Helping kids cope with parents' MS
NorthJersey.com Mon, 31 Jul 2006 4:52 AM PDT
Alyssa, 10, is an avid swimmer. Davoun, 9, likes to rap. Geri Marie, 10, reads a lot. And Donald, 14, is a football player. The kids are from different areas and backgrounds, but they all have one thing in common: Their mothers have multiple sclerosis.

EDITORIAL: Hope for MS Patients
RedNova Fri, 28 Jul 2006 6:03 PM PDT
By Omaha World-Herald, Neb. Jul. 28--Multiple sclerosis baffles all it touches -- medical professionals, victims and victims' families and friends.
Study Being Used Worldwide to Improve Lives of People with MS
Newswise Fri, 28 Jul 2006 2:15 PM PDT
An RTI International study of programs and policies needed to enhance the quality of life for people with multiple sclerosis (MS) is being used around the world to benefit those with the disease.

hello friends,

please see the public document below. Canada (which has a national health plan) purchases Copaxone directly from Teva Neuroscience (the manufacturer in Israel). the COUNTRY of Canada is taking action against Teva for their outrageous pricing practices with Copaxone (see below). i am one of the many who had to stop taking it after 5 months. why? because i couldn't afford it and i'm underinsured. no one could/would help me obtain the medicine. not NORD. not the Montel Williams Foundation. not Clay Walker's "Band Against MS" foundation (they never replied to my e-mails). i exhausted every possible avenue, trying to get the medicine i need. i owe it to my CHILDREN - my 4 and 9 year old daughters, my loves - to try and stave off further disability as long as i can.

i could not take Avonex because it caused high liver enzyme levels and i had to stop taking it and switch to Copaxone. at least Biogen had a "compassionate use" program and they gave me Avonex for free! Teva has no such program and even one of Teva's U.S. pharmacists, Romana Slavik, told me that she was surprised that there was no "compassionate use" program offered by Teva, her own employer! the U.S.. branch of Teva is in Pennsylvania. repeated phone calls to Shared Solutions and Teva last January yielded evasive answers to my queries about the price increase. Shared Solutions told me to call Teva. i called Teva and they told me to call Shared Solutions. the ball kept getting bounced back and forth and honest answers were not forthcoming.

the PRICE for Copaxone (after i did a lot of price comparision shopping nationwide and in Canada) went from approximately $1100 for a 30-day supply last september, to quotes i received last night from 4 different pharmacies telling me the cost would now be over $1800 for a 30-day supply! (to be fair, a couple of pharmacies came in at about $1600). this is absolutely insane. i don't know if Teva raised the cost of Copaxone because they anticipated a loss of revenue with the reintroduction of Tysabri on the market. i'm not sure. in my next post, i will show you PUBLIC figures, wherein Teva, the company itself, is boasting about the HUGE increase in profit they showed in the first quarter of 2006.

i have been making phone calls to Teva in Israel, asking them to EXPLAIN this outrageous cost increase. i have contacted the president and "upper-level" staff at NMSS to find out if they 1. know about this huge price increase and 2. if they know about Canada's action and Teva's posting of record profits.

PLEASE, if you can, go to the Teva Neuroscience website. you can click on "contact us" and SEND THEM AN E-MAIL, DEMANDING AN EXPLANATION FOR THIS BLATANT FINANCIAL EXPLOITATION OF PEOPLE WITH MULTIPLE SCLEROSIS.

thank you so much for wading through this post. next, i will post the Teva profit statement. below is the explanation of the action against Teva, taken by the Canadian government.

caroline

===========================================

IN THE MATTER OF the Patent Act R.S.C. 1985, c. P-4,
as amended

AND IN THE MATTER OF Teva Neuroscience G.P.-S.E.N.C.
(the "Respondent") and the medicine "Copaxone"

NOTICE OF HEARING

TAKE NOTICE that the Patented Medicine Prices Review Board (the "Board") will hold a hearing at its offices in the Standard Life Centre, 333 Laurier Avenue West, 18th Floor, Hearing Room 2, Ottawa, Ontario, commencing on October 16, 2006, at 9:30 a.m., or as soon thereafter as the hearing may be held. A pre-hearing conference has also been scheduled for August 4, 2006, at the Board=s offices, Hearing Room 2, at
9:30 a.m.

A. Purpose of the Hearing

1. The purpose of the hearing is to determine whether, under sections 83 and 85 of the Patent Act (the "Act"), the Respondent is selling or has sold the medicine known as Copaxone in any market in Canada at a price that, in the Board's opinion, is or was excessive and if so, what order, if any, should be made.

B. Power of Board With Respect to Excessive Prices

2. In the event that the Board finds that the Respondent is selling Copaxone in any market in Canada at a price that, in the Board's opinion, is excessive, the Board may, by order, direct the Respondent to cause the maximum price at which the Respondent sells Copaxone in that market to be reduced to such level as the Board considers not to be excessive and as is specified in the order.

3. In addition, in the event that the Board finds that the Respondent has, while a patentee, sold Copaxone in any market in Canada at a price that, in the Board's opinion was excessive, the Board may, by order, direct the Respondent to do any one or more of the following things as will, in the Board's opinion, offset the amount of the excess revenue determined by it to have been derived by the Respondent from the sale of Copaxone:

a) reduce the price at which the Respondent sells the medicine in any market in Canada, to such extent and for such period as is specified in the order;

b) reduce the price at which the Respondent sells one other medicine to which a patented invention of the Respondent pertains in any market in Canada, to such extent and for such period as is specified in the order;

c) pay to Her Majesty in right of Canada an amount specified in the order.

4. In addition, in the event that the Board, having regard to the extent and duration of the sales of Copaxone at an excessive price, is of the opinion that the Respondent has engaged in a policy of selling Copaxone at an excessive price, the Board may, by order, in lieu of any order it may make pursuant to paragraph 3 hereof, direct the Respondent to do any one or more of the things referred to in that paragraph as will, in the Board's opinion, offset not more than twice the amount of excess revenue estimated by it to have been derived by the Respondent from the sale of Copaxone at an excessive price.

C. Grounds for the Proposed Orders and the Material Facts

5. Board Staff has conducted an investigation into the price of Copaxone 20 mg/1.0 mL solution in a pre-filled syringe for subcutaneous injection (DIN 2245619), a patented medicine sold in Canada by the Respondent. The material facts relied upon by Board Staff for the purpose of the Notice of Hearing and the Order sought from the Board are described in the Statement of Allegations of Board Staff dated April 10, 2006, a copy of which is attached.

D. Procedure

6. The Board will conduct this proceeding in accordance with the proposed Patented Medicine Prices Review Board Rules ("Rules"), unless otherwise provided in this Notice of Hearing or in any subsequent communication from the Board.

7. The Board will conduct the hearing in public unless the Board is satisfied on representations made by the Respondent that specific, direct and substantial harm would be caused to the Respondent by the disclosure of information or documents at a public hearing, in which case the hearing or any part thereof may, at the discretion of the Board, be held in private.

E. Response

8. If the Respondent wishes to oppose the proposed Order, the Respondent shall, no later than May 23, 2006, file with the Board and serve upon all other parties, in accordance with section 18 of the Rules, a response dated and signed by the Respondent. Take notice that if the Respondent has not filed a response by

May 23, 2006, or within such longer period as the Board may by order provide, the Board may make such findings and orders pursuant to section 83 of the Act as it deems appropriate.

F. Intervention

9. Ministers referred to in subsection 86(2) of the Act ("Ministers"), who intend to appear and make representations before the Board shall, in accordance with section 20 of the Rules, file with the Board and serve on the Respondent and all other Ministers a statement of intervention, dated and signed by the said Ministers, on or before May 23, 2006.

10. Any person other than the Respondent or Ministers who claims an interest in the subject matter of this proceeding may apply to the Board, in accordance with section 19 of the Rules, for leave to intervene in the proceeding, on or before June 6, 2006.

11. The Respondent and Ministers may make representations with respect to any application to intervene by filing their representations with the Board and serving a copy thereof on the Applicant on or before June 20, 2006.

G. Pre-hearing Conference

12. A pre-hearing conference is scheduled to commence at 9:30 a.m. on August 4, 2006, at the Board's offices, Hearing Room 2, for the purpose of, inter alia, the following:

a) receiving and considering representations and deciding whether disclosure at the hearing of information or documents would cause specific, direct and substantial harm to the Respondent and, if so, determining whether the hearing or any part thereof shall be held in private and the procedure to be followed at such hearing pursuant to subsection 86(1) of the Act;

b) determining applications for leave to intervene in the proceeding;

c) determining the application of subsection 87(1) and related provisions of the Act and the Rules to information or documents, including the attachments referenced in the Statement of Allegations of Board Staff;

d) determining requests for the confidentiality of any document to be filed in the proceeding;

e) determining matters relating to the production of documents;

f) determining motions respecting interlocutory or preliminary matters;

g) determining whether written submissions may be made by parties in addition to or in lieu of oral evidence or representations at the hearing; and

h) determining any other matter provided for under section 21 of the Rules.

13. Parties participating in the pre-hearing conference shall file and serve on all other parties on or before July 28, 2006, a memorandum providing:

a) a concise statement of any issue that the party intends to raise at the
pre-hearing conference together with, for each issue, an identification of the decision sought by the party and the submissions of the party in support of its position;

b) an identification of all documents and information that the party requests to be treated as confidential or privileged in the proceeding together with the submissions of the party in support of each request;

c) any application a party intends to make pursuant to subsection 86(1) of the Act together with the party's submissions relating thereto;

d) any general submissions the party wishes to make respecting the conduct of the proceeding; and

e) the official language or languages that the party wishes to use.

H. Confidentiality Requests

14. Any claim for confidentiality, made in connection with a document filed with the Board or requested by the Board or any party, shall be filed with the Board and served on all parties and accompanied by the reasons therefore, and where it is asserted that specific, direct and substantial harm would be caused to the party claiming confidentiality, the party's claim shall contain sufficient details as to explain fully the nature and extent of such harm.

15. A party claiming confidentiality in connection with a document shall indicate whether the party objects to providing an abridged version of the document to other parties and, if so, shall state the party's reasons for the objection.

16. Any party wishing the disclosure of a document filed with the Board in relation to which there has been a claim for confidentiality may file with the Board and serve on all parties within seven days of being served with the claim for confidentiality:

a) a request for such disclosure setting out the reasons therefore; and

b) any material in support of the reasons for public disclosure.

17. A party claiming confidentiality may file a reply with the Board and serve a copy thereof on the party requesting public disclosure within seven days of being served with the request for disclosure.

I. Preliminary Matters

18. Any preliminary matter proposed to be determined by way of an order of the Board shall be dealt with at the pre-hearing conference and shall be commenced by a notice of motion filed with the Board, in accordance with section 26 of the Rules, and served on all parties on or before July 7, 2006.

J. List of Supporting Documents

• Statement of Allegations of Board Staff dated April 10, 2006, and
• Attachments
• Patent Act
• Patented Medicines Regulations, 1994
• Patented Medicine Prices Review Board Rules (Proposed)
• Compendium of Guidelines, Policies and Procedures

DATED at Ottawa, this May 8, 2006

______________________________

Sylvie Dupont
Secretary of the Board

All information requests and/or correspondence should be addressed to:
The Secretary of the Patented Medicine Prices Review Board
Standard Life Centre
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario
K1P 1C1

Toll-free number: 1-877-861-2350 Direct line: (613) 954-8299
Fax: (613) 952-7626 E-mail: sdupont@pmprb-cepmb.gc.ca

RESPONDENT

TO:

Teva Neuroscience G.P.-S.E.N.C..
999 Maisonneuve West Blvd., Suite 550
Montréal, Québec
H3A 3L4

AND TO:

MINISTERS

AND TO:

The Honourable Maxime Bernier, P.C., M.P.
Minister of Industry
235 Queen Street
11th floor
Ottawa, Ontario
K1A 0H5

AND TO:

The Ministers responsible for health in each province and territory:

The Honourable George Abbott, M.L.A.
Minister of Health
Province of British Columbia
Room 337, Parliament Buildings
Victoria, British Columbia
V8V 1X4

The Honourable Iris Evans, M.L.A.
Minister of Health and Wellness
Province of Alberta
Room 323, Legislature Building
Edmonton, Alberta
T5K 2B6

The Honourable Len Taylor, M.L.A.
Minister of Health
Province of Saskatchewan
Room 361, Legislative Building
Regina, Saskatchewan
S4S 0B3

The Honourable Tim Sale, M.L.A.
Minister of Health
Province of Manitoba
Room 302, Legislative Building
450 Broadway
Winnipeg, Manitoba
R3C 0V8

The Honourable George Smitherman, M.P.P.
Minister of Health and Long-Term Care
Province of Ontario
Queen's Park
Hepburn Block, 10th Floor
80 Grosvenor Street
Toronto, Ontario
M7A 2C4

Docteur Philippe Couillard
Ministre de la Santé et des Services sociaux
Président du Comité ministériel du développement social
Gouvernement du Québec
Édifice Catherine-de-Longpré
1075, chemin Sainte-Foy, 15e étage
Québec (Québec)
G1S 2M1

The Honourable Brad Green, M.L.A.
Minister of Health and Wellness
Province of New Brunswick
7th Floor, Carleton Place
520 King Street, P.O. Box 5100
Fredericton, New Brunswick
E3B 5G8

The Honourable Chris d'Entremont, M.L.A.
Minister of Health
Province of Nova Scotia
4th Floor, Joseph Howe Building
1690 Hollis Street, P.O. Box 488
Halifax, Nova Scotia
B3J 2R8

The Honourable Chester Gillan, M.L.A.
Minister of Health and Social Services
Province of Prince Edward Island
2nd Floor, Jones Building
11 Kent Street, P.O. Box 2000
Charlottetown, P.E.I.
C1A 7N8

The Honourable Tom Osborne, M.H.A.
Minister of Health and Community Services
Government of Newfoundland and Labrador
Confederation Building, West Block
Prince Philip Drive, P.O. Box 8700
St. John's, Newfoundland and Labrador
A1B 4J6

The Honourable Brad Cathers, M.L.A.
Minister of Health and Social Services
Government of Yukon Territory
2071 - 2nd Avenue, P.O. Box 2073
Yukon Government Administration Building
Main Floor
Whitehorse, Yukon
Y1A 2C6

The Honourable J. Michael Miltenberger, M.L.A.
Minister of Health and Social Services
Minister responsible for the Status of Women
Minister responsible for the Disabled and Minister responsible for Seniors
Government of the Northwest Territories
Legislative Assembly, P.O. Box 1320
Yellowknife, NWT
X1A 2L9

The Honourable Leona Aglukkaq, M.L.A.
Minister of Health and Social Services
Government of Nunavut
P.O. Box 2410
Iqaluit, Nunavut
X0A 0H0

New Multiple Sclerosis Vaccine

PORTLAND, Ore. (Ivanhoe Broadcast News) -- Multiple sclerosis short-circuits the wiring in the brain, causing loss of feeling, vision problems, fatigue and weakness for about 400,000 Americans. Now a new vaccine is showing promise.

Sue Carlson works up to 12 hours a day helping others feel better. But four years ago, she could barely muster enough energy to work a half day. Multiple sclerosis weakened the entire right side of her body. "I had to move a body part predominantly with my left side and prop it on pillows or towels or blankets in order to do the work I needed to do," she says.

But after six months on an experimental vaccine called NeuroVax, her strength came back. "And it just kept getting better and better and better."

NeuroVax works by increasing the number of disease-fighting white blood cells in the immune system. It did that for all 40 patients who received it. Unlike standard treatments, which have to be given daily or weekly, the vaccine only has to be given once a month, and it doesn’t cause flu-like side effects.

"What patients want are treatments that are not only effective, but also aren't not impacting their quality of life because of side effects," Neurologist Dennis Bourdette, M.D., of Oregon Health & Science University in Portland, tells Ivanhoe.

Researchers say the results are encouraging, but larger studies are needed before it can be approved.

Neurologist Arthur Vandenbark, Ph.D., also of Oregon Health & Science University and Portland V.A. Medical Center, says, "We still have to have a large enough trial that goes on for a minimum of two years where we see a difference between the vaccinated patients and the control group or the placebo group."

After a year without an injection, Carlson is waiting for a new trial to begin, hoping that another dose of the vaccine will give her even more strength.

Patients say the only side effect of the vaccine is a sore arm.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

If you would like more information, please contact:

Multiple Sclerosis Center of Oregon at OHSU
3181 S.W. Sam Jackson Park Road
Portland, OR 97239-3098
(503) 494-5759
msnews@ohsu.edu
http://www.ohsu.edu/ms

http://search.ivanhoe.com/archives/p_archive.cfm?storyid=12364&channelid=CHAN-100013&CFID=5486258&CFTOKEN=cd9c4b87f87731e1-B4F32360-1560-0C03-9CD6E69BA64B81EC&jsessionid=4630dbf289b512734373

Biogen's Slow Growth

Motley Fool - USA
... The big news for Biogen and partner Elan (Nasdaq: ELN) this quarter was the return to the US market of its multiple sclerosis drug, Tysabri. ...
See all stories on this topic

Biogen Idec and Elan Announce Availability of TYSABRI(R) for the ...
Finanzen.net - Germany
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc(NYSE: ELN) today announced the commercial availability of TYSABRI(R)(natalizumab) for the treatment of ...

Elan's Tysabri back on US shelves
RTE.ie - Ireland
Pharmaceutical company Elan and its partner Biogen have announced that their multiple sclerosis treatment Tysabri is now available again in the US. ...

Tysabri returns to market in US, Europe
Washington Post - United States
DUBLIN (Reuters) - Irish drug maker Elan (ELN.I) said on Monday its multiple sclerosis treatment Tysabri had returned to the market in the United States and ...

Elan/Biogen Idec: Tysabri back on the shelves
Pharmaceutical Business Review - USA
By Chantal Moore. Elan and Biogen Idec have successfully re-launched Tysabri in the US and introduced it to several European markets. ...
See all stories on this topic

Tysabri is back on US market
Unison.ie - Bray,Ireland
DRUGS company Elan and its partner, Biogen, said yesterday that their multiple sclerosis (MS) treatment Tysabri is now available again in the US. ...

Tysabri is back, but Elan is down -- time to buy
MSN Money - USA
... issue of Marketscope (Subscribers) (Free Trial), I said that Elan's (ELN, news, msgs) competitors would be pulling out all their guns to try to slow Tysabri. ...

Elan reintroduces Tysabri
Ireland Online - Dublin,Ireland
Athlone-headquartered pharmaceutical giant Elan has announced the reintroduction for sale in the US and Europe of multiple sclerosis drug Tysabri. ...

Biogen Idec, Elan announce availability of Tysabri
MarketWatch - USA
(BIIB) and Elan Corp. (ELN) announced the commercial availability of Tysabri for the treatment of relapsing forms of multiple sclerosis in the US. ...

Slow Rollout Seen For Elan Tysabri

newratings.com - USA
1015 GMT [Dow Jones] NCB Stockbrokers' Orla Hartford sees a relatively slow rollout for MS drug Tysabri in the US and EU. "It'll ...
See all stories on this topic

Biogen Idec and Elan Announce Availability of Tysabri (Natalizumab ...
DG News - USA
... announced, the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for the reintroduction of Tysabri as a ...

DAILY CHECK-UP
Kentucky.com - Lexington,KY,USA
... said yesterday its multiple sclerosis treatment Tysabri is now available in the United States, 17 months after the companies pulled the drug from pharmacies. ...

Short-term T-bills mixed
San Diego Union Tribune - United States
... Biogen Idec and Elan Corp.'s multiple sclerosis treatment Tysabri returned to the market yesterday in the United States and several European countries. ...

Tysabri returns to market after almost 18 months
Boston Globe - United States
... of Ireland began commercial sales of Tysabri, the promising multiple sclerosis treatment that has been off the market for almost 18 months on concerns about ...

Elan confirms Tysabri's EU prices, which are higher than expected
MarketWatch - USA
PLC (ELN) Tuesday confirmed the prices of multiple sclerosis drug Tysabri in three EU markets, which are higher than market forecasts. ...
See all stories on this topic

Biogen Idec and Elan Announce Availability of TYSABRI(R) and ...
Financial News USA (press release) - La Puente,CA,USA
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc recently announced the commercial availability of TYSABRI® (natalizumab) for the treatment of relapsing ...

Biogen Idec, Elan Rerelease Tysabri

MSN Money - USA
... said Monday its multiple sclerosis treatment Tysabri is now available in the US 17 months after the companies pulled the drug from pharmacies. ...
See all stories on this topic

Elan -2.8%, Mkt Awaits Concrete Tysabri Data
newratings.com - USA
0920 GMT [Dow Jones] Elan (ELN) -2.8% at EUR10.40 after saying it launched MS drug Tysabri for relapsing patients the US and in 4 EU countries. ...
See all stories on this topic

10.45am Markets Update
RTE.ie - Ireland
... ahead. In Dublin, Elan fell 10 cent to €10.60 as it announced that its MS drug Tysabri was now available again in the US. Drinks ...

http://abclocal.go.com/wls/story?section=health&id=3796186

January 9, 2006 - Multiple sclerosis can leave its victims unable to move and in constant pain. It's an autoimmune disease that wrecks havoc on the central nervous system. In some cases, no treatment works. Now, a new therapy stops the disease's progression and gets patients out of bed and back on their feet. On her 40th birthday, Andra Litman was taken down a path unthinkable. "Unless you're in this body, I don't know how you can begin to imagine," she says.

Doctors diagnosed this artist, attorney, and mother of two with multiple sclerosis, a disease that left her unable to even turn over in bed. Then she started a new treatment. She was out of a wheelchair and on her feet in one month.

Neurologist Olaf Stuve, M.D., Ph.D., says the cancer drug rituximab (Rituxan) is the first treatment to target the B cells in patients with MS, and it could be the first effective treatment for patients when nothing else works.

"The response to the Rituxan in those patients were really dramatic, in terms of not only stopping disease progression, but really helping the patient to recover some of the neurological function," Dr. Stuve, of UT Southwestern Medical Center in Dallas, tells Ivanhoe.

Instead of a daily or weekly injection, rituximab requires two infusions every six months. White spots, or lesions on a patient's brain before treatment, are hallmarks of MS. After treatment, they are gone.

Dr. Stuve says, "I think it will be a very effective therapy and probably more effective than what we have available at this time."

Litman says, "The first thought every morning when I woke up for four years was, 'Is it a shot night?'" Now, she can tune her thoughts to what matters most.

Since rituximab only targets one aspect of the immune system, it poses fewer side effects than standard treatments. Dr. Stuve is just beginning a study on using rituximab to treat primary-progressive MS (PPMS), a specific form that affects 10 percent of patients and for which there are no effective treatments.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

New hope for Multiple Sclerosis sufferers
Daily Mail Fri, 21 Jul 2006 11:24 AM PDT
Multiple Sclerosis sufferers were offered the hope of a normal life today after doctors discovered a pioneering drug treatment. A five-year study found that patients with the aggressive form of MS had a reduced relapse rate of 90 per cent under the regime

Drug combination fuels hope for MS fight AP via Yahoo! News Fri, 21 Jul 2006 1:54 PM PDT Four years ago, 28-year-old multiple sclerosis patient Karen Ayres was wheelchair-bound and paralyzed. "I was trapped in a body that wouldn't do anything," she says. Now, following an experimental drug treatment, she has regained mobility and is studying for a doctoral degree.

The blend of drugs that can ‘stop MS in its tracks’ Great News Network Sat, 22 Jul 2006 10:45 AM PDT Liverpool - Multiple Sclerosis sufferers were offered the hope of a normal life today after doctors discovered a pioneering drug treatment.

Drug cocktail offers hope against MS The Monterey County Herald Sat, 22 Jul 2006 3:08 AM PDT Four years ago, Karen Ayres was paralyzed from the neck down by multiple sclerosis.

Doctors encouraged by MS drug combination Miami Herald Sat, 22 Jul 2006 0:18 AM PDT Four years ago, Karen Ayres was paralyzed from the neck down by multiple sclerosis. ''When I was lying in my hospital bed, not even able to twitch my toes, I was jealous of anyone who could walk,'' she said.

The blend of drugs that can 'stop MS in its tracks' Daily Mail Sat, 22 Jul 2006 1:24 AM PDT A treatment offering fresh hope for sufferers of multiple sclerosis has been discovered by British scientists. They are pioneering a regime which uses a combination of drugs to halt the ravages of the devastating neurological disease

Drug cuts MS attacks by 90% The Scotsman Fri, 21 Jul 2006 8:31 PM PDT PATIENTS with multiple sclerosis treated with a new combination of drugs saw the number of attacks they suffered cut by 90 per cent, researchers said yesterday.

MultiCell Raises $1.7 Million Funding RedNova Fri, 21 Jul 2006 12:10 PM PDT MultiCell Technologies has raised $1.7 million in a private placement to help fund, among other things, further development of its multiple sclerosis fatigue drug MCT 125.

Blogs let disease sufferers connect The Monterey County Herald Sat, 22 Jul 2006 3:08 AM PDT For people facing a health crisis, a pat on the shoulder, a willing ear or just a smile can offer much-needed comfort. But when a sympathetic soul isn't readily available, technology is.

3rd Annual Wheelchair Wash Festivity Reaches Out To The Disabled Community
Medical News Today Sat, 22 Jul 2006 0:04 AM PDT
FamiliaUnida and Blue Cross of California (Blue Cross) are teaming up to host theThird Annual Wheelchair Wash timed to commemorate the upcoming 16thAnniversary of the Americans with Disabilities Act (ADA) on July 29 from9:00 a.m. to 6:00 p.m. at the Familia Unida Office, located at 4716 EastCesar Chavez Avenue in Los Angeles, CA. [click link for full article]

Stem Cell Research Enhancement Act

http://capwiz.com/nmss/issues/votes/?votenum=206&chamber=S&congress=1092

07/18/2006 Senate Roll Call No. 206 109th Congress, 2nd Session Passed: 63-37 (see complete tally)

By 63 yeas to 37 nays (Vote No. 206), Senate passed H.R. 810, to amend the Public Health Service Act to provide for human embryonic stem cell research, clearing the measure for the President.

Vote Map: Senate Roll Call No. 206

Votes For :	63
Votes Against :	37

Texas (Roll Call #206) Cornyn (R): Hutchison (R): Nay Yea Click state for details

http://capwiz.com/nmss/issues/votes/?votenum=206&chamber=S&congress=1092

LAST UPDATE: 7/20/2006 9:11:11 PM
Posted By: Vickie Jean Summers
This story is available on your cell phone at mobile.woai.com.

Two pharmaceutical companies have launched a new drug in the fight against multiple sclerosis (MS).

Biogen Idec and Elan Pharmaceuticals announced they'll be marketing a drug called Tysabri® (natalizumab). The FDA approved Tysabri® in June for relapsing multiple sclerosis.

The drug is recommended for patients who did not respond to, or could not tolerate, other approved therapies approved for multiple sclerosis. It's not meant to be combined with other therapies and is not recommended for individuals who have compromised (weakened) immune systems.

The drug should be available for MS patients in several weeks. The delay will allow medical personnel to receive training for properly administering the drug.

Tysabri's given to patients by I.V. infusion on a monthly basis. Infusions of the drug are only available at registered infusion sites where medical personnel have been trained in Tysabri's use and in the risks of PML. PML, or progressive multifocal leukoencephalo­pathy, is a brain disease that occurred in three people who received the drug in clinical trials of Tysabri. Two of the patients who developed the disease died.

Tysabri is only available to patients and prescribing physicians who have registered in TOUCH, a prescribing program designed to assess the risk of PML.

For more information about Tysabri, visit the National MS Society's Web site at http://www.nationalmssociety.org/tysabri.asp.

http://www.woai.com/news/local/story.aspx?content_id=AB320407-3416-4B91-89CE-666415F19121

Antisense bounces back from darkest day
The Age - Melbourne,Victoria,Australia
... Overseas, drug companies Biogen and Elan Corporation had announced that they were withdrawing their multiple sclerosis drug Tysabri from the market following ...

MS sufferers are 'ignored by NHS' PA via Yahoo! UK & Ireland News Tue, 18 Jul 2006 11:58 PM PDT Health chiefs have been accused of largely ignoring the plight of thousands of multiple sclerosis (MS) sufferers who face a daily struggle against disability. MS sufferers 'largely ignored by NHS' Daily Mail Wed, 19 Jul 2006 3:39 AM PDT Health chiefs were today accused of largely ignoring the plight of thousands of multiple sclerosis sufferers who face a daily struggle against disability Heat Makes Illness Worse For Some Residents Blurry vision, muscle spasms, and fatigue common for those with MS WDEF Chattanooga Tue, 18 Jul 2006 3:01 PM PDT Sarah Johnson dreads the heat. During the summer months 6 years ago, she started dragging at work after getting hot. "The heat just zaps my strength, for me I just go to sleep. The heat drains me and I get really sleepy," says Johnson who soon learned she has Multiple Sclerosis. Antibodies seen stopping Alzheimer's Chicago Tribune Wed, 19 Jul 2006 3:38 AM PDT Material found in body shows early promise Treatment with antibodies naturally produced in the body appears to halt the memory-robbing progression of Alzheimer's disease, according to promising early research that scientists plan to expand over the next year. Antibody treatment shows promise in treating Alzheimer's progression The Olympian Wed, 19 Jul 2006 7:04 AM PDT Treatment with antibodies naturally produced in the body appears to halt the memory-robbing progression of Alzheimer's disease, according to promising early research that scientists plan to expand during the next year. Antibodies might halt Alzheimer's Seattle Times Wed, 19 Jul 2006 0:27 AM PDT Treatment with antibodies naturally produced in the body appears to halt the progression of Alzheimer's disease, according to promising... Demand for community nurses grows EurekAlert! Wed, 19 Jul 2006 5:31 AM PDT An ageing population and the increasing number of people living at home with chronic illnesses are placing increasing demands on Australia's community nursing resources. Pederson Calls Out Kyl on Funding RedNova Wed, 19 Jul 2006 5:10 AM PDT By Daniel Scarpinato, The Arizona Daily Star, Tucson Jul. 19--The measure to provide federal funding for embryonic-stem-cell research quickly found its way into Arizona politics after Senate approval Tuesday. Even before a vote, Republican Sen. Victhom Human Bionics announces a pre-ITA meeting with Health Canada for Neurostep(TM) system CNW Group via Yahoo! Finance Wed, 19 Jul 2006 8:49 AM PDT Victhom Human Bionics Inc. announces today that it met last week with the Medical Devices Bureau of Health Canada to discuss the clinical development of its Neurostep medical device, a closed loop functional electrical stimulating device designed to treat gait disorders secondary to a lesion of the central nervous system such as foot drop.

http://www.msnbc.msn.com/id/13864044/

The frivolous bills
The two Republican Senators from Pennsylvania, Rick Santorum and Arlen Specter, authored one of the companion bills. It directs the federal government research establishment to search for means of obtaining embryonic stem cells from sources other than human embryos.

This is meaningless for two reasons.

The NIH and other agencies can already fund such research. The bill provides no new money to do it. And, although some complicated schemes have been proposed, no one knows how this could be accomplished. Its main goal is provide cover allowing anti-stem cell senators to say they are doing something positive

The third bill, the “Fetus Farming Prohibition Act” from Sen. Santorum, along with Sen. Sam Brownback, R-Kan, would make it a crime to use stem cells (or any other tissue) if the material comes from a pregnancy initiated and terminated specifically to produce tissue. It also prohibits using tissue from human embryos grown in animals.

No one I know is considering either scenario. As I mentioned, 400,000 frozen embryos remain in laboratory freezers so there is no need for wild schemes to get more.

The end game
Sources say Mr. Bush will veto only the substantive bill.

The other two will pass the House quickly after the Senate approves them and the President will sign those into law. There is a slight chance the Senate will override the veto of the main bill, but the House definitely will not.

The entire process will be orchestrated so that the President’s veto and the failed overrides will take place in less then 24 hours — as one legislative aide told me, “within one news cycle” — to minimize the publicity.

Show over.

© 2006 MSNBC Interactive

http://www.msnbc.msn.com/id/13864044/

New hope for patients with aggressive multiple sclerosis
News-Medical-Net Tue, 18 Jul 2006 3:18 AM PDT
A new combination treatment regime, for patients with aggressive forms of multiple sclerosis (MS), is offering new hope to a group of patients who would otherwise be at high risk of early disability.
HEALTH: `Montel' show about MS features area girl
The Charlotte Observer Tue, 18 Jul 2006 0:16 AM PDT
Since he was diagnosed with multiple sclerosis in 1999, TV talk-show host Montel Williams has dedicated one program per season to people with the disease.

Novartis still sees EU submissions for Galvus, Rasilez before end ...

Forbes - USA
... Novartis added that FTY720, an oral once-daily treatment for relapsing forms of multiple sclerosis, is currently in Phase III development and US and EU ...

Novartis Generates Strong Sales and Earnings Growth in the First ...
PharmaLive.com (press release) - Newtown,PA,USA
... the completion in 2005 of several Phase III trials and ahead of anticipated investments during the second half of 2006, including for FTY720 (multiple sclerosis ...

Drug firm Novartis books $1.7B
CNN International - USA
... Novartis also said its FTY720 oral once-daily treatment for multiple sclerosis had recently started final Phase III clinical studies. ...

http://ihavems.com/

http://fescenter.case.edu/Start_Here/FES_Center_Video.htm

We have just received word that the debate and vote on HR 810: The Stem Cell Research Enhancement Act could happen as early as this week. Please take a few minutes today to take the following steps:

FIRST: Check the list below for the names of your Senators. If they are included, call or fax them a letter immediately and urge them to vote in favor of HR 810. Tell them the following:

HR 810: The Stem Cell Research Enhancement Act is extremely important to me, as a voter, and to over 100 million Americans who stand to benefit from stem cell research.

Please note: Two other bills (S 2754 and S 3504) are also being considered as part of a package with HR 810. Stem cell advocates
agree that these two other bills are irrelevant and that Senate votes for these bills do not equal support of stem cell research. It is only by voting YES on HR 810 that your Senators can prove that they are listening to their constituents, and to over 70% of Americans polled, showing true support for the advancement of stem cell
research in the United States.

State - Senator

AK - Lisa Murkowski

AK - Ted Stevens

AL - Jeff Sessions

AL - Richard C. Shelby

AR - Mark L. Pryor

AZ - Jon Kyl

AZ - John McCain

CO - Wayne Allard

CO - Ken Salazar

DE - Joseph R. Biden, Jr.

FL - Mel Martinez

FL - Bill Nelson

GA - Saxby Chambliss

GA - Johnny Isakson

IA - Chuck Grassley

ID - Larry E. Craig

ID - Mike Crapo

IN - Richard G. Lugar

KS - Sam Brownback

KS - Pat Roberts

KY - Jim Bunning

KY - Mitch McConnell

LA - David Vitter

MD - Paul S. Sarbanes

ME - Olympia J. Snowe

MI - Debbie Stabenow

MN - Norm Coleman

MO - Christopher S. Bond

MO - James M. Talent

MS - Thad Cochran

MS - Trent Lott

MT - Conrad Burns

NC - Richard Burr

NC - Elizabeth Dole

ND - Kent Conrad

NE - Chuck Hagel

NE - E. Benjamin Nelson

NH - Judd Gregg

NH - John E. Sununu

NM - Pete V. Domenici

NV - John Ensign

OH - Mike DeWine

OH - George V. Voinovich

OK - Tom Coburn

OK - James M. Inhofe

OR - Ron Wyden

PA - Rick Santorum

SC - Jim DeMint

SC - Lindsey Graham

SD - John Thune

TN - Lamar Alexander

TN - William H. Frist

TX - John Cornyn

TX - Kay Bailey Hutchison

UT - Robert F. Bennett

VA - George Allen

VA - John Warner

WV - Robert C. Byrd

WV - John D. Rockefeller, IV

WY - Michael B. Enzi

WY - Craig Thomas

HR 810 is the best chance for our country to vigorously pursue research that experts agree offers the potential for better treatments and cures for over 70 diseases and injuries. It offershope to millions of Americans who are suffering today, and millions more who are at risk in the future.

Tipsheet: Focus on Multiple Sclerosis Newswise Mon, 10 Jul 2006 9:29 PM PDT The current issue of the Journal of Rehabilitation Research and Development (JRRD) is dedicated to multiple sclerosis rehabilitation.

JRRD tipsheet: Focus on multiple sclerosis EurekAlert! Mon, 10 Jul 2006 11:58 AM PDT The authors describe how the Multiple Sclerosis (MS) Centers of Excellence use healthcare information technology to care for veterans with MS. The approach is based on a chronic-disease model that was effective for diabetes, asthma, and depression.

First trial to investigate effects of cannabinoids on progression of multiple sclerosis News-Medical-Net Mon, 10 Jul 2006 9:34 PM PDT Clinicians from across the UK have now embarked on the world's first trial to investigate whether cannabis derivatives could play a role in slowing the progression of multiple sclerosis.

Consumer Health UPI Tue, 11 Jul 2006 9:14 AM PDT BALTIMORE, July 11 (UPI) -- Medications that affect the central nervous system can impact cognitive function and fatigue in multiple-sclerosis patients, find U.S. researchers.

Health trust won't pay for cannabis ITV.com Tue, 11 Jul 2006 4:13 AM PDT A pensioner who's crippled with pain due to multiple sclerosis has been told her health trust will not fund a cannabis based drug, even though it's the only medicine which offers her relief, and is available to patients living elsewhere in the country.

Parkinson Studies Find More Apathy than Depression, Experience Needed for Brain Stimulation Senior Journal Tue, 11 Jul 2006 8:52 AM PDT July 11, 2006 – Two studies in current scientific journals look at Parkinson disease, which affects about one of every 100 people over the age of 60, and is the most common neurodegenerative disease after Alzheimer's disease. One study found Parkinson patients – often considered to be at high risk of depression – can be apathetic without being depressed and says apathy my be a core feature of the

European Commission approves revision of therapeutic indication for Rebif PharmaBiz Tue, 11 Jul 2006 0:45 AM PDT Serono reported that the European Commission has approved an update of the Summary of Product Characteristics (SmPC) of Rebif (interferon beta-1a), in order to align it with current medical practice.

Yoga helps disabled kids relax, relate and release Baltimore Sun Tue, 11 Jul 2006 5:35 AM PDT Riley Jackson and Shane Perlow, both 7 and ordinarily full of energy, were lying on their backs and taking deep yoga breaths while little plastic frogs on their bellies steadily rose and fell. Soon, they were wobbling and grinning through "tree pose" and hissing enthusiastically for "cat pose." Riley, who has missing front teeth, gaily sang "London Bridge Is Falling Down" as he wiggled into

Prevention Is Better Than Cure: Fighting Autoimmune Diseases Medical News Today Tue, 11 Jul 2006 4:03 AM PDT Centenary scientist Associate Professor Barbara Fazekas de St. Groth, a leader in inflammatory bowel disease research, has demonstrated for the first time the important role of T cells in the prevention of autoimmune diseases in humans. [click link for full article]

Envisioning a Neuro ICU for Preemies at UCSF
UCSF Today Tue, 11 Jul 2006 8:11 AM PDT
Each year in the United States, approximately 80,000 children are born very prematurely. During the past three decades, medical science has provided these tiny preemies with an increased chance of survival — largely through treatments that ensure their lungs can function optimally.

http://www.medscape.com/viewarticle/540389

Yael Waknine

July 10, 2006 — The European Commission has approved a recombinant parathyroid hormone once-daily subcutaneous injection for the treatment of postmenopausal osteoporosis in women at high risk for fractures and natalizumab monotherapy to delay the progression of disability and reduce the frequency of relapses in patients with relapsing remitting multiple sclerosis; Australia's Therapeutic Goods Administration has approved a new indication for zanamivir, allowing its use for the prophylaxis of influenza in patients aged 5 years and older.


Recombinant Parathyroid Hormone Injection (Preotact) for Postmenopausal Osteoporosis in EU

The European Commission approved in April recombinant [rDNA origin] parathyroid hormone [PTH] subcutaneous injection (Preotact, made by NPS Pharmaceuticals and marketed by Nycomed) for the treatment of postmenopausal osteoporosis in women at high risk for fractures. The marketing authorization is valid in all 25 member states of the European Union.

In contrast with teriparatide (Forteo, made by Eli Lilly and Company), the recombinant protein is full-length and contains all amino acid fragments.

The approval was based primarily on 18-month data from the multicenter, randomized, double-blind, placebo-controlled, phase 3 Treatment of Osteoporosis with PTH (TOP) trial (N = 2600), showing that once-daily use of the recombinant PTH product significantly reduced the risk for first and subsequent vertebral fractures by 66% and 69%, respectively, in postmenopausal women who had received at least 75% of the prescribed doses (per-protocol patients, n = 1870).

Results also showed that per-protocol patients receiving PTH experienced significant increases in mean spine, total hip, and femoral neck bone mineral density compared with placebo.

According to a company news release, PTH was linked to transient increases in serum calcium. During the TOP study, increases of more than 10.7 mg/dL in serum calcium levels from baseline were observed in 21% of patients treated with the study drug vs 3% of those receiving placebo; the associated discontinuation rate was 0.7%.

The PTH product (Preos, made by NPS Pharmaceuticals) is currently being considered for approval by the US Food and Drug Administration.


Natalizumab (Tysabri) for Relapsing Remitting Forms of MS in EU

On June 29, the European Commission approved natalizumab intravenous infusion (Tysabri, made by Biogen Idec and Elan Corporation, plc) for use in all 25 member states of the European Union as monotherapy to delay the progression of disability and reduce the frequency of relapses in patients with relapsing remitting multiple sclerosis (MS). The drug is intended for use in patients with high disease activity despite treatment with a beta-interferon and in those with rapidly evolving severe disease.

According to a company news release, the approval was based on a submission that included 2-year phase 3 clinical trial data; findings from a comprehensive safety evaluation; suggested labeling; and a risk management plan designed to inform physicians and patients of the benefits and risks of natalizumab therapy, thereby minimizing the potential risk for progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

The monoclonal antibody was first approved for this indication by the US Food and Drug Administration (FDA) in November 2004 and was later withdrawn from the market by the manufacturer in February 2005 after 3 patients developed PML during clinical trials.

Because 2 of the patients were also taking interferon beta-1 alpha (Avonex, made by Biogen Idec), a causal role for natalizumab was not established. On June 5, 2006, the FDA allowed the reintroduction of natalizumab into the US market with a restricted distribution program and revised safety labeling to warn of the risk for PML.


Zanamivir for Inhalation (Relenza) to Prevent Influenza in Adults and Children

On May 1, Australia's Therapeutic Goods Administration (TGA) approved a new indication for orally inhalable zanamivir (Relenza with Diskhaler, marketed by GlaxoSmithKline under license from Biota Holdings Ltd), allowing its use for the prophylaxis of influenza in patients aged 5 years and older.

The approval was based on a review of data from 4 large-scale, placebo-controlled studies. In 2 studies of postexposure prophylaxis in households with members aged older than 5 years, use of zanamivir within 1.5 days of symptom onset for treatment of the index case and its prophylactic use in other household members were equally effective for significantly reducing the spread of influenza (4.1% vs 19.0%).

Results from the other 2 trials showed that zanamivir significantly reduced the risk of developing influenza symptoms in adults aged 18 years and older (mean age, 29 years; 86% unvaccinated) and individuals aged 12 to 94 years (mean age, 60 years) during community influenza outbreaks (56% aged older than 65 years; 67% unvaccinated; 2.0% vs 6.1% and 0.2% vs 1.4%, respectively).

Zanamivir should be administered at approximately the same time each day. The recommended dose of zanamivir for household prophylaxis in patients aged 5 years and older is 10 mg (inhalation of two 5-mg blisters) once daily for 10 days, initiated within 1.5 days of symptom onset in the index case.

For the prophylaxis of influenza in a community setting, the recommended regimen for zanamivir in adults and adolescents is 10 mg daily for 28 days, initiated within 5 days of the outbreak being identified. The safety and efficacy of this regimen has not been studied beyond 28 days.

Because of the risk for potentially fatal bronchospasm, zanamivir should not be used in patients with underlying airway disease, such as chronic obstructive pulmonary disease or asthma.

Zanamivir should be discontinued in patients who develop bronchospasm or demonstrate a decline in respiratory tract function; immediate treatment and hospitalization may be required. Some patients without prior pulmonary disease may also have respiratory tract abnormalities from acute infection that could resemble an adverse reaction or increase patient vulnerability to such reactions.

The indication was approved by the US Food and Drug Administration on March 29, 2006. Zanamivir was previously approved by the TGA and FDA for the treatment of uncomplicated acute illness due to influenza A and B virus in patients aged 7 years and older who have been symptomatic for no more than 2 days.

Reviewed by Gary D. Vogin, MD