This Is MS Multiple Sclerosis Community: Knowledge & Support

[HarryZ]

Ian,

I am not going to continue to publicly debate with you what I post. I doubt very much the readers here want to listen to you question what I say and then suggest, through some preposterous comments, that I should stop participating, go away or be banned.

Twice in the past year you have taken a similar line only to privately message me with apologies for being so frustrated in your situation and taking this frustration out on me in the public forum. Well Ian, three strikes and you are out...as they say in North America....and I am therefore not going to reply to your ludicrous comments about me and what I say.

If Arron wishes to allow you to make these comments, that it his prerogative as the moderator. But I somehow think the readers are simply not interested in these debacles.

Harry

[TheTysabriBull]

There is no doubt in my mind that Dr. Larry Steinman is one of many professional thought leaders in the field of MS research. However, lets take a closer look at his previous role in the development of natalizumab through to its recent FDA marketing re-approval.

Dr. Steinman did play a small part in the early laboratory development of antegren (natalizumab). He was working for Athena Labs(later acquired by Elan PLC) back in the early 1990's where this monoclonal anti-body was discovered in the lab by Ted Yednock. Elan currently owns all the patents and IP on natalizumab. Around 1992 Dr. Steinman left Athena labs to pursue his own research and development in the field of autoimmune neurology etc. Today he is one of the founders and current directors of BayHill Therapeutics:

http://www.bayhilltherapeutics.com/founders.html

As you say Harry, "interestingly" enough, Dr. Steinman has possible conflicts of interest because Bayhill has a drug approaching later stage clinical trials in the MS pipeline, Multiple Sclerosis (MS) BHT-3009: Plasmid encoding the MS-specific autoantigen myelin basic protein. Phase I/II clinical studies are underway in MS patients.

http://www.bayhilltherapeutics.com/overview.html

In most of the RECENT press where Dr. Steinman has made negative public commentary about the "safety" of natalizumab I have not seen any disclosure that he may have any possible business interest in a future competing therapy that will be indicated for MS.


Harry, I've already made my well-informed choice and also conclude that I'm willing to take the very small unknown risk of developing PML while CURRENTLY on Tysabri monotherapy. I was previously at 100% risk of MS progression having failed 2 of the older and inefficacious ABCR interferons for 10 years. By the way, the side effect profile of Tysabri was very close to the side effect profile of placebo in the monotherapy AFFIRM clinical trial.

[bromley]

Bull,

I wouldn't waste your time. As you say, you have made your decision and all I can do is wish you, Lauren and Pete the best of luck and hope that you see the benefits you are after. Please keep us posted on how you do - the good and the bad. Someone has to try new drugs when they first come to market, and your actual experiences and the lessons learned etc will hopefully benefit those in the future as these sorts of drugs are refined and made even more effective and safer.

Ian

[amelia]

Sorry folks, but it comes down to MY CHOICE!!!!!!! When Gary went to the DR to get hooked up with Tysabri, there was NO POSITIVE statements made about it. I don't know what went on in the meetings to get everyone approved for infusions, but some of the DRs have come out doing everything in their power to NOT give it to you. If you read the pamplet they give out to you, you might get PML is stated so much it is redundant! It didn't emphasize how much good it could do for you. SAD!!! IF I WANT TYSABRI, I SHOULD BE ABLE TO GET ALL INFORMATION AND MAKE MY OWN DECISION! Right now the gov't is making the decision. And yeah, you should hear the POSSIBILITIES of side effects, but how many times do you go to the DR and they give you the side effects of anything else so intensely! They DON'T! Even with chemo and cancer, they give you HOPE that the drug will work.

[HarryZ]

As you say Harry, "interestingly" enough, Dr. Steinman has possible conflicts of interest because Bayhill has a drug approaching later stage clinical trials in the MS pipeline, Multiple Sclerosis (MS) BHT-3009: Plasmid encoding the MS-specific autoantigen myelin basic protein. Phase I/II clinical studies are underway in MS patients.

I think most people who have followed Tysabri know that Dr. Steinman works for another, competitive company. Most "expert" opinions given on behalf of a particular drug by a doctor have the drug company employing the doc or paying him for his opinion. That's the way it is in the pharmaceutical industry. Even the NMSS follows this practice and hires Dr. Bowling to write expert opinions on their behalf....perhaps you can remember the original scathing article he wrote about LDN on their behalf.

But Steinman has a lot of credibility in the field of MS medications and when he speaks, people have a tendency to listen.

Harry, I've already made my well-informed choice and also conclude that I'm willing to take the very small unknown risk of developing PML while CURRENTLY on Tysabri monotherapy. I was previously at 100% risk of MS progression having failed 2 of the older and inefficacious ABCR interferons for 10 years. By the way, the side effect profile of Tysabri was very close to the side effect profile of placebo in the monotherapy AFFIRM clinical trial.

And like I've said many times in the past, that is a decision that you and you alone have the right to make. I sincerely hope it works out the best for you.

Harry

[HarryZ]

Amelia,

I can imagine the frustration you seem to continually experience in trying to get Tysabri approved for Gary. As is often the case in the US, doctors are very leery about litigation if something goes wrong and that often clouds their judgment.

BTW, where are you at the moment in getting the Tysabri approved for Gary?

Harry

[TheTysabriBull]

You also have a choice of who you select to be your physician or specialist. My typically conservative and cautious neuro, who is currently TOUCH certified, had also given in to my eagerness to be prescribed this novel therapy in late 2004 and signed my pevious prescription on December 1st of 2004 during the initial launch of Tysabri. After the absurdly long voluntary suspension with eventual FDA reapproval, he did not want to prescribe it to me and actually tried talking me out of it! During my TOUCH interview a few months back I told him that I would be glad to sign a legal waiver if he would be more comfortable in prescribing the drug. He signed my TOUCH prescription enrollment that day! With the now better known and very small risk of possibly developing PML during natalizumab therapy, which is clearly stated on the new label for Tysabri, the ambulance chasing lawyers in the U.S. will have a much harder time suing the sponsors if possible rare cases of PML develop over time. It is a previously known clinical fact that PML occurs in severely immune comprimised individuals as well as spontaneously in the human population. A treatment naive MS patient is USUALLY NOT an immune comprimised patient unless they have also have HIV/AIDs or some other rare disorder of their immune system. Most of the drugs used in treating MS today are disease modifying, immune modulating, or immune suppressing. Unfortunately, PML did occur in 3 patients who received natalizumab in clinical therapy. That fact can never be refuted BUT, there is also supportive clinical evidence that Tysabri can now be more SAFELY delivered to immune competant and properly diagnosed MS patients while maintaining constant vigilance for any rare occurance of PML or other types of infection. I like my significantly improved chances of keeping my MS and disability progression in check while also gaining a much higher quality of life as weighed against an extremely rare possibility that I could develop PML and die. My choice!

[amelia]

Harry,
I have posted in a few places, but you have probably missed them. When going through the MRIs for Tysabri, a stange thing happened. He had NO scars. Since his involvement has always been in the spine and optic nerves, he has no scars, and he has spinal stenosis, they want to change his DX after 10 years. They think he has Devic's Disease, which is MS's twin sister in our book. There is a blood test for it and Gary took it Monday. It's a 5 days minimum wait for the results, so we are in limbo right now. Tysabri may or may not work for Devic's and don't know if anybody definitely DXed with it is getting it. With all the tight restraints, it is doubtful that Gary can get it. But Rituxan in a small study showed to halt the disease. Better than Ty for Devic's, because it depletes the B cells only, which is they know if Devic's issue. Frustrating, but in some ways, treatment can be better. With the Rituxan, still a strong treatment and risk of PML, he wil take a short course, 4 weeks, then they will monitor his blood for the B cells. If and when they come back, they will give a booster dose to know the B cells back down. Without B cells, Devic's doesn't attack. But he won't take something all the time. We just leave everything up to God and go on. Heck, what else can you do. But I am still a heavy supporter of Ty. Gary just isn't a patient,yet.

[HarryZ]

Amelia,

What an ordeal you two are having to go through!! It's bad enough that Gary has to through all the daily suffering as well as get caught up in the red tape.

I'm not sure how one would hope someone had Devic's disease as a diagnosis but I suppose from what you describe, it's better and far more treatable than MS. I really hope this all pans out for both of you. I know how a serious illness can effect both people in this situation.

I know most of us here are eagerly waiting to hear some good news from you.

Harry

[TheTysabriBull]

I think most people who have followed Tysabri know that Dr. Steinman works for another, competitive company. Most "expert" opinions given on behalf of a particular drug by a doctor have the drug company employing the doc or paying him for his opinion. That's the way it is in the pharmaceutical industry. Even the NMSS follows this practice and hires Dr. Bowling to write expert opinions on their behalf....perhaps you can remember the original scathing article he wrote about LDN on their behalf.

But Steinman has a lot of credibility in the field of MS medications and when he speaks, people have a tendency to listen. .

Harry, you said it yourself, "most people who have followed Tysabri know that Dr. Steinman works for another, competitive company." How can you utter such a shallow statement, especially since you are the most flagrant pontificator about business conflicts of interest on this MS message board?

How do YOU know what most people in his very small group or circle of friends know about Dr. Steinman's conflicts of interest? Furthermore, keeping in context of previously stated opinion, any public professional commentary is usually directed at the entire community, not just a proselective small group of cronies who MAY already know about a specific individual's conflicts of interest! It cracked me up when some of the conflicted NMSS research advisors and so called experts said we have "more information" than the entire community but, we can't tell you what it is. That's hypocrisy, especially if they are supposed to be ethical medical experts supporting the entire MS community. Now that Tysabri has been re-approved under TOUCH in the US, I guess some of those multi-conflicted NMSS expert consultants to the FDA must NOT have known as much as they claimed to have known BEFORE the drug was eventually re-approved by the FDA! There was an ominous and obfuscating undertow from conflicted MS experts and competitors that did not want to see Tysabri come back at all, regardless of any revised risk map and label for commercial re-launch of this highly efficacious and novel monotherapy for safely treating any form of active MS!

[HarryZ]

Harry, you said it yourself, "most people who have followed Tysabri know that Dr. Steinman works for another, competitive company." How can you utter such a shallow statement, especially since you are the most flagrant pontificator about business conflicts of interest on this MS message board?

What's shallow about it? I would think that Steinman carries a heck of a lot more weight on his comments about Tysabri since he was one of the docs that discovered it and likely has far more knowledge about it than 99% of the docs that will prescribe the drug. That's a far cry from a drug company hiring a doc as a paid spokesman and then providing him with a script on what to say about it.

How do YOU know what most people in his very small group or circle of friends know about Dr. Steinman's conflicts of interest?

Probably from the fact that it has been mentioned on more than one occasion in various threads about Tysabri, especially shortly after it was pulled and a flurry of posts were made.

It cracked me up when some of the conflicted NMSS research advisors and so called experts said we have "more information" than the entire community but, we can't tell you what it is. That's hypocrisy, especially if they are supposed to be ethical medical experts supporting the entire MS community.

Well, if you've ever read my comments about the NMSS you'll understand why I agree with your statement. They will go beyond hypocrisy if they feel threatened in any way and I've seen that happen with them.

Now that Tysabri has been re-approved under TOUCH in the US, I guess some of those multi-conflicted NMSS expert consultants to the FDA must NOT have known as much as they claimed to have known BEFORE the drug was eventually re-approved by the FDA! There was an ominous and obfuscating undertow from conflicted MS experts and competitors that did not want to see Tysabri come back at all, regardless of any revised risk map and label for commercial re-launch of this highly efficacious and novel monotherapy for safely treating any form of active MS!

The world of big pharma and the FDA operate in mysterious ways. The conflict among the experts with regards to Tysabri will never go away because Tysabri is now part of the big 4 MS pharma marketing wars. Just watch how the competitors go to war against each other to ensure that they maintain or increase their market share. The amount of money involved here is staggering and these people will go to the end of the earth to make sure they get their share.

Harry

[amelia]

Tysabri is now part of the big 4 MS pharma marketing wars

But don't forget, Harry, the other drugs don't have to put you through the ringer to get it like Ty.

[HarryZ]

Amelia,

But don't forget, Harry, the other drugs don't have to put you through the ringer to get it like Ty.

That's very true but they have been around a long time now and never had the PML possibility. Each one of those drugs has a market share that has been established. Originally, Tysabri was going to eat into that share, big time, perhaps even costing Biogen some loss with Avonex. I'm sure that's why Avonex was mixed in with Tysabri in the trials.....use both and really increase the revenue.

Would be interesting to sit in on the various marketing/sales meetings with these pharmas and watch them plot their strategy with these MS drugs!

Take care.

Harry

[amelia]

The trend of many drugs coming down the pipeline are once a month or a series of treatments, then you are not on anything constantly. I wonder how that will play with the Pharma co.? They will still be expensive, but not in the long haul of it.