In Contact - July 2007

Water on the Brain?

Following statements made in recent columns, I can confirm that I am indeed regularly bilious from the almost non-stop solution and lens recalls this past year. I hope my gastric distress is not amoebic in origin!
Cause or effect?
Not wanting to be a hypochondriac, I do however suspect I am now also suffering from water on the brain.
Tap water and issues surrounding acanthamoeba have once again been highlighted by AMO?s voluntary recall. Complete was linked to a significant number or acanthamoeba keratitis [AK] cases by the CDC in the US.
I won?t repeat specifics here as they are detailed in this link and at the FDA.
I suggest one takes a look at the American Academy of Optometry?s ?Best Practice? document for some useful info. The AOA also has some guidelines.
Every time acanthamoeba raises its ugly, virulent head, tap water gets a soaking.
There have been suggestions that a reduction in chlorination of tap water in the US may have sparked an apparent increase in reported cases of AK. We know that tank water, spa pools, and certain other water sources carry a higher risk. Recent research in Korea shows acanthamoeba and other free-living amoeba are present at significant levels in tap water.
Apparently the US EPA was concerned by health risks associated with disinfection by-products [DBPs]. The DBPs are created by, among other things, the chlorine breakdown of organic contaminants in water. As reported in a paper by Joslin and Tu, the EPA have thus apparently altered chlorination over the past decade and this may be contributing to this latest AK scare.
Of course further study is under way.
Here?s the very latest paper by Joslin et al. It's so current It's not even hot off the press as It's still, as I write, in press. A number of respected Australasian eye care personalities are also about to publish a review article - planned well before the current AK scare - in a forthcoming edition of CEO. Subscribers can access it via the usual channels under ?List of Issues?, ?Early online articles?. There are a number of other local practitioners who have published acanthamoeba related papers.
The current issue of CEO is, coincidentally, chock-full of papers relating to something I've featured a number of times in this column; as recently as April ?07. Clinical and Experimental Optometry July 2007 - Vol. 90 Issue 4, has around seven articles dedicated to EBM, including two editorials on the subject from respected leaders of the profession.
Anthony Adams? editorial is but one I would highly recommend reading.
I do hope balance prevails?

AK47

Speaking of balance the aforementioned AK story merely highlights the solution industry?s problems. I've tried to avoid writing about it for a few months but it just won?t go away.
It's a pain in the proverbial.
It doesn?t matter where you stand. It has effects, costs money for all concerned and is a down right hassle.
One can only have strategies to minimise impact.
On the other hand prevention is better than cure.
Fortunately a preference for and practise built on a high level of dailies and RGPs, with a long stated dislike for no-rub multipurpose, has helped minimise impact. Backup systems, strategies and communication all help limit potential problems.
As I've said many times:
Long term safety and corneal integrity are paramount in contact lens care.
Compliance is but one problem. A whole raft of corporate branded and re-badged MPS, with varying formulae and care instructions, have confused consumers and confounded contact lens practitioners. Different labels and even totally different names from country to country also cause problems. Corporate sell off?s, merger-acquisitions and formulation changes have tested patients and patience. Bureaucratic delays have helped, compounded and confounded the issues.
As bureaucracy does.
It's not conducive to stability. It's not good for contact lenses.

Moving Right Along

I hope all this, as well as CIEs, staining and other issues are resolved effectively. It should be a lesson to all. I trust that commonsense prevails and that better, safer systems are developed.
Ideally, the industry must increasingly move further toward and focus more energetically on high-tech, low-cost, biocompatible daily concepts. There are a number of next generation packaging, delivery and lens systems evolving right now. If the money spent on years of solution development, chemicals galore, trials, marketing, packaging, transport and so on, were redirected toward daily concepts there?d be a significant shot in the arm and an immediate boost to R&D.
Recent sales, mergers and potential deals have totalled in the hundreds of millions and some top five billion. There are some interesting facts, history and interesting developments afoot, all tied in with all sorts of mergers and international trading agreements. A lot of it is in Asia, a large, progressively myopic developing market. Companies that were unheard of until recently and others that were only valued at a few million dollars a decade ago are now ?worth? hundreds of million. Money talks.
We?ll see all manner of comings and goings for some time I suspect.
Some good developments are in the pipeline that will enhance safety and efficacy.
The roosters do however also come home to roost, from time to time. It cannot be all about profit and shareholders. When things get over-heated, a correction or crash is sure to follow. Ultimately the housing market, exchange rates and the silly money being thrown around by cash-rich private equity firms will suffer similarly. It's starting to look a bit like the conditions that prevailed just prior to the dotcom and 1987 crash, if you ask me.
Safety, efficacy and practicality must win the day.

Rocket Fuel or H20?

Last month we briefly considered poor wetting..
Allergy, as a cause or effect, was part of it.
Wetting of RGPs can be a problem for some wearers. Allergy, material and solution issues are not always the problem. I've covered contamination, environmental issues, make-up, face & hand cr?mes and residues from, in particular moisturising soap, ad-nauseum in this column for nigh on twenty years.
This tap water issue made me recall an interesting conversation I had at the GKC in Las Vegas.
I first met the person concerned at the 11th ICLC meeting in Hunter Valley in 2004. We had a long, detailed chat about contact lenses, late into the night under a starry Aussie sky, drinking fine Aussie wine.
As you do.
One often learns more in such encounters, in much more pleasant surroundings, than one does in enforced, regurgitated CPD sessions.
Of course no CPD points are awarded for such learning.
I digress?
At any rate this experienced hands-on contact lens manufacturer knew a thing or two about RGPs and their problems. We kept in contact over the years and arranged to catch up at the GKC, this past January ?07.
Of course RGPs cropped up again. We talked about how some patients, irrespective of material, solutions, hand washing and elimination of cr?mes and cosmetics, still seem to grease up a lens. No matter what.
Sometimes right from insertion.
He suggested tap water was the possible cause.
?Tap water?? I asked.
He?d recently opened a new lab. The lab had top quality water filtration systems and all the necessary ?clean room? and handling technology. Lenses they produced were superbly cleaned and were shown to wet well. They did however receive some complaints about wetting from an adjoining contact lens practise. Lenses that had simply travelled through a few doors would have wetting problems when fitted to patients. They couldn?t figure it out.
From personal experience I suggested that maybe a staff member using hand cr?me or similar was responsible? I was wrong.
The same solutions were used in the manufacturer and the practise. They discovered that the lenses were checked, cleaned, rinsed with tap water and then disinfected prior to checking on the patient. They thus analysed the tap water: A direct from mains source as opposed to the lab?s super-filtered supply. They filtered the water and the wetting problems promptly resolved. I was astounded.
What was the problem, I asked? Petroleum products I was told! At a level that exceeded US EPA standards.
While digging around for information about tap water standards in the US for the acanthamoeba story I thought ?Let?s take a look and see if I can find some official confirmation of this interesting information I was given?.
Could some US tap water now include significant levels of petroleum products?
It turns out it is not only possible, but a documented fact. Check out this site. You will see that item #1 records that rocket fuel is present in tap water. I also recall that after hurricane Katrina in New Orleans, there was and may well still be petroleum contamination of tap water.
It really is rocket science!

Perspective.

Tap water and acanthamoeba are certainly very interesting and complex topics but of course one has to keep perspective.
Less than a hundred years ago, lack of chlorination of tap water led to innumerable deaths, from a multitude of bugs. Some regard chlorination of tap water as one of the major successes in public health, these past hundred years. The standards and level of testing, for numerous things, is extensive.
It is of course interesting to note that acanthamoeba did not even warrant a mention in a major review of waterborne bugs and tap water. Nor is it a test organism in the FDA evaluation of contact lens solution efficacy.
Not for much longer I suspect?
If you?re interested in this broad ranging subject check out the FDA?s 510(k) guidelines for the necessary standards, controls and tests - many pertaining to safety - that surround solutions, preparations for use in the eye and with contact lenses: All one hundred and seventy two pages of closely spaced text and standards. Acanthamoeba gets only two mentions, and that limited to the risk associated with homemade saline - from salt tablets and distilled water - a practice that had all but died by the late seventies and early eighties. Another paper gives it ten mentions and describes the history of why acanthamoeba was not included as a challenge organism.
It's not as if nobody at the FDA or EPA cares. They apparently care plenty. Decades of scientific research and bureaucracy have seen to the development of highly involved standards. Mostly they work well to ensure public safety.
Unfortunately life is complex and not without risk.
A litigious society has seen to it that large multinationals [and others] have no choice but to execute crippling recalls. They get stung whether they do it sooner or later.
Sooner is usually better??

Carpe Diem

Full credit to the ABs on their great win over the Boks.
Most would agree it was the first significant game of the season. I figured whoever won this game would take the Tri Nations. The Wallabies and Boks will have to dig deep to stop the ABs taking home the trophy. I do however still think the RWC will be a different scenario and would dearly like to see an AB/Bok final.
The Aussies did well in the opener, as predicted. One can never underestimate those Ockers. The ABs and Boks have learned that lesson the hard way over the years. Although the Bok?s winning drop-goal formula worked for that game, Steyn went from hero to zero in the AB encounter as he had a shocker in the last ten.
Lewis Hamilton continues to break every rookie record worth breaking in Formula 1. He now leads the world championship with a race in hand after just seven races. After placing third in his very first F1GP, he followed up with four consecutive second places and then two wins in a row?
Isn?t life amazing?

 

For more information or any comments email Alan at incontact@optom.co.nz.