Antegren implications

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Antegren implications

Postby bromley » Fri Oct 29, 2004 10:15 am

Dear all,

In a month's time we will hopfully know if Antegren has been given approval by the FDA. Let us assume that approval is given on the basis that it is more effective than the current CRAB drugs (why is it that the four CRAB drugs have the same effectiveness - I've seen estimates of 25-30% at reducing attacks - surely you would expect some variation?). I think it would be worth starting a discussion on what the implications might be if Antegren is approved. Hopefully, Antegren will be much more effective at reducing / preventing attacks - which will be good news for ms sufferers. But what might be the implications of this. One would imagine that if the effectiveness is much greater, that many would want to switch from the current CRAB treatments. There is also the attraction of a once monthly infusion rather than daily / weekly self injections. But what would the implications be for the existing CRAB treatments? One would assume that they would rapidly lose their market share. Would this be a good thing? What if the manufacturers of the CRAB treatments decided to withdraw their treaments because it was uneconomical to continue manufacturing them? It might, however, provide an impetus for these companies to invest more in more effective treatments - which would be a good thing. But what if Antegren gained a massive market share but in 2-3 years time it was shown to lose its effectivess? Also, how quickly would neuros allow their patients to move to Antegren - are there any ethical issues?

Some of the CRAB companies are investing in tablet based ms treatments - these would be more convenient, but would need to match the effectiveness of Antegren. Pressure would need to be kept on Antegren's manufacturers to keep improving their product - i.e the effectiveness of the treatment. Pressure might also come from treatments such as Campath and Aimspro (both mono-clonal antibody treatments - as I understand it). I think we are in for a very interesting 18 months with new treatments coming onto the market. Lets hope (and pray) that they really improve the lives of people with ms. I'd be interested to hear if others share my optimism (current).

On another issue, I recall reading an article that ms sufferers being treated for leukemia (spelling?) had shown an improvement in their ms - or at least their ms progression had stopped. Does anyone know if research is being done in this area? There must be an attraction for government health budgets - one-off treatments must be cheaper than long-term use of CRAB type treatments at $10,000 a year.

The primary objective of most ms charities is to find a cure for this disease. What would be the economic consequences (I'm not including MS suffers in this equation) - less work for neuros, no more ms nurses, less work for drug reps, less profit for drug companies, redundancies at ms charities, less profits for companies who make crutches, wheelchairs, chair-lifts etc. When you add it up we're keeping a mini-industry afloat. One could imagine the reaction at a drugs company if a junior scientist came in and said he'd found a one-pill cure for ms? On a postive note, it was reported today that a vaccine for cervical cancer (100% effective) could be available in three years. Why not for ms?



Best wishes - sorry for the long posting

Bromley
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Postby raven » Fri Oct 29, 2004 10:41 am

Hi Bromley
The pharma companies would argue that there is a difference between the effectiveness of the CRAB drugs. There are trials running at the moment examining Rebif vs Avonex. As these are both interferon beta-1b the difference will probably be slight.

Biogen are also running trials on Avonex + Antegren. I assume that these are to show an 'upgrade' pathway for existing Avonex users.

What happens to the other treatments if Antegren is shown to be much more effective? That's a commercial question. Like any other product they will have to either improve or fall by the wayside.

As far as your question on leukemia goes, Campath is a licensed treatment for leukemia which has been trialled for MS. BTW Antegren is also a monoclonal antibody.

Finally your comments about a 'mini industry'. It's a lot more than mini. Biogen are anticipating $10 Billion revenue from Antegren. Add up the costs of Doctors, research, nurses and all the other medications we take and the final figure would be staggering!

I'm not a conspiracy theorist but you have to wonder if a cheap and effective treatment were discovered, would the pharmas bury it?

Food for thought

Robin
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Postby magpie » Fri Oct 29, 2004 11:28 am

Hi Bromley

Pharama companies are under pressure to continually come up with new or slightly different drugs all the time. Each drug has to be patented and the patent runs out after 14 years. After this time any drug company can make generic substitutes of them and they can be marketed at much cheaper prices. Therefore there is a sort of cycle of new drugs coming onto the market all the time. For example you mentioned the fact that they are trying to make CRABS into a tablet form. Think about it, it's not just for the benefit of the patient, it will be a 'new' drug with a 14 year patent on it and therefore much more profitable when the patent has run out on the injectable CRABS drugs and there are cheaper generic substitutes around.

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Re: Antegren implications

Postby HarryZ » Sat Oct 30, 2004 4:55 pm

Bromley,

You have certainly asked a number of good questions to which there aren't any answers as yet. It will take a couple of years of Antegren use outside of the clinical atmosphere to see just how good this new drug may be.

At the moment I'll hold my judgment on Antegren but at the same time have doubts that it is going to be as good as Biogen has hyped it to be. This treatment is again based on the fact that MS is solely an autoimmune disease and that theory has really been questioned in the past couple of years. I believe that the initial cause is not autoimmune and it's later on in the disease that the immune system realizes that something is going on with the myelin and tries to erroneously fix it....causing more damage.

From the business side of things, Antegren could certainly shake things up a bit!

Harry
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Postby OddDuck » Sun Oct 31, 2004 5:03 am

I'm not a conspiracy theorist but you have to wonder if a cheap and effective treatment were discovered, would the pharmas bury it?


Hey, Robin! Well, I can tell you from DIRECT experience that you can't even get a pharma to LOOK at a cheap and probable effective treatment! But I'm still not giving up.

I have challenged them all (NMSS researchers, the pharmas, Vanderbilt (Sriram and Moses), David Hafler (Johns Hopkins), my previous neuro from the Mayo, etc. etc., to tell me that I'm full of it regarding my discovery regarding desipramine, which surprisingly, according to research done many times over many years, appears to do all that the CRABs do, plus does what Antegren does, plus has probable regenerative efficacy due to its affects on GAP 43 (axonal regrowth) and its prevention of DNA fragmentation; not to mention its neuroprotective affects. Can any of them say that I AM full of it? Nope..........not a one. As a matter of fact, the NMSS encouraged me to keep trying to get SOMEBODY out in the research field to look at it.

If you will notice, my former neuro (Mayo clinical researcher) could find no flaws, and the NMSS research panels could find no flaws. Problem is, and not ONE person can explain this to me, nobody will even so much as test it. AND it has even been shown lately that a TZD has beneficial effects for progressive MS, which desipramine's mechanisms of action are comparable to a TZD. It has a much broader spectrum of action than anything else to date.

So....I ask why? Constantly, I ask why. My push for a research trial isn't based on anectodal patient claims, it's based on hard-core laboratory and clinical research performed many times over many years, wherein the same results (as I compiled previously) were found over and over again.

BUT.............my suspicion as to why they won't even research it? It's CHEAP and an oral drug. That's why. But it is just sitting there, and could possibly (looking more and more like "probably") be helpful for progressive MS. At least in combination therapy, too.

Well, call me the "conspiracy theorist", also, then.

Deb

EDIT: P.S. And if it's proven helpful for MS? What then? Can you IMAGINE the economic backlash? And from a drug that's been around since the 60s? Oh....sure....they're gonna bury it, allright.
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Postby raven » Sun Oct 31, 2004 5:39 am

Deb,
I know exactly what you mean. I hear the word is that Antegren has an 80% - 90% lesion reduction efficacy. Impressive huh? The following is taken from NMSS clinical trial data...

Agent: Antibiotic therapy (minocycline) COMPLETED
Purpose of study: To control development of brain lesions
Possible mechanism: Inhibits matrix metalloproteinases
Study description: Open label, crossover
Dose/route: 100 mg bid po
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 10
Start date: October 2001
Observation period: 36 months
Investigators: L. Metz
Sites: University of Calgary, Alberta
Results/Publications: Gd lesions reduced by 84% in Rx (Abstract #S31.001, AAN 2003, Annals of
Neurology 2004 May;55(5):756)
Funding: Canadian Institute of Health Research
Last update: Summer/Fall 2004


Hmmm, 84% lesion reduction, oral and cheap! But I don't see any Neuros advocating it's use. Although Serono are now working on a non-antibiotic isomer of the tetracyclines. No doubt the isomer will be patentable and will be extremely expensive when it pops out of the trials.

Keep trying with your efforts to get Desipramine recognised. Along with those advocating LDN. Maybe one day someone will sit up and listen that there are alternatives out there that are at least as effective as the injectables, with less side effects and at greatly reduced cost.

Was that a flying pig I saw going past the window??? :(

Robin
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Postby OddDuck » Sun Oct 31, 2004 5:42 am

Robin,

:lol: Man, I hear ya!!

Deb
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Postby wilson » Sun Oct 31, 2004 6:05 am

Hi Raven/Robin

Can you point me to the study done in Canada concerning Minocycline?

I was taking the antibiotic for a month but discontinued because I noticed I was having some breathing difficulty at times when lying down. I went to see an Allergist and had several allergy tests done. All tests came back negative. He told me that it was highly unlikely that Minocycline is guilty of the breathing problems.

My allergist was very interested in my idea that I was taking Minocycline as a treatment for MS. I would like to forward these results to him. He may be able to help me in the future if he runs across an open-minded neuro. As you know, they are extremely hard to find.

Thanks
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Postby raven » Sun Oct 31, 2004 6:34 am

Hi Wilson
The link for the data is here:

http://www.nationalmssociety.org/pdf/research/clinicaltrials.pdf

It makes very interesting reading. Particularly noteworthy are the trials for which no results have been published. The implication being that the results were not what the sponsors of the trials were hoping to achieve so the results were withheld.

Regards
Robin
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Postby magpie » Sun Oct 31, 2004 11:24 pm

Why did you guys ignore my posting?

Pharma companies are not charitable organisations they want to make profits! Desipramine, Minocycline, Naltrexone, these are all drugs that are off patent. Why would a drug company want to carry out an expensive trial on a drug that was off patent and therefore very inexpensive? Not a profitable way to run a company.

Cures are not profitable. A DMD is far better. If a patient is prescribed a DMD, a drug company will have that business for 14 very profitable years.

I don't think there are any conspiracies going on just plain greed.

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Postby SarahLonglands » Mon Nov 01, 2004 2:39 am

Morning, Magpie,

You hit it right on the head with this one: it is just plain greed, nothing more and nothing less. Aventis are not even interested in getting roxithromycin registered in the UK for that reason: registration costs money and the drug will soon be out of patent if it isn't all ready. Actually it probably is, since it was developed by a much smaller French company which was then swallowed up by the big giant.

And it took a couple of months to squeeze this response out of them.

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Postby OddDuck » Mon Nov 01, 2004 3:53 am

Pharma companies are not charitable organisations they want to make profits!


Ok....here's a potential volatile question, then.

Why aren't the "charitable" organizations who say they ARE looking for any treatments that will help MS pushing for testing of these drugs? And they are using OUR money and contributions....directly. And yet we have no say in how/where it is spent? I don't know, it confuses me. But then again, where is the charitable organization that is looking for "pharmaceutical treatments and/or therapies", instead of a "cure". There's the difference. It's in the literal interpretation of the goal of the organization. I just realized that. ARE there any organizations who say or whose goal is strictly to find treatment options?

(I should start a non-profit whose sole goal in the meantime - while others are looking for a cure - is strictly testing out of patent or outside the mainstream pharmaceutical options for treatment/therapy. Ya know? There are enough organizations looking for a "cure", and that's wonderful, but in the meantime, all these possible treatments are ignored because we can't make a claim that they might "cure" MS? How many progressive MSers, for one, would be forever grateful for even some OPTIONS for possible treatment?)

And I can't believe that there wouldn't be a marketing "spin" a pharma could attach to a drug that is found to be helpful in MS, even if it's an old one out of patent. So, in the meantime, let's just waste millions testing drugs they KNOW won't work? As an example, they spent all that time and money testing Rolipram, when even "I" predicted and knew it was a waste of money! I mean, come on..........their own in vitro laboratory tests told them (and me) that much! Now THAT'S profitable! (?) Not to mention the millions they are spending testing and retesting the CRABS? For how many more years is THAT going to go on? Like you said, magpie, just until the patent runs out on them? Yep, that's a good way to invest or re-invest profits.

Naw...........I can't believe somebody can't spare a little time and/or money toward testing some of these other pharmaceuticals that may help. There would be money in it, allright. They just need to have a decent intelligent marketing person on their staff, is all.

Makes you wonder where the corporate marketing experts are these days, if that's what the problem is.

:? :(

Deb

EDIT: I guess it would take making noise through the media and/or utilizing political pressure (which is what I threatened to do before when I wasn't getting appropriate responses to my inquiries). That's what gets people's attention on just about anything, isn't it? Applying the "pressure".

SECOND EDIT: Oops, this got a little off-thread, didn't it? Sorry.
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Postby billf » Mon Nov 01, 2004 8:44 am

Seriously, how about somebody write a letter to the MS societies (US, British, Canadian, etc.) and ask them what they would do if a cure was found. Art, what will you do with the Boston Cure Project if a cure is found?
I'm afraid I've burned my bridges with the NMSS and they wouldn't give me the time of day if I wrote a letter. However, if no one else will do it, I will. We can't avoid sending such letters just because we think they won't respond honestly or at all. At the very least, someone will read it and think about it, and you never know what seeds will get planted as a result.
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Postby OddDuck » Mon Nov 01, 2004 9:40 am

Bill,

I'm still in a good relationship with the NMSS Headquarters in New York.

The thing is, what are we really asking? If a cure was found, the non-profit would either disband (and lots of people would lose their jobs) or they would need to refocus their resources on something besides finding a "cure" for MS. (Which there could be several options there.)

Frankly, I believe that the best that will be found is how to effectively manage MS, but not completely "cure" it. Similar to diabetes and other chronic conditions that just plain take lifelong therapeutic management.

That's where I see the largest gap right now in MS research. All the focus on finding a cure, and only the pharmas are trying to find ways to "treat" MS in the meantime. Frankly, I wouldn't mind having some other non-biased organization besides a "for profit" corporation trying to find ways to manage MS effectively.

Deb
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Postby Arron » Mon Nov 01, 2004 11:52 am

Just to quickly comment on this very interesting tangent that was brought up:

If a cure was found,

a) It would be the happiest day of most of our team's lives
b) We would change the direction of the site to become a resource for people diagnosed with MS and curious about how/what/when's of the cure(s)

To be realistic, it seems at this point that no single treatment will cure all types of MS (just as no single painkiller cures all types of headaches), so there will always be pros and cons, strategies and recourses.

And Deb, regarding your goals for an MS NPO and the role it could play-- we should talk... shoot me a PM
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