This Is MS Multiple Sclerosis Community: Knowledge & Support

On January 27, there was a teleconference that originated from Philadelphia. It was called "A New Era in the Treatment of Multiple Sclerosis." It was networked to 24 other cities where other experts in the treatment of MS could listen in. The medical panel was paid for by Biogen/IDEC and the main topic was Tysabri. I certainly didn't participate in this 1 1/2 hour conference but an associate of mine did.

The lead doc went over the many different stats on the Affirm and Sentinel Tysabri trials as they compared to the placebo group.

There were two very interesting pieces of info on the trials. In the Sentinel trial, 15% of the participants had changed from either Rebif, Copaxone or Betaseron to Avonex so they could take part in this trial. That is something that I had not seen before.

The other was a question from the audience:

"Why does the placebo data with this drug look surprisingly like the drug data on the CRAB meds?" The answer..."We looked at all of the trials when designing this one and filtered out the outliers that skewed the data in the other trials."

Now I'm certainly no expert when it comes to understanding the process of clinical trials but this answer was interpreted by one MS professional as basically admitting to putting only potentially successful patients in your trial and not a random sampling of the population for whom you're developing this medication.

Now if this was the case, could this perhaps have played a major role in why the data for the trial showed such impressive figures?

I have no idea but am putting out the info for comment. The transcript of the entire teleconference is supposed to be available on the net within a month.

Harry

Harry,

<<this answer was interpreted by one MS professional as basically admitting to putting only potentially successful patients in your trial and not a random sampling of the population for whom you're developing this medication. >>

I'm not sure that I am correctly understanding the one MS professional's interpretation of the answer. Was his reference to "putting only potentially successful patients in your trial" addressed specifically to the placebo arm of the trial? Afterall, it was the similarity of the placebo data that the questionnaire from the audience was asking about.


Optimist

Optimist,



I believe the inference was the fact that the MS patients were carefully screened for the trial and that they excluded patients whom they thought wouldn't do very well.(Based on the data they obtained from all of the previous interferon trials) Generally, they choose patients at random from a particular group so that they get a fairly good cross-section of participants. According to what was said at this conference, that wasn't done! Supposedly a number of participants were quite surprised to hear this comment.

Hopefully when the full transcript of this conference is released, a better picture of what was said will be seen.

Harry

Harry,

Quote:
[ I believe the inference was the fact that the MS patients were carefully screened for the trial and that they excluded patients whom they thought wouldn't do very well.(Based on the data they obtained from all of the previous interferon trials]

To my way of thinking, that is a HUGH jump from the answer
..."We looked at all of the trials when designing this one and filtered out the outliers that skewed the data in the other trials", to the MS professional's interpretation... " that the MS patients were carefully screened for the trial and that they excluded patients whom they thought wouldn't do very well". I surely don't think you should use the word "fact" in referring to his interpretation as his interpretation is highly subjective and far from fact. To me it seems the interpreter had to be looking for a reason not to be impressed with the trial data and that is his right. I really hope all the Phase 111 data will be released to us soon.


Optimist

Harry, I agree with optimist, outliers could be on either side of the desired patient profile. The one time I interviewed to be part of a clinical trial I was turned down because my disease wasn't active enough. One would think I was the perfect patient as far as the drug company was concerned.

One other thing that Cherie got into in her thread over on mssucks is that 2 people died during the trials. Somehow I missed that news, to me that's a big deal even if the percentage of people who died is low. Still people died! I don't think that happened with the abcr drugs.

Peter

Peter,



They "could" be on either side of the desired profile but they could also be on "the" side you want the patient to be. I don't know and that's why I put the info of this conference up for comment. I got the one interpretation from Cherie and am waiting to hear from another person I know who has been through the clinical trial process.




Peter, I didn't receive the info from MS Sucks so I didn't know about the two people who died....first time I heard about that is now!! Without knowing it sounds like the patients may have had a terrible anaphylactic shock to the Tysabri which is very possible. This drug is a monoclonal antibody and there are a couple of other drugs in this category that are extremely dangerous. In fact, the FDA makes the manufacturer place what they call " a black box warning" on them because of how deadly they can be for the wrong person.

Yep, the faster they get the Phase III trial data out so all the "experts" can look at these trials, the better off everyone will be. So far almost everything that we get about Tysabri comes from Biogen and their reputation in the medical trial world isn't the greatest!

Harry

It's part of an ongoing thread that Cherie started and here's a little piece of what she wrote. ( with apologies to Cherie)

Yes the deaths were of patients in the trial, and directly related to the infusions (while the patients were receiving the infusion they coded, were attempted rescusitation and it failed). And yes, deaths in trials are not uncommon and may be considered "collateral damage".

This information came to me from a drug rep (Serono) so I called Biogen's local rep and she confirmed it. Then I called a physician who had participated in the trials. He also confirmed that there were two deaths reported but the information is in the year two data and has not yet been officially released.

Peter,

Thanks for that info. I realize that it may have been part of the two year data but when a patient dies from the infusion, I don't think one has to keep this info from the public because it isn't part of your one year data...unless of course, you are the company who is trying to ensure maximum revenue from a new drug!!

Interesting on how those two deaths may have been perceived as "part of the risk" in a trial. About 8 years ago my wife took part in a MS trial with a drug called TNF. This drug stopped and reversed the MS in that poor little mouse so the researchers were very excited about it. Marg was the first person in Canada to receive the drug or placebo. About one year later a man who was on the high dose of the drug, died. The trial was abruptly stopped and totally canceled. Marg was on the placebo!! Whew!!

Harry

Harry, I think I mentioned to you the trial I interviewed for. It was a trial for another monoclonal antibody with the catchy name "Anti-CD 154 Ligand. While they were recruiting for the phase II trial in ms a woman died in the phase II trial for Crohn's so that shut down the whole drug trial.

It's been 3 years now and they still haven't restarted the trial even though the head of the local ms center ( he's one of the researchers who came up with this drug) say's it will restart soon. He's been saying that for 2 years.

Peter

So if people died in the other trials and they were shut down, why wasn't Tysabri shut down and why is it released to the public?

Isn't there a way for them to do a mini-test (not the whole iV drip) to see if a person has an anaphalactic reaction before they infuse the whole thing and risk a crisis?

And no one died from the ABCR's, did they? I heard a couple people needed liver transplants, but did anyone die?

I echo Eric's question... if people died from Tysabri, why would they let the trials continue when in other trials even severe side effects immediately brought them to a close? e.g., Elan's Alzheimer's trial from years ago was stopped when some patients developed brain inflammation...

and to think the FDA approved it with only one-year data available in THIS political environment where they are under extreme fire for allowing dangerous drugs onto the market (e.g., Vioxx)... something is not adding up here.

_________________
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I agree that there's something missing in this story, it's hard to believe that the FDA would let the drug go on the market if there was a major problem. They have probably discovered through autopsy if there was a preexisting condition that led to the deaths. How that translates into denying people the drug if that have that condition I haven't a clue.

Peter

Peter,

That's all that we have heard so far is that two patients who were part of the trial, died after receiving a Tysabri infusion, supposedly going into anaphalactic shock. Beyond that we don't know any other detail because Biogen, to my knowledge, has certainly not published this information.

It certainly opens the door for a lot of questions. Perhaps some of the readers here who are Tysabri supporters and have provided us with a lot of information (all from Biogen BTW) can again obtain some details on these deaths and give us some facts that aren't known at this time.

Harry

I thought the risk of anaphylactic shock is in the first few infusions. Why would this only show up after one had been getting infusions for more than one year and thus in the two year data if it is indeed there?


Optimist