Happy Birthday, Baby!



FDA Approves First Oral Treatment for Relapsing Forms of MS
A New Disease-Modifying Therapy for MS

Novartis Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Gilenya (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). Gilenya is the first oral disease-modifying therapy available for the long-term treatment of MS. The approval of a treatment that may be taken orally (by mouth), versus injection or infusion, is exciting news for members of the MS community.

Seven other disease-modifying therapies (including two identical drugs marketed under different brand names) have been previously approved by the FDA and are presently available by prescription. These are given via self injections at the patient's home or by infusion at a medical facility.

Gilenya (pronounced as "Jil-EN-ee-ah") presents a new option for individuals with MS. While many members of the MS community presently take one of the previously approved disease-modifying therapies and are doing very well on these therapies, not everyone responds to or is able to tolerate these medications. Particularly for these individuals, and for people who are uncomfortable with injections and/or experience injection-site reactions, the prospect of a new oral medication for MS is very encouraging.

MSAA Chief Medical Officer Dr. Jack Burks explains, "Gilenya represents the first FDA-approved oral drug for MS, which will provide additional opportunities to greatly help many people affected by this disease. The effectiveness data for Gilenya is very impressive. The MS world is excited to add this new class of drug in an oral capsule. However, patients and their doctors must realize that new classes of drugs come with new types of side effects that will require attention. Learning about these adverse events and how to minimize them are an important consideration in deciding if this drug is right for each individual patient."

Administration, Therapeutic Action, Efficacy, and Other Oral Drugs in the Pipeline

This new oral drug will be available by prescription in early October. The dose is a single 0.5 mg capsule taken once daily, with or without food. Since it has been approved as a first-line treatment, doctors may prescribe this medication as a first disease-modifying therapy for MS; in other words, a patient does not need to try other treatments prior to starting on Gilenya.

Formerly known as "FTY720," Gilenya is the first in a new class of immunomodulatory drugs called S1P-receptor modulators. It is similar in structure to a naturally occurring component of cell surface receptors on white blood cells. Gilenya blocks potentially damaging T cells from leaving lymph nodes, lowering their number in the blood and tissues. It may also reduce damage to the central nervous system (CNS) and enhance the repair of damaged neurons. Additionally, animal data suggest that this drug may provide neuroprotective effects. If treatment with Gilenya is discontinued, white blood cells are no longer retained in the lymph nodes and they return to circulation in the body.

Gilenya has been shown to reduce relapse rate and delay the progression of disability, as well as reduce brain lesion activity and brain volume loss as seen on magnetic resonance imaging (MRI), when compared to control groups given a placebo. In addition, in a one-year study, Gilenya compared favorably over interferon beta-1a (Avonex®).

Gilenya is one of five oral medications that have been recently under investigation for the treatment of MS. These include oral cladribine, which has been given Fast Track status by the FDA and may be approved later this year or in early 2011, and oral laquinimod, which has been given Fast Track status as well. Additionally, the developers of oral teriflunomide have recently announced positive data from their pivotal trials, while oral BG-12 (dimethyl fumerate) is also in phase III studies with the hopes of filing for FDA approval in the near future.

Clinical Trial Information

The information in this section is an excerpt from the upcoming cover story, "Multiple Sclerosis Research Update." The full cover story will appear in MSAA's Summer/Fall 2010 issue of The Motivator, due out in late October. The "Multiple Sclerosis Research Update" was written by Diana M. Schneider, Ph.D and reviewed by MSAA's Chief Medical Officer Jack Burks, MD. The information to follow is an overview of some of the pivotal trial results for Gilenya.

The FREEDOMS Phase III study of low-dose (0.5 mg) and high-dose (1.25 mg) Gilenya (fingolimod) versus placebo is scheduled to end in March 2011. Outcome measures to date show the drug to be safe and well tolerated. Interim data show a 60-percent reduction in annualized relapse rate, a significant reduction in disability progression, a 74 to 82-percent reduction in the burden of disease as measured by MRI, and a reduction in whole-brain atrophy.

An extension study, FREEDOMS II, evaluated long-term safety, tolerability and efficacy; all 1,080 participants received Gilenya. Two deaths resulted from Herpes virus infection in the FREEDOMS trials; both of these individuals had received a higher dose than that submitted to the FDA. No deaths were reported in lower-dose group, which used the same dose as approved by the FDA.

The TRANSFORMS Phase III trial was a 12-month study of the efficacy of two doses of Gilenya (0.5 mg and 1.25 mg) as compared to weekly intramuscular injections of Avonex in individuals with RRMS. Its primary outcome measure was a reduction of relapse rate. Secondary measures include frequency of relapses, inflammatory disease activity as measured on MRI, and time to progression of disability.

In the TRANSFORMS trial, the annualized relapse rate was lower with Gilenya 0.5 mg (0.16) versus Avonex (0.33) at 12 months. The proportion of relapse-free patients was also higher with Gilenya. In summary, Gilenya was more effective in reducing relapse rate and relapse frequency, resulted in less deterioration in the ability to independently perform daily activities, was associated with a lower rate of brain atrophy, and showed a greater effect on reducing MRI measures of lesion activity.

Another new clinical trial began in April 2010. It has 1,850 participants, all of whom are receiving Gilenya. This trial is scheduled for completion in April 2011. The primary outcome measure is the safety and tolerability profile in patients with relapsing forms of MS. Secondary measures include the incidence of macular edema (swelling behind the eye) and any changes in heart rate or function as seen on an electrocardiogram. Secondary measures also include patient-reported outcomes based on surveys of health status and treatment satisfaction.

The 36-month INFORMS study in 940 individuals is the only trial now ongoing for PPMS. It will evaluate the effect of Gilenya relative to placebo on delaying the time to sustained disability progression, as well as safety, tolerability, and the effects on MRI parameters.

Side Effects, Adverse Events, and Precautionary Steps to Minimize Risks

These oral medications offer the advantage of not requiring injections or infusions, as with drugs approved prior to September 2010. Oral medications do not cause related side effects such as injection-site reactions and flu-like symptoms. However, these new drugs are not without potential side effects and adverse events, which need to be discussed with one's healthcare provider prior to making any treatment decisions.

The most commonly reported side effects with Gilenya include headache, flu, diarrhea, back pain, abnormal liver tests and cough. Women are strongly advised to use contraception to avoid pregnancy while taking Gilenya - and to continue contraception for two months following the discontinuation of Gilenya. Although no studies have been conducted to see the effects of pregnancy with humans while taking Gilenya, animal studies suggest that it could cause fetal harm. Researchers also do not know if the drug is passed through breast milk, so the makers of Gilenya also strongly advise against breast feeding.

Adverse events with Gilenya include: a reduction in heart rate (dose-related and transient); infrequent transient AV conduction block of the heart; a mild increase in blood pressure; macular edema (a condition that can affect vision, caused by swelling behind the eye); reversible elevation of liver enzymes; and a slight increase in lung infections (primarily bronchitis). Infections, including herpes infection, are also of concern.

A number of precautionary steps have been put in place to minimize risks and enable doctors to better evaluate and treat any possible adverse events. Within six months prior to starting Gilenya, patients should be given a baseline evaluation for any issues with the heart, lungs, liver, eyes and vision, as well as white-blood-cell count (which may indicate an existing infection). Present medications also need to be considered. Vitals (blood pressure, pulse, etc.) should be taken at baseline and periodically while on treatment.

Since the drug causes a reduction in circulating white blood cells, individuals considering Gilenya also need to indicate if they have had chicken pox or a chicken pox vaccination recently; if so, they may need to wait before starting the medication. Individuals who test negative for the chicken pox virus may need to be vaccinated and delay starting Gilenya. Patients will also need to avoid vaccinations with live viruses.

When beginning the drug, patients must be observed at a medical facility for the first six hours following the first dose. This is necessary as Gilenya may slow the heart rate, with the most significant drop usually occurring within the first six hours. While taking this drug, patients need to contact their doctor immediately if they experience any symptoms such as dizziness, tiredness, slow or irregular heartbeat, breathing difficulties, visual changes, or signs of an infection or liver problem.

If an adverse event occurs, the treating physician may determine the best follow-up treatment. In the case of an infection, in studies, Gilenya was usually discontinued for two weeks. No withdraw issues occurred, however, when restarting the drug, patients need to be observed again for the first six hours following the first return dose. In studies, macular edema occurred in a small number (0.4 percent) of those treated with the approved dose. In such instances, study protocol required patients to discontinue Gilenya and the condition generally improved or resolved afterward in most but not all cases.

A Risk Evaluation and Mitigation Strategy (REMS) has been approved to provide information to patients as well as healthcare professionals on how to use the drug safely, along with possible risks that may occur. Novartis will conduct a five-year observational safety study to further evaluate any adverse events. They have also organized a voluntary registry for women who become pregnant while taking or within two months after discontinuing this drug to document possible effects.

Both patients as well as medical professionals are encouraged to visit Gilenya's website at www.gilenya.com for more detailed information on this new treatment. Individuals may also call Gilenya's Patient Service Center at (877) 408-4974 for more information. The Patient Service Center can also provide advocacy with insurance claims as well as financial assistance to those who qualify.

Copyright 2010 MSAA
Multiple Sclerosis Association of America
National Headquarters
706 Haddonfield Road, Cherry Hill, NJ 08002


Fighting Rape in the Congo

The Los Angeles Times
October 23,2010

For more than a decade, rebel soldiers from Rwanda have committed atrocities in the neighboring Democratic Republic of Congo with almost complete impunity. They kidnap children, murder men and are conducting a strategic campaign of raping and torturing women. In August, the United Nations confirmed that members of the Democratic Forces for the Liberation of Rwanda, or FDLR, and another militia were responsible for hundreds of rapes in the Walekali region — and rape is a tepid word for the brutal attacks. Victims were mutilated with broken bottles, tree branches and bayonets, and shot in the genitals.

That is why the recent arrest in Paris of Callixte Mbarushimana, the executive secretary of the FDLR, on a warrant from the International Criminal Court charging him with war crimes is momentous. It comes after 18 months of international cooperation by governments that tracked his movements through France, Germany, Congo, Rwanda and other countries. It also comes amid increasing pressure from aid organizations, human rights activists, philanthropists, religious groups and artists to stop the violence and, in particular, the rapes.

Human Rights Watch, the Enough Project, Women for Women International and many other groups, working with Africa-based organizations such as Friends of the Congo, have sustained awareness of a crisis that otherwise would be remote and unseen by much of the world. In Los Angeles, that mission is largely undertaken by Jewish World Watch, founded by Rabbi Harold M. Schulweis and Janice Kamenir-Reznik. What started with a few dozen area synagogues has grown into a global coalition including churches, schools and community organizations. The group has partnered with African and Israeli organizations to underwrite the training of Congolese doctors to repair the mutilations of rape victims, create a burn center in eastern Congo and fund a program to teach vocational skills to survivors of the violence.

Increasingly, activism and art have become partners. This month, the group honored Pulitzer Prize-winning playwright Lynn Nottage before a performance of her searing drama "Ruined," about three Congolese rape survivors living in a brothel. In New York, a series of Congo-related films recently kicked off Congo Week.

The arrest and indictment of one FDLR leader will not halt years of conflict, although State Department officials rightly hope that Mbarushimana's capture will inspire other rebels to lay down their guns. Nor can one play, a handful of films or the work of several charities bring peace to Congo. But taken together, they offer hope.

Michael Moore to Juan Williams

The Huffington Post October 23, 2010

Michael Moore
Oscar and Emmy-winning director

Juan Williams Is Right: Political Correctness About Terrorists Must End!

Dear Juan,

Sorry to hear you got fired by National Public Radio for saying on Fox that you get nervous when you see Muslims on a plane with you. It was dumb to say such a thing, but I don't think saying one dumb thing should be a firing offense. (I do think an NPR journalist wanting to take money from Fox News to be a regular commentator should be a firing offense, but that's another story).

But there's more to this -- and some important things that everyone is missing.

For instance, what you said about Faisal Shazad, the Pakistani immigrant who wanted to bomb Times Square. When he was being sentenced this month, he claimed, according to you, that his attempted attack was just "the first drop of blood." We can't let political correctness blind us to this, you explained.

I guess Shahzad made a big impression on you, because after being fired you went back on Fox and told them, "You can't ignore the fact what has recently been said in court with regard to 'this is the first drop of blood in a Muslim war against America.'"

Sadly for you (and this is also why you shouldn't be working for a real news organization like NPR), Shahzad never said that. If you were a real journalist, you would have quoted him accurately. What he actually said was that he was the "first droplet of the flood," not blood. But I know how easy it is to mishear things when scary Muslims are talking. And I guess it's not a huge difference anyway.

What really matters is that you're 100% right: We shouldn't let political correctness stop us from paying close attention to what people like Shahzad say. The problem is you just haven't taken it far enough.

So Juan, I'm asking you to join me on a crusade -- whoops! scratch that, let's call it a "mission" -- to publicize these statements by Faisal Shahzad as widely as possible. Because most of the media have not spent much time on what he had to say.

Here's what he said at his recent sentencing (after talking about being a droplet in a flood):

[Saladin] liberated Muslim lands... And that's what we Muslims are trying do, because you're occupying Iraq and Afghanistan... So, the past nine years the war with Muslims has achieved nothing for the U.S., except for it has waken up the Muslims for Islam. We are only Muslims trying to defend our people, honor, and land. But if you call us terrorists for doing that, then we are proud terrorists, and we will keep on terrorizing until you leave our land and people at peace.

And this is what Shahzad said when he plead guilty back in June:

I want to plead guilty, and I'm going to plead guilty 100 times over, because until the hour the U.S. pulls its forces from Iraq and Afghanistan, and stops the drone strikes in Somalia and Yemen and in Pakistan, and stops the occupation of Muslim lands, and stops killing the Muslims, and stops reporting the Muslims to its government, we will be attacking U.S., and I plead guilty to that.

Then there's email that Shahzad sent to a friend in 2006:

Everyone knows the current situation of Muslim World... Friends with peaceful protest! Can you tell me a way to save the oppressed? And a way to fight back when rockets are fired at us and Muslim blood flows? In Palestine, Afghan, Iraq, Chechnya and else where.

And then there's what Shahzad was telling friends and relatives even before that:

Mr. Shahzad had long been critical of American foreign policy. "He was always very upset about the fabrication of the W.M.D. stunt to attack Iraq and killing non-combatants such as the sons and grandson of Saddam Hussein," said a close relative. In 2003, Mr. Shahzad had been copied on a Google Groups e-mail message bearing photographs of Guantánamo Bay detainees, handcuffed and crouching, below the words "Shame on you, Bush. Shame on You."

So what do you say, Juan? Now that you have a new $2 million contract with Fox, let me come on with you for some in-depth discussions about the terrorists' real motivations. We can't let another day go by letting the PC brigade stop us from telling the truth: Terrorists aren't trying to kill us because they hate our freedom. They're killing us because we're in their countries killing them.


Michael Moore

P.S. If you want to understand suicide bombings, be sure to read the new book that studied every instance of it for the past 30 years. It's been used by many groups of many religions, not just Arabs and not just Muslims. And almost all such terrorism has one motivation in common: occupation by foreign militaries.

P.P.S. Here's something else that I'd sincerely love to talk about with you: what do you think when you see rich middle-aged white men talking on TV about how they get nervous around African Americans on the street? And then they explain that we can't let political correctness stop us from talking about black-on-white crime?

Does it drive you crazy that they say this without even being conscious of the history of far greater violence by white people toward blacks? And do you maybe understand now how those middle-aged white guys get it so wrong?

UPDATE: Juan, you probably remember in 1986 when the Washington Post Magazine ran a Richard Cohen column defending jewelry store owners who wouldn't buzz in young black men. It caused such a big controversy that the New Republic ran a bunch of responses to it, including one by you. You might find it interesting to go back and read what you wrote then -- for instance, "Racism is a lazy man's substitute for using good judgment... Common sense becomes racism when skin color becomes a formula for figuring out who is a danger to me."


Glass Harp


NBC Video

Visit msnbc.com for breaking news, world news, and news about the economy

Obama Related to Palin & Limbaugh

NEW YORK (AP) — And you thought it was strange to hear that Barack Obama was related to Dick Cheney. Well, betcha can't guess who he's related to now!

Yup — the president has family ties to none other than Sarah Palin, according to the genealogists at Ancestry.com, a discovery the family history site made when looking for connections between political foes.

And that's not all — Obama also is apparently related to radio host and relentless critic Rush Limbaugh. Might you want to reconsider some of your recent comments, Mr. Limbaugh, now that you're apparently family?

A genealogist at the Utah-based Ancestry.com, Anastasia Tyler, said Obama and Palin are 10th cousins through a common ancestor named John Smith, a pastor and early settler in 17th-century Massachusetts. Obama is related to Smith through his mother, as is Palin, Tyler said.

"Smith was against the persecution of the Quakers," Tyler said in an interview. "He was a very socially conscious man."

As for Limbaugh, he's also a 10th cousin of the president — one time removed — through a common ancestor named Richmond Terrell, who Tyler said was a large landowner in Virginia, also in the 17th century. "His history is a little more nebulous," Tyler said.

How do the genealogists come up with this stuff? Tyler said they start by picking the people they're interested in, then examine their family trees, going back further and further into history, looking for common surnames and locations.

In the recent project, genealogists looked at the trees of Obama, Palin, and Limbaugh but also a few others, including House Speaker Nancy Pelosi, and Fox pundits Glenn Beck and Sean Hannity. They didn't find anything much with the latter three.

But former President George W. Bush? He's related to BOTH Obama and Palin, the site found. Obama and Bush are 11th cousins through common ancestor Samuel Hinckley, and Bush and Palin are 10th cousins one time removed, also through Hinckley — who, and stay with us now, was John Smith's father-in-law.

Ancestry.com has revealed in the past that Obama is related to investor Warren Buffett and actor Brad Pitt. It has also found that Palin, the former Alaska governor and GOP vice presidential candidate, is a distant cousin of both Franklin D. Roosevelt and Princess Diana.

The site isn't the only source of this sort of celebrity genealogy information — in 2007, Cheney's wife, Lynne, discovered ancestral ties between the Republican vice president and Obama while researching her book. She said the relationship was eighth cousin, though the Chicago Sun-Times traced it as ninth cousins once removed.

And one other thing from Ancestry.com: It also found that Palin is distant cousins with Senate Majority Leader Harry Reid and conservative author and pundit Ann Coulter, through John Lathrop, who was exiled to the United States from England for being a pastor of an illegal independent church.

Happily for both Obama and Coulter, no doubt, they do not seem to be related.


George Carlin on Limbaugh

Bill Hicks Destroys Limbaugh

Christine O'Donnell


Mad Dogs and Englishmen

Dancing Tot

Cute Girl-Catchy Dance




George Gets a Guitar

Beatles in Cleveland

Cee Lo Green (Fuck You)

Beat It (The Red Army)


The Beatles (Prostitues & Lesbians)


The President Takes a Fall


Julian & Sean Lennon