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Saturday, August 30, 2008

Enrollment completed for (15) Year Avonex Study

Pharmaceutical Business

Biogen completes enrollment for relapsing multiple sclerosis study
29th August 2008
By Staff Writer

Biogen Idec has completed enrollment in the Assurance trial, a long-term follow-up study which will assess up to 15 years of Avonex treatment in an effort to provide detailed data on the long-term efficacy of the drug.

Assurance is a multi-center, open-label follow-up study of patients with relapsing multiple sclerosis (MS) treated with Avonex or placebo for at least two years in the Phase III pivotal trial.

» Read More

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Teva sues Novartis, Momenta over Copaxone patent

Yahoo News

By Bill Berkrot Thu Aug 28, 6:18 PM ET

NEW YORK (Reuters) - Teva Pharmaceutical Industries Ltd sued Swiss drugmaker Novartis AG and Momenta Pharmaceuticals Inc on Thursday, accusing them of infringing patents on its multiple sclerosis drug Copaxone.

Israel-based Teva had said in July it intended to sue after the Sandoz unit of Novartis applied to U.S. regulators to sell a generic version of the medicine.

The lawsuit, filed in U.S. District Court in Manhattan, claims that any generic version of Copaxone infringes patents that Teva contends are valid and enforceable.

Teva, itself a large maker of generic drugs, has maintained it has patent protection on Copaxone in the United States until May 2014 and in much of Europe until 2015.

Cambridge, Massachusetts-based Momenta said last month that the generic Copaxone application asserts that Teva's patents are invalid.

Copaxone, known chemically as glatiramer acetate, is an injected medicine that had U.S. sales of $1.1 billion last year.

A Sandoz spokesman said the company would not comment on pending litigation. Momenta could not immediately be reached for comment.

Teva is seeking to have the court declare that the defendants have infringed its patents, and that any approval of a Novartis generic not be granted until after Teva's patents expire.

The suit also seeks to prevent Novartis and Momenta from any commercial manufacture or sale of a generic Copaxone.

It asks the court to order Sandoz to withdraw its application seeking to sell the generic and award Teva monetary damages and interest to compensate it for misappropriation of Teva trade secrets as well as any further monetary relief the court deems just and proper.

(Editing by Richard Chang)

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Thursday, August 28, 2008

Headaches as a Symptom of Multiple Sclerosis

( Stuart easily identifies with this symptom)

This article was Written by: Julie Stachowiak, Ph.D.,

- Updated: June 17, 2008 Health's Disease and Condition content is reviewed by Suman Jayadev, MD

Everybody has a headache occasionally. However, people with multiple sclerosis (MS) are much more prone to migraine-like or cluster headaches than people in the general population. While the cause of most headaches is a mystery, some headaches in people with MS can be caused by lesions, depression or specific medications that they are taking. You should see your doctor for: Any type of unusual headache, a headache that keeps recurring, or one that lasts for a long time.

What Do MS-Related Headaches Feel Like?

Headaches that are directly associated with MS have been described as:

» Read More

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Respiratory Problems in People with Multiple Sclerosis

Coughing and Shortness of Breath as Symptoms of MS

Written By Julie Stachowiak, Ph.D., -- Updated: June 11, 2008 Health's Disease and Condition content is reviewed by Suman Jayadev, MD


Just when you thought that the tingling and numbness, the fatigue, the MS hug and the memory problems were enough, turns out that people with multiple sclerosis (MS) are prone to respiratory problems, as well. In fact, most of us would test pretty low on pulmonary function tests designed to assess the strength of our respiratory muscles.

Fortunately, for most of us, these problems are not noticeable or do not impede us in any significant way. Even better, it turns out there may be exercises that we can do to prevent this from getting worse.

What Do Respiratory Problems in MS Feel Like?
MS-related respiratory problems can take several forms, including:
Shortness of breath
Difficulty breathing deeply
Frequent sighing
Not enough air

» Read More

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Wednesday, August 27, 2008

How often do you awake feeling Blue?

I often wonder how many of my MS peers have mornings like I am having today, and have been happening more and more frequently. I can't seem to pull myself together and am learning quickly how much I despise mornings.. Knowing that I need to get things done in the mornings and not being able to do them is getting very frustrating.. Mornings are when it's time to do things and get things accomplished. Especially living here in South Florida, where the afternoon heat and humidity forces us that have heat sensitivity to remain indoors.

Today though, I awoke with another round of Vertigo. I had plans, which got canceled (good thing) because I wondered how I would make the drive. Then I went to take the dogs for a quickie walk, and found that my legs really didn't want to do any walking.. Instead they insisted that sitting would be a better option. I pushed regardless, as I needed to do some walking and after rounding the first bend on my street, decided that I should have maybe listened to what my legs were trying to tell me just a few minutes prior.. They didn't want to move another meter on their own.

Good thing my Dog (Snoop) was on her leach as she was then told "home" and to "pull"... Yes, she really is trained to do this. And being pulled, forcing my legs to move, is a lot easier than my brain simply telling each leg and foot to do their thing.

Finally getting back inside my home, I sat at my desk, took out a sheet of paper to write what I needed to do for today and then learned that I could barely hold the pen and worse,, couldn't read what I was writing.

How is it that I can type, but can't write? And so, then thought to type what you are reading here so that I can get your feedback...

If you awaken, feeling anything similar to what I just wrote, please tell us how you feel. I know, that I can't be the only one awakening this way... Yes, I do know it's called Fatigue.. You would think that I would know all about this and I probably do, but it's still nice to know, that I am not alone.....

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Having your email address, will enable others to communicate with you, so if possible, enable this.

Participating in a Clinical Trial? Talk to Your Neurologist

by Dr. Kantor - as found on MS Central .com

Wednesday, August 13, 2008

We are getting closer the release of the first oral medicines in the treatment of Relapsing-Remitting MS (RRMS) with the goal of preventing relapses (and hopefully progression and disability). Altruistic patients worldwide are taking part in multiple clinical trials testing the safety and efficacy (effectiveness) of these new forms of medicines.

These newer medicines are giving the MS Community hope because they do not involve needles, but also because they may be found to work even better (higher efficacy) than our older medicines. Unfortunately, however, two patients in one of the trials passed away recently from infections.

MS is an autoimmune disease, and so the body attacks itself (the myelin covering the nerves and the nerves themselves), much like in Diabetes mellitus type 1 (childhood diabetes) where the body attacks the pancreas (the organ which releases insulin). Because MS involves the immune system being hyperactive, many of the medicines to treat MS are immunosuppressants to try to push the immune system down. Immunosupression also makes it harder for the body to fight off infections.

Fingolimod (also called FTY720) is a novel oral medicine being tested in three Phase 3 trials both in the United States and worldwide). Phase 3 trials are large trials where patients either receive the medicine being tested (in this case, Fingolimod) or another standard medicine (or placebo). Fingolimod is being tested in two placebo-controlled Phase 3 trials (one in the United States and the other in the rest of the world) and in one Avonex®-controlled Phase 3 trial) where patients receive a daily pill and weekly injections into the muscle and they do not know if they are receiving the real pill and a fake injection or a fake pill (placebo) and a real injection (Avonex®). The idea of this trial is to compare the safety and efficacy of the new medicine Fingolimod with an older well-established medicine (Avonex®).

The patients volunteering for these trials are true heroes – they are pioneers leading the way for the development of new medications and making it possible for the entire MS community to have greater access to new medicines. Just as the patients who were in the original trails of Avonex®, Betaseron®, Copaxone® and Rebif® blazed the way for hundreds of thousands of MS patients to lead better lives, these patients in the newer clinical trials should be applauded and thanked for their commitment to helping all MS patients and families.

Being in a clinical trial, however, carries with it risk. If we knew everything about the safety and efficacy of the medicine being tested, then we wouldn’t need these trials. Therefore, there may be risks which are not discovered until something bad happens.

This summer, Novartis (the makers of Fingolimod) announced that a patient in Italy receiving FTY720 in the clinical trial, developed disseminated Varicella Zoster (the infection of chickenpox and shingles) and passed away. Another patient in South Korea developed herpes encephalitis (an infection of the brain by the herpes virus) and also passed away.

The hearts and thoughts of the entire MS community go out to the families and friends of those heroes.

The MS research community is remaining vigilant in the earlier detection and diagnosis of potentially fatal infections while patients are being exposed to immunosuppressants. Patients in the Unites States are still enrolling in the placebo-controlled trial of FTY720 for the treatment of relapsing MS. Patients and doctors are keeping an eye out for any further infections, and the earlier they can be found, the better we can treat them with antibiotics and antiviral medications.

The recent deaths reemphasize the need to have an open dialogue with your neurologist, whether you are in a clinical trial or not, and to retain and claim your true position as the center of the MS Team in M*STAR (the Multiple Sclerosis Team Approach Rule).

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Share a Laugh with this week's humor

Michael Phelps, Olympic Gold Medal Winner for swimming,
at a very young age.

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Study finds toxins in some herbal medicines

I have heard many of you say that you trusted natural medications above prescription meds. Please know that herbal preparations can be as potent and powerful as anything produced by the drug companies. If you use any of the products listed in the article shown below, please take care.
Cherie C. Binns RN BS MSCN

Study Finds Toxins in Some Herbal Medicines

Traditional herbal supplements used by thousands of Americans may contain dangerously high levels of lead and other toxins, a study shows.

Nearly 21% of Ayurvedic medicines — plant-based products used in India for thousands of years to promote health — actually contain lead, mercury or arsenic, according to a study in today's Journal of the American Medical Association.

Arsenic can cause cancer. Lead and mercury can damage the kidneys and brain, especially in children, says study author Robert Saper of the Boston University School of Medicine and Boston Medical Center. More than 80 people have developed lead poisoning worldwide from Ayurvedic medicines since 1978, the study notes. Symptoms include fatigue, anemia and abdominal pain.

Although Ayurvedic medications are largely used by adults to treat problems ranging from indigestion to infertility, about 4% of the 193 products that Saper tested were labeled for use in children.

Saper and his colleagues purchased all of the medicines on the Internet. In a 2004 study, he also found lead, mercury and arsenic in 20% of Ayurvedic supplements sold in Boston-area stores. About 750,000 Americans have used Ayurvedic medicine, says Michael McGuffin of the American Herbal Products Association, whose members include the makers of traditional herbal products.

Manufacturers and the owners of websites mentioned in the article say they carefully test their products for safety. Peter Bowes, owner of Seattle-based Tattva's Herbs, says his company's own tests found much lower lead levels than those listed in the study.

McGuffin notes that it may be impossible to ensure that herbal products are 100% lead-free, because even fruits, vegetables and dairy products can be contaminated with lead, which can be found in soil or water.

McGuffin notes that government and professional agencies set widely different safety standards for lead, mercury and arsenic. While most of the products in Saper's article have lead levels that exceed California's standard, only two violate the World Health Organization's standard.

Saper says the Food and Drug Administration should set maximum daily dose limits for toxic metals in dietary supplements. Although the FDA currently doesn't specify how much lead is permitted in these products, it can pull products off the market if they're found to be unsafe. The FDA, for example, banned Ayurvedic products cited in Saper's 2004 study.

McGuffin says the government and industry should seriously consider such limits: "If we know what the target is, it makes it easier to hit the target."

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Tuesday, August 26, 2008

Non-Partisan thoughts - For Entertainment Only

Save taxpayers $4,973,800

A president's pension currently is $191,300 per year, until he is 80 years old.

Assuming the next president lives to age 80. Sen. McCain would receive ZERO pension as he would reach 80 at the end of two terms as president. Sen. Obama would be retired for 26 years after two terms and would receive $4,973,800 in pension.

Therefore it would certainly make economic sense to elect McCain in November.

How's that for non partisan thinking???


Biogen Idec shares gain on Tysabri outlook

AP - Yahoo Finance
Tuesday August 26, 11:40 am ET

Biogen Idec shares rise as Wall Street maintains positive multiple sclerosis drug outlook

NEW YORK (AP) -- Wall Street continues to maintain a positive outlook on Biogen Idec Inc.'s multiple sclerosis drug Tysabri, as another safety label change seems to have appeased the Food and Drug Administration and the company said two patients suffering from potentially fatal side effects are recovering.

The Food and Drug Administration late Monday said it is working with the company to address label changes to the drug, though the Cambridge, Mass.-based company said it has already updated the warning.

The prior label warning addressed the risk for patients taking the drug in combination with other therapies, while the new addition addresses the risk for patients taking only Tysabri to treat the autoimmune disorder.

"In a sign of support for the drug, the FDA stated that Tysabri monotherapy may lead to a lower risk of PML compared to Tysabri used in combination with other immunomodulatory therapies," said Thomas Weisel Partners analyst M. Ian Somaiya, in a note to investors. "We view the label change as relatively minor and believe it reflects the FDA's support for continued Tysabri use."

He reaffirmed a "Market Weight" rating, though, over concern there could be further downside to the stock if new cases are reported in the U.S.

Biogen shares gained 55 cents to reach $54.16 before midday.

The stock is still down about 22 percent from July 31, the last trading day before Biogen and its partner Elan Corp. reported two new cases of a rare viral infection called progressive multifocal leukoencephalopathy, or PML, in European Tysabri patients. The drug was pulled from the market in 2005 after being linked to the rare brain disease but was reintroduced under restricted sales conditions in mid-2006.

American Depository Shares of Elan jumped 60 cents, or 4.2 percent, to $14.85 Tuesday. The stock has traded between $9.55 and $37.45 over the last 52 weeks.

There are about 32,000 patients on Tysabri worldwide, with 17,800 in the U.S., the company has said. Sales nearly tripled to $200 million during the second quarter, with treatments costing about $30,000 per year.

Deutsche Bank-North America analyst Mark Schoenebaum also reaffirmed a "Market Weight" rating on Biogen, keeping a positive outlook for the drug, but acknowledging that more PML cases are likely in the future.

"The lack of new cases and recovery of these two cases may provide a short-term upswing for Biogen's stock," he said, in a note to investors.

He is maintaining an estimate of 56,000 patients on Tysabri by 2013.

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An MS Peer in the Netherlands needs help

The following was received from Lisa Emrich of Brass and Ivory

Hello All,

You may know that Herrad of Access Denied: Living with MS is in desperate need of a special type of air pressure cushion. What she needs is an air cushion which changes pressure as you sit on it to prevent the development of pressure sores.

Unfortunately, in the Netherlands access to such expensive and specialized equipment is severely limited and Herrad has not been provided with this important tool. In fact, she is now in such a state to require 3-weeks of bed rest in an attempt to heal wounds.

This is a struggle she has dealt with for awhile, often asking questions regarding treatments we might use in the US to help heal/prevent open sores from developing.

Anne of Disabled Not Dead has started a campaign to collect funds to provide Herrad with the equipment she so desperately needs.

I have decided to contributing all of the existing funds in my PayPal account and have set it up to accept donations specifically for the purchase of Herrad's special cushion. The cost for one to be custom-made for her wheelchair is approximately $450 and for one for use in bed (when she now needs even more) is about $900.

I am leaving it up to Anne to make the actual purchase arrangements as she knows exactly what it is that Herrad needs. If you don't already know, Anne's career was in medicine and this is her expertise.

So please, to donate to Herrad's Cushion click on the PayPal Button below. Together we can make this happen for a fellow MS Blogger in need.


Have questions? Contact Lisa Emrich [


Thank you Stu for you help in this endeavor. I appreciate it greatly.



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24/7 Telephone Peer Assistance from "MS Friends"

MSFriends is the first and only 24/7 telephone peer support Initiative for people living with Multiple Sclerosis. All of our highly trained volunteers are living with MS themselves so they understand and care about each caller. MSFriends was created to help end the isolation and fear that comes with a diagnosis of Multiple Sclerosis. We are here any time of the day or night to take your calls at 1-866-673-7436 (1-866-MSFriends). Please call us and visit our website at, we are here for you!

If you are interested in becoming an MSFriends telephone peer support volunteer, please read the requirements on our website at

If you feel you meet the requirements, please email


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Juices Found to Affect Drugs' Effectiveness:

Stu says: "Quite understandable with the amounts of acidity found in many juices"

This article was contributed by Karen Hart in Ft. Myers (thanks Karen):


By Kathleen Doheny
HealthDay Reporter Tuesday, Aug. 19, 2008; 1:00 PM

Copyright © 2008 ScoutNews, LLC. All rights reserved.

TUESDAY, Aug. 19 (HealthDay News) -- Grapefruit juice, long known to boost the absorption of certain medications, isn't the only juice that doesn't mix well with drugs, according to the Canadian researcher who first identified the ill effects of grapefruit juice.

Other common juices, including orange and apple, may limit the body's absorption of drugs, compromising their effectiveness, said David Bailey, a professor of medicine and pharmacology at the University of Western Ontario, in London, Ontario, Canada.

Bailey was expected to present his research Tuesday at the American Chemical Society's national meeting, in Philadelphia.

"The original finding is that [grapefruit juice] markedly boosts the amount of drug that gets into the bloodstream," Bailey said. He first reported that nearly 20 years ago when he discovered that grapefruit juice increased the body's blood levels of the drop felodipine (Plendil), used to treat high blood pressure.

Since the original finding, other researchers have identified dozens of other medications that could interact adversely with grapefruit juice, Bailey said.

Doctors traditionally warn against drinking grapefruit juice if you're taking certain medications for high cholesterol, high blood pressure and heart rhythm problems, according to the American Academy of Family Physicians.

In his latest research, Bailey found that grapefruit juice, as well as orange and apple juice, can lower the body's absorption of some medications. Those drugs include the anti-cancer drugs etoposide (Etopophos, Vepesid); certain beta blockers like tenormin (Atenolol) and talinolol (Cordanum), used to treat high blood pressure and prevent heart attacks; cyclosporine, which is used to prevent organ transplant rejection; and some antibiotics, including ciprofloxacin (Cipro), levofloxacin (Levaquin), and itraconazole (Sporanox).

Bailey also found that healthy volunteers who took the allergy drug fexofenadine (Allegra) with grapefruit juice absorbed only half the amount of the drug, compared with volunteers who took the medicine with water.

In each case, substances in the juices affected the absorption of the drugs. Some chemicals block a drug uptake transporter, reducing drug absorption; other chemicals block a drug metabolizing enzyme that normally breaks down the drugs, he said.

"We don't [yet] know all the drugs affected," Bailey said.

Michael Gaunt is a medication safety analyst at the Institute for Safe Medication Practices in Horsham, Pa. He said, "If this study holds true [in future research], you are going to have to warn people in a similar fashion" about other juices.

Gaunt's advice for now: "In general, it's safest to take medication with water."

Bailey agreed. If you opt for water, he said, "a glass is better than a sip. It helps dissolve the tablet." And cool water is better than hot, he added, because your stomach empties cool water faster, sending the medication on its way to the small intestine and finally the blood stream.

More information

To learn more about juice and medication interactions, visit the American Academy of Family Physicians

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Tysabri PML Cases in Europe Prompt FDA to Seek Labeling Change

Date Published: Monday, August 25th, 2008

Federal regulators informed healthcare providers today that monotherapy with Tysabri has been linked to two new European cases of progressive multifocal leukoencephalopathy (PML). The U.S. Food & Drug Administration (FDA) said it is working with Elan and Biogen Idec, the manufacturers of Tysabri, to amend the product labeling to inform prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.

In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the dug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.

» Read More

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Sunday, August 24, 2008

Multiple Sclerosis decreases as the amount of vitamin D available to the body increases...

Medical News Today
Article Date: 23 Aug 2008 -

Study Highlights Link Between Vitamin D And Multiple Sclerosis

Vitamin D, the principal regulator of calcium in the body, may prevent the production of malignant cells such as breast and prostate cancer cells and protect against specific autoimmune disorders including multiple sclerosis (MS) according to an article by Sylvia Christakos, PhD, of the UMDNJ-New Jersey Medical School.

In the article, Christakos reports that research shows that the incidence of MS decreases as the amount of vitamin D available to the body increases, either through sunlight exposure or diet. The article notes that MS is "for the most part, unknown in equatorial regions" and that the prevalence of the disease is lower in areas where fish consumption is high. The study is available online in the Journal of Cellular Biochemistry.

» Read More

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In the Worst Of Cases -

In the worst of cases, this "is" possible --
By Mary Lewis - Citizen Staff Writer
Published: Thursday, August 21, 2008 6:07 PM PDT
Steven Greg Wright, a resident of Elk Grove for 44 years who suffered from multiple sclerosis for the past 25 years, lost his battle with the disease and died Aug. 19, 2008 at the age of 50.

Before MS completely incapacitated him, Elk Grove residents knew him as a community booster: active with the Elk Grove Lions Club, volunteer fireman, EMT, member of DART, Elk Grove Historical Society, El Dorado Rescue Team and the Elk Grove chapter of the MS Society.

He was also a ham operator, member of the NRA, and for relaxation, loved to go to the movies.

He was born in Los Angeles County June 19, 1958 and grew up in Elk Grove, attending Elk Grove Elementary, Joseph Kerr Middle and Elk Grove High schools, graduating from the latter in 1976.

He then worked for Citizens Utilities Company for 12 ½ years until illness forced him to retire.

Mr. Wright participated in Lions Club activities, especially sight conservation, for many years, and for his efforts received the Fred O. Summer Fellow, the Gordon Daniels award, and the highest award Lions can bestow: the Melvin Jones Fellow. The Elk Grove club made him a lifetime member.

He also worked with the Healthy Start program at the Elk Grove Unified School District, and was awarded a Sight First plaque.

“Steve helped me so much with the Chamber of Commerce, especially when I was president,” said his mother Elaine Wright, also a community-involved person. “And he was very much involved with Elk Grove’s second try at incorporation.”

For several years he was able to live by himself in an apartment with much help from his parents and friends. One friend, Dr. Arnold Lewis who used to help with feeding him dinners, said: “Steve inspired all of us by bravely accepting his handicap, and I look forward to renewing our cherished friendship, when we both can speak and hear more clearly while swapping those horrible jokes.”

His sister said, “Steve had a smile that could light up a room and a spirit that drew you to him. He loved his family and his country, and loved being a part of the Elk Grove community.”

Mr. Wright is survived by his parents, Jim and Elaine Wright of Elk Grove; sisters Marlene Flores and husband Mario also of Elk Grove, and Marilyn Wright and husband Gary Johnson of Arden Park; niece Amanda Rafidiarimanda and husband Didier of Paris, France; and nephews Darren McAuliffe of Grants Pass, Ore. and Max Johnson of Arden Park.

He was the nephew of Robert Graham and wife Lyallyn of Aurora, Ore., and cousin of Jeremy and Ian Graham of Aurora.

There is a viewing today (Friday) from 4 to 8 p.m. at East Lawn Elk Grove Mortuary, 9189 East Stockton Blvd. Services will begin at 11 a.m. Saturday, Aug. 23 at the Church of Jesus Christ of Latter-day Saints, 8697 Elk Grove Blvd.

Remembrances may be made to the Rhoads School, c/o Elk Grove Historical Society, P.O. Box 562, Elk Grove, CA 95759; or to the Multiple Sclerosis Society. A Web site, created by Mr. Wright’s niece Amanda, has been created under The Steven Wright Memorial Research Fund, where donors may also sign in on the guest book.

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The Cost of feeling better can spell "Financial Ruin" for Many

Rising bill for new drugs threatens to overwhelm patients, employers

Putting a strain on mutual cashflow
The Seattle Times

SEATTLE --Sally Garcia, a 53-year-old lawyer disabled by multiple sclerosis, was torn.

A new-generation medication, Copaxone, was really working for her. After two decades of being in and out of hospitals, Garcia was taking steps to work again.

Her wallet, though, was in severe distress. Under her Medicare prescription plan, Garcia's share of the expensive drug was $330 per month. All together, medications were taking a third of her disability payments -- her only income -- and she couldn't swing it.

» Read More

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