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SallyC 12-14-2006 08:51 PM

Quote:

Originally Posted by lady_express_44 (Post 49852)
I have a hard copy of the BMJ article, but can't access it on their website because you need a membership to do so.

The article was called "Lessons for clinical trials from natalizumab in multiple sclerosis", written by Abhijit Chaundhuri:

http://www.bmj.com/cgi/content/citation/332/7538/416

The hard copy reads "On 18 February 2005, 10 days before the public announcement, the FDA received information from Biogen Idec of one confirmed death and one possible case of progressive multifocal leucoencephalopathy in patients receiving natalizumab for Multiple Sclerosis".

Cherie

Well that happened too, but that's not what I'm talking about. A Trial Doc informed Biogen of PML being a factor on the 9th of Feb, if I recall it correctly.

Damn I wish I could find it.:confused:

Harry Z 12-15-2006 12:00 AM

Sally,

Quote:

Originally Posted by SallyC (Post 49903)
Well that happened too, but that's not what I'm talking about. A Trial Doc informed Biogen of PML being a factor on the 9th of Feb, if I recall it correctly.

Damn I wish I could find it.:confused:

I know what you mean....the article we are both referring to gave the name of the trial doc and the date he stated that he informed Biogen. (Feb 9) I've spent a lot of time searching the net for this article but still no success.

Harry

gonnamakeit 12-15-2006 12:57 PM

Tysarbi trial
 
Is this the page you are looking for?


Stanford Doctors Spotlight Fatal Flaw In Multiple Sclerosis Drug Trial
05 Mar 2006

When Anita Louise Smith enrolled in an experimental drug trial in 2002 in Colorado, she had a diagnosis of multiple sclerosis but no symptoms and was looking to reduce the chances of being ravaged by the disease. Last year, she died at the age of 46 from an infection linked to the drug.

This tragedy - recounted in an article in the March 4 issue of The Lancet by two Stanford University School of Medicine neurologists - serves as a telling case study of what can go wrong in clinical trials. In their article, Annette Langer-Gould, MD, and Lawrence Steinman, MD, warn of the pitfalls of testing a drug with unknown side effects in patients who would do fine without the drug.

The drug in question is natalizumab, which has the brand name of Tysabri. In November 2004, the U.S. Food and Drug Administration fast-tracked its approval for use in multiple sclerosis patients following promising results seen early in two clinical trials. But within months of the approval, some patients taking the drug had developed a rare infection - progressive multifocal leukoencephalopathy, or PML - and Smith and one other patient had died.

Langer-Gould, a clinical instructor in neurology, treated a patient who was part of the clinical trial and developed PML after taking Tysabri; the patient survived. But that experience, coupled with an examination of Smith's case, prompted Langer-Gould to approach Steinman about writing an article that would examine the appropriateness of testing a drug on people with no evidence of the disease and who are not disabled at the time of the trial.

"We are arguing that people with no disability should probably not enter into a clinical trial or be recruited into clinical trials, because where is the potential benefit to them if nothing is wrong?" said Steinman, professor of neurology and neurological sciences and of pediatrics.

"This situation represents a systemic problem," said Langer-Gould. "It is not just one company being a rogue, doing something out in left field."

Langer-Gould and Steinman argue that if a drug has a known risk of death, it should only be used on patients who are likely to suffer severe disability from the targeted disease - and for whom there are no other options. In other words, those who have tried all the other available therapies. That is almost the reverse of what happened in the Tysabri trial, which excluded the most severely affected patients.

"A big mistake was made in these trials that, in my opinion, is easily preventable," said Langer-Gould. "All they need to do is tighten up entry criteria into multiple sclerosis clinical trials and we could avoid similar types of problems in other trials."

Multiple sclerosis results when the immune system attacks the protective myelin sheath surrounding nerve cells, causing them to misfire and leading to loss of motor control and possibly paralysis. Tysabri appeared to block this effect and, after the first year of the two-year clinical trials, did not appear to cause more infections.

Steinman was involved early on in the development of the drug, publishing on its effects in 1992. Even then, he had suspicions that the drug's mechanism of action - blocking the entry of immune cells into the nervous system - might also make patients more vulnerable to infections. Indeed, PML is an infection that usually affects people whose immune systems are compromised.

"It was a shocking development that a drug that had so much promise and so many potential benefits ended up causing two deaths and one very serious injury," said Steinman. "It is kind of a cruel Greek drama, something that may be more beneficial than anything yet developed for multiple sclerosis, but yet may be far more dangerous than those other approved drugs."

The FDA withdrew Tysabri only three months after its approval. The FDA is now considering re-approving the drug. On March 7 and 8, an FDA advisory panel is meeting about the possibility of bringing back Tysabri as a single therapy (in the trials, it was combined with another drug).

"I predict it will come back with really hellacious warnings," said Steinman. "I think the right course would be to have it undergo more testing, but I don't think that is practical or fair to patients; they ought to have the opportunity to decide with their physicians if they are willing to take the one in a thousand risk of dying."

But Steinman and Langer-Gould expressed reservations about the drug returning to the market. They noted that its effects, while impressive, are in general not much better than what is seen with other available drugs: The risk of relapse dropped from an average of two relapses every three years using other approved multiple sclerosis drugs to one every three years with Tysabri.

"Do you want to expose someone to the risk of death for eliminating one relapse every three years?" said Steinman. "I say no."

"I'm not sure if it is wise to re-approve it," added Langer-Gould. "The question is, will the FDA rise to the occasion and admit their mistake and try to prevent future mistakes or are they going to ignore it?"

###

BROADCAST MEDIA CONTACT: M.A. Malone at (650) 723-6912 (mamalone@stanford.edu)

Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu/

Contact: Mitzi Baker
mabaker@stanford.edu
Stanford University Medical Center

Article URL: http://www.medicalnewstoday.com/medi...p?newsid=38837
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Harry Z 12-15-2006 01:57 PM

Quote:

Originally Posted by gonnamakeit (Post 50051)
Is this the page you are looking for?

This is a good article but unfortunately not the one we are looking for. The one we want quoted an actual trial doc who said that he had advised Biogen of his patient's PML on Feb 8 or 9 and that they hadn't acted on it until two weeks later. It's out there somewhere.....just a matter of finding it.

Thanks for your efforts though...they are much appreciated.

Harry

SallyC 12-15-2006 04:40 PM

In my search, I found this interesting report that seemed to have been swept under the rug by Biogen/Elan, in getting approval for the re-introduction of Tysabri.

The source link is at the bottom of this article. Some good stuff there.

Sally


September 02, 2005
Analyst Report Forecasts Some Choppy Waters for Return of Tysabri

FDA Adverse Event Reports Show Tysabri May Be Tied To Other Serious Side Effects
On August 29, 2005 The Wall Street Journal ("WSJ") reported that a list of adverse event reports made to the FDA related to the Tysabri included several rare infections, some of which were fatal, apart from the rare brain infection called progressive multifocal leukoencephalopathy.

Tysabri, a multiple-sclerosis drug, was withdrawn from the U.S. market on February 28, 2005 due to increasing concerns that Tysabri use could cause progressive multifocal leukoencephalopathy ("PML"). At that time, the companies responsible for Tysabri, Elan Corp. of Ireland and Biogen Idec Inc. of the U.S., said two patients with multiple sclerosis ("MS") taking Tysabri had contracted PML, with one patient dying from PML. The two companies later confirmed a second fatal case of PML in a patient using Tysabri to treat Crohn's disease, a gastrointestinal disorder.

The new WSJ article is based on information obtained through a Freedom of Information request made to the FDA by an pharmaceutical industry analyst at Morgan Stanley, Steven Harr. Following an analysis of the Tysabri data which he received from the FDA, Mr. Harr issued a report on August 25, 2005 describing some adverse event reports for Tysabri which showed a number of Tysabri patients had died of rare infections. "We're not trying to put a death knell on Tysabri, but there are signals in there that something's going on. It's important for patients and investors to know," Mr. Harr said in an interview.

A spokesman for Biogen immediately dismissed Mr. Harr's report, stating that Biogen and Elan had performed a detailed safety analysis of Tysabri. The companies' analysis, according to this spokesman, found no statistically significant differences between serious adverse events with patients given Tysabri and patients given a placebo in several clinical trials. "We have an enormous amount of information in our hands," the spokesman said. "The [FDA's adverse event reports] database is a limited tool."


According to the WSJ article, by staff reporter Sylvia Pagan Westphal:
The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosuppression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a rare infection of the central nervous system. Four other deaths were possibly caused by sepsis, an uncontrolled infection that spreads through the body. The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML."
Despite the problems that may be posed by these possible new side effects, Mr. Harr predicted that Tysabri has a good chance of returning to the market. In fact, Biogen and Elan said earlier in August 2005 that they hope to get the drug back on the market. The companies announced, then, that they had screened more than 2,000 MS sufferers who took Tysabri in clinical trials for signs of PML. According to the companies, the screening produced "no new confirmed cases" of PML.


Lars Ekman, executive vice president and president of research and development at Elan, had this comment:
Patient safety remains our top priority.... We are committed to finalizing the safety evaluation for Crohn's disease and rheumatoid arthritis, which is progressing well and on track to be completed by the end of the summer. We look forward to working with regulatory authorities to determine the path forward for Tysabri.
Given these new adverse event reports of other serious infections in Tysabri users other than the rare brain infection PML, there seems to some choppy waters ahead for Biogen and Elan as they try to get Tysabri back on the market.
(Posted by: Tom Lamb)

http://www.drug-injury.com/druginjurycom/side_effect_infections_necrotizing_fasciitis_sepsi s/index.html

BBS1951 12-15-2006 05:55 PM

That is pretty creepy :eek:

Harry Z 12-15-2006 08:28 PM

Sally,

I can remember reading this article back then and the typical Biogen reply in that there was no statistically significant difference between the Tysabri users and those on placebo. The question I had at the time was what the heck was in the placebo to cause those patients the number of infections that they ended up with?!!

Makes you wonder just how much "skewing" goes on in these trials!

Harry

SallyC 12-15-2006 11:52 PM

The thing that strikes me, is that PwMS are still not being told all the facts. It may be only 1 in 1000 fatalities due to PML, but there were 7 others who died from other infections, after being on Tysabri, and those deaths should certainly be in the count.:mad:

So Deaths attributed to T are approx. 3 in 1000 or 1 in 333. That changes the risk factor in a big way, IMO.:eek: There are also several who have suffer infections and are still surviving, including one with PML. This should also be part of the deciding factors, to use Tysabri.

There are severeal Neuros just not wanting to take the chance on T with their patients....Maybe they have considered the true statistics/risks here. I applaud their restraint, on behave of their patients.

Remember, this is not a cure and from what I've learned, doesn't just keep the bad T-cells from crossing the blood brain barrier, but also the good, leaving your immune system unable to fight off ANY infection, for some people.

Harry Z 12-16-2006 09:01 AM

Sally,

You hit the nail on the head when you said that the docs MUST tell their patients of ALL the risks if they want to try Tysabri. If after that is done and the patient still decides to go ahead with the drug, then that is the patient's perogative and right to do.

In my opinion, good marketing/advertising always trumps good science (in the short term, anyway) and there aren't too many pharmas better at it than Bigoen. Before Tysabri got approved the first time, you only had to follow how Biogen's marketing people hyped this drug, continually quoting the high numbers in both reduction of lesions and "risk" of disease progression over the placebo patients in the trials. The dangerous side of the drug was all but ignored and minimized when information about the infections surfaced. Heck, the press had to use the freedom of information act to obtain this detrimental data.

For sure, Tysabri is a drug were the users must be carefully and constantly monitored for these dangers. I just hope there aren't any more "surprises" with it as more and more MS patients start to try it.

Harry

BBS1951 12-16-2006 11:13 AM

There will be surprises of course. However, there will also be miraculous improvement. It is so hard to know where the balance is.

1942Linda 12-16-2006 03:53 PM

I can't wait to start....
 
my neuro got TOUCH certified last week and my MRI is tomorrow. after a 6 mo wait i see light at the end of a long dark tunnel at last....i have failed all the other drugs and take Tysabri willingly and with the hope that it will help.

the chance of problems exists, but my chance of deteriorating is far higher. if it helps me i will be thrilled. if it only stops progression, i will be satisfied. if it does neither, at least i will know that i tried.

at the moment sitting around doing nothing is not an option.

those of you who consistently criticize the drug companies are not going to change anything. take your arguments to them. this is a place for those of us who need these drugs to come and share.

i just hate the controversy it creates.

SallyC 12-16-2006 06:24 PM

Quote:

Originally Posted by 1942Linda (Post 50400)
my neuro got TOUCH certified last week and my MRI is tomorrow. after a 6 mo wait i see light at the end of a long dark tunnel at last....i have failed all the other drugs and take Tysabri willingly and with the hope that it will help.

the chance of problems exists, but my chance of deteriorating is far higher. if it helps me i will be thrilled. if it only stops progression, i will be satisfied. if it does neither, at least i will know that i tried.

at the moment sitting around doing nothing is not an option.

those of you who consistently criticize the drug companies are not going to change anything. take your arguments to them. this is a place for those of us who need these drugs to come and share.

i just hate the controversy it creates.

Hi, Linda.:) I appreciate your choice, especially since you seem to have all the facts. But, a lot of PwMS follow their Doc's advise without knowing all the possible dangers with this drug.

When we share about these matters, don't you think we should share the Pros as well as the Cons. I think a lot about my Family of PwMS here and do not like what I see, when the marketing tactics of Biogen, (In this case) are outweighing the the whole truth.

I was just as excited as everyone else, when Tysabri first came to market. I believed all the hype too and looked forward to trying it.

When it was pulled from market, I began to take a closer look and found out so much more that we not only were not told, but was actually withheld from public view by both Biogen and the FDA.

I still think that Tysabri has a potential to help PwMS, but some may pay the consequences and that scares me. Not for me, because I choose not to take a chance, but for those who may suffer in the future, from the possible side effects of T.

I wish you nothing but success with T, Linda. I truely hope its a miracle drug for you and others.

Please come back and let us know how it goes. I, for one, would be very pleased if none of my fears ever come to pass.

Hugs,

Harry Z 12-16-2006 08:21 PM

Linda,

Quote:

those of you who consistently criticize the drug companies are not going to change anything. take your arguments to them. this is a place for those of us who need these drugs to come and share.

i just hate the controversy it creates.
I think that most of us here know very well that we aren't going to change the way that big pharma operates. That's not what we are trying to do.

What we are doing is trying to inform the forum participants about all aspects of the MS drugs, Tysabri included. If one were to only read what the drug companies tell us, you would only ever get one side of the story and that would be the "everything is perfect" side. You only have to listen to the news every day to discover about all the problems that many drugs have caused in the past couple of years.

There is nothing better than being well informed and being able to make your decision of what medication to use based on as much knowledge as possible. Yes at times there is going to be controversy but that will always happen when you have differences of opinion.

Harry

1942Linda 12-17-2006 11:37 AM

I am not here to argue, so please don't misunderstand my point.

yes, we do need to be informed. that is our job as patients. the job of the drug companies is to try to find new drugs. pretty basic....we criticize them for that!!!

yes, they are profit oriented. what if they gave up on MS and worked on other diseases? then we'd really have ourselves in an uproar.

do you suppose they have Monday morning meetings to look at death statistics and profit reports.

I am informed and choose Tysabri. I want everybody to have choices about what they take.

this is NOT about the drug companies is it? if so, i'm in the wrong place. I thot it was about Tysabri and getting help.....I have PRMS and nowhere else to turn. I'm grateful it is now available.

only my opinion.

Pegshere 12-17-2006 12:57 PM

4th infusion
 
Hi there,, been keeping tabs on this thread,,, and some of the talk spooks me, since I am on the 4th infusion of Tysabri, but then I think, I didn't really have a choice in the matter,, since the other drugs didn't work on me,, so far so good, I am not here to sway people, everyone is different,, I hear people who felt "human" again after one infusion,, no not me, in fact of the matter, I think I get a little worse,, my bad days definetly out number the good ones,, but I am hanging in there tough,
I did take a leap of faith,,

I did have a hand and finger problem,{left hand} after my infusion,, they say MS related, { couldn't move either,, had a MRI, going to PT now} my therapist says it sounds like a TIA..

later then

Peg

SallyC 12-17-2006 12:59 PM

And your opinion is well taken, Linda. You're right, it's not about the drug companies, it's all about us and our care. I agree that we need these drug companies pushing for new meds for us.

Sometimes I am angry at why it takes so darn long for promising Meds to come to market. The process is so slow and we are not getting any better or any younger.

I only wish that they could come up with more natural remedies, to make us better, instead of all these chemicals, which compromise our Immune Systems.:eek:

The Scientists are coming up with new theories, about what causes our myelin to be attacked, every day, which could lead to new, more efficient Meds.

I am thankful when big pharma grabs onto these theories and goes forward with it. Their motivation makes no difference to me, but our FDA should insist on full side effect/dangers disclosure. I don't like it coming out in dribs and drabs after the fact.:rolleyes:

Good luck, Linda.

Harry Z 12-17-2006 12:59 PM

Linda,

Quote:

yes, we do need to be informed. that is our job as patients. the job of the drug companies is to try to find new drugs. pretty basic....we criticize them for that!!!
The job of drug companies is to discover and develop new drugs that will make them a lot of money....that's why they are in business. And there are a lot of good drug companies out there.

What we criticize here (and other MS forums) are drug companies that develop medications that haven't been thoroughly tested enough before being made available to the patients that will use them. Without going into detail, that is what happened to Tysabri when it was quickly approved, subsequently pulled from the market and then re-approved under some very strict conditions.

I don't think anyone is saying that patients shouldn't have the choice of using whatever drug they feel is right for them....as long as the patients have ALL the proper information before making that choice.

Quote:

yes, they are profit oriented. what if they gave up on MS and worked on other diseases? then we'd really have ourselves in an uproar.
Believe me that won't happen....as long as there is the possibility of making a lot of money from a MS drug, big pharma will always be around!

Quote:

I am informed and choose Tysabri. I want everybody to have choices about what they take.
And there is absolutely nothing wrong with that. But the vast majority of MS patients who choose to use Tysabri don't have the availability of obtaining this information like those who use the internet. If they made their decision solely based on what big pharma tells them or their docs, then that can be a problem. Do you think that Biogen would tell prospective customers that a number of patients died from infections during the trials? This kind of information had to be sought out and obtained by the press through the Freedom of Information Act. The lawyers of Anita Smith's family (patient that died from PML) had to go to court and force Biogen to make available the data of the trials so the lawyers could review the trial data! This is why we criticize Biogen and other drug companies who act like this.

Quote:

this is NOT about the drug companies is it? if so, i'm in the wrong place. I thot it was about Tysabri and getting help.....I have PRMS and nowhere else to turn. I'm grateful it is now available.
It's all part and parcel without the two being separated. You aren't in the wrong place..you are attempting to obtain info to perhaps help you make a decision on what medication to take. What most here are doing is providing you with as much information as possible and it is up to you to make that final decision.

Harry

SallyC 12-17-2006 01:12 PM

Quote:

Originally Posted by Harry Z (Post 50634)
It's all part and parcel without the two being separated. You aren't in the wrong place..you are attempting to obtain info to perhaps help you make a decision on what medication to take. What most here are doing is providing you with as much information as possible and it is up to you to make that final decision.

Harry

Exactly!

The "Devil's Advocate" is a rotten job, but someone has to do it..:D

SallyC 12-17-2006 01:24 PM

Quote:

Originally Posted by Pegshere (Post 50632)
Hi there,, been keeping tabs on this thread,,, and some of the talk spooks me, since I am on the 4th infusion of Tysabri, but then I think, I didn't really have a choice in the matter,, since the other drugs didn't work on me,, so far so good, I am not here to sway people, everyone is different,, I hear people who felt "human" again after one infusion,, no not me, in fact of the matter, I think I get a little worse,, my bad days definetly out number the good ones,, but I am hanging in there tough,
I did take a leap of faith,,

I did have a hand and finger problem,{left hand} after my infusion,, they say MS related, { couldn't move either,, had a MRI, going to PT now} my therapist says it sounds like a TIA..

later then

Peg

Hi Peg, I am so sorry that Ty doesn't seem to be working it's miracle on you....Damn.....:(

A TIA/small stroke? Wow! I hope not. My DH had many of those. Do you have any slurring of speech or shaking...left side weakness? Sometimes Neuros misDX TIAs when it is actually a MS exacerbation. That's how my DD was DX with MS. They thought, at the hospital that it was a small stroke and then she was DX with MS.

Thinking of you and hugging you tight through this set back...((((((((((Peg))))))))))

Harry Z 12-17-2006 02:56 PM

Peg,

None of us want to "spook" anyone when it comes to providing as much info as possible about Tysabri or any other MS medication. But when providing this information you have to provide as much as you can, whether it be good or "not so good". That's the only way a person can determine what decision is best for him/her.

I'm sorry to hear that the Tysabri doesn't appear to be helping you at this time. Perhaps a little more time may change things. Like all drugs for MS patients, some help and others don't. MS patients have reacted differently to medications out there for years and I doubt Tysabri will be any different. Let's hope things turn around for you soon.

Take care.

Harry

1942Linda 12-17-2006 03:22 PM

you win Harry
 
OK, I give up Harry. I've never seen a post of yours not jumping all over big drug companies and how evil they are. well, just who is going to do all the work and how are they going to test the drugs and get them approved? you tell us the alternative.

....and here i am in the very arguement I sought to avoid.....

the other drugs failed me, i need this drug. i am informed and make that choice to take what the big evil drug company has as the newest treatment.

what do you suggest i do otherwise???

i am open to suggestion. I shall check back after my MRI this afternoon.

Linda

wannabe 12-17-2006 09:39 PM

Peg - are you going to have another infusion? That's scary. Hope it's not related to the T. :(

I think medicine consumers NEED to be aware because when we hear that the FDA is under funded and has the same doctors on their payroll as are on the payrolls of the drug companies.. well, it feels like we NEED another watchdog. Sometimes that has to be us if we don't feel that anyone else is taking our best interests to heart.

The pharmaceutical companies aren't making our best interests as their #1 priority. Making money is. They didn't try to fast track Tysabri to get it to 'the people' faster, they did it to make money faster.

The bottom line is that pharmaceutical companies are in it for the money. WE are in it to get the best safest treatment for ourselves. Sometimes those objectives conflict. Sometimes the pharmaceutical companies are willing to take greater risks with our health in order to make a profit than we would be willing to take ourselves for a meager potential benefit. The risk-benefit analysis WE do versus the one the pharmaceutical companies do is totally different... ours doesn't involve profit. :) And with the concerns about the FDA, well... we have to be even more vigilant ourselves in assessing what the risks are versus what the REAL benefits might be.

Desperation skews ability to realistically assess benefits versus risks. After all, a theoretical risk of death is a LOT different than actually dying a very difficult, debilitating death from a medication. I don't know if we can really appreciate the risk when we can only think of it in terms of being theoretical. Especially when the probability of continued progression IS very real to us. I think the realness of the progression clouds our ability to properly assess what a theoretic risk of DYING really means. It may well be that if BOTH were theoretical, risk of dying from med versus risk of disability progression, our decisions might be very different because we could be unemotional about both decisions. After all, death is permanent, whereas disability just means life adjustments. Would someone risk ending their life in order to lessen disability progression?

I'm not saying that ANY life is better than death, but it's just hard to make an objective risk-benefit analysis when our emotions are involved with the very real experience of disability and disease progression. And since we experience disability progression, we become very emotional about it, just like the family of the dead woman who took Tysabri has a very emotional and overwhelming feeling about the risk of death not being worth it. It's all your perspective.

I am worried that our perspective can cloud our better judgment, which is very difficult to be objective about anyway since we have an emotional reaction to our PRESENT circumstances but cannot have the same level of reaction to dying from a medication, just because we don't have that experience. Given that the woman's family is suing the drug company, I'm thinking that when THEY went through the dying from Ty, they now in retrospect believe that it wasn't a risk worth taking. Maybe we should try to put ourselves in their shoes because they have a perspective very much valuable to our own risk-benefit analysis. It turns the theoretical risk of death closer to reality, and balancing THAT against an ACCURATE, REALISTIC assessment of what the drug might do is important. After all, it's not really the drug company that is giving us the accurate, realistic assessment of the drug's benefit. They are giving us the best possible view. And yet from our own learning, we discover that it's not that much better than the ABCR's, which really aren't very good at all.

So I appreciate the discussions because I want ALL information in order to help inform myself as much as possible. I WANT to hear about the people who are benefiting, and I want to hear from those who aren't or who get sicker. I don't want to make a decision based on the drug company's 'hype' but I want to have the cold hard facts and numbers. I want the WHOLE picture. It oftentimes takes an independent reviewer or fora like these to tease that information out.

Harry Z 12-17-2006 09:52 PM

Quote:

Originally Posted by 1942Linda (Post 50674)
OK, I give up Harry. I've never seen a post of yours not jumping all over big drug companies and how evil they are. well, just who is going to do all the work and how are they going to test the drugs and get them approved? you tell us the alternative.

Hey, wait a minute Linda...you obviously didn't read my previous post...

Quote:

And there are a lot of good drug companies out there.
Why is it that when someone points out the deficiencies of a drug company, it is calling them "evil"? There are good drug companies and "not so good" drug companies. I just happen to think that Biogen isn't in the "good" category and have given examples of why I have that opinion. Merck is another one that isn't on my favorite list because of how they hid the dangers of Vioxx and so is Parker Davis for how they deliberately and falsely misrepresented Neurontin. They did such a "snow job" on Neurontin that they are up on criminal charges for that fiasco.

I have nothing against a drug company developing a drug and bringing it to market...as long as they are ethical in how they do it. We know that not all of them are and usually they get caught and pay the price.


Quote:

.and here i am in the very argument I sought to avoid..
Why are you viewing this as an "argument"? We just happen to have a difference of opinion and are expressing our own views...geez, I'm not looking at this in a confrontational way at all.

Quote:

the other drugs failed me, i need this drug. i am informed and make that choice to take what the big evil drug company has as the newest treatment.
I am not in any way questioning your requirement to try Tysabri and have stated that. The drug is available and those who want to try it have the opportunity to do so as long as their doc follows the established rules. But the whole introduction of Tysabri could have been handled SO much better if Biogen had only followed the normal protocol. They didn't, rushed it, caused thousands of MS patients needless grief and are making its choice far more difficult now than was ever intended. That's why I don't have any respect for the company.

Harry

SallyC 12-17-2006 11:53 PM

Very well said, Wannabe.

Thank you for your post.:)

cjohnston 03-14-2008 03:17 PM

tysabri
 
Quote:

Originally Posted by msladyinca (Post 29562)
Been there, done that, and please don't roll your eyes at me or the published data (that borders on rudeness)..and I don't need to re-inform squat, you are more than welcome to believe whatever TRIAL guru opinions you want to, but if you start posting falsehoods, as in your ealier post, I won't hesitate to point them out for ALL to see.

Good evening to you.

Lauren

hey lauren

I am new to all of this, my doctor is giving me the choice of copaxon or tysabri. and i have no idea what to do, i dont know this drugs as i am/was on betaseron.

how is it going for you

thanks

msladyinca 03-14-2008 04:30 PM

Hi CJohnson,

Thank you so much for your comment...I don't post here very often as I never really received a very warm welcome nor much support with my Tysabri infusions as I was one of the first MS patients back on Tysabri therapy in 2006. Furthermore, much misinformation about Tysabri is posted on this site. Perhaps you will receive a better and more supportive reception here than I ever did.

I actually post on many other MS sites elsewhere on the web, where I am supported in my choice of therapy, and I support others with their choice of therapy. I am also co-owner of a MS Support Group on a different site. Don't get me wrong though, there are a few members here that are very nice and supportive.

In answer to your question, Tysabri has kept my MS stable and I have not had a relapse nor any disease progression in over 17 months. I am scheduled for my 19th Tysabri infusion next week, and I am looking forward to it very much. (Wooohooo!) I don't have any side effects whatsoever from Tysabri, and I love the convenience of an infusion once every 28 days.

Tysabri's superior efficacy of 67% in preventing further relapses, their accumulating disabilities, and slowing the disease process down far outweighs the efficacy of Copaxone which is 29%, plus you have to inject yourself daily with Copaxone and it takes approximately 6 months to a year for Copaxone to start working in the body, that's if it does work for you. To be fair, Copaxone does work great for some people. It didn't work for me though, nor did Avonex (which is an interferon [beta-1a], much like Betaseron is [beta-1b]).

Tysabri started working for me approximately 2 weeks after my very first infusion, and gives me hope for improvements each time I have been infusion.

Please feel free to visit my blog, which is also my Tysabri Diary... also, please feel free to contact me directly if you would like further Tysabri information which is accurate.

I support you in whichever medication you choose to fight your MS. Good luck to you, and all my best...

Lauren :)

tovaxin_lab_rat 03-14-2008 06:29 PM

Quote:

Originally Posted by msladyinca (Post 236963)
Hi CJohnson,


In answer to your question, Tysabri has kept my MS stable and I have not had a relapse nor any disease progression in over 17 months. I am scheduled for my 19th Tysabri infusion next week, and I am looking forward to it very much. (Wooohooo!) I don't have any side effects whatsoever from Tysabri, and I love the convenience of an infusion once every 28 days.

Tysabri's superior efficacy of 67% in preventing further relapses, their accumulating disabilities, and slowing the disease process down far outweighs the efficacy of Copaxone which is 29%, plus you have to inject yourself daily with Copaxone and it takes approximately 6 months to a year for Copaxone to start working in the body, that's if it does work for you. To be fair, Copaxone does work great for some people. It didn't work for me though, nor did Avonex (which is an interferon [beta-1a], much like Betaseron is [beta-1b]).

Tysabri started working for me approximately 2 weeks after my very first infusion, and gives me hope for improvements each time I have been infusion.

Please feel free to visit my blog, which is also my Tysabri Diary... also, please feel free to contact me directly if you would like further Tysabri information which is accurate.

I support you in whichever medication you choose to fight your MS. Good luck to you, and all my best...

Lauren :)

Welcome to Neurotalk Lauren. ;) Thanks for posting such good information and it's nice to see you!

Snoopy 03-14-2008 06:39 PM

Quote:

Originally Posted by msladyinca (Post 236963)
Hi CJohnson,

Thank you so much for your comment...I don't post here very often as I never really received a very warm welcome nor much support with my Tysabri infusions as I was one of the first MS patients back on Tysabri therapy in 2006. Furthermore, much misinformation about Tysabri is posted on this site. Perhaps you will receive a better and more supportive reception here than I ever did.

I actually post on many other MS sites elsewhere on the web, where I am supported in my choice of therapy, and I support others with their choice of therapy. I am also co-owner of a MS Support Group on a different site. Don't get me wrong though, there are a few members here that are very nice and supportive.

In answer to your question, Tysabri has kept my MS stable and I have not had a relapse nor any disease progression in over 17 months. I am scheduled for my 19th Tysabri infusion next week, and I am looking forward to it very much. (Wooohooo!) I don't have any side effects whatsoever from Tysabri, and I love the convenience of an infusion once every 28 days.

Tysabri's superior efficacy of 67% in preventing further relapses, their accumulating disabilities, and slowing the disease process down far outweighs the efficacy of Copaxone which is 29%, plus you have to inject yourself daily with Copaxone and it takes approximately 6 months to a year for Copaxone to start working in the body, that's if it does work for you. To be fair, Copaxone does work great for some people. It didn't work for me though, nor did Avonex (which is an interferon [beta-1a], much like Betaseron is [beta-1b]).

Tysabri started working for me approximately 2 weeks after my very first infusion, and gives me hope for improvements each time I have been infusion.

Please feel free to visit my blog, which is also my Tysabri Diary... also, please feel free to contact me directly if you would like further Tysabri information which is accurate.

I support you in whichever medication you choose to fight your MS. Good luck to you, and all my best...

Lauren :)


Hello Lauren, I'm glad you stopped in. Your more than welcome at NeuroTalk and have always been, at least in my opinion ;)

Curious 03-14-2008 06:48 PM

:Wave-Hello:hi lauren. lots has changed since you joined. you only posted a few times.

as you can see.....the ms forum has grown is a wonderful way. :D

as we know, not every drug works for everyone. but we would like all to post their experiences.

also, if you can post the links to the research data, that would be great. it really helps for all to have the sources, so they can make informed choices as to their own treatments.

i hope you give nt a second chance. i think it had been over a year since you posted.

Curious 03-14-2008 11:41 PM

btw...i just want to remind everyone....that this is an old thread that was bumped up by a new member to ask on original poster on the thread a question.


the last post that had been made was 12/06

we do have Tysabri Sticky thread to continue all discussions.

here is the link:

http://neurotalk.psychcentral.com/thread37891.html

SallyC 03-16-2008 09:20 PM

I would like it on record, that I never ever questioned Lauren on her choice of DMD, only her "facts" posts.

I am so happy that Tysabri seems to be helping Lauren and for all of you, it is helping. That has always been my wish for you in spite of all the misinfo, about Tysabri that has floated around out there.

Some may say that Tysabri advocates such as Lauren, take the opposite approach and want only the PRO news to be known and none of the Cons. :confused:

Thank you for posting, Lauren and I hope you will continue to do so and to enjoy all the great features of Neurotalk. :hug:

Victorya 03-16-2008 11:07 PM

Quote:

Originally Posted by msladyinca (Post 236963)
Hi CJohnson,

Thank you so much for your comment...I don't post here very often as I never really received a very warm welcome nor much support with my Tysabri infusions as I was one of the first MS patients back on Tysabri therapy in 2006. Furthermore, much misinformation about Tysabri is posted on this site. Perhaps you will receive a better and more supportive reception here than I ever did.

I actually post on many other MS sites elsewhere on the web, where I am supported in my choice of therapy, and I support others with their choice of therapy. I am also co-owner of a MS Support Group on a different site. Don't get me wrong though, there are a few members here that are very nice and supportive.

In answer to your question, Tysabri has kept my MS stable and I have not had a relapse nor any disease progression in over 17 months. I am scheduled for my 19th Tysabri infusion next week, and I am looking forward to it very much. (Wooohooo!) I don't have any side effects whatsoever from Tysabri, and I love the convenience of an infusion once every 28 days.

Tysabri's superior efficacy of 67% in preventing further relapses, their accumulating disabilities, and slowing the disease process down far outweighs the efficacy of Copaxone which is 29%, plus you have to inject yourself daily with Copaxone and it takes approximately 6 months to a year for Copaxone to start working in the body, that's if it does work for you. To be fair, Copaxone does work great for some people. It didn't work for me though, nor did Avonex (which is an interferon [beta-1a], much like Betaseron is [beta-1b]).

Tysabri started working for me approximately 2 weeks after my very first infusion, and gives me hope for improvements each time I have been infusion.

Please feel free to visit my blog, which is also my Tysabri Diary... also, please feel free to contact me directly if you would like further Tysabri information which is accurate.

I support you in whichever medication you choose to fight your MS. Good luck to you, and all my best...

Lauren :)


Hi Lauren,

If I'm not mistaken, you're from that "other" MS board??!! Welcome to NT.

Did I read this right? Have you had 19 infusions??? Glad to hear things are going well for you.

msladyinca 03-19-2008 05:35 PM

...19th Tysabri infusion report
 
Thank you everyone. I just finished my 19th Tysabri infusion and everything went fine. Even had my blood drawn afterwards to check my liver function enzymes which I have done every six months pursuant to my neurologist's instructions. I even have a six-month follow-up appointment with my neurologist tomorrow.

One of the infusion nurses at my infusion site mentioned to me that her sister is being tested for MS, and so far, it's looking like she's going to receive a confirmed diagnosis of MS very soon. She asked me many questions about Tysabri, and I gave her whatever information I had, as well as my opinions about Tysabri, and suggested that her sister discuss Tysabri with her neurologist.

It is dinnertime here, and I'm getting ready to have my regular treats: pizza and mudslides, then I'm off to bed after I do my physical therapy exercises. Life is good...,

Hope everyone is well, and stays well.

All my best, Lauren

PS: Victoria, I post on many different MS sites/forums, not just one other.


Riverwild 03-19-2008 06:06 PM

Quote:

Originally Posted by msladyinca (Post 240488)
Thank you everyone. I just finished my 19th Tysabri infusion and everything went fine. Even had my blood drawn afterwards to check my liver function enzymes which I have done every six months pursuant to my neurologist's instructions. I even have a six-month follow-up appointment with my neurologist tomorrow.

One of the infusion nurses at my infusion site mentioned to me that her sister is being tested for MS, and so far, it's looking like she's going to receive a confirmed diagnosis of MS very soon. She asked me many questions about Tysabri, and I gave her whatever information I had, as well as my opinions about Tysabri, and suggested that her sister discuss Tysabri with her neurologist.

It is dinnertime here, and I'm getting ready to have my regular treats: pizza and mudslides, then I'm off to bed after I do my physical therapy exercises. Life is good...,

Hope everyone is well, and stays well.

All my best, Lauren

PS: Victoria, I post on many different MS sites/forums, not just one other.

Hi Lauren!

Glad to hear # 19 went just fine! Have a mudslide on me and come on up to the Tysabri thread here under stickies and add your information!:) People need to hear it all!

Nancy

sheena 03-19-2008 07:50 PM

Hi Lauren, I'm so glad everything went well for you today. I knew it would! Mine went great yest with really no sides to speak of. Having a few problems, but thank God they started before the infusion so noone can blame TY. I love this drug. Thank You for everything ~Sheena~:hug:

DaDiva 04-01-2008 08:14 PM

Woowzaaaa!!!!!

I just read all of this Old Tysabri Stuff - Whatever works let's rejoice:D

I just had #19 yesterday and cannot say enough Good Stuff about Tysabri For Me and my MeSs - Again - For Me!!!!!

It has brought to me a New Life - A long time ago I had 1 infusion Feb 15 05 & I think it was the next day it was pulled from the market. At that point I had just turned 47 & had a whole life ahead of me. I had a New relationship & I was trying to live life as well as I could with a crap disease. I was and still not as disabled as some but I want My Life to be My Choice. I am still Not afraid of PML or whatever my come my way. I have had a wonderful Love Life that I would have missed out on had I not chose to take a risk on Ty :heartthrob:
MeSs is just a part of my Life these Days. It is Not who I am but it is a part of me - You all can argue all day long while I am out traveling, enjoying life, Having Great Sex:p and doing All of the Things that I would have missed out on if I was still shooting Avenox & hoping for the best.
I recently had a 3 tesla MRI of brain & spine and I have No New Lesions and everything Looks Great:D:D

I belong to a wonderful Ladies group. We have Lunch every other month. I also belong to a beading club. I play Bunco once a month and I'm going to 7 Feathers Casino next week. I went to a wine dinner a few weeks ago & had a Blast. I take cooking classes although I still hate to cook. My Honey is taking me to Santa Rosa for Vacation in May. We are going Salt Lake City in June. Just went back to the Bay Area to visit my son in Feb. I hosted Christmas at my home and enjoyed the Holidays with my Lovely Family.
There are more plans but not enough time to list all.......Sometimes I am too busy to do it all But the fact is that I am doing this stuff that 2 years ago were just good ideas but not really a reality in my Life.

I have a Life these Days that I was missing out on 2 years ago. Thanks to Tysabri I can enjoy these days...........Oh Yah - We have tickets to several concerts for this summer!!! I get front row seats since I am disabled. One of the perks - Parking and front row seats - Yipeeee for me!!!

I'm not saying Everyone should change their meds - Not at all - It's about having a CHOICE - My Choice!!!!!

Life is So Good these Days..........
Best Wishes to All
DD~


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