Friday, December 31, 2010

Out Goes the Tiger, In Comes the Rabbit - 2010 The Year in Review

Fellow Bloggers,

It's time for TSB's second annual year in review. Time flies when you're having fun.  Based on the Chinese Calendar,  2010 was the Year of the Tiger.  Unfortunately for Tiger Woods and the spine industry, it's a year that couldn't come to an end any sooner.   Considering that the U.S. has mortgaged our future with our Asian brethren,  2011 will be the year of the Rabbit.  The Hsin Mao 2011 symbolizes sensitivity, prudence, and wealth earned with hard work.  Maybe we will realign our priorities and revitalize the importance of family.  The only drawback to the year of the Rabbit, is that you may not express your feelings in words, but make it up in deeds.  Therefore, TSB is already breaking with tradition.  Hopefully, we will all start off and complete the cycle on terra firma.

2010 was an unpredictable and divisive year in spine, a microcosm of a much larger story.  Many of our illustrious CEO's will be happy to close the books on 2010.  There is an old Chinese proverb that says, "men in the game are blind, to what men looking on see clearly."   If anything, much uncertainty still remains for spine.  A thriving industry, where 20% was the rule rather the exception,  spine is  in search of the holy grail.  The challenge of containing cost while providing quality care in a discerning manner is here to stay.  Meaning, the industry is under public scrutiny, more than ever before, and we are going to have to provide effective remedies.  Access to investment capital is making it much more difficult for start up companies to bring new ideas and technologies to the market, and it will become harder, as more and more layers of the onion are peeled back on healthcare.  Yes, fellow bloggers, there is much untapped capital sitting on the side line, but no one is interested in betting the house on more hardware.  Besides, banks in this country would rather play in the derivatives market and overseas, than help its own people.  Fiscal austerity is here to stay.  All will be held accountable.

The first quarter of '10 was a taste of things to come.  NuVasive began the year poised to move up the ladder, only to experience a slight derailment, having to defend XLiF with the insurance industry and the analysts' which included, enlisting NASS to address coding issues, and providing data to substantiate the clinical efficacy of XLiF.  Rumor was that Luiz Pimenta sent his pictures of Shakira (who was that blonde?) dancing up and down the steps to highlight how effective this procedure is.  In addition, the Bear made some formidable predictions that were based on KOL's that surgical volume was not slowing down,  even though the healthcare economy was readjusting itself to market conditions.  A 52 week high of $46.83, NUVA is now $26.01 attributed to surgeries being denied by the insurance companies. Welcome to the new decade in healthcare,  accounting for 25% of the GDP.  With much uncertainty in the market, it will be interesting to see how defiant the Bear is in his guidance for the upcoming year.  Stryker was another big story.  During the first quarter, TSB blogged that Stryker should retire OP-1 and stop the Kabuki Theater with Apatech by pulling the trigger on acquiring this biologic, only to be upstaged by Baxter.  Stryker's Ego will defend that selling OP-1 to Olympus was addition by subtraction, distancing oneself from a segment of the market that has led to a series of investigations and litigation.  As Stryker continues to look for the next new thing, maybe Olympus will be a future partner?  The industry has learned that Stryker is not very good at biologics.  The quarter also brought us the Trans 1 and Life Spine marriage,  a marriage made for divorce court.  One thing for sure, after a 52 week high of $4.11 per share TSON closed at a $1.98.  Like NUVA, TSON is dealing with chronic reimbursement issues, and it will become even more challenging for them as the scrutiny intensifies.   Zimmer made some perfunctory noise.  But when doesn't Zimmer make some noise?  If there ever was an organization that is out of its spinal element, it is the Big Z.  DD are you listening, TSB is giving you free advice, cut your losses and get rid of the spine division, you're completely out of your league.  Legacy companies continue to hire the same people over and over expecting different results.  If you want talent, you need to move spine out of Minnesota to a warmer climate.  What is it about this company, and spine?  Yet, TSB believes that the biggest story of the first quarter was the rise of the POD.  Surgeon distributors intend on saving the  U.S. healthcare market by driving down the cost of implants by eliminating the sales representative from the equation.  In addition to POD's, word on the street is that some insurance companies are considering passing on the direct cost of the implants to the patients.  We will be following this as it develops.   POD's need to be scrutinized, claiming that it's not about the profits, it's about cost containment.  If that isn't a bit of pretzel logic, what is?  We learned that the spine industry is no different than Wall Street.  As long as you can stretch the laws, anything is possible.  The legality of this model will eventual be challenged regardless of what has transpired on the Left Coast. Legacy companies are concerned about the deleterious effect that POD's will have on its business distribution models and profits.  The so-called "ankle biters" in the industry are elated, because everything is not global but local when it comes to their business, leveraging their geographical strengths and relationships.  The bottom line POD's are not going away, at least not in the very near future.  If anything, the states will have to challenge this model, before it ever becomes a federal issue.

The second quarter brought us a run for the roses.  Questions arose regarding the industry's odds on favorite NuVasive, in achieving its guidance for the year, while the rest of the industry burned.  As summer approached, rumors swirled that US Spine had the proverbial "For Sale"sign up on the front lawn.  Cardo Medical and Amedica were the then leading contenders, the rest is history.   During the quarter, we heard rumblings on the Street that Applied Spine R.I.P., and Disc Motion were hanging on the ropes.  Was there a symbiotic relationship there?  Since then, Craig Corrance was hired as the new CEO at DMT.  TSB now believes that Corrance, aka Virgil Kint, is the real Kaiser Soze.  If Andy Greenburg could not raise capital, wouldn't invest his own money and couldn't sell the company, what does that tell you?   We reported about the continued lack of transparency at NASS, based on the fact that surgeons report stock, honorarium and consulting fees, but fail to report that they are actual investors in certain companies.  As a tribute to the ailing Queen of Soul, "Shame, Shame, Shame ......... Shame on You."

Lanx became everyone's darling in the third quarter.  Confusion arose as to whether they were hiring former Medtronic employee Michael DeMane as CEO.   Another company with a one-trick pony, and an aberrant BOD's,  Lanx is better known for getting rid of employees than making progress.  Talk about a company that flushed an entire year down the drain.  Today, they have hired Dan Gladney in hope that he will lead his flock to the promised land.   Hopefully he will have the vision to clean house using the "inside out" employed on DGI's technology.  In many respects,  Lanx was the 2010 poster child for incompetance.   The K2M story was bigger than anything else, selling majority ownership to Welsh, Anderson, Carson, and Stowe.  The company is now poised to be package and sold to a legacy company.  S&N's name keeps surfacing.   Just what the industry needs, more GE wonks trolling the aisles at NASS.   You know what the late Lowell George always sang, "Time Loves A Hero."  Biomet CEO, Jeff Binder made some noise during a earnings call, stating that Biomet was looking to place an emphasis on "highly differentiated products."  Ahem!  Based on their portfolio and track record in spine, the only differentiating story in 2011 will be whether they are closing Biomet Spine in Parsippany, NJ and relocating the division to the corn fields of Warsaw, Indiana.  It is inevitable that the moving van is not that far behind.  If anything,  this will allow Binder to get rid of the dead wood that exists in that division.

The fourth quarter brought the industry much legal angst.  Synthes was finally slapped with a nominal fine for their complicity in the Norian debacle. $23 million is mere pocket change for Mr. #7 aka Hansjoerg Wyss considering that he used $35 million of his own to prop up the environment in Montana.  The industry awaits word as to whether the Fantastic Four will serve some jail time.  Sometimes, one has to wonder how someone so smart, could be so dumb?  NuVasive and Globus are enriching the legal industry with their tete-a-tete, while AlphaTec is under tremendous scrutiny for potentially manipulating and misleading investors that purchased ATEC stock only to watch it collapse. This has resulted in a class acton law suit involving investors which probably are made up of pension funds that were silly enough to buy into Healthpoints BS.   The question still remains, how lame of an excuse can one use, by claiming that they had difficulties integrating Scient'x?   At best, Scient'x had revenue of $20-$25 million and a market cap of $60 million?    In addition to the aforementioned suits, once again Tom Errico and Stryker are at each others throats.  This has been, and is a love-hate relationship.  But what really jumped out at the industry during this quarter is the continued onslaught by the government and the press regarding surgeon royalties and consulting agreements which for one reason or another, always leads back to Medtronic.  With Hawkins departure, TSB sees the Evil Empire placing a CEO that will focus on rehabilitating its reputation with the Government. Once again, Drs.  Kuklo, Polly, and Rossner are now under investigation by the US Senate's Dynamic Duo of Grassley and Baucus for using Hydrosorb off label.  Hydrosorb is probably a biocompatible and biodegradable polymeric device that was a carrier for INFUSE.  Yet, one must wonder how much longer will this charade continue?  Whether or not Mssrs. Kuklo, Polly and Rossner used this product off label should not even be of concern to Batman and Robin, considering that the patients that have been contacted, and all seem to be doing fine.  One does have to wonder what is going on at Walter Reed in the name of medical progress?  The most recent article that was released on December 30th in Bloomberg exposing Twin Cities Spine as a "Fusion Factory," performing a weekly spinelalapalooza  should be cause for major concern.  If NASS, AANS, or CNS does not have the ability to police and question its own members regarding their outcomes, the government will definitely step in.  

So in closing, TSB wants to wish all our readers and their families a healthy and prosperous 2011.  We will continue to monitor and report on the industry in the most efficient and honest way possible, regardless whether our opinions differ. What we can tell our bloggers is that this year alone, we had over 800,000 viewers, with 500,000 unique visitors and send a special thanks to each and everyone of you that contributed your opinions and comments.  

53 comments:

  1. Great job this year TSB. This is an excellent blog. Thanks for all the hard work you put into it!

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  2. Echoing @1:25, excellent job. There is no remedy like the truth

    More spine coverage (similar to WSJ) from Bloomberg
    http://noir.bloomberg.com/apps/news?pid=20601109&sid=akgS7Fb6dBcg&pos=10

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  3. G-d bless free markets, but that house in 2:14's link, which looks like the Neverland Ranch took steroids, is obscene.

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  4. You forgot to mention Centinel Spine! Centinel Spine will go bankrupt in 2011.

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  5. TSB,, Wonderful blog & congrats on a tremendous year on the blog!! Having read this blog, perhaps you should have titled it,, "Liars & Tigers & Bears,, Oh My!!".

    As it was clearly a terrible year for all (3),, and some of those referenced by you in the blog above certainly fall into more than 1 of these categories,,

    Happy New Year to all!!

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  6. Bravo!! Looking forward to your insights in 2011 and wishing you and your family health and happiness

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  7. Thank you for keeping this blog alive and kicking. I enjoy reading it every day. Happy New Year.

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  8. I'm halfway through the latest WSJ article, and the author has yet to reveal his/her N. This was my cue to stop reading:

    "The patients illustrate the costs and risks of fusion surgery. They are not a scientifically representative sample of Twin Cities Spine patients, the majority of whom the firm says are happy with the treatment they receive."

    What a useless piece of writing.

    Anyway, happy new year!

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  9. 5:48 - I think your up a little too early. The authors of the article are listed at the top of the page and the quote you provided is from a marketing person at Twin Cities Spine - not the authors.

    This was an AWESOME read by the way!

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  10. 8:22, I am not 5:48, but I have to defend him...I shudder to think how you present studies to surgeons, assuming you are a rep. 5:48's reference to N is the Number of patients, not the names of the authors. N is often overlooked in journalism.

    TSB, thanks for the blog, I always look forward to your insights, even when we disagree. I believe that you are making a significant impact on the industry by building this forum. Exchange of ideas and opinions is a healthy and constructive exercise. I, for one, approach my job and my customers with more confidence and better informed because of the industry information that I seek. You contribute a lot to that pursuit. Happy New Year!

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  11. 9:18 and 5:48
    Agreed, This hit piece on TCS is a joke. According to article they do 1300 fusions a year. Yet, Bloomberg only finds 11 people with a bad outcome. Even if they were in the same year that percentage is .008

    Fed law prohibits doctors from discussing these patients so we don't get the full picture of what type of patients they were.

    This report is swiss cheese.

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  12. 9:18 and 10:58--5:48 here. Thanks for explaining to 8:22.

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  13. All of you: you just read in the article what you want to read, not what's written. But the bottom line is: even if the story is slanted, it's yet more bad press for spine.

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  14. This report only discusses poor outcomes in 11 patients, yet isn't anyone in the medical community concerned that Twin Cities could be a "fusion mill?" How does one surgeon perform 400-500 fusions per year? It should be cause for concern when royalties and consulting agreements "potentially" become the impetus that blurr the lines in someone's judgement between what constitutes good medical decision making, and decisions that are "potentially" driven by volume for $$$$. If this behavior did not exist in spine, we wouldn't be having this discussion. To quote TCS marketing director, do these numbers sound like " a conservative course of treatment in the vast majority of TCS cases?" Roughly 33% of their cases are lumbar fusions. In 2009 Dr. Pinto co-authored a study on 125 patients who had undergone fusion on 4 or more levels. Out of these patients only 80 patient were accounted for in the study, what happened to the other 45 patients? But you know what Sage Francis rapped:

    "I just sit there and let the thoughts flood
    And I remind myself that it's all right, it's all good,
    It's all love, it's not though,
    Cuz there's a kink in the armor,
    A pot hole I'm sinkin' in, the more I think of the drama,
    So I stand up, I start to pace, in my living room....

    The water line is rising and we do stand there....."

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  15. First off TSB, great work all year and thanks for all you do!

    This article sensationalizes for the sake of the story by clearly presenting the adverse side of spinal fusion for low back pain. However there are two striking statements in it that merit note:

    "Suffering from an aching back, truck driver Mikel Hehn went to see surgeon Jeffrey Gerdes in 2008. The St. Cloud, Minnesota, doctor diagnosed spinal disc degeneration, commonly treated with physical therapy, and said surgery wasn’t called for.

    UNHAPPY WITH THE ANSWER Hehn turned to Ensor Transfeldt, a surgeon at Twin Cities Spine Center in Minneapolis. Transfeldt performed fusion surgery on Hehn, screwing together three vertebrae in his lower spine"

    The four capitalized words are exactly what is wrong with the US healthcare system and this patient population. Any low back pain patient considering surgery HAS to realize that if you are risk averse, take the rehab and make the best of it. That's what Doc A was advocating. If you are a risk taker then have the surgery realizing that you taking a risk that you will be one of the 20% who are substantially worse off after surgery, even in the best of hands. If you don't like the odds, don't have the surgery! Patients who believe "I can't live like this" or are "unhappy with the answer" are deluding themselves. Yes, you can live like this, yes rehab and lifestyle modification can help you, and yes, things can be even worse after surgery. Yes, you also have a 60 percent chance of being much better too, and whether that is a chance worth taking is up to you. Mr. Hehn, whom I have sympathy for, needs to live with the unfortunate consequences of a decision he himself made.

    The other staggering point is:

    "Fusion has helped spine surgeons become the best paid doctors in the U.S. Their average annual salary is $806,000, more than three times the earnings of a pediatrician, according to the American Medical Group Association, a trade organization for doctor practices." -- I knew they were well paid and that is their salary range, but that that is better than any other doctor category is news to me. If I ever again hear of a spine surgeon complain about declining reimbursement I'm going to puke.

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  16. DD will never have the stones to admit that Zimmer's flirtation with Spine is a complete joke. As long as Zimmer Spine can kick their profits up to Warsaw, DD will continue to bleed that division dry. When ZS ceases to be profitable, it will be shed. Warsaw never has and never will understand the Spine market.

    It doesn't take a genius to figure out that questionable, unqualified, and out-of-touch people remain in positions of influence (ex corporate Abbott field sales management and a pathetic current division CFO (who's other title is "new bus. development" ... what a joke, unless that means developing business for the competition)).

    Meanwhile, the "good guys" in upper positions of power figure out this trainwreck within 12-18 months and quickly update their resumes and get the hell out of MSP. DD and Paulsen are influenced into terrible strategic decisions by these of same moronic leaders with ZERO accountability and horrible outcomes.

    Let's face it . . . Warsaw made a HUGE bet on Dynesys and lost. If MDT had Dynesys I'm 90% sure it would have been approved by the FDA. Warsaw is way out of their league in Spine.

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  17. Instead of everyone always looking at the surgeons & saying that they "cut" too much,,, has anyone ever stopped to REALLY look at many of the patients having surgery?? Believe it or not,, many patients are WAY overweight, out of shape, lazy and most of all WANT to have surgery in order to take time off from work.

    YES,, many patients opt for fusion surgery because they don't have to lose weight, don't have to work out, can keep living like slobs and can take advantage of their workers comp claims.

    I've been in spine nearly 12 years and have heard many, MANY stories of patients who have come right out and told their surgeons they'd rather have surgery than be faced w/ any of the challenges listed above.

    Do some surgeons "operate too much"?? Sure,, but it isn't all because of them simply wanting to be "fusion factories",, they simply know that if they don't do the surgery, said patient will end up in one of their competitors offices w/ the same request for surgery.

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  18. In reference to the surgeons using Hydrosorb off label. It was not a carrier for rhBMP-2, nor could it be used in that manner. It was made of a resorbable polymer ; it was designed to be a nexgen interbody device. Bone graft substitutes or bone graft could be placed in it or around it like in any interbody device. Of course if INFUSE, by surgeon's choice, was used with it, then we better call for a full senate investigation, castigate the surgeons and amp up the mafia like government shake down on MDT. What a joke.

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  19. I once saw a patient, all 350 lbs of her, in a spine surgeons office who after looking at all of the usual films turned around and suggested that she lose some weight before deciding on surgery. He called it a conservative/holistic approach. He was the third doc that she had gone to. In response to TSB's point, how many surgeon's would do that? Realistically, any doc that knows his craft wants to stay away from this type of patient, it's either a lawsuit waiting to happen, or a phone call every Friday at 4:00 asking for more drugs. Cutting for the sake of cutting, some other surgeon is going to do the case does not justify cutting every breathing person.

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  20. 918 1058 548, WSJ is not a scientific journal and its standards do not include n or p values. it is bad press.

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  21. MM - you're not gonna get much ra ra behind you regarding this article. There are too many MDT lovers on here.

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  22. Not looking for love, just looking a forum where we can discuss why are we fusing so many patients? It's okay to love Medtronic, but you know what the great Waylon Jennings sang:

    ...looking for love in all the wrong places, looking for love in too many faces, searching your eyes, looking for traces.. of what I'm dreaming of....

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  23. I agree with 6:50 and prior, similar sentiments, although my N is only 1. It took my PT six months to work. Why are some of our devices indicated for use after six weeks of conservative care when it can take much longer than that?

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  24. 6:43, I'm by no means an MDT-lover. In fact, I look forward to watching them lose their market-leading position to us over the next few years. That said, others have correctly noted the article is sh*t.

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  25. TSB, I like the new look. The old one was good, but something new for the new year is cool too.

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  26. TSB,

    Thank you for holding everyone's feet to the fire, especially Birchler's. Hopefully in 2011 we will see him sashay out the door:)

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  27. Try try as they may, this article and others like it will do nothing to blemish MSD. These articles bounce off the force field like dry spit wads.
    Even if the amounts paid to physicians are obscene by most standards they will pass muster when it comes down to it. Do any of you knuckleheads thing MSD would do anything these days to get their ass in a sling? The answer is NO.

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  28. You MDT fellas are pretty cocky, eventually you'll slip up and step on your own dicks

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  29. 10:02 : 2nd the new look.

    And has anyone else conjured up ideas of funny business at MDT due to Hawkins resigning the day their royalties made the cover of WSJ? Big checks to surgeons aside, is there something greater afoot in Memphis?

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  30. How do you get a job with MDT spine when you don't have to sell and bring no value in the case and then get tons of cases cuz your company literally writes your surgeons checks for using their products. It's like winning the lottery of device jobs. Oh right right right, your relationships are SO strong (he says in that sarcastic Homer voice). And yes I am jealous cuz I wish my company was handing out not just regular checks, but fat checks like candy.

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  31. We had all better check our closets for skeletons regarding consulting agrmts, etc. Not to worry when everyone has to begin reporting their pmt to MDs in a year or so, things will really get crazy.

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  32. TSB, you think there's any truth to the rumor about Zimmer buying Alphatec? I don't see it happening but would be curious to get your thoughts.

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  33. Where did you hear Zimmer was going to buy Alphatec? That would give Zimmer decent products to put in the physicians hands, just doubt it would happen.

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  34. Another year and still no appropriate reimbursement for PRP/Platelet Gel/AGF/Autologous Conditioned Plasma.... ..Whatever we're calling it these days! Any word on the street whether this stuff survives another year?

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  35. Sorry, but the appropriate reimbursement for PRP (ie ZERO) is in place.

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  36. I heard the Zimmer buying Alphatec rumor too!

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  37. I have a hard time believing Zimmer would buy a company built on the POD model. There is just no way anyone is going to buy a company full of POD business. Zimmer made that mistake with Abbott ... knowing that the majority of Abbott's US business was consultant driven.

    Huh you say? Go back to the investor analyst call at the beginning of 2010 when the Big Z CFO (Jim Crines) announced they were writing down the value of that acquisition by $70+ Million. This is why the anon poster above is ripping on current/former Abbott management. The big Z, being clueless in spine, paid way too much for that pile of crap in Austin. And in the Big Blue Z's infinite wisdom they kept that crap pile open AND moved their distribution from Memphis to Austin. reaaaallllll smart since every other spine company with half a chance knows to locate their distribution next to the main FedEx hub.

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  38. HAHAH If I was an idiot who put $ into ATEC, I'd want someone to buy me out too!!!!! Not going to happen. Maybe ATEC can merge with Amedica or Trans1 to further investor confidence and prolong the agony before going bankrupt.

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  39. I heard Talbot and Holman are putting in an offer to purchase Alphatec.

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  40. If Talbot and Holman are putting an offer in, I'm in. At least their putting their money into a real company

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  41. How do you figure ATEC is "built on the POD model"? They do sell to PODs, but that is wholesale and they don't particularly like it, but it is business and they are immune from the legal issues involved. They just sell to the stocking distributor, they are not involved in the ownership or payment of docs.

    Who are Talbot and Holman?

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  42. I heard that SS Fusion Medical in Florida left ATEC. Is this true? Wasn't he the largest distributor they have? What happened?

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  43. Yes you are correct and chalk one up for SYK

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  44. I am clueless on Talbot and Holman as well?

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  45. Talbot and Holman are two venture capitalists that have ties to purchasing small to medium sized medical device companies.

    Troy Talbot and Court Holman are very dialed in to Alphatec and the rumor is they are interested in buying a piece of the action.

    Look out!

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  46. Suffice it to say there was more to the SS Fusion deal than a simple switch in companies. Having seen ATEC and SYK core spine products up close and personal, I think he will have a hard time converting his docs to SYK. It will be interesting to see if his reps go with him.

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  47. Talbot and Holman. Are they the Zimmer Spine Distributors up in the Minesota, ND, SD area?

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  48. Talbot and Holman deux capitaliste de venture? Didn't Messieur Holman invest in that dog of a company Cripple Spine?

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  49. 10:25 Not only did his reps go with him, but he is now the big boss of lots of SYK reps in Fla. Oh and by the way I would think a rep selling $10-12 MM doesn't make a move like that without making sure docs would agree with switching in advance

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  50. SYK bought a company that the distributor owns with the stipulation he had to ditch ATEC and go to work for SYK. Based on the rumors of what they paid him for the company, he won't care if his docs switch or not.

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  51. From reading this blog, docs hate reps who make more than them, so they will all really hate him now.

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  52. Interesting that SYK would take on this ATEC distributor who has a sleezy reputation. SYK professes they want good and ethical people but then turn around and hire this guy. I also heard the same rumor about millions of dollars paid by SYK to him for a tracking software company. I guess Scanell will take on anyone and pay anything to increase sales regardless of the impact on SYK's reputation and his other distributors who do the right thing. I guess all he cares about is sales and to hell with SYK's reputation.

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  53. Lawson learned the hard way about Scannell. We in the trenches now must live TS dream. Many good stories told. It's a long way to fall.

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