THALIDOMIDE UK VIEWS 

THE USE OF THE DRUG THALIDOMIDE

 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.

EU backs return of banned drug THALIDOMIDE 2008

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drug regulators approved licensed for thalidomide to treat bone marrow cancer, nearly 50 years after the medicine was withdrawn as a treatment for morning sickness around the world because it caused thousands of children to be born with birth defects.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 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

thalidomide UK warns that the

new licence for Thalidomide

in Europe must be strictly policed.

Freddie Astbury President of Thalidomide UK (48,born without arms or legs) commented on the licensing of thalidomide by the EMEA (European Medical Evaluation Agency) today.

 “We have 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 undertaken.”

 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 being born.

 Freddie 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”.

 “We will 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.”

 Celgene, 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 the PPP.

 Freddie 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 drug.

 Glenn 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.”

 “However 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.” 

 MEDIA ENQUIRIES TEL 0151 222 1814

 The Presidents Report Freddie Astbury

‘The Drug that Came Back to Haunt Us’

 Over the last five years Thalidomide UK has worked tirelessly to reduce the chances of babies being born with missing limbs and internal deformities.

 It all started before Thalidomide UK was setup back in 1993 on 1^st 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.

 The 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.

 A small 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 worldwide.

 The group 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.

 The group shortly afterwards ended their call for a ban on the drug and finished.

 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 acceptably safe.

 I soon realised that we would be asked the question whether ‘Thalidomide should be used’.

 Before I 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.

 It was 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.

 I contacted 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.

 Over the 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.

 Everyone 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 people's opinion.

However 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.

 We never 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.

Freddie Astbury

Freddie Astbury

The Drug 'Thalidomide' Today

Thalidomide Is Back

Thalidomide 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?

Thalidomide UK 'Advisory Group' Buys The Drug 'Thalidomide'

(since we obtained the drug Pharmion have changed there procedures)

Photograph Below

Freddie Asbury (President) 'holding the drug thalidomide'.

For more information regarding this subject please view The Drug Today 'Thalidomide UK Views

The Drug Thalidomide Is Not Ready To Be Licensed In Europe.

Thalidomide & Patient Groups have told the (EMEA) European union that the drug thalidomide should not be granted a license by Pharmion, under its current application.

The groups believe that the current guidelines (Pharmion Risk Management Programme) needed to restructured.

Freddie 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.

However the EMEA could ignore the advice given by the groups and the drug could be licensed in Europe in June or July 2004.

The EMEA

The European Agency for the Evaluation of Medicinal Products

Before any 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.

Ad-Hoc Groups

Ad-Hoc Advisory Group Of Victims’ And Patients’ Organisation On Thalidomide Group Representatives and Procedures.

Treatments

View the various illnesses and diseases that the drug thalidomide is used for today.

Thalidomide V Leprosy

This lady from Brazil suffers from leprosy she was prescribed thalidomide. View the results before and after the drug thalidomide was taken.

Before 

After

The Child of Brazil

This Childs 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

In the 90s they were many Brazilian children born with deformed limbs as a result of their mothers taking thalidomide.

Are babies still being born with thalidomide damages? Who Knows

Various Views

The views of thalidomide and patient group do vary in the current use of thalidomide

Patient Advice

We give 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.

Peripheral Neuritis

Author Dr Colin Crawford

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 nervous system.

W.H.O

View the World Health Organisation on whether the drug thalidomide should be used today?

Thalidomide Does Exists in Semen

New Warnings 'Male Patients. - New research has shown that thalidomide does exists in semen, which was not known in the 60s.

Letters to the Editors

(Medical/Pharmaceutical Journals)

Related Medical Links:

Pharmaceutical Journal Ref: Use of Thalidomide 

Celgene Claims

Poll Re-Created:  02/04/05

FDA Orphan Product 2004

Drug May Prove Beneficial for Multiple Myeloma

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 alone.

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

AVITE PRESS RELEASE:

The lies and abusive pricing associated with thalidomide

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. BUT

Murcia, Friday 08 April 2005 

The Views of Thalidomide UK

Thalidomide UK is obviously concerned about the AVITE’S Press Release; we are planning to meet Celgene’s scientists shortly.

We believe that the drug lenalidomide should not be prescribed to pregnant women and must have strict guidelines.