FDA advisory committee rejects Ablatherm application


In an entirely unsurprising result yesterday, an advisory committee to the U.S. Food and Drug Administration (FDA) voted very clearly against the approval of EDAP TMS’s Ablatherm technology for treatment of low-risk, localized prostate cancer using high-intensity focused ultrasound (HIFU).

As we had mentioned in an earlier set of comments, it was very clear prior to the advisory committee meeting that there were major flaws in the application submitted to the FDA by EDAP TMS, and one honestly has to wonder whether senior management at EDAP TMS had been listening seriously to anything they had been told by the FDA about this application.

Following relevant presentations by the company and by FDA reviewers, in addition to their own personal reviews of all of the relevant information, the members of the  Gastroenterology and Urology Devices Panel voted as follows:

  • On the question of whether the Ablatherm technology was sufficiently safe to warrant approval, 3/9 members voted yes; 5/9 voted no; and there was one abstention.
  • On the question of whether the Ablatherm technology was sufficiently effective in the proposed therapeutic use, 9/9 members voted no.
  • On the question of whether the risk/benefit ratio justified the use of the Ablatherm technology, 8/9 members voted no and there was one abstention.

Formal rejection by the FDA of the application by EDAP TMS for approval of this particular form of the Ablatherm technology is completely predictable after this type of advisory committee outcome. Whether Ablatherm will “get the message” and do better studies in order to seek approval of newer forms of the Ablatherm HIFU technology is unknown at this time, but it is extremely clear that the company hadn’t done any of the types of clinical trial that could reasonably be expected to be necessary to seek such an approval in the USA today; nor were the data that the company did submit even close to showing a compelling rationale for approval of this form of HIFU technology for the proposed use.

EDAP TMS issued a media release following the announcement of the result of the advisory committee hearing. Hopefully they (and others) will have learned that FDA approval of this type of new technology will require much more compelling data moving forward than has necessarily been the norm in the past.

We should be very clear, however, that it would be unwise to make decisions about the upcoming advisory committee assessment of the application for approval of SonaCare Medical’s HIFU technology based on EDAP TMS’s experience. There are some reasons to believe that SonaCare has made much greater efforts to comply with FDA requests for compelling clinical data on the effectiveness of SonaCare’s technology, and the SonaCare application is for the use of its Sonablate® 450 HIFU device as a form of salvage therapy in men who have progressive disease following first-line treatment with radiation therapy. In other words, even if the Sonablate 450 device is approved by the FDA, that approval will not include its use as a form of first-line treatment for men with localized prostate cancer.

29 Responses

  1. Thankfully, a responsible decision on this technology. The voting decision should be made clear in any website promoting this treatment. Given the high positive biopsy rate, it would seem unlikely that doing it as a second line therapy will offer a sufficient benefit either.

  2. Yes, I agree, one has to wonder why they even submitted an application, maybe for the advertising it would get from stories?

    $147 billion generated a year from the cancer industry certainly cannot be messed with, and that doesn’t count the monies given to cancer charities. Cheap ultrasound couldn’t possibly hold a candle to the money brought in by radiation, drugs, and surgery and especially with all the surgical/radiation failures having to be repeated

    I knew the clinical trials were not completed, as I knew two men who went to two of the hospitals who were conducting the trials and they were not told they had the option of entering the HIFU trials; clearly the hospitals had no intention of getting them completed. The only hospital which completed the trial was the one Dr. Scionti worked at. Dr. Scionti being a HIFU advocate/doctor.

    I realize that my antedotal experience with HIFU, being stellar, and now 6 years out means nothing.

    This news makes me reject the entire health industry in the U.S.A.; I’m sure I am not alone.

    But I do still hold out hope for the second line therapy, as I hear the results are 88% success.

  3. It is pretty obvious that EDAP screwed up from the beginning. They did not conduct clinical trials, and the FDA advisory committee report shows that EDAP attempted to use unvetted studies from Europe and comparative data for cryo to make their point. They didn’t.

    But to suggest that the HIFU technology is compromised by one company’s incompetence to follow FDA protocol is a little much.
    It might be prudent to wait to see the results of SonaCare’s FDA application since it appears they did follow FDA protocol, did have clinical trials, and we’ll soon see if they had proper statistical comparison for the registry for radiation salvage.

    I also continue to find it humorous that da Vinci robotic surgery, the du jour treatment in the US, never had to be FDA vetted, since they were able to suggest that this procedure was “an extension of a current treatment.” Priceless.

  4. Who suggested “that the HIFU technology is compromised by one company’s incompetence to follow FDA protocol”? I specifically stated that people should not make that implication!

  5. Who? Well, you can begin with Dr. Chodak’s multiple negative HIFU missives on Medscape or his comment here.

  6. Well you may not like it but Dr. Chodak is just as entitled to his opinion as you are (and certainly as Ron is), and I would point out that no company that I am aware of is now conducting trials that are liable to lead to an approval of HIFU as a first-line therapy for any stage or grade of prostate cancer in the near future.

    The Sonablate data may or may not demonstrate sufficient effectiveness and safety to allow for their technology to be approved as salvage therapy post-radiation. We shall see. However, the fact that Dr. Scionti has still not published any data from his series of 600+ patients absolutely horrifies me now, because no one can use as an excuse any longer the idea that publishing those data might in some way prejudice FDA approval of an application for Sonablate technology to be used as a first-line therapy.

    I have to tell you that to any neutral observer there has been a massive failure on the part of the French and the American HIFU industry to develop any type of compelling, data-based rationale for the clinical use of this technology in treatment of localized prostate cancer. By comparison, the Israeli company InSightec received approval of their ExAblate HIFU technology for treatment of uterine fibroids in 2004, for palliative treatment of bone metastases in 2012, and are now just starting to look at the potential for the use of this technology in treatment of earlier stage forms of prostate cancer. Whether they can gain such an indication in time is, of course, unknowable.

    Clearly gaining approval for the clinical use of HIFU has been far from impossible since the early 2000s … but it does require good data!

  7. I agree with what you said. But as carefully as I can put this, Dr. Chodak has used his credentials to write multiple missives on Medscape, read by many.

    He does not just write them as his “opinion,” as we can all see. In fact, he often writes as if his position is fact. He has been against HIFU from Day 1 and yet has never witnessed or performed HIFU … certainly validating your point that even though he is a retired physician, this is only his opinion.

  8. Jim:

    There are many columns like that of Dr. Chodak’s on the Medscape web site that deal with a wide variety of different topics. None of these are considered by the medical community to be anything other than opinions. Facts require data. The only “fact” available about HIFU to date has been a massive lack of good data. The lack of that data most certainly does drive Dr. Chodak’s opinion, as it does mine.

    I do not believe that either Dr. Chodak or I are “against HIFU”. However, we are quite certainly “against” the promotion of HIFU as some sort of important breakthrough in treatment for prostate cancer in the absence of data to support this concept.

  9. WAS SKEPTICAL; SPOKE AT HEARING; NOW VERY CURIOUS (slide CC-70 on the FDA handout of the company’s presentation)

    I have read through the posts through Sitemaster’s reply of 7/31 at 3:27 pm. I also read the FDA materials prior to the advisory committee meeting, read the company’s materials at the meeting, saw the slides and heard the presentations for both, studied many clinical results abstracts and papers on HIFU prior to the meeting after years of paying fairly close attention to what appeared to be discouraging results, and gave a skeptical public statement of 5 minutes at the hearing itself.

    WHY I WAS SKEPTICAL: The main reason is that PSA survival (a.k.a. biochemical recurrence free survival) in low-risk groups has just consistently looked poor in many studies as HIFU results showing median follow-up matured beyond the 2-year point, with questions emerging around 3 years as the success level declined, and with unfavorable levels of success at the 4- and 5-year points of median follow-up compared to surgery and radiation. I suspect this is part of the basis for Dr. Chodak’s lack of enthusiasm, though the positive biopsies post-treatment are clearly a legitimate concern also.

    The FDA doesn’t like PSA success as an end-point. Clearly it is not great for late-stage patients, but it looked like a fine indicator to me for low-risk groups. It is quite clear that the research/clinician community involving HIFU uses PSA success most of the time. I had not seen criticism of that endpoint in the abstracts and occasional complete papers I was reading.

    MY PRESENTATION. I had some points I wanted to make in the short time available, but planned to adjust what I said to what I heard in the morning presentations that covered the FDA concerns, company presentation, and initial discussion from the advisory panel. Right off, in the first slide after its introductory slides, the company in effect chided the FDA by showing a map of the world with countries darkened to show where HIFU was approved and in use at 260 clinical sites involving 40,000 patients. Of course the USA was conspicuous by its absence among the developed countries. However, I was struck by how closely that map lined up with the map of developed countries that had approved use of thalidomide around the middle of the last century — the time when it led to an initially unexplained explosion of birth defects. The FDA had protected us in the US against that — perhaps its most shining hour, and I noted that map similarity in my comments, tying the mention to use of thalidomide in my own therapy.

    I used most of the rest of my time to address the woefully short follow-up time in some of the research the company discussed and in its planned post-marketing study (8-year follow-up looking for mets on men with initially local disease). I was speaking to the choir as the FDA and panel were thinking along the same line. I concluded that, though there were some interesting studies that suggested HIFU might be valuable, I was skeptical based on the evidence presented. I was far from alone in that view.

    WHY I’M NOW CURIOUS — THE PSA “BOUNCE”. At 9 minutes into its talk the company presented slide CC-70 entitled “PSA Spike after HIFU.” It showed two graphs, the first a “spaghetti chart” of individual patient PSA trails over time after HIFU through 10 years, and the second an illustrative graph for just one of these patients through about the 100-month point. (These tables appear to be based on results from the paper by Inamoto et al, Clin Med Insights Oncol 2011; 5: 101-106, which is available at no cost via http://www.pubmed.gov. However, these two graphs are not in the paper itself, which I have.) You can view the graph (and entire slide presentation) on the FDA’s web site (see page 35 (sponsor paging) or 36 (pdf)).

    The graphs very clearly show that an initial sharp spike in PSA is very common: the text says that it was universal at the 2-day point in the 176 men in the study. But that acute spike aside, the graphs show many subsequent spikes, generally rapid but some prolonged, at various times after therapy (one around the 90-month point), and with variable duration. I was struck that none of the tracks end above a PSA level of about 12, and most are well below 10, even with that long follow-up.

    Now virtually all of the studies I’ve seen have used PSA success criteria that we are used too, most often the Phoenix criterion of nadir +2. It seems clear to me that these spikes, though likely harmless from a survival standpoint, would bust the failure definition. In other words, HIFU may look like its failing, from as PSA viewpoint, when it actually is not. Apparently the whole idea of a bounce for HIFU is quite recent, with the Inamoto paper having been published only 3 years ago in 2011.

    I’ll have more to say, I hope, time permitting, on the hearing and this issue, but I wanted to get this out for discussion, and especially get Ron’s reaction.

    For me, though I do have other questions such as the rate of positive biopsies after treatment – a big concern to the advisory committee, recognition that bounces probably have a major effect on HIFU patient PSA levels could be a game changer.

  10. Neither for or against HIFU here. Starting my third year at SWOG I have come to appreciate the value of well-designed clinical trials that prove efficacy. Given the data presented the FDA made an appropriate call. And while SonaCare may or may not get an approval, I still have not seen much more than anecdotal data on it’s success. All trials have proven to be less than convincing that HIFU is as effective oncologically as any treatment we already have. But if you’d like to toss in 25 grand the best selling point is a bonus trip to the Bahamas or to some Mexican resort community. Just don’t drink the water.

  11. Dear Jim:

    Having looked at the slide you refer to, I have absolutely no idea what EDAP thought it was trying to suggest by presenting these data. There is no context, so they have no meaning. How were these particular patient data selected for presentation? No one is suggesting that HIFU can’t be used to treat men with low-risk prostate cancer. The question that was being asked was, is this form of treatment effective and safe in the treatment of low-risk prostate cancer? Based on anything approaching normal criteria, the answer appears to be no. But don’t get me wrong, because I have the gravest doubts that surgery or radiation therapy are effective or safe treatments for the majority of men with low-risk prostate cancer either. However, that is not a question that the FDA has ever been in a position to address.

  12. THE BOUNCE continued

    Sitemaster, thank you for looking at this slide. I too am somewhat puzzled what they were trying to convey and am interested in seeing the transcript that will be published within a few months.

    That slide sure caught my attention, but the sponsor did not at all attempt to address the point that the customary biochemical failure criteria do not fit HIFU well. They do make the point on the slide that the observed spikes are “an expected effect and [are] not correlate[d] with subsequent biochemical failure.” I feel they had an opportunity to push this point hard but they certainly did not do so; it was almost a passing mention.

    Your point about the questionable worth of any treatment for low-risk prostate cancer is key, in my view, and was well appreciated by the advisory committee. I’ll post about that next.

  13. QUESTIONABLE WORTH OF A N Y TREATMENT FOR LOW-RISK PROSTATE CANCER, AS THIS ISSUE RELATES TO HIFU

    This relates to the closing sentences in Sitemaster’s comment of 2:41 pm today.

    The company presentation used the radical prostatectomy arm of the PIVOT trial for comparison to HIFU results, including effectiveness results, as in slides CI-74 on page 37, CI-75 on pdf page 39 and elsewhere (especially CI-74, concluding on slide CI-78 that “Three supporting comparisons consistently demonstrated similarity of Ablatherm HIFU results to PIVOT and SPCG-4 Radical Prostatectomy)”.

    However, the FDA, in preceding analysis that laid out its view at the start of the session was well aware that PIVOT suggested that Watchful Waiting (not Active Surveillance but less rigorous WW) had turned out to be not inferior to surgery in the PIVOT trial. The committee panel too indicated several times they were well aware of that. Therefore, the company basically was proving that HIFU for low-risk men was about on par with doing nothing, a point which, not surprisingly, did not aid their cause a whole lot.

  14. SAFETY AND HIFU FROM THE ADVISORY COMMITTEE’S VIEWPOINT

    The vote on safety was lopsided on the negative side, but that is somewhat misleading because of the definition of “safety.”

    Basically, the FDA definition of “safety,” which was read aloud both at the start of the panel discussion and at the time of voting, hinges on a balance of benefits outweighing harms. As was well expressed a number of times at the hearing, there had been no proof of benefit based on the evidence presented. Therefore, any harms — and there were some documented — would skew the balance toward the conclusion the treatment was “unsafe”. I join most of the committee in its view that the treatment is no more dangerous in terms of side effects than other common treatments. In that sense, it is “safe.”

    All this said, I’m confident the definition, the discussions and the vote all made good sound sense.

  15. HEAVY HITTERS ON THE ADVISORY PANEL

    The full roster is available online at the site I’ve indicated above, but there were several heavy hitters known to most of us on the panel, and I thought they did a fine job, as did the chair and most of the other members of the panel, some of whom were not that familiar with prostate cancer.

    Drs. Patrick Walsh of Johns Hopkins, Eric Klein of the Cleveland Clinic, and Mark Garnick of Harvard all contributed expertise and insight to the proceedings. It really helped speed things confidently along to have that high caliber of expertise available. Sometimes such experts tend to dominate the discussion in an unhelpful way, but that did not happen at this hearing.

    About a minute of my statement had to do with my own therapy and results, as it was relevant to the issues. I was interested if Dr. Walsh would react to the success of my primary ADT including a 5-alpha-reductase inhibitor (actually both at times but not mentioned by me), an approach he has not endorsed in the past, to put it mildly. On the other hand, Dr. Klein has been an advocate of 5-ARI drugs. It all went down smoothly, and I had a chance to talk in the hall with Dr. Walsh after the session. He was glad to hear I had done so well and complemented me on making good choices.

    I had read before on this site that he was now not quite so enthusiastic about surgery for prostate cancer. He actually said at the meeting that he could see a day coming when surgery would be supplanted by other approaches!

    Our survivor representative was Terry Kungel from the Maine Coalition to Fight Prostate Cancer. Terry did a great job!

  16. Tony Crispino,

    I am one of those prostate patients who did “toss in” $25K for a nice trip to Bermuda for HIFU, done by Dr. Scionti. I came home with no incontinence, no impotence, and no cancer. There are thousands of prostate cancer patients who would love to have alternative choices to surgery or radiation. Instead many have to deal with side effects of their decision, of which are worse than having cancer in the first place.

  17. Hi elucidated1,

    Did you experience a bounce, the subject toward the end of my 1:47 pm and 3:28 pm posts? “The bounce” appears to be a fairly recent topic in HIFU research circles per the study cited in my comment. Is it discussed much among HIFU veterans and their doctors? Did Dr. Scionti advise you about it? If so, can you share his expectation about likely timing, intensity, and duration?

    My impression from the study was that there is a universal initial bounce or spike in PSA that occurs virtually right after HIFU and is very short and intense (high PSA), followed by a second bounce that can be a long time later, most of the time not in men who have had neoadjuvant ADT.

  18. Dear Jim:

    If you take a patient’s PSA level almost immediately after HIFU, it would be almost inevitable to see a rise in that PSA level compared to the level at diagnosis. Why? Because you have just broken down prostate and prostate cancer cells, inevitably increasing the potential for release of PSA into the bloodstream. This is not, by any definition, a “bounce”! Furthermore, I would not expect any competent physician to be taking a patient’s PSA level for several weeks after HIFU — for exactly this reason. It would not reflect the “real” impact of treatment on the survival of cells producing PSA. For exactly the same reason, one doesn’t take a patient’s PSA immediately after any other form of treatment either. Indeed, it is customary to wait for 8-12 weeks post-surgery to take a PSA level that is considered relevant to assessment of surgical outcome.

  19. Replying to your 8:59 am:

    I see that and of course fully agree about the short term spike in PSA. I’m thinking they measured that at 2 days just for research purposes.

    What I find intriguing is the many spikes and more extended temporary elevations that occurred well after that initial spike. Those elevations do look like bounces. If they are, that might be quite significant for interpreting evidence about the long-term success of HIFU.

    However, I wish the paper had provided more detail and more graphs and tables. That said, they were breaking new ground. I’m going to study the paper again. I’m also surprised there is not more published research on this bounce phenomenon with HIFU. Maybe I missed other relevant papers, but the Inamoto paper is the only one resulting from this PubMed search: prostate cancer AND HIFU AND bounce. I would have thought the HIFU community would have jumped on this and produced a number of studies since publication of this paper in 2011. The lack of such papers diminishes somewhat my expectation that this is a favorable development for HIFU.

  20. NO LUCK SEARCHING FOR HIFU “BOUNCE” RESEARCH, BUT FOUND NEW UCHIDA TEAM PAPER

    Dr. Jessica L. Foley, Scientific Director for the Focused Ultrasound Foundation, which promotes HIFU and is based in Charlottesville, VA, gave a statement in favor of HIFU at the hearing. I have just visited the Foundation’s web site, and under the prostate section found the following just-published paper from Uchida and colleagues at Tokai University and Hachioji Hospital in Japan:

    Uchida T, Tomonaga T, Kim H, et al. Improved outcomes owing to high-intensity focused ultrasound devices version-up for the treatment of patients with localized prostate cancer. J Urol. 2014 Jul 28. pii: S0022-5347(14)04047-6. doi: 10.1016/j.juro.2014.07.096. [Epub ahead of print]

    This team has published a series of papers before on their clinical experience, which was not encouraging as it showed a clear pattern of PSA success levels declining to unimpressive levels at around the 4- and 5-year point for median follow-up. I mentioned that pattern for the Uchida team specifically in my statement at the hearing.

    The abstract for this paper looks more encouraging, among other things suggesting improvement (5-year results compared) for successively later versions of the Sonablate HIFU system. I hope to read the complete paper and find that it addresses the “bounce” issue.

  21. After reading the FDA medical device panel’s comments on Ablatherm, it certainly makes one wonder if da Vinci and radiation for PCa would have been approved by the current FDA panel. Both treatments certainly have issues with significant side effects and suspect outcomes for many.

  22. Hi elucideated1,

    You might want to take a look at the graphed results of the Prostate Cancer Results Study Group, which were published in BJU International. The studies were culled using criteria that foster a more apples-to-apples comparison basis using biochemical recurrence-free survival (BRFS, a.k.a. success based on PSA), by a group including many widely recognized experts. Those results show BRFS at high levels and long-term for many studies of radiation and surgery for low-risk disease, although usually performed at well-known centers.

    HIFU just has not been able to demonstrate such success for low-risk patients, where the bar is pretty high. The bar is high because we now know from active surveillance and even watchful waiting research that large proportions of low-risk patients will do fine with no treatment at all.

    HIFU does not look successful, on the basis of a number of international studies, using PSA as the yardstick around the 4- to 5-year point and later for low-risk patients. However, at the hearing one graph hinted that the “bounce” phenomenon occurs in many patients well after acute side effects have passed, and that may artificially lower the apparently low long-term PSA success level, as the usual PSA criteria, such as the Phoenix criterion of nadir + 2, appear to not handle late bounces above 2 very well. That’s the theme of several of my posts here. If you can provide insight or experience, I would appreciate it.

    That said, HIFU is still not off the hook for demonstrating effectiveness, even if the PSA issue is resolved favorably. The other treatment success criterion that looks most promising to me, and in my estimation to the advisory committee and probably the FDA itself for HIFU, is decently low rates of positive biopsies after HIFU. Unfortunately, at least in the data presented to the committee, that biopsy rate looked uncomfortably high, the observation that Dr. Chodak was referring to in the first post here.

    Hopefully other evidence will favorably resolve the biopsy issue. The hot-off-the-press paper by Uchida and team does address this issue in part, and I hope to read the complete paper soon. Again, if you can provide insight here, I would appreciate it.

  23. How could they vote negative while the European board of urologists recommends the use of this device and France is even reimbursing for it? With more than 40,000 patients being treated for prostate cancer with this Ablatherm HIFU device in Europa, Canada, South America, Russia, … the advisory committee did vote negative against it for safety and efficacy. Can you believe that? A device with the highest accuracy to kill the prostate tumor cells with less risk for getting incontinent or impotent, with less other side effect and where the patient walks in and out the hospital for the treatment at the same day. … Why did the advisory committee did vote negative against it? Why did Dr. Klein from the Cleveland Clinic in the USA say it is not effective nor safe, while his colleagues from Cleveland Clinic Canada (Maple Leaf) did more then 700 procedures with Ablatherm HIFU with a very high success rate?

  24. REGARDING JULY 28 UCHIDA TEAM STUDY: BREAKTHROUGH?

    At 4:29 pm today (August 9, Saturday) I posted my analysis of the complete paper on the new HIFU thread posted by Sitemaster: “How NOT to get your technology approved rapidly by the FDA”. I’m really impressed.

  25. Hi Annicka,

    Sitemaster’s analysis in this and a more recent article, as well as comments clearly document why a negative vote made sense. I was there and gave a public statement as a skeptic. While at least for the time being I have become enthusiastic because of the July 28 Uchida study, there was no reason to be enthusiastic based on the evidence at the hearing.

    You raised several concerns. Here are some things you might want to think about.

    You asked how the US could vote negative in the face of European acceptance as well as acceptance in Canada, South America, and Russia. Think of the map of developed countries that accepted thalidomide back in the 1950s/1960s, before that drug was nailed for creating an avalanche of birth defects. The drug was marketed for respiratory infections, insomnia, and morning sickness, but the US FDA did not approve it based on inadequate testing, in its opinion. That thalidomide map closely resembles the map of countries now using HIFU. Sitemaster’s latest post addresses more aspects behind the disapproval.

    Yes, I can believe the FDA advisory panel voted against safety. Its decision was sound as there was clear evidence that HIFU was not a free ride for side effects, and as of the hearing there were very real doubts about its effectiveness, especially considering a high rate of positive biopsies after treatment. The committee, especially Dr. Mark Garnick of Harvard, tried to understand that issue, but the company lacked both an explanation and detailed data. Ask yourself: if you are considering a course of action that has no clear benefit and does have some risks and likely physical costs, would you do it? That’s basically why the committee voted that HIFU was not safe.

    You are under the impression that HIFU has “the highest accuracy to kill the prostate tumor cells”. If that is true, why have so many patients in so many international trials experienced higher rates of recurrence than with other therapies, a substantial rate of needing repeat HIFU, and a substantial rate of positive biopsies after treatment. The Uchida paper just published may change that, but, until now, the landscape has been bleak.

    You are thinking the patient has “less risk for getting incontinent or impotent,” Continence seems not to be a significant issue, long-term, but potency is another matter. The latest Uchida study that I find encouraging still notes an ED rate of 34.9% at 2 years, which is pretty substantial.

    I hope this helps explain the panel’s vote.

  26. You should do some study work and compare the recurrence rate of low-risk prostate cancer between radiation therapy and HIFU and you will see that radiation gives more recurrence, although radiation is FDA approved. Next you compare what happened as a sole case which happened 40-50 years ago with the present?! Wow, you think the rest of the world is retarded and only the doctors in the US know what they are doing? … The entire adcomm vote was corrupted.

    FDA approves the ebola vaccine which has been only tested on animals, but their advisory committee refuses to vote positive when there are more than 40,000 men which are successfully treated with Ablatherm?! It is getting more and more clear the FDA uses two ways to decide on approval: if the company is American (like the ebola vaccine company) or a non-American company (like EDAP). Ask yourself why the European association of urologists recommends the Ablatherm HIFU and why France is already reimbursing it when it would not be safe and efficient. China will approve the Ablatherm in December, so your stupid FDA adcomm (I hope the FDA panel will be more intelligent) would look ridiculous (like saying: ‘hey 1 and 1 is not equal to 2, the rest of the world is wrong and we are right’)

  27. Dear Annicka:

    You are entirely entitled to express your opinions, but we do ask people to express them politely on this site, please.

    We also ask people to please get certain very specific facts right. The FDA has not “approved” any experimental ebola vaccine at all. It has allowed selected products to be administered under experimental protocols to a very small number of people (including some non-Americans) on humanitarian grounds.

    You also need to appreciate that the HIFU information that was submitted by EDAP TMS to the FDA to date related exclusively to Ablatherm equipment that is no longer being used in most of the world because it is outdated. This reflects the failure of EDAP TMS to understand the regulations under which the FDA operates in the USA and to respond to what was requested of them. You may not like this, but it is the way the world works.

  28. ACTIVE SURVEILLANCE — THE ELEPHANT IN THE ROOM AT THE EDAP (ABLATHERM) HIFU FDA ADVISORY COMMITTEE HEARING

    Those of us who believe in active surveillance (AS) as a highly effective approach for many men with low-risk cancer should be encouraged by what transpired at the HIFU hearing. I was there and was impressed by how far AS has come since about a decade ago.

    I’ll keep this short as anyone who wants to dig into the prominence of AS at the hearing will be able to do an electronic search of the hearing transcript that the FDA will publish within the next few months. Also, the background material presented by the FDA as well as the slides presented by EDAP are already available and searchable. (Go to http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm and scroll down to the links for material posted on July 30 and July 29.)

    The FDA staff and several advisory committee panel members were clearly concerned about AS as a likely preferred approach for the low-risk men who were the target group for the EDAP application for HIFU approval. The company was asked a number of times why AS was not used for comparison to HIFU and whether AS should not be the benchmark for judging future HIFU success. Their response essentially was that AS was not yet on anybody’s radar when they were planning their research. My recollection is that Drs. Garnik and Klein, especially prominent on the panel, pressed home the relevance of AS in a low-risk population. I was a bit surprised when famous pioneering prostate cancer surgeon Dr. Patrick Walsh, in this general context, said he could see a day coming when surgery would not be used to treat prostate cancer!

    After the votes, the FDA’s Dr. Benjamin Fisher, PhD, Director of the Divison of Reproductive, Gastro-Renal, and Urological Devices, asked a number of questions to get the panel members’ advice on how to evaluate prostate cancer devices, especially for low-risk men but also for higher risk men. Question 7 essentially asked what comparison would be good for HIFU (and perhaps other technology — not in my notes). There was general agreement that AS would be very good, though one of the other senior FDA staff present did not fully understand AS; Dr. Walsh helped clarify it for him. (The lack of familiarity is not strange as the FDA staff deals with many different diseases and technologies, and the senior level also deals with many management issues. That’s a point to keep in mind for those of us who testify or make statements at FDA hearings.) The panel chairman concluded that there appeared to be no consensus but that AS was prominent among responses.)

    No one challenged the relevance or role of AS for low-risk prostate cancer patients. AS is emerging as a key benchmark for evaluating approaches for managing low-risk disease.

  29. MEDICAL IMAGING AT THE EDAP (ABLATHERM) HIFU FDA ADVISORY COMMITTEE HEARING

    Medical imaging, especially MRI imaging, came up for favorable mentions throughout the day for assessing and managing prostate cancer, specifically including newly diagnosed prostate cancer that appeared to be low-risk using the usual D’Amico and associated criteria.

    I was struck with the impression that advanced imaging is really taking hold in the community of experts who treat prostate cancer.

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