Lori's 2-Year Angioversary

A shout out to Lori and contratulations on your upcoming, St. Patty's day Angioplasty anniversary. What is really amazing here is the before and after pictures. Not only is Lori a much more dynamic being, she has lost weight, gained muscle and ATTITUDE! Well done, girl!

The MS Pharma Market

It looks like a big fight for marketshare is heating up in the MS drug market. And it looks like Novartis AG is positioning itself to get an upperhand on MS marketleader Biogen and MS oral wannabe, German-based Merck KGaA.

Gilenya from Novartis got FDA approval in September, 2010, making it the first oral drug for treating relapsing-remitting Multiple Sclerosis patients, aimed at reducing the number of relapses. A direct competitor to the market-leading drug Tysabri from Biogen, but it's a competitor with a difference. Gilenya is physically less hard to take, administered in tablet form, while Tysabri is an injectable. The price difference is quite substantial too although not on the side of Biogen: Gilenya wholesales at $48,000 per patient per year, while the cost of Tysabri is now around $42,800/year (I wasn't able to determine if this is a wholesale or street price - you tell me). 

Incidently, Tysabri has gone through two price hikes in the past 12 months - 18.7% in June, and 7% in January, making it 35% more expensive than it did 3 years ago. Perhaps the agressive price increase is a reaction to Gilenya's higher price point. Or maybe it's a reaction to the stagnation the drug is seeing in sales, stagnation that, in at least one report, is due to fear of developing progressive multifocal leukoencephalopathy (PML), the fatal brain disease developed by some Tysabri customers. In fact, this week, 6 more incidents of PML by Tysabri patients were reported, bringing the number of Tysabri customers suffering from that fatal brain disease to 85. 

So with a new kid on the block and stagnating sales, and the numbers of PML rising, could things get worse for Biogen?

Yes.

On January 20th, 2011, Biogen Idec got the dreaded news that their new MS drug, Fampyra, would not be given the right to market in Europe (although it's been on the market in the USA since January, 2010.) To make matters worse, at the same time they were refused, Novartis was given the go-ahead to market Gilenya in Europe. And despite a  pharmacovigilance plan attached to it's marketing authorization - perhaps due to the numerous side-effects of the drug - it looks like Novartis is on a roll and wants to be market king.

And then there's the lawsuit.

At the end of January, Novartis AG filed a complaint against Biogen Idec alleging that Tysabri infringes a 1997 diagnostic gene sequence patent. A source at Bloomberg tells me that Novartis wants a declaration that the companies have infringed the patent which would then entitle the company to damages or the very least leverage in a licensing dispute. The complaint doesn't say how much they're seeking in damages. Of the $4.7 billion worth of sales that Biogen Idec put through the cash register in 2010, 72% of those sales were because of Tysabri and older MS drug Avonex  

And we shouldn't forget about Merck KGaA. The German-based pharmaceutical company has developed cladribine - another oral pharmaceutical - but the FDA turned down their request because of safety concerns. Merck outlined the FDA's response in a press release and say they will respond to the FDA's concerns, but pointed out that the effectiveness of the tablets wasn't under the magnifying glass. Cladribine was given marketing approval in Austrialia and Russia in 2010 under the trade name Movectro.

Looking A Gift Horse In The Mouth

When is a gift actually a burden? Or when does a warm gesture actually give you a cold chill?

The Alberta Government has come forward with a big bundle of money to track the people with Multiple Sclerosis who have gone for CCSVI treatment out of country. A big bundle is the equivalent of $1,000,000 and, on first glance, I would get on my cowboy boots and start whooping "Yeehaw" and "Yahoo" and jump on the "round-em-up" wagontrail.

But if we look a little closer at this, if we take a look at the gift horse in the mouth, I wonder how this trial is going to pan out.

The University of Calgary, the University of Alberta and other experts will be partaking in this "observational study" to determine if the angioplasty treatments used to treat venous stenosis is actually safe and effective. 

A online database will be set up, and Albertans who have been treated for this procedure, or who expect to go away for this treatment - which is not available in Canada - will be encouraged to report their results over a three year period. At the end of the three year study, the Alberta Government supposes it will have enough information to determine if treating CCSVI has value, and determine if they will then proceed with clinical trials of their own.

From the outset, the Alberta Government and the Alberta Branch of the MS Society of Canada don't agree on the number of people they'll be enrolling in the study. The Alberta Government estimates that 30 Albertans have gone for the treatment. The MS Society estimates that number to be around 100. Irregardless, the first challenge for the researchers will be to track these people down and convince them to volunteer for the study.

And convincing them might be the most difficult part of their job. The people who have gone away have done so without support from their health care system, including the majority of their primary health care providers, their neurologists. Many began their journey by going out-of-province to private clinics to have the veins in their neck examined by Doppler and MRV scans, giving them the ammunition they felt they needed to make a treatment booking that would take them out of country. They've paid for all of this out of their own pockets or with the help of generous donations from others, with most venturing off to destinations they'd never imagined visiting, like Poland or India or Bulgaria, to countries that were foreign in everything from language to food to lifestyle.

And once back home, many have re-examined the position of their provincial government and the MS Society which they had been such a big part of, and questioned why these institutions have been so slow to embrace CCSVI when so many people in the province where they live are suffering from this disease. They started talking amongst themselves, and on social networking hubs like Facebook and started sharing their treatment stories - and not just about CCSVI - and began to collectively feel like pawns in a chess game designed by big pharma. 

And still they forged ahead, with protests designed to raise awareness, with letters to the provincial and federal Ministers of Health, to their MP's and MLA's, to the Premier, the Prime Minister, to the MS Society of Canada, demanding that the angioplasty treatment be allowed in Canada. They provided statistics, based on personal experience, of drug cost before treatment to drug cost after treatment to prove the financial benefit of supporting CCSVI. They've joined and started clubs to reach out and share their stories, experiences, address books and worries with others, in total honesty.

And now they'll be asked to contribute once again. I wonder how these jaded, former fundraisers will react when all they've seen to now is indecision and delays. And although we all know that the book hasn't been written yet on CCSVI best practices for either treatment or post-treatment care, we do know that enough people have been treated worldwide to glean a snapshot of the effectiveness of treating blocked jugular and/or azygous veins: all that would be required for that would be a fact-finding visit to Poland or Bulgaria to see their records. If the Alberta government had done that, the people who've been treated might have seen that as an olive branch and get in line to volunteer. As it stands, it looks like another delay tactic for another three year's of waiting.

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Referral Fees for CCSVI Treatments?

A clinic in Mexico is offering referral fees to people who recommend others to go to their clinic for CCSVI treatment.

It's an interesting approach to expanding your client base, and is a popular marketing technique, used in everything from car sales to buying wine online.

I'm a bit of a purist when it comes to my blog. I don't run any ads, I pay for the space out of my own pocket and I am not paid by any third party to write the things that I do. I write the stuff I do, gentle reader, because of some unexplained belief that in this world we live in, there isn't all that much room to make a real difference. And I have this tunnelvisioned belief that perhaps, with the things that I write, I can.

That's my position. But I'm pretty sure that if I started actively referring people to their clinic, I could start rolling in the dough.

Their referral structure is well thought out. Refer someone and you get $500 cash. If you would prefer to donate that $500 towards the person's treatment, your $500 is matched by another $500 from the clinic so the person you refer will save $1000 on their treatment. You get to decide if you win, or they win - or you can even split the amount you donate to the next patient, again with a match from the clinic.

Last week I spent a morning with Sandra Birrell on Skype. Sandra runs the UBC-CCSVI Facebook page and does an outstanding job of that, One of the many things we discussed is the dedication people have to their CCSVI doctors, and most believe that where ever they went, they made a good choice.

However dedicated they are, the concensus is you need to make your own choice. That can be done in a number of ways including your own research, word of mouth recommendations, the cost, the location --and availability.

I want to know what you think. Would discounts make difference to your treatment decisions?

CCSVI, Vein Integrity and The Way Forward

Folks are worried about stents. I would venture a guess that these worries are rooted from the stent migrations that were reported at the beginning of this year and were trounced on by the media, MS Societies and packs of neurologists as being yellow highlights as to why CCSVI shouldn't be treated before the research is done. In arguments from naysayers, stent migration is a topic that comes up time and time again - as well as the question of the integrity of the veins post-treatment.

I know people who have been stented. I know of one man who wasn't stented to begin with but returned a month later for the recommended stent. I know people who are worried about needing blood thinners afterwards. I know others who feel that stents aren't necessary.

Yesterday, I got a call from Gianfranco Campalani, an Italian cardiovascular surgeon living in Belfast who I've written about before. He called to fill me in on a conference that happened last weekend in Glasgow, organized by The Essential Health Clinic and the MS-CCSVI-UK branch. 

While telling me about the conference, I found out that Gianfranco traveled back down to his hometown of Ferrera this summer and was treated again, making it his third angioplasty treatment in three years. Gianfranco, as you may recall, has primary progressive Multiple Sclerosis. His first treatment was done by Paolo Zamboni's team three years ago. Last summer, he started having back and leg spasms again and convinced colleagues at the hospital he works at in Belfast to treat him there. They balloon angioplastied his right jugular at that time, but when he returned to Ferrera three months ago, they found his left jugular had restenosed. He says his outcome was fantastic.

I asked him if he was worried about the integrity of his veins with all that angioplasting going on. He says no. He told me that if he had to, he would get it done every six months. He also quipped a little aside that as a cardiac surgeon, he knows a thing or two about the integrity of venous structures.

The question of re-angioplasting, however, is a topic that he discussed with different members of the presenting panel at the CCSVI - The Way Forward conference. The panel comprised a who's who of CCSVI and included Poland's Marian Simka, E. Mark Haacke of MRV fame, Bulgaria's Ivo Petrov, Jordan's Mamoon Al-Omari as well as Chair Tom Gilhooly and Donald Reid of the Essential Health Clinic, who had performed the UK's first CCSVI treatments just days before.

What emerged from his discussions with them, as well as presentations from the panelists as told to me by Michele Findlay, stenting is a hot topic. There are talks about stents being developed with blood thinner releasers being built into them. There are talks about disolving stents and expandable stents. And then there's the position of the doctors themselves, who appear to be recommending stenting only as a last resort, not a first option.

As well, a variety of methods in angioplasting seems to be emerging. One of the doctors uses a slow, dual balloon method for expanding the veins, starting with a smaller balloon first and going to a larger balloon after. And there is a 24-hour method also being used, I believe in this is coming from Dr. Tariq Sinan from Kuwait, where the patient is monitored the day following the procedure to determine if the veins are showing appropriate fluidity and, if not, they are re-ballooned, thereby drastically reducing the short-term need for retreatment.

Other methods were discussed, including a cutter balloon which shreds the stenosed plaque upon impact. All in all, very exciting developments but developments, non-the-less, which need study to determine which methods work the best for the different barriers that are seen blocking the veins.

The bottom line is this: there have been over 3,000 people treated for CCSVI worldwide. About 7% of the patients seen don't appear to have any stenosis whatsoever. The discussion about the relationship between CCSVI and MS continues. Dr. Simka, for example, believes CCSVI is a factor in MS but not the only factor: diet, environment and genetics could also be contributing factors. 

I hope to get all the presentations from the conference in the next day or two and will try to report on those presentations then.

To see a series of slides from the presentation, click here.

Panelists at the CCSVI - The Way Forward Conference held in Glasgow, UK, October 30th, 2010. From left to right: Tom Gilhooly, Gianfranco Campalani, Ivo Petrov, Mark Haake, Marian Simka, Mamoon Al-Omari, Donald Reid.