[Viva] Fwd: CTAC Daily Info - January 4

Wed Jan 5 10:52:21 PST 2011

I am particularly pleased with #3.  The Indian Govt has refused a patent
request in its country which means cheaper medicine by Cipla can reach its
citizens - yay!
Here's for all those countries that are standing up to big pharma.
Denise

---------- Forwarded message ----------
From: Ken Buchanan <kenb at bcpwa.org>
Date: Wed, Jan 5, 2011 at 10:04 AM
Subject: CTAC Daily Info - January 4
To: BCPWA Group <BCPWAGroup at bcpwa.org>

 In this e-mail:

1.      2010 Federal Disability Report / Rapport fédéral sur les personnes
handicapées de 2010

2.      FDA Approves Gardasil as First Anal Cancer Vaccine

3.      Abbott's Kaletra HIV-Drug Patent Rejected in India, Allowing Cipla
Copies

4.      J&J helps develop blood test to spot 1 cancer cell in a billion
healthy ones

1.

*2010 Federal Disability Report / Rapport fédéral sur les personnes
handicapées de 2010*

Le français suit l'anglais

Dear Colleagues,

It is with pleasure that we share with you the 2010 Federal Disability
Report, released by Human Resources and Skills Development Canada.

The report can be accessed in HTML or PDF format on the internet at:

http://www.hrsdc.gc.ca/eng/disability_issues/reports/fdr/2010/page00.shtml

Print and alternate formats (Large Print, Braille, Audio Cassette, Audio CD,
e-Text Diskette, e-Text CD or DAISY) can be ordered by phone, TTY, fax, mail
or online.

Phone: 1 800 O Canada (1 800 622 6232)

TTY: 1 800 926 9105.

Fax: 819-953-7260 (long distance charges will apply)

Mail: Publications Services, HRSDC, 140 Promenade du Portage, Phase IV, 12th
Floor, Gatineau, QC, K1A 0J9

Online: http://www12.hrsdc.gc.ca

Kind regards,

The Office for Disability Issues

--

Chers collègues,

Nous sommes heureux de vous présenter le Rapport fédéral sur les personnes
handicapées de 2010, produit par Ressources humaines et Développement des
compétences Canada.

Vous pouvez consulter le rapport en format HTML ou PDF sur Internet au lien
suivant :

http://www.rhdcc.gc.ca/fra/condition_personnes_handicapees/rapports/rhf/2010/page00.shtml

Vous pouvez commander des formats imprimés et substituts (gros caractères,
braille, audio sur cassette, audio sur CD, fichiers de texte sur disquette,
fichiers de texte sur CD ou DAISY) par téléphone, par ATS, par télécopieur,
par la poste ou en ligne.

Téléphone : 1-800-O Canada (1-800-622-6232) ATS : 1-800-9269105 Télécopieur
: 819-953-7260 (des frais d'interurbain s'appliqueront) Poste : Services de
publications, RHDCC, 140, promenade du Portage, Phase IV, 12e étage,
Gatineau (Québec)  K1A 0J9 En ligne : http://www12.rhdcc.gc.ca

Veuillez agréer l'expression de nos sentiments distingués.

Le Bureau de la condition des personnes handicapées

2.

*FDA Approves Gardasil as First Anal Cancer Vaccine*

http://www.aidsmeds.com/articles/hiv_gardasil_anal_1667_19644.shtml

December 23, 2010

The U.S. Food and Drug Administration (FDA)
announced<http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237941.htm>December
22 that it has approved the first vaccine to prevent anal cancer
for males and females ages 9 to 26. The vaccine, called Gardasil, was
already approved to prevent genital warts and cervical cancer in girls and
young women as well as genital warts in boys and young men.

Gardasil is a vaccine that targets four strains, or types, of human
papillomavirus (HPV): Types 6 and 11, known to causes genital warts, and
types 16 and 18, known to cause cervical and anal cancer. It was first
approved in 2006 to prevent both genital warts and cervical cancer in girls
and women ages 9 to 26, and later approved in 2009 to prevent genital warts
in boys and young men, which it does quite effectively. Until now, however,
the drug has not been approved to prevent anal cancer.

Though anal cancer is relatively rare in the general population, rates are
far higher in men who have sex with men (MSM), and it’s nearly 60 times more
common in HIV-positive MSM. For this reason, providers who treat people with
HIV have been eager to see the vaccine approved for this purpose.

“Treatment for anal cancer is challenging; the use of Gardasil as a method
of prevention is important as it may result in fewer diagnoses and the
subsequent surgery, radiation or chemotherapy that individuals need to
endure,” said Karen Midthun, MD, director of the FDA’s Center for Biologics
Evaluation and Research in Rockville, Maryland.

When Gardasil was first approved in 2009 to prevent genital warts in males,
the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices
declined<http://www.poz.com/articles/hiv_gardasil_anal_761_19439.shtml>to
recommend vaccination for all boys and young men, as it had for girls
and
young women. Activists have been hoping that FDA approval for anal cancer
prevention will convince the CDC panel to make this recommendation and
therefore lead public and private health insurance to cover Gardasil’s cost
in boys and young men, which most currently do not.

3.

*Abbott's Kaletra HIV-Drug Patent Rejected in India, Allowing Cipla Copies*

By Adi Narayan Bloomberg - Jan 4, 2011 1:57 AM El
http://www.bloomberg.com/news/2011-01-04/india-rejects-patent-application-for-abbott-s-kaletra-hiv-drug.html

Abbott Laboratories was refused copyright protection on its AIDS drug
Kaletra by India’s patent office, allowing Cipla Ltd. and other generic-drug
companies to continue selling copies.

Steps involved in making Kaletra “do not constitute an invention,” the
agency’s Mumbai office said in documents dated Dec. 30. The patent
application by Abbott Park, Illinois-based Abbott had been challenged by the
Initiative for Medicines, Access & Knowledge, as well as Cipla and Matrix.

Abbott is reviewing the patent decision and determining its next steps,
spokesman Scott Stoffel said today. Newer versions of the drug don’t require
refrigeration and needn’t be taken with food, making them better suited for
patients in developing countries, he said.

Kaletra, which combines two antivirals, is one of the preferred second-line
treatments to fight drug-resistant HIV, according to the World Health
Organization, which recommends governments include it on their list of
essential medicines. The product generated about $1.37 billion in sales in
2009, making it Abbott’s second-best seller after the arthritis drug Humira.

--------------------

*Abbott's HIV drug patent plea rejected for lack of novelty*

BS Reporter / New Delhi January 04, 2011, 1:23 IST
http://business-standard.com/india/news/abbott%5Cs-hiv-drug-patent-plea-rejected-for-lacknovelty/420650/

India has rejected an HIV drug patent application filed by US-based Abbott
Laboratories, as it lacked “novelty” under domestic laws. The denial of
patent will help domestic drug-makers to produce and market low-cost
versions of this drug in the developing world.

The rejection of Abbott’s patent application over a combination of lopinavir
and ritonavir, sold under the brand name Aluvia, ended the four-year long
intellectual property battle between the company and four pre-grant
opponents.

In its order on December 30, Mumbai patent office said the drug lacked
novelty and did not have any innovative production steps to qualify for
patent protection under domestic laws. The Indian Patent Act does not permit
patenting of incremental innovations of known substances.

Hailing the verdict, civil society groups said it sets an important
precedent to stop pharmaceutical companies from “gaming” the patent system.

“New formulations of Kaletra (another brand name) have provided physicians
and patients with real improvements in its use, dosing and convenience. The
heat stable solves specific convenience limitations of Abbott's earlier
version, which required  refrigeration and had to be taken with food. These
challenges have been resolved with the new tablet, and there is significant
benefit for patients in developing countries and resource limited settings.
Abbott is reviewing this decision and determining its next steps,” wrote
Scott Stoffel, spokesperson of Abbott in an e-mail response.

The pre-grant opposition against Abbott’s patent application was filed by a
non-profit organisation, Initiative for Medicines, Access & Knowledge
(I-MAK) and domestic pharmaceutical companies Cipla, Okasa and Matrix.
According to I-MAK, the combination of lopinavir and ritonavir is considered
to be the front line of defense for HIV positive patients who have failed to
stay healthy with the first round of medicines available today.

“India, the world’s leading supplier of affordable medicines, can now supply
this drug to patients across the globe who are desperately waiting for
treatment,” a statement from I-MAK said.

The Clinton Health Access Initiative had recently negotiated a price of $440
(about Rs20,000) per patient per year for generic versions of this drug from
four suppliers.

According to I-MAK, Abbott holds at least 75 patents on this particular
combination drug. The verdict can be challenged in the appellate body, the
Intellectual Property Appellate Board. It is not clear whether Abbott would
do so.

4.
*J&J helps develop blood test to spot 1 cancer cell in a billion healthy
ones*

[image: The Canadian Press] <http://www.thecanadianpress.com/>*By **Marilynn
Marchione, The Associated Press** | **The Canadian Press** – Mon, 3 Jan
12:17 AM EST*

BOSTON - A blood test so sensitive that it can spot a single cancer cell
lurking among a billion healthy ones is moving one step closer to being
available at your doctor's office.

Boston scientists who invented the test and health care giant Johnson &
Johnson will announce Monday that they are joining forces to bring it to
market. Four big cancer centres also will start studies using the
experimental test this year.

Stray cancer cells in the blood mean that a tumour has spread or is likely
to, many doctors believe. A test that can capture such cells has the
potential to transform care for many types of cancer, especially breast,
prostate, colon and lung.

Initially, doctors want to use the test to try to predict what treatments
would be best for each patient's tumour and find out quickly if they are
working.

"This is like a liquid biopsy" that avoids painful tissue sampling and may
give a better way to monitor patients than periodic imaging scans, said Dr.
Daniel Haber, chief of Massachusetts General Hospital's cancer centre and
one of the test's inventors.

Ultimately, the test may offer a way to screen for cancer besides the
mammograms, colonoscopies and other less-than-ideal methods used now.

"There's a lot of potential here, and that's why there's a lot of
excitement," said Dr. Mark Kris, lung cancer chief at Memorial
Sloan-Kettering Cancer Center in New York. He had no role in developing the
test, but Sloan-Kettering is one of the sites that will study it this year.

Many people have their cancers diagnosed through needle biopsies. These
often do not provide enough of a sample to determine what genes or pathways
control a tumour's growth. Or the sample may no longer be available by the
time the patient gets sent to a specialist to decide what treatment to
prescribe.

Doctors typically give a drug or radiation treatment and then do a CT scan
two months later to look for tumour shrinkage. Some patients only live long
enough to try one or two treatments, so a test that can gauge success
sooner, by looking at cancer cells in the blood, could give patients more
options.

"If you could find out quickly, 'this drug is working, stay on it,' or 'this
drug is not working, try something else,' that would be huge," Haber said.

The only test on the market now to find tumour cells in blood — CellSearch,
made by J&J's Veridex unit — just gives a cell count. It doesn't capture
whole cells that doctors can analyze to choose treatments.

Interest in trying to collect these cells soared in 2007, after Haber and
his colleagues published a study of Mass General's test. It is far more
powerful than CellSearch and traps cells intact. It requires only a couple
of teaspoons of blood and can be done repeatedly to monitor treatment or
determine why a drug has stopped working and what to try next.

"That's what got the scientific community's interest," Kris said. Doctors
can give a drug one day and sample blood the next day to see if the
circulating tumour cells are gone, he explained.

The test uses a microchip that resembles a lab slide covered in 78,000 tiny
posts, like bristles on a hairbrush. The posts are coated with antibodies
that bind to tumour cells. When blood is forced across the chip, cells ping
off the posts like balls in a pinball machine. The cancer cells stick, and
stains make them glow so researchers can count and capture them for study.

The test can find one cancer cell in a billion or more healthy cells, said
Mehmet Toner, a Harvard University bioengineer who helped design it.
Researchers know this because they spiked blood samples with cancer cells
and then searched for them with the chip.

Studies of the chip have been published in the journals Nature, the New
England Journal of Medicine and Science Translational Medicine. It is the
most promising of several dozen that companies and universities are rushing
to develop to capture circulating tumour cells, said Bob McCormack,
technology chief for Veridex.

The agreement announced Monday will have Veridex and J&J's Ortho Biotech
Oncology unit work to improve the microchip, including trying a cheaper
plastic to make it practical for mass production. No price goal has been
set, a company official said, but the current CellSearch test costs several
hundred dollars.

The companies will start a research centre at Mass General and will have
rights to license the test from the hospital, which holds the patents.

In a separate effort, Mass General, Sloan-Kettering, University of Texas
M.D. Anderson Cancer Center in Houston and Dana-Farber Cancer Institute in
Boston will start using the test this year. They are one of the "dream
teams" sharing a US$15 million grant from the Stand Up to Cancer telethon,
run by the American Association for Cancer Research.

Already, scientists have been surprised to find that more cancer patients
harbour these stray cells than has been believed. In one study, the test was
used on men thought to have cancer confined to the prostate, "but we found
these cells in two-thirds of patients," Toner said.

This might mean that cancer cells enter the blood soon after a tumour
starts, or that more cancers have already spread but are unseen by doctors.

Or it could mean something else entirely, because researchers have much to
learn about these cells, said Dr. Minetta Liu, a breast cancer specialist at
Georgetown University's Lombardi Comprehensive Cancer Center. She led a
session on them at the recent San Antonio Breast Cancer Symposium and has
been a paid speaker for Veridex. She hopes the cells will someday aid cancer
screening.

"The dream is, a woman comes in for her mammogram and gets a tube of blood
drawn," so doctors can look for cancer cells in her blood as well as tumours
on the imaging exam, she said.

That's still far off, but Mass General's test already is letting doctors
monitor patients without painful biopsies. Like Greg Vrettos, who suffered a
collapsed lung from a biopsy in 2004, when he was diagnosed with lung
cancer.

"It had spread to both lungs and they couldn't operate," said Vrettos, 63, a
nonsmoker and retired electrical engineer from Durham, N.H. Tests from the
biopsy showed that he was a good candidate for the drug Iressa, which he has
taken ever since. He goes to Boston every three months for CT scans and the
blood test.

"They could look at the number of cancer cells and see that it dropped over
time. It corresponded with what the scans were showing," Vrettos said of
doctors looking at his blood tests.

The test also showed when he had a setback last January and needed to have
his treatment adjusted.

"I think it's going to be revolutionary," he said of the test.

Béatrice Cardin

Organizational Development and Communications Manager

Canadian Treatment Action Council (CTAC)

Phone/Fax:  (416) 410-6538

ctac at ctac.ca <ctac at bellnet.ca>

*w*ww.ctac.ca <http://www.ctac.ca/>
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