Wednesday, July 6, 2011

The FDA's Gift of Giving

The last few weeks in spine has made it interesting to read everyone's comments regarding INFUSE.  Your commentary has made TSB think about how truly gamed the system is by those spine/orthopedic companies that wield economic power in the industry.  The principle behind any oligarchy is that economic power yields political clout and influence. The obvious companies come to mind, Medtronic, Johnson & Johnson/Synthes, Stryker, Zimmer, Biomet, Nuvasive (Billion Dollar Baby), Orthowreck, and Globus. Don't believe that?  Just walk in a North American Spine Society Meeting. The big boys are situated right at the front entrance, while the ankle biters are hidden in the back near the restrooms, hoping that surgeons looking to relieve themselves will grace them with their presence.  Our society cherishes the idea that all Americans have an equal opportunity to make money.  A rich and privileged class of companies that have consistently used government relationships to enrich themselves in the best of times, and protect themselves in the worst, only to cry out for big government to stay out of their business.  If one truly believes in "free-markets," one understands that our economic system was founded on the notion of fair competition in a free market.   Most of these companies cry like an adolescent when it comes to being held accountable, in many respects believing that they should be treated like their Wall Street brethren, blaming the federal agencies for their inability to generate more revenue by placing restrictions and regulations on innovation, resulting in jobs being exported overseas, and crying for even more deregulation.  Just like the housing market, the spine market is beginning to realize that the days of glory are gone, unless of course you are the industry's Maggie Fitzgerald and are selling futures to the analysts that your company will one day be a billion dollar baby.

So what's the gist of this post.  Considering the rants regarding INFUSE, its clinical efficacy, and  off-label use, no one has still answered the $1 million dollar per day question, did the FDA drop the ball on INFUSE, and were they pressured into making a decision that has potentially hurt a percentage of patients rather than make their lives better? Could someone at the FDA have been influenced by tried and true methods?  Let's face facts, all we hear are the stories and papers that espouse the use of this pharmaceutical, but what about the horror stories?  Many readers and platforms love to skewer the FDA, blaming them for the industry's inability to bring innovation to the marketplace, complaining that there needs to be a relaxing and restructuring of the submission process.  But could this be a scenario where the FDA really failed at what its suppose to do best?  Protect the public?  Is the FDA looking out for our best interest?  And, is it just the FDA, or, have the courts now set precedent?

In 2009, lawsuits on behalf of thousands of plaintiffs with Medtronic heart defibrillator wires, which have been known to be the "shittiest" in the industry and had been know to fracture and potentially send lethal shocks to patients, had been dismissed by U. S. District  Judge Richard H. Kyle on the basis of the Preemptive Doctrine. Undoubtedly, Judge Kyle's background as a Minnesotan, nor, that his son's law firm had previously done work for Medtronic had nothing to do with his decision. The Preemptive Doctrine is based on the Supremacy Clause, which dictates that the federal government in exercising any of the powers enumerated in the Constitution, must prevail over any conflicting or inconsistent state exercise of power.  Does the Preemptive Doctrine then open the door for more devices to slip through the system that are not ready for implantation?  Maybe we should hook up Judge Kyle and his son to one of those defibs, just for shits and giggles to see if they like it? And then there is Wyeth.  Wyeth sold the rights to BMP-2 to Medtronic. Will they be asked to testify and grace the Senate Finance chamber with their presence, knowledge, and experience on how this drug was originally intended for delivery and use? Wyeth could be the key in answering many open ended question about how this product should have been commercially brought to this market.  Pure conjecture would say that Wyeth knows much more than anyone of us know.

So in closing, it will be interesting to see how long the Senate investigation will take.  Will Ishrak call on his buddy Jeff Immelt to pull strings on Capitol Hill, while Medtronic continues to grease the wheels of the Congress and the Millionaires Club spending more money on lobbyists fighting their cause? And who has incurred the cost, or the wrath of the many revisions that took place due to INFUSE growing like wild fire?  The taxpayer?  All for the love of science and medicine, no doubt.    Until then, Caveat Emptor.


  1. How much does the standard Spine Regional Manager make? 150K Base? 2% paid on growth? What are the compensation plans you are seeing in the field?

  2. What a great piece of gossip! Seems like a couple of facts matter. Medtronic did disclose the difference in retrograde ejac to the FDA (see, page 8 of the pdf). So it was in the public record. In 2002. Was this discussed at panel? Don't know.

    Also, the same FDA document states "When ddd was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances."

    IMO, the Spine Journal noise is about marketing and the surgeon community going hatfield vs. McCoys (academics vs. consultants). The consultants are conflicted while enrolling patients. They write papers that are silent on certain problems. And the academics finally call them out (though 9 years seems a little slow).

    No question, InFuse is a commercial success. After a decade of hype, maybe it goes back to where it was in the clinical trial - equivalent to the control (autograft) - 71.0% vs. 70.9% (InFuse vs. Control)?

  3. The issues in the study that get quoted are from a threaded titanium PLIF cage. That technique left the cage too far posterior and the posterior end of the cage open. They realized this was not a good technique and discontinued the study. How many surgeons still put in "Ray" type cages now? None!

    Most of the surgeons that use BMP (Infuse) now in a Posterior Interbody approach, place it within a cage and in front of a cage and have seen no problems with that technique. The issues occur, although relatively infrequent, are when the BMP sponge migrates out of the interbody space by improper placement., too close to the posterior edge. The same thing could occur with improper placement of autograft bone. Do you want to pull that off the market too?

    All this hype is created by companies jealous that they do not have a competitive product to Infuse, and the Federal Agencies and politicians looking for deep pockets to bleed - Medtronic. Ask your surgeons who use infuse yet were never a paid investigator why they use Infuse.

    Move on to some other real issues that affect our industry - like the potential elimination of 510k's, excise tax on medical devices, and how to even the playing field by eliminating POD's and other payoffs....just sayin - (ex-medtronic distributor)

  4. FDA did not drop the ball. All the "new" complications being brought up now were in the original documents, available for scrutiny for the last 9 years, just like 1:02 says. For Carragee to drag it out now as if it's new information is laughable. He's just another academic that is bitter because university research has become all but irrelevant in orthopaedics. The only sizeable study done without industry support in the last decade was the SPORT debacle. BMP just happens to be the pawn in a battle for academics to try to prove some value to society before their spending gets slashed to save entitlement programs.

    You'll see these knuckleheads going to bat for insurance companies and Medicare, arguing why you shouldn't get an expensive new treatment that could seriously improve your outcome or save your life. They're a bunch of ivory tower ideological cranks that wish eugenics hadn't been discredited.

  5. Disclaimer: 7 year spine rep, not with Danek

    The issue is plain and simple: overdosing. When used appropriately, I've heard nothing but rave reviews from my surgeons who use BMP ( to be fair, it's a small amount). The issues arise when 2 large kits are used for a 1 level tlif. Now you're looking at bony growth in the canal and a myriad of other complications

    The issue here is not the FDA. The issue is misuse and mishandling by surgeons who clearly are aware of what they are doing. Dumping huge amounts of BMP into these patients because it fills their pockets. I agree with 1:05, many surgeons who use the product unbiasedly agree that, when used

  6. To 1:38's point regarding overdosing. Given that this is truly an issue, does it not lend credence that rh-BMP2 should have been considered a drug and not a device when subjected to the FDA's application process?

  7. The issue is overdosing, where to use Infuse and the potential complications and side effects. You can say it is used fine in a PLIF or TLIF cage with the proper dose but you cannot support that with clincal evidence. In fact, that study was stopped due to complications along with most other studies outside of the notorious single level ALIF with an LT Cage and the Trauma study where they can't find the patients.

    Even if the complications are small sub set of patients they are there. And so the issue also becomes did Medtronic report these complications in their IDE study for approval (no) and did they promote the product for off-label usage that could potentially harm patients (yes). Didn't some guys from Synthes just go to jail for that? And if they didn't promote it off label why are there different sizes and why is 95% of the usage off label. We all know why. The corporate guys and sales reps can't sell off label but get them to a meeting with their peers and some doctor making millions in royalties will be just fine with telling everyone and their brothers they use it in PlIFs, TLIFs and ACDFs. Then all the sales rep has to say when asked is, "I heard Dr. X, Y and $ use it that way... but that's off label." Wink, wink.

    Finally, if it was just a dosing issue where is the dose response study? Ahh that would probably hurt sales as a lot more small kits would be used, which is giving a complement that Infuse does indeed grow bone. However, as is being widely reported it potentially has a lot of harmful complications or side affects associated with its usage. I think you Medtronic homers make a better arguement when you blame the patients for their complications. Stupid patients!

  8. When is Globus going public?

  9. 3:40 - sounds like a great topic to discuss on

    There's even a sub-forum for that very question!!

    1:48 - I agree with you.

  10. Which spine company pays the best severance package ?
    I was given 7 months of severance 5 yrs ago for 2.5 yrs of work at MDT.
    Also, how do you spice up this site ? You let us upload photos of things we see and people we see on a daily basis. I want royalties for this site.
    Bow down MM.

    Blogmaster Flex

  11. Sounds like the standard in most industries, Three months for each year of service. As for spicing up the site, we're working on it. You want royalties for what, an idea? We still love you, thanks for the comment.

    Grand Master Flash MM

  12. Blogmaster Flex and MM:

    Industry standard being 3 months for each year of service? Are you serious? I know someone who worked at Trans1 for 3 years, was let go and received 4 weeks of severance...and they had to negotiate it UP from 2 weeks of severance, which was the original offer.

  13. That's what you get when you work for Trans1. How ebarrassing. Had to talk up to get 4 weeks. Pathetic.

    I also think we should be able to upload photos and make comments on this site about everyday things we see and hear. How much fun would that be ? Now thats spineblogger innovation. Typical MM though, thanks for the idea move along. You sound like Globus' customs instruments team: "ya ya ya we'll get back to you on that idea.... tick tock tick tock, globust !"

  14. 7:17

    If you work for a real company that's the going rate. If you work for some shylock outfit that's what you get. Ever wonder why the financial community laughs at this industry? It's easier to treat people fairly than stick the screws to them. Then you wonder why so many people bad mouth management in this industry. AMATEURS don't behave like major leaguers, thats why their companies are considered the farm system.

  15. TSON is a terrible company to work for.


    Scroll down and read Carragee's reponse after reading Zedeblick's letter to The Spine Journal editor.

  17. Taking bets here: Carragee and Zdeblick end up in a fist fight at NASS.

    These guys should go on Jerry Springer and air it out.

  18. Zdeblick is right that Carragee's paper is flawed. It's pretty wimpy methodology to be using as ammo to after fellow surgeons. I wonder who put him up to it?

  19. Zdeblick is pretty flawed for making it personal. He really took off the gloves with his letter. He was very much out of line to bring up Dr. Carragee's "18 month hiatus". Carragee was fighting for this country and risking his life so that D bags like Zdeblick can live freely and peacefully with his $20M+ in Medtronic money. Obviously, Carragee doesn't give a rat's ass what Zdeblick or what anyone else thinks. He cares about patients and his study brings to light evidence that male patients need to know the risks. I love his letter in response and that he didn't let Zdeblick's dramatic outburst overshadow the study's findings.

  20. Does NE one else find it breathtaking that the Boyz in Blue may have just utterly destroyed a Spine Implant Dynesty in one decade?

    Mickey Mouse could have done a better job leading Danek.

    Surgeons will begin to distance themselves from these losers as the stink thickens in the summers heat.

    Who wants to 'Buy' Medtronic Spine?
    See below:

  21. the return of healos !!


  22. 1:38
    You bring up a point that carries over to other implants as well. We frequently see film from surgeons that cause us to say wtf. Companies spent a lot of money on marketing, training and printing surgical techniques, and surgeons ignore them and won't even read anything before trying a new product. Then, when it doesn't go well, they blame the product, the rep and everybody else but themselves. I have been in surgery many times and tried to get a surgeon to listen about proper placement or sizing, and been ignored, or worse told to shut up. The result is that patients suffer because of poor technique and implant choices. There was a lot of talk in past posts about the value of sales reps in the OR. I am not in sales anymore, but believe that if surgeons would leave their egos at the door and listen go their reps more, results would be better. Just sayin

  23. Wow! Zdeblick made two mistakes. One, he failed to recognize that by definition Carragee has the last word in every round of this fight. So two, he should have stuck exclusively to completely defensible accusations in his attack. So even if some were valid points, clearly a couple of his arguments didn't hold water, and by bringing them up he opened the door for Geno to counter punch.

    Gotta hand it to Carragee and Co because they hit Tommy Z. with both barrels. Man, what a beat down. He's been through a lot, but this one's going to really hurt.

  24. There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2–associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate <0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy.

    Where are the Infuse homer's now? I mean I heard it can grow bone when placed on a Cue ball!

  25. This was the most impressive series of comments on any TSB topic yet. If only TSB had lived up to his normal standard instead of the liberal rant on big bad companies that are putting the little guy down. come on TSB, nut up and realize that MDT got big by being good. But they are not the same company they were and the "free market" will decide their fate. I used to work for them and I can tell you the defensive positions they take have debilitated them greatly. Lawyers are running the show and the fact that they have promised increased profits by "reducing the cost of sales" will have an effect. Not a good one to be sure. They definitely have gotten cocky and tried to use their market share to hijack the industry and the industry is pushing back. They'll be around, they will just have a black eye like caromed did after settling the pedicle screw litigation leaving the docs exposed to lawsuits.

    Nobody's perfect and greed tends to magnify and accelerate the imperfections.

  26. What's behind the claim the adverse events weren't reported. The FDA submission ( has the list of adverse events listed, including RE. After looking at it, I was surprised that nearly every single adverse event was noticeably more prevalent in the study group. It seems unlikely, since some adverse events I would categorise as mechanical or a result of the exposure.

    Why is the claim being made the data was withheld?

  27. Because the physicians didn't correlate the complications to the product. To a tee they all said the complications were unrelated. Really? Now they are reporting them a decade later to cover their ass after Medtronic has made billions and the doctors millions. Don't worry they will be giving it back!

  28. If you go back and look at the SS&E and posted by 5:54 you can see that it was all right there in the listing of adverse events. 5:54, you say every AE was noticeably more prevalent in the study group. I don't think that's true. Make sure you are looking at percentages and not raw numbers- as it was a 2:1 randomization.

    The question is how to interpret that table. By my count there are 23 categories of adverse events. Most of them are pretty close and certainly not significant. The two that stand out are RE, which shows more with InFuse and Graft Site Related which shows more with autograft.

    I'm not a professional statistician but I know a little bit. I know that if you look at 20 things posthoc, then one of them is probably going to show up as statistically significant. There needs to be a correction of a p-value to account for multiple tests. MDT clearly didn't 'hide' anything in the SSE. I think Dr. C is looking at the SSE data with the benefit of hindsight and carrying an axe to grind. He's right to design a follow on study to look at RE and as it happens, his finding confirm the observation in the SSE. I don't think its fair to say that it was hidden at the outset. That said, Dr. Z., as smart as I'm sure you are... not smart to say you've no financial interest at all. Don't insult us all.

    Its to bad that its all gotten so personal and ugly. Its not good for any of us.

  29. SSAE ?
    SSE ?
    AE ?
    P-values ?

    Sounds very intelligent.

    This is anneasy issue to interpret let's make it simple for us lesser intelligent folks.

    People have been killed by this product used 'off label' and lives ruined.
    There are clear adverse events that are directly related to infuse and MSD knew it.
    90+ % of it's use is 'off label' and MSD knew it.

    The company hired an in house MD named Yolanda Cillo to field all off label questions from surgeons on how to use 'off label'.
    When the surgeon had a question on off label use, the sales reps were instructed to give the surgeon a sheet of paper to write the question down. The rep faxed it into Dr Cillo and info was sent regarding how to use the product off label or they were sent 'studies' performed by surgeons independent of MSD on 'off label' use.
    Peer to peer exchanges of this sort were deemed OK.
    This was very convenient and we all thought we were 'doing the right thing'.

    I reported on a few of the adverse events on a few occasions only to be told that the events of inflammation were unrelated and not due to use of rhBmp-2.

    Why sacrifice 800 mil in revenue and all of those consultancy agreements when your revenue dollars are decreasing in the spinal implant market?

    Listen,respond, deliver?
    Dollars first, patients second.

  30. 9:34, your post is ridiculous, inflammatory and sophomoric. InFuse is the single most important product to be introduced in the history of orthopedics.

    I wish our regulatory system was designed where it was easier, once something of this magnitude is discovered, to then find and disseminate appropriate uses and in this case dosing. It grows bone in an ALIF setting. Now, lets through small pilots scientifically assess the proper use in other areas of the body. The process as it stands now is overly onerous, expensive and inefficient. A great product, a lot of hard work and yes profits. That should follow.

    One thing is for sure, if i needed a fusion, i would demand InFuse.

  31. 10:10, agree with you on the process being completely broken and horrendous. Do not share your criticism of 9:34. The information in his post is factual to the extent I know what went on. Fact is that MDT, or rather Danek, has willfully ignored and belittled all signs and symptoms of possible problems until the outside pressures became too much. They probably copied their strategy from the Exon Valdez or BP spill. Those backfired too, and I to this day will not put either brand in my car.

  32. 8:56

    You make some good points. I missed the fact it was a 2:1 randomization. But was it not required to test the statistical significance of each AE? How can you hide that? If the FDA simply took the authors word that those were not related, then they have some blame to account for. As for the graft site complications, that, of course, is N/A for the study group because they did not harvest graft from those patients.

  33. Regarding the underreporting of adverse events, it's not so much underreporting to the FDA that the academics are railing about, but rather they are claiming that the adverse events were underreported or underrepresented by the authors in the journal articles that subsequently came out including the trial data. While the company is accountable for what is presented to the FDA, all the data was there and besides, the FDA can fend for themselves. But it sounds like the authors may have ignored their ethical obligations and omitted, misconstrued or misrepresented data in the journal publications, and that's what Carragee and Co. are pissed about.

  34. 9:34, your post is ridiculous, inflammatory and sophomoric


    It's Fact.

  35. Hey MM, what an arrogant pompous prick of a response on the Trans1 severance topic. You must of lost some business somewhere along the way. Who do you work for?

  36. Hey 7:13

    The comments made related to that question was never intended to be pompous. If that's the way you construed them, our apologies. Remember, if you don't like the answer, don't ask the question, unless you want to hear what you want to hear. The bottom line is that any company that any of our TSB team members have worked for, have received three weeks. And the truth be told, only a "shylock" of a company would treat you the way you or anyone else was treated. Peace be with you, and with your spirit.

  37. so i pose a question: if you had to receive a fusion, would you demand InFuse?

    Posterior Lumbar?
    Anterior Lumbar?
    Anterior Cervical?
    Posterior Cervical?

  38. I would demand they not use infuse! Why be exposed to potential complications unnecessarily? If you don't smoke, aren't a diabetic, it's not a revision surgery I can think of no procedures or times I would want the product. And yet I have seen pediatric surgeons use this product on kids despite the warnings and potential complications. It is just wrong. If I saw one of my doctors trying to use my cervical plate in the eye, I would question the application and try and talk him into a more suitable device. I probably make more off a cervical plate than the Danek rep makes off Infuse so that just goes to show you the difference in ethics.

  39. Hey 6:32, Doc here. Tell me, when is the last time you implanted a cervical plate (other than in a saw bone)?? When is the last time you placed BMP in an implant and implanted an acutal human body, that is still alive?? Tell me and enlighten me to the "potential complications" my friend?? Anymore than complications than that VBR that you have been pushing on my "off label" wink wink Dr.

  40. 9:51 to my knowledge PEEK and titanium vbr (wink) devices when implanted properly don't cause inflammation, dyspygia, sterility, immune response, ectopic bone growth, hyper active osteoclast and osteoblast activity, and cancer. Some of these warnings may be on the vbr implant ifu but they are certainly not seen routinely. I have never implanted a cervical plate, pedicle screw or vbr. From your argument I suppose the guy that dropped the bomb on Hiroshima is the only one qualified to make nuclear bomb decisions or we should but the same Wall Street bankers who wrecked the economy in charge of fixing it. I may not have gone to med school or ever implanted devices but I have an informed educated opinion. I suggest you read the clinical data out there and the infuse ifu and form your own. If after that you want to keep slamming it in because it increases your fusion rates that is between you and your patients and the trial attorneys.

  41. 3:24, another "strong" attempt to make an arguement out of nothing. Did I EVER say I personally implanted BMP along with an implant?? I think you need to re-read my blog. I stated "when is the last time you implanted BMP/implant". Maybe instead of reading that surgical tech guide you should pay more attention to what is said. You are comparing Wall Street and the Hiroshima bomb to how a surgeon treats his/her pt's? My lord help us, that you are out there educating surgeons/staff in your territory. So much for the "informed educated opinion". My opinion..glad you are not my rep.

  42. 9:51
    Just a shot in the dark here, but you aren't really a doctor are you?

  43. 5:45...9:51 here. Test me!

  44. 9:54 I am glad I am not your rep too! Your probably the surgeon that says, "shut the fuck up" every time the rep tries to keep you from trouble and help you get out. Your MD gives you the right to do what you see fit to treat your patients but that doesn't make it right and therein lies the difference. I respect your position and title and I realize Infuse works (grows bone) and has helped many many patients. However, like threaded cages and dynamic stabilization many surgeons have over used these products (and others), pushed the envelop and their patients have suffered from the many adverse events/complications associated with this product. I don't blame the surgeons as I really believe the company has negligently promoted this product off label and misinformed the surgeons or played down the potential harmful effects of this device. I don't need to implant Infuse, VBRs or go to med school to form my own opinions (they might only matter to me and granted don't pay the bills although I am still pretty successful). I do spend a lot of time educating myself and I am confident more and more information is going to come out supporting my opinion. I am not a dumb rep, sided with the government in a conspiracy to rob you of a product that makes your fusions successful outcomes. However, I do believe that if not used properly this is a product that does more harm than good. I believe there is an oath about that. That opinion is formed through the many surgeons that have shared with me their experience with Infuse over the last few years and not the recent press clippings. Please read the warning label on the IFU and if your comfortable proceeding than smoke three packs a day!

  45. 4:37 again you fail to understand that I was not supporting BMP (cause that’s what it is dumbass) Infuse is a trademark name that I do not endorse.
    Secondly, I don’t think I have ever told my rep to "shut the fuck up". I have told him to tie my gown up cause that's all you are good for in the OR. Do you really think I need your dumb ass in the OR telling me what not to use or how my tech that has years more experience and has seen more instrument sets than you could ever imagine. While my tech is not a sales rep, he/she has more class in his/her middle finger than most of the reps out there, and YES I am including you, so here's to you! Hold on, I think it’s time for me to go schedule another 360 and pop some DBM/HCP in the cage. what else is in your bag today that you could enlighten me with??? Oh is that a new MIS pedicle screw? Please tell me more about it...NOT! Just an FYI…I rarely have a rep in the room. Do I really need you standing there smelling up the room with that cheap wannabe cologne you wear trying to impress my staff?

  46. Yes I really think you especially need a rep in the room. In my experience those who think they have all the answers have the least. Why don't you expand on your BMP-2 experience of putting it live human beings as your anecdotal experience certainly makes you an expert. In fact, instead of studies the FDA should just run the new products through you for approval. Between you and your expert tech we could really streamline this approval process, which is truly fraught with problems and delays.

    I am good for some other things, such as an occasional joke!

  47. 9:49 blah blah blah