Multiple Sclerosis studies, especially about CCSVI, need to be done without ties to Big Pharma

A new article in the Annals of Neurology has made its way across various blogs and discussions about Multiple Sclerosis around the internet. It’s about CCSVI. And when we saw this article’s head line here, “Cerebrospinal Drainage Not Tied to Multiple Sclerosis,” along with the disclaimer:

Several of the researchers on this study disclosed financial relationships with pharmaceutical companies, including Pfizer, Sanofi-Aventis, and Merck-Serono.

Our first reaction was that any study that is to be done (especially one involving a treatment that could potentially make MS drugs a thing of the past)  the authors need to be free of any ties to pharmaceutical companies. The authors are:

1. Claudio Baracchini MD
2. Paola Perini MD
3. Massimiliano Calabrese MD
4. Francesco Causin MD
5. Francesca Rinaldi MD
6. Paolo Gallo MD, PhD

Here are the full conflicts of interest from the article:

C.B. has received compensation for being a board member, expert testimony, payment for development of educational presentations including service on speakers’ bureaus, and has had travel/accommodations expenses covered or reimbursed by Pfizer, Guidotti, Sanofi-Aventis, Novartis.

M.C. has been a member of the board of Merk-Serono, Sanofi-Aventis, and Bayer-Shering; a consultant for Merk-Serono and Sanofi-Aventis; given expert testimony for Biogen-Dompé Italy and Bayer-Shering; received honoraria from Merk-Serono, Sanofi-Aventis, and Bayer-Shering; and had travel/accommodations expenses covered or reimbursed by Biogen-Dompé Italy, Merk-Serono, Sanofi-Aventis, and Bayer-Shering.

P.G. has been a member of the board of Novartis, Biogen-Elan, Merk-Serono, Sanofi-Aventis, and Bayer-Shering; has been a consultant for Biogen-Elan, Sanofi-Aventis, and Bayer-Shering; has given expert testimony for Biogen-Dompé Italy, Sanofi-Aventis, and Merk-Serono; has received honoraria from Novartis Farma, Biogen-Elan, Sanofi-Aventis, Merk-Serono, and Bayer-Shering; and has had travel/accommodations expenses covered or reimbursed by University of Padova, Novartis Farma, Sanofi-Aventis, Biogen-Dompé Italy, Merk-Serono, and Bayer-Shering.

P.P. has received honoraria from Biogen-Dompé Italy, Sanofi-Aventis, and Merk-Serono; and has had travel/accommodations expenses covered or reimbursed by Sanofi-Aventis, Biogen-Dompé Italy, and Merk-Serono.

All of the above pharmaceuticals make Multiple Sclerosis drugs and have a large stake in those drugs. They cost a lot of money. See more about how much money here, here and here. And here as well.

This Foundation is not going to go into the details of the findings of the study. That is best left to experts in this field.

And as we find discussions on this study, we will post them here like the one at the MS blog on About.com. I threw in my two cents as well.

This Foundation just wants to point out the conflicts of interest to demonstrate that studies like these need to be done by those free and clear of the ties as shown above, like being members of the board of Pfizer, Sanofi and Merck. Seriously.

Much more information about CCSVI at The Reformed Multiple Sclerosis Society.

Biogen reports 6 new cases of PML with Tysabri

The article below is taken directly from Reuters.

If you are taking Tysabri, made by Biogen, we urge you to please go and speak with your doctors as the total number of deaths reported is now at 16, while 69 people remain in varying states of disability from PML–on top of having Multiple Sclerosis. More information on what PML is here at WebMd and here at Wikipedia.

Good source for all MS drugs is: Drugcompare.destinationrx.com.

More Tysabri information here, here and here.

Everything below is taken directly from Reuters.

Biogen reports 6 new cases of PML with Tysabri

(Reuters) – Biogen Idec Inc said six patients taking its multiple sclerosis drug Tysabri developed a potentially fatal brain infection in December, bringing the total number of such cases associated with the drug to 85.

The biotechnology company said that as of January 7, the overall incidence of progressive multifocal leukoecephalopathy, or PML, was 1.06 per 1,000 patients, up from 1.0 in 1,000 last year.

Biogen, which makes the drug with Irish drugmaker Elan Corp Plc, temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.

The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.

After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.

Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.

Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.

Biogen shares were down $2.02 or 2.9 percent to $66.76 in afternoon New York trading, while Elan shares were down 10 cents or 1.5 percent to $6.37.

(Reporting by Toni Clarke, editing by Gerald E. McCormick)

Keeping an eye on Tovaxin from Opexa Therapeutics.

Why are we keeping an eye on Tovaxin? Because Opexa seems to understand that not killing the patient is the best way to go about trying to treat Multiple Sclerosis. The only adverse effects reported in the clinical trials so far have been mild to moderate reactions at the site of injection. No one has died!

Although there was a random glitch with their trials in 2009, where the control group had a very low relapse rate and the treatment group a high relapse rate, the newest trials have been very positive:

The analysis produced encouraging results which showed that these patients, when treated with Tovaxin, had a 64% reduction in annualized relapse rate versus placebo (p=0.046, n=70). This statistically significant efficacy result, coupled with the superior safety profile of Tovaxin, was highlighted during the FDA meeting to emphasize what the Company believes to be a promising benefit-to-risk profile for Tovaxin.

Opexa Therapeutics announced that they are preparing to start the late-stage clinical trials for Tovaxin, a new MS drug that uses your own T-cells to make a “personalized T-cell vaccination for the treatment of MS.”

Let’s break this down into easy to understand terms about how a “personalized T-cell vaccination” would work. Taken directly from Opexa’s website is this graphic that explains the process:

The treatment will consist of donating blood and creating a vaccine using the patient’s own cells. The vaccine cells will be irradiated to render them unable to divide, but able to evoke an immune response. The vaccines will be administered in the doctor’s office as a subcutaneous injection in the arm given five times a year.

No brain melt as can happen with Tysabri. No compromised immune system, bradycardia or macular edema as can happen with Gilenya. Campath, not as yet approved by the FDA, has had deaths in their clinical trials.

What remains to be seen is the cost. Will Opexa go the way Novartis did and charge $48,000 per year? (and Gilenya is a pill) or will they find a way to satisfy themselves and their shareholders and charge a reasonable fee for what looks to be a very promising therapy? Time will tell.

You can read more useful information from those who were in the Tovaxin trials here, at the This Is MS Forums.

Analyzing Patient Assistance Programs for Multiple Sclerosis: AVONEX and AVONEX Services

As part of our continuing efforts to highlight all the patient assistance programs available through the pharmaceutical companies that make the disease modifying drugs for Multiple Sclerosis, we continue with AVONEX. The price of AVONEX is approximately $3,000 per month.

What we want to know about these programs is:

1. How easy is it to apply?
2. What is needed to apply?
3. How easy is it to receive the assistance?
4. Do they really work in terms of helping MS patients with financial assistance?
5. What is offered?

AVONEX offers a program called AVONEX Services that covers a co-pay program and an access program. The only way to apply to these programs is via a phone call to them at 1-800-456-2255. There is no online application. From the phone call I placed to AVONEX Services, it seems that a prelimary phone interview is the way to get things rolling, where certain information is taken from you and then turned over to their financial assistance team. You must have a prescription for AVONEX to begin the process.

If you have insurance and cannot meet your co-pay, their financial assistance team will do insurance research to see if you do have coverage for the drug. If you still cannot afford your co-pay, a 2nd screening is done by the AVONEX Services financial assistance team. Eligibility, I was told, is done on a case-by-case basis.

I did not receive a clear answer on what the qualifiers are for the programs and I have asked them to contact me further so I can post them here.

As far as being underinsured or uninsured, AVONEX Services offers something called their access program. Again, details remain sketchy but I came away from my conversation with AVONEX Services with these points:

• They do help those who are on government assistance.
• They do help both new and current AVONEX users.
• They do offer a temporary assistance program, of up to two (2) years, to get those who need AVONEX free of charge.

Beyond that, I am not certain on a few other issues. For example, it was said several times that “they partner with financial institutions,” to help you with payment. When asked what financial institutions they partner with, I was told that information comes from the financial assistance team. Again, it is unclear to me what that means.

Sending MS patients to charitable organizations to get their AVONEX was also mentioned, but that was it; it was mentioned with no further details. Why they would mention a program to send patients to charitable organizations when they have a program in place for up to two (2) years, leaves the overall impression of gaps within their patient assistance program. Again, I am waiting for more details from AVONEX.

I finally inquired about the Affordable Care Act and the impending six (6) month waiting period to apply for the new high risk pools and what, if anything, was Biogen doing about this. Are they prepared for this and would they be willing to begin a program that will get this group of people their drugs for free? I left my contact information and I await their response.

AVONEX is manufactured by Biogen Idec who also make Tysabri. Stock quote for Biogen can be found here.