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Thursday, April 19, 2007
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Tuesday, April 17, 2007
By Steven Reinberg
TUESDAY, April 17 (HealthDay News) -- A controversial multiple sclerosis drug called Tysabri also reduces vision loss associated with the disease by 47 percent, a new study found.
"Vision loss is probably one of the most disabling things that happens to people with MS," said lead researcher Dr. Laura J. Balcer, an associate professor of neurology at the University of Pennsylvania School of Medicine. "The exciting thing is, first, that we now have an eye-chart test that can pick that up and can show if treatments help vision. Second, this particular drug appears to help prevent vision loss."
In the study, Balcer's group looked at the results of two trials -- called AFFIRM and SENTINEL -- that included 2,138 people with relapsing MS. More than half the patients received Tysabri (generic name natalizumab) every four weeks for two years.
To evaluate eyesight, the researchers used a specially developed eye chart of low contrast letters. They found vision loss was reduced by as much as 47 percent among the people taking Tysabri, compared with those taking a placebo.
"Vision is one more dimension of MS that the drug helps," Balcer said. "It has already been shown that the drug reduces the rates of relapses and disability."
Balcer thinks that other MS drugs may have similar effects on vision, and there is now a test that can be included in trials to evaluate this. "Now, we can get to see how these other medications may help vision," she said.
The findings are published in the April 17 issue of the journal Neurology.
Tysabri's history has been marked by some controversy.
It received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy. In June 2006, the FDA allowed the drug to return to the mart, but with strict conditions. According to the new guidelines, Tysabri can only be administered by approved doctors, infusion sites and pharmacies that register and comply with a patient-safety program designed by Biogen-IDEC, the maker of Tysabri, and approved by the FDA.
One expert thinks that despite the vision benefit, Tysabri should be reserved for patients with aggressive MS or those who failed other medications.
"This study confirms the benefits of this particular MS drug in relapsing MS patients," said Dr. Anne H. Cross, a professor of neurology at Washington University School of Medicine, in St. Louis. "In addition, it validates the use of a new vision test which is relevant to MS."
But the benefit to vision doesn't negate the risks associated with the drug, Cross said. "I don't think I will change my prescribing habits based upon this paper," she said. "I will probably continue to use it in the same type of patients I have been using it in in the past."
However, Nicholas LaRocca, the director of health care delivery and policy research at the National Multiple Sclerosis Society, said the new study provides additional insight into the benefits of the drug and may influence the decision whether to start using it or not.
"For patients who are on natalizumab or considering natalizumab, this gives them another piece of information to consider as they are trying to make their decision," he said.
According to the U.S.National Institutes of Health, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted. Many researchers believe MS to be an autoimmune disease -- one in which the body, through its immune system, launches a defensive attack against its own tissues. In the case of MS, it is the nerve-insulating myelin that comes under assault.
The National Multiple Sclerosis Society can tell you more about multiple sclerosis.
Monday, April 16, 2007
* MS Chatters
* MS World - Patients Helping Patients!
* Famous people with MS ( Hey, How come I am not on this list ?????)
Saturday, April 14, 2007
April 12, 2007
Story found in the Accelerated Cure Project MS News site
Repetitive transcranial magnetic stimulation (rTMS) may improve spasticity in multiple sclerosis. rTMS is a non-invasive method of stimulating localized regions of the brain with magnetic fields. This research showed that repetitive stimulations improved spasticity in people with MS when compared to sham stimulation.
Tuesday, April 10, 2007
Published: Saturday, 7-Apr-2007
Immunology researchers at the Kimmel Cancer Center at Jefferson studying a multiple sclerosis (MS)-like disease in mice have shown that the amount of "damage" to the central nervous system's protective blood-brain barrier, in essence, opening it, almost always correlates to the severity of the disease.
The findings, reported online in the Proceedings of the National Academy of Sciences, can be used for testing potential MS therapies and for better understanding the role of the blood-brain barrier in disease processes.
Scientists led by D. Craig Hooper, Ph.D., associate professor of cancer biology at Jefferson Medical College of Thomas Jefferson University in Philadelphia, and Hilary Koprowski, M.D., professor of cancer biology at Jefferson Medical College and director of Jefferson's Center for Neurovirology and the Biotechnology Foundation Laboratories, wanted to find out what factors might affect the onset and severity of EAE (experimental allergic encephalomyelitis), an MS-like autoimmune disease often used as a model. They studied various strains of mice, each lacking some genes associated with inflammation and immunity, and looked at what happened to the blood-brain barrier.
They discovered that the amount of blood-brain barrier damage and subsequent permeability increase correlated to the severity of disease, and surprisingly, in nearly every case, the mouse's genetic make-up didn't matter. The mice developed EAE even without supposedly crucial factors in inflammation and autoimmunity and disease.
"We've now shown in all of these mice missing certain components of the immune system that, as expected, opening the blood-brain barrier and letting cells and factors in from the circulation is critical to the development of disease," Dr. Hooper says. "The fact that the extent of the permeability change correlates with the severity of clinical disease signs shows that this is an important element in determining how sick these animals can get.
"This puts an emphasis on the fact that blood brain permeability changes are an important aspect of the development of a CNS inflammatory disease like EAE, an animal model of MS," he says.
According to Dr. Hooper, previous studies by his group and other researchers have shown that blood-brain barrier permeability is critical in the development of MS. To study this permeability, he and his co-workers looked at a range of mice lacking certain genes for various types of immune system and inflammatory cells such as NF kappaB, TNF-alpha, and interferon alpha, beta and gamma that contribute to disease. The researchers established EAE in each mouse strain and examined what was common to all of the animals when they developed disease.
"What's astounding is that mice that wouldn't be expected to develop EAE because they have major defects in their immune system are still able to develop disease," though at different rates, he notes.
However, mice missing the immune protein TNF-alpha often did not show disease, despite the increase in brain barrier permeability, causing the scientists to speculate about its role in the disease. "This is the first proof that there are permeability changes in all of these animals and the first hint that permeability doesn't always equal disease," he says.
Dr. Hooper notes that the work is part of the long-range goal of determining the exact role of blood-brain barrier permeability in disease. "These results tell us a great deal about the mechanisms that damage the blood-brain barrier," he says. "All of these factors that are missing in the mice aren't essential to opening the blood brain barrier."
Saturday, April 7, 2007
Published: April 8, 2007
WASHINGTON, April 7 — Senior members of Congress from both parties are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year.
Prospects for the legislation have increased since Democrats took control of Congress this year. Consumer groups, employers and insurers are lobbying for the bill, which they see as a way to hold down health costs.
The proposal faces formidable scientific and political obstacles. Brand-name pharmaceutical companies contend that biotechnology products, made from cells and living organisms, are so complex that a copy will never be identical to the original and therefore cannot be certified as safe without testing in humans.
Biotech medicines are the fastest-growing category of health spending, with sales of $40 billion last year, up 20 percent from 2005, according to IMS Health, a market research company. More than 400 biotech products are in the pipeline, for more than 100 diseases, including cancer, AIDS, diabetes and Alzheimer’s.
Conventional drugs are synthesized by putting atoms together from basic chemicals and are often in pill form.
Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion.
Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
“Some level of clinical testing should be required in all cases,” said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: “I would never take a biologic that had not been tested in humans. The risks are too high.”
But Dr. Woodcock said: “Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.”
Many biotech drugs are effective but expensive. Avastin, a cancer treatment made by Genentech, can cost $4,400 to $8,800 a month, with a maximum cost of $55,000 a year for people who qualify for the company’s patient assistance program.
Cerezyme, a drug made by Genzyme for Gaucher disease, costs $200,000 a year. Enbrel, made by Amgen for rheumatoid arthritis and psoriasis, costs an average of $16,000 a year.
Biotech treatments for multiple sclerosis range in price from $16,000 to $25,000 a year. “Many patients are denied access to these important drugs because even the co-payments can reach thousands of dollars a year,” said Arney Rosenblat, a spokeswoman for the National Multiple Sclerosis Society.
Consumers save billions of dollars a year by using low-cost generic versions of conventional drugs, which are approved by the government under a 1984 law.
One author of the 1984 law, Representative Henry A. Waxman, Democrat of California, is pushing a bill that would authorize the Food and Drug Administration to approve safe, lower-cost versions of biotechnology drugs.
Senators Charles E. Schumer and Hillary Rodham Clinton of New York, both Democrats, have introduced an identical bill, with support from several Republicans, including Senators Susan Collins of Maine and David Vitter of Louisiana.
The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.
But AARP, the lobby for older Americans, has joined the Consumers Union, Aetna, the Blue Cross and Blue Shield Association, Caterpillar, General Motors, Kaiser Permanente, and Walgreens and other chain drugstores in a coalition supporting the legislation.
The bill reflects the initial negotiating position of the generic drug industry and its allies as Congress begins serious negotiations to reach a compromise.
A co-author of the 1984 law, Senator Orrin G. Hatch, Republican of Utah, predicted that Congress would pass legislation on the issue this year.
Mr. Hatch is trying to work out a compromise, more acceptable to brand-name drug makers, in negotiations with Mrs. Clinton and Senators Edward M. Kennedy, Democrat of Massachusetts, and Michael B. Enzi, Republican of Wyoming.
Mr. Kennedy represents a state with scores of biotech companies and is chairman of the Senate committee with authority over the issue. Mr. Enzi is the senior Republican on that panel.
They are seeking a balance like the one struck in the 1984 law, which fostered a booming generic drug industry while protecting the patent rights of brand-name drug makers — a crucial incentive for research on new drugs.
The manufacture of biotech drugs is more complex and costly than the production of conventional medicines. But economists cite another reason for the high prices: biotech medicines generally face no competition from copycat drugs.
When the first generic copy of a conventional drug becomes available, it may cost 15 percent less than the brand-name product. If several competing generic versions are available, the price often falls by 60 percent or more.
Prof. Henry G. Grabowski, a health economist at Duke University, said prices would decline less for biotechnology drugs.
But Scott McKibbin, an aide to Gov. Rod R. Blagojevich of Illinois, said biotech drugs were so expensive that discounts of just 10 percent to 20 percent would save tens of millions of dollars for the state’s Medicaid program and the state employees’ health plan.
The debate over biotech drugs is filled with paradoxes. Brand-name drug companies, which have for years criticized the regulation of drug prices in Europe, now point to Europe’s strict regulation of “follow-on biologics” as a possible model for the United States. Democrats, who have often criticized the F.D.A. as lax in enforcing drug safety laws, now say they trust the agency to decide whether copies of biotech drugs are safe and effective, without the full range of tests required for new products.
Thursday, April 5, 2007
Join the MS Action Network, the center for advocacy at the National Multiple Sclerosis Society. Together, we represent the interests of people with MS as important policy decisions are made in both the public and private sectors. Our advocacy is focused on: federal funding for MS research; quality health care; long-term care; disability rights; and health insurance and prescription drug coverage. The MS Action Network works on these important issues at the federal, state and local levels.
The three Florida chapters of the National Multiple Sclerosis Society have partnered together to form MS-CAN. The mission of MS-CAN is to raise awareness of and interest in governmental issues and public policy that may affect the quality of life for people with MS and empower them to take effective action.
Following the decisions of several HMOs to reduce or drop their coverage of self-Injectables or increase the co-payments to an alarming 25% plus of the cost, the National MS Society South Florida Chapter launched an initiative in support of non-discrimination for access to MS treatments.
Visit the National site for more information on advocacy
Tuesday, April 3, 2007
Instead of trying to work around these obstacles, take advantage of the ways technology can flex to your changing - and often unpredictable - needs. Customizable products and features are designed with you in mind, and can help make living with MS easier.
Some elements of accessible technology are already built into computers. Having trouble seeing the cursor on your computer screen? With just a few clicks, you can make the cursor bigger or change the blink rate. You can also enlarge the text of your entire computer screen.
Other elements are specially made for individuals with dexterity, vision, speech, or cognitive difficulties. For example, if you have trouble moving your mouse around, you might want to consider using a trackball instead.
Technology also can improve how you take your disease-modifying therapy. Having trouble taking it at the right time each day? Consider setting a reminder on your cell phone or sending yourself a text message.
For more ways to make the computer easier to see, hear and use, visit www.microsoft.com/enable.
Monday, April 2, 2007
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