(For Hebrew translation please click here).
My name is Tim, and I live in the UK with my partner Bronwen whom I have now known for 27 years.
We have two sons, Ryan now 18 and Cai 14.
Bron has Behcet’s Disease, which was confirmed when she was about 7 years old. She has seen many doctors through out the UK, and has tried almost all known drugs used for Behcet’s. When we decided to have children, we asked our doctors if there would be any chance that they may also have the disease, and we were told it was not inherited, and it would be a “Million to One chance!” that if we had a child the child would have Behcet’s.
Our two boys both have Behcet’s and it has been a struggle to try, at times, to lead a normal life and fit in to society’s ways. That is apart from dealing with the ignorance from some doctors, social workers and council staff , not to mention some welfare officers.
But thank God there are some people and doctors who take the time to try and understand what Behcet’s really is.
I will now like to talk about what this story is about.
After my family had exhausted almost all drugs given to Behcet’s sufferers with no or very little help in controlling the disease, they were then given a drug that brings the thought of horror to all who remember it back in the early sixties; this drug is of course Thalidomide. This was mostly because we fell into the category for allowing an unlicensed drug to be used, that is they were all suffering from the disease, tried most drugs without much success and there were 3 in the family affected.
I am only going to talk about Bron’s care and monitoring while she was being prescribed Thalidomide.
We were quite ignorant to the side effects and necessary monitoring of Thalidomide, so like most patients we relied on our doctors. All we knew was that Thalidomide caused birth defects and that Bron must not get pregnant. We were not told at what time in pregnancy Thalidomide could affect the foetus, nor were we ever counselled about family planing. Bron was asked “what are you doing as a contraceptive” and that was it! Bron was taking the pill and it was left like
that. A letter was sent to us to tell us there was a tiny risk, it said;
“There is a tiny risk of Thalidomide affecting the nerves, you would get pins and needles in the hands and feet, but this is reversible if you stop the drug.”
We now know this was the warning of Thalidomide neuropathy.
Bron began taking Thalidomide. In the late 1989 she was on 100mg 3 times a week. It was not long after, probably a few weeks, that her ulcers had cleared, and this was the same for the boys; Thalidomide was working!
By April 1990 Bron was concerned as she was putting on weight and had not had regular periods. She was also experiencing strange tingling sensations. When she saw her doctor she told him of this and he assured her there was nothing to worry about, and like all patients, we believed the doctor knows best. But because her doctors did not really convince us that Bron might not be pregnant, she decided to go to our family planing hospital to ask for a pregnancy test to satisfy our minds.
(She had always said it would be one of the most terrible things to be taking Thalidomide for Behcet’s only to have a poor child who is born with teratogenic side effects of Thalidomide, and then have this poor child [who has a good chance of being a Behcet’s sufferer too] take Thalidomide itself)
The staff just looked at Bron as though she was mad by saying she was on Thalidomide and this was the reason why she requested the test. That was until she showed them the bottle with Thalidomide written across the front. Luckily, she was not pregnant. We know that for a woman who has Behcet’s and all the symptoms associated with it like intestinal problems, which cause constipation then diarrhoea and then having to take a cocktail of drugs for the illness, just relying on the pill is not enough.
Some time later Bron was asked to attend her GP’s well woman check, where tests such as checking your cholesterol are done. While there, Bron explained to the nurse about her weight gain, and the nurse took a blood sample to test her thyroid function. Within a week the nurse rang her to say that she was hypothyroid and now needed thyroxin. We really wonder why those top doctors did not do this test or even think of it.
Then in November 1991 Bron was asked to appear on a national TV show to mark the 30th anniversary of when Thalidomide was withdrawn. Bron was to talk of the benefits that this drug has made to our family’s life and how well it has helped to control their Behcet’s.
On that same TV programme was an MP who was concerned that some doctors may show less than competence in the careful monitoring of patients’ family planning and the patients themselves while on the drug. He used the words the “willy nilly use of the drug”. He went on to say that he had sought a meeting with Virginia Bottomley, who was at that time the Governments Secretary of Health, where she assured him that there were strict guidelines for the use of Thalidomide, and that it would be monitored.
Later, we began to think that we should do something ourselves. So after a long talk we decided that I should have a vasectomy. We then went along to our local family planing doctor and explained why we felt I should be sterilised.
The doctor was quite horrified that Bron had been taking this drug for such a long time without any proper counselling. She wrote off to arrange my vasectomy. She also said that because Bron was taking Thalidomide we would not have to wait very long.
I eventually had the operation about 6 to 8 months later, and then had to wait 3 months for the first sample ,then another month for the second, after which I waited for a couple of months. As I had not heard anything, I rang the hospital to find the Results. I was told the two samples had been lost and I would need to have two more done. So then, after all this time and 4 tests, I could not believe it when they told me it did not work and I would have to have another operation. So I was put back on the waiting list for another 4 to 6 months.
After nearly two years and two operations it finally worked. A while later I needed to return because of a problem as a result of the operation. When I went in to see the doctor and we started talking, he said (in a sarcastic manner) “how do you know the sterilisation was successful?”. Now I really started to lose my temper. I told him the reason the operation was done, and that if he couldn’t get down to the facts I would ask to see another Doctor. After he took his pompous sarcastic head off, the rest of the consultation went Ok.
In the meantime, Bron was still having strange sensations, but now it was more numbness then tingling. She told her doctors and they kept reassuring her it was nothing to worry about and everything was all right. She had her first nerve test in August 1993, and was told nothing about the results of this test. We thought that if any thing were wrong, we would be told. By about 1994 Bron has already developed numbness in her legs, arm and mouth; she said it was a heavy feeling and continued to tell her doctors of this, but continued taking Thalidomide.
Her appointments were spaced about every 6 months and each time Bron will be given a 6-month supply of Thalidomide. Once, her appointment was changed to a later date, and her prescription would not have lasted till that time. So Bron rang the doctor’s secretary to ask if she could pick up the prescription to get the Thalidomide. The secretary told Bron that she could ask our GP to write out the prescription and get it at the chemist. Bron tried to explain, that the drug was prescribed under a named patient basis, and that only the hospital could prescribe it, as it was not permitted for a chemist to supply it. But Bron was made to try the secretary’s suggestion anyway. After this wasted attempt to do as the secretary had asked, Bron had to ring her back only to tell her the same thing as previously. She eventually got the drug from the hospital, and also wrote a complaint about the whole thing.
In September 1995 Bron had her second nerve test; she was not told of the result at that time.
Bron is a member of the Behcet’s syndrome society, and they hold an AGM every year, and invite doctors to talk about any advances in treatment for the disease.
She attended the AGM of October 1995, where she heard a doctor talk of the use of Thalidomide for the treatment of Behcet’s. Then came the big crunch; he said that 6 months is a long time for children to take Thalidomide. He also talked about the importance of nerve tests, and the period between them (6 months), and most of all the importance of pregnancy tests and family planning. Bron felt terrible to think that her and the boys had been taking this drug for almost7 years. She, in the 7 years, had only 2 nerve tests, and no pregnancy test except the one she arranged. We were now losing all confidence in the doctors who prescribed Thalidomide to her. It then sounded like the MP was right, the “willy nilly use of the drug”. We decided to ask our GP if he could request an appointment for Bron and the boys to see this Doctor who gave the talk for a second opinion.
In March 1996 Bron attended an appointment to see her doctor, who told her then that her nerve test was abnormal. He also suggested increasing the Thalidomide dose, as her ulcers were becoming more prominent. But Bron told him that she had arranged to see another doctor, and that her appointment was in fact in a few days time.
The family did go and see him in the March 1996. He told Bron that she must not take Thalidomide, as it looked like she had by then developed irreversible nerve damage. It has now been confirmed as irreversible Thalidomide Neuropathy. This doctor wrote to our GP and the doctors who prescribed Thalidomide to say that he advised Bron to stop, and the reason why. He also gave information for other treatment to try.
This Doctor is an expert on Behcet’s disease, and we also now know that he was one of the doctors who were asked by the UK’s Committee on the Safety of Medicines to produce guidelines for the clinical use and the dispensing of Thalidomide, published in 1994.
Other papers he published or was involved in producing were Thalidomide- The Way Forward and Clinical Experience with Thalidomide in the Management of Severe Oral and Genital Ulceration in Conditions such as Behcet’s Disease: Use of Neurophysiologacal Studies to Detect Thalidomide Neuropathy.
At the end of March that year Bron became ill. This was quite literally because she was on no treatment at all, having been on a drug for 7 years then suddenly stopping. She had one of the worst flare-ups ever, ulceration in her mouth, throat, digestive tract, front and back passage; also suffering joint pains, diarrhoea and this time severe trembling.
She rang her doctor’s secretary to get an appointment to see if they could start any of the treatments referred. The secretary refused and said “if you need an early appointment then your GP must arrange this”. Of course the next day Bron’s GP did just that but was still refused by the secretary. Our GP then asked to speak to the doctor to express his concerns. Later that day the doctor rang and spoke to our GP’s secretary only to say the same, which is Bron had an appointment in a few months time and she did not need an earlier one. He was refusing to provide every patient’s basic right, which is the right to receive health care on the basis of your clinical needs. Since then Bron has changed to another hospital and a new doctor.
We did complain at the way she was treated and the lack of monitoring, we also met with the Chief Executive of that hospital and the head of the Rheumatology department to express our concerns of the lack of monitoring .The Chief Executive was very understanding, but unfortunately the Rheumatology head said that not all doctors saw the need to do the test the same way as in the guidelines, as this was the personal view of the doctors who produced the guildlines, and not that of all doctors.
But this guideline was asked for and sanctioned by UK’s C.S.M.
All doctors must weigh up the risks and benefits of using a drug for the illness it is prescribed for, but in Bron’s case her ulcers were coming back, and there was been strong evidence of neuropathy for a long time. The last thing anyone wants is another illness on top of the one the drug was given for in the first place. Behcet’s, unlike HIV and other diseases Thalidomide is now used for, is not as life threatening, and there must be a considerable difference in weighing up of the risks and benefits. (Its use should not be “willy nilly”).
We have now learnt so much about Thalidomide, that we cannot understand why any reasonable doctor will not consider the importance of pregnancy tests and monitoring nerve tests for the prescribed patient.
In the late 1950s, when Thalidomide was put on the market as a sedative, it was gradually becoming known that neuropathy was a side affect, and in fact the American FDA would not licence it for use in their country for that very reason, until more information was learnt. As in other literature I have read, the people of the rest of the world became the human guinea pigs to decide whether or not they would allow it to be licensed. But then came the horrible truth, that Thalidomide had caused one of the most terrible human teratogenic effects on unborn babies. This was the end for its use in the world; it was never licensed in America save for a few clinical trials.
Because of the ignorance of some doctors in believing that a drug cannot affect an unborn child, and the slowness of the drug’s withdrawal, there were so many victims; tens of thousands of babies born affected by Thalidomide, and many of those poor children died leaving distraught parents to carry on a life time of questioning, “why did this happen?”
Thalidomide was withdrawn from use in 1960 here in the UK because of its teratogenic effect, but also because of peripheral neuropathy. Then in the early 80s it began to quietly came back to use, but as it had no licence it was only to be used in clinical trials and in cases where all other drugs had been exhausted and had not worked for the patient. The drug would be used under a named patient basis only, and the doctor prescribing it would be fully responsible for the health and safety of the patient. Only a doctor who had the experience of Thalidomide and of the disease it was being prescribed for, would be allowed to use it. As far as we knew from the TV program, which Bron appeared on in 1991, this was to be monitored. But this was not happening.
In 1996 I phoned and spoke to a person at the UK’s Medicine Control Agency, asked when guidelines were first produced and explained about the one mentioned on the TV programme in 1991. I was told that there had been no guidelines until those of 1994. I then asked our own Member of Parliament to check this, and she did. The Department of Health confirmed that there had been no guidelines until 1994. My final question was for the MP who said in 1991 that the secretary of health assured him there were strict guidelines and that the government would monitor it.
He just referred me back to our own MP and wished me luck.
As I had already spoken to our MP, I did not think it would be worth saying the same thing to her again. I decided to contact the UK’s Thalidomide society and ask if they knew that some doctors were prescribing Thalidomide and still reluctant to follow the guidelines. The society then contacted the Pharmacy and prescribing branch of the Department of Health, who told them that "Current guidance is that thalidomide should only be used in exceptional circumstances: guidelines must be followed and the prescribing doctor is entirely responsible." Someone somewhere is being misled.
I then contacted the Thalidomide Victims Association of Canada, as they were involved with establishing the guidelines used in America called S.T.E.Ps. I expressed my worries as to how Thalidomide was sometimes being used here in the UK, and this was their reply:
“We at the Thalidomide Victims Association of Canada share your concern, but are also aware there is little that can be done by victim's groups concerning it. The drug thalidomide is managed in Great Britain under a "compassionate drug release program" (not the exact name, but you get the idea) similar to the situation in Canada. This means that everything surrounding the distribution etc. of the drug is controlled by the government without any obligation to report to the public. The government must obey all regulations surrounding patient confidentiality and therefore does not disclose who is receiving the drug. As well, there are no rules about what information or education surround each prescription, and they have no capacity (mechanisms) to monitor the drug or patients. It is for that very reason that the Thalidomide Victims Association of Canada is FORCED to prefer licensing of the drug in our own country… as we did in the United States. Licensing means that you can force the manufacturer to comply with regulations that can be mandated (legislated) at the time of licensing.
Thalidomide is better licensed than unregulated as the public then has access to a different level of information and accountability from all concerned (pharmaceutical companies and prescribers) and so that the patient has more mandated and consistent information and behaviour control.”
I would like to thank Vivien Kerr of the TVA, Randolph Warren and Paul Haddad of the TVAC, for allowing me to use their thoughts in this story.
I have to say now that I do not want to deny Thalidomide anyone it may benefit, but ours is not the only case where Thalidomide has been used without proper monitoring. I would expect that if a doctor was to prescribe patients a drug, then the doctor should have enough knowledge of the disease, as well as of the drug and how to monitor for its side effects. It is the patients right. If not, then leave it to the experts.
Next year is the 40th anniversary of when Thalidomide was withdrawn from use here in the UK. I wonder if another TV programme was made to acknowledge this, how many people would come forward to say “I have been prescribed this drug and have not been monitored as in the guidelines.
Finally, what is the point of the department of Health and Safety of Medicines asking for Guidelines and then not enforcing its use? Also for the MPs to ignore this even when its put under their nose… This is not putting into practice the lessons learnt from such a dangerous drug - Thalidomide.
Appendix 1- January 2002 (Tim, U.K)
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Appendix 2- February 2003 (Tim, U.K)
Tell us what you think about this story.
For your information: Thalidomide neuropathy by Dr. Colin Crawford
Readers' comments
>>TIM READ YOUR STORY ON TALS SITE. SO GLAD FINALLY GOT OUT. << Laurie, USA
>>In israel we seldom use thalidomide for
severe skin manifestations of lupus
(SLE) and in cases of severe aphtous stomatitis in Behcet's.<< Prof. Eldad
Ben-Chetrit, Hadassa medical centre, Israel