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Saturday, March 5, 2011

Alberta doctors advised how to treat MS liberation patients




EDMONTON - Alberta doctors are being told there isn't a lot of information on how to provide followup care for multiple sclerosis patients who have undergone an unproven procedure outside the country.
A document written by a committee of doctors and circulated by the province's College of Physicians and Surgeons says there's little research on how to treat people who have undergone the controversial liberation therapy.
"There's situations where it's not going to be really clear as to what the followup specifically should be or the treatment should be," said college registrar Trevor Theman. "Physicians need to use their best judgment."
Some liberation patients have complications after they return and in many cases don't get proper medical records or information from the doctor who treated them.
While Alberta doctors have an ethical obligation to look after such patients, the document says they're not obliged to continue treatments prescribed by foreign practitioners — especially if they can't get information about what the foreign doctor has done.
The document also suggests college members shouldn't prescribe drugs for purposes other than their intended use and don't have to routinely monitor for blood clots.
There just isn't enough knowledge on the effects of blood thinners on patients who have undertaken the therapy, Theman said.
"There's no studies. We don't know if that's a good thing to do and we don't know what the safety in this situation is."
That leaves Alberta doctors in a tough spot, said Theman.
"It is a very difficult situation to be in."
More research is needed on the topic, Theman said.
Ontario has struck a panel on how doctors can provide followup care for liberation therapy patients.




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Thursday, March 3, 2011

US seeks more data on MS treatment, Oral Cladribine


Bloomberg News - March 3, 2011

ZURICH — Merck KGaA failed to win US regulators’ backing for its multiple sclerosis pill cladribine, shutting the German drug maker out of the market for new treatments for the crippling disease for now.

The Food and Drug Administration asked for more analysis or additional studies to get a better understanding of the medicine’s risks, Darmstadt-based Merck said. Merck plans to seek an end-of-review meeting with the FDA to determine whether data already collected will be sufficient to address the concerns, according to the statement.

Merck had expected to compete with Switzerland’s Novartis AG, whose drug Gilenya became the first pill in the United States to combat multiple sclerosis when it won approval in September. Now the German drug maker is losing its foothold in the market as setbacks accumulate for cladribine and its older injected treatment Rebif faces competition from new therapies, said Cornelia Thomas, a London-based analyst for WestLB AG.

Without US approval for cladribine, Merck’s sales this year are likely to climb 10 to 15 percent, chief executive Karl-Ludwig Kley said last month. That compares with an estimate of 13 to 18 percent if the drug had won clearance.



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Remain CURRENT with educational information of
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Wednesday, March 2, 2011

FDA Turns Down Cladribine for MS


By John Gever, Senior Editor, MedPage Today
Reviewed by 
March 02, 2011


Review

The FDA said it won't approve the oral multiple sclerosis drug cladribine without more data on its safety and benefit-risk balance.

Merck KGaA, the drug's German manufacturer, said it has received a complete response letter from the FDA indicating that the company would have to provide additional analyses of its clinical trials data or conduct new studies to satisfy its concerns.

However, the company said it was encouraged that the letter confirmed that the existing trial data were adequate to support the drug's efficacy in reducing MS exacerbations and progression.

Cladribine is currently marketed as a chemotherapy drug for certain leukemias and lymphomas. A series of studies has shown that it inhibits activity and proliferation of lymphocytes involved in MS, prompting Merck KGaA to seek approval for cladribine as a treatment for the autoimmune disease.





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 Multiple Sclerosis when registered at
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Higher Vitamin D Content to Reduce Breast Cancer, Colon Cancer and Multiple Sclerosis Risk


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According to a new study conducted by researchers from University of California at San Diego, more vitamin D can cut the risk of several major conditions, including breast cancer. Study co-author Dr. Cedric Garland, a professor of family and preventive medicine at the University of California at San Diego, declared in a statement that daily intakes of vitamin D by adults in the range of 4,000-8,000 IU are needed to reduce the risk of several diseases such as breast cancer, multiple sclerosis, colon cancer and type 1 diabetes.
Vitamin D supplements can be found in pills or capsules containing 1,000 or 2,000 international units. However, researchers said the 4,000 to 8,000 IU a day is still much lower than the range considered to be safe by the National Academy of Science’s Institute of Medicine.
The clinical survey was based on another study of several thousand patients  who have been taking supplements ranging from 1,000 to 10,000 IU per day. The subjects have also undergone several  blood tests to determine the levels of vitamin D metabolites circulating in their blood.
Last year, according to an announcement released by the National Academy of Sciences Institute of Medicine (IOM) committee,  4,000 IU a day of vitamin D was safe for adults and kids aged 9 and up.
The report released by Garland and his colleagues suggested that 4,000 IU a day is a safe level and that soon it would become common for adult to take the dose daily.
Source: Staho.com


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Remain CURRENT with educational information of
 Multiple Sclerosis when registered at
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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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