THOUSANDS of deaths from colon cancer could be prevented by a drug that wipes
out rogue polyps in the lower bowel. The drug, called exisulind, has been
submitted for approval to the US Food and Drug Administration and may get the
green light before the end of the year.
If an American licence is followed by European approval it could provide a
new source of controversy for Britain鈥檚 cash-strapped National Health Service,
experts warn. John Burn, professor of clinical genetics at the University of
Newcastle upon Tyne, told 快猫短视频 that cost would be a 鈥渕ajor
factor鈥� in deciding whether British patients get the drug, which would need to
be taken for long periods.
Results from a phase III study unveiled late last month show exisulind鈥檚
potential to protect patients with a genetic predisposition to colon cancer.
People with this condition, called familial adenomatous polyposis (FAP), have a
tendency to grow polyps in their lower intestine that can turn cancerous. The
new drug works by causing such polyps鈥攂ut not healthy cells鈥攖o
wither and die. Results of a lab study to be published later this month in
Cancer Research show that the drug kick-starts the programmed cell-death
mechanism鈥攁poptosis鈥攊n polyp cells.
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FAP affects around 1 in 10 000 people in developed countries and unless
treated is likely to lead to colon cancer in early adulthood. To avoid this,
teenagers with FAP often have part of their bowel surgically removed. But polyps
can still appear in the rectum. Clinical studies by Cell Pathways of Horsham,
Pennsylvania, which developed exisulind, have shown impressive eradication of
polyps from the rectum of patients who have already had parts of the bowel
removed, but who attend clinic once or twice a year to check for new polyps in
remaining parts of their lower intestine.
鈥淪ome patients are polyp-free,鈥� says Rifat Pamukcu, founder of Cell Pathways
and vice-president of R&D at the company. 鈥淢y hope would be that we reduce
the need for surgery,鈥� he says.
The clinical trials show that sustained use of the drug roughly halved the
number of polyps for each year patients took it. The team wants to test the
drug鈥檚 ability to ward off polyp growth in younger people with FAP and so
eliminate the need to take out their bowel.
David Harrison, head of pathology at the University of Edinburgh, says that
the drug provides a welcome new slant away from aggressive therapies. He says
that if the drug is safe enough to be taken long-term, it might be possible to
delay removing the colon in patients with FAP, or even avoid the operation
altogether.
But, questions over Britain鈥檚 ability to afford pricey new cancer drugs came
to the fore last year when the Cancer Research Campaign surveyed the use of the
innovative British-developed brain tumour treatment temozolomide. Rationing in
Britain鈥檚 health service meant the drug was being used 10 times as much in
France, Italy and Germany.
Gordon McVie, the CRC鈥檚 director-general, says the National Institute for
Clinical Excellence鈥攆ormed last year to judge whether treatments are
sufficiently cost-effective to be available on the NHS鈥攎ight rule against
the drug, or take years to approve it because of the huge backlog of treatments
it is currently reviewing. 鈥淭his is a real worry,鈥� he told 快猫短视频.