As the nation starts to transform its approach to healthcare, there are clearly more questions than answers regarding what the future will bring. For the research community, the questions are no less compelling than they are for healthcare professionals, institutions, employers and prospective patients. Funding is the obvious engine that drives all research endeavors. Traditionally, funding for medical research comes from four sources—the drug and device industry, the NIH or other governmental agencies, private charitable sources and academic university budgets. In recent years, tightening reimbursements and uninsured care have placed increased strains on university hospital budgets, limiting the funding formally available to support the development of young researchers. The financial recession has certainly taken its toll on available charitable sources, although many foundations and organizations are in fact weathering the storm and will likely remain a limited but durable resource in the future. The two big “players” in the arena are industry and NIH. It is here that uncertainty, at least for now, reigns.

In general, industry support is essential in order to bring promising ideas into clinical reality. Before introducing a new medication or device, it is quite obviously necessary to demonstrate to some reasonable degree that the medication/device is both safe and effective. Since no therapy is either 100% safe or 100% effective, the key is to define the knowable limits of safety and efficacy sufficient for an educated and reasonable judgment to be made regarding release and marketing (hopefully by the FDA). In order to accomplish this, testing must be completed in numerous stages, at first in the laboratory setting, then in an animal population, then in a very limited population of normal volunteers, then in a gradually expanding population with the condition which is being treated. All of this takes time and, you guessed it, dollars. It is not unusual for the total cost from drug discovery to clinical release to accumulate to the billion dollar range. The price of failure becomes challenging at best. It is for this reason that patent laws protect the drug manufacturers’ ability to recoup their investments (which must include not only the successes, but all the failed investments as well), so as to encourage future development. If new legislation restricts or taxes the drug and device industry in order to raise much needed funds (and we are not saying that it shouldn’t), industry will likely respond by being more risk averse. If the bar for acceptance of new therapies is raised to demonstrate not only safety and efficacy, but also comparative advantage over currently available therapeutic options (a highly reasonable request), the incentive for industry-sponsored clinical research will be diminished. Perhaps a contraction and/or refocusing of this industry are not so bad in the big picture of how a country allocates its healthcare dollars. However, in the short run, there is likely to be a “cooling” of available funding for clinical research.

The real question that remains unanswered is the impact that health care reform will have on the NIH. Traditionally, the NIH has been the bastion of basic science research. Somewhat risk averse because it is distributing large sums of public money, the NIH process has nonetheless been remarkably free of political directive. Aside from the issue of embryonic stem cell research, NIH funding has largely been based on broad research strategies and rigorously evaluated by experts in the various fields being studied. What is currently being discussed with regard to comparative effectiveness research is a shift in this approach, from a research community-based approach to a governmental agency/policy approach to setting priorities and making funding decisions. (see VanLare’s article in the March 18, 2010 New England Journal of Medicine). This shift would signal a major shift in research funding, one of huge political significance. Not least amongst the major unsettled issues that such a change in direction would raise is who is left that is committed to medical research based upon scientific validity rather than commercial or political consequence? It is in just such a scenario that rare institutions such as the Florida Heart Research Institute, with its unbiased and independent commitment to stopping heart disease through research, education and prevention, take on added importance and significance.



Before construction can commence in a hospital environment, proper consideration must be given to the isolation and control of contaminants that may arise due to construction-related activities. The control and remediation of these contaminants are addressed in project specific Infection Control Risk Assessment (ICRA) Plan, the development of which is critical to the elimination or minimization of risk to hospital patients and staff. The development of a project specific ICRA plan involves the careful coordination of a hospital’s Infection Control Practitioner, Safety Officer, Director of Facilities, Director of Construction, representatives from departments adjacent to affected areas, and the contractor employed to perform the work.

The first step in developing a cohesive ICRA plan is to identify the invasiveness of the construction activities that are to take place based on scope and duration, typically identified as type ‘A’, ‘B’, ‘C’ or ‘D’ activities. Obviously, a project involving the repainting of walls (type ‘A’) or replacement of telephone/computer cabling (type ‘B’) will be less invasive than one involving demolition of partitions (type ‘C’) and relocation of major mechanical systems (type ‘D’), or one where the envelope of the building is compromised for an extended period due to the potential for water infiltration (type ‘D’).

Once the scope of work is adequately understood, the risk level of the areas affected must be evaluated, commonly referred to as identifying patient risk groups. Risk assessment is based on the sensitivity of patients in adjacent areas and described from ‘low’ risk to ‘high’ risk. Less stringent measures would be required in a Radiology Department (‘medium’ risk) as compared to one where there are heavily immune compromised patients, such as Oncology (‘high’ risk).

Once the scope of work is defined and the risk level to patients assessed, preventative measures can be adequately delineated. Low risk projects might simply require the isolation of areas with fire retardant plastic sheet barriers and the cleaning of the space during and after completion with an approved disinfectant. A high risk project might involve such extensive measures as isolating the mechanical system, keeping the space under negative pressure using HEPA filtration units, incorporating anterooms where workers can be cleaned before re-entering active hospital spaces, requiring workers to wear shoe/clothing protection (“bunny suits”), etc. Whatever the measure may be, they must be clearly and effectively specified so they may be properly carried out by the construction team. It is quite common to use an “ICRA Matrix” to assist in identifying the above-mentioned types and risks when implementing an ICRA plan. Not only will this ICRA Plan become the most critical part of the preconstruction planning between the General Contractor and Subcontractors, but it will also serve as a rubric by which the site must be continually graded for effective infection control.



Gervasio A. Lamas, M.D., director of cardiovascular research and academic affairs at Mount Sinai Medical Center, has been named Latino of the Year by the Latin Business Club of America for his outstanding contributions to medicine and the community. The award recognizes individuals whose efforts expose Latino influences above and beyond Latin markets.

Born in Havana, Cuba, Dr. Lamas received his BA in biochemical sciences (cum laude) from Harvard College and his M.D. with honors from New York University. He completed his internship and residency at the Brigham and Women’s Hospital of Harvard Medical School, where he later served as assistant professor of medicine. Dr. Lamas relocated to South Florida in 1993, when he started work as chief of cardiology at Mount Sinai Medical Center. During the last decade, he has had authority and responsibility for the enrolling thousands of patients in more than a dozen U.S. and international trials, in order to improve cardiac care and prevent death and disability from heart disease. He served as chairman of the Mode Selection Trial in Sinus Node Dysfunction (MOST), a trial that revolutionized cardiac pacemakers. He presently serves as co-chairman for the Occluded Artery Trial (OAT), and study chair for the Trial to Assess Chelation Therapy (TACT), a $30 million trial sponsored by the National Institutes of Health. Dr. Lamas has served as President of the Miami Chapter of the American Heart Association, and District Counsellor for the American College of Cardiology. Dr. Lamas also served on the American College of Cardiology/American Heart Association joint committee that re-wrote the national guidelines for the treatment of heart attacks. Dr. Lamas is author of 130 publications, including 78 original reports, 14 book chapters and 38 reviews. He also directs the training program in cardiology at Mount Sinai Medical

Center and works as a clinical cardiologist with the South Florida Medical Institute.



As I write this, New Orleans, Mississippi, and Alabama are still reeling from Hurricane Katrina and Texas is bracing itself for an unwelcome visit by Hurricane Rita. We Floridians are no strangers to the potential devastation of a hurricane. So these are not fun times for any of us who share the Gulf Coast.

When faced with a storm of such magnitude, you cannot help but be forced to put things in perspective. In pure size, both Katrina and Rita were massive storms, bigger than any of the states they threatened and, in fact, dwarfing even Texas. The power of their winds and rushing water overwhelmed anything mere mortals could devise to stop them. All anyone could do was get out of the way (if possible), wait it out, then go back to see what, if anything, was left to rebuild. It made us, masters of the known universe, seem small indeed.

These storms had a message for everyone, even those of us fortunate enough—at least this time—not to be directly in their paths.

To begin with, they made many of us think about what we would do if we were caught up in the devastation. One day you have a house, a car, a job, a routine … the next, everything you have come to know and to rely on has been swept down the street, literally. How many of us could face such a prospect and have the courage and the fortitude to recover?

But it also gave us another perspective. In the Felix household before Katrina and Rita, many of life’s annoyances would dramatically affect Carol and me: everything from a blown fuse to someone taking the last Diet Coke from the refrigerator. How unfortunate or ill timed such nuisances would seem.

But now, in the aftermath of these hurricanes—and realizing that more will come and, like a frustrating game of Russian Roulette, some might turn their frightening power on Florida—we’ve adopted a new attitude. Our code phrase to invoke is “No Biggie.”

The cable guy didn’t show up for the third time in a row. No Biggie. Let’s turn off the TV and play Canasta.

One of our old pipes sprung a leak and we need to call a plumber? No Biggie. At least we have fresh water. And it’s not covering everything we own.

Flat tire? No Biggie. Let’s call the Auto Club and relax. Wherever we had to go, it’ll be there tomorrow.

I appreciate that we humans have short attention spans, so I know it won’t be long before once again I ’m upset because the pizza is delivered late, or it rains after I’ve washed the car, or I spill something on my laptop …

But for now, all of those are No Biggies. No matter what minor irritant befalls me, I’m feeling pretty fortunate right now.

Charles Felix, Publisher



While working for HospiceCare of Southeast Florida, Caren Bock realized the need for a children’s book that could prepare, inform, and guide children through the experience of a loss. Inspired by her husband John, family, and dear friend Susan G. Telli, Caren created Wings: A Story of Transformation, a delightful children’s book about the transformation of life and death. This unique story is about a young boy named Christopher and his friend, a caterpillar named “Fuzzy”, who through transformation becomes a beautiful butterfly leaving Christopher to cope with his change. As a critical care pediatric RN, Caren feels this book will help many families through difficult times. Wings offers care and support to children, parents, grandparents, guardians and families, counselors as well as healthcare providers as they face end-of-life, and deal with the issues that come after the death of a loved one.

All proceeds of this book will be donated to HospiceCare of Southeast Florida, Inc.

HospiceCare of Southeast Florida, Inc. will be celebrating their 25th Anniversary with the Book Launching of Wings, on November 17th from 5:30-8:30 p.m. For more information, call (954) 467-7423 or visit www.hospicecareflorida.org.