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How to fund trials

Posted: Fri Dec 10, 2010 12:34 pm
by Rosegirl
What if radiologists (and other appropriate physicians) chose to fund CCSVI trials?

In the past, most MS trials have involved drugs and were funded by pharmaceutical companies. This was a logical business decision since those companies would profit by the success of the trial.

WHY IT WOULD HELP PATIENTS
Why not apply that same model to the testing and treatment of CCSVI by doctors and the clinics with which they are associated? Creating centers that could both diagnose and treat CCSVI would be extremely helpful for the patient population as well as facilitating the transfer of information between the various disciplines that will make future treatments even more effective.

THE ADVANTAGES FOR DOCTORS
Of course, the most obvious benefit is that this would enable physicians to offer potentially life-changing treatment to patients in a manner that would be both efficient and cost effective. We have already seen that our doctors are as awestruck and elated over the success of some procedures as are the patients they treat.

We should also be realistic in recognizing that there is a business component, and there is a vast, underserved customer base that is clamoring for service.

Let's assume that there are 400,000 MS patients in the US (some estimates are significantly higher). If only one percent of those people were treated annually, there is currently no clinic or group of doctors who could handle 4,000 patients! Capturing that population (and its revenue stream) would certain involve an investment in facilities, personnel, training and equipment. But the economies of scale would enable a clinic or multi-clinic practice to provide convenient, comprehensive care at a relatively small price, even as the effectiveness of the treatment is increased by the building of a patient data base that compares treatment methodologies to outcomes.

US physicians worry about desperate patients who use medical tourism services to locations that are too expensive for the patient to return for follow-up care. The response to that problem is to create regional centers that serve as magnet facilities that offer the additional transportation, housing and medical services required by patients with advanced disease.

As indicated above, some patients will restenose or require additional treatment. That adds to the revenue projections.

Further, although the MS population has embraced the concept of CCSVI treatment, there is also speculation that there are other chronic conditions that might also be related to, and treated by, similar procedures.

The proposal above is obviously over-simplied, but it provides a service that potentially improves the life of the MS patient, rewards the physician with the satisfaction of healing and makes a very profitable business model.

Any comments?

Posted: Fri Dec 10, 2010 2:02 pm
by esta
far too logical..............

Not a formal trial but market demand

Posted: Fri Dec 10, 2010 2:44 pm
by MarkW
Hello Rosegirl,
The senario you describe is not a trial in the usual medical/pharmaceutical sense. There is market demand for balloon venoplasty (from pwMS with money or insurance) and vascular specialists will respond to this market demand. I would be surprised if thousands of balloon venoplasties were not performed in 2011 in the USA, driven by market demand.
I have not seen a trial design which is double blind placebo controlled trial for balloon venoplasty. My opinion is that it is impossible to design an ethical trial of this.

Kind regards,
MarkW

Re: How to fund trials

Posted: Fri Dec 10, 2010 2:56 pm
by bretzke
Rosegirl wrote:What if radiologists (and other appropriate physicians) chose to fund CCSVI trials?

edited for brevity....

The proposal above is obviously over-simplied, but it provides a service that potentially improves the life of the MS patient, rewards the physician with the satisfaction of healing and makes a very profitable business model.

Any comments?
Rosegirl-

Great thoughts.

There are quite a few clinics and CCSVI treatment centers popping up in the U.S. Folks are currently being tested, diagnosed and treated through self-funding or insurance coverage. Trials ARE being funded by patients.

As long as the docs share information and continue to improve testing and treatment, the CCSVI parade will march on.

Double-blinded studies don't make a lot of sense. Since pwms are very aggressive in seeking out alternative treatments, they are a lousy test group. One "test subject" may be on tysabri. Another may have tried bee stings, LDN or stem cell therapy. Others could be on a CRAB drug and use inclined bed therapy. Any "clean" studies would have to eliminate all these variables to get accurate results.

CCSVI is running under the radar in the U.S.. Canada has had great media coverage and folks are more aware, north of the border.

The genie is out of the bottle. CCSVI will be proven or debunked through nontraditional means.

Brian

Ethical trial

Posted: Fri Dec 10, 2010 3:07 pm
by Rosegirl
Mark

What makes trials done by drug companies more ethical?

Also, some trials are already underway, and in a relatively short period of time, at least some will be completed.

If you accept the premise that CCSVI will help a significant number of people, given the time it will take a facility to be set up and functional, this might be a very rational business plan. We know that current providers have, at least in some cases, a waiting list that has hundreds of people on it.

How will these people get treated in a timely fashion?

Posted: Fri Dec 10, 2010 5:38 pm
by cheerleader
There are already double blind placebo controlled clinical trials with sham procedures underway in the US (2 in Albany, 1 in Buffalo and one soon at Stanford.)

To view a video where Dr. Michael Dake and Dr. Manish Mehta discuss the necessity of these double blinded sham trials, as well as information on how to join a clinical trial, please visit:
www.ccsvi.org

CCSVI Alliance is working hard to make this happen in the US---you can support us in our efforts, and all donations are tax deductible in the US and heartily appreciated.
www.ccsvi.org

thanks,
cheer