide,
was used by expectant mothers to control
symptoms of morning sickness. Tragically, this
led to many babies being born with often severe
physical disabilities. There are 31
thalidomiders in Wales.
The First Minister, who will meet thalidomide
survivors in Gorseinon, Swansea today,
said: "I believe that addressing the ongoing
needs of thalidomiders rests with the UK
Government as it authorised the use of
thalidomide.
"While survivors in Wales will have access to a
share of the funding announced by the Department
of Health, I wanted to provide additional
funding to ensure that people affected by
thalidomide in Wales receive the care and
support they need.
"I am pleased that the UK Government has
expressed its sincere regret and deep sympathy
for the injury and suffering endured by all
those affected when expectant mothers took the
drug between 1958 and 1961.
"The funding I am announcing today will help
thalidomiders manage the continuing and
increasing health needs as they get older.
"We will be working with the Thalidomide Trust
on how this funding will be distributed to
maximise the benefits for individuals."
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The Numbers: The
Thalidomide Trust
Third Sector, 2 March 2010
The figures behind the charity which provides
relief and assistance to people suffering from
congenital disability because of Thalidomide.
£12.4m - The charity's income for the financial
year ending 5 April 2009, broadly in line with
its income in the previous year
£7.4m - The sum received from drinks firm Diageo
in the financial year. It contributes annually
to the trust, which was set up after a
settlement with Distillers (Biochemicals), the
firm that distributed Thalidomide in the UK, now
owned by Diageo
466 - The number of beneficiaries the charity
helps
£9.96m - Total grants made by the trust in the
year, compared with £13.1m the year before
-18.1% - Total return on the charity's
investments in the financial year. The value of
assets fell from £120.1m to £97.1m
£282k - The cost of investment management during
the year
£100k - No employee was paid more than this
10% - Maximum percentage of pensionable income
contributed to employees' pension schemes.
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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 foetal
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.