Wednesday, August 6, 2008

Paris approved this message

I have to admit that these TV ads/campaign ads are annoying. Fear-mongering with a sweet voice over.

Seriously. Why show more images of your opponent rather than sharing the reasons why you support the ideas you do?

Why not design an ad which explains that those in your political party (and the current admin) believe that birth control is tantamount to abortion? Somehow I think have the lining of your uterus dredged is a bit more significant than taking a hormone pill which affects ovulation or prevents an egg from implanting in that uterine lining. But then again, you don't have a uterus. My bad.


So here's the John McCain ad....




To which, Paris Hilton presents this response....




And here's a Huffington Post report found on Yahoo News...

Hilt-Owned -- Paris Responds to McCain's Ad

Seth Grahame-Smith
Tue Aug 5, 11:12 PM ET

Love her or hate her, you've gotta hand it to Paris Hilton

She just made John McCain her bitch.

In less than two minutes, she accomplished not one -- but FIVE things McCain himself has been unable to do in two years of campaigning:

1) Come off as intelligent and self-effacing.

2) Present a well-reasoned energy policy.

3) Generate excitement on the internet.

4) Win over a new block of supporters.

5) Say the word "Hilton" without the preface "Hanoi."

Yeah, I know -- it's just a funny little video. But no matter what the flacks say, I promise you they aren't laughing over at Camp McCain. Because as you read this, that funny little video is spreading faster than a case of Cancun herpes...and it's only Tuesday.

Team McCain can expect to be thrown off message (assuming they have one beyond "Yay, motorcycles! Yay, race cars!") tomorrow as the MSM picks this up and plays it to death. They know their candidate will be asked to respond, and that he has no choice but pretend he finds the whole thing amusing, or paraphrase Tucker Bound's envious, childish response: "Paris Hilton might not be as big a celebrity as Barack Obama, but she obviously has a better energy plan."

Either way, he looks ridiculous, because he's engaging in a dialogue with...Paris Hilton. Expect the "celebrity" backlash to continue all week (the last before we tune out and watch the Olympics).

Who knows? Maybe the media will also remember that for all his "celebrity" talk, John McCain's the guy who made cameos in movies like Wedding Crashers and TV shows like 24 -- and whose daughter, Meghan, is like, totally bff's with Heidi Montag from The Hills. (But let's face it...they probably won't).

Here's to you, Paris. You may be famous, but unlike some people -- you aren't ashamed to admit it.

And that's hot.

Seth Grahame-Smith is the author of Pardon My President: Ready-to-Mail Apologies for 8 Years of George W. Bush.



And here's more in The New York Times Politics Blog, today...
The Caucus: The Next Round of the TV Ad Wars…

By Michael Falcone
Published: August 6, 2008

The McCain campaign has released its latest television ad, which once again calls Senator Barack Obama “the biggest celebrity in the world.” Today’s ad, however, also asserts that Mr. Obama’s policies would hurt the American family.

I'z Sleepy

I'm sitting here with my new laptop (yes, everybody should clap and applaud - it only took forever to curse the other one enough times to go shopping).

So I'm sitting here trying to catch up on all my favorite blogs. And I can't keep my eyes open.

I make it about one sentence, then I think I'm reading but that's just the sound of my voice in my head talking. What it's talking about, I don't really know. But it thinks it's still reading, yet my eyes are closed.

I had plans for real blog material today. But I'm going to have to put it off.

Going to give in to the nap spirits. I'll come back later.

ZZZZZZZZZZZZZ

Tuesday, August 5, 2008

Electronic Health Records Really Could Be Used Against You

Ok. Set aside the fact that I have multiple sclerosis and rheumatoid arthritis for just a moment and imagine this scenario.

I apply for a new health insurance policy and I've been fairly healthy, nothing major I think. The insurance company saves time and money and checks my "health credit report" which determines my 'risk' to the insurer rather than gathering medical records from physician offices.

Since the credit report is drawn from prescription records, perhaps the fact that I've used Valtrex indicates a higher risk. Valtrex is a drug used by patients who have genital herpes. But it can also be used by patients who develop shingles. Can you tell me which of these is a chronic illness and which is not? To a computer it hardly matters.

So based on my "health credit score" insurance could be denied or assessed at a very high premium level.  But the good news is that the decision was made in on the spot.

What's not to love about that?

Yesterday Carole highlighted an article in The Washington Post.


Premium Info: Prescription Data & Health Coverage
Records Aid Insurers but Prompt Privacy Concerns

by Ellen Nakashima
Monday, August 4, 2008
Health and life insurance companies have access to a powerful new tool for evaluating whether to cover individual consumers: a health "credit report" drawn from databases containing prescription drug records on more than 200 million Americans.

Collecting and analyzing personal health information in commercial databases is a fledgling industry, but one poised to take off as the nation enters the age of electronic medical records. While lawmakers debate how best to oversee the shift to computerized records, some insurers have already begun testing systems that tap into not only prescription drug information, but also data about patients held by clinical and pathological laboratories.

Traditionally, insurance companies have judged an applicant's risk by gathering medical records from physicians' offices. But the new tools offer the advantage of being "electronic, fast and cheap," said Mark Franzen, managing director of Milliman IntelliScript, which provides consumers' personal drug profiles to insurers.

The trend holds promise for improved health care and cost savings, but privacy and consumer advocates fear it is taking place largely outside the scrutiny of federal health regulators and lawmakers.

Ingenix, a Minnesota-based health information services company that had $1.3 billion in sales last year -- and Wisconsin-based rival Milliman -- say the drug profiles are an accurate, less expensive alternative to seeking physician records, which can take months and hundreds of dollars to obtain. They note that consumers authorize the data release and that the services can save insurance companies millions of dollars and benefit consumers anxious for a decision.

"Some insurers can make a decision in the same day, or right on the spot," Franzen said. "That's the real 'value-add.' "

But the practice also illustrates how electronic data gathered for one purpose can be used and marketed for another -- often without consumers' knowledge, privacy advocates say. And they argue that although consumers sign consent forms, they effectively have to authorize the data release if they want insurance.

"As health care moves into the digital age, there are more and more companies holding vast amounts of patients' health information," said Joy Pritts, research professor at Georgetown University's Health Policy Institute. "Most people don't even know these organizations exist. Unfortunately the federal health privacy rule does not cover many of them. . . . The lack of transparency with how all of this works is disturbing."
(Note: I do not know if Valtrex specifically would increase one's "health credit score". I am simply hypothesizing.)

Monday, August 4, 2008

The Mermaid in the Pool

[Begin reading my story with Eyes in the Back of My Head]

Once upon a time, many moons ago, there was a young mermaid. She lived on the land among the humans yet did not know she was a mermaid.

In her dreams, she shared the ocean waters with the giant manatee and the baby sea turtles. When life on land became troublesome, she felt trapped in a riptide and dragged beneath the darkness. But when life was fine, the water was crystal clear and sky blue.

The mermaid told of her dreams to a very good friend who suggested that she test the waters and go for a swim. 

The water felt cool and the pressure against her limbs was soothing. A few trips to the pool and the mermaid was hooked. She began to look forward to Mondays, Wednesdays, and Fridays each week and began to count how many laps she completed, each day, each week, each month.

The mermaid was thrilled the very first time she swam a full mile in the pool. She had never swum this way before. Oh sure, she had splashed around, but never relished in the flow of each backstroke. Nor had she ever tried swim flippers.

Not long, the mermaid saw clear blue waters during the day, everyday.

Then one day, the mermaid was swimming glorious laps in the pool. Flying through the water with the help of flippers and stretching far overhead with each backstroke.

Suddenly the mermaid hit a wall. Not the edge of the pool, but something nearly as hard and dangerous.

The mermaid had run head-on into a woman who had entered her lane and was lolly-gagging as she was chatting with friends.

Bam!! Right into the woman’s back, going at a rather quick clip.

“Damn, that hurt!!”

My head was crushed straight down into my spine. Muscles tensed, headache surged, all as the neck felt “cricked.”

The pain in my neck continued for days as I tried to recover. My shoulders were tight and playing my horn became uncomfortable. But that is not new, cause musicians often play through pains of which the audience is never aware.

The mermaid had a doctor’s appointment just a few weeks later and mentioned the tingling in her left hand. But she also mentioned the crash in the pool and both thought pinched nerve.

“Keep an eye on it and if it gets worse, let me know,” said my doctor.

A month later my new Sweetie (who I had just met the week before that doctor’s visit) was gently rubbing my shoulders. Then he was rubbing my back.

“That’s really weird. What’s going on?” she thought.

The mermaid couldn’t feel his hands on the left side of her back. The right side was fine, but the left side was numb.

Really numb.

So she called her doctor and scheduled a visit because she also noticed that her left arm was numb. From finger tips to spine, numb.

That’s when the doctor wanted to know more about the pinched nerve.

“I want you to have an MRI. Just get a better look at what might be going on in your neck,” the doctor said.

In the following month, the mermaid was meeting with a neurologist for an expert opinion. A monumental month.

July 2005, 100 MILES in the pool since the New Year and the transition to neuroland.


Next time: The doctor never said the words, “You have MS.”

Sunday, August 3, 2008

What would you like me to talk about?

What topics interest you the most?

What kind of stories do you find inspiring or hopeful?

What type of research would you do if you could?

What is important to you and helps you deal with MS on a daily basis?

What topics seem to be forgotten or taboo?


I have some ideas brewing and just want to brainstorm for more ideas.

Please leave your thoughts in the comments section or feel free to email them directly.

Friday, August 1, 2008

Two New Cases of PML in MS Patients Taking Tysabri


Aug 01, 2008

Two New Cases of PML Develop in People with MS Taking Tysabri

Biogen Idec and Elan Pharmaceuticals informed drug regulatory authorities about two new confirmed cases of PML in individuals who were taking Tysabri® (natalizumab) as a monotherapy (not in combination with other therapies). PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. Although FDA prescribing information includes a black box warning about the risk of PML, the three previous cases of PML that occurred in the context of clinical trials were in patients who had taken Tysabri in association with other immune-modulating or immune-suppressing medications.

Details: The companies held a conference call for prescribers and investors to provide details about the two cases, both of which occurred in European males. One had received Tysabri as a first line therapy because of the aggressive nature of his disease, and had been on Tysabri alone for 17 months before developing a slowly progressive focal twitching and weakness in one arm. Brain MRI showed a non-typical lesion but his spinal fluid was negative for JC virus until it was done a second time. He received five courses of plasma exchange and is currently stable and at home.The second case has been reported to be a male who had received immune-suppressing and immune-modulating therapies in the past. He used Tysabri alone for 14 months before developing weakness on one side of the body. Despite treatment with steroids his symptoms progressed and included cognitive changes. His MRI was not typical for MS, and spinal fluid was positive for JC virus. He is reported to be hospitalized and is slated to receive plasma exchange therapy.

Background: Tysabri is a laboratory-produced monoclonal antibody. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the "blood-brain barrier" into the brain and spinal cord. It has been shown to be effective in reducing the risk of disability progression and exacerbations (relapses).

In the United States, the drug is available only through a risk management program called TOUCH, and is only available through doctors and infusion sites enrolled in the program. The program is designed to monitor patients for possible signs of PML and other serious opportunistic infections. Separate risk management plans are also in place in individual countries in Europe.

The companies recently reported that nearly 32,000 patients have been dosed with Tysabri. Of those, nearly 14,000 have been on the drug for at least 12 months, and 6,600 have been on the drug for at least 18 months. Up to this time there have been no previous confirmed cases of PML in patients using the drug as monotherapy.

Recent, small-scale studies supported by Biogen Idec have investigated the use of plasma exchange, a blood-cleansing treatment, to clear the bloodstream of Tysabri in the event of PML, for which there is no established therapy. The studies suggested that plasma exchange could indeed clear much of the drug from a person's bloodstream, but it was not possible to determine experimentally whether that would lead to a reduction of PML symptoms.

Comment: These incidents of PML are unfortunate and disappointing, and we hope for the best possible outcomes for these individuals and their families. However, their occurrence is within range of the predicted frequency of PML cases, estimated by a published report and by the FDA, of approximately 1 in 1,000 people taking the drug. "We are encouraged that the risk management plans in place for early surveillance, such as the TOUCH program in the U.S., are doing the intended job of identifying possible cases of PML early so that patients can be treated quickly," said John R. Richert, MD, executive vice president of research and clinical programs at the National MS Society . "It will be important to observe whether plasma exchange therapy in these new cases will have an ameliorating effect on their PML."

These incidents highlight the need for individuals taking Tysabri to be sensitive to any occurrence of new, unusual symptoms and to contact their prescribing physician or infusion nurse immediately if they occur. Signs of PML may include any new or worsening neurological symptoms such as any changes in thinking, eyesight, balance, strength and other symptoms.

Tysabri is a registered trademark of Biogen Idec and Elan.

The National MS Society is proud to be a source of information about MS. Our comments are based on professional advice, published experience and expert opinion, but do not represent individual therapeutic recommendation or prescription. For specific information and advice, consult your personal physician.

Biogen and Elan report Tysabri brain disease cases

By Deena Beasley and Bill Berkrot
Reuters, published August 1, 2008
LOS ANGELES/NEW YORK: Biogen Idec and Elan have notified regulators of two new cases of a potentially deadly brain disease in multiple sclerosis (MS) patients being treated with Tysabri.

Biogen shares dropped about 23 percent in after-hours trading, while Elan's shares fell 45 percent in New York.

"This is going to have very broad, very wide ramifications for the commercial prospects of the drug because there's just a lot of uncertainty here," said Cowen & Co analyst Eric Schmidt.

Tysabri, co-marketed by Ireland's Elan and Cambridge, Massachusetts-based Biogen, was withdrawn from the market in 2005 after three patients developed the brain infection known as progressive multifocal leukoencephalopathy (PML).

The drug returned to the market in 2006 with warnings after the U.S. Food and Drug Administration decided MS patients willing to accept the risks should be able to have access to the drug's potential benefits.

The two new PML patients, one of whom is hospitalized, are in the European Union, the companies said.

More cases are likely and physicians are likely to reduce the number of patients they start on the drug as they are reminded of long-term potential safety issues, Morgan Stanley analyst Steven Harr said in a research note.

Elan and Biogen said more than 31,800 patients were being treated with Tysabri as of the end of June and second-quarter sales totalled $200 million (100 million pounds).

"We've said all along, and the FDA has also stated and it's clearly outlined in our label that we expect to see additional cases of PML," Biogen spokeswoman Naomi Aoki said. "These are the first cases we've seen since the reintroduction in the U.S. and approval in Europe two years ago."

She said the company believes that heightened clinical vigilance has been the best way to monitor for PML and that heightened vigilance was critical in identifying these cases.

Schmidt said, the "key fear factor in the market place is going to be what happens when you treat beyond two, two and a half years ... Nobody knows the answer and that's kind of scary."

"I think you'll see a general pause in the market place, especially in the U.S., where safety has become more of a lightning rod issue, in part driven by the litigious nature of our society," the analyst said.

Tysabri also won U.S. approval this year to treat adults with moderate to severe Crohn's disease who have had a poor response to, or cannot take, other therapies.

Shares of Biogen, which closed at $69.76 on Nasdaq, fell to $53.68 after hours, while shares of Elan, which closed at $20.05 on the New York Stock Exchange, were trading at $11.00.

Elan's shares had already lost one-third of their value on Wednesday when investors sold the stock after disappointing data on an experimental Alzheimer's drug Elan is developing with Wyeth.

Biogen and Elan have a scheduled a conference call with analysts and investors for Friday morning.

(Reporting by Deena Beasley and Bill Berkrot; editing by Jeffrey Benkoe and Carol Bishopric)

Biogen Idec and Elan Corporation, plc
Host Conference Call For Investment Community


Date: Friday, August 1, 2008

Time: 8:30a.m. ET
Length: 1 hour

Listen to Webcast here


Below is the report filed with the SEC on July 31, 2008.
Item 8.01 Other Events.
On July 31, 2008, Biogen Idec Inc. and Elan Corporation, plc notified relevant regulatory agencies of two confirmed cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with TYSABRI in the commercial setting. Additional information about these cases is set forth below.
Case 1


On July 30, 2008, following a period of clinical evaluation, Biogen Idec received confirmation of a diagnosis of PML in a MS patient in the European Union (EU).



The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.



As reported to the company on July 31, 2008, the patient remains clinically stable and ambulatory at home.



Background:

-
Patient in EU with aggressive MS who was naïve to prior disease modifying therapy;


-
TYSABRI monotherapy for approximately 17 months;


-
Clinical vigilance led to early identification of signs and symptoms of possible PML and medical work-up which included MRI scanning and CSF testing, but PML was not confirmed at that time;


-
However, given continued clinical suspicion by treating physician plasma exchange was initiated as outpatient;


-
Subsequent testing of CSF detected JCV DNA which was reported to the company on July 30, 2008;


-
It was then determined by PML experts that the latest CSF results together with the clinical history, physical findings, and MRI results are consistent with the diagnosis of PML.
Case 2


On July 31, 2008, Biogen Idec was notified of a diagnosis of PML in a second MS patient in the EU.



The diagnosis was made based upon the detection of JCV DNA in the CSF in the setting of clinical signs, symptoms, and MRI findings consistent with the diagnosis of PML.



As reported to the company on July 31, 2008 the patient is currently hospitalized.



Background:

-
Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons;


-
TYSABRI monotherapy for approximately 14 months;


-
Evaluation for possible PML included MRI scanning and CSF testing;


-
CSF testing detected JCV DNA, which was reported to the company on July 31, 2008;


-
The CSF results together with the clinical history, physical findings, and MRI results are consistent with the diagnosis of PML.