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David

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Source: ALS Society of Canada
Date: April 1st, 2009
Title: A Blockbuster Approach to Funding ALS Research

Two seemingly disparate strands – a runaway blockbuster and a clinical trial of a promising new therapeutic approach to a fatal neuromuscular disease – are being woven together in a new initiative by the ALS Society of Canada.

The first strand is a short memoir called Tuesdays with Morrie, which catapulted a little-known disease into the forefront of world attention in 1997; the success of the book has kept it there ever since. More than 11 million copies of Tuesdays with Morrie have been sold worldwide, and it spent more than four years on The New York Times best seller list. The story was adapted as a television movie in 1999 and as a play that was performed in New York City in 2002.

Most people know the story: sports columnist Mitch Albom reconnects with his former college professor, Morrie Schwartz, who is in the final stages of amyotrophic lateral sclerosis (ALS). Albom spends 14 Tuesday afternoons with his mentor, learning anew about life, laughter and love. But the clock is ticking. Albom knows that the final lesson will be about death: ALS is an unforgiving disease and there are no survivors.

Across the ocean, another strand. In 2008, a small Italian study of 44 people published the results of a 15-month trial: daily doses of the drug lithium, used to treat bipolar disorder, taken together with riluzole, significantly slowed the progression of ALS. By year’s end, the ALS Society of Canada proudly announced the launch of the first Canadian national clinical trial. The objective of the trial is to confirm the effectiveness of lithium in slowing the progression of ALS in patients in the early stages of the disease.
“Since there is no cure for ALS yet, research into treatments gives hope to ALS patients and their families,” explains David Cameron, president and CEO of ALS Canada.
This remarkable achievement was made possible as a result of ALS Canada’s leadership role in facilitating the establishment of the Canadian ALS Clinical Trials and Research Network (CALS). CALS is a consortium of ALS clinicians across the country who have incorporated to develop and deliver groundbreaking treatments and scientific discoveries that will forever change the future of Canadian ALS research. The lithium trial is the first joint effort between CALS and the Northeastern ALS Consortium (NEALS) in the United States.

One year after the publication of the Italian study, the Canadian lithium clinical trial, under the leadership of Dr. Lorne Zinman, medical director of the ALS Clinic at the Sunnybrook Health Sciences Centre in Toronto, is underway. At nearly $1,000,000, the trial is the largest ALS Canada research commitment to date. ALS Canada is able to make this investment thanks to the generous support of the Temerty Family Foundation: their gift of $250,000 is the largest solicited gift that ALS Canada has ever received.

Denise Figlewicz, PhD, director of research at ALS Canada says, “The promising results from the Italian study data served as the impetus for new research and treatment strategies. This is very exciting news for the ALS community.”

And now, these two separate strands – Tuesdays with Morrie and the lithium trial – are being woven together. To fund the trial and our other important research initiatives, ALS Canada is hosting the exclusive opening night of the stage version of Tuesdays with Morrie on Friday, May 8, at the Winter Garden Theatre in Toronto. The play is being mounted by the Harold Green Jewish Theatre Company. It will be directed by Gemini Award–winning actor/director Ted Dykstra. The role of Morrie will be played by Hal Linden, star of the 1970s police comedy Barney Miller, and Rick Roberts of Traders fame will play Mitch.

For tickets or for more information, please contact:
Laurie Pringle at 416-497-2267 ext. 219

About ALS:
ALS, also known as Lou Gehrig’s disease, is a fatal neuromuscular disease that attacks and paralyzes the muscles, ultimately resulting in death. ALS can affect men and women from any ethnic origin at any age. Approximately 2,500–3,000 Canadians are living with the disease. And 80 per cent of those affected will die within two to five years of diagnosis. According to the World Health Organization, neurodegenerative diseases are predicted to surpass cancer as the second leading cause of death in Canada by 2040.

About the ALS Society of Canada:
The ALS Society of Canada was founded in 1977. ALS Canada is the only national voluntary organization dedicated solely to the fight against ALS and to support for those with ALS. The mission of the ALS Society of Canada is to fund research towards a cure for ALS and to support provincial Societies to provide quality care for those affected by ALS. http://www.als.ca
 

Big Mike

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Don't mean to be the bearer of bad news but the Itialian lithium study was badly flawed and follow-up studies haven't been very encouraging. However, maybe the Canadian study will prove once and for all if lithium has efficacy in treating ALS, especially early in the course of the disease. I certainly hope so.

I still think the best hope for treatment in the next few years will be in the form of stem cells and, perhaps, gene therapy.
 

John1

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Mike,

When I heard that ALS Society of Canada was spending $1,000,000 of hard-to-raise funds on this study I was horrified. I have spent the past several years involved in local funding raising and was struck dumb when I heard the news. Similar responses came from other ALS research groups in the US. I emailed some of the principal investigators involved in the study and asked them why, when a large, well conducted, fast-off-the-mark study involving nearly 200 trialees on lithium had demonstrated quite clearly that the lithium does not work, was the Society spending a million dollars to do it again. The study was completed before this one even got itself organized to begin. Some of my contacts did respond and one acknowledged it had little likelihood of success but at least the Society would learn how to conduct a trial. The other said that this was a gold-plated placebo study and dismissed the other because it lacked placebo controls. I wonder if they even read the results of the other. I suspect that the decision had been made to go ahead before the other trial results were available and by then, the organization had a certain momentum and the person who could and should have decided, OK, this is a dead end, let's cut our losses and save the money for something that has promise, failed to act. To read the press release, one would think that nothing has been done since the early Italian study and that great things can be expected of this. Grrrr.
 

John1

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The ill-conceived lithium trial has finally reached its predictable conclusion and the trial has been stopped after wasting who knows how much hard-to-raise research funds.

"Lithium trial stopped
A Randomized Clinical Trial of Lithium Carbonate with Riluzole
Versus Placebo with Riluzole in ALS Shows No Benefit

In February 2008, Dr. Francesco Fornai and colleagues at the University of Pisa, Italy, reported in a pilot study that lithium carbonate at dosages of 300-450 mg daily (titrated to a plasma level of 0.4-0.8 mEq/liter) combined with riluzole showed a large positive effect in people with ALS (Fornai, F., et al., Lithium delays progression of amyotrophic lateral sclerosis. PNAS, 2008.105(6): p. 2052-2057).

To further investigate lithium carbonate as a possible treatment for ALS, a randomized, blinded, multicenter trial of lithium carbonate with riluzole versus placebo with riluzole was conducted in people with ALS in the U.S. and Canada. The study used similar dosing to the Italian study. The study was conducted by the Northeast ALS (NEALS) and Canadian ALS (CALS) Consortia and was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health, The ALS Association and the ALS Society of Canada. This unique collaboration between investigators and funding organizations resulted in a novel study design and expeditious execution of the trial to efficiently answer a critically important clinical question. Study leaders included Drs. Swati Aggarwal, Lorne Zinman, Jeremy Shefner and Merit Cudkowicz.

An interim analysis was conducted after enrollment of the 84th subject and presented to the NINDS Data and Safety Monitoring Board in September 2009. Based on the interim analysis the trial was stopped for futility. This study did not show the same beneficial effect of lithium carbonate on the progression of ALS as the prior pilot study conducted in Italy.

Although the results are disappointing, it was very important for the ALS community to quickly and efficiently determine if the large benefit first observed for lithium could be replicated in a well controlled trial. With the ongoing assistance and commitment of patient volunteers, researchers can now focus on other promising therapeutics for patients with ALS."

I particularly love the self-congratulatory remark " it was very important for the ALS community to quickly and efficiently determine if the large benefit first observed for lithium could be replicated in a well controlled trial". In fact the trial came late to the game. An excellent, large, well-designed trial had been conceived, conducted and interpretted by Patients Like Me many months before this behemoth managed tos struggle to its feet. The PLM trial found unequivocally that lithium conferred no benefit to PALS and cost the ALS community not one research dollar.

Can you tell I'm angry?
 
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