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Home > Archive > Lasik Eyes Surgery > December 2004 > NHS (UK) and LASIK: FDA and Vioxx, Celebrex - Similarities
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NHS (UK) and LASIK: FDA and Vioxx, Celebrex - Similarities
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| gospa68@aol.com 2004-12-20, 7:17 pm |
| The Cox-2 inhibitor drugs controversy reached an all-time high this
past week due to Pfizer's announcement that Celebrex was implicated in
a 2X normal incidence of myocardial infarctions (heart attacks). Many
predicted this would be the case when Vioxx was first pulled from the
market.
The withdrawal of Vioxx and, now, the related MI problems of Celebrex
are bringing medical marketing into question. Many elements of medicine
have, in recent years, been fueled by marketing. Marketing has drowned
out medical science in pushing drugs and certain medical procedures.
As a result, the media spotlight will be turning to other drugs and
procedures since this subject has captured the public's imagination.
And soon, LASIK will be entangled in this web.
The media spend on LASIK ads reached $350 million in 2000. It fell off
after 9/11 but is on the rise again and is estimated to be about $225
million. A significant difference in this field is that it is not the
manufacturers spending the marketing dollars. While they provide copy
and suggested ads, it is the doctors and delivery systems like TLC that
are underwriting the ads.
The role of the CRSQA and other self-proclaimed "patient advocacy"
groups will be called into question when the curtain rises. These third
party organizations are not independent and are part of the overall
marketing effort.
For those who missed the UK NHS story, it has been included below:
WK
THE LONDON SUNDAY TIMES
December 06, 2004
EYE SURGERY DEEMED TOO RISKY FOR NHS
By Sam Lister
Watchdog says the chances of damage in treatment do not justify
widespread use
Moves to make laser eye surgery available on the NHS are likely to be
blocked by the Government's clinical watchdog amid growing concerns
over its long-term safety for patients.
A year-long review by the National Institute for Clinical Excellence
(NICE) into the procedure known as Lasik, which is currently available
only at private clinics, has concluded that current evidence on the
treatment's safety does not justify its widespread use on the NHS.
The decision comes after revelations in The Times of two American
lawsuits alleging that a type of laser used by Boots, the high street
chemist, could develop faults leading to blurred vision and damage to
eyesight.
Boots, which was unaware of the concerns before being contacted by The
Times, later announced that it would close its nine laser treatment
centres by the end of the year after failing to win public confidence
in the high-tech procedure.
Bruce Campbell, chairman of NICE's interventional procedures advisory
committee, said that there was very little information about how many
people had been harmed as a result of the Lasik procedure.
A draft of the NICE report, to be published on December 15, has
concluded: "There are concerns about the procedure's safety in the
long term and current evidence does not appear adequate to support its
use without special arrangement for consent (from the NHS)."
Professor Campbell said that questions about the potential damage
caused to some patients had not been answered, leaving the treatment a
cause for concern.
"Lasik offers improvement to people who have mild or moderate trouble
with their vision. This is a problem that can easily be corrected by
spectacles or contact lenses, so any risk of damage to the eye by Lasik
is a real concern," he said.
"Although many people have had Lasik treatment, there is very little
information about how many are harmed as a result. We know that vision
gets worse in a few people after Lasik and eye specialists are also
concerned about the effects of thinning the cornea of the eye in the
long term. We need to know more about these potential problems."
In its draft report, NICE concludes: "current evidence does not
appear adequate to support its use without special arrangements for
consent and for audit and research."
As myopia can be corrected safely with spectacles or contact lenses
NICE says that an alternative treatment "must have excellent safety
to be suitable for use".
Laser surgery, which was introduced in Britain in 1989 in the form of
PRK (photo refractive keratectomy) costs about =A32,000 to =A33,000 and
is performed on about 100,000 people each year in Britain.
The model Cindy Crawford, the actress Nicole Kidman and the singer
Barry Manilow are among celebrities reported to have undergone the
procedure.
Lasik is the most popular type, where a flap about one third of the
thickness of the cornea is cut, the bed underneath reshaped using the
laser and then the flap is replaced. Last year the medical journal
Ophthalmology said that the failure rate for eye surgery was one in
ten, not the one in a thousand figure widely advertised.
Which?, formerly known as the Consumers' Association, has said that
people having surgery are "gambling with their sight". It found
that some clinics do not highlight possible side-effects until after
patients are signed up for treatment. The Medical Defence Union said
that negligence claims involving laser eye surgery had more than
doubled among its members since 1998.
Minor side-effects that have been reported are dry eyes and night-time
"starbursts". It is estimated that in about 2 to 4 per cent of
patients there will be a measurable decline in the quality of vision.
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| Glenn - USAEyes.org 2004-12-20, 7:17 pm |
| >The role of the CRSQA and other self-proclaimed "patient advocacy"
>groups will be called into question when the curtain rises. These third
>party organizations are not independent and are part of the overall
>marketing effort.
This is an outright lie. There is absolutely no truth to this
accusation. None whatsoever.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| serebel 2004-12-21, 2:11 am |
| How on Earth can anyone possibly connect or compare viox, etc. to
refractive surgery?
Wizzer, you are truly F...ed up.
SErebel
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| Glenn - USAEyes.org 2004-12-21, 7:11 pm |
| Desperation, that's how.
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| glennhaggle@yahoo.com 2004-12-22, 10:08 pm |
| Absolutely. WizKid is sounding sillier and sillier every day. He must
be running out of scare tactics. After all what could drugs and
refractive surgery devices have in common, other than that they are
developed by pharmaceutical companies and regulated by the FDA?
Glenn Haggle
Executive Director
Council for Refractive Surgery Quality Reassurance
Email to glenn haggle at yahoo dot com
http://www.lasikisnotthatbad.org
http://www.lasikcomplicationsarentthatbadeither.org
I am not Glenn Hagele.
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