Hooch wrote:In all fairness Cece not as much had been published about using IVUS back in 2010 but I asked for it when I was treated by Dr Siskin in Sep. 2010, meaning we certainly knew about it here (from Dr Sclafani I believe). I was told that it was expensive and not necessary (I was disappointed) and I think it is still not used in his practice in Albany.
On a slightly different subject I believe that my husband was a control in the Ian Rodger's study at McMaster's in Hamilton. At the time we thought the study was being run by Dr Mark Haacke and it included MRI (not MRV) but I believe Dr Haacke didn't have anything to do with it in the end as when I spoke to him in Nov. 2011 he seemed to be surprised by my question. My husband has received no feedback and they said that would be the case unless they found anything abnormal.
It may be slightly different for me because of my citizenship. I believe it is part of the ethics of informed consent in a clinical trial, to give the patient access to as much information as possible, that has any conceivable relevance, as and when that information becomes available.
Consent and relevant information, I think, include changes to the design or changes to the personnel in a trial if they become necessary. I think they include any new information bearing on the trial's methods, current, planned, amended, etc. Also I think they include reasons for early termination. I would be surprised if they did not cover a subject's access to all the data collected about themselves, or about the patient's own health status, if new information about it is learned in the study.
Being informed does not end when the patient signs the consent form. It requires the active, ongoing, intentional participation of the investigator, to protect the human subjects.
Many scientists and doctors would consider continuing to use methods that are inferior to other, well-known ones, to be acting in bad faith. The patients may want to be informed of the existence of new improvements. Financial or other costs of new improvements may be worth the effort of changing a study's design. The practice of only comparing a treatment to placebo, and not to existing first-line treatments, is suspicious medicine to me.
The relationship of CCSVI with 'MS', and even its existence, in and out of the 'MS context, continue to be questioned. It is to be hoped this is not done intentionally, to confuse assessment of the PTA procedure's efficacy.
The principle of due diligence, in my belief, applies. The professionals involved have been adamant, in publicizing deaths that have any relation, even coincidental, to the proposed treatment. I think of this diligence as a debt owed to those who have died in the effort to improve the lot of their fellow "MS" sufferers.
That the study was already designed or planned, does not influence matters. When harm is a possible consequence, plans can and do change. In my opinion, they should also change when there is evidence of an improvement that can be reasonably applied, or an offer of assistance with improvements has been made. If standards are recommended by international consensus, many studies may be affected.
In this area, much contention has occurred. If the price of agreement with interested parties is unnecessary progression of the disease, is it too high?
There has been a marked lack of co-operation between some of the participants in this research.
I think we are still a long way from an inexpensive alternative to DMDs, steroids, and other existing treatments for 'MS', if only because of the momentum of their requisite revenue streams.