FDA Issues Warning on CCSVI

[Billmeik]

Ya I think it's just a beaurocatic hurdle but I smell big brother. Maybe not but I think the pharmas should feel rattled. So much so that they make a few calls. throw a few hurdles.

[MarkW]

I am interested in this news, as NICE in the UK is encouraging 'robust controlled research'. Is there any evidence that pharma is behind this move ?? In the UK the anti CCSVI lobby is a neuro led group.
MarkW

[1eye]

The headline of this topic seems a bit premature. Also, just because some bureaucrat somewhere calls a PTA catheter a "significant risk device", whatever that is when it's at home, does not mean it is not safe enough to be used thousands of times a day in hospitals all over the world. If they object not to the device itself, but to the way it is proposed to be used in a specific trial, they should say so, be prepared to back up that assessment, and not hide behind some meaningless bafflegab. If someone forgot to dot some i's or cross t's in one application to one NIST trial, that does not mean science itself has been halted in it's tracks. I had not heard that the FDA had jurisdiction over what scientists can and cannot do, whether in mouse or human trials. What has a catheter got to do with either food or drugs?

[tiltawhirl]

Is there any evidence that pharma is behind this move ?? In the UK the anti CCSVI lobby is a neuro led group.MarkW

Imagine my shock!



tilt

[bestadmom]

It took one day for the NMSS to jump into the game and turn it around to benefit their biggest supporters - pharma and the neuros.

http://www.nationalmssociety.org/news/n ... x?nid=6354

[munchkin]

This was in The Winnipeg Free Press on line edition.

The U.S. Food and Drug Administration has issued a warning about the so-called 'liberation therapy,' a controversial procedure that proponents claim helps with the symptoms of multiple sclerosis.

The FDA is warning health-care professionals and patients that injuries and death have been associated with the use of the experimental procedure.

The therapy was devised by Italian physician Paolo Zamboni, who says MS is caused by vein blockages in the neck and upper chest that prevent blood from being drained from the brain.

He says opening these veins with balloon angioplasty reverses symptoms of MS; Zamboni calls the vein blockages chronic cerebrospinal venous insufficiency or CCSVI.

The FDA says studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

Scores of Canadians have travelled overseas to get the treatment; at least two Canadians are known to have died after undergoing the therapy.

Dr. William Maisel, the chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, says patients considering the treatment should discuss the pros and cons with a neurologist or other doctor familiar with MS and CCSVI.

In a release, the FDA says it has learned of adverse events experienced by people who have undergone the treatment, including death, stroke, detachment and migration of stents that are sometimes used to open the veins, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the procedure.

The agency says it is informing doctors and researchers that if they want to do clinical trials on CCSVI, they must comply with FDA regulations. Earlier this year the FDA sent a warning letter to a researcher and his or her sponsor after learning they were conducting a trial without FDA approval. The trial has since been stopped.

[David1949]

This was in The Winnipeg Free Press on line edition.

The FDA is warning health-care professionals and patients that injuries and death have been associated with the use of the experimental procedure.

OK FDA you warned us now shut up and get out of the way.

[1eye]

The FDA is warning health-care professionals and patients that injuries and death have been associated with the use of the experimental procedure.

It's gummint. Took them this long to figure out what happened in California in 2009? I am concerned that the powers that be are going to try to shut down Brad Wall's trial by remote control. Maybe he should move it to Poland? Or Mexico? You know, free countries.

"FDA Warns Doctors Tonsil Operations Lead To Sore Throats."

[Cece]

Here's the actual communication from FDA. I don't like it.
http://www.fda.gov/MedicalDevices/Safet ... 303318.htm
Among their recommendations:

Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).

If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.

Why is the FDA involved with this? Some of us continue our MS regimen and some do not. The choice to pursue CCSVI treatment and the choice to submit to ongoing medications with dangerous side effects are separate choices. I have discussed CCSVI with my neurologist and I believe that someone less informed on CCSVI than myself would be misled by some of the things my neurologist had to say.

Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins.

Are we promoting CCSVI treatment? Or are we sharing information, discussing research, and sharing our own experiences with the procedure, both good and bad? There is a difference there. The information shared here has been far more accurate than the information shared by my neurologist.

The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.

They are distinguishing between CCSVI and MS as separate entities, which is an often-lost important point.

[fiddler]

I've been away from TIM'S for most of this last year.. But this headline made me think I'd gone back two years in time since the same BS game was being played then, with the same falsehoods and arguments... Time for them to get a new scriptwriter. You'd think that with the billions backing the effort, they could do better than that.

It's now just over two years since my Polish adventure (ballooned both jugs, stent in left). Most of my improvements from that procedure have mostly held up: fatigue is still better than pre-liberation, my balance is still better, as is my autonomic functions. About 6 months ago I started to feel a little more tired and balance a little worse, so I had a second round in California two months ago. With that treatment (ballooning of rt jug and azygous, verifying that left jug stent is still fine), I saw no improvement... sometimes you win big, sometimes you don't.

Thirty months ago, at the rate I was going downhill, I expected to be in a wheelchair quite soon. We were thinking about all the things we were doing for the last time. We haven't talked about "last time" things since my first liberation. With my fatigue and balance still better than it was then, I still am able to walk. For me, this has been more than worth the FDA's "significant risk".

...Ted

[Squeakycat]

Here's the actual communication from FDA. I don't like it.
http://www.fda.gov/MedicalDevices/Safet ... 303318.htm
Among their recommendations:

Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).

If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.

Why is the FDA involved with this?

The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.

I wonder which neurologist(s) wrote the FDA press release?

• ITEM . . . . discuss the potential risks and benefits with a neurologist
  ITEM . . . . continue to follow the MS treatment plan outlined by your neurologist
  ITEM . . . . MS is a progressive, immune-mediated disorder of the brain and spinal cord

I may have been somewhat alarmist in titling this thread, but I smelled a rat and now the FDA has gone public.

In my experience, you can always count on the FDA to side with manufacturers over the public. Bet my last penny that the agency did not initiate this activity without a little push from manufacturers or their lackeys with an interest in keeping MS patients on drugs.

[bestadmom]

Hey Squeakycat,

It sounds like my neuro, Aaron Miller, the head neuro for the NMSS talking. The only thing missing was "You are going to die on the table."

[tiltawhirl]

Here's the actual communication from FDA. I don't like it.
http://www.fda.gov/MedicalDevices/Safet ... 303318.htm
Among their recommendations:

Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).

If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.

Why is the FDA involved with this?

The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.

I wonder which neurologist(s) wrote the FDA press release?

• ITEM . . . . discuss the potential risks and benefits with a neurologist
  ITEM . . . . continue to follow the MS treatment plan outlined by your neurologist
  ITEM . . . . MS is a progressive, immune-mediated disorder of the brain and spinal cord

I may have been somewhat alarmist in titling this thread, but I smelled a rat and now the FDA has gone public.

In my experience, you can always count on the FDA to side with manufacturers over the public. Bet my last penny that the agency did not initiate this activity without a little push from manufacturers or their lackeys with an interest in keeping MS patients on drugs.

That jumped out at me too. I didn't discuss this plan with my Neuro at all. It was almost like I was hiding it. Suuure I am going to go to him for his input when I know damn well he'll start with the bee stings drivel.

Hey Squeakycat,

It sounds like my neuro, Aaron Miller, the head neuro for the NMSS talking. The only thing missing was "You are going to die on the table."

This is utterly shocking, laugh out loud hilarious, and very sad all at the same time. Only a Neurologist would contrive such a collective CF of negative propaganda.


tilt

[Squeakycat]

Hey Squeakycat,

It sounds like my neuro, Aaron Miller, the head neuro for the NMSS talking. The only thing missing was "You are going to die on the table."

Bet they are drinking champagne tonight at the NMSS after this coup. (The bubbly was sent over by the MS Drug Manufacturers Association with a note that read, "Good Work!") :>)

They did say you are going to die, they just left out the bit about on the table.

Adverse Events: CCSVI procedures have been associated with serious, even fatal, complications. The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment. Other serious complications of the CCSVI procedure reported primarily as individual incidents or case series in medical journals include: at least one death, stents migrating from their original location to another part of the body (including the heart), venous injury, blood clots forming in the jugular vein or in stents, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding. The frequency of these serious complications is not known.

Yesterday when I saw what happened with Dr. Mehta, I smelled a rat. Today the sucker ran right out across the room waving this FDA Safety Communications.

Let's at least hope that the manufacturers and brainiologists provided some intensive care lubricant when they told the FDA to bend over. :>)

[Squeakycat]

http://www.sirweb.org/news/newsPDF/SIR_ ... _51012.pdf