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Prof. halts MS trial after fears

A cutting-edge vascular treatment program for multiple sclerosis (MS) at Stanford Medical School was terminated in December after some patients undergoing the therapy had complications.

Michael Dake, a Stanford professor of cardiovascular surgery, had surgically widened the internal jugular veins of select MS patients with stents, or mesh wire tubes. The procedure, called an angioplasty, attempted to fix a blockage limiting blood flow from the brain to the heart.

This insufficiency, termed CCSVI, was originally discovered by Dr. Paolo Zamboni, the director of the Vascular Diseases Center at the University of Ferrara in Italy. Zamboni hypothesized that the limited blood flow through the veins contributed to inflammation in the brain associated with MS.

MS patients who had angioplasties in Italy reported improved quality of life, leading to considerable excitement among members of the MS blog community. The wave of interest spread across the globe to Stanford, where Dake became the primary American doctor to perform the new surgery on MS patients.

Although the U.S. Food and Drug Administration (FDA) had not yet approved stents for this particular purpose, physicians have leeway in applying previously approved devices in new ways, according to the Stanford School of Medicine’s public affairs office. The office said Dake lawfully attempted the new surgery on MS patients — some 40 altogether, although the school would not confirm the exact number.

“Dake has used balloon angioplasty and stents in his practice of medicine, based on his knowledge of vascular insufficiency and of certain medical devices and his experience as a cardiovascular surgeon,” wrote Paul Costello, a spokesperson for the medical school, in an e-mail to The Daily.

Then one of Dake’s patients died of a brain hemorrhage on a flight back from visiting the doctor at Stanford. There is now a Facebook group in her memory attempting to raise money to aid further research into CCSVI therapy.

Another patient had to undergo emergency surgery, The Wall Street Journal reported.

In an e-mail to colleagues in December, Dake announced the termination of his angioplasty program until clinical trials could be secured.

“In the interval before our clinical protocol is approved by the appropriate regulatory agencies and necessary trial management infrastructure is secured, no further endovascular procedures including venograms, balloon angioplasty or stent placement will be performed for the evaluation or management of extracranial venous obstruction in any patients, with or without a diagnosis of Multiple Sclerosis,” he wrote. “I have made this decision after deep soul-searching.”

Stanford is now in the process of applying for grants and clearance to undertake a clinical trial of the therapy to begin late this year or early next year.

An advisory on the Department of Neurology’s Web site dissuades patients from pursuing the therapy at the moment.

“No, [the MS center does not recommend the procedure] at this time,” it said. “There is insufficient evidence of benefit, and possible risk.”

Costello confirmed that the University was no longer performing the procedures.

“The procedure is no longer taking place at Stanford awaiting a clinical trial,” Costello said.

It remains to be seen whether or not the FDA grants Stanford clearance for a clinical trial involving 100 patients in which neuroimaging could confirm whether or not vein blockage is actually a problem related to MS, and whether or not treatments like Dake’s and Zamboni’s could be effective.

  • RZ

    I am in favor of Dr. Dake continuing this work. The story of the patients WITHOUT complications needs to be included here. I am one of many who has regained function and has an improved quality of life because of the incredible knowledge of Dr. Dake. CCSVI is a new discovery, but without brave and caring doctors like Dake, we would not be moving forward and helping those of us battling MS. I would like to see another story outlining the incredible improvements in the patients Dr. Dake treated for CCSVI. Dake needs to be applauded for his courage and willingness to help those suffering from this awful disease.

  • dialed in

    I agree with RZ, where are all of the positive news stories that came from Dr Dake’s work on this? I’ve read many blogs, ect from some of the patients that were treated for this by Dr Dake and there are some amazingly positive results. A couple of his patients even claim to not have MS any more. He’s done more for MS patients in a few short months than the entire Stanford Neurology dept has been able to do since it’s establishment, so why even listen to the neuro’s? They are just protecting their funding by big pharma, Dr Dake is actually helping MS patients.

  • Genius

    I absolutely admire what Dr. Dake has done with MS patients. Buffalo University and other studies underway are showing a possible direct link between MS and CCSVI- this is exciting stuff and Stanford should support Dr. Dake in this endeavor. Some of the benefits that the treated patients are experiencing are just amazing. The current drugs for MS are not without risks, side effects and complications – case in point, Tysabri, with 40 plus PML cases and 11 deaths so far . . . We need to think outside the box to fight and hopefully cure MS.

  • Alan McGowan

    In amongst the repeated negative statements in this piece a number of things need to be said to restore a semblance of balance. Dr Dake has a great deal of experience in this area and is held in very high esteem by the many patients he has helped. His involvement in this area pre-dates Dr Zambonis first paper and I would not say he is in any way a follower of Zamboni’s but rather a valued colleague. He has himself greatly assisted in the development of both the theory and treatment of CCSVI and it’s links to MS. He is certainly one of the most experienced Drs. in the world in the effective treatment of CCSVI. Contrary to the last statement in this piece there is now little room for doubt that this treatment is both effective and in the majority of cases entirely safe. Although it is true that the Stanford MS centre (and many others) does not recommend this treatment. The number of people who have received diagnoses for CCSVI worldwide must be over 1000 by now yet there is no recommendation for treatment of any sort! Clearly research to determine the best and safest form of the treatment is urgently needed. I am confident that this is precisely what Dr. Dake now intends to do. In my view, and many other MS sufferers he deserves to be commmended for the excellent work he has done in relation to CCSVI not vilified.

  • BC

    I am also one of Dr. Dake’s patients. I hope for nothing more than this work to be continued. Dr. Dake’s care has given me my life back. Thank the heavens for Dr. Dake! I am in complete agreement with RZ! If you really want a great story, contact us, the ones that have gained so much from this. If you heard our stories of the improvements in our minds and bodies you would want to help us fight for this work to be continued and supported, for the hundreds of thousands of others with MS.

  • Joan Beal

    Please contact me for the rest of the story. The WSJ article was incomplete and biased. Dr. Dake had requested to remain off the record, and that promise was violated by the reporter. The reporter was referred to me- I am not a patient, but a patient advocate. I brought Dr. Zamboni’s research to Stanford last year, and Dr. Dake tested my husband. It was upon seeing his severe venous occlusion in both jugular veins (95% right and 80% left) that we discussed a treatment procedure. We did not come to Stanford asking for any treatment, we just wanted to see if Dr. Zamboni’s theory was applicable in my husband’s case. It was. My husband has recovered from crippling fatigue, which we now believe is due to venous insufficiency, rather than his MS. Dr. Dake was treating venous insufficiency, not my husband’s MS.

    Please, do your university the service of reporting the facts, not rumor and innuendo. Dr. Dake is a vascular surgeon, and my husband had a vascular disorder. Whether or not this ends his multiple sclerosis remains to be seen–but he is thankful for Dr. Dake, his knowledge and talent. Your university should be, too. I am available for comment and clarification– Joan Beal

  • MSDX

    I don’t think we can blame the media. Their goal is to go for sensational story, big eyes, gasps and outrage…

    However, let’s bring ALL the data on the table. Dr. Dake had many many successes as clearly attested to by his patients right here! Yes, there were tragedies, that is why the research needs to be done! Otherwise people would be jumping on the wagon WITHOUT the proper research, finding the doctors willing to perform and UNTESTED procedure which is never a good idea.

  • Ronals Husker

    You should take Joan Beal’s offer to give you the facts. I want to believe you are embarassed for the article you put out. The people who suffer from MS deserve better. As a journalist, you owe us a corrected factual report.

  • Silverbirch

    I fully support the works of Dr. Dake and hope that he continues in what he stared out to do. This is Medicine and finding solutions relating to the human body does not come with out its problems.
    This theory has teeth find it and show doubting Thomas.

    In the not so distant past organ transplants had their problems.
    Invention of penicillin also had its negative effects.
    Columbus had the whole world tell him he was wrong.

    MS center does not recommend the procedure – well this is funded by pharmaceutical companies; be wary of the smiling serpent.

    The success stories of patient’s world wide need to be accounted for.

    FDA please support Stanford the world is watching guide and support this great man.

    Good will come of this.

    Kindest regards

  • George Bell, Sydney, Australia

    I support Dr Dake’s initiative. The neurologists are having a “head in the sand” attitude to CCSVI. While they are dragging their feet, the newly diagnosed MS patients have to suffer damage to their CNS unnecessarily because they have not been told about CCSVI and the possibility to correct this venous problem through angioplasty. Early intervention would help these individauls to lead a normal life.

  • Amazed

    You people honestly feel the author should be embarrassed for only reporting the truth or that the author should have done a better job of reporting the “facts”?

    It’s not hard to tell that these comments were intentionally solicited from a fringe group http://www.thisisms.com/ftopicp-101810.html#101810 who is convinced, without supporting evidence, that venous occlusions are the cause of Multiple Sclerosis and its symptoms.

  • Joan Beal

    Our “fringe” group–which is merely noting the ever-mounting evidence of venous insufficiency in MS and requesting further research– now includes Georgetown University and Jacobs Neurological Institute-where neurologists and vascular departments are working together. There are also university and private practice vascular doctors around the globe investigating CCSVI today. Here is a recent AP story from the New York Times:
    http://www.nytimes.com/aponline/2010/03/22/health/AP-US-MED-HealthBeat-MS-Bad-Veins.html
    Here is the first clinical trial: http://clinicaltrials.gov/ct2/show/NCT01089686?term=ccsvi&rank=1
    Please see Dr. Mark Haacke’s current research: http://www.ms-mri.com/
    Dr. Dake was one of the first to investigate this correlation, and we would hope that Stanford would encourage clinical trials and continued research at his institution.

  • Alan McGowan

    @Amazed

    I think you will find that the views expressed above are not based on feelings but on the evidence which these people have either personally witnessed or has been published at ThisIsMs. The fact that the comments were solicited explains the speed with which these comments appeared but not their content. Your assertion that their convictions are without supporting evidence is also wrong. There are dozens of citations of relevant research at ThisIsMs and these people have read them. Take Joan Beal up on her offer to supply you with more information. When you have dipped into the immense body of knowledge she has about this subject you may realise how unbalanced and misleading this piece is. Being an MS sufferer is a serious business. Articles like this effect my future; they should be fair and balanced. It is not a question of whether the statements made are true. The truths which have not been said are equally important. I agree it is important that trials should be safe. It is far more important that this research is not quashed and attacking the reputations of leading exponents is one way of furthering that. The other commonest way (as in this article) is to continually assert that CCSVI is not proven as a cause of MS and therefore no treatment is yet indicated. Neither Dr Dake nor Dr Zamboni have made this assertion. Nor do the posters above. CCSVI has been shown in about 1000 patients now who have MS synptoms. Those that have had this treated have probably passed 500 and the vast majority have shown great improvements. We accept that having CCSVI is not proven as the cause of MS. That is why research is needed. But I could also say that having a broken leg is not proven as the cause of MS. Is that justification for not treating the broken leg?

  • Randall Doser

    Percutaneous Transluminal Angioplasty (PTA) was first performed by Dr. Dotter in 1964 at Oregon Health Sciences University in Portland. This is not fringe medicine, but a safe and effective procedure that has been employed millions of times over the past 50 years. The only thing controversial here is the Neurological community’s willingness to sacrifice MS patients on the alter of their own intellectual pride. This whole situation reminds me of the movie Patch Adams. The are only two types of doctors: those that care about their patients, and those that pretend to. Dr. Dake has been thoroughly exposed as the former.

    Having MS is like watching your house burn down around you in slow motion. Neurology wants to turn off the fire hoses while they debate what caused the fire. How about we save my house and have your little debates afterward?

  • John Walters

    What no one has reported on and will never be able to measure, is the number of lives Dr Dake has actually saved, by providing hope to people facing a grim future.

    Remember, 20 of the 93 “suicides” Dr. Kevorkian “assisted” people with had MS.

  • RZ

    The intent of my thread (which Amazed has added to his comment) was to add the positive results from Dr. Dake’s patients to this article. No one is trying to convince anyone that CCSVI is the answer to MS. The studies need to be done and done quickly. Dr. Dake is admired in his field and admired as a man. I believe his successes need to be reported in addition to the complications for a more balanced report.

  • Amazed

    “The intent of my thread (which Amazed has added to his comment) was to add the positive results from Dr. Dake’s patients to this article.”

    The entirety of Dr Dakes “successes” are in the realm of subjective evidence. Not knowing how many registrants felt they were helped by the operation and how many felt they weren’t helped, with in mind that it is subjective evidence, how would you have the author describe the “successes”?

  • RZ

    I would have the author describe them as our experiences.

  • CF

    I am also one of Dr Dake’s patients and I am also much better. Our stories should also be told. Dr Dake is one of the finest Doctors I have ever met and I am proud to have the honor of being a stent patient.

  • HC

    They say a picture is worth a thousand words, so perhaps your next story can be be written after you have checked out a few of our MRV’s. When Dr. Dake showed me the images from my MRV, the problem was quite apparent even to my untrained eye.
    At this point, there are thousands of patients with MS in the US and abroad trying schedule MRV’s to determine whether or not they also have this veinous anomaly. Many of these patients are meeting resistance. Why? Is it because we are in uncharted waters?
    My kudos go to Dr. Dake for being the first doctor in the United States to be willing to simply look. He could have said that he had never heard of this before and shut the door, like countless others are currently doing. But, he did not. He listened, he looked, and he saw the problem. It was so simple and yet so profound.

  • Rose

    I am living and walking proof that the diagnosis and venous procedure Dr. Dake performed on me WORKED for me. I became permanently disabled with MS 10 years ago. MS has many symptoms and alot of us have some or all and they are different for everyone. The common thread is that MS ruins lives. Since I had my venous problems diagnosed and treated by Dr. Dake, I do not have one symptom of MS that I have suffered with for 10 years. I know it is a small study so far, but what I have experienced is a miracle. Dr. Dake is truly excited and as happy for my improvements as I am.
    He is a generous person and is as excited about the possibilites of CCSVI as us MSers are. Truly.
    He is one person we really want in our corner. Because he cares. The blood flow thru my brain is improved and I am MS Free. Now that I am out and about, friends are speechless when they see me. I took the horrible injections for years. I had a progressive year last year and chose CCSVI treatment when I read the studies. It made sense. And it worked. And I will be forever grateful for Dr. Dake and his talent that Liberated my life, my husband, my family and friends. MS attacks us all.
    Sincerely, Rose
    I would love for Stanford to see me now!! Dr. Dake has but I want the whole Neurology staff to see the results.

  • Lora

    Dear Julia Brownell,

    The facts you presented in your article were accurate enough and I felt the over all content of your report was not slanted in either direction, pro or con CCSVI.

    What I take issue with was your headline, your caption, was not accurate. I realize that journalist are taught to create captions that “grab” the reader, but the headline sets the “tone” and readers were set up to believe there was something more to the delaying of the procedures than just simply the delay until the proper clinical trials are in place.

    A more appropriate and neutral headline could have been, “Prof. delays performing promising treatment on MS patients with CCSVI until a clinical trial is in place”

    The inaccuracies in your headline were twofold as follows.

    1) “Prof. and fears” do not belong together in ANY sentence regarding Prof. Dake.
    2) “Halts MS Trials” is technically incorrect, as at the time, there was not a trial in progress.

    Multiple Sclerosis patients and advocates are determined to find answers to MS. There are billions of dollars available for the testing of pharmaceutical treatments and pitifully little funding left for non- pharmaceutical options. Negative reporting of this promising avenue of research is unconscionable, we need help in acquiring funding and where is there a better research facility than Stanford University ?

    I would hope from the response you’ve had to your first article on CCSVI and Joan Beal’s generous offer to provide you with up to date research into CCSVI, along with many of Dr. Dake’s prior patients offering to talk with you “on the record” that you might write another article stating these facts as clearly and neutrally as your first.

    Dr. Zamboni and Prof. Dake have never once said this is a cure for MS, they simply are finding venous problems in the vast majority of MS patients tested and Dr. Zamboni has put out a call for, research, research and more research into this correlation.
    The biggest hurdle to finding out the true correlation of MS & CCSVI through research is the lack of funding! Stating the facts accurately and unbiased is one of the best ways to achieve this goal, and MS patients everywhere will appreciate those efforts.

    Respectfully,
    Lora

  • RZ

    Thank you and I would be very happy to speak with you. For more information on the patients treated and my personal account (screen name magoo) go to http://www.thisisms.com/ftopict-8346.html. I look forward to your next article.

  • SammyJo

    Julia, thank you for taking another look at this – here’s my story http://healingpowernow.com
    I am a CCSVI patient of Dr Dake’s. He saved my life 10/29/09 with a procedure to open my jugulars which were both blocked. This is plainly a success to me from the reversal of symptoms I’m experiencing, AND from the research reported so far, AND the positive patient experience reports popping up around the world. I say to Stanford University, you should be leading the USA in CCSVI research, by supporting Dr Dake’s efforts. I was so thrilled to go to such a renowned medical institution as Stanford. Now I am shocked that you are missing such a big moment in history!

  • costumenational

    If it wasn’t for doctors like Dr Dake nothing would go forward in this world.

  • spiros

    This article is old news and noone should care. CCSVI is a reality and as always, thruth will shine.