SAS
Tenth Annual Global Symposium on Motion Preservation Technology
April 27-30, 2010
New Orleans, LA

Thank you and good morning.

It’s a great honor for me to serve SAS as the incoming President. I’d like to thank everyone for being here at the 10th annual SAS Global Symposium, right here in New Orleans – the Crescent City. This is one of America’s great cultural cities – the birthplace of Jazz music and Cajun cuisine. If you haven’t done so already, I encourage you all to get out there, enjoy New Orleans, and bring back gifts and stories to your families and co-workers back home.

The 10th annual SAS Global Symposium is our jazziest yet. We are honored to have the previous US Secretary of Health and Human Services, Michael Leavitt, to talk with us, as well as the world-renowned Healthcare Economist, Uwe Reinhardt. They will tell you in a moment what’s going on with healthcare reform. SAS has an excellent scientific program underway for you, covering the latest evidence on spinal arthroplasty, interspinous implants, biologics, and other innovative surgical technologies. Just as important, we have a large exhibit hall where you can see all the newest devices and instruments available to spine surgeons, and learn more about upcoming treatments. I’d like to thank the SAS staff for organizing the conference, and especially Drs. Albert and Goldstein, and the entire scientific committee for choosing the many excellent speakers you’re hearing this year.

As you may know, the SAS name has evolved. Originally, SAS stood for “Spine Arthroplasty Society”, but now, to reflect our growing mission, SAS is also the “International Society for the Advancement of Spine Surgery”. We still cover spinal arthroplasty, but we’ve expanded our scope to all surgical treatments that help spine patients. Now I know some of you, whenever the speaker starts talking about his organization’s name, you take that opportunity to check your email or catch up on some much-needed sleep. But I’d like you all to listen closely to this explanation of SAS’s new name, because it speaks volumes about who we are and where we’re going.

SAS is now the “International Society for the Advancement of Spine Surgery”. SAS has always been international, but we really want to emphasize how quickly and effectively we are reaching around the globe. We have an International Committee, chaired by Dr. Büttner-Janz, to ensure that SAS maintains an international perspective on everything we do. At last year’s conference we had attendees from 55 countries on all 6 continents. We have chapters in Korea, China, Taiwan, India, and the Middle East, and starting this June in Latin America too. We had an Asia/Pacific regional meeting in January in China, and in June we’re having our Latin American conference in Cabo San Lucas, Mexico – we hope to see you there.

SAS is a society that deals only with innovative spinal technology, from occiput to pelvis, minimally invasive to maximally invasive, young to old, and degenerative to deformity. So SAS is the place where spine surgeons can discuss the things relevant to us and more importantly our patients. But the first letter “S” in “SAS” is for “Society”. And that means you all have to get involved. We can’t have a discussion without you. SAS is its membership. We believe that every surgeon has a responsibility to learn about new technology, to improve patient care. As the eminent Finnish surgeon Krister Höckerstedt once wrote: “the surgeon who takes the profession seriously and continues to improve and use new treatments and technology seems to perform better and is more satisfied than those who do not.” So get involved, read the SAS Journal, and keep coming to these conferences – Mexico in June and Las Vegas next year.

The “A” in “SAS” stands for “Advancement”. SAS promotes progress and innovation in spine surgery, providing information not easily available elsewhere. Sure, there are other multidisciplinary or sub-speciality spine societies. But our society is unique as a global organization concentrating on the newest treatments for the total spectrum of spine surgery. The field of spine surgery is changing rapidly these days due to important developments in science and technology, and the resulting myriad of new treatments. SAS is the most forward-thinking society, focused on the latest and upcoming technologies. SAS advances spine surgery into the future. The SAS Journal is proud to have a new major publisher – Elsevier. So the SAS Journal, under the editorial leadership of Dr. Hansen Yuan, along with Drs. Anderson and Zigler, will continue to bring you excellent research reports on spine surgery, with a focus on emerging technologies.

The final “S” in “SAS” is for spine surgery. This is crucial to understand. SAS is a society for spine surgery. That’s why we exist, and we don’t get sidetracked into any other topics. We welcome anyone to our meetings who wants to know more about spine surgery, but still SAS is a society for spine surgeons who perform spinal surgery – that is our one and only focus here. So SAS, as a professional society, will serve as the voice for spine surgeons and our patients. SAS is applying for membership in the Federation of Spine Associations. So in cooperation with other professional societies we are dedicating substantial effort to advocating for spine surgeons and spine patients in this critical moment of health care reform. SAS will be the society that speaks our viewpoint – as spine surgeons – on the many challenges and opportunities facing us and our patients.

Now, over the past decade you’ve all heard a lot about Evidence-Based Medicine. You’ve seen both the benefits and the problems that “EBM” has brought to spine surgery, as well as the hot debates it has set off in the medical community and beyond. On the one hand, evidence-based medicine is a robust, methods-driven system that has critical advantages to bring to clinical medicine. On the other hand, EBM has also brought problems every time it has been misapplied by zealots or political bureaucrats without adequate medical scientific training. EBM has been both an attempt to improve the quality of medical care and an attempt to control costly clinical practices, neither of which has been completely successful.

So more recently we’ve been hearing a lot about “Comparative Effectiveness Research”, which is like the nephew of Evidence-Based Medicine. President Obama started his term by allocating 1.1 billion dollars for comparative effectiveness research. The main feature of comparative effectiveness research is that, as the name implies, it compares two or more real-world active treatments, (or diagnostic tests, or prevention programs, or whatever else). One of the main problems with medical research is that it has not been geared toward helping us make choices among the available options. Most of medicine’s best research – its randomized controlled trials – compare whatever drug to a placebo. But at the end of the day, these trials doesn’t tell us much, because of course a placebo isn’t effective, and no patient would ever consider taking placebos. Moreover, trials often exclude all kinds of patients, due to age, comorbidities, and whatever else, but then we never know if the trial results apply to these kinds of excluded patients. So comparative effectiveness research will use meta-analysis, randomized comparative trials, and datamining of giant patient registries to compare two or more real-world treatments in the typical real-world patient populations that we treat every day.

In spine surgery specifically, there are many things that remain poorly studied or lack consensus. Comparative effectiveness research could help us resolve some of these uncertainties. Spine surgery is already far ahead of most other medical specialties in this game, because most of our best research has been comparative all along – we don’t really ever waste time and money studying placebos or waitlists in our clinical trials. Looking at arthroplasty for example, the early FDA trials were all comparative effectiveness research, because the comparison group – fusion – is an active real-world treatment that we routinely use. And now the ongoing trials of Kineflex and Activ-L are even more purely comparative, because they compare one disc against another. These studies may shed light more generally for all discs on the relevance of various disc design features. For another example, comparative effectiveness research could show us what are the best ways to prevent infections in our patients, by comparing different preventive measures in large multicenter studies or national patient registries. Simply stated, studying different procedures under identical conditions allows us to compare them and make future choices.

But we need to be vigilant that CER is not abused for the wrong ends. The Institute of Medicine’s definition of comparative effectiveness research explicitly states that its purpose is to assist consumers, clinicians, policy-makers, and purchasers to make informed decisions that will improve health care. But there’s a slippery slope between simply “assisting people to make decisions” versus “making those decisions for them”. CER should not be restricting patient access or forcing surgeon decisions. Research really only provides knowledge about the statistical track-record of a procedure. Surgeons absolutely must still use their training and experience to make the right clinical judgments. And patients need to have some choices, so they can get the health-care that best suits them. CER can help us all make better decisions, but it cannot make those decisions for us.

So more research is needed to guide choices, not to eliminate them. Increased promotion of research should benefit us all by reducing uncertainty. But this research should be reviewed by doctors who have the experience needed to correctly interpret the results and detect any flaws. Moreover, evaluations of the research for or against a procedure should be made by the relevant medical societies in evidence-based guidelines, not by economists and administrators. Now whatever happens with healthcare reform overall, CER is not going to disappear anytime soon. So we, the spine surgery community, need to grab this bull by the horns, and steer it down the right roads. We need to proactively design and run the research studies that will answer the kinds of questions we really want to know.

And we all need to recognize something. The recent global economic recession and healthcare reform have brought spine surgery to a pivotal moment of defense. But good quality research can demonstrate the value of spine surgery to people who don’t see it day in and day out. For example, a few years ago Washington State was going to end coverage for arthroplasty. SAS and five other societies presented the published scientific evidence to Washington’s Health Technology Assessment Program and convinced them to cover arthroplasty. Much more research is still needed to support our claims on the benefit, safety, and value of spine surgery to any doubters in government and the public. And we need that research now. If we wait another five years, it’ll be too late. For example, the Medicare Coverage Advisory Committee published a paper in Spine three years ago asserting that the evidence for fusion was weak. They concluded that Medicare bases its coverage decision on evidence of clinical benefit, and they called upon the spine community to close those gaps in the evidence. We, the spine surgery community, need to comprehend what they’re saying and respond proactively. SAS is working on this topic right now.

Research is also needed to “clean house”. Industry keeps trying to add new things to the “toolbox” of patient care, but to make room for them, we have get rid of things that don’t work that well. For example, I have many questions about EMGs and their constant usage by people who do them. I’m also concerned about the number of epidural steroid injections people get. And what about all the brand-name narcotics which are so expensive. Are they really any better than cheap generic narcotics, or is everyone riding around in a Rolls Royce these days? A lot of this stuff wastes money that could be better spent on the treatments that do work. So we need more house-cleaning research.

We need new research to improve patient selection for some procedures. For example, among patients receiving fusion for degenerative disc disease, are there certain patient factors – age, smoking, Worker’s Comp, depression – that reliably predict lack of clinical improvement? We also need research to determine if some forms of treatment for a condition are better suited to specific subgroups of patients than others. For example, does kyphoplasty bring greater clinical benefit to certain subsets of vertebral fracture patients, such as the elderly or women, while vertebroplasty is better suited to other subsets of patients? These are questions we need to answer to better match the optimal treatments with the right patients.

Research is also needed now to demonstrate the value of what we do, as you heard in the Symposium yesterday afternoon. The recent global economic recession and healthcare reform means that everyone is looking at the price of everything and what they get for their money. There’s a lot of research showing that we deliver major clinical improvements. Privately, we know that spine surgery is a worthwhile investment in a patient’s long-term health, but we have not published enough on its cost-effectiveness. We need to increase our collaborations with professional healthcare economists to get this evidence and message out there to the public and policy makers.

We also need to look beyond the crisis issues of today, and make investments in the therapies of tomorrow. Spine surgery 20 years from now will be even better than spine surgery today, but how much better depends on us now. Recent major discoveries in the life sciences have led to promising new treatment concepts in spine surgery. Genetics opens up many opportunities, including personalized treatment, pre-symptomatic prevention, and new therapeutic interventions. Stem cells and tissue engineering hold the possibility to regrow damaged neural, bone, or soft tissue structures. We need to strengthen the basic and translational research that will create new spine treatments for our children and grandchildren.

Now we all need to realize that the days of a single surgeon making major research breakthroughs are fading into the past. Biomedical research in the current era is an increasingly complex enterprise requiring extensive teams of specialists using sophisticated equipment. We need greater cooperation between networks of surgeons, basic scientists, engineers, and other specialists, in order to continue making advances in spine surgery. We also need practicing surgeons to contribute your data to giant national registries. And we must always remember that industry plays a major key role in R&D. Universities, hospitals, and government do great basic research on the one hand or clinical research on the other. But they don’t do much translational research, and they certainly don’t ever bother to develop products that we can actually use in patient care. Maybe they should, but currently they don’t. Without industry collaboration, medical progress would remain entirely theoretical.

Recently, industry relations with doctors have come under scrutiny. A few highly-publicized scandals, such as Merck’s Vioxx and Astra Zeneca’s Zoladex, have led to widespread discussions and overdue professional reforms. It is now understood that relations between physicians and industry, and any other kinds of potential conflicts of interest, need to be openly disclosed to the public. SAS has recently approved a new disclosure policy in-line with other spine societies. Surely there’s no harm in greater transparency. Similarly, inappropriate physician-industry relations need to be replaced with appropriate physician-industry relations, as described by AdvaMed among others. For example, consulting arrangements should be a fair market-rate fee for real service and expertise, not any of those old “nudge-nudge” consulting fees. We’d all like to avoid a situation where a few more national media scandals lead to widespread loss of public confidence and greatly increased government regulation. So both surgeons and our industry partners need to be proactively self-regulating about all this.

Beyond these disclosures, there have been a range of opinions about which physician/industry relations to permit or restrict, but the middle-road position of the Institute of Medicine is likely to prevail. In brief, they call for a removal of industry influence in continuing medical education and also recusal of surgeons with conflicts of interest from research and policy committees. Some critics have gone even further and called for an end to industry-supported research, but fortunately, that is NOT the position of the Institute of Medicine. They recognize that industry plays many vital roles in the development of new therapies – roles that universities, hospitals, and governments do not, and cannot do.

First, hundreds of companies, large and small, take long-shot gambles on the pre-clinical research of possible products, yet only a small fraction ever get all the way out of the lab and into the hospital. Much of this research would never get done if it weren’t for enterprising people taking risks on innovation. Second, many multicenter, multiyear clinical trials wouldn’t even exist without industry funding and logistical management. Yet this is precisely the kind of level-one evidence that government and insurers are always demanding. Third, a better understanding of the existing therapies, and incremental improvements of them, comes about in large part through companies diligently monitoring their own products. Dismissing industry-sponsored research as “tainted” because of industry funding is misguided. As Residents learn in “Journal Club”, it’s the study methods that determine the reliability of the findings. Conversely, companies making medical products need the input of university researchers and practicing surgeons, to improve the products they’re offering. Industry is incapable of improving patient care without the input, guidance, and innovation suggested by healthcare professionals. So it makes no sense to place restrictions on that feedback loop. But we do need a new model for research collaborations between surgeons and industry.

In the old model, a company would come to surgeons and say, “Look, we’ve got this amazing new Spine-Widget, and we want you to do a study on it. You enroll the patients, we’ll provide the widgets; you do the surgeries, we’ll fund it.” But the public is getting increasingly skeptical of these arrangements, due to perceived conflicts-of-interest. In the new model, a university department, private foundation, or professional society such as SAS will develop a portfolio of priority research themes that need to be addressed. Private donors, including industry, will contribute unrestricted sponsorship to this research program. Researchers will propose specific studies addressing the topics identified, and the foundation, university, or society will select specific studies to receive funding, based on peer-review of the proposal merits. This model will create a buffer-wall against inappropriate influence while ensuring closer dialogue, and it will make precious data more widely available for the greater good of the entire spine surgery community. This new model will launch us forward into the future, all together.

In closing, spine surgery is at a historic pivotal moment. Many breakthrough technologies are in the pipeline these days, and at the same time government is getting involved in healthcare like never before. We the spine surgery community need to proactively get research out there showing the benefits and value of our best available treatments. Medical companies have a crucial role to play in the R&D of the surgical technology we use to help our patients. SAS will be the meeting place and mediator among spine surgeons from around the world and between surgeons and our industry partners. It is a great honor for me to serve in the year ahead as the President of SAS, the International Society for the Advancement of Spine Surgery.

I want you all to get actively involved with SAS. The future of spine surgery is in our hands, right here, right now. Thank you all for coming. Enjoy the conference, and go live it up tonight in New Orleans – the Big Easy.

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Dr. Uwe Reinhardt is a respected writer and speaker on the economics of healthcare, serves as a member of many prestigious healthcare committees, including the Council on the Economic Impact of Health Reform, the Committee on Technical Innovation in Medicine, and the National Leadership Coalition on Health Care. In addition, this Princeton professor is a member of numerous editorial boards.

Professor Reinhardt is the James Madison Professor of Political Economy and Professor of Economics at Princeton University where he teaches courses in microeconomic and macroeconomic theory and policy; accounting for commercial, private not-for-profit and government enterprises; financial management for commercial and not-for-profit enterprises; and health economics and policy.

A leading health policy expert, Professor Reinhardt has served on a number of government commissions and advisory boards, among them the congressional Physician Payment Review Commission, the National Council on Health Care Technology of the DHEW (now DHHS), the Special National Advisory Board of the VA, the National Advisory Board of the AHRQ, DHHS, the Kaiser Commission on Medicaid and the Uninsured, and the World Bank External Advisory Panel for Health, Nutrition and Population.

Professor Reinhardt is also a trustee of Duke University and the Duke University Health System, and a trustee of the National Bureau of Economic Research (NBER).

He is the president of the International Health Economics Association, is on the board of the National Institute of Health Care Management, and is chairman of the coordinating committee of the Commonwealth Fund’s International Program in Health Policy.

In October 2006 Professor Reinhardt was appointed by Governor John Corzine of New Jersey to chair the health reform commission for the state.

Professor Reinhardt has been or is a member of numerous editorial boards, among them the New England Journal of Medicine, the Journal of the American Medical Association, Health Affairs, The Journal of Health Economics, and the Milbank Memorial Quarterly.

Please welcome Dr. Uwe Reinhardt.

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Governor Michael Leavitt

After gaining a university degree in business, Governor Michael Leavitt spent a decade and a half in the insurance industry, becoming CEO of a company that is now one of the nation’s largest insurance brokerages. He turned to public service, was elected three times as Governor of Utah (1993-2003) and was, then, appointed a member of President George W. Bush’s cabinet. While he served in two positions on the Bush Cabinet, Leavitt views his primary task in both jobs as improving the nation’s health.

At the Environmental Protection Agency he implemented higher standards for ozone, diesel fuels and other air pollutants. He organized and managed a collaboration to develop our nation’s plan to clean up the Great Lakes.

In four years as secretary of health and human services, Leavitt is credited for successfully implementing the Medicare Prescription Drug benefit. He also created national strategies and implemented plans for several major components of the health care system including: health information systems, personalized medicine, pandemic preparedness and medical emergency response. As secretary he led a government-wide effort to devise and implement a new strategy on the safety of imported products, opened FDA offices globally and negotiated historic agreements in China, India, Latin America and Europe.

Leavitt advocated health diplomacy as a way to significantly impact American foreign policy. He traveled to 38 countries overseeing American interests in HIV AIDS, Malaria, pandemic preparedness and product safety. At the conclusion of his service the Chinese government made him the first U.S. government official to ever be awarded the China Public Health Award.

Please welcome Governor Michael Leavitt.