VOLUME 7, ISSUE 38 | DECEMBER 6, 2011

week in review

Are You the Victim of Monopolistic Insurers? 4Check This List to Find Out ◆ Physicians have been the tar- get of antitrust prosecutions by the Jus- tice Department and the Federal Trade Commission for years. Now the gov- ernment wants to hear from physicians about potential antitrust market prac- tices by hospitals and insurers in their communities. Read what the lawyers want you to look for.

Carragee for the Prosecu- tion ◆ In the recent issue of The 8Spine Journal Eugene Carragee, MD, writes more like prosecutor-in- chief than editor-in-chief as he resumes his attack on the use of rhBMP2 and On (and Off) the Re- its clinical investigators. The plaintiff’s cord ◆ Chris Bono, M.D. breaking news bar is cheering. But NASS members are finds alarming differences reeling. Who to believe? Read the de- 16 between abstracts and manuscripts… Infuse Hurts 2Q12 tails here. Air Force Maj. Erik Nott, M.D is award- Medtronic Spine Sales ed the Purple Heart…new funding ...... program…news on impingement… 20 First Dedicated Meniscus Transplant and more… Center ...... Is Age 90 the New 85? ...... Former Synthes Execs Jailed ...... Seitz vs. Burkhead in Tavenner Nominated to Head CMS Orthopaedic Cross- ...... ® ◆ 12fire Fixation Debate Osteoporotic Bone Screw Scores Well Washington Generals vs. the Harlem in Sheep Test Globetrotters? All we know is when ...... Buzz Burkhead and Bill Seitz debate Injured Athletes: Who is Responsible? the audience gets an entertaining edu- cation. Did Dr. Seitz cement a victory or did Dr. Burkhead press fit his advan- For all news that is ortho, read on. tage? You be the judge.

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Orthopedic Power Rankings Robin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

This Week: CMS to require 100% prepayment medical review (up from 10%-30%) beginning January 1, 2012, for certain orthopedic DRGs. New admin burden on hospitals will not affect hip, knee, extremity, spine or trauma volumes. Ortho equities looking good.

Rank Last Company TTM Op 30-Day Comment Week Margin Price Change

Last week’s sell off put ZMH’s P/E at 10.39, the 1 1 Zimmer 27.75% (5.63%) lowest of all orthopedic companies. Very cheap earnings and still #1. Since 2006, MDT’s dividend more than doubled 2 2 Medtronic 28.63 1.88 from $0.44 / share to $0.94 / share. Almost as cheap as ZMH. OFIX is the least expensive PEG stock in ortho. 3 3 Orthofix 14.72 (4.25) And management routinely beats EPS estimates. What’s not to like? Up two spots this week. 2012 is shaping up to be 4 6 Stryker 25.23 (0.29) strong year for ortho overall but SYK certainly. Up four spots. SNN’s return on capital much higher Smith & 5 9 22.80 3.27 than its cost of capital. SNN to be “discovered” by Nephew investors in 2012? Johnson & The mood is turning from safety havens to 6 5 26.33 0.66 Johnson underpriced growth stocks. That’s not JNJ. Profit margins rising at CNMD, we think, but market 7 4 Conmed 9.65 0.31 turning to undervalued, higher margin ortho companies. Nice bounce this past month. Was actually the best 8 10 Integra 15.38 10.49 performing ortho stock.

Hit hard this past week. It’s tough to be the small 9 7 Exactech 7.69 (10.93) manufacturer in ortho these days.

Phenomenal profit margins, but middle of the pack 10 8 Kensey Nash 34.24 0.71 in terms of growth expectations.

1-888-749-2153 | www.ryortho.com 3 VOLUME 7, ISSUE 38 | DECEMBER 6, 2011 Robin Young’s Orthopedic Universe Top Performers Last 30 Days Worst Performers Last 30 Days Company Symbol Price Mkt Cap 30-Day Chg Company Symbol Price Mkt Cap 30-Day Chg

1 Integra LifeSciences IART $31.27 $839 10.49% 1 Bacterin Intl Holdings BONE $2.11 $86 -33.02% 2 ArthroCare ARTC $29.62 $815 9.18% 2 MAKO Surgical MAKO $28.76 $1,198 -20.60% 3 TranS1 TSON $1.72 $47 8.86% 3 TiGenix TIG.BR $0.91 $83 -17.19% 4 Wright Medical WMGI $14.66 $577 3.39% 4 Symmetry Medical SMA $7.75 $281 -13.89% 5 Smith & Nephew SNN $45.74 $8,173 3.27% 5 NuVasive NUVA $12.83 $542 -11.09% 6 Medtronic MDT $34.61 $36,548 1.88% 6 Exactech EXAC $14.10 $185 -10.93% 7 Kensey Nash KNSY $25.70 $222 0.71% 7 Alphatec Holdings ATEC $1.90 $170 -8.65% 8 Johnson & Johnson JNJ $63.47 $173,327 0.66% 8 RTI Biologics Inc RTIX $4.27 $236 -8.57% 9 Conmed CNMD $25.89 $723 0.31% 9 Tornier N.V. TRNX $18.66 $733 -7.58% 10 Stryker SYK $47.62 $18,223 -0.29% 10 Zimmer Holdings ZMH $48.92 $8,765 -5.63%

Lowest Price / Earnings Ratio (TTM) Highest Price / Earnings Ratio (TTM) Company Symbol Price Mkt Cap P/E Company Symbol Price Mkt Cap P/E

1 Zimmer Holdings ZMH $48.92 $8,765 10.39 1 Wright Medical WMGI $14.66 $577 31.19 2 Medtronic MDT $34.61 $36,548 10.39 2 RTI Biologics Inc RTIX $4.27 $236 26.69 3 Orthofix OFIX $32.20 $593 12.48 3 Synthes SYST.V X $165.49 $19,657 20.95 4 Smith & Nephew SNN $45.74 $8,173 12.57 4 ArthroCare ARTC $29.62 $815 20.71 5 Integra LifeSciences IART $31.27 $839 12.92 5 NuVasive NUVA $12.83 $542 19.15

Lowest P/E to Growth Ratio (Earnings Estimates) Highest P/E to Growth Ratio (Earnings Estimates) Company Symbol Price Mkt Cap PEG Company Symbol Price Mkt Cap PEG

1 Orthofix OFIX $32.20 $593 0.76 1 NuVasive NUVA $12.83 $542 4.29 2 RTI Biologics Inc RTIX $4.27 $236 0.94 2 Wright Medical WMGI $14.66 $577 3.44 3 Zimmer Holdings ZMH $48.92 $8,765 1.11 3 Kensey Nash KNSY $25.70 $222 3.04 4 Stryker SYK $47.62 $18,223 1.23 4 Johnson & Johnson JNJ $63.47 $173,327 2.14 5 Exactech EXAC $14.10 $185 1.27 5 Symmetry Medical SMA $7.75 $281 2.00

Lowest Price to Sales Ratio (TTM) Highest Price to Sales Ratio (TTM) Company Symbol Price Mkt Cap PSR Company Symbol Price Mkt Cap PSR

1 Symmetry Medical SMA $7.75 $281 0.78 1 TiGenix TIG.BR $0.91 $83 133.64 2 Exactech EXAC $14.10 $185 0.97 2 MAKO Surgical MAKO $28.76 $1,198 27.05 3 Alphatec Holdings ATEC $1.90 $170 0.99 3 Bacterin Intl Holdings BONE $2.11 $86 5.56 4 Conmed CNMD $25.89 $723 1.01 4 Synthes SYST.V X $165.49 $19,657 5.33 5 Orthofix OFIX $32.20 $593 1.05 5 Tornier N.V. TRNX $18.66 $733 3.22

PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.

Advertise with Orthopedics This Week Click Here for more details or email [email protected] Tom Bishow: 410.356.2455 (office) or 410.608.1697 (cell)

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Are You the Victim of Monopolistic Insurers? Check This List to Find Out By Walter Eisner

ing of market forces, structures, and dynamics in the health care industry.

She told the health care lawyers that the biggest obstacle to an insurer’s entry or expansion in the small- or mid-sized- employer market is scale. New insurers cannot compete with incumbents for enrollees without provider discounts, but they cannot negotiate for discounts without a large number of enrollees. This circularity problem makes entry risky and difficult, helping to secure the position of existing incumbents.

Preventing Domination

“It is, therefore, imperative that the wicourts.gov and mncourts.gov/RRY Photo Creation Division prevent mergers or acquisi-

hysicians, including orthopedic study of U.S. insurance markets, 83% surgeons, have complained for of the 368 metropolitan areas studied Pyears that the Department of Justice were highly concentrated. In 95% of (DOJ) and Federal Trade Commission the metropolitan areas, one or more (FTC) have targeted them for antitrust insurers had a combined HMO+PPO violations while hospitals and insur- market share of 30% or greater. And in ance companies have escaped scrutiny 47% of the areas, at least one insurer and prosecution as they become domi- had an HMO+PPO market share of at nant health care players in their com- least 50%. munities. Department of Justice Seeks Input “More than 30 groups of physicians have been prosecuted over the past 14 Now the DOJ is signaling that it wants years for alleged antitrust violations help from physicians to identify anti- when dealing with insurers,” Michael competitive practices by insurers and Connair, M.D. told OTW on November hospitals. 28. In a 2010 speech, then Assistant Attor- Highly Concentrated Insurance ney General Christine Varney told the Markets American Bar Association/American Health Lawyers Association that it is At the same time, according to an essential that the government continue American Medical Association (AMA) to refine and expand its understand- Advertisement

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dation during the past 20 years, says Allen. “In many areas throughout the country, physicians now face a domi- nant hospital with the power to cripple physician-owned facilities. Physicians are also confronted with health insur- ers that possess ‘monopsony’ or ‘buyer’ power—the ability to reimburse phy- sicians at rates that are so far below a truly competitive level that physicians may be driven from the market and patients may receive diminished service and quality of care.”

Health insurer monopsony power, says Allen, enables dominant insurers to insist on anticompetitive contractual AAOS Website provisions. “One such provision is the so-called ‘most favored nation’ clause, tions that will create, or even increase concerning such conduct may be of in which the dominant health insurer the size of, dominant health insurance interest to DOJ,” said Allen. demands that a physician accept from plans, particularly in the small-group it the lowest reimbursement rate that and individual markets,” said Varney. Allen told OTW that there is now an the physician accepts from any other appreciation by the government of the The new prosecution attitude was dis- frustrations experienced by physicians played in an October 2010 meeting on antitrust matters. Allen participated between representatives of the Ameri- on a speaker panel at the October 2010 can Medical Association, the American meeting that included a DOJ official. Where world-class Academy of Orthopaedic Surgeons That official expressed a willingness solutions revolve (AAOS) and Democratic Rep. John to review cases forwarded by the AMA around you. Conyers, Ranking Member of the U.S. where physicians conclude they are the House of Representatives Judiciary victims of anticompetitive conduct. Committee. Conyers held a congressio- nal hearing after the meeting with the Contact the AMA physicians and developed a framework for physicians to use to provide infor- Allen made it clear that he is neither mation to the DOJ and FTC regarding offering legal assistance nor agreeing to potential antitrust activities by domi- act as an agent or representative for any nant hospitals and insurers in their individual physician. With that under- areas. standing, he is interested in receiving information on health insurer or hospi- In a just published article in AAOS tal anticompetitive conduct for possible NOW, Henry Allen, JD, senior attorney referral to DOJ, assuming that the AMA for marketplace advocacy for the AMA believes the agency would consider the provides a list of behaviors that may be information important. anticompetitive when conducted by market dominant health insurers and Hospital and health insurance markets US 1.260.747.4154 · IRELAND +353 94 904 3500 hospitals. “Accordingly, information have undergone significant consoli- Advertisement

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an anticompetitive practice. He says if • The dominant hospital condi- your area includes a dominant hospital tions the granting or continuation or health insurer, and you believe that of privileges on an agreement by any of these activities are occurring, physicians that they not seek priv- you may want to share that information ileges from other hospitals in the with him at the AMA. area. • The dominant hospital pressures its Allen can be reached at Henry.Allen@ employed physicians to not refer ama-assn.org. patients to freestanding outpa- tient facilities or to specialists not Below is Allen’s summary of potential employed by the hospital. anticompetitive behaviors from the • The dominant hospital gives AAOS NOW article. employed physicians financial benefits if they only refer patients Anticompetitive Behaviors to other employed physicians. • The dominant hospital initiates The following behaviors indicate that “sham proceedings” against another a hospital and a health insurer may be hospital, physician-owned hospi- working together to limit competition: tal, or physician-owned outpatient Henry Allen, JD center. For example, the dominant • A hospital and a health insurer in hospital knowingly submits mate- health insurer. Another tactic of health the same area refuse to deal with rially false statements about the insurer monopsonies is to offer reim- competing insurance plans and small hospital in a certificate of bursement rates that prevent would-be competing physician-owned facili- need application or files frivolous competitors from entering the market. ties. lawsuits against the other hospital Therefore, appropriate enforcement • A health insurer refuses to contract or facility. of antitrust laws is critical to prevent with a physician-owned specialty • The dominant hospital institutes anticompetitive health insurer merg- hospital or outpatient center, while “conflict of interest” policies that ers and to prohibit actions that inhibit permitting a dominant hospital exclude physician owners of a com- the entry of new health insurers into a to add new facilities to its already peting specialty hospital or out- market.” existing network. patient center from the hospital’s • A health insurer offers reimburse- medical staff. Allen continued that the consolidation ment rates that discriminate against • The dominant hospital refuses to of hospital markets has made it dif- a dominant hospital’s rivals. enter into transfer agreements with ficult, and sometimes impossible, for • A dominant hospital offers bun- physician-owned facilities. physicians to open and operate free- dled price discounts to insurers in • The dominant hospital requires standing surgery centers. “Dominant exchange for an exclusive arrange- that physicians perform a certain hospitals have shown a willingness to ment with the hospital; as a result, percentage of procedures at the use their market position to hurt phy- smaller competing hospitals or phy- hospital. sician-owned surgery centers and the sician-owned facilities are unable to • The dominant hospital creates an physicians who work at or invest in obtain a contract with the insurer. alliance with staff physicians to those centers.” • A hospital and insurance company collectively negotiate with health merge, or one acquires the other. insurers. According to Allen, identifying anti- • The dominant hospital negotiates competitive practices by hospitals and Dominant Hospital an exclusive managed care contract health insurers is a critical first step in with a critical health insurer or with protecting orthopedic practices and The following behaviors indicate that a several different health insurers. physician autonomy. He summarizes dominant hospital may be abusing its • The dominant hospital merges with the types of conduct that could indicate market position: or acquires another hospital.

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• The dominant hospital refuses to contract with a health insurer for certain services unless the health insurer agrees to use it for nonre- lated services as well. For example, a dominant hospital that is the only provider of Level III neonatal care in the area refuses to allow health insurers to contract for perinatal services unless they also agree to use it for nonperinatal services.

Dominant Health Insurer

The following behaviors indicate that a dominant health insurer may be abus- ing its market position to hurt smaller health insurers; such conduct would ultimately hurt physicians by giving the dominant health insurer “buyer power.”

• The dominant health insurer demands that a physician accept from it the lowest reimbursement Advertisement rate that the physician accepts from any other health insurer (“Most future insurance products and pay- will have potential anticompetitive Favored Nation” clause). ment methods offered by the com- implications for physicians as it relates • The dominant health insurer threat- pany as a condition of participat- to Accountable Care Organizations and ens to terminate a physician’s pro- ing in any of the insurer’s products. insurance exchanges. The opportunity vider status if the physician agrees This can include requiring the phy- provided by AAOS and the AMA to to contract with another health sician to participate in an insurer’s offer direct evidence of anticompeti- insurer. health maintenance organization. tive insurance company and hospital • The dominant health insurer pays • A dominant health insurer merges market activity is one that orthopedic discriminatory reimbursement rates with or acquires another health surgeons should take seriously. to physicians who work with a rival insurer. health insurer. Tell Henry Allen what you see in your • The dominant health insurer insists Make a Difference community. Again, his email is Henry. that physicians agree to an “all- [email protected]. ◆ products clause,” which requires The health care reform legislation, if it them to accept all present and survives the Supreme Court challenge,

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Carragee for the Prosecution By Robin Young

ugene J. Carragee, M.D., editor in chief of The Spine Journal (TSJ), Eresumed his prosecutorial debating style in the journal’s latest issue as he responded to a letter to the editor citing omissions from the June 2011 issue of The Spine Journal and his own critical review of 13 early rhBMP2 studies.

The letter to the editor in question came from six frequently published (Journal of Bone and Joint Surgery and SPINE among other journals) and esteemed authors concerning one of their studies which Carragee et al. had selected for criticism in the June 2011 issue of The Spine Journal. In their letter this group of investigators found that Carragee had omitted key, material information Screen shot from the movie Inherit the Wind starring Spencer Tracy, Frederick March and Harry Morgan. which might well have changed Carra- Courtesy Wikimedia Commons gee’s conclusions regarding their study. arthrodesis. J Bone Joint Surg Am terolateral spine fusions. The authors Carragee’s response, published in the 2009;91:1377–86. enrolled 98 patients. Forty-five were November issue of TSJ, left almost no • Dimar JR, Glassman SD, Burkus randomized to the iliac crest bone graft room for further discussion and will, KJ, Carreon LY. Clinical outcomes group. Fifty-three were randomized to we expect, prove to be chilling to any and fusion success at 2 years of the BMP/compression resistant matrix other investigators who also found, as single-level instrumented Postero- group. we did at OTW, a pattern of omission lateral fusions with recombinant and error in the June 2011 issue of The human bone morphogenetic pro- Two years after the last patient was Spine Journal. tein-2/compression resistant matrix enrolled, the authors published a sum- versus iliac crest bone graft. Spine mary of their results. The six page report The authors of the letter to the editor 2006;31:2534–9; discussion 2540. offered three conclusions and a table were Drs. Dimar, Glassman, Burkus, which listed 12 categories of adverse Pryor, Hardacker and Carreon. Who to Believe? events for both the BMP patients and the control patients. Here are the con- Here are the citations for the two stud- In 2006 Dimar, Glassman, Burkus, clusions: ies in question: and Carreon published, in SPINE, the • Dimar JR, Glassman SD, Burkus results from their part of a prospective, 1. Both patient groups, the ICBG JK, et al. Clinical and radiographic randomized FDA investigational device group and the rhBMP2/CRM group, analysis of an optimized rhBMP-2 exempt (IDE) study of a new dose improved after surgery. Specifically, formulation as an autograft replace- of rhBMP2 in a novel, compression the two groups exhibited similar ment in posterolateral lumbar spine resistant carrier for instrumented pos- clinical outcomes as measured by

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the Short Form 36, Oswestry Low Back Pain Disability Index, leg and back pain scores at the two year Total Ankle Replacement The only mobile-bearing total ankle mark after surgery. replacement in the US 2. The group receiving rhBMP2/CRM had less operative blood loss and a shorter operative time (no second Long Term DATA IS KIng! surgery to harvest bone graft). The first prospective US study to have published long 3. The rhBMP2/CRM group had a term outcomes with the STAR ankle prosthesis found it higher fusion rate based on two- to be an excellent long term option for the treatment 1 year CT scans of ankle arthritis.

Twelve categories of complications were 9.1 Years Average Follow-up listed in a table for both the rhBMP2/ 91% of Prostheses Remain Implanted CRM and ICBG patients. Carragee said in his June 2011 article that the Dimar 92% of the Patients Were Satisfied study did not mention BMP related complications. In a direct refutation of

Carragee, OTW reproduced the Dimar 1Mann J, Mann R, Horton E. “STAR™ Ankle: Long-Term Results”. Foot & Ankle International, Vol. 32, No. 5, May et al. table in our critique of the June 2011, 473-484. Food and Drug Administration Premarket Approval 1380 South Pennsylvania Ave. 2011 issue of TSJ. # P050050. Approval Order issued on May 27, 2009. Morrisville, PA 19067 www.totalsmallbone.com Caution: United States federal law restricts this device Tel (215) 428-1791 www.star-ankle.com to sale by or on order of a physician. Fax (215) 428-1795 www.staranklereplacement.com STAR is a trademark of Small Bone Innovations, Inc. Four years later, in July 2010, the FDA MKT 160614 Rev A published an executive summary of the Advertisement entire FDA monitored rhBMP2/CRS study—which included the Dimar et three Dimar, et al. conclusions. Here • At 24 month follow up, the al. patients along with patients from is a brief list of those FDA conclusions AMPLIFY group had statistically 28 other study sites for a total of 463 which, like Dimar et al., looked at the lower rate of non-union adverse patients of which 234 received the 24-month outcomes. events—4.2% for AMPLIFY versus rhBMP2/CRS (now branded AMPLIFY) 10.3% for control (page 27) and 229 received ICBG. • Investigational group (rhBMP2/ CRS) and control groups (ICBG) But FDA Didn’t Approve AMPLIFY… The FDA’s summary ran 69 pages. were comparable in demographic and baseline characteristics (page The FDA’s review, however, looked In that FDA report, the complications 24) at data which was collected after the associated with the broader study were • The average operative time was Dimar et al. study in 2006. With five- reproduced in detail. Ultimately, the statistically less in the AMPLIFY year data, the FDA decided that AMPLI- range, type and severity of those com- patient group (page 25) FY, which has different pharmacoki- plications were too much for the FDA • The average blood loss was statisti- netics and pharmacodynamics than and the AMPLIFY dosage of rhBMP2 cally less in the AMPLIFY patient InFuse, had too many safety questions was not approved for commercial sale. group (page 25) to be approved for sale. Specifically, the • At 24-month follow up, the rate FDA said (Under the FDA rules, ANY All of this information was made avail- of adverse events was NOT statis- adverse event of any kind from any able for free to the general public. The tically significant between the two source was included): FDA’s conclusions were more extensive groups—87.4% of the AMPLIFY than those in the Dimar et al. study patients had an adverse event ver- • Of 25 categories of adverse events but, and this is key, they were consis- sus 87.9% of the control patients— listed by the FDA, the AMPLIFY tent with and supported each of the [emphasis added] (page 26) patients exhibited a statistically

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significantly greater incidence rate • The total number of AMPLIFY patient lished in SPINE in 2006 should have of adverse event than the control who reported having cancer at the been more comprehensive and could group in five areas (page 30). Those 60-month follow up was 12 (out of have included more information about five areas were: a total population of 234) and the complications. o Arthritis/bursitis total number of control patients who o Back and/or leg pain reported cancer at the 60-month fol- But the Dimar study, in contrast to Car- o Neurological adverse event low up was 5 (total control popula- ragee’s work, was unemotional, data o Trauma tion of 229) (page 33) driven and when it came to conclusions, o Cancer • At 60-month follow up, the num- landed on three simple ones and clearly • There were a high number of seri- ber of adverse events increased for kept the door open for more study. It ous back and/or leg pain adverse both groups (page 27) did NOT promote the product in any events in both groups but the rate • At 60-month follow up, the way that this reader could discern. in the AMPLIFY group was high- AMPLIFY group had a lower rate er—10.0% versus 8.0% (page 31) of adverse events than the control Carragee for the Prosecution • The total number of serious adverse group—92.9% for AMPLIFY ver- events was less for the AMPLI- sus 93.8% for control (page 27) So we return to the question of who FY patients than for the control to believe. The problem with Carragee patients—52.7% versus 55.8% Bottom line: the FDA said: “Long-term is that he is aggressively promoting a (page 31) data, although not intended as the pri- point of view and is omitting informa- • The rate of cancer, however, mary outcome measure of success, sug- tion which would modify his conclu- tended to be higher among the gests a less favorable profile. There is a sions. These omissions are clearly trou- AMPLIFY patients than for the concerning number of cancers in this bling to a growing number of experi- control patients. Here we will quote study and all rhBMP-2 clinical spine enced and respected North American directly from the FDA document: studies. Recombinant BMP-2 has sys- Spine Society (NASS) members. When “Although the rates (of cancer) in temic effects, not unlike any other drug, an author is omitting information, the the investigational group tended to and the medical community does not question of bias and agenda become be higher than those in the control, have enough information that relates to paramount. they are not statistically different at its long term pharmacological effects.” the 24 month analysis. However, We have disclosed some of Carragee statistical significance is borderline So, the System Worked? omissions in previous OTW articles. between the AMPLIFY and con- trol groups when all cancer events Looking back and having read both Carragee’s style of aggressive promo- though [sic] the 2010 Annual Dimar and the FDA review, it seems to tion has found its way into the form of Review are considered” (page 33) us that the six page study that was pub- argumentation that he employed in his response to the letter from Dimar et al. Simply put, Carragee is employing a prosecutorial style—which is a style we would not customarily expect to find in the pages of The Spine Journal.

What is a prosecutorial style of argu- mentation?

There are three basic elements:

1. Impugn the credibility if not integ- rity of any writer who would argue against the proposition Courtesy The Spine Journal and Elsevier

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receiving millions of dollars of royalties that were actually paid to an entirely different surgeon for a purpose entirely unrelated to rhBMP2 or the study in question.

But perhaps most worrisome, as we doc- umented previously in OTW (Medtron- Courtesy North American Spine Society ic and Carragee on Collision Course in Court?,October 25, 2011), one lawsuit 2. Avoid ambiguity. Ignore informa- ies, a fact, unfortunately, omitted or has already been filed which cites Car- tion which might conflict with the denied by the original authors in both ragee’s work as a key piece evidence for narrative of the case disclosures.” the plaintiff. 3. Find a simple storyline and ham- mer it home. For example: ‘cor- Clearly Carragee is accusing these The fact that Carragee uses the pros- rupt surgeons spin study data and authors of taking “multi-million cor- ecutorial style of argumentation, we therefore NASS’s membership lives porate funding” to perform the studies. believe, encourages the plaintiff’s bar. dangerously’ First of all, Carragee’s comment is factu- ally incorrect. OTW has been checking We at OTW are trying to apply more In Carragee’s response to Dimar et al., with these authors and so far, every one light than heat to this issue, but as the these elements of the prosecutorial style of them has told us that they received evidence of omissions and mistakes were, we believe, in full view. no compensation for performing the associated with Carragee’s work contin- studies. None. At all. Secondly, as we ues to grow and as Carragee increasing- Examples of Carragee’s Prosecuto- documented in earlier articles, the ly assumes the mantle of prosecutor if rial Style money Carragee is referring to is for any not also judge and jury, we are becom- payment made for anything at anytime ing ever more worried and concerned. Here, for example, is a selection from paid to any single author listed in the Carragee’s response to the Dimar, Glass- study. Carragee made no effort to find Space in this article precludes us from man, Burkus et al.’s letter to the editor out if any of these payments could, in listing every material omission or mis- of The Spine Journal; “The authors fact, be reasonably connected to these take that sadly now characterizes Car- received substantial sums for consult- studies or rhBMP2. ragee’s work in TSJ regarding rhBMP2 ing, royalties, and other support from and the investigators who have studied Medtronic and had extensive financial So, as we documented in earlier arti- the compound. ties with this manufacturer for many cles, a researcher (and we used Dr. years before and after publication.” Scott Boden as an example—although But, stay tuned. We are collecting exam- Then, two paragraphs later, Carragee the same is true of other researchers ples of Carragee’s omissions and errors writes: “It is clear, however, that mul- mentioned by Carragee) who refused and will be supplying them to both our ◆ timillion dollar corporate funding was compensation for conducting the study readers and NASS soon. received to perform both of these stud- was then credited by Carragee with

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Seitz vs. Burkhead in Orthopaedic Crossfire® Fixation Debate By Elizabeth Hofheinz, M.P.H., M.Ed.

Proposition Cemented Glenohumeral Fixation: Standard of Care William H. Seitz, Jr., M.D. Cleveland Clinic Cleveland, Ohio For the Proposition: William H. Seitz, Jr., M.D. VS Cleveland Clinic Cleveland, Ohio Wayne Z. Burkhead, Jr., M.D. University of Texas Against the Proposition: Dallas, Texas Wayne Z. Burkhead, Jr., M.D. University of Texas Dallas, Texas Moderator: Thomas S. Thornhill, M.D. This debate was held in May 2009 at Harvard Medical School the Current Concepts in Joint Replace- Boston, Massachusetts ment™ Spring meeting in Las Vegas, Nevada. Wikimedia - KaihsuTai and Current Concepts in Joint Replacement/RRY Photo Creation “For elective arthroplasty, humeral stem new techniques for later reconstruc- Moderator: component fixation is affected by differ- tion, I think cementless has some good Thomas S. Thornhill, M.D. ent surfaces. There are in-growth and qualities…but the results are still too Harvard Medical School on-growth surfaces. For the younger variable. Besides, if you do have good Boston, Massachusetts person a cup arthroplasty is preferable in-growth and fixation in a cementless to a large stem if it’s an elective implant.” prosthesis, a well fixed in-growth stem Dr. Seitz: “I’m going to talk to you can be just as difficult to remove as a about humeral fixation in joint replace- “We’ve learned, after 55 years of follow- cemented one.” ment. For intramedullary stem fixation, up, which press fit implants loosened cement has become the gold standard. and which subsided. Then we went to “So what does the data show? Harris The question is, ‘Can a press fit implant cement. Suddenly we have cement con- and Jobe demonstrated that full cemen- stand the test of time?’ For those that cerns. I think this follows the experi- tation provided a very tight fixation— have in-growth or on-growth trabecular ence in the hip and knee world where better than press fit—in reducing rota- metal components the question is, ‘Can putting these implants in very young tional micromotion. Peppers and Jobe the tip of the stem get a tight fit?’” patients has happened. My colleague demonstrated in other cadaver studies and friend Buzz Burkhead will say that that axial micromotion was present “Cementation is preferable to set the if you don’t cement it the revision is when cementation was not done. Distal head height appropriately. And a tra- easier, but that’s two operations.” canal fill is very important in keeping becular metal component may help in the stem from rocking and subsiding. terms of getting the tuberosity fixation. “Is cementless revision easier? With the The use of a cement restrictor and gen- But still, head height and distal stem fit new implant designs and techniques tle injection techniques are very effec- is the standard for fractures.” for glenoid grafting and impaction, and tive in preventing this.”

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And all the data that Bill showed you How well do you know your tissue bank? is old data using a component that was designed for cement in a cementless fashion. I’ll try to bring you up to date.”

“Charlie Neer’s first implant was a cementless component, and the rea- son that some of these osteoarthritic OUT OF patients failed wasn’t because of implant failure…it was because of glenoid wear. EVERY In fractures the goal is to create a milieu favorable for tuberosity healing, so using a little cement is probably reasonable. 10 0 But you want porous coating that will POTENTIAL MTF attract in-growth of the tuberosities to ACCEPTS the implant as well as promote healing DONORS... ONLY to the shaft. So avoid lots of cement.”

“You also have to look at the design of 3 humeral implants. I’ve always favored a trapezoidal type shape to gain fill in the promixal component. I’m not worried 125 May Street n Edison, NJ 08837 n 732-661-0202 n mtf.org much about distal stem fill.” Advertisement “In one clinical study, Torchia and Cof- a very tight fit with meticulous canal “So there is data out there…long term field showed in 89 patients implant preparation, but you should still con- results of uncemented humeral compo- and bone radiolucent lines in 70% of sider that cup arthroplasty.” nents in shoulder arthroplasty. In 2007 uncemented stems; 40% showed a sub- Verborgt showed that these patients did sidence and shift in position. In rheu- “When you need to use a stem, cement extremely well, and even though radio- matoid patients it’s even worse. Two with a distal restrictor plug, especially graphically some of them appeared to studies showed 42% and 27% radio- if there’s any questionable bone quality, be at risk at an average of about nine graphic loosening while cemented whenever there is osteoporosis, in rheu- years, none of these patients had been stems showed 0% loosening.” matoid arthritic patients, in fractures. revised.” This will give you both rotational stabil- “Our goal is to have stable humeral fixa- ity and will avoid axial micromotion.” “The surface replacements now are all tion. When we do revisions, invariably, used in a cementless fashion, so you if it’s an issue of loosening, it’s not the Dr. Burkhead: “Seth always picks his should consider using those in younger humeral side…it’s the glenoid side. ” favorite guy, like Bill Seitz, and puts me patients with osteonecrosis. The fact up against him because he knows I’m that cemented components never loos- “Our future directions? Bone in-growth, not that smart. I’m like the Washington en is a fallacy as well. This data from especially in implants that have tra- Generals up here every year…against January 2009 from Mayo Clinic (Cil) becular metal, have a real promise in the Harlem Globetrotters.” involved 38 revision arthroplasties. The younger patients. If I must do an elec- humeral components were cemented in tive arthroplasty in a younger person “Debates are fun at meetings, but in the 29 of those, with in-growth implants I’m going to probably do a minimally real world you have to individualize used in nine cases.” invasive resurfacing. If you do have to each patient. Sometimes you do need put a stem in, then you should make cement, but not all porous coated com- “Rational uses of cementless fixation? sure you have a good tip fill, you have ponents and porous coatings are alike. Surface replacement or hemiarthro-

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plasty in the young patient; hemiar- mented humeral components worked do it. It may be just the embolization throplasty or total shoulder arthro- well. These were plasma spray, no of marrow elements and fat that is the plasty in older individuals. Sometimes in-growth; a little bit of subsidence… cardiotoxicity.” the cement can be quite cardiotoxic, so not much loosening…this was on the use a small amount in older patients; humeral side. In hips we started with Dr. Burkhead: “But the monomer has with a minimal amount of cement in all cemented implants, then hybrids. been shown to be cardiotoxic, hasn’t it?” fractures—just enough to get stability; Most hips of type A and type B bone and then obviously the glenosphere in a are uncemented…so you’re telling me Moderator Thornhill: “In massive reverse is cementless currently.” now that I should start cementing my doses injected on its own. Um, Bill, total shoulders on the humerus?” cement restrictors…Alan Boyd looked “So if you don’t believe me, Bill, and up a group of our periprosthetic frac- you don’t believe Rick Matsen or Bob Dr. Seitz: “If you look at the rheuma- tures and they frequently occurred at Coffield, maybe one of my patients toid patients that you looked at 23 years the junction right between the bone and can convince you [showing video]. I ago they’re very different than the sur- the end of the cement restrictor. One was telling him that JP Warner at Har- gical rheumatoid patients today. Those of the suggestions from that was that vard couldn’t get a good result with patients tended to be very low demand, maybe it would be better not to have this operation. Patient: ‘I had my right very sedentary. Today’s rheumatoid it because they didn’t loosen and you shoulder done in November ’94, so patients have a lot of disease modify- didn’t want to have that sharp demarca- that would be 14 years this November. ing drugs…by the time they get their tion. Is that a bunch of baloney?” It’s been fantastic…pain free. The left shoulder they still have a fair amount of shoulder was done six months ago and activity and they frequently have better Dr. Seitz: “The technique of cement it too is totally pain free. Now I don’t soft tissues. They should be cemented. injection in a humerus is different than know what’s wrong with those *&^%$ I don’t think that you should cement that in a hip. In general we don’t use up at Harvard, but you got to work at it everybody. Obviously, Seth gives us a as much pressurization in a humerus… to get it better baby.’” charge to take a passionate stand, but I think that in anybody where there is Patient drops and does pushups…says, a question of bone stock, then I would “Don’t mess with Texas.” cement them. And a hip is very different than a shoulder in terms of the forces Moderator Thornhill: “Buzz, you on it.” obviously didn’t look on the schedule to see where the moderator was from.” Moderator Thornhill: “But our rheu- matoids also have better bone quality, Dr. Burkhead: “Oh, I absolutely knew with their DMARDs [Disease-Modify- where he was from. He’s talking about ing Anti-Rheumatic Drugs] so it may go your patients, not the faculty at Har- both ways. Buzz, you said that doing an vard.” uncemented will prevent cardiotoxicity of the cement. Do you really believe Dr. Seitz: “That was an impressive that?” video. The only thing is that I didn’t see any scars on his shoulder. You’re a really Dr. Burkhead: “In an older patient with fine surgeon.” a four part fracture—when I used to do hip surgery, I had two intraoperative Dr. Burkhead: “Well he does and I am. cardiovascular events using cement, so Thank you.” yes I absolutely believe it.”

Moderator Thornhill: “Bill, many Moderator Thornhill: “Because it years ago we looked at our rheuma- turns out that the monomer itself prob- toid patients and found that unce- ably doesn’t give it enough quantity to Advertisement

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fractures…in both of them it was well below that…they were in the supracon- dylar area.”

Moderator Thornhill: “When you have to remove cement that is well fixed in the humerus, what is your preferred technique?”

Dr. Seitz: “My preferred technique is to get the implant out first. If it’s really good, hard bone then I will try to fragment it and remove it with rib- bon osteotomes and power. I don’t use ultrasound. If I have to slot the bone I will, especially if it’s weaker bone.”

Dr. Burkhead: “I usually use an episi- otomy—single split—and then advanc- ing sized drills into the deeper part of the cement mantle after you get past the implant. I want to make one point on the fractures: these two events that I had were hips that were fractured, but people that come in with fractured shoulders also can be hypovolemic. If they have a big metaphyseal split they can also put a lot of blood into their 7th Annual Stem Cell Summit arm, just like somebody can put into their thigh. And that was really the point…that if you have somebody that’s in extremis it’s a good idea to skip the cement and go to an uncemented com- ponent.”

Moderator Thornhill: “Thanks to both Register Early and Save speakers.” ◆ If you havenÕt already saved the date of February 21, 2012, mark your calendar now. And if you want to ensure your spot at 2012Õs Stem Cell Summit AND save more than $500, take Please visit www.CCJR.com to register advantage of our low early bird registration rate today. for the upcoming 2012 CCJR Spring Preregistration is now open! Meeting, May 20-23 in Las Vegas, www.stemcellsummit.com Nevada. Advertisement

there’s a transition point. The issue is ullary canal. So I use a cement restric- that you don’t want the cement which is tor, but I can think of two patients of injected to dribble down the intramed- my own who have had periprosthetic

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On (and Off) the Record By Elizabeth Hofheinz

ear OTW Reader: Chris Bono, evaluation of all randomized controlled at the International Spine Intervention M.D. finds alarming differences trials for lumbar spine that have been Society. The solution? It all comes down Dbetween abstracts and manuscripts… done in the last ten years. We were to journals and reviewers ensuring that Air Force Major Erik Nott, M.D is looking for inconsistencies between the abstract completely reflects the awarded the Purple Heart…new fund- the abstracts and the manuscripts...we information in the article itself. Some- ing program…news on impinge- found an alarmingly high rate of incon- times the abstract’s conclusions are ment…and more… sistencies. And these were not necessar- quite a ways away from what the data ily industry sponsored studies—some showed.” Abstracts Not Matching Manuscripts were government sponsored. Regard- Christopher Bono, M.D., chief of spine less, however, we found many studies Casts for Injured Fashionistas If at Brigham and Women’s Hospital, and that failed to include pertinent nega- you’re going to suffer, do so in style… Deputy Editor of The Spine Journal is tives and positives in the abstracts-- CastMedic Designs has a new line of up to some eye opening research. He apparently in an effort to slant some swanky accessories for medical walking tells OTW, “Last year I had one of our results in one way or another. Our work boots. It all began last summer when fellows—Jeff Lehmen, M.D. —do an has just now been accepted as a poster Christina Daves, founder of CastMedic

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thrilled that foot and ankle is gaining popularity; actually, this is the first year that we have more applicants to foot and ankle fellowships than there are spots. More and more people are realizing the draw of the specialty—namely, that not only is it fun and varied, but there are many jobs to be had. Sports medicine and foot and ankle are still working out their ‘overlaps,’ and there are a lot of surgeons who do sports medicine and foot and ankle. Overall, there is more arthroscopy in foot and ankle now because we doing more training in arthroscopy and people are pioneer- ing its use in the specialty. People are realizing that foot and ankle surgeons encounter so many different issues, and there are so many bones and joints in the foot, that they will never be bored. CastMedic Designs CastMedic Designs In addition, there is ample room to con- tribute to the research arena because Designs, broke her foot and had to use Foot and Ankle Popularity on the Rise this is a relatively young field.” a walking medical boot for eight weeks. Scott Ellis, M.D., director of research She scoured the Internet for anything to for the foot and ankle service at Hospi- NASS: Outstanding Paper Award “dress-up” her boot but came up empty tal for Special Surgery, tells OTW, “I’m in Basic Science Dr. Steven Leckie, a handed. Now, she has created over 60 fifth-year orthopedic surgery resident products including faux-fur wraps, at the University of Pittsburgh, and his decorative socks, flowers, and themed colleagues from the Ferguson Labora- buttons for children. With decorating tory, received the prestigious Outstand- the boots and making people feel happy ing Paper Award in Basic Science at the and fun while wearing them, CastMedic recent North American Spine Society Designs is hoping its products can help (NASS) Annual Meeting. Their paper in the healing process and if not, at least entitled “Injection of AAV2-BMP2 and put a smile on someone’s face. AAV2-TIMP1 into the Nucleus Pulpo- sus Slows the Course of Intervertebral New President for PA Orthopaedic Disc Degeneration in an in vivo Rabbit Society Dr. Greg Gallant of Doylestown Model,” will be published in The Spine has been named president of the Penn- Journal December 2011 issue. sylvania Orthopaedic Society, a profes- sional medical specialty organization New Orthopedic Hospital in the representing more than 1,000 orthope- Philippines The Tim Tebow Foun- dic surgeons in Pennsylvania. Gallant is dation and CURE International have a former president of the Bucks County announced plans to build a children’s Medical Society, a fellow of the Ameri- hospital in the Philippines, the country can Academy of Orthopaedic Sur- where Tebow, the starting quarterback geons and immediate past president of for the Denver Broncos and a Heis- Doylestown Hospital’s medical staff. He man Trophy winner at the University serves various clinical instructor roles of Florida, was born. The Tebow CURE and is team physician for Delaware Val- Hospital in Davao City will be a 30-bed ley College. Advertisement

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announced a collaborative grant pro- gram that will broadly cultivate multi- disciplinary clinical spine research. The jointly establish Collaborative Spine Research Foundation (CSRF) will focus on advancing the science and practice of the highest quality spine care. The CSRF board of directors, comprising equal numbers of neurosurgeons and orthopedic surgeons, will oversee the establishment of grant and award crite- ria; the establishment and enforcement of conflict-of-interest standards; the recruitment of qualified, independent peer-review teams; and the develop- ment of strategies to secure financial support from spine-care stakeholders.

Thomas Lowe New VP at Millstone Medical Outsourcing—an entity pro- viding advanced inspection, clean room packaging, loaner kit processing, and distribution services—has announced that the company has hired Thomas C. Lowe as Vice President of Business Development. Located in Warsaw, Mr. Lowe will be responsible for develop- ing key accounts and supporting Mill- stone’s medical device manufacturing customers. Lowe’s background includes more than 18 years of generating new business. Prior to Millstone, he spent 14 years with a Tier 1 supplier to the medical device industry, where he was primarily responsible for identify- ing, building, and managing strategic

Advertisement accounts. Biomechanics News on Impinge- surgical facility focusing primarily on Timmy’s Playroom, which will provide ment Tom Brown, Ph.D., the Richard orthopedics; the hospital is expected to faith, hope and love to children before and Janice Johnston Chair of Orthopae- open in mid-2013. and after their surgeries. dic Biomechanics at the University of Iowa, tells OTW, “The most interesting The hospital, which is CURE’s first in OREF, NREF Announce Grant Pro- research here at the moment involves the Philippines and 12th worldwide, gram Two flagship foundations for the impingement and dislocation of will be on the island of Mindanao, a advancing spine care through support hard-on-hard total hips. There are particularly poor area of the Philip- for research, the Neurosurgery Research various adverse metal on metal engage- pines. About one-third of the children and Education Foundation (NREF) ments associated with edge loading, treated at the hospital are expected to be and the Orthopaedic Research and some of which comes from impinge- charity cases. The hospital will house a Education Foundation (OREF), have ment. We are doing finite element

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computer modeling, looking at adverse engagements of hard-on-hard materi- als and the shedding of metal debris. The effects of curvature of the lips of metal acetabular components are prov- ing intriguing…you might think that if lips are gently curved then that would reduce high contact stress, but we are finding that the large radii of the lips means reduced acetabular coverage of the head…and more tendency to sublux and edge-load. We were very surprised at the severity of the effect; orthopedists need to know that if they have patients who are likely to impinge, then large lip curvature may not be such a good thing.”

Purple Heart for Orthopedic Sur- geon Air Force Major Erik Nott, M.D., an orthopedic surgeon with Saint Louis University (SLU), received the Purple Heart on November 7, 2011 after being wounded in Afghanistan last May. Dr. Nott is a member of an elite, eight-per- son medical operations unit that pro- vides close support for military troops on special missions. That fateful day, as the military medical personnel walked away from their most recent patient, gunshots rang out. Under enemy attack, Dr. Nott recognized the sever- ity of the situation and grabbed two of his teammates, sending them into the nearest structure as the marine special operations team and special forces snip- ers returned fire. During the past four years, Dr. Nott has been on missions in Afghanistan, Haiti, Croatia and Africa. When not deployed, Dr. Nott teaches residents and medical school students at SLU and cares for patients at Saint Louis University Hospital. ◆ Advertisement

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review all the published literature and constant currency basis for the remain- company report their independent findings. der of the company’s 2012 fiscal year. Infuse Hurts 2Q12 Spinal Revenue Wells Fargo analyst Larry Biegelsen said Medtronic Spine Sales the weak spine sales were not “as bad as expected,” and beat consensus by $17 Overall reported Spinal revenue of edtronic, Inc. reported a 6% million. He believes Infuse sales will $839 million declined 1%. Internation- increase in revenue to $4.1 billion decline further based on the negative M al reported sales for the Spinal business during its second fiscal quarter. commentary and data presented at the increased 17%. Core Spinal revenue NASS meeting in early November. “In of $631 million, which includes core “I’m pleased we delivered another addition, the ongoing Department of metal constructs, interspinous process quarter of consistent growth in a dif- Justice (DOJ) investigation into the off- decompression devices (IPDs), and ficult environment,” said Omar Ishrak, label promotion of Infuse could create balloon kyphoplasty (BKP) products, Medtronic’s new chairman and CEO in additional headline risk.” a November 22 press release. “A major- declined 3% on a constant currency basis. Biologics revenue of $208 mil- ity of our businesses, and nearly all of Ishrak: “Depending on Yale” our geographies, contributed to this lion declined 4% on a constant curren- cy basis, driven by the decline in Infuse growth. As we continue to focus on During a question and answer session sales, but partially offset by revenue innovation, globalization, and execu- with Wall Street analysts on Novem- growth from other biologics products. tion, I see tremendous opportunities ber 22, Ishrak said that aside from the for growth in the future.” financials, the company’s position on Overall, the company said the Core Infuse is that, “we always put patient Infuse Controversy Metal Constructs business saw sequen- safety and quality first. We believe in tial growth of 5% during the quarter. the clinical data that we submitted to The Spinal franchise continued to Garry Ellis, the company’s CFO attrib- the FDA, and we know that, that data struggle as sales of Infuse fell 16% after uted the growth to new products such supports safe use in the indicated areas. the North American Spine Society’s as Solera. He expects the spine business We’re depending on the Yale study to (NASS) official publication, The Spine to decline in the low single digits on a look at the data transparently and we Journal, accused Sales will take action resulting from whatever researchers of fail- Medtronic Spine 2Q12 % Change ($ in millions) we find in Yale study.... Integrity, patient ing to report com- safety and quality are our highest pri- Total Reported Sales $839.0 down 3%* plications due to orities and that will continue to be so, payments from Core Spinal $631.0 down 3%* irrespective of what financial sort of the company. The Biologics $208.0 down 4%* consequences we have here.” company has pro- * Constant currency basis vided funding to Source: Medtronic, Inc —WE (November 30, 2011) Yale University to

Medtronic, Inc. HQ/Wikimedia Commons and Bobak Ha’Eri

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“He [Wyss] made some of the very criti- precipitously, shortly after surgeons legal cal decisions that put the trials on the injected bone cements SRS, with bari- ultimate pathway,” said the attorney.” um sulfate, or XR into their vertebrae. Former Synthes The bone cements were produced by Execs Jailed Michael Huggins was president of Syn- Norian, a wholly owned subsidiary of thes North America during the time of Synthes. he sad journey of Huggins, Higgins the trials, while Thomas Higgins was a Tand Walsh has come to an end with senior vice president. Each defendant Synthes did not have approval from the prison sentences imposed on them by a received nine months in jail with three FDA to use the cement to treat vertebral federal judge in Philadelphia. months probation and a $100,000 compression fractures. fine. John Walsh, who was the direc- U.S. District Judge Legrome D. Davis tor of regulatory affairs of the company, The defendants were sentenced under sentenced the three former Synthes received a five-month prison term. the responsible corporate officer doc- Inc. executives to prison on November trine. That doctrine holds executives 21 after they pled guilty to conducting David Sell of the Philadelphia Inquirer responsible if illegal activity happened unapproved medical trials for a bone reported that Judge Davis said Huggins on their watch and if they did noth- cement. Three people died during those showed a “knowing disregard” for the ing to stop the activity upon learning unapproved trials. No evidence directly safety of patients. of it. Sell reported that Wyss was not linked the deaths to the use of the prod- charged and that prosecutors declined uct. “You are being punished for the deci- to say why. sions you made and personally partici- A fourth defendant Richard Bohner’s pated in,” Judge Davis told Huggins and “The government is pleased with the sentencing was postponed after his the packed court room at the Federal sentences,” reportedly said lead pros- attorney collapsed at the hearing. The Courthouse at 6th and Market Streets. ecutor Mary Crawley, of the U.S. Attor- attorney had just made a statement that ney’s Office in Philadelphia. “We believe Synthes Board Chair Hansjörg Wyss was The patients died on the operating table it sends the right message to medical- the undisputed leader of the company. when their blood pressure dropped device and drug companies that lying to the FDA and disregarding patient safety has consequences.”

Huggins was immediately taken into custody. Judge Davis, according to the Inquirer story, gave Higgins two weeks to report to prison so he can arrange for extra medical care for his wife. Davis gave Walsh until November 28 to report because the 22nd was his young daughter’s birthday.

Synthes previously agreed to plead guilty, sell the Norian unit and pay a $23.5 million fine to settle the case. The agreement allowed the company to keep operating in the U.S. without its products being banned from Medicare reimbursement programs.

morguefile.com and kconnors —WE (November 21, 2011)

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“Many arthritic, bone-on-bone patients, was somewhat torturous as we needed large joints often younger than 60, are told to sit at to collect enough patient data over a home and wait for their knee replace- long enough period of time for a proce- First Dedicated Menis- ment; however, the technology and dure that was not reimbursed by insur- cus Transplant Center expertise exists that can return them to ance or even accepted in the general their activities and keep them from hav- orthopaedic community. The feeling ing a knee replacement for an average was that a meniscus could not survive hey have left no stone unturned of approximately ten years,” stated Dr. in the arthritic knee nor would it make Tin looking for a solution to menis- Stone in the November 29, 2011 news enough of a difference to the patient cus pain…OK, lame joke aside, there release. outcomes. Determined patients who is news from The Stone Clinic in San asked, ‘Doc, isn’t there a shock absorber Francisco. They are announcing the Dr. Stone told OTW, “The Meniscus you can put in my knee and buy me opening of the world’s first dedicated Transplantation Center is the culmina- time,’ drove the process. In the 2-12 meniscus transplant center. tion of over 20 years of our research and year outcome study, only 18 patients development to optimize the replace- in the first 119 severely arthritic knees In 2010, The Stone Research Founda- ment of this key shock absorber of the required conversion to a joint arthro- tion reported on long-term results of knee. Now that substantial data and plasty. Many insurance companies now meniscus transplantation in arthrit- patient experiences confirm the ben- do reimburse for meniscus transplan- ic knees with a 79% success rate at efit of replacing the meniscus, even in tation and the dedicated rehabilitation improving pain and function. Their arthritis, we feel confident that a core program required for success.” peer-reviewed, prospective study in the team focused on this tissue transplanta- Journal of Bone and Joint Surgery (Br) tion is fundamental to obtaining supe- —EH (November 30, 2011) proved that a meniscus transplant com- rior outcomes.” bined with an articular cartilage stem cell paste graft procedure can delay Asked about the development process, knee replacement for an average of 9.9 Dr. Stone commented to OTW, “The years, even in the presence of arthritis. process of forming a dedicated center

The Stone Clinic Advertisement

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Is Age 90 the New 85? The report also states that a person Slowing Spread of who has lived to 90 years of age has a life expectancy today of 4.6 more years Cancer to Bones s age 90 the new 85? In 1980, there while those who pass the 100 year mark utting the brakes on bone cancer… were 720,000 people aged 90 and are projected to live another 2.3 years. I A study involving 30 countries has older in the United States. Last year The majority (84.7%) of those 90 years P shown that denosumab can slow the that number had increased to 1.9 and older reported having one or more spread of prostate cancer to bones in million people who were age 90 and limitations in physical function. Some men at high risk of disease progres- older. By 2050 that number is expected 66% had difficulty in mobility-related sion. The article—published online in to reach eight million, according to a activities such as walking or climbing the Lancet—is by Professor Matthew R. report—“90+ in the United States: stairs. 2006–2008”—from the U.S. Census Smith, Massachusetts General Hospital, Cancer Center, Boston, Massachusetts, Bureau, commissioned by the National An older person’s likelihood of living in and colleagues. Institute on Aging (NIA) at the National a nursing home increases sharply with Institutes of Health. age. The proportion of those aged 85-89 who live in nursing homes is 11.2 but The report states that a majority of the the percentage jumps to 31% for those 90-plus population are widowed white aged 95-99. women who live alone or in a nursing home. Most are high school graduates. “With the aging boom it is critical to Social Security provides almost half of develop demographic data providing as their personal income, and almost all detailed a picture as possible of our old- of them have health insurance coverage est population,” said National Institute through Medicare and/or Medicaid. of Health Director Richard J. Hodes, M.D., according to the November 11 press release. “The information on a variety of factors—income, health status, disabilities and living arrange- ments—will be particularly use- Wikimedia Commons and Jensflorian ful to research- Preclinical studies suggest that osteo- ers, planners and clast inhibition might prevent bone policymakers.” metastases, possibly via a molecular pathway involving the signaling mol- Copies of the ecule RANKL. Denosumab is a fully report are avail- human monoclonal antibody that spe- able at http:// cifically targets, binds and inactivates www.census.gov/ RANKL. In this study, the authors prod/2011pubs/ analyzed the effects of denosumab on acs-17.pdf. bone-metastasis free survival in men with castration-resistant prostate can- —BY (November cer, who had no evidence of bone 28, 2011) Wikimedia Commons and Brandon Myrick metastases at baseline, and a high risk

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of progression based on standard pros- gists from around the world,” said Bert tate-specific antigen (PSA) tests. extremities van Meurs, senior vice president and general manager, Interventional X-ray, The study enrolled 1,432 patients across Patient Positioning for Philips Healthcare, in the Novem- 30 countries, with 716 assigned to Problems? New Tech- ber 23, 2011 press release. “With denosumab and 716 to placebo. Deno- customers’ input, particularly their sumab significantly increased bone- nology! hands-on evaluation of early designs, metastasis-free survival by a median we’ve developed a mobile C-arm that ometimes…the larger the patient, of over four months compared with is easy to position, even for very large the larger the problem of position- placebo. Denosumab also significantly S patients.” ing. Royal Philips Electronics—using delayed time to first bone metastasis. the input from surgeons worldwide— However overall survival was similar has introduced something that should To simplify communication between in both groups. Rates of adverse events help. The Veradius Neo mobile C-arm surgical team members and make it and serious adverse events were similar sports a flat detector to allow surgeons easy to quickly move to a requested in both groups, except for osteonecrosis to more easily and precisely handle chal- position, the Veradius Neo now has (weakening and destruction of the jaw lenging patients and procedures. It also a color-coded geometry. Once in the bone) and hypocalcaemia. A total of 33 features a completely new C-arc geom- desired position, the system’s advanced (5%) patients on denosumab developed etry, which is designed to accommo- flat detector technology provides high- osteonecrosis of the jaw versus none on date even obese patients with increased quality images without the distortion placebo, and hypocalcaemia occurred maneuverability. Veradius Neo also that is inherent in images produced in 12 (2%) of patients on denosumab offers flexible dose management set- by previous generation image intensi- and two (<1%) on placebo. tings and advanced flat detector imag- fier technology. Surgeons can use these ing technology to support surgeons undistorted images to help place screws The authors said in the November 16, in performing the latest image-guided and other devices with precision. 2011 news release: “Extensive contem- surgical interventions to help improve porary preclinical research suggests a patient care. As indicated by the company, the flat vicious cycle of complex bidirectional detector on the Veradius Neo has a interactions between prostate cancer “Veradius Neo is truly the product of a greater dynamic range than older cells and the bone microenvironment, collaborative process that included the image intensifier technology, meeting and tumour–bone interactions have input of many surgeons and technolo- these high requirements by provid- been advanced as the foremost mecha- nism for the bone-dominant pattern of metastases in prostate cancer.”

They conclude: “Improvement in bone- metastasis-free survival and time to first bone metastasis with denosumab treat- ment in our study shows that a bone- targeted agent can delay time to bone metastasis in men with prostate can- cer. Our findings also provide the first direct clinical evidence for the impor- tant role of the bone microenvironment and RANKL signaling in the develop- ment of bone metastases in men with prostate cancer.”

—EH (November 21, 2011) Wikimedia Commons and Medical Travel Riga services

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ing high contrast digital subtraction angiography (DSA) runs and roadmap guidance. Regarding X-ray dose, the Veradius Neo incorporates a full range of dose management features that allow low X-ray dose for lengthy minimally invasive procedures. Philips beam fil- ters enhance the quality of X-ray while the monoblock design results in sharp pulses to support excellent dose effi- ciency. The easily removable grid on the flat detector makes it possible to visual- ize small anatomy and extremities with exceptional image quality.

—EH (November 28, 2011)

Magic Wand for Preop Planning

magic wand for orthopedists? AMaybe…it’s the Sectra Visualiza- tion Table. Sectra, a company born out Advertisement of Linköping University in Sweden, is using algorithms to identify a bone or a the structure, functions and processes bone fragment, according to the user’s inside the body. They can, for exam- touch interaction, and remove it from ple, visualize different kinds of tissues the image. Accordingly, orthopedic and cut through sections with a virtual surgeons can gain an overview of the knife. joints, thereby facilitating pre-operative planning specifically in orthopedic sur- Per Elmhester, Ph.D. MScME, RadIT gery. As with the rest of the functional- Product Manager Clinical Solutions, ity, the new segmentation tool is oper- told OTW, “The image data is acquired ated using the fingertips. by a CT scanner and sent to the Sec- tra Visualization Table where the 3D “I had the opportunity to test the new volume is rendered automatically. The segmentation tool and it feels like this user then simply points at the bone table knows what I am thinking, it is to be removed and selects ‘cut’, and like magic,” says Göran Sjödén, asso- instantly the bone or bone fragment is Sectra ciate professor, consultant orthopedic removed. The most challenging task in surgery at Sundsvall Hospital in Swe- developing the bone segmentation tool den, in the November 22, 2011 news With Sectra Visualization Table, a large was definitely to keep the intuitive user release. “This will improve the quality medical multi-touch display, mul- interface. The feedback we’ve received of my operations as I see things I am tiple users can interact collaboratively from users so far indicates that we suc- never able to see on a regular X-ray with the real-size 3D images gener- ceeded!” image. And the table’s user interface is ated by CT and MRI scanners to gain really intuitive.” deeper understanding and insight into —EH (November 25, 2011)

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last 10 years, but they are complex and information on the potential long term trauma can be difficult to diagnose, especially dangers of head injuries. on the field. While medical, sports Injured Athletes: Who and equipment experts are working to All panelists agreed that everyone is is Responsible? evolve technology, guidelines and rules responsible—no matter what the age or to keep contact sports safe—equipment level of play—when a potential injury thics and the injured athlete… alone does not protect the brain from to the brain is involved there is no gray EExperts from NYU Langone Medi- being jarred during contact. area: athletes must be removed from cal Center and NYU School of Continu- play and receive appropriate medi- ing and Professional Studies’ Preston Participants also concluded that aware- cal attention despite any desire of the Robert Tisch Center for Hospitality, ness is vital: The more players, trainers, athlete, and even a parent, to continue Tourism and Sports Management held coaches, parents and sports organizers playing. a panel discussion recently on the eth- understand about the real—and often ics of who is responsible for ensuring hidden—dangers of head injuries, the The members of the panel included appropriate medical treatment of an more likely the right decisions will be orthopedic surgeons, professional team athlete that is injured—particularly if made on the practice field, sideline physicians, ethicists, former profession- the player may have a concussion. The or locker room. Professional leagues, al athletes, coaches and members of the panel was hosted by the Department of retired players and other advocacy sports media. Orthopaedic Surgery at NYU. groups also help the medical commu- nity develop best practices and sup- Claudette Lajam, M.D., assistant profes- Key takeaways from the evening include: port better awareness in youth and sor in the Department of Orthopaedic Understand the issues—a great deal has recreational programs. The media and Surgery, NYU Langone Medical Center been learned about concussions in the Internet play a key role in providing and a team physician for USA Cycling, told OTW, “What the orthopedist might not know about concus- sion is that symptoms of a serious injury may not appear until hours or days after an injury. It is imperative to take into account the mechanism of injury and the energy involved when making the determina- tion of keeping an athlete in play after a significant head impact.”

—EH (Novem- Wikimedia Commons and Philadelphia Eagles ber 23, 2011)

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AAOS Programs Wins AAOS surgeon-members’ office wait- the dangers of distraction behind the ing rooms. The public relations effort wheel. CLIO Award eventually reached airports, shopping malls, buses and bus shelters, as well Sandra Gordon, director of public rela- riving itself used to be exciting as broadcast across the country. Since tions for AAOS, told OTW, “Creating the enough…now many feel the need D then, the campaign has included a Decide to Drive Campaign has been one for speed and speed dialing, texting, etc. national survey on behaviors and per- of the most meaningful pieces of work The American Academy of Orthopaedic ceptions of distracted driving, a web- in my career. I had the honor of meeting Surgeons (AAOS) and the Auto Alliance site allowing users to report incident of and working with Smokin’ Joe Frazer, are trying to do something about that. distracted driving (www.decidetodrive. who was our campaign spokesperson. Its national “Decide to Drive” Public org), Facebook and Twitter campaigns, In filming our television public service Service campaign, designed to spread a partnership with the Driving School ad, I will never forget the sound that awareness of the importance of driver Association of America, and more. the two cars crashing made. I remember focus behind the wheel, received the that sound every time I get behind the Silver Award at the CLIO Healthcare Just this fall, the program created a dis- wheel and might even be tempted to Awards—one of the world’s most-rec- tracted driving classroom curriculum to multitask. But, most important, I know ognized awards competitions for adver- distribute to more than 10,000 schools the campaign is making a difference in tising, design and communications. nationwide to help teach fifth and sixth the lives of so many people…includ- graders to urge their parents, and oth- ing orthopaedic surgeons. The stories “Distracted driving can cause lifelong ers, to keep their eyes on the road. The posted on www.decidetodrive.org are injuries that orthopaedic surgeons campaign also is sponsoring a poster amazing and it is hard to imagine what would rather prevent than treat. “Decide contest for children and teens in grades drivers do behind the wheel.” to Drive” was organized to function as 5 through 12, inviting them to develop a national conversation—between chil- a public service ad to warn drivers of —EH (November 21, 2011) dren and their parents, among drivers in various online forums, and between surgeons and their patients—and the conversation has certainly started,” said AAOS CEO Karen Hackett, FACHE, CAE, in the November 11, 2011 news release. “On behalf of the Academy’s 36,000 members, our staff and the Academy’s creative and sponsoring partners, we are grateful to have won this award. Hopefully this win will reiterate our message.”

The “Decide to Drive” partnership began with printed PSAs—spon- sored by the Orthopaedic Trauma Association—in the form of counter cards placed in thousands of Sandra Gordon, Director of Public Relations/AAOS

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spine Keynan was the first surgeon world- gressive bone in-growth in between the wide to implant the XPED Pedicle implant’s expanded wings, and ease of Screw System. “So far, we have suc- removal—despite the bone in-growth. Osteoporotic Bone cessfully implanted the XPED in over The increased osteointegration over Screw Scores Well in 20 patients, with the longest follow-up time, as well as bone in-growth inside Sheep Test being one year. All patients are doing the expandable area, provided a pro- well and experience a decrease in pain gressively robust fixation of the screw six-month long study in sheep of and an improvement in functionality,” within the vertebral body.” He added Athe XPED expandable screw result- he said. that further studies are needed to deter- ed in a favorable outcome, according to mine long-term outcomes. Dr. Ory Keynan, the principal investi- As a result of the study he said, “We gator. Dr. Keynan is head of Service for were able to demonstrate three very —BY (November 28, 2011) Degenerative and Age-related Spinal important features of the XPED expand- Disorders at the Sourasky Medical Cen- ing screws: ease of deployment, pro- ter, Tel-Aviv. He explained that “solid fixation of pedicle screws is the corner- stone of a successful spinal fusion. It’s particularly important in compromised bone quality such as in the elderly pop- ulation, in various bone pathologies, and in revision surgery.”

The XPED Pedicle Screw System is manufactured by Expanding Ortho- pedics, Inc. a privately owned Israeli company which launched the product

at the EuroSpine Congress in Milan in Expanding Orthopedics Inc. October 2011.

substance. Her appointment got unex- people pected support from Republican House Majority Leader Eric Cantor of Virginia. Cantor said Tavenner was “eminently Tavenner Nominated qualified” according to the AP report. to Head CMS He doesn’t get a vote because the Sen- ate approves the appointment, but his arilyn Tavenner is taking over as support may help her with Republican MAdministrator of the Centers for senators. Medicare and Medicaid Services (CMS) after 42 Republicans in the U.S. Senate The White House announced her nom- blocked the permanent appointment of ination November 23 and she took over President Barack Obama’s choice, Don- the agency on December 2. ald Berwick, M.D. Former HCA CEO The Associated Press (AP) reported on November 29 that agency observers are Tavenner, 60, served as Medicare’s prin- expecting a change of style, but not of Marilyn Tavenner/hampton.gov cipal deputy administrator under Ber-

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wick. The AP reported that she started Affairs and Quality at Alphatec Spine, that sold products in the vascular, urol- her career as a nurse at two Hospital Inc.. At Covidien she was responsible ogy, oncology, and surgical specialty Corporation of America (HCA) facilities for global registrations, regulatory com- markets. in Virginia. She eventually rose to chief pliance and product labeling for a busi- nursing officer and then hospital chief ness unit with more than $1 billion in Ms. Harrison received a BS degree in executive in 1993. She then entered annual sales. biochemistry from San Diego State government service as Virginia’s health University and completed the Execu- care secretary. She came to Washington Ms. Harrison brings more than two tive Development Program for senior last year as Congress was debating the decades of regulatory, clinical affairs regulatory professionals through the health care reform law. and quality experience to her new role Kellogg School of Management. In her at Alphatec Spine where she will be spare time she enjoys bike riding, look- The Association of American Physicians responsible for providing overall strate- ing after her dogs and country music. and Surgeons (AAPS), a group of pri- gic direction and leadership. vate physicians, released a statement “We are pleased to have Fran Har- on November 30, declaring that the Before her employment at Covidien, rison join Alphatec Spine,” said Dirk “new CMS pick [is] no better than Ber- Ms. Harrison served as the global vice Kuyper, the company’s president and wick.” AAPS also pointed to Tavenner’s president, regulatory/clinical affairs and CEO. “Fran’s expertise will provide the 25-year career at HCA, which alleg- quality compliance at Lumenis, Ltd., a necessary leadership in a global regu- edly defrauded Medicare and Medic- company that sold surgical, ophthalmic latory environment in which the path aid resulting in $840 million in fines and aesthetic laser systems, as well as to product approval is becoming less in 2000 and another $640 million in Class II disposable products. Prior to predictable, especially as we bring our 2003. The head of HCA at the time was that position, she held a series of pro- innovative products to market, both Rick Scott, who is now the Republican gressively senior regulatory affairs roles in the U.S. and internationally. Fran’s governor of Florida. at C.R. Bard, a medical device company experience will provide us with the necessary leadership The Washington Post reported that for- with respect to regu- mer colleagues describe her as a patient- latory, clinical affairs centered manager, a hands-on medical and quality, which will professional equally comfortable in the help us achieve both board room and the emergency room. our short-term and And in contrast to Berwick, Tavenner long-term goals.” isn’t associated with a grand vision for health reform or a particular policy Alphatec Spine, Inc. a agenda for Medicare and Medicaid. wholly owned subsid- iary of Alphatec Hold- —WE (December 2, 2011) ings, Inc., is a medical device company that designs, develops, Francis Harrison manufactures and Joins Alphatec markets products for the surgical treatment er the November 16 press release, of spine disorders, pri- PFrancis Harrison, the former global marily focused on the vice president, regulatory affairs for aging spine. Covidien of Boulder, Colorado, on October 17, accepted the position of —BY (November 28, 2011) vice-president for Regulatory, Clinical Francis Harrison

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