Two patients sue for harm caused by unproven MS

[coltgirl]

You'd think that after Tuskegee, cases like these would never happen again. Apparently, Michael Dake, a cardiovascular doctor at Stanford University, is being sued for performing experimental surgery on participants with and without MS (one of the plaintiffs never received a diagnosis of MS) outside of an approved clinical trial: http://eon.businesswire.com/news/eon/20 ... -Sclerosis

“The evidence we’ve gathered shows that Dr. Dake conducted unproven, high-risk procedures on his patients to address a hypothetical condition that numerous medical experts either questioned or did not believe existed,” said McGuinn. “Dr. Dake did not advise his patients of the fact that CCSVI was only a theory based on an unproven hypothesis or that there were significant and potentially life-threatening risks associated with the procedure he wanted to perform on them. In Mr. Zahn’s case, Dr. Dake implanted five stents into the neck of a man who did not even have multiple sclerosis and who had expressly asked the doctor not to do so.”

Dake also inserted four stents into Wittwer’s veins in 2009...Wittwer underwent two separate stenting surgeries. The stents have not improved his symptoms, and one has become completely blocked, or occluded, increasing his long-term health risks. The stents also cause chronic pain, sleeping problems, and lingering fear that others will become blocked or migrate to his heart – potentially fatal complications.

According to the complaint, Dake did not warn plaintiffs Zahn and Wittwer of the serious, life-threatening risks of his experiments. He also failed to tell them that stents are not approved by the Food and Drug Administration (FDA) to treat CCSVI.

And the following is just sickening:

Zahn repeatedly told Dake that he did not want stents. Nonetheless, during the procedure Dake increased the level of Zahn’s sedation until he was essentially unconscious, and then turned the planned 30-minute diagnostic venogram into a five-hour surgery, placing five stents in Zahn’s jugular and azygos veins.

IMO, this is what makes what Dake did so egregious.

I would like to know how Dake was able to find his unwitting participants. Did he pose as an MSer here or on facebook in order to troll for likely victims? Or did he place ads online? I know that Robert Trossel put an ad in a UK MS magazine offering unapproved stem cell treatments.

Wittwer and Zahn hope to stop this from happening again, and to help raise awareness so that other patients can make informed decisions about undergoing experimental procedures.

Wittwer and Zahn should be commended for speaking out against doctors who take advantage of vulnerable MSers. I hope that they get the justice they seek and so deserve.

[HarryZ]

Wittwer and Zahn should be commended for speaking out against doctors who take advantage of vulnerable MSers. I hope that they get the justice they seek and so deserve.

Remember, there are ALWAYS two sides to every story and I'm sure in this case, the same applies. That is why we have a justice system which will hopefully get to the truth.

Harry

[cheerleader]

coltgirl--these two gentleman and many others read my report of my husband's diagnosis and subsequent treatment at Stanford here on This Is MS in 2009. I brought Dr. Dake Zamboni's research. We knew he was not treating MS, but fixing venous malformations...which is what he does, and he is an expert in venous stenting. This was not part of a CCSVI clinical trial. It was diagnosis and treatment of venous malformations. These gentlemen sought out Dr. Dake themselves. They signed consent forms and waivers before treatment. The only way people are treated at Stanford is after signing release forms. They went there of their own free will. My husband is now 3.5 years past treatment, which worked for him--but he could have had an adverse effect. He took a risk, even signing a paper that listed death as a potential complication. He was awake and alert, and talked with Dr. Dake throughout his procedure. I am terribly sorry for those that were not helped, and those who had adverse events, but they sought this treatment out themselves, of their own free will. This press release tells one side of a very biased story, told from the viewpoint of a legal team. As Harry says, the real story is more complex. Do not judge.
cheer

[jimmylegs]

i'm actually very glad to hear that radeck is still with us. never knew his real-life name name back in the day.. i have wondered what became of him every now and then, ever since he stopped posting here at TIMS.

[HarryZ]

As Harry says, the real story is more complex. Do not judge.
cheer

Real stories almost always are more complex than what we initially read.

Stanford Medical Center has a world wide reputation and you can bet the two individuals had to sign all the appropriate documents before having the procedure done. But if the results are disappointing, some people feel they have a right to sue and claim damages. Arguing their situation on the internet isn't going to help their cause.

It makes you wonder about all the MS patients who used Tysabri and ended up with PML or other serious infections. Have they initiated similar damage actions against their docs and Biogen?

Harry

[Cece]

The stents also cause chronic pain, sleeping problems, and lingering fear that others will become blocked or migrate to his heart – potentially fatal complications

The fear of migration is an unnecessary fear after the stent has endothelized into the vein, which happens within weeks of the procedure. We've had people still worried about this over a year afterwards.

[HarryZ]

The stents also cause chronic pain, sleeping problems, and lingering fear that others will become blocked or migrate to his heart – potentially fatal complications

The fear of migration is an unnecessary fear after the stent has endothelized into the vein, which happens within weeks of the procedure. We've had people still worried about this over a year afterwards.

Interesting how conjecture seems to find its way around the internet without having to rely on scientific fact! Thanks for providing this info to counter the obvious incorrect fiction on the initial post.

Harry

[patientx]

The stents also cause chronic pain, sleeping problems, and lingering fear that others will become blocked or migrate to his heart – potentially fatal complications

The fear of migration is an unnecessary fear after the stent has endothelized into the vein, which happens within weeks of the procedure. We've had people still worried about this over a year afterwards.

Interesting how conjecture seems to find its way around the internet without having to rely on scientific fact! Thanks for providing this info to counter the obvious incorrect fiction on the initial post.

Harry

Really?

http://www.ncbi.nlm.nih.gov/pubmed/16005088

A 55-year old lady presented to the emergency department with progressive dyspnea and fatigue. One year before, she received two stents in the left iliac vein....
ECG showed atrial fibrillation and an transesophageal echocardiogram documented a severe tricuspid valve regurgitation and two stents in the right ventricle, one in the right ventricular outflow tract...

http://www.ncbi.nlm.nih.gov/pubmed/18503913

...culminating in asymptomatic delayed venous migration of a stent to the right atrium after 3 years. Open heart surgery was required to remove the embedded stent fragments...

http://journal.publications.chestnet.or ... id=1375885

...placement of two 7*37 and 7*27 stents that were placed on the venous side 5 years before presentation.
... Incidentally stent material was found in the left lower lobar pulmonary artery and in the right atrium extending to the right ventricle. The position of the stent was confirmed with a transesophageal echocardiogram.

[HarryZ]

I would imagine the various results of this kind of surgery are going to depend on who is doing the surgery. Good surgeon, good results. Not so good surgeon, not so good results.

Harry

[cervocuit]

In Jan 10, dr Franceschi, a worldwide renown angiologist, told me that what they were doing at Stanford (jugular veins stenting) was MADNESS.

[HarryZ]

In Jan 10, dr Franceschi, a worldwide renown angiologist, told me that what they were doing at Stanford (jugular veins stenting) was MADNESS.

Interesting take! Almost starting to sound like the various opinions in the wonderful world of MS medicine!!

Harry

[patientx]

I would imagine the various results of this kind of surgery are going to depend on who is doing the surgery. Good surgeon, good results. Not so good surgeon, not so good results.

Harry

You missed the point. These case studies show that stent migration beyond "weeks of the procedure" is not an unfounded nor "unnecessary" concern. The conjecture or "incorrect fiction" was in assuming this couldn't happen.

[HarryZ]

You missed the point. These case studies show that stent migration beyond "weeks of the procedure" is not an unfounded nor "unnecessary" concern. The conjecture or "incorrect fiction" was in assuming this couldn't happen.

No, I didn't miss the point. You can always get problems with any kind of surgery, regardless of what type it may be. Indicating that this kind of surgery is dangerous as opposed to normal risk is what my "incorrect fiction" comment referred to. And depending on the surgeon will make a difference as well. I'm guessing that if one looked at all the stents done in the past 10 years, the number of migrating stints would be less than the percentage of problems associated with patients using Tysabri.

[patientx]

You missed the point. These case studies show that stent migration beyond "weeks of the procedure" is not an unfounded nor "unnecessary" concern. The conjecture or "incorrect fiction" was in assuming this couldn't happen.

No, I didn't miss the point. You can always get problems with any kind of surgery, regardless of what type it may be. Indicating that this kind of surgery is dangerous as opposed to normal risk is what my "incorrect fiction" comment referred to. And depending on the surgeon will make a difference as well. I'm guessing that if one looked at all the stents done in the past 10 years, the number of migrating stints would be less than the percentage of problems associated with patients using Tysabri.

The fear of migration is an unnecessary fear after the stent has endothelized into the vein, which happens within weeks of the procedure.

Stating that stent migration cannot happen beyond a few weeks of implantation is wrong, as shown by past cases, and gives people bad information. I don't know why you can't see that, but it has nothing to do with Tysabri, You can guess all you want, but now who is dealing in conjecture?

And depending on the surgeon will make a difference as well.

Then you seem to be saying that people should avoid doctors who have had complications from implanting stents. If that's the case, this would include the subject of the original posting.

[HarryZ]

The fear of migration is an unnecessary fear after the stent has endothelized into the vein, which happens within weeks of the procedure.

Stating that stent migration cannot happen beyond a few weeks of implantation is wrong, as shown by past cases, and gives people bad information. I don't know why you can't see that, but it has nothing to do with Tysabri, You can guess all you want, but now who is dealing in conjecture?

Wait a minute, I didn't say that about the stents...someone else did. My comment was about the impression that stenting was a very dangerous procedure and the original message could be interpreted that migration took place more often than not. While any surgery can have risk and yes, migration could take place, it happens very little in this kind of operation. This is what my "fiction" comment came from and perhaps I should have used another word.

As for the Tysabri comment...you missed the point. I was comparing the risk of migration to the risk of ending up with PML or other infections...likely far less with the stenting procedure than by using Tysabri. Yet thousands of patients continue to use Tysabri just as hundreds of patients have stenting surgery.

And depending on the surgeon will make a difference as well.
Then you seem to be saying that people should avoid doctors who have had complications from implanting stents. If that's the case, this would include the subject of the original posting.

Having lived with a critical care nurse manager for 35 years, believe me there are great surgeons out there...and there are those who I wouldn't want to operate on my cat! If one is considering a stent operation,(or any kind of major surgery) one should look at the doc's record. It wouldn't take much to figure out the level of competency by seeing his/her results.