The birth of an orthopedic superpower, the death of a young engineer, dangerous accusations of clinical investigative bias, turmoil in markets and companies and reflections of an inventive genius were picked by our readers as the most popular stories on the pages of Orthopedics This Week in 2011
Readers clicked their way to over 6 million page views of stories during the year. Those clicks, tracked by Google Analytics, told us what readers found most interesting.
Before we list the top ten stories, one important story just barely missed the cutoff but was important to our readers because it reminded us of the humanity and purpose of our great orthopedics industry.
Hope and Love
On June 6, Jeff Guyer, a young orthopedic engineer asked us to “continue to breath in hope and breathe out love” in his last blog before peacefully passing away. The son of Rick and Shelly Guyer reminded us that engineers, surgeons, nurses and all the other providers love to go to work every day in the hope to improve patients’ lives.
Jeff led a team that designed the GLIF (guided lumbar interbody fusion) procedure which won an OTW Best Spine Technology Award in 2009.
The Year’s Top Ten Stories Picked by OTW Readers
The Wall Street Journal Bungles Surgeon Story
The Wall Street Journal reported in October that a patient died in April in Jackson, Mississippi, due to a surgeon’s ownership in a medical device company. The neurosurgeon, Adam Lewis, M.D., is an investor in Spinal USA LLC.
We found the facts didn’t match the accusation. It was another bungled, misleading story from WSJ about physician ownership in the business of healthcare. We set the record straight.
The Spine Blogger Unmasked?
In February 2009 an anonymous blogger began scorching surgeons for being greedy and spine companies for producing “me too” products. We were asked if we know his identity and in July we wrote what we found.
By September 2010, some of the blogger’s followers began to call for his unmasking. A series of posted comments from his followers speculated that he was John Nieradka, a former colleague of ours at OTW.
In another posting on the blog, “John N.” responded to followers that he was flattered, but that he wasn’t the blogger.
An Overlooked Spine Market
While spine’s innovation rate may no longer be the juggernaut it once was and independent auditing/actuarial firms like Milliman appeared to be trying to re-draw the boundaries of spine care, a small San Jose company which could be the next Kyphon, didn’t seem to be affected.
In May we reported on SI-BONE, Inc., a three-year-old firm that appears to have uncovered an overlooked corner of the spinal implant market, the treatment of sacroiliac pain which, in size, maybe as large as 20% of all spine surgeries!
The new company is being directed by a few experienced medical device hands and one veteran of the Silicon Valley electronics world. None other than Mr. Kyphon himself, Mark Reiley, M.D., is SI-BONE’s founder.
The Ten Most Disruptive Trends in Orthopedics
Ten potentially disruptive trends gathered momentum in 2011 that we believed would change orthopedics forever. From least to most, here were our picks in August.
- Everyday 10, 000 baby boomers turn 65 in the United States.
- 125 million Americans suffer from a chronic medical condition.
- 3.6 billion prescriptions were filled last year in the U.S.—not counting medical marijuana.
- Pace of technology change is accelerating at an exponential rate.
- The smart phone is becoming a medical device.
- The number of robotic-assisted surgeries performed worldwide has increased three-fold over the past two years.
- Adult stem cells have been used in more than 190, 000 patients in the U.S. since 2004 with no reported adverse events.
- Artificial intelligence systems are now beating humans in quiz shows.
- 50% of doctors are now employed by large healthcare corporations.
- The U.S. Government will pay less than it is paying now for healthcare in the United States.
Mutiny at Smith & Nephew
Nine former employees of Smith & Nephew’s Visionaire team in Memphis got sued on March 11 by the company for conspiring to take company secrets and start their own business. A former colleague blew the whistle on them.
Three of the alleged “mutineers” fought back and claimed the company committed libel and owes them money.
Gary Michelson, M.D. Revisited and Surgeon/Industry Relationships
Seventeen years ago, Gary Michelson, M.D., called Sofamor Danek and asked if he could make some suggestions on improving one of their products. He was told, “No thanks, ” and if he thought he could a better job, he should do it himself.
He did exactly that, registering 955 patents and eventually winning a $1.35 billion dollar patent award from Medtronic, the largest in American history.
In June and July we revisited an earlier interview with the surgeon inventor and then talked with him about innovation, and the current state of the relationship between industry and surgeons. Michelson did not pull punches.
He told OTW that in the early ‘90s, many surgeons who were receiving money from implant suppliers and being called consultants were actually doing almost nothing other than influencing their colleagues to use that same supplier’s products.
Wright Medical in Turmoil
Perhaps no company in orthopedics had as much disruption to their business in 2011 as Wright Medical Group, Inc. from federal investigations into industry surgeon relationships.
Wright entered into a deferred prosecution agreement (DPA) with the government in 2010 and paid a $7.9 million fine.
But shortly before a Wright board meeting on May 4, 2011 to talk about compliance issues, the wheels came off. There was an unexpected and shocking announcement that Gary Henley, the CEO since 2006, resigned “without good reason.”
Others were fired and other senior executives resigned. The company said it had found “credible evidence of serious wrongdoing” regarding its compliance with the DPA.
Physician-Owned Distributorships, Risks and Investigations
Nothing made device reps and manufacturers see red more in 2011 more than over physician-owned distributorships (PODs), which reportedly have captured between 10-15% of the U.S. spinal market. Are they legal or not?
In June, a bipartisan group of U.S. Senators asked the Office of Inspector General (IOG) to investigate the growth of PODs and let them know if federal legislation is needed to keep them legal and ethical.
OTW laid out the legal arguments from lawyers by both sides. The verdict? PODs are legal until the government says they are not legal. In the meantime, everyone is waiting for the IOG report.
Carragee and NASS Living Dangerously
In June, The Spine Journal (TSJ), owned by publishing giant Elsevier and the official publication of The North American Spine Society (NASS) shocked the spine world by accusing well-known research physicians of omitting evidence in 13 clinical studies of Medtronic, Inc’s INFUSE because of payments from the company.
OTW looked at the studies and discovered that Eugene Carragee, M.D, editor of TSJ had committed a number of deeply troubling mistakes, omissions, and what appeared to us to have been a systematic pattern of intellectual dishonesty in his accusations.
Carragee and his fellow authors embarked on an aggressive PR campaign to convince regulators, Centers for Medicare and Medicaid Services, and the general public that both patients and physicians who used INFUSE had been “living dangerously” over the past couple of decades.
These actions prompted Charles Branch, M.D., former editor of TSJ to say in OTW that with the June journal issue and NASS press releases, “fanning the fire, ” the 2011 NASS meeting became more of a “professional society circus, ” and the chance for a true scientific debate “has been lost forever in the polarity of the accused and the accusers lining up to do battle.”
An Orthopedic Superpower is Born, the Synthes/DePuy Merger
In April a new orthopedic superpower was born as Johnson & Johnson (owner of DePuy Orthopaedics, Inc.) announced it will acquire Swiss device maker, Synthes, Inc. for $21.3 billion.
The resulting firm will become the world’s largest orthopedic company with annual orthopedic shipments of around $9.3 billion. In market share terms, the combined entity would have about 28% market share. The #2 and #3 companies would be Stryker Corporation at 14% and Zimmer Holdings, Inc. at 13%.
We reported the most important characteristic of this combination is the lack of overlapping products and sales personnel in four of the five major categories—knee, hip, trauma and extremities. As a result, integration of such large firms and their respective armies of sales, support, research and clinical personnel will be fairly painless.
In spine, however, we reported the opposite. DePuy Spine and Synthes have substantial and comprehensive overlap in terms of products, product categories and personnel. Indeed, in this case, we wondered who was really acquiring whom. Synthes, which markets its spinal implant products on a platform of direct sales personnel, may well emerge as the dominant surviving spinal implant organization.
We wrote that the merger will likely set in motion a massive game of musical chairs among spinal implant sales people throughout the industry as there is significant product and territory overlap between DePuy Spine and Synthes Spine.
So farewell 2011. We’re eager to report on the new events of 2012.
