We are often asked about  clinical trials that are going on in the UK and also in the rest of the world. Sadly there are no clinical trials that relate specifically to birdshot, and hardly any current ones in the UK for uveitis.

Uveitis Information Group website has a whole section on clinical trials that you might like to read before even considering one. There is also a booklet published by the UK Clinical Research Collaboration which may be of interest to you.

Understanding Clinical Trials

As a result of this, Doctors are being urged to choose the lowest possible dose when they prescribe cholesterol lowering statins.

If you currently take statins  you may wish to review this with your GP and Ophthalmologist, discuss the benefits against the risks to find out if drug you are prescribed should be changed.

The link below takes you to the published paper.

http://www.bmj.com/cgi/content/full/340/may19_4/c2197#SEC1

“What I am looking for is an opportunity to have some completely confidential phone calls with people, though I am happy to visit with my support worker if that would be preferable. I can provide more detailed information including how I guarantee confidentiality separately if necessary.

The overall research question I want to ask is How Reasonable is Reasonable Adjustment for Visually Impaired Employees?

The phone call will be a discussion rather than a questionnaire. I will be asking people to talk generally around topics . So I will rarely ask a direct question but instead say things like – Tell me about your reasonable adjustment arrangements? Or what sorts of things would make it easier for you to provide a good reasonable adjustment arrangement for your staff?

These answers from all the volunteers will help me later answer some more specific research questions like:-

• What is the influence of RA (Reasonable Adjustment) on Recruitment opportunities ?
• Do RA arrangements in employment work well?
• What makes a good RA arrangement?
• Do RA arrangements persist over time?
• How are they reviewed?
• What happens when problems arise or things go wrong?
• What are the important but small things that can go wrong?
• Would it be helpful to include review of RA arrangements in Health and Safety Risk Assessment?
• How will the new duty to prevent Indirect discrimination affect RA arrangements?
• What are the Human Rights implications for RA.

There are other areas but as I say it is unlikely that I will ask these questions directly and baldly but instead pick up points from general discussion. I want to encourage a free flow rather than formal question and answer sessions.

This year I am starting with 3 groups.

1. People with visual impairment who have had experience of RA for more than months. I have a limited number of volunteers in this category but need more.

2. Managers and HR providers of RA arrangements. I am desperately short of volunteers in this category, which I intend to work on this year.

3. Unemployed people with Visual Impairment who have tried to access employment over the last 6 months. I have some limited volunteers but need more.

I would be absolutely delighted if any of you would allow me the time to talk to you on the phone either as a Manager, HR Professional, or employee.

I am flexible and can ring either during the day or the evening.

I can send out information on a CD also if you would like more information.

For information during the next few years I will be interviewing further groups.

These will include interviews with Job Centre Plus services, including Access to Work administrators and assessors, Health and Safety Reps as well as Trade Union Equality Reps will be approached. There will be a separate project looking at formal enforcement systems, including observation of Tribunals, (already piloted ), interviews with legal reps, and observation if possible of mediation sessions.”

This information was brought to us by “Inclusion London”

We read about this in the latest Vision Newsletter March 2010. It is interesting to see that some serious research is being done into the affect of Saffron on AMD.  A couple of our members have suggested that Saffron appears to have helped them but we had no idea that scientific research was being done.

“A clinical trial has found that saffron, the famous Indian spice, can improve vision in patients with AMD, according to new reports. The trials were conducted by Silvia Bisti of the University of Sydney. The trial participants showed significant vision improvements after taking a saffron pill for three months, she said. “Measurements using objective eye sight tests showed patient’s vision improved after taking the saffron pill. When they were tested with traditional eye charts, a number of patients could read one or two lines smaller than before, while others reported they could read newspapers and books again.” The trial was double blind and randomly controlled, involving 25 subjects over six months. Half the group were given a saffron pill for the first three months followed by a placebo, while the other half were given the pills in the reverse order. “All patients experienced improvements in their vision while taking the saffron pill,” Dr Bisti said. “But when they stopped taking the pill the effect quickly disappeared”

http://www.myvisiontest.com/news.php

In April 2000, Regulation (EC) No 141/2000 of the European Parliament and the Council on Orphan Medicinal Products came into effect. Since then, over 700 products have received orphan designation to treat rare disorders.

The regulation established the criteria for orphan designation in the EU and delineated the incentives, including market exclusivity, protocol assistance, and access to the centralised procedure for marketing authorisation. The regulation was also developed to encourage the research, development and marketing of medicines to treat, diagnose or prevent rare diseases.

Two workshops and a conference are scheduled to take place at EMA headquarters in London. The first workshop, on nanomedicines, is scheduled for April 26-27, and the second, on May 10, will focus on stem cell-based therapies.

Then on May 3-4 there will be a conference, entitled 10 Years of the Orphan Regulation in Europe, featuring plenary sessions, discussions and three parallel workshops on the development of products for rare diseases, research for rare diseases and patients’ views on the Regulation.

Further details are available from the EMA.

We will keep you up-to-date if we hear of any interesting developments.

ScienceDaily (Feb. 20, 2010) — Scientists have confirmed that the healthful substances found in green tea — renowned for their powerful antioxidant and disease-fighting properties — do penetrate into tissues of the eye. Their new report, the first documenting how the lens, retina, and other eye tissues absorb these substances, raises the possibility that green tea may protect against glaucoma and other common eye diseases.

The whole article can be found by following this link.

http://www.sciencedaily.com/releases/2010/02/100218125520.htm

The survey has found that rare disease patient organisations (such as BUS, the Birdshot Chorioretinopathy Uveitis Society) play important roles as catalysts for research on their respective diseases. They can also be valuable partners in identifying the gaps and supporting early research in areas not covered by the public or private sectors.

The presentation can be accessed at:

http://www.eurordis.org/sites/default/files/publications/3_FBignami_RDD2010.pdf

We would like our first  Birdshot Patient Day to be the start of increased awareness about birdshot,  better diagnosis of the disease and increased research into better and less toxic treatments.  The Day will be a true partnership between patients, healthcare professionals and researchers, and it is our opportunity to begin to influence the research agenda into Birdshot.

Annie and Rea

“Don’t use it for more than five years!”

We recently came across this article about the long term effects of Alendronic acid and thought we should bring it to your attention.  The long and the short of it is that it is not a good idea to use the drug for periods of longer than 5 years,  as it has the effect of making your bones go brittle and actually causing breaks.

Naturopath,  Jacob Schor, ND, FABNO,  writes:

“The drugs that have been used with apparent success to treat osteoporosis may now have a problem. Alendronate may weaken bone and lead to increased fracture risk.

Alendronate is the drug we know as Fosamax. It belongs to a class of drugs called bisphosphonates. These chemicals were developed in the 19th century but were not investigated until the 1960s for bone metabolism. Their non-medical use was to soften water in irrigation systems used in orange groves. The rationale for giving them to people is that they prevent the dissolution of hydroxylapatite, the principal bone mineral, so stopping bone loss. Only in the 1990s was their actual mechanism of action explained when Merck brought Fosamax to the market place.

There is little doubt that these drugs do what they are supposed to over the short term: they increase bone density and decrease fracture risk.”

“From the first use of these drugs, there was always a theoretical worry. Recall that there are two main processes that occur constantly in the bone: osteoclastic activity that breaks down old bone, and osteoblastic activity that builds up new bone. This constant turnover of bone maintains healthy and strong bone. These drugs stop the osteoclastic activity so that the old bone is left untouched. This increases bone density measurements. The worry was that because these drugs halt normal bone turnover people using them would end up with dense but more brittle bones. As the early studies consistently showed a rapid reduction in fracture rates, this concern faded.

These early worries unfortunately were not just a product of naturopathic paranoia; the problems just took a few years to show up.

The May/June 2008 issue of The Journal of Orthopaedic Trauma published a report on “Low-energy femoral shaft fractures associated with alendronate use.” The authors reviewed records of 70 patients who had sustained low energy femur fractures. That means their femurs broke without any major stress. Rather they did little things such as walking or stepped off a curb and thus triggered the breaks. These weren’t young people, their average age was about 75. Of these 70 patients, 25 of them, a little over a third (36%), were taking Fosamax. Nineteen (76%) of those 25 patients demonstrated a simple, transverse fracture with a unicortical beak in an area of cortical hypertrophy. This is a rare and peculiar type of fracture. Only 1 patient of those not taking Fossamax (2%) had this kind of bone break. When the statistics were worked out, the numbers tell us that Fosamax use significantly increased risk of these fractures: the odds ratio was 139.33, 95% CI [19.0-939.4], P < 0.0001). You can say those taking Fosamax were about 140 times more likely to get one of these rare fractures. It took about 7 years for this problem to occur. Those taking Fosamax less than 2.5 years were not at greater risk.

A 2009 paper in Geriatrics continued this story. It tells us that, “The fractures are often preceded by pain in the affected thigh…” this paper suggests that patients not take Fosamax for longer than five years. Another 2009 article, this one in Clinical Calcium, echoed this warning and suggested that, “… alendronate treatment might be stopped for a while after 5 years to prevent [these kinds of]… fractures.”

Few doctors and fewer patients are paying attention to duration of Fosamax use. Most patients will report they’ve taken Fosamax, “for awhile.” We need to start spreading the message, “for awhile” should be less than five years.”

“In our practice we are suggesting a break from use after a shorter period of time, about three years. Discontinuing Fosamax use and relying solely on naturopathic treatments even for an interval of time, may, in the long run prove to be a safer course of action.”

For the full article and links to the relevant research:

http://www.denvernaturopathic.com/fosamaxBreak.htm

This study looked at the the effect of intravitreal bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) on visual acuity and macular thickness in patients with inflammatory choroidal neovascularization (CNV) or cystoid macular edema (CME).

The study concluded that Bevacizumab appears to stabilize the eyes with inflammatory choroid neovascularisation or cystoid macula edema.

This type of treatment is only available in the UK on the NHS for people who have wet AMD. If it does help people with choroidal neovascularization (CNV) or cystoid macular edema (CME), (possible complications of birdshot chorioretinoapthy), as this research would indicate, we need to take action and lobby for it as a possible treatment.

Disease severity and outcomes with immunomodulation in Irish Patients with Birdshot Chorioretinoapthy. D.J. Kilmartin, A.C. Hogan, S. Jungkim, P. Kenna, Dept of Ophthalmology and Research Foundation, Royal Victoria Eye & Ear Hospital, Dublin, Ireland

Objective: To assess disease severity and outcomes in Irish BirdshotChorioretinopathy (BCR) patients when first receiving immunomodulatory therapy.

Methods: Retrospective case series of 11 BCR patients attendinga national tertiary uveitis clinic. Data collected included demographic details, functional assessment with fluorescein angiography, optical coherence tomography, Goldmann perimetry, electrophysiology, immunotherapy and clinical outcomes.

Results: Twenty two eyes of 11 patients, 7 female and 4 male, mean age 42 years with a mean follow up of 16 months (range 7-80) were assessed. At initial referral, Snellen visual acuity was 6/12 or better in 91% and 6/6 in 45% eyes; twenty eyes had active intraocular inflammation with choroiditis/vitritis (20), disc swelling (10), cystoid macular oedema (8). At baseline severe optic nerve dysfunction was evident in all eyes with reduced colour vision on Ishihara plate testing (14), blind spot enlargement (20) and paracentral scotomas (14) on Goldmann visual field, reduced amplitudes of pattern visual evoked responses (9) and advanced optic atrophy (2). Mean duration to tertiary referral was nine months (range 1-24) and 55% had a previous oral prednisolone pulse. During follow up patients were treated with oral prednisolone (11), mycophenolate mofetil (9, 2 intolerant) and tacrolimus (4). Disease relapses (n=19) occurred in 6 patients after achieving clinical inactivity, 58 % attributable to cystoid macular oedema. At latest follow up 73% of eyes had Snellen visual acuity 6/12 or better and were clinically inactive but all eyes had persistent optic nerve dysfunction.

Conclusions: Despite good presenting visual acuity, all Irish BCR
patients had significant optic nerve disease. Although treated
appropriately with combination immunosuppression, there was no
demonstrable improvement in optic nerve function due to delayed presentation.