The Parkinson Alliance Summer/Fall 2002 Catalyst Growing Funds for Parkinson’s Research Udall Centers Getting it Together INSIDE by, Ken Aidekman Message from the President . 2 n the process of funding research curing Parkinson’s would require a level Message from the Ithere exists a natural give and take of organization imposed upon scientists Executive Director . 4 between the pursuit of pure science from outside the scientific commu- Team Parkinson Going National . 5 and the effort to accomplish treatment- nity. It may seem like common sense Barry Green Takes on Medicare oriented goals. Fundamental curios- that cooperation and sharing among and Makes a Difference . 5 ity and the desire to contribute to a scientists will speed us toward a cure, American Legion Raises growing body of knowledge motivate but it is by no means proven and it still $51,000 for the Alliance . 5 scientists. A large part of their time is requires a certain amount of creative Alliance donates to The Todd M. spent fashioning studies that have suf- thinking to successfully implement. Beamer Foundation . 5 ficient scientific merit to be funded and The Morris K. Udall Act stipulates Past Events . 6-7 then, once funded, carrying out the that “The Secretary (of the NIH) shall Upcoming Events . 8 experiments that will prove or disprove provide for the establishment of 10 their hypothesis. With a lot of hard Parkinson’s Research Centers. (In fact, of Excellence for Parkinson’s Disease work and a bit of luck the results of there are 11 centers.) Such centers shall Research. 2002 was the first year in their labors will be published in jour- … coordinate research with other such which NINDS invited laypersons from nals and add to our understanding of Centers and related public and private the Parkinson’s community to observe neuroscience. To judge each published research institutions.” The National the proceedings and provide input. report on the basis of how much closer Institute of Neurological Disorders and While including us at the meeting it has brought us to a cure would be Strokes (NINDS) staff has been given may seem a bit unorthodox, there are counter-productive because no one can the job of facilitating research by pro- advantages. anticipate the exact pathway that will moting interaction between indepen- So what good does it do to have a ultimately lead to a cure. dent Udall researchers. Unfortunately, group of non-scientists around strug- By passing the Morris K. Udall they do not have the time, neither the gling to keep up with the latest devel- Act, Congress clearly instructed the resources nor the expertise to solve the opments in research? One thing we National Institutes of Health to make many complex issues they face within can do is pass on information about the extraordinary science that is being “By passing the Morris K. Udall Act, conducted. At the morning “data blitz” Congress clearly instructed the National session, Udall Center directors gave Institutes of Health to make their best effort fifteen-minute summary presentations about the latest work done at their to cure Parkinson’s disease.” institution. In the afternoon research- ers covered specific issues of shared their best effort to cure Parkinson’s a reasonable period of time. On the concern in breakout sessions, including disease. Not only were they told what plus side, they are taking steps to foster the discussion of biomarkers, genetics, to do, but also they were given guide- coordination. One of these steps is to animal and cell models and clinical and lines for how they should do it. Part of reach out to members of the private the plan involved the establishment of neuropathological correlates. During community who have a strong interest Morris K. Udall Centers for Parkinson’s the breakouts participants often raised in curing PD. Research, including an outline of how questions that lent themselves to input they should interact. For better or With this directive from Congress in from an audience with a diversity of worse, those who drafted the original mind, NINDS convened its Fourth backgrounds and experience outside Udall Bill made the assumption that Annual Meeting of the Udall Centers the scientific and academic community. continues on page 3 Message from the President Medicare’s Powerful Role in Setting Surgical & Clinical Standards in Patient Care lateral, and surgeons practice anywhere posed language on the status of bilateral from single-staged to four-staged pro- subthalamic nucleus deep brain stimula- cedures. Variations in procedures were tion as being “substantially more effec- initially necessary due to the FDA’s tive and improving health outcomes by limited approval of unilateral thalamic a substantial margin for a well-defined surgery for tremor, and the insurance set of Medicare patients with Parkinson’s companies were not willing to extend disease.” The same wording was also ap- their coverage to experimental pro- proved for bilateral stimulation of the cedures. In January 2001, the FDA internal globus pallidus. The impetus gave provisional approval to the use of for the panel to consider Medicare’s cov- Medtronic hardware for bilateral deep erage of the procedure was the result of brain stimulation of the subthalamic one person with Parkinson’s disease re- n December 2000, after suffer- nucleus and globus pallidus thus open- questing that the CMS issue a national Iing with Parkinson’s disease for 23 ing the door for single staged, bilateral coverage decision for the bilateral use of years, I had deep brain stimulation of procedures. But many surgical prac- the Medtronic device in the subthalamic the subthalamic nucleus at New York tices continue to operate with the uni- nucleus. University Hospital. Through my con- lateral, multi-staged system. Some be- In presenting data pertinent to the tact with PWPs, and my involvement lieve that their patients encounter less panel discussion, expert medical wit- with Re-Wired for Life (www.rewire negative side effects with one protocol; nesses testified representing the FDA, dforlife.org), I learned that the most others firmly believe the opposite. the Medtronic Company, and neurolo- frequently asked questions PWPs and On September 25, 2002, Carol Walton gists and neuro-surgeons promoting their family members ask are: (1) how and I attended the second public meet- the bilateral placement of electrodes in do I find the best surgical team; (2) how ing in Baltimore that was convened to both the subthalamic and globus pal- dangerous is this surgery; (3); what im- hear, discuss, and act upon the rec- lidus regions of the brain rather than provements can I expect after surgery; ommendations made to the Center the earlier approved unilateral thalamic and (4) does insurance cover the cost of for Medicare and Medicaid Services stimulation. the procedure and after care? (CMS) by the Medicare Coverage As the number of middle to late stage These questions and my curiosity Advisory Committee’s Medical and Parkinson’s patients increase, the de- prompted me to research various issues, Surgical Panel members. This is the mand for deep brain stimulation will including the existing protocols of entry point where patient advocates— multiply. More and more patients will surgery and after-care; which regula- either as individuals or representing a be willing to “take a chance” having tory agencies are involved with setting group—can enter the system and ask brain surgery at even a younger age. for a change in current practices. standards of performance; insurance Now is the time to implore the medical coverage for DBS, especially as it relates Medicare controls the national agenda profession to grapple with the heavy to the subthalamic nucleus; and what for defining the type and amount issues of setting up professional cri- performance standards are currently of coverage approved for diagnosing teria that holds patient safety as para- in place to insure patient safety while and treating each disease. State carri- mount. navigating the within the health care ers handle the national mandates for Medicare Coverage Policy: system. Medicare. Therefore, it is of utmost http://www.cms.gov/coverage. I learned that there are no standards importance that the rules and regula- Medicare Cov. Advisory Committee that are evident for existing protocols tions mirror the best treatment options http://www.cms.hhs.gov/coverage/ of surgery and after-care. Surgeons use presently available and future advances 8b1.asp. their own criteria for patient selection, are carefully considered. pre-operative screening, preferred site of The Medical and Surgical Panel met implantation, choice of unilateral or bi- for the second time (first hearing was Margaret Tuchman in June 12, 2002) and unanimously President, The Parkinson Alliance 2 voted in favor of accepting the pro- The Catalyst— Vol. 2, No. 2 The Catalyst—Vol. 2, No. 2 3 continued from page 1 Take, animal models, for instance. In the total PD research pie. In a normal rived from working backgrounds in many recent years the number of different ani- state of affairs scientists would prefer diverse fields. We also have the time, mal models in PD research has multiplied that total funding available for research perspective and, hopefully, the motiva- significantly. Scientists have developed grants should not be cut back for the tion to attack obstacles on the road to a transgenic mice which can synthesize sake of administrative needs. But, ap- cure. What may start out as a frustrating greater than normal amounts of proteins parently, the attractiveness of gaining problem from one perspective can be an that are of interest in PD. They can also greater access to innovative resources excellent opportunity for others to help. develop “knock-out” models in which the is sufficient for many scientists to ac- However, it will take a bit more visibility animal is unable to make certain proteins.