So now that they've scientifically "proven" that DMD's

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So now that they've scientifically "proven" that DMD's

Postby CureIous » Wed Jul 18, 2012 6:06 pm

do not work, do not delay progression, or do any of the 40k/year things that they told us had been proven by yet other "scientific" studies, I question why anyone would hold such a candle to CCSVI?

Please help me understand why venoplasty halted my progression in its tracks, but all those tens of thousands of wasted dollars on interferons are a good investment towards "delaying the progression of disability because white matter lesions were reduced in x number of volunteers over x amount of time?

Pardon me for my skepticism of the moneyed up scientific process, I apologize for not getting on board with the supposed safety net that the interferons were supposed to have provided me, at a substantial cost. Shame on all of us who put two or three brain cells together in making decisions, we seem to be a very large very costly experiment gone awry, and yet we are supposed to be in awe at the advances being made.

What we sound like is a bunch of sick, needy suckers. Any chance at a better future is better than no hope at all, yet those who so readily dismiss venous involvement out of hand, seemingly have no issue whatsoever with buying DMD's hook line and sinker, because some fancy lab coated pharmatist told em so.

Feel like a guinea pig yet?

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Re: So now that they've scientifically "proven" that DMD's

Postby HappyPoet » Wed Jul 18, 2012 8:58 pm

Edited: Please note that the "MUST-READ" Bloomberg article I wanted to post is now posted below NHE's post. I apologize for the confusion.

New York Times: "Multiple Sclerosis Drug Doesn’t Prevent Onset of Disability, Study Finds"

http://www.nytimes.com/2012/07/18/healt ... l?_r=2&hpw

New York Times wrote:The most widely prescribed drug for treating multiple sclerosis has little or no effect on a patient’s progression to disability, a new study has found.

The medicine, interferon beta, does help reduce the development of brain lesions and limit the frequency of relapses, but until now there have been few well-controlled long-term studies demonstrating its effectiveness at preventing the onset of irreversible disability.

Researchers at the University of British Columbia prospectively collected data on 868 M.S. patients treated with interferon beta, comparing them with 1,788 patients who never took the drug. Using a well-validated scale, they found that those who took interferon beta were no less likely to suffer long-term disability than those who took none.

Interferon beta drugs are commonly used to treat relapsing-remitting M.S., the most common form of the disease. M.S. is an autoimmune disease that damages the myelin sheath surrounding the nerve cells. Its course varies widely, but it is usually a relapsing illness that produces a variety of symptoms, including muscle spasms and difficulty walking, bladder and bowel problems, vision and hearing disturbances, speech problems, difficulties with reasoning and attention span and more.

The disorder is chronic and incurable, and its outcome is variable and hard to predict. But life expectancy can be normal, and many people live with the disease for decades, still able to walk and work with minimal disability.

The senior author, Helen Tremlett, an associate professor of neurology at the University of British Columbia, cautioned that the study, published online on Tuesday in the Journal of the American Medical Association, does not show that interferon beta is useless.

“These drugs were licensed because they reduce relapse and have a better outcome with lesions,” she said. “That has not changed.”

Other experts found the study discouraging. “It’s an interesting paper and an important paper,” said Dr. David A. Hafler, chairman of the neurology department at Yale. “If interferon does have an effect on disability, then it’s a relatively small effect.”

Dr. Claire Riley, director of the Multiple Sclerosis Clinical Care & Research Center at Columbia University, was equally impressed with the work and somewhat troubled by its results. “It’s a little dispiriting to see this well-designed, well-conducted assessment showing no association between reduction of disability progression and interferon use,” she said. “But the key is that all M.S. is not created equal, and we now have eight approved drugs in four different classes that allow us to better react to patients who are not having a response to therapy.”

Previous studies have found that interferon beta does prevent disability, but the authors point out that many of them were marred by methodological problems — the use of control groups too ill to start medication, for example — that this study avoided.

At the same time, they acknowledge certain weaknesses of their own study, in particular the problem that people who take no medicine are also likely to be among those who are the least ill and therefore least likely to become disabled in any case.

But after controlling for sex, age at onset, disease duration, relapse rate and other factors, they could find no association between taking interferon beta and any reduction in progression to disability. Relapses and brain lesions do not, apparently, drive disability, Dr. Tremlett said.

“There may be other processes at work,” she added. “In an ideal world, we want drugs that target whatever is driving long-term disability. We need other drugs aiming at other targets in the brain.”

A version of this article appeared in print on July 18, 2012, on page A14 of the New York edition with the headline: Multiple Sclerosis Drug Doesn’t Prevent Onset of Disability, Study Finds.
edited.
Last edited by HappyPoet on Thu Jul 19, 2012 5:04 am, edited 1 time in total.
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Re: So now that they've scientifically "proven" that DMD's

Postby CureIous » Wed Jul 18, 2012 9:25 pm

Yeah, if only they knew, so much for science, my contention has always been that they can "prove" whatever is needed, as needed, as long as too many people dont die, and FDA be damned, they WILL get it through, lets count how many deadly drugs we've seen on our TV sets, on the lips of most Americans, but thank God they are FDA approved, only to discover later on...

Why people insist on having THAT system "prove" to them that CCSVI is for real is beyond me, those so quick with the conspiracy label and meek as lambs when faced head on with evidence in black and white to the contrary. Think for yourselves because we guinea pigs are all alone anyways.
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Re: So now that they've scientifically "proven" that DMD's

Postby HappyPoet » Wed Jul 18, 2012 10:15 pm

Two days ago, Biogen Idec's stock reached a new 52-week high, and the stock is up 30% for the year. Unbelievable. Outrageous. A cash cow is a formidable beast to slay.
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Re: So now that they've scientifically "proven" that DMD's

Postby marcstck » Wed Jul 18, 2012 11:39 pm

It's important to remember that the interferon drugs were not approved based on their ability to impede progression but rather on the indications that they reduce relapse rates and the number of enhancing lesions seen on MRI studies. It was hoped (and by some, assumed) that this would translate into delayed progression as well, and many Neuros and patients adhered to these drugs based on those assumptions, but it was never asserted in the clinical trials that led to the approval of the interferons that they had any effect on progression.

For some, the drugs did, and still do, offer a much improved quality of life. There are patients who experienced multiple relapses per year who have seen their relapse rates dramatically diminished, and for them that's a big plus, even though it is disappointing that the drugs do nothing for disease progression.

Having said all that, hopefully this new information will make MS Neuros and researchers take a step back and reevaluate just what the hell is going on here, as it's clear that counting lesions and relapse rates is not the way to go about looking for a truly effective treatment for MS. All of the recent evidence suggests that MS is not a white matter disease working from the outside in, as has been assumed by most for the last few generations or so, but is a gray matter disease that does its damage from the inside out. Progressive MS is looking especially complicated, with B cell follicles and lymphatic tissues taking up residence within the CNS, behind the BBB, creating a rogue dysfunctional immune system within an immune system. Enhancing lesions and relapses are just bright shiny objects that have distracted researchers away from whatever the underlying etiology of MS actually is, whether it be vascular, infectious, genetic, toxic, or, most likely, a combination of all of these.

BTW, progression has never been an endpoint in MS drug trials because it is so difficult to quantify, as many patients progress so slowly that each stage of drug trials would by necessity take 5+ years to complete. Neither the drug companies, because of the costs, or patients, because of the perilous nature of their existence, would put up with clinical trials that could last decades before the therapy in question could come to market.

Time to erase all the white boards and start over, beginning with trying to figure out if MS is truly a focal disease, as has been assumed since it was first identified, or a diffuse disease of the gray matter. New disease models need to be constructed, including those for CCSVI, which also largely looks at the disease from a focal white matter point of view. Refluxing blood causing perivenous white matter lesions is now obviously not the primary driving force behind the disease, although long-term hypoperfusion of blood through the CNS could certainly play a large part in the disease of some patients.
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Re: So now that they've scientifically "proven" that DMD's

Postby NHE » Thu Jul 19, 2012 2:07 am

marcstck wrote:It's important to remember that the interferon drugs were not approved based on their ability to impede progression but rather on the indications that they reduce relapse rates and the number of enhancing lesions seen on MRI studies. It was hoped (and by some, assumed) that this would translate into delayed progression as well, and many Neuros and patients adhered to these drugs based on those assumptions, but it was never asserted in the clinical trials that led to the approval of the interferons that they had any effect on progression.


From the doctors prescribing information for Avonex...

Image


It's likely that 2 years was not long enough to be meaningful.


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Re: So now that they've scientifically "proven" that DMD's

Postby HappyPoet » Thu Jul 19, 2012 4:54 am

With my sincerest apologies, here is the correct "MUST-READ" article published by Bloomberg.
The article posted above is from the New York Times (link above now matches that story).

Bloomberg: "Biogen, Bayer Drugs Don’t Slow MS Progress, Study Finds"

http://www.bloomberg.com/news/2012-07-1 ... finds.html

Bloomberg wrote:The most commonly prescribed multiple sclerosis drugs, including those made by Biogen Idec Inc. (BIIB), Bayer AG (BAYN) and Merck KGaA, failed to slow disability progression in a long-term study that raises new questions on whether the treatments can achieve that goal.

Researchers compared historical outcomes for MS patients in British Columbia to assess the use of interferon beta drugs. The results, published online in the Journal of the American Medical Association, found the medicines didn’t delay progress of the patients’ disability.

“It dampens somewhat the enthusiasm for so-called first- line therapies,” said Ludwig Kappos of University Hospital in Basel, Switzerland, and author of an editorial that accompanied the study, in an e-mail.

MS is an autoimmune disease that affects about 2.1 million people worldwide and can lead to limb numbness, loss of vision and paralysis, according to the National Multiple Sclerosis Society. The most common form, relapsing-remitting, is characterized by sporadic flare-ups followed by periods of inactivity.

Avonex, made by Biogen, Bayer’s Betaseron and Merck KGaA (MRK)’s Rebif generated $6.6 billion in 2011 revenue, according to data compiled by Bloomberg. Called disease-modifying drugs, they have been shown to slow the frequency of relapses and reduce the development of brain lesions. Their ability to slow disability progression has been less clear, wrote the researchers, led by Afsaneh Shirani of the University of British Columbia, in the paper reported yesterday.
Evidence Needed

“A key feature of MS is clinical progression of the disease over time manifested by the accumulation of disability,” the researchers wrote. “There is a lack of well- controlled longitudinal studies investigating the effect of interferon beta on disability progression.”

The study used data from the British Columbia Multiple Sclerosis database from 1985 to 2008. It compared three groups: 868 patients with relapsing-remitting MS who were treated with interferon beta therapy from July 1995 to December 2004; 829 patients who met the criteria to receive interferon beta therapy in that time period yet were untreated with it; and 959 patients who met the same criteria before interferon beta therapies became available in 1995 in Canada.

The use of two control groups sought to eliminate the chance of bias based on patients choosing not to receive therapy for reasons such as less severe disease, the researchers wrote.
Disability Measurement

The analysis considered advancement to a score of 6 on the Expanded Disability Status Scale, or EDSS, a commonly used metric to measure disability progression in MS. That score means a patient requires help from a cane or crutch to walk about 100 meters.

The study found that 10.8 percent of patients in the treated group reached an EDSS score of 6, compared with 5.3 percent in the contemporary untreated group and 23.1 percent in the historical untreated group.

“We did not find evidence that administration of interferon beta was associated with a reduction in disability progression in patients with relapsing-remitting MS,” the researchers wrote. “Our findings bring into question the routine use of interferon beta drugs to achieve this goal in MS.”

Biogen, based in Weston, Massachusetts, said its Avonex has been shown in clinical trials to slow disability progression.
‘Positive Impact’

“Regulators worldwide have reviewed and confirmed the positive impact of Avonex on slowing disease progression,” Jeff Boyle, a spokesman for the drugmaker, wrote in an e-mail. “In fact, Avonex is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.”

Merck, based in Darmstadt, Germany, said its Rebif has shown to be effective in “all three key measures of treatment efficacy: reducing relapses, delaying disability progression and reducing active brain lesions,” Heather Connor, a spokeswoman for the company’s EMD Serono unit, wrote in an e-mail. “The overall clinical benefits of disease-modifying therapies, including Rebif (interferon beta-1a) have been established in well-controlled Phase 3 clinical studies.”

The historical data used in the study doesn’t reflect current treatment practice, said Marcy Funk, a spokeswoman for Leverkusen, Germany-based Bayer.
Conversion Delay

“The results of the Phase 3 Benefit study showed that Betaseron treatment at the early stage of the disease can significantly delay conversion to clinically definite MS,” Funk wrote in an e-mail. Current practice, she said, “encourages treatment at the first sign of relapsing-remitting MS.”

The results don’t mean neurologists should immediately change prescribing practices, said Kappos, the editorial author.

“I don’t think it should change clinical practice as long as we do not have better options, but it reminds us of the need to better define a target population of responders to the established compounds and to find not only rather safe but more effective treatments,” he wrote.

Newer therapies such as Biogen’s Tysabri and Novartis AG (NOVN)’s Gilenya, the first oral therapy approved for MS, are examples of more effective treatments, Kappos said.
Added Risk

Kappos also cited their potential for increased risks. Tysabri, Biogen’s second best-selling medicine after Avonex, with $1.1 billion in 2011 revenue, is associated with a danger of contracting a brain infection called progressive multifocal leukoencephalopathy, or PML. The company has developed a test to help determine patients’ risk.

Teva Pharmaceutical Industries Ltd. (TEVA) sells Copaxone, another older MS therapy that isn’t in the same interferon beta class. While it wasn’t evaluated in this study, Copaxone doesn’t necessarily offer a better chance of delaying disability progression as it “has been shown to be very similar to the interferons in head-to-head trials,” Kappos wrote.

Teva declined to comment on the study, Denise Bradley, a company spokeswoman, said.

The data’s implications may be limited because the study was designed to show a 40 percent risk reduction with interferon treatment, more than the 30 percent shown in trials of the interferon beta therapies or Copaxone, Kappos and Tobias Derfuss, also of University Hospital in Basel, wrote in their editorial.

“Therefore, it is likely that neurologists will continue to prescribe interferon beta and other interferons and patients with relapsing-remitting MS will continue to self-inject these agents,” they wrote. “However, the rigorously collected data of Shirani and colleagues reinforce the conclusion that the associations between use of interferons and long-term disability, although plausible, remain unproven.”

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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Today's rant:

Postby 1eye » Thu Jul 19, 2012 8:53 am

This is just too easy: to write in an Internet forum about what I have known for a long time; too easy to cackle about the neurologists.

They have been the patsy, here. If it weren't for big drug vendors with big bucks already invested, these poor schmucks would have had nothing to run studies and write papers and hang reputations on.

The fact that some of them happen to have misused their positions, gone on TV and radio and in newspapers, written letters, called politicians, and generally tried as hard as they could to defeat the legions of "MS" sufferers in their quest for health, is not relevant. The real criminals have been vendors who paid off and bribed doctors, pushed through and sold poison to sick people: misused the medical structure to make humongous usurious profits.

If it weren't for big multinational banks scandals and a depression engineered by people who have 99.99 percent of everything and want more, it might make sense to be concerned about the drug companies, or the stymied efforts to fight disease. But when the most immoral and corrupt and murderous are not the ones we have been scammed into thinking are trying to help us, when what the drug establishment do pales in comparison to what the super-rich do to maintain the flows of oil and weapons and fake credit information, we are probably better off shutting up about "MS".

I was watching the Daily Show last night and thought: when the line between telling the truth and sedition gets fine enough, we had all better watch out. Jon Stewart is still very funny but it's getting to be too hard to laugh.

Relapses: what is the formal definition? Is there even a rigorous description of lesion burden, or a standard way to measure it? The "MS" person knows that it only takes one relapse to take away walking, playing an instrument, eating without choking, eyesight, the list goes on. With each new event, the danger looms that whatever is damaged will not return. From the beginning, damage only varies by degree, fairly randomly. For everyone with "MS".

How do these drugs affect decline of cognitive ability? For all the things that have not been measured, do the interferons make things better, or worse? Will the withdrawal from their use invite more damage than if they had never been taken?

My friend Dr. Bob told me when he was in medical school that he would not try a new drug or operation until it had been used on other people for 25 years. Unfortunately, somebody has to be the guinea pig. It is not that easy to stay healthy for 25 years.

If health is worth more than money (and it is), and if 1 % of the people have 99 % of the wealth, in the future (after everyone is obese and has diabetes), will they also have 99% of the health?
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Re: So now that they've scientifically "proven" that DMD's

Postby Jimmykilt » Fri Jul 20, 2012 3:44 am

I've always been suspicious about the link between lesions and progression. I was diagnosed 5 years ago by "one of the best neuros" in the world with a negative lumbar puncture, negative vep and no physical or mental symptoms - purely on an MRI following a gym accident. They pushed the dmds like there is no tomorrow, often quite aggressively. I study data for a living and decided that the evidence was insufficient, in my mind, to pump nasty drugs into my body with uncertain benefits. Fast forward 5 years, and if I do indeed have MS, I have been very lucky, as I still have no symptoms, but I put that down to relatively healthy living, good diet and a load of vitamin d3 (originally 12, now 71).

It's amazing that people still believe everything their neuro tells them.

Btw, there's someone on the ldn forum already rubbishing the results, and if I am not mistaken, it's the same person who said ccvsi was responsible for the death of thousands of people on mshealthboards. In my view, those people are as dangerous as the neuros.
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Re: So now that they've scientifically "proven" that DMD's

Postby the_r » Sat Jul 21, 2012 3:29 am

marcstck wrote:BTW, progression has never been an endpoint in MS drug trials because it is so difficult to quantify, as many patients progress so slowly that each stage of drug trials would by necessity take 5+ years to complete. Neither the drug companies, because of the costs, or patients, because of the perilous nature of their existence, would put up with clinical trials that could last decades before the therapy in question could come to market.


What's wrong here is not that existing trials are flawed by using a surrogate parameter that turned out to be of limited value. It's wrong that in 5 years most neurologists will most likely still prescribe drugs based on white matter lesion counting. And most radiologists will still be scanning for white matter lesions exclusively.

MS is now known to be very complex. But who is starting an effort to actually get that info out to the practicioners?

Yes, you are right, nobody wants to wait years and years to see ROI with all the hazards involved. However, it might be possible to find better surrogate parameters rather than just giving up. Again, there doesn't appear to be enough effort when WM lesion and/or relapse rate reduction is sufficient to get a drug approved.
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Re: So now that they've scientifically "proven" that DMD's

Postby LR1234 » Sat Jul 21, 2012 9:11 am

Can I just add one point in the debate.....?

"The study considered whether patients advanced to a score of 6 on the Expanded Disability Status Scale, or EDSS, which is used to gauge disability in MS and means that a patient requires help from a cane to walk 330 feet. The study found that 10.8 percent of patients in the treated group reached a score of 6, compared with 5.3 percent in the untreated group and 23.1 percent in the historically untreated group. In other words, there was no statistical significance."

It is fair to say that those who had treatment available to them chose not to have it because their MS was probably milder...

So the 5.3% untreated when medicine choices were available are probably skewed as these were patients probably doing pretty well MS wise (overall)

I think the 10.8% who chose to take Interferon are probably closer to the historically untreated group (who had no choice of meds) than the optional untreated group.

Which would show the interferons might actually help. (EDSS wise....does nothing to measure cognitive issues)

Does anyone know what I mean or have I got it confused?
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Re: So now that they've scientifically "proven" that DMD's

Postby the_r » Sat Jul 21, 2012 9:23 am

Another problem with a historical control group is that MS detection rate has gone up. Until commercial use of MRI, less mild cases were detected overally. So with that in mind both treated and sametime untreated group ought to have more milder cases.

So now you tell me, which makes more of a difference? :p

I think unless we can put either into numbers, there's no way to decide.
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Re: So now that they've scientifically "proven" that DMD's

Postby LR1234 » Sat Jul 21, 2012 9:54 am

the_r wrote:Another problem with a historical control group is that MS detection rate has gone up. Until commercial use of MRI, less mild cases were detected overally. So with that in mind both treated and sametime untreated group ought to have more milder cases.

So now you tell me, which makes more of a difference? :p

I think unless we can put either into numbers, there's no way to decide.



This is true too!! So only the people with definable obvious issues would be involved in the study??? mmm
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Re: So now that they've scientifically "proven" that DMD's

Postby 1eye » Sat Jul 21, 2012 5:44 pm

It's pretty clear to me.

I did not read the study but would be awfully suspicious if gave no baseline information on EDSS scores. Seems to me the delta is more meaningful than % who reached 6.0.

Sounds a bit like they were saying: "This is the drug to prevent progression to level 6.0, after which we might as well throw up our hands and give up". Unfortunately, progression continues, all the way to 10 (death).

Untreated historically: 20%
Treated: 10%
Untreated during the study: 5%

I don't think you can say that the historically untreated group had no other choices. You are not considered "SPMS" until you require a cane for walking: EDSS 6.0. If that were the endpoint, then everyone must have been below 6.0. They would have been considered "RRMS", and eligible for Copaxone or Betaseron, probably others. I think people probably went in the study because if it succeeded, they would be treated for free.

10% is twice as high as 5%. If a factor of 2 is insignificant, the worst case is the drug makes disability worse, and the best case is it does nothing for disability.

I was considered 6.0 because someone saw me with a cane. I did not need it usually, till the end of the day.
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Nothing is"proven" for DMD's or CCSVI

Postby MarkW » Sun Jul 22, 2012 11:51 am

I realise that most people on this forum want to rant against DMDs but I suspect you are wasting your energies. Big pharma comps and neuros are set in their direction and will take years to be moved to the fact that MS is a multifactorial disease. I suggest that the idea of treating stenosed veins because it seems to help MS symptoms is a easier battle to win. DMDs seem to help about 30% of pwMS (but not me), treating CCSVI seems to help over 60% of pwMS. We need to promote de-stenosis as one strand of treating the symptoms of MS not the whole answer.
Fighting to have de-stenosis made available to pwMS is more likely to succeed than fightng DMDs, in my rarely humble opinion.
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http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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