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.

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The very high expectation Genzyme has for Campath, now known as Lemtrada.

We have been posting (see here and here) on Genzyme’s possible treatment for Multiple Sclerosis, Campath, or as it is now being marketed, Lemtrada. Campath is a drug used to treat certain types of cancer but now Genzyme is looking to sell it for the treatment of Multiple Sclerosis. They think they can reach around $3 billion in sales doing so as well.

To get an idea of how much money is already involved in the marketing of this drug, which still has not received FDA approval, I found an article at PR Week where it was reported, back in December of last year, that Genzyme had already engaged a PR firm, Cohn & Wolfe, to help in their “global pre-launch communications,” of the drug.

Genzyme has said that the drug could generate between $3 and $3.5 billion in annual sales by 2017. That is, simply, a lot of money for one drug. But, considering what the CEO of Genzyme, Henri Termeer said of the market for Multiple Sclerosis, they obviously have very high expectations for their drug:

Termeer also noted that the overall market for multiple sclerosis is $14 billion, and Genzyme executives said their research showed there is significant demand for new treatment options. Alemtuzumab, they said, is more effective, convenient, and easier for patients to tolerate than drugs now on the market.

We agree with Mr. Termeer that there is a very significant demand for new treatment options, especially ones that don’t just manage the disease (or cause other debilitating diseases in the process, see Tysabri and brain infection, PML), but ones that could actually cure the disease. It’s why so many people with MS are looking at the new liberation treatment for CCSVI with great hope. 

To get an idea, a glimpse if you will, of how much Genzyme (or Sanofi, if the take-over does succeed) will charge for their still unapproved Multiple Sclerosis treatment of Campath/Lemtrada, a little mathematics and some fact gathering is in order.

Remember, Campath/Lemtrada is still a relatively inexpensive drug, especially for the treatment of Multiple Sclerosis, since the amount of the drug used is much smaller than for the treatment of cancer. So for Genzyme to be touting the market in the billions, we wanted to get an idea of how much they think they can charge.

We’ll start here with the population of the United States. It is, roughly, 310 million people. One report has it at 307 million, while this from the Census Bureau has it at 311 million. We’ll use 310 million as a mid-range, easy-to-calculate number.

Of that number, roughly 400,000 people have been diagnosed with MS. No one really knows how many people have it, according to the National Institutes of Health. My number is being a bit generous, by about 50,000, to play it safe.

What I found is, based on my numbers, roughly, .1% (that is point one percent) of the population of the United States has Multiple Sclerosis.

Based on Mr. Termeer’s number of the Multiple Sclerosis market being around $14 billion globally (I am assuming globally here) then Genzyme hopes that this one drug will corner around 21% of the global Multiple Sclerosis market–$3 to $3.5 billion of a $14 billion market.

And it still has not been approved. And they’ve hired a PR firm to help in pre-launch communications. Are they this certain? There are high expectations for this one drug and it seems there are even higher expectations on the pricing of this drug.

How much does Genzyme have to charge to gain 21% of the market?

Genzyme will either have to corner a very large share of the Multiple Sclerosis market by 2017, unless a cure is found before then, or raise the sales price of the drug for Multiple Sclerosis patients to hit those numbers.

Campath now generates roughly $112 million in sales for Genzyme* (2008 sales figures) so to get to $3 billion, that would have to be, roughly, a 97% increase in price combined with a deep market reach.

But how many people have Multiple Sclerosis and more importantly how many people globally with MS have access to adequate health care? Who can afford this?

The numbers on those questions remain elusive. We think that Genzyme sees its billions coming from raising the price of this relatively inexpensive drug to the price shared by the drug, Gilenya (which was first synthesized in 1992 for use in organ transplants),which is the most expensive Multiple Sclerosis treatment available at $48,000 per year.

Already MS patients are seeing issues with getting their supply of this expensive drug. See the MS World.org forums here and here.

It would be more humane (if this drug does get FDA approval) for Genzyme to keep their expectations of achieving a $3 to $3.5 billion share of a market more in line with reality and with what people with Multiple Sclerosis have to go through–from a body that is leaving its sufferers frustrated and debilitated, to insurance issues like the ones you see here.

After all, spin and PR it any way you want, Genzyme (and Novartis, since Gilenya or Fingolimod is relatively cheap to synthesize), its investors and executives are hoping to make money as the Multiple Sclerosis market grows–betting more will be diagnosed and suffer its effects–and then more money will be made from a drug that is, after all, relatively inexpensive for the treatment of MS in the first place.

How much money is too much?

*I could only reach the cached version of the article I quoted. Here is the original link:
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=50472 It is a snapshot of the page as it appeared on Dec 29, 2010 23:18:07 GMT. The current page could have changed in the meantime

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.

Teva, maker of Copaxone, wants to keep it expensive, but at whose expense?

With the news that a generic version of Copaxone was possibly on the horizon, Teva, maker of the drug filed three Citizen Petitions with the FDA to block the approval of any new drug application that may result in a generic, and cheaper, version of Copaxone.

Taken from Teva’s website:

Teva Files Citizen Petition Surrounding Purported Generic Version of Copaxone®

Jerusalem, Israel, December 12, 2010 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that the company has filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of COPAXONE® (glatiramer acetate injection).

Teva’s requests in this CP are based on the inability to establish acceptable “sameness” of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence. Teva urges that any purported follow-on version of COPAXONE® undergo pre-clinical testing as well as full-scale clinical trials with measured clinical endpoints in multiple sclerosis (MS) patients to prove safety and efficacy.

Teva also requests that the FDA convene a multidisciplinary Advisory Committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.

Maybe in the interest of public health but more in the interest of Teva’s stock price. And in what we think is a sneaky way to keep the price of Copaxone high and out of generic hands and a lower cost, they also requested a new drug approval for a more concentrated injection of Copaxone. The FDA did not approve this, stating new clinical trials would be necessary. Of course, Teva is using that ruling as a means to keep a generic off the market. So what happened to their stock price? It climbed on the speculation that no generic would enter the market. Taken directly from Bloomberg.com on December 26, 2010:

Teva Pharmaceutical Industries Ltd. climbed the most in more than two weeks on speculation failure by the company to win U.S. approval for a new formulation of its multiple sclerosis drug Copaxone means it will be more difficult for competitors to enter the market.

The shares of the world’s largest maker of generic drugs increased 2.9 percent, the biggest gain since Dec. 9, to 187.70 shekels at the 4:30 p.m. close in Tel Aviv. The stock has lost 12 percent this year.

The two companies involved in the generic version of Copaxone are Novartis AG (maker of the $48,000 per year Gilenya) and Momenta Pharmaceuticals Inc.

Teva has sued to block both companies from making a copy of the drug. And Momenta, they are suing Teva for patent infringements. CAMBRIDGE, MA — December 2, 2010 — Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents.

And you with MS? You are still stuck with an expensive drug, with a mechanism of action that is not fully understood,while those out to make money from your disease, from pharmaceutical companies to investors the world over, have zero awareness of your lives and how it has been affected by MS.

Call us cynical but when we read where Teva settled for $169 million for misrepresenting their drug prices to Medicaid programs in our country, “The first settlement against Teva Pharmaceuticals was resolved last summer with Teva paying a 169 million dollars, more than 50 million of which went to Texas,” we have to take issue with a company who hid documents showing the true costs of their drugs so that they could take taxpayer money–your money. Their intentions have absolutely nothing to do with helping you with your disease and all the PR in the world can’t change that fact. You can find the articles here and here.

It’s time for a single payer system in our country and it’s time for Uncle Sam to step up and use his buying power to tame the health care industry beast.