This Is MS Multiple Sclerosis Knowledge & Support Community

Observer wrote:Harryz - more hearsay. An 'MS Professional' who is privy to something. That's simply wrong (on the Professional's part) to say things like that and NOT give details. "I've got a secret" How childish of this person on the Braintalk forum, and this person further claims that erroneious information (presumably from Biogen Idec) has falsely raised people's hopes, and then she goes and tries to throw cold water on those hopes WITHOUT PRESENTING ANY FACTS OR DATA. Good grief!

More rumourmongering. Very disappointing indeed. And I might add that on the Braintalk Forum the 'MS Professional' has been criticized and her interpretation of the Webcast has been disputed. I do not intend to get into that, but its important that readers are aware of it - supposedly people 'who know a lot about MS' are making comments that perhaps reflect their personal bias more than the facts. Again, disappointing, but to be honest we ALL have our biases (yours truly included!).

I urge readers to listen to the webcast, and there apparently is a transcript to be made available on the msleaders.org website (though I cannot yet find it). However, for those interested it has already been posted in multiple parts on the Elan Yahoo Message Board. Here is the link to the first part of the transcript on the YMB:

http://finance.messages.yahoo.com/bbs?. ... mid=502628

There are several parts, so after reading this first post, select Msg List and you'll see the next several parts in sequence.

Everyone should do themselves a big favor and take what Clinical 1 says with a grain of salt. She likes to believe she's the end all be all, to MS info. She is inaccurate, A LOT! She does not like to be questioned and when she is, she becomes very defensive. Beware.

Harry,
Do you know for a fact that Clinical1 is in contact with all of the neurologist that she claims to be in contact with?

Why do you think Biogen would leak information to her?

Curious.

Cool,

Do you know for a fact that Clinical1 is in contact with all of the neurologist that she claims to be in contact with?

I can assure you that when Clinical 1 says that a neurologist has told her something or a drug company sales rep has commented to her, it isn't being made up....period!!!!

You know, there are two sides of the MS medical world...the pharmaceutical world who are very powerful, have tons of money and are masters at marketing, sales and communication. The other side is the people who actually work with MS patients on a day to day basis...the docs, nurses and clinicians. These people can sift through the rhetoric and have a far better understanding of what works and what doesn't. Clinical 1 is part of the second group and while she doesn't sport a 100% "right all of the time" record, I would trust her 10 times more than I would any drug company when it comes to info about MS.

Why do you think Biogen would leak information to her?

I don't think it's a question of a Biogen rep "leaking" information to Clinical 1 or any other medical person. You have to understand that when two people meet together, one being in MS medicine and the other a Biogen rep, certain comments may be made in confidence and one trusts that the other will keep it that way. Of course, this isn't a guarantee that the info won't be made public but in most cases, if these people want to continue to have any kind of working relationship with the other person, confidentiality will be kept. And everyone on this forum, at some point in time, would have experienced this kind of situation at some time in their life.

Clinical 1's main goal is to help MS patients. She has MS herself and understands a great deal about the disease. And she has no interest whatsoever in stating information that may mislead anyone.

Harry

01/03/05 Barron's Article excerpt Up and Down Wall Street by Alan Abelson:

But the company does have a half interest in Tysabri and, by Larry Feinberg's reckoning,
that's pure gold.

He figures there are roughly 800,000 MS patients in the U.S. and Europe.
Of these, 330,000-350,000 are on drug therapy and another 100,000 have had
to quit therapy because of side effects or because the drugs didn't work.

Tysabri, Larry says, is twice as effective as anything now in use and
has few side effects. Which is why he expects as many as a quarter of
the 180,000 U.S. MS patients on drug therapy to switch to Tysabri by the
end of this new year, and at least half by the end of '07. He expects
Europe to give its official OK to the drug by midyear and acceptance
there to follow the same pattern as in the U.S. Moreover, he anticipates
something like 50,000 of the 450,000 MS sufferers here and in Europe now "untreated"
to go on Tysabri, boosting the potential number of users to 200,000.

Better,

With those kind of numbers, it isn't surprising as to why Biogen accelerated the approval schedule of Tysabri and is going "full steam ahead"! Can you imagine what that will do to the bottom line?!!

This, of course, assumes that no "surprises" happen along the way with Tysabri.

Harry

HarryZ wrote:Cool,

I can assure you that when Clinical 1 says that a neurologist has told her something or a drug company sales rep has commented to her, it isn't being made up....period!!!!

I happen to know for a fact that some of it is being made up....period!!!!

Cool,

I happen to know for a fact that some of it is being made up....period!!!!

Perhaps you would like to elaborate a bit on that statement. Correct me if I'm wrong, but if you are saying that Clinical 1 is purposefully making up incorrect information, then you are saying that she is deliberately misleading the readers. That, I feel, would be a serious accusation by you!

Harry

Believe me or not
Believe her or not
The decision is yours

Everyone should talk to their neuro to make important decisions, where their MS is concerned.

I'm not getting any deeper than that.

It will all come out, eventually. Watch and see.

Cool,

Believe me or not
Believe her or not
The decision is yours

I don't believe your comment about Clinical 1 has much to do about whether you believe what she says or not. I, as well, have always advocated the philosophy you just mentioned when it comes to believing what people have said on the net. But you appeared to go a step further in suggesting that what she said was being "fabricated" and was a deliberate attempt to mislead the readers. That's why I was asking for a clarification.

I'm not getting any deeper than that.

Probably a wise decision!

Everyone should talk to their neuro to make important decisions, where their MS is concerned.

I don't disagree but we all know that there are some neuros out there who don't give their patients the time of day. That's when the patient ends up going to a nurse clinician and in many cases, to the internet!!

I can remember one message from a MS patient in Toronto who had gone to the St. Michael's MS Clinic for suspected MS. After a series of tests, the neuro called her home and left a message on her answering machine..." Yes, you have MS, I'm going to prescribe you Avonex. Come back and see me in 18 months." I'ts no wonder these patients become frustrated and go to other sources of assistance.

It will all come out, eventually. Watch and see.

Yes, I guess we are all waiting to see what happens because we have such little information at the moment.

Harry

From Neighborhood Newspapers

New drug helps fight against multiple sclerosis
Local physician explains the benefits of Tysabri

By JAN HOGAN VIEW STAFF WRITER

A, B, C, R and now T. Medical research is changing the alphabet for those with multiple sclerosis.

A new drug, called Tysabri (pronounced Ty-SAB-Ree) was recently approved by the Food and Drug Administration.

Local neurologist Dr. Leo Germin, 1399 Galleria Drive in Henderson, had so many patients asking about it, he and the pharmaceutical company which makes Tysabri held an informational meeting at JW Marriott in Summerlin.

"This new agent reduces relapses by two-thirds," Germin told the dozens of patients assembled there. "It's twice as effective as anything we've had before, and that's a big deal."

MS affects everyone differently. The disease causes white blood cells to attack brain neurons and, in effect, short circuits messages to the rest of the body.

Some patients have relapsing symptoms, others get progressively worse. Over time, the size of the brain shrinks as tissues die off.

The chronic disease affects roughly 400,000 people in the United States. Many will progress to the point where they need a wheelchair and 24/7 care if they do not go on therapeutic medication.

But even people on the old drugs were aware their effectiveness wasn't encouraging. Those medications --- Avonex, Betaseron, Copaxone and Rebif --- were shown to help only 37, 29, 22 and 12 percent (respectively) of patients taking them.

In clinical trials, Tysabri reduced the rate of relapses by up to 66 percent and reduced the development of new or newly enlarging MRI-detected brain lesions. That number was even higher for test patients on both Tysabri and Avonex.

Northwest Las Vegas resident Kenneth Shade, 45, was at the JW Marriott to learn about the new drug. He began experiencing paralysis in his legs and a spastic bladder 11 years ago but was not officially diagnosed with MS until February 1998. He opted not to go on any of the therapy drugs then available.

"I wondered if the side effects were worth it," Shade said. "That was until about two years ago when I lost the vision in my right eye, which was really scary. It kind of made me think. So ... I'm here to learn more."

Delores Heffren, 62, of Green Valley, began having symptoms 30 years ago. She first realized something was wrong when she stepped into a bathtub filled with water. One leg registered no sensation. But the other was nearly scalded by the too-hot water. The woman who was always eager to hit the dance floor now uses a walker and electric scooter to get around.

"I have times when I can barely walk," she said. "But thanks to Dr. Germin, he comes up with these miracle drugs. I'm hoping this new drug will prevent me from getting worse."

The meeting used a PowerPoint presentation that included MRI slides of patients with MS. Germin used visuals like two red balls affixed with Velcro to demonstrate how MS causes cells to cling together.

He also pulled out a yellow "Do Not Cross" police tape when explaining how the brain normally has a natural barrier to keep out marauding white blood cells. The barrier is compromised in people with MS.

The new drug, as it was explained in layman's terms, approaches the disease in a new way. It essentially makes the marauding white blood cells too slick to stick to blood vessel walls. If they can't stick, they can't worm their way past the barrier and into the brain.

In an unusual move, the FDA fast-tracked the drug to get it to market. The only stipulation it made was a name change (in trials it was called Antegren) to ensure the handwriting on prescriptions was not mistaken for Avonex.

Like the other treatments, the new drug still comes with transient side effects, including headache, fatigue and joint aches. It is administered in a clinical setting intravenously. It also is expensive, reportedly about $23,000 a year.

thanks for the info.

But even people on the old drugs were aware their effectiveness wasn't encouraging. Those medications --- Avonex, Betaseron, Copaxone and Rebif --- were shown to help only 37, 29, 22 and 12 percent (respectively) of patients taking them.

This statement is WAY off.

You can see that a lot of numbers are "thrown" about when it comes to the CRABs. From what I have read over the years about them, I'm thinking those quoted in the article aren't that far off when it comes to the efficacy of them. Of course, the companies who make them will argue long and hard that the benefits are higher.

I recently read on another MS forum an interesting point about Tysabri and the CRABs. In the earlier CARB drug trials, the patients used had been diagnosed for a mean average of 2.5 years. It is an accepted fact that newly diagnosed patients, even though they may have had symptoms for several years earlier, have a much higher exacerbation rate at this stage of their MS.

After about 8-10 years after diagnosis, the number of exacerbations naturally drops off quite a bit. The Tysabri trials used patients that had the disease an average of 9.1 years. The number of exacerbations that these patients experienced was significantly reduced compared to the CRAB drugs but the comment was made as to whether these two types of drugs were comparing apples to oranges. Don't know but it was an interesting comment. What is also a bit confusing is that Tysabri is being recommended for newly diagnosed, mild MS cases. Will be interesting to see if the numbers hold up once the drug starts getting used by the general MS population.

Of course, this schedule of disease progression doesn't always happen. My wife had her first serious attack in 1971. She never had a second major attack until 1991 and she wasn't on any kind of medication all during this time.

Harry

coolycat wrote:thanks for the info.

But even people on the old drugs were aware their effectiveness wasn't encouraging. Those medications --- Avonex, Betaseron, Copaxone and Rebif --- were shown to help only 37, 29, 22 and 12 percent (respectively) of patients taking them.

This statement is WAY off.

That is the most ridiculous thing I have ever heard....no telling where this person go 12% for Rebif.

Comments from a participant

Notes from MS seminar

Just got in from the evening seminar for MS patients at a local hospital in Boston suburb. Met Jive there, too. The following are notes I took. Just note that I do not have a medical background and I usually am in bed at this time. Hope this is understandable and helpful.


January 10, 2005 meeting for MS patients regarding Tysabri with Dr. Tosches, Milford, MA

This is one of 4 sessions that will be held to explain Tysabri to MS community. Needed to do this in four sessions to accommodate the number of patients. The room was filled to capacity – approx. 70 people.

Dr. Tosches spent first ½ of meeting explaining Tysabri, the tests that were conducted (affirm and sentinel studies) and who would be candidates. He did stress throughout the evening that the decision to stay on current therapies or switch to Tysabri (or combo) would be very individualized between patient and doctor. Dr. Tosches further explained if patient was using a chemo approach now, then they would obviously want to try Tysabri because of the difference in side effects. If the patient was Interferon, Copaxon then the Dr. may suggest staying on both or switching to Tysabri. When asked about if insurance would cover a dual therapy approach, he explained that Tysabri takes 4 weeks to show results and during the initial 4 weeks he would suggest that patient be on both their current therapy and Tysabri and if patient shows signs of improvement, then he would start to shift to monotherapy. If patients continues to improve, monotherapy would be the way he would go and if patient starts to show more attacks or poor MRI’s, then they would continue with both drugs. He stated that patients would have some backlog of their current drugs and during those initial 4 weeks, they would be requesting only Tasabri. He doesn’t know how insurance companies would respond to reimbursement of both drugs but he didn’t seem too concerned.

Drug Administration:

1. one hour infusions
2. one addl hour for observation (checking for reaction to drug). Initial infusions may be longer as observation and safety are paramount.
3. infusions are given every 4 wks.

Dr. Tosches pointed out the side effects specifically and also stated that they were small in percentage and very manageable

Treatment sites:

1. Hospital Infusion Centers
2. Private Infusion Centers- there are large neurology practices that are setting up for this
3. Home Infusion Service

They anticipate beginning of Feb 2005 will be their first infusion at this site. Concerns for drug reactions and safety from the audience were supported by the experience of infusion staff and that the emergency room was nearby if necessary. The Dr. later explained since the drug is new, it was best to take precautions with extra observations after infusion, perhaps longer infusions if allergic reactions occur and/or Benadryl administered first if patient prone to allergic reactions, etc.

Dr. Tosches said all the physicians and scientists who have looked at this drug are very excited. He stressed it is not a cure for MS and he did not think it would reverse lesions. The focus was to stop a patient from progressing further with the disease.

Clinical attacks and MRI’s (given 2-3 times per year) would be how they monitor effectiveness of Tysabri.

The following was a question and answer period.

1. How long should Tysabri be taken? – Don’t know. Could be year, several years, lifetime.
2. Should patients switch from their current disease modifying therapy?
The answer to this is very individualized between patient and their doctor. If currently under a chemo approach, then switch to Tysabri for the difference in side effects. If on Interferon, Copaxon, Avonex – stay on both or switch to Tysabri.
Note: my take on this is the Dr. was being diplomatic but his bias was to use Tysabri as a monotherapy after he satisfied his comfort level for safety and effectiveness. After session he confirmed this thought to Jive and me.

3. Insurance Issues- this site is submitting approvals (200+ have been submitted) now and have gotten acknowledgement from Insurance companies that they have received paperwork but are waiting for approval responses. As of yesterday, he found out that the insurance companies are SWAMPED with patients wanting this drug. He noted that each plan determines its own coverage but he expect Medicare will approve this drug as they have been supportive of MS drugs in the past and the other insurance companies will follow Medicare’s lead. He said he felt strongly that the applications would be approved.

When concerns were raised about the cost of Tysabri, Dr. Tosches diminished the concern by saying it wasn’t that much more than the current therapies and that the insurance co’s will look at more than just initial cost ( i.e. decrease need for future medication, hospital stays, etc.). He was very optimistic.

He told of the new head to head study being conducted of Rebif vs. Tysabri and how unusual that was for a drug company to take on another competitor head to head.

There was another woman present in the meeting that Dr. Tosches introduced. I didn’t catch her name or her title but I did hear she was with UMASS Medical in Worcester which was one of the clinical trial sites for Tysabri (they had 15 patients in the trial). She explained that the one year data trial of Tysabri/Placebo vs. Tysabri/Avonex showed that the statistical lines of the two trials were divergent. In other words, if we projected the statistical line out it would suggest that the longer you stay on Tysabri alone the more divergent the effectiveness of that treatment would be over Tysabri/Avonex together.

After the meeting I spoke with her one on one and she told me the following:

UMASS Worcester was a test site with 15 patients
There were 3 test sites in Boston
One test site in Norwalk, Connecticut
One test site in Providence

For infusion centers:

1. Milford, MA
2. Worcester, MA
3. Boston, MA
4. Springfield, MA
5. Providence, RI

She said initially, they want to be careful in monitoring any and all side effects and she felt it safer to do infusions in hospitals where emergency care was nearby.

That's the end of my notes. Good night and pleasant dreams to all.

Janet

Janet.

Thank you for the detailed post. I know it must have taken a lot of energy to complete.


Just a couple of comments...don't I always have a few of these

Dr. Tosches said all the physicians and scientists who have looked at this drug are very excited.

Perhaps the docs and scientists that Dr. Tosches has spoken to but there are some MS docs who don't share this level of excitement. Dr. B. Thrower, Dr. M. Freedman and Dr. M. Kremutchutzky to name a few.

When concerns were raised about the cost of Tysabri, Dr. Tosches diminished the concern by saying it wasn’t that much more than the current therapies

Perhaps Dr. Tosches isn't very good at math....it is estimated that Tysabri is going to cost twice as much as the current CRAB drugs!!

He told of the new head to head study being conducted of Rebif vs. Tysabri and how unusual that was for a drug company to take on another competitor head to head.

Not sure where Dr. Tosches has been for the past few years because there has been a number of head-to-head drugs trials done among the CRAB companies. It isn't very unusual at all especially with the huge MS drug market out there.

Harry