Drugs firm blocks cheap blindness cure
- From: J <nswex@nalid;non>
- Date: Fri, 28 Dec 2007 04:06:49 -0500
http://www.guardian.co.uk/medicine/story/0,,1799772,00.html
Drugs firm blocks cheap blindness cure
Company will only seek licence for medicine that costs 100 times more
Sarah Boseley, health editor
Saturday June 17, 2006
A major drug company is blocking access to a medicine that is cheaply and
effectively saving thousands of people from going blind because it wants
to launch a more expensive product on the market.
Ophthalmologists around the world, on their own initiative, are injecting
tiny quantities of a colon cancer drug called Avastin into the eyes of
patients with wet macular degeneration, a common condition of older age
that can lead to severely impaired eyesight and blindness. They report
remarkable success at very low cost because one phial can be split and
used for dozens of patients.
But Genentech, the company that invented Avastin, does not want it used
in this way. Instead it is applying to license a fragment of Avastin,
called Lucentis, which is packaged in the tiny quantities suitable for
eyes at a higher cost. Speculation in the US suggests it could cost £1,000
per dose instead of less than £10. The company says Lucentis is
specifically designed for eyes, with modifications over Avastin, and has
been through 10 years of testing to prove it is safe.
Unless Avastin is approved in the UK by the National Institute for
Clinical Excellence (Nice) it will not be universally available within the
NHS. But because Genentech declines to apply for a licence for this use of
Avastin, Nice cannot consider it. In spite of the growing drugs bill of
the NHS, it will appraise, and probably approve, Lucentis next year.
Although Nice's role is to look at cost-effectiveness, it says it cannot
appraise a drug and pass it for use in the NHS unless the drug is referred
to it by the Department of Health. The department says its hands are tied.
"The drug company hasn't applied for it to be licensed for this use. It
wouldn't be referred to Nice until they have made the first move," said a
Department of Health spokeswoman. "They need to step up and get a licence.
If they are not getting it licensed, why aren't they?"
New drugs for the condition are badly needed: those we have now only slow
the progression to blindness. With Avastin, many patients get their sight
back with just one or two injections.
Avastin was first used on human eyes by Philip Rosenfeld, an
ophthalmologist in the US, who was aware of animal studies carried out by
Genentech that showed potential in eye conditions. This unlicensed use of
Avastin has spread across continents entirely by word of mouth from one
doctor to another. It has now been injected into 7,000 eyes, with
considerable success.
Professor Rosenfeld has published his results and a website has been
launched in the US to collate the experiences of doctors from around the
world. But although the evidence is good, regulators require randomised
controlled trials before they grant licences, which generally only the
drug companies can afford to carry out.
Prof Rosenfeld said the real issue was drug company profits. "This truly
is a wonder drug," he said. "This shows both how good they [the drug
companies] are and on the flip side, how greedy they are." He would like
to see governments fund clinical trials of drugs such as Avastin in the
public interest.
Rising drug bills are a big problem on both sides of the Atlantic. In the
UK, said David Wong, chairman of the scientific committee of the Royal
College of Ophthalmologists, doctors are fighting battles to persuade
primary care trusts to pay for drugs to stop their patients going blind
while they wait for Nice to decide on Lucentis and another expensive drug
called Macugen. That decision is not expected before the end of next year.
About 20,000 people are diagnosed with age-related macular degeneration in
the UK each year. "From the patient's point of view, if they have an eye
condition that deteriorates very quickly, there is no question of
waiting," said Professor Wong. "We're talking about days and weeks, rather
than months. The question is should we do nothing and say there is no
randomised controlled trial to prove Avastin is of value?" He called for
primary care trusts to agree to pay for the planned phasing-in of new
drugs for the condition.
Last night Genentech said its main concern over the use of Avastin to
treat eye conditions was patient safety. "While there are some small,
single-centre, uncontrolled studies of Avastin being performed, safety
data on patients who are treated with Avastin off-label is not being
collected in a standard or organised fashion," said a spokeswoman for the
company.
Pharmaceutical firms say they need to launch drugs at high prices because
of the hundreds of millions of pounds spent on developing them. Critics
point out that the company's calculations also include the marketing
budget.
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I have not searched clinical trials to ascertain if there's (been) more
recent trials on this.
(IOW to ascertain if what they say is true and/or the results).
http://en.wikipedia.org/wiki/Macular_degeneration
Advanced AMD, which is responsible for profound vision loss, has two
forms: dry and wet. Central geographic atrophy, the dry form of advanced
AMD, results from atrophy to the retinal pigment epithelial layer below
the retina, which causes vision loss through loss of photoreceptors (rods
and cones) in the central part of the eye. While no treatment is available
for this condition, vitamin supplements with high doses of antioxidants,
lutein and zeaxanthin, have been demonstrated by the National Eye
Institute and others to slow the progression of dry macular degeneration
and in some patients, improve visual acuity.
Neovascular or exudative AMD, the wet form of advanced AMD, causes vision
loss due to abnormal blood vessel growth in the choriocapillaries, through
Bruch's membrane, ultimately leading to blood and protein leakage below
the macula. Bleeding, leaking, and scarring from these blood vessels
eventually cause irreversible damage to the photoreceptors and rapid
vision loss if left untreated.
Until recently, no effective treatments were known for wet macular
degeneration. However, new drugs, called anti-angiogenics or anti-VEGF
(anti-Vascular Endothelial Growth Factor) agents, when injected directly
into the vitreous humor of the eye using a small, painless needle, can
cause regression of the abnormal blood vessels and improvement of vision.
The injections frequently have to be repeated on a monthly or bi-monthly
basis. Examples of these agents include Lucentis, Avastin and Macugen.
Only Lucentis and Macugen are FDA approved as of April 2007. Macugen has
been found to have only minimal benefits in neovascular AMD and is no
longer used. Worldwide, Avastin has been used extensively despite its "off
label" status. The cost of Lucentis is approximately $2000 US while the
cost of Avastin is approximately $150.
http://en.wikipedia.org/wiki/Lucentis
Ranibizumab (trade name Lucentis) is a monoclonal antibody fragment
derived from the same parent murine antibody as bevacizumab (Avastin). It
is much smaller than the parent molecule and has been affinity matured to
provide stronger binding to VEGF-A. It is an anti-angiogenic that has been
approved to treat the "wet" type of age-related macular degeneration
(ARMD), a common form of age-related vision loss.
Ranibizumab was developed by Genentech and is marketed in the United
States by Genentech and elsewhere by Novartis [1], under the brand name
Lucentis.
More here http://en.wikipedia.org/wiki/Bevacizumab
J
.
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