Xenical en kanker
Er was eens een fabrikant die met een
wondermiddel op de markt kwam voor mensen met overgewicht. De markt reageerde positief op
het nieuwe medicijn en de vele journalisten papagaaiden het goede nieuws weer door want is
weer goed voor de oplages (weet u nog, de DNA afslankpil!).
Dus dacht de fabrikant laten we eens
denken aan schaalvergroting en eens kijken naar een over de toonbank middel (zonder
recept). De Amerikaanse keuringsdienst FDA zag geen problemen dus alles leek erop dat het
Xenical sprookje een mooi einde zou krijgen.
Maar het sprookje werd bruut verstoord
door de boze heks in de vorm van een Amerikaanse consumenten organisatie die het middel
het liefst zo snel mogelijk ziet verdwijnen gezien de resultaten van de studies die werden
gedaan door de fabrikant.
Het wondermiddel bleek toch wat minder
fijne kantjes hebben die wat minder bekend waren bij het grote publiek dus blies deze
organisatie het mooie sprookje uit en komt het medicijn nu op een heel andere manier in
het middelpunt van de belangstelling.
De FDA wordt blijkbaar ook weer eens in
zijn hemd gezet en ligt wederom onder vuur. Volgens deze organisatie is aspartaam niet
schadelijk, kan kwik in vaccins geen kwaad maar kwik in vis wel, en moest het feit dat er
in limonade met extra vitamine C benzeen kan zitten 15 jaar worden stilgehouden. Dus het
sprookje zal waarschijnlijk geen leuk einde krijgen voor de farmaceuten die toch al zo
onder vuur liggen.
In het verleden heeft de consumenten
organisatie Public Citizen ook al jaren eerder gewaarschuwd voordat medicijnen zoals
Vioxx, Ephedra, Bextram, Baycol, Rezuline van de markt werden gehaald na oa veel druk van
consumenten.
Ron
Petition to the FDA to
immediately remove the diet drug orlistat (XENICAL) from the market
April 10, 2006
Andrew Von Eschenbach, M.D., Acting
Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Von Eschenbach:
Public Citizen, representing more than
100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA)
pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21
C.F.R. 10.30, to immediately remove from the market, the prescription version of Xenical
(orlistat, Roche Pharmaceuticals). This drug, which treats obesity, causes a significant
increase in the incidence of aberrant crypt foci, which are widely believed to be a
precursor of colon cancer.[1],[2] This finding makes it even clearer how ill-advised
switching orlistat to OTC status would be, something FDA is currently considering. (An
“approvable” letter, meaning FDA will approve the drug if certain conditions are
met, is said to have been sent by the FDA to Glaxo—the manufacturer of the OTC
version---in the past several days.) We are joined in this petition by Dr. Theresa
Pretlow, Professor of Pathology and by Dr. Thomas Pretlow, Professor in the Departments of
Pathology, Urology, Oncology, and Environmental Health Sciences at Case Western Reserve
School of Medicine. Their research, consisting of some 42 papers on colorectal cancer
including 15 specifically on aberrant crypt foci, has helped to establish the relationship
between aberrant crypt foci and colon cancer.
As Director of the National Cancer
Institute, which has funded a substantial portion of the work by Drs. Pretlow establishing
the link between ACF and colon cancer, you have repeatedly talked about preventing death
and suffering from cancer. The failure to ban the prescription version of this drug or,
worse, to make it much more widely available by allowing OTC sales, is a decision that is
likely to increase cancer incidence.
http://www.citizen.org/publications/release.cfm?ID=7423
Roche Meeting with Stiff
Opposition to Its Efforts to Market Xenical as an OTC Diet Drug
Pharmaceutical giant Roche Holding AG had
hoped for a smooth approval of Xenical as the first over-the-counter (OTC) weight-loss
drug. Xenical is manufactured by Roche Pharmaceuticals (a unit of Roche Holding AG) and is
the higher-dose version of the OTC spin-off that will be sold under the name orlistat.
Once an FDA advisory committee had voted 11-3 to recommend the OTC version of Xenical for
marketing, Roche had assumed final approval was assured. Now, however, that pathway seems
less sure.
http://www.newsinferno.com/archives/1078
Xenical Fat Blocker and Cancer
Risks
According to new research, fat blocker,
Xenical has been allegedly linked to aberrant crypt foci (ACF), the earliest sign of colon
cancer. During initial clinical trials, Xenical also showed an increased risk of breast
cancer and vitamin deficiency. Xenical (orlistat) is a pharmaceutical drug used to help
obese or overweight adults and children lose weight by blocking and preventing fatty food
from being digested. Xenical is prescribed to patients with a body mass index of 27 or
more. Essentially, it blocks one-third of the fat from being absorbed into the body.
http://www.lawyersandsettlements.com/case/xenical_cancer
Consumer group calls for Xenical
withdrawal
The petition, which was also signed by
Theresa Pretlow and Thomas Pretlow, both pathology professors at Case Western Reserve
School of Medicine, has cited two studies that showed those patients on Xenical lost about
13 pounds while those not receiving the drug lost seven pounds. It described orlistat as
“a drug that has shown minimal efficacy coupled with a still unresolved potential to
cause breast and colon cancer”.
http://www.pmlive.com/pharm_market.cfm?show
Article=1&ArticleID=4538
Details: Theresa P. Pretlow,
Ph.D. (Professor)
Mailing Address:
10900 Euclid Ave.
Cleveland, OH 44106-7288
Tel (216) 368-8702
theresa.pretlow@case.edu
http://www.cwru.edu/med/pathology/fac/pretlow_ter.html
Dr Theresa Pretlow is interested in the
development of cancer, i.e., the changes that take place during the transformation of
normal cells to malignant ones. Aberrant crypt foci (ACF) are lesions that were first
identified microscopically in unembedded colons from rodents as soon as 2 weeks after a
single dose of carcinogen. Her laboratory was the first to report these lesions in the
macroscopically normal colonic mucosa of humans. The frequency of these lesions is
increased in patients with colon cancers compared to those without colon cancer and in
patients with hereditary conditions such as familial adenomatous polyposis (FAP) compared
with patients with sporadic colon cancer.
Links
http://www.usatoday.com/news/health/2006-04-10-xenical-otc_x.htm
