Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency
in Multiple Sclerosis: A Longitudinal, Magnetic Resonance Imaging,
Blinded Pilot Study
P. Zamboni,a R. Galeotti,a B. Weinstock-Guttman,b G. Cutter,c
E. Menegatti,a A. M. Malagoni,a I. Bartolomei,d J. L. Cox,b F. Salvi,d and
R. Zivadinov,b Ferrara and Bologna, Italy; Buffalo, NY; and Birmingham,
Ala
From the University of Ferrara, Ferraraa; NY State University in Buffalo,
Buffalob; University of Alabama, Birminghamc; and Bellaria Neurosciences.d
Background: Chronic cerebrospinal venous insufficiency (CCSVI) is
characterized by stenoses of the internal jugular veins or the azygous vein, or
both. It has been recently reported that this condition contributes to severe
dis-regulation of the physiologic mechanisms of cerebral venous outflow in
patients with multiple sclerosis (MS). Endovascular treatment (EVT) was
demonstrated to be a safe and effective CCSVI treatment, but only in an
unblinded clinical evaluation.
Methods: We designed an open-label, magnetic resonance imaging
(MRI)-blinded, two-center, randomized, EVT intervention parallel-group,
12-month study (EVTMS) after an initial cross-sectional (CVIMS) study.
CIVMS enrolled 16 relapsing-remitting MS patients (8 from Ferrara, Italy
and 8 from Buffalo, NY). All 16 patients who completed the CVIMS study
and presented severe Doppler venous hemodynamic (VH) anomalies accepted
participation in the EVT intervention prospective study (EVTMS).
Half of the cohort, the early intervention group (4 from Buffalo and 4 from
Italy), was randomly selected to have the EVT procedure in Italy at 3
months, whereas 6 patients comprised the delayed control intervention
group (late group) at 6 months; 2 patients were followed-up without any
EVT. The EVT procedure consists of selective venography complemented
by balloon dilatation when significant stenoses are detected. All patients will
be prospectively evaluated at 3, 6, 9, and 12 months with ultrasound
imaging, MRI, and clinical examinations.
Results: For the CVIMS cross-sectional study, mean age at baseline
was 36.1 7.3 years, mean disease duration was 7.5 1.9 years, and median
Expanded Disability Status Scale (EDSS) was 2.5. The mean number of
gadolinium-active lesions at baseline was 0.38 1.5. The mean number of
T2 lesions was 27.1 10.5. Median of VH of CCSVI was 4 (range, 2-5).
The six MS patients investigated and none of the HCs met the VH criteria
for CCSVI (P .0001). MS patients showed significantly lower net cerebrospinal
fluid flow compared with the HC (P 0.038), which was
associated with the number of anomalous VH criteria present (r 0.79, P
.001; Fig, A) and confirmed by the strong relationship with the venous
hemodynamic insufficiency severity score (r 0.77, P .0007). Moreover,
increases in the number of anomalous VH criteria present were negatively
associated with lower whole brain volume (Spearman R –0.5; P 0.05;
Fig B). The 1-year blinded EVTMS longitudinal study will be concluded
next October and results analysis completed within the Fall.
Conclusions: CCSVI is associated with abnormal cerebrospinal fluid
flow dynamics and decreased brain volume. Finally, the EVTMS study
should provide valuable data on preliminary efficacy of EVT for CCSVI
associated with MS.
Tuesday, June 22, 2010
Monday, June 21, 2010
NHS 'has wasted millions on MS drugs which did nothing to help patients'
The NHS has wasted millions of pounds on MS drugs which did nothing to help patients, according to experts.
They called for a Government-backed scheme to provide the drugs to be scrapped and called for a public inquiry.
In total at least £250 million could have been saved if a review had been carried out on the “costly failure” after its first two years, they warn.
This money could have been used to help other health service patients, including those with multiple sclerosis.
Charities backed the call for the scheme to be abandoned.
Set up in 2004 it was intended to allow expensive MS drugs on the NHS.
A key feature of its design was that the price of the drugs would be cut if they proved ineffective.
However, there has been no price reduction over the past six years, despite signs that the drugs were not working.
Recent research results show that patients actually did worse on the drugs than if they were given a placebo.
Prof George Ebers, from Oxford University, one of a number of MS experts who have written articles in the British Medical Journal (BMJ) criticising the project, said: “The scheme may have been well intentioned, but perhaps the public interest would be served by an independent inquiry.”
More than 100,000 people suffer from the devastating disease in Britain.
Patients experience difficulty walking or speaking and there is currently no known cure.
MS itself is caused by the destruction of myelin, a fatty protective sheath surrounding the body's central nervous system.
The MS society backed calls for the scheme to be abandoned.
Simon Gillespie, the charity’s chief executive, said that while it had given many patients people access to drugs it was “stuck in the past and has failed to take account of the most up to date evidence and practices.”
He added: “We are calling on the new government to work to ensure that people with MS across the UK have equity of access to the right drug, at the right time in line with current evidence.
“This cannot be achieved through the current scheme."
The four drugs involved Avonex, Betaferon, Copaxone and Rebif, cost around £8,000 per patient per year.
In 2002 they were rejected for use on the NHS by the National Institute for Health and Clinical Excellence (Nice), the Government’s drugs rationing body, because they were too expensive.
However, the following year the Government and the pharmaceutical companies involved agreed to start a “risk sharing” scheme, which saw an initial reduction in the price with the promise of more to come if the drugs did not work very well.
Around 10,000 patients in Britain are thought to have received the drugs thanks to the scheme.
A Department of Health spokesman said: "The risk sharing scheme has brought many benefits to MS patients including better access to drugs, a stronger network of MS specialists including specialist nurses and a better platform for MS research.
“We continue to monitor the progress of the scheme to ensure best value for money.”
Saturday, June 19, 2010
BRIBERY IN MEDICINE
This is a 4-part story
ON HIS OWN, Don has determined that virtually every medical scientist in America is on the take one way or another, mostly for research funds. Almost all academic institutions are intentionally teaching their students lies about stem cells, straight from the embryonic playbook. “There is no way that we at RSCI can be right about the embryonic hoax time after time and these crooks don’t know they are lying.” Why does RSCI care so much? Because these are the murderers who would rather you die from a disease they will never be permitted to cure, than allow Repair (adult) Stem Cells to help you!
There are more books out today on medical corruption than any other subject in medicine. So let’s take a look at the entire picture---and we’ll even put the occasional book title in bold italics.
HOW CORRUPT IS THE FDA?
By far, one of the most disconcerting bribery-influenced systems surrounds the FDA and the USDA, two government agencies that are supposed to protect the American public. The FDA has been repeatedly linked to bribery, and this corruption is public knowledge, thanks to the 1989 generic drug scandals.** Ironically, it was a pharmaceutical company, Mylan, that exposed the pharmaceutical industry's influence on the drug approval process.
After suspecting corruption in the fast approval of some pharmaceuticals and not others, Mylan hired private detectives who "caught FDA agents red-handed taking bribes in exchange for expediting drug approval," explains Kenny Ausubel in When Healing Becomes a Crime. This resulted in the conviction of four FDA employees and, most significantly, loss of public trust.
Unfortunately, health care corruption in this country doesn't end with the FDA; it has infiltrated the whole system. Drug companies regularly use trips, dinners, cash and free drugs to "persuade" doctors to prescribe new and expensive pharmaceuticals, according to many sources. These bribery expenses pay for themselves many times over, as the most popular drug may not be necessarily the most effective or the one with the least number of side effects, but rather the one that has been promoted and advertised the most. In other words, the majority of American doctors care not a whit about their patients’ health compared to their commissions!
HOW CORRUPT IS BIG PHARMA?
Now, of course, the pharmaceutical companies disguise their bribes under the altruistic term "gifts," but Natural Alternatives author Michael T. Murray finds the term suspect, asking poignantly, "If the drug company didn't expect the gift to influence the doctor's decision, why would it give the gift?" He goes on to clarify, "A gift implies that there are no strings attached." As much as they would not like to admit it to others, or especially to themselves, doctors know that these "gifts" are linked to an ulterior motive, according to Dr. Jerome P. Kassirer in his book, On the Take. In other words, you may not always be able to trust your doctor to make an objective decision about your care.
AND THE RESULTS OF BRIBERY ARE DEATH, PERMANENT DAMAGE, AND FAILURE TO CURE:
What does this mean for you as the consumer? Plenty. Though bribery is harmful anywhere, the use of bribery in the health care system is especially dangerous, making it more important than ever for you to take an active, informed role in your health care. Yes, bribery is prevalent in modern society, but it doesn't have to control your life.
NEXT ISSUE The experts speak on bribery:
**EDITOR’S NOTE:
Generic drug bribery takes a new form in the 21st century, stealing from you and making many drug companies richer!
When a patent runs out, the “law” says anyone may manufacture and sell the drug, and the price then drops significantly. But the crooks who keep you in their overpriced medical prison have an illegal way to keep the price up so they can keep robbing you beyond 20 years. They go to the generic companies and offer them more money than they can make legitimately to not make the drug! So it goes generic, but the price stays up at 300%, 400% 500% of the legitimate price, you get robbed, and all the crooked drug companies get even richer as you get sicker and poorer.
THE FDA COOPERATES IN THIS SCAM BY PRETENDING TO GO AFTER THE CROOKS BUT THEY NEVER DO. It’s still going on as you read this article.
Keep your sense of humor
1. My husband and I divorced over religious differences. He thought he was God and I didn't.
2. I don't suffer from insanity; I enjoy every minute of it.
3. Some people are alive only because it's illegal to kill them.
4. I used to have a handle on life, but it broke.
5. Don't take life too seriously; No one gets out alive.
6. You're just jealous because the voices only talk to me.
7.. Beauty is in the eye of the beer holder.
8.. Earth is the insane asylum for the universe.
9.. I'm not a complete idiot -- Some parts are just missing.
10..Out of my mind. Back in five minutes.
11..NyQuil, the stuffy, sneezy, why-the-heck-is-the-room-spinning medicine.
12..God must love stupid people; He made so many.
13..The gene pool could use a little chlorine.
14..Consciousness: That annoying time between naps.
15..Ever stop to think, and forget to start again?
16.. Being 'over the hill' is much better than being under it!
17.. Wrinkled Was Not One of the Things I Wanted to Be When I Grew up.
18.. Procrastinate Now!
19. I Have a Degree in Liberal Arts; Do You Want Fries With That?
20..A hangover is the wrath of grapes.
21..A journey of a thousand miles begins with a cash advance.
22..Stupidity is not a handicap. Park elsewhere!
23..They call it PMS because Mad Cow Disease was already taken.
24..He who dies with the most toys is nonetheless DEAD..
25. A picture is worth a thousand words, but it uses up three
thousand times the memory.
26.Ham and eggs...A day's work for a chicken, a lifetime commitment for a pig.
27..The trouble with life is there's no background music.
28...The original point and click interface was a Smith & Wesson.
29..I smile because I don't know what the heck is going on
2. I don't suffer from insanity; I enjoy every minute of it.
3. Some people are alive only because it's illegal to kill them.
4. I used to have a handle on life, but it broke.
5. Don't take life too seriously; No one gets out alive.
6. You're just jealous because the voices only talk to me.
7.. Beauty is in the eye of the beer holder.
8.. Earth is the insane asylum for the universe.
9.. I'm not a complete idiot -- Some parts are just missing.
10..Out of my mind. Back in five minutes.
11..NyQuil, the stuffy, sneezy, why-the-heck-is-the-room-s
12..God must love stupid people; He made so many.
13..The gene pool could use a little chlorine.
14..Consciousness: That annoying time between naps.
15..Ever stop to think, and forget to start again?
16.. Being 'over the hill' is much better than being under it!
17.. Wrinkled Was Not One of the Things I Wanted to Be When I Grew up.
18.. Procrastinate Now!
19. I Have a Degree in Liberal Arts; Do You Want Fries With That?
20..A hangover is the wrath of grapes.
21..A journey of a thousand miles begins with a cash advance.
22..Stupidity is not a handicap. Park elsewhere!
23..They call it PMS because Mad Cow Disease was already taken.
24..He who dies with the most toys is nonetheless DEAD..
25. A picture is worth a thousand words, but it uses up three
thousand times the memory.
26.Ham and eggs...A day's work for a chicken, a lifetime commitment for a pig.
27..The trouble with life is there's no background music.
28...The original point and click interface was a Smith & Wesson.
29..I smile because I don't know what the heck is going on
Wednesday, June 2, 2010
Post Liberation Update
On Thursday the 27th. of May I had my "Liberation " in Albany,NY. I can tell you that after 3 angioplasty and a total time of 1 1/2 hr.'s and then a 2 hour wait flat on my back, I was up and on my way back to the hotel feeling better than I had in 4 years. I walked up the steps at the hospital,the way normal people do. No drop foot and walking without a cane or limp. That night we went out for dinner, still felt great and flew back to Raleigh on a 6 AM flight, walked through the RDU airport, still no drop foot, limp or cane. Got home and had to show off by lifting my legs in a marching gait and then up and down the stairs,then I decided that I would vacume the den. Well, that's when I think I over did it. The rest of the day(Friday) my symptoms were back and stayed that way until Tuesday, June 1st. I started to feel better with the ability to again walk without the drop foot and improvement in many of the other pain in the ass MS symptoms. My IRVS thinks it may be possible that the angioplsty veins may have re-stenoised,(collapsed) and we will see how I do over the next week or so and if necessary I will go back and be stented. Today I feel half way. Hope to get a Video posted soon.
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