It's 1/2 way through 2014, still no cure

[Myoak]

Apologizes J-Bo,

Sorry I didn't answer your request, I only now read your post. Hope you were able to find the entire article ok.

The conclusion was most interesting to me. Presuming most of the 22,000 HIV positive were on HAART (highly active antiretroviral therapy) and finding the incidence of MS in HIV+ was about 1/4th of the rate in millions of those not HIV positive is notable. That could be due to the antiretroviral.

A monoclonal antibody thus far called GNbAC1 was developed to act against MSRV ( multiple sclerosis- associated retrovirus). This small trial tested for safety. It is interesting that human research involving antiretroviral treatments for MS now has two substances, Raltegravir (Isentress) and GNbAC1.

GNbAC1, a Humanized Monoclonal Antibody Against the Envelope Protein of Multiple Sclerosis—Associated Endogenous Retrovirus: A First-in-Humans Randomized Clinical Study
http://www.clinicaltherapeutics.com/...12)00649-2/pdf

[JerryD]

So, isn't it great to read about a study that was probably completed in 2013 that seems to have been successful and then there is little new information about it for almost 2 years. Where did the monoclonal antibody go ? On vacation !
I admit that I am an impatient cuss, but give me a break!

[Myoak]

The Drug Development Path in MS takes 15-20 years. Each Phase takes about 2 to 3 years on average except the FDA submission and licensing which averages about a year, sometimes more.

1. Phase 0 Development in cell cultures & animals
2. Phase 1 Toxicology in normal humans
3. Phase 2a Safety and dose in humans with MS
4. Phase 2b Studies for efficacy in MS
5. Phase 3 Large scale trials (1,2,or 3) in MS
6. FDA submission and licensing
7. Phase 4 Post-release safety studies

After FDA approval many doctors wait until a drug has been on the market for a year or more before they prescribe it because an unforeseen issue may arise when the drug is given to a broad population.

[Myoak]

Following up on drug development and MS treatments...

One big sticking point in the process is the large scale phase 3 trials. Very few entities have $40-50 million to spend on Phase 3 trials except the big pharmas. And, they have no incentive to fund research for inexpensive generic drugs or supplements which compete with their expensive patented drugs.

Because of that, Phase 2b is as far as many treatments will ever go. The FDA does not approve drugs w/o pivotal phase 3 trials. LDN went as far as Phase 2b, no further. Clemastine is another cheap generic in trial. Even if it is found to be highly effective it will not see Phase 3 trials unless it can be altered and patented.

Simvastatin (a cholesterol med) is a generic which has been shown to slow brain atrophy in human trials. But it is very unlikely to ever see Phase 3 trials because… who will fund them? The drug companies developing proprietary drugs for slowing brain atrophy won’t.

Alpha Lipoic Acid is being used in a MS trial. Same fate. Even if effective, like LDN, it will never see Phase 3 trials because no one will fund them.

Thus, the official position from doctors and disease societies is the same old grind… “we just don’t know enough about them” or “there is just not enough evidence”.

It has been about 8 years since the promising LDN trial was completed in Italy; no follow-up Phase 3 trials yet. No one is expecting one, either.

Patients will have to make their own decisions based on Phase 2b trials because none of the above is likely to have a phase 3 trial.

The good news is that things which proved effective in small trials are worth considering.

[JerryD]

Thanks, Myoak, for clarifying the part that profit plays in finding the 'cure'. As always, we MSers need a 'miracle' because if we depend on 'big pharma' to find us a cure, where's the profit in that?

[drater]

Still no cure

The answer to your question is short and simple. If researchers found a cure for ANY disease,they would lose hundreds of millions of dollars. People's suffering isn't important; money is. After all," money makes the world go 'round."

[Myoak]

Drater, welcome and your answer is spot on. For a longer version...

The truth is your friend. And the truth is that there is presently no realistic path to FDA approval w/o the involvement of drug companies. They exist for profit and only they can afford expensive Phase 3 trials. Very, very seldom if ever, are disease societies or the government involved in Phase 3 trials which can cost $40-50 million each. Pharma develops drugs for profit. They get the return if it turns out (and many don’t), not government or disease societies.

In that environment it does seem as though people suffering is not important. But we ought to guard against becoming calloused. Suffering is important to many, probably most who dedicate their lives to medicine.

There are clinicians and university researchers by the thousands who labor mightily to relieve suffering. I think of researchers like Dr. Jill Smith at Penn State whose young niece dying of Crohn’s related issues motivated Dr Smith to find an answer for Crohn’s. And it looks as though she found that answer in LDN, which btw, many MSers use.

The point being there are lots of researchers and doctors motivated for the right reasons.

Under our present system inexpensive treatments which are generic or cannot be patented will not get FDA approval because no one funds large studies for them.

No one gripes about that fact more than I do. But we don’t want to become persistently negative. Rather, we want to find the positives in the reality we face.

We realize due to business reasons Phase 2 trial is as far as some things will ever be developed. We realize it is pointless waiting for trials which are not going to happen. So we are empowered by the realization we must use the information from Phase 2 trials to make judgments.

Not everyone’s cup of tea, to be sure. Not everyone has time or capability to judge if something promising from a Phase 2 trial in MS might be safe or effective for them.
But some will put in time and study and if something has a very good safety profile it is understandable they may want to try it. So we talk about those things whether diet, drugs, supplements or whatever.

LDN use, for example, is so far past the clinicians it has become laughable. These people are so narrowly focused most have no clue, IMO, tens of thousands of MSers worldwide use LDN daily. However, occasionally a prominent doctor or disease society will make a statement like, “it concerns me so many are using LDN without adequate evidence”.

It concerns them people use LDN but it doesn’t concern them enough to study it! Laughable isn’t it?

Good heavens, why not just admit being in bed with Pharma and get it over with?

For our part, we should accept the fact business profits guide MS treatments. As MSers and caregivers we should be on guard that bitterness isn’t guiding us but betterness, not a word but you know what I mean. Good attitude is a part of good health.

Best to all and welcome, Drater.

[dyin_myelin]

It is a liability issue too. I asked my nurse practitioner why I couldn't have LDN, liability? "Yes." Some hozebag down the lane would take LDN, get a head cold, fall down the stairs, and sue him into oblivion. So, I can't get LDN unless I drop hundreds at a "functional medicine" woo practice that takes no insurance.

We need an ACT UP! action. That these meds need to be fast tracked so people stop suffering from this disease. Dying from AIDS is no worse than being blind, incontinent, foggy headed, unable to walk. I don't know what needs to happen, iron clad liability waivers, caps on malpractice, in order to help get these treatments available. People spend $200,000 for HSCT, doctors who have been touched by the disease personally develop special diets and CCSVI because they are *desperate* to get rid of it and have no problem instituting their pet theories into practice right away. /rant over

[Thinkimjob]

Apparently, there will be an Ebola vaccine by November. Excellent work scientists, because this a hideous disease, and presumably they know exactly what causes it.

MS?
Okay, no horrible rapid death and no potential pandemic, but please, please, please, before I drop off this mortal coil, surely someone can at least just work out what the trigger is.

I read somewhere that MSers with HIV do well so far as the MS goes. Reporter was gobsmacked. Yes, dear, HIV suppresses your immune system. But if you take the retrovirals to keep you alive, your immune system springs back into action, and your MS returns.

Imagine the cocktail of drugs you'd be on to keep that balanced.

[Myoak]

The article linked below states, “It indicates that those (HIV) infected and undergoing treatment are 60% less likely to develop MS than their uninfected peers. Moreover, further analysis showed this value leapt to 80% among those who had been infected and treated for more than five years.”

How comprehensive was the study? “In total, they found 21,207 HIV-positive individuals and compared them with 5,298,496 controls of similar ages and ethnic backgrounds.”

MS occurs far less frequently in HIV patients than the rest of the population. MS isn’t made worse by HIV treatment; it is made better, in fact much better.

HIV positive patients’ immune systems benefit from the assistance of HIV anti-retroviral drugs; lives are lengthened by using those drugs. Also, MS benefitted immensely as demonstrated in the data base studied. This study is spectacularly important to MSers, IMO.

More will come of this finding, I’m sure. I hope with Ms. Job that it will be in our lifetimes. I believe an anti-retroviral treatment for MS will be developed. Perhaps, fast-tracked like Ebola treatments?

Perhaps, not. Ebola has no competing treatments. MS has plenty of cash cow treatments to protect. US Pharma and political lap-dogs will make certain it is illegal to import anti-virals if proven effective in MS. Actually, they already block importation of medicine; but just for us, not themselves.

Pharma buys drugs overseas and sells them to us (look at the label on your script for the manufacturer then Google the name to find where the pills in your bottle came from). But it is illegal for us to buy off-shore.

Strange that everything under the sun can be imported from overseas, but they want to jail me if I buy my meds from there like the drugstore chains and big pharma companies do.

Again, look at the manufacturer on your labels. Many are off-shore. Hmmmm, I wonder if big Pharma has anything to do with the state of this affair?

Thank God for the researchers investigating a viral cause for MS. They certainly can’t count on help from Pharma, disease societies, or much help from government (NIH); an inseparable ménage a trios.

Recognizing the situation we need to be thoughtful of who we support. IMO, huge progress in treating MS will come from isolated pockets of researchers working minus funding from the three amigos mentioned.

Those researchers need our support and encouragement. They have my sincere gratitude. I can’t help but think of the decades of work done at Penn State with LDN. Hopefully, other universities will serve as research hubs involved with MS meds. An anti-viral is sure to be one of them.

http://www.economist.com/news/scienc...sis-antithesis

Best

[SNOOPY]

Myoak:
Simvastatin (a cholesterol med) is a generic which has been shown to slow brain atrophy in human trials. But it is very unlikely to ever see Phase 3 trials because… who will fund them? The drug companies developing proprietary drugs for slowing brain atrophy won’t.

It's not about funding.

There are FDA warnings on Statins due to serious side effects which can happen at even low doses. Statins are dangerous.

There are Neurologists who recommend that their MS patients NOT use Statins.

http://www.fda.gov/forconsumers/cons.../ucm293330.htm

[Myoak]

The FDA requires Phase 1 trials to address safety issues. Only when safety is established can Phase 2 trials be undertaken. Methods are similar in Europe.

The Phase 2 trial below concluded, “This trial, in actively progressing SPMS demonstrates a positive effect on clinical disability and a putative neuroprotective role. No anti-inflammatory effect was seen. A phase III trial is warranted.”

The MS-STAT trial: high dose simvastatin demonstrates neuroprotection without immune-modulation in secondary progressive multiple sclerosis (SPMS) – a phase II trial
http://registration.akm.ch/einsicht....NMASKEN_ID=900

Snoopy’s post makes the case for having a Phase 3 trial for simvastatin. Opinions are nice but proof is priceless. Careful balance of risk and reward requires evidence. Large trials are required for evidence-based medicine.

Quoting Snoopy’s link “This new information should not scare people off statins", says Amy G. Egan, M.D., M.P.H., deputy director for safety in FD FDA’s Division of Metabolism and Endocrinology Products… Dr Egan continues regarding statins, “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

The Phase 2 trial using simvastatin in MS demonstrated neuroprotection in SPMS. It reduced the rate of brain atrophy in SPMS. Larger trials are required to support or not support that finding. There may be neuros who recommend not taking simvastatin, as Snoopy said.

However, I do know that MS specialists at Cleveland Clinic prescribed simvastatin for 3 MSers (not in the SPMS trial), one being a relative. My guess is that there are many on simvastatin which I don’t know about. Maybe someone here will speak up here if they are.

If there are neuros recommending against taking statins surely they would want scientific proof to weigh the benefits and risks to MSers on statins. Phase 3 trials would help clinicians balance risk and reward with greater clarity.

The reason there is not likely to be a large scale Phase 3 trial of simvastatin is lack of funding. Simvastatin is a generic. Funding of Phase 3 trials for generics in MS is rare as hen’s teeth because there is no path to recoup funding for Pharma.

Phase 3 trial of simvastatin in MS has nothing to do with safety; Phase 1 trial addressed that issue. This Phase 3 trial, or lack thereof, is dependent upon funding, not safety issues.

Sorry Snoopy, we disagree on this one.

[SNOOPY]

Opinions are nice but proof is priceless. Careful balance of risk and reward requires evidence. Large trials are required for evidence-based medicine.

My comments regarding Statins are not based on opinions.

I was on a Statin for approximately a year and a half to 2 years at a very low dose. In that time and without prior knowledge of the side effects a Statin can have I lost my quality of life.

I had serious memory problems to the point my husband was leaning towards Alzheimer's.

I could no longer drive as I would get lost in very familiar areas and could not remember where I was going. I became weak enough that leaving the house to do anything became very difficult and almost impossible. Fatigue increased and emotionally I was a wreck.

I had NeuroPsych testing done due to the memory problems. The NeuroPsych said the memory problems related to Statin use was being seen quite often in his field. He was going to write an article on the issue of Statins and submit it to the FDA and my case would be an example.

Fortunately, once the Statin was stopped my memory problems improved and with hard work on my part I was able to regain my strength and endurance.

Unfortunately, Statins side effects are very similar to MS symptoms that many of us experience. It is quite easy to assume your MS is getting worse when in fact a medication can be the problem.

BTW, my Neurologist does not like to see his MS patients on Statins and was concerned when I listed a Statin as a medication I was taking.

I would recommend anyone considering Statin usage to discuss this with your Neurologist before hand and be very aware of the damage a Statin can do.

I was told the side effects I experienced were not common. However, with research I found my experience to be common and the FDA has been researching memory problems and Statins (all Statins) for awhile.

If you research Statins and memory you will find quite a bit of information.

[KatieAgain]

I have some recent personal experience

As probably most of you know I am on TY.

I had a break through flare and was put on IV steroids. It was also discovered I had medication induced Anemia. The cardiologist was concerned about the steroids raising my Cholesterol and with the existing Anemia which can cause heart problems, so he put me on a Statin.

My MS Specialist, my Oncologist and PCP (whose wife has MS), were all upset about me being put on a Statin...but no one told me why.

30 days in, I started getting really sore like I had run a Marathon, and was having pretty serious issues walking. I could not lift my arms either. I actually had a routine appointment with my MS Specialist. He said it was the Statin and to stop taking it immediately. A week later I was fine.

The Statins can cause severe muscle damage to the point it is irreversible. What I found out is the mixture of Statins with many of the DMDs dramatically increases that risk.

I was told it was fairly common. But for me, my total cholesterol is 163. I don't need to be on a Statin. If I ever do need a Statin...I need to come off a DMD. That's probably not going to happen...unless Statins can cure MS.

Statins are indeed serious and they can mimic MS Symptoms to the point of being dangerous. And it is not fun if you are one of those people.

I think Statins for SPMS or PPMS where no DMD is being taken should continued to be studied.

[Myoak]

Snoopy,

I’m very sorry about the negative effects you encountered while taking a statin and happy about your successful resolution. According to a 2004 book by Dr. Michael Roizen too low a cholesterol value may cause neurologic or immune dysfunction. That knowledge should be accounted for by every treating neuro.

Thank you for highlighting the problems you had, Snoopy, because others could encounter the same.

But to be fair we have to acknowledge that millions, perhaps tens of millions over the last 2 decades have taken statins and not reported your experience.

Well over 15 million Americans and 7 million Britons are on statins by some estimates. I think we have to be careful of projecting the results of a single case more widely to people who have not experienced similar problems.

Out of those millions are there others like Snoopy? Likely there are. How many? That would be a question only a large scale study could answer, and should, IMO.

Snoopy, your answer to why there isn’t a large scale trial of simvastatin in MS was, “It’s not about funding”. Then you presented it as a safety issue. I’ll try again making the point that it is an issue of funding by another approach.

The joint ACTRIMS-ECTRIMS conference opened this week-end in Boston. The video presentation below was Saturday made by Dr. David Baker. He talked about the 10-14 years and $1.5 billion cost of getting a MS drug to patients.

Only Pharma has that kind of money. The symbiotic relationship of Pharma, disease societies, and government is, IMO, dominated by Pharma. It is a follow-the-money scenario deep throat (Watergate) would have urged to get at the facts behind what gets developed and what doesn't for MS.

Snoopy, your kind of post about personal experience is always welcomed and appreciated. It is very valuable and will alert others if they experience similar symptoms. Thank you.

Here is the link I mentioned: https://plus.google.com/106702687978421980742/posts

If, for some reason the link gets shot down, YouTube has video on the ACTRIMS-ECTRIMS conference. Enter “Dr.Baker and what’s new in the lab” for the video I referenced.

Best to you Snoopy. Thanks again for your excellent post about your personal experience. It is helpful and may prove invaluable to those affected as you were.