Dr. Hubbard's update on the FDA

[Cece]

from the Hubbard Foundation newsletter

Dr. Hubbard's Update on the FDA

On Wednesday 7/25/12 an FDA Fidld Office inspector met with one of our sites and told them verbally to discontinue enrolling subjects in the Hubbard Foundation Registry. The inspector said that they were aware the Hubbard Foundation had requested ID exemption and believed that new guidelines will be prepared by September. The Hubbard Foundation has still not received a direct response from the FDA. We are still confident there is no legitimate reason for the FDA to deny our request.

Asked to discontinue enrolling subjects. New guidelines by September. I don't think this affects patients who are currently a part of the registry? I hope that the FDA will be reasonable and allow this research to continue.

[1eye]

Maybe they think if they just close enough businesses the whole problem will quickly go away? Or if they can just get through to Labour day (or failing that, to election day) without anyone actually finding out anything, then it will be someone else's problem? Do they just want to outlaw some medical practices, or just any that are involved with CCSVI? And, we must ask again, if they're really trying to protect American citizens, why are they allowed to travel outside the US? Just confine them completely, to a jail cell, if necessary. In fact, why not have everyone with MS locked up? Sterilized also, so they can''t make any more bureaucrats any problems? Maybe Dole could sell us some pesticides?

Here in Canada, it's different. Similar, just a tad less American.

[Cece]

I had thought that Dr. Hubbard's registry might be left alone because it is a registry. The FDA covers prospective research, not retrospective research.

[NHE]

I had thought that Dr. Hubbard's registry might be left alone because it is a registry. The FDA covers prospective research, not retrospective research.

I think that the key word in the above quote is "enroll" which seems to state that they wish to prevent any new patients from joining the registry not eliminate the follow-up of prior patients already in the registry. It appears that they are methodically going out of their way to stop CCSVI treatment. However, more people have likely been harmed from drugs such as Tysabri and Novantrone yet that argument seems to fall on deaf ears plugged with pharmacash.

[Cece]

The Hubbard newsletter mentions that they should receive a response from the FDA by April 8th.

If procedures are still proceeding with or without the FDA approval on the registry, then the only thing a 'no' response accomplishes is the loss of the data.

[HappyPoet]

Hi Cece,

Iirc, the loss of patient data means the data cannot be used in a published study, but can you please clarify the first part of your sentence? Does this mean that Dr. Hubbard will continue to perform CCSVI procedures even if the FDA does not give its approval? Thx.

[Cece]

Hi Cece,

Iirc, the loss of patient data means the data cannot be used in a published study, but can you please clarify the first part of your sentence? Does this mean that Dr. Hubbard will continue to perform CCSVI procedures even if the FDA does not give its approval? Thx.

I thought Dr. Hubbard's patients were treated by Dr. Ponec and that Dr. Ponec would choose on his own whether or not to continue treating either way? Is he currently treating, quietly? The approval (or lack of approval) coming on the 8th is just for the registry.

Ok I reread my sentence and it was confusing. I meant that procedures are still proceeding by many different IRs, not just Dr. Ponec through the Hubbard Foundation but Dr. Arata, Dr. Sclafani, etc. If the FDA does not approve registry studies, then there are still procedures being performed (30,000 estimated thus far) with the data being lost.

[HappyPoet]

Thanks, Cece! Such a shame that so much data is lost.

[Cece]

latest update from their newsletter:

FDA Registry for MS CCSVI Treatment and Data Collection

News Update
The FDA is expected to respond September 3rd to our latest revision sent last month at which time we responded to their request regarding the use of stents by providing clear guidelines for their very limited use.

I would like to see the FDA let this happen!

[1eye]

How can they stop data collection, publication, even voluntary medical treatment? Are they threatening licenses too?

[Cece]

latest update, not good
https://www.dropbox.com/s/a44q0a4d5csvv ... -18-13.pdf

[David1949]

Here is what government has been doing:

-NSA is spying on phone calls and emails of millions of innocent Americans without a warrant- a violation of the 4th amendment.

-TSA is searching thousands of innocent American air travelers in very invasive ways, also without a warrant. They search people in wheelchairs, grandmothers, hot looking women and frightened children. To date they haven't caught any terrorists.

-Passed the NDAA act of 2012 which authorizes indefinite detention without trial of anyone suspected of involvement with terrorism including US citizens. That is in total violation of the 5th and 6th amendments. Under that act government can now say you're a terrorist and throw you in prison without presenting a single shred of evidence that you are guilty of anything, and without giving you the opportunity to proclaim your innocence to a jury.

-The president has claimed the authority to order the assassination of US citizens without any judicial or congressional authorization, and he's done it at least 4 times that we know of.

-Passed the Obamacare act which forces people to have health care insurance whether they want it or not. If you don't get it from your employer or medicare or medicaid then you have to buy it yourself and if you don't buy it you will have to pay an additional tax at income tax time. And BTW it has to be a government approved plan.

Does it surprise anyone that the FDA is not allowing Dr. Hubbard to continue the registry? Can you say tyranny? What the hell happened to the land of the free?

[Rogan]

Wow, thanks for posting this FDA notice of rejection.

The underlying assumption for this registry study is that variants of the jugular and or azygos veins contribute in some way to the pathology or symptomatology of MS. We have concerns about the correctness of this assumption, in light of the results of the recently published study, Traboulsee et al. (Lancet. 2013 Oct 8). In that study, subjects who had definite MS, were unaffected siblings of MS patients, or were healthy controls were prospectively assessed for CCSVI using Zamboni ultrasound criteria, venography criteria, and assessed for venous stenosis>50%. There was no difference between groups for any of the diagnostic criteria currently used for CCSVI. The lack of association between venous findings and MS was also seen in the recently published CoSMo study (Comi et al., Neurol Sci. Epub ahead of print 24 January 2013). In light of these finds, please provide a scientific rationale for performing venoplasty and/or stenting in patients with MS based on the inclusion criterion “50% stenosis or valve pathology [of jugular and/or azygos veins] identified at catheter venography.”

I would like to respond to this above.

For starters the Traboulsee study only looked at 142 people. Why shouldn’t the FDA be concerned that this study was not statistically large enough? Also the study did find stenosis in 74% of people with MS. Also this study was conducted in Canada. Why should a US regulator be concerned with foreign studies? Finally doesn’t the FDA know that if one person receives a full body MRI scan the doctors with find on average 3.8 concerns. We all have tons of problems in our bodies when one applies high tech imaging. The cadaver study in Cleveland noticed that many healthy people had stenosis in their neck veins. Some errors in our bodies will kill us, some don’t.

“please provide a scientific rationale for performing venoplasty and/or stenting in patients with MS based on the inclusion criterion”

This is a big circular debate. The Hubbards are trying to provide you with a stupid scientific rationale and you will not let them! The FDA can’t have it both ways. They say Ah, you are un-scientific, the Hubbards say fine we’ll make some observations regarding this treatment, then the FDA says no you are not scientific. The heart of science is observation. That is all they are trying to do.

Does there always need to be a scientific rationale? What happened to a clinical observable rationale? Does a doctor need to consult research when repairing a wound? The rationale is that venoplasty and/or stenting helps blood flow and brain profusion. This has been proven. BNAC study, Zamboni, Beggs, Haacke.

I’ll post more later regarding the statistical possibility that the three FDA agents, Samuel, Joyce, and Victor, may or may know someone with MS and the odds that they may or may not have clogged veins. Also I will post the stats on how likely they or their friends will survive if the take the MS Societies advice of “Studies show that early and ongoing treatment with an FDA approved therapy can reduce future disease activity and improve quality of life for many people with multiple sclerosis.”

I will then calculate the probability that these FDA regulators are biased because of payoffs.

I will then look into the legal relief one can pursue regarding this matter. This document is invaluable in that it starts to explains one’s rights in the face of the FDA.

Finally I pray for Victor and Joyces and Samuels health. Because if they or their loved ones come down with MS the only help available to them are FDA approved drugs. Because as we must know, what happens in your neck is irrelevant to what happens in your brain. And as we know we can give mice EAE and then cure it and get FDA approval.

[Rogan]

Ok, now I would like to respond to the FDA’s Disapproval Response item #2 regarding

“But did not substantively respond to our statistical recommendation” and “We continue to request that you please consider addressing these statistical concerns in order to improve the quality of evidence the proposed registry will be able to generate.”

Great the FDA want’s the stats. Here they are:

The power of a statistical test is the probability that the test will reject the false hypothesis.


Power nearly always depends on the following three factors:

1. the statistical significance criterion used in the test (statistical significance is a statistical assessment of whether observations reflect a pattern rather than just chance.)

2. the magnitude of the effect of interest in the population

3. the sample size used to detect the effect


So for starters let's lay out the data as we all know it.

People in the World With MS
2,500,000

People in the US with MS
400,000

People in the US on an FDA approved DMD
200,000

People in the World who have had PTA to unblock veins
3,0000

People who have been cured of MS
0

People who have been cured of MS using PTA therapy
9,000

So let us roughly test these constants for sensitivity

DMD Sensitivity to a cure
0/2500000

Sensitivity to a cure using PTA therapy.

9,000/3,0000

CONCLUSION
Infinitely greater sensitivity that PTA therapy for CCSVI helps MS more than an FDA approved DMD

Sensitivity to the word "May help" in drug literature regarding FDA approved DMD's

All

Sensitivity to the word "May help" in CCSVI literature

None

Sensitivity to the using a cane in x number of years
7 years with PPMS Unknown number of years after PTA treatment for CCSVI

Sensitivity to using a cane with RRMS
20 years Unknown number of years after PTA treatment for CCSVI

Next I will calculate the odds that these helpful FDA agents may or may not contract MS.

[1eye]

Where the FDA is involved, I don't think you can even characterize this debate as "scientific". Besides, the playing field may shift at any moment, for any reason. One is left in a situation where what the listener wants determines what will be considered, listened to, or heard. Dollars pollute the ground at every turn. My conclusion is that for anyone to be recognized in this enterprise of healing CCSVI, is almost a guarantee of the attention of undesirables, so talking about it on an Internet forum is likely to be a dangerous activity. Nothing against you others, for trying. Though there have been some battles won, perhaps it is better to leave this struggle to historians. Perhaps a loosely coupled network of enthusiasts with no forwarding address?

So I have of late taken an interest in tick bites. What could be a Darwinian explanation for this bite to be a vector of an individual, particular disease, to the exclusion, for the most part, of others? For that matter, why is the bite of one, specific kind of mosquito the one that propagates malaria? Why that tick, and why that mosquito?

It seems to be symbiotic, but what's in it or the tick? What's in it for the mosquito? Food, yes, but why not EBV, or Scarlet fever? Why not a mosquito for Lyme's or a tick for malaria? Dogs get bit, but do they get sick? And why only malaria, and why only Lymes?

These are things I am thinking more about, lately. I couldn't give an expletive about Traboulsee, or Buffalo, or any of that whole flap-doodle. I'm going to die. So what?