Other Articles

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Arthroscopic Treatment for Tennis Elbow: Coming on Strong
“Tennis elbow” or lateral epicondylitis is, according to our PearlDiver database, one of the most reported diagnosis for problems with the elbow. Lately clinical evidence has shown that arthroscopic treatment for tennis elbow can provide long-term stability and, in most cases, return of the elbow to its optimal function. Check out the data from PearlDiver.

Do Republicans Make Better Orthopedic Surgeons?
A recent Nature Neuroscience journal study of the decision making differences between liberals and conservatives appears to argue in favor of Republican surgeons! Which, frankly, explains a lot—to BOTH sides and, to stretch an analogy almost to its breaking point, it may also explain why McCain’s health care plan is different from Obama’s. Read OUR take here.

"Sound of Music" Turns to Greek Tragedy for Smith & Nephew
Smith & Nephew’s Swiss (mis)adventure with Plus Orthopaedics is turning into a Greek Tragedy. The company’s whole acquisition strategy is being called into question. Read how CEO Illingworth explained it to the brutal British press.

“Dear John Letter” for Hip Resurfacing?
“Dear John H. Resurfacing: I hope this little note finds you well. We certainly have had some great times and, gosh, I’ll never forget those wonderful moments when the FDA approved your PMA. We’ve just celebrated our second anniversary together and, well, I’m just not feeling the magic anymore….” Two years after FDA approval, how happy are orthopedists with hip resurfacing? Read our analysis here.

In the Beginning, There Was the End: Manuscripts 101
Dr. Paul Manske, Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis and Editor-in-Chief of The Journal of Hand Surgery, shares his thoughts and experience on the details of shepherding a manuscript through publication.

Did ConMed Get Re-Wired?
Ever hear about the neurosurgeon who used an $80 Bosch power drill to do brain surgery? It really happened. Surgeons like their power tools. Increasingly they also like a particular line of sterilizeable power tools from ConMed’s Linvatec unit. Did ConMed get re-wired? We have the details here.

Rising CMS Orthopedic Payments for 2009
If you treat orthopedic problems in the elderly who have complications and comorbidities, you’re going to like CMS’s proposed payment system for 2009. Read about how to maximize your reimbursements.

Replace or Fuse? Can’t Decide?
An upcoming paper titled “Controversy of Total Ankle Arthroplasty” says the answer should increasingly be “replace.” Certainly as an outpatient procedure and with new technologies like Wright Medical’s new INBONE system, replacement/arthroplasty is on the rise. Using PearlDiver data we map out this very important market.

Implant Retrieval Labs 101
The secret life of…implants? Dr. Joshua Jacobs, Professor and Chairman of Orthopaedic Surgery at Rush University Medical Center in Chicago, discusses the details of implant retrieval labs. Preclinical testing to predict implant performance, studying components when implants are removed, and the value of observing the pathogenesis of the failure at different time points in the process, are examined here.

A prosecutor from New Jersey has issued an administrative subpoena to Synthes Spine in Pennsylvania, seeking information about physician participation in clinical studies presented in 2005 to the FDA for Synthes Spine's ProDisc™. The FDA approved the device in August 2006.

Dueling Prosecutors

This time, however, the prosecutor isn't Christopher Christie, the Republican U.S. Attorney of the hip and knee deferred-prosecution fame, but the new Democratic Attorney General of New Jersey, Anne Milgram.

U.S. Attorney Christopher Christie and New Jersey Attorney General Anne Milgram

A spokesman for the New Jersey attorney general's office told OTW that the action was spurred by a New York Times article on January 30, 2008 (“Financial Ties Are Cited as Issue in Spine Study,” by Reed Abelson). That article, which we found to have many flaws, cited confidential information from a patient lawsuit settled last year that said physicians at about half of the 17 research centers involved in clinical trials of the ProDisc stood to profit if the device succeeded. The New York investment firm Viscogliosi Brothers, LLC also received the administrative subpoena. The investment firm had formed Spinal Solutions, which originally owned the device but was not the applicant for FDA approval because Viscogliosi Brothers had sold Spinal Solutions to Synthes before the ProDisc PMA (premarket approval application) was submitted by Synthes.

Subpoenas

The subpoenas, issued on February 4, seek information from Synthes for the period of January 1, 1999, through the present and focus on whether required disclosures were made regarding surgeons who endorsed ProDisc as researchers and also had an investment interest in the device.

We wondered under what authority the attorney general of the state of New Jersey was issuing subpoenas regarding a PMA application at the federal agency. We put that question to Leland Moore, a spokesperson for the attorney general’s office. He said that the attorney general's office usually doesn't even acknowledge that it has issued subpoenas and that he could only cite the press release announcing the subpoenas.

The release stated, "Among other things, the subpoenas seek information concerning the investment backing that funded ProDisc’s development. The subpoenas also seek information concerning physician participation in, and the results of, clinical studies of ProDisc. It was largely on the basis of clinical study results presented in 2005 that FDA approved ProDisc for commercial sale and distribution in the United States.”

The statement continued, “A principal focus of the state’s inquiry is whether required disclosures were made regarding surgeons―including some licensed to practice in New Jersey―who endorsed ProDisc as researchers and also had an investment interest in the device."

FDA Disclosures

We talked to the FDA and asked if they were also investigating Synthes' PMA application and the required disclosures. Karen Riley, a spokeswoman for the FDA, said that the term "investigation" was too strong, but that they were looking into the application by Synthes. She did not know why the New Jersey attorney general was issuing the subpoenas. She also acknowledged that the Times article spurred their inquiry.

Here's what the FDA requires in section 54.4 of Title 21 for Financial Disclosure of Clinical Investigators:

"The applicant must also completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is not a full-time or part-time employee of the sponsor for each covered clinical study. Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study with sufficient accurate information needed to allow subsequent disclosure or certification."

The FDA will make their inquiry and we'll eventually find out if proper disclosures were or were not made. But the non-answer given to us of the New Jersey attorney general's authority to investigate this situation is buried at the end of the press announcement of the investigation.

Righting Wrongs

The investigation is being conducted by the New Jersey Attorney General’s Affirmative Litigation Section.

What does an "Affirmative Litigation Section" do?

When New Jersey Attorney General Milgram announced the new unit last July she said, “By creating the Affirmative Litigation section we have taken an important step on behalf of all New Jersey citizens. This section will seek to proactively pursue civil litigation aimed at righting wrongs and improving the quality of life throughout our State.”

We're not kidding. According to the attorney general’s office, "the Affirmative Litigation Section is responsible for initiating legal action to advance the public good by seeking damages, injunctive relief, development of favorable precedent or a change in policies, practices and actions that run counter to the public interest. The new unit is also responsible for pursuing litigation that enforces the Attorney General’s statutory and common-law powers to protect the public and advance legislative mandates.”

And the mandate continues, “The section will not take on cases or legal matters from existing Division of Law sections. Rather, the new section will generate cases through research and investigation, polling of state agencies, communicating with public interest groups, coordinating efforts with its counterparts in other states, and exchanging information with the National Association of Attorneys General, as well as other multi-state organizations."

Last month the affirmative litigation unit issued a subpoena to Amgen over allegations it marketed its $5.4 billion arthritis drug Enbrel for uses other than what the FDA approved.

Further evidence of Attorney General Milgram's interest and authority in investigating medical devices and pharmaceuticals was offered when she convened a task force last September to "explore the issue of pharmaceutical companies and medical device makers giving gifts and other compensation to physicians, and to determine what impact, if any, such practices have on patient care in New Jersey."

In announcing the task force, Attorney General Milgram said, "The task force will study the impact of gift-giving and compensation practices on the physician-patient relationship and the extent to which such arrangements legitimately advance the medical profession’s knowledge of new therapies and devices. The task force will also examine potential steps to prevent and identify abuses in the area of physician gifts and 'incentives' including public disclosure of data, direct physician disclosure to patients, and/or a limitation on payments accepted by these professionals."

Star Chamber Justice

The dueling prosecutors in Jersey, Christopher Christie and Anne Milgram, are symptoms of a failing structure of rules, regulations and complicated ethical standards that govern the relationships between physicians, patients and industry.

When the FDA's own Science Board claims that the agency is broken and can't fulfill its mission; when prosecutors don't disclose statutory authority underlying their actions; when federal and state agencies rely on flawed newspaper reporting; when deferred-prosecution deals keep details about alleged illegal behavior by surgeons and companies secret; and when federal monitors are hired by their friends to oversee industry with no judicial oversight―the whole system begins to feel like a Star Chamber.

Seizing the Opportunity

The relationships between physicians and industry are confusing as indicated by our report from last year’s NASS meeting. This confusion is creating an opportunity for those who criticize the physicians working with industry to develop safer and more effective devices for patients. Physician societies need to address this crisis before the public trust in physicians is irreparably harmed and dueling prosecutors and professional demagogues across the country start dictating to physicians and industry exactly how they should behave.

The opportunity to define a new and healthy relationship between physicians and industry is begging to be discovered. Who will seize that opportunity? The professional societies or the professional demagogues?