# 356 Tuesday, August 7, 2007 - PRIORITIZING RESEARCH, AND PREVENTING U.T.I.s I am not in a very good mood right now, having just spent seven hours in the hospital. It?s okay, sort of?Roman ?just? had a UTI, a urinary tract infection. A UTI can quickly lead to a kidney infection and kidney failure. People do occasionally die of UTIs, but he didn?t. He had been in continual pain for two days, and it got worse. Terri, his wife, was unavoidably out of town, so Roman and I have been spending quality time together, doing all the fun stuff families get to do, when a loved one is paralyzed. Getting Roman to accept going to the hospital is roughly equivalent to relocating the Titanic?it can be done, but it is not a chore to take on lightly. But finally Gloria was through fooling around, and called an ambulance. Emergency was full, so Roman?s gurney had to stay in the hallway for a while before a doctor could be freed up. Blood tests, x-rays, etc., and lots more waiting. Finally at one in the morning, the doctor gave his diagnosis, and Rome got to ride in the ambulance again. He is home in bed as I write this now, four luxurious hours of slumber later. (so if the writing is even worse than usual?huh, what? Oh, sorry, dozed off again.) Which brings us to the point? Two bills to think of, one solid and useful, the other (in my theological opinion) straight from Hell. The good one first. A man named Steve Winter (you might recall this column wrote about his efforts before) is working hard to try and get Medicare to revise its policy about catheterization kits?. Currently, Medicare funds a maximum of one single-use ?cath kit? per week. This policy forces paralytics to re-use the single-use kits, virtually guaranteeing urinary tract infections, which can be incapacitating and potentially fatal. This policy is not only cruelly uncaring, but appears to be in direct violation of F.D.A. standards. (The only exception to the ?one kit per week? policy is if the patient can medically document two major UTI episodes in a twelve month period.) Imagine having to repeatedly ?sterilize? a plastic tube (the most common method is to boil in vinegar) which will be re-inserted into a loved one?s urinary tract forty to fifty times a week. It is never completely sterile, and the plastic eventually falls apart in the process! This of course affects the poor disproportionately; the rich can afford to buy all the cath kits they require. Here is the bill Winters supports (H.R. 1831, see below) which would revise the Medicare policy on catheterization kits for paralyzed people. Don?t forget, this is the good bill; the bad bill follows? H.R. 1831: To remove the frequency limitation on Medicare coverage for intermittent catheterization HR 1831 IH 110th CONGRESS 1st Session H. R. 1831 To remove the frequency limitation on Medicare coverage for intermittent catheterization. IN THE HOUSE OF REPRESENTATIVES March 29, 2007 Mr. RENZI (for himself, Mr. KENNEDY, and Mr. RAMSTAD) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL To remove the frequency limitation on Medicare coverage for intermittent catheterization. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. REMOVING FREQUENCY LIMITATION ON MEDICARE COVERAGE FOR INTERMITTENT CATHETERIZATION. Effective January 1, 2008, the Secretary of Health and Human Services in making coverage determinations respecting intermittent catheterization under part B of title XVIII of the Social Security Act shall not deny coverage of a replacement catheter on the basis of frequency of use. That was the good bill; now comes? the other. There was a horror movie, I recall, called, The Other. I did not see it, but it was about evil wrapped in the guise of good. Which fits. Imagine a law which would prioritize NIH funds in favor of adult stem cell research? What?s that you say? Surely no legislation would be that--- (pause while I hunt for an appropriate word?many leap to mind?cruel, short-sighted, asinine, no, no?um? misguided, yes, that fits?misguided. Colossally misguided. The ?Patients First Act of 2007? is all of the above, and much more, but webmaster Karen does not like me to curse. The Patients First Act (wonderful name, huh? Too bad the rest of it does not match)?the Patients First Act (H.R. 2807, Forbes/Lipinski) prioritizes stem cell research funding in a way that gives all the advantage to adult stem cell research. The bill authorizes the ?prioritizing? of research that is closest to clinical trials. Now, let?s see, which kind of stem cell research had a fifty year head start, and vastly preferential funding? Can anybody say ?adult stem cell research?? Compare that to the welcome given to embryonic stem cell research, attacked non-stop by the religious right and its allies in Congress and the White House?and SCNT research, not only completely unfunded, but so hated by the anti-research folks that they tried four times (2001, 2003, 2005, 2007) to pass a criminalization bill against it? Here is the main poison part of the bill: ??prioritizing research with the greatest potential for near-term clinical benefit in human patients, provided that such isolation, derivation, production, testing, or use will not involve-- `(1) the creation of a human embryo for research purposes; `(2) the destruction of or discarding of, or risk of injury to, a living human embryo; or `(3) the use of any stem cell, the derivation or provision of which would be inconsistent with the standards established in paragraph (1) or (2). If enacted into law, this virulent little chunk of poison would do irreparable harm to the research we support. It would stack the deck permanently in favor of adult stem cell research, ?prioritizing? it to the head of the line for funding, making sure no embryonic or SCNT research would ever jump to the head of the line. Its authors, Representatives Republican J. Randy Forbes (VA-04) and Democrat Daniel Lipinski (IL-03) are proof that no political party holds a monopoly on short-sightedness. Here?s the whole mess. Well, the day begins, folks?good luck to us all. H.R. 2807: To intensify stem cell research showing evidence of substantial clinical benefit to patients, and... HR 2807 IH 110th CONGRESS 1st Session H. R. 2807 To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes. IN THE HOUSE OF REPRESENTATIVES June 21, 2007 Mr. FORBES (for himself and Mr. LIPINSKI) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the `Patients First Act of 2007'. SEC. 2. PURPOSES. It is the purpose of this Act to-- (1) intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions; (2) promote research and human clinical trials using stem cells that are ethically obtained and show evidence of providing clinical benefit for human patients; and (3) promote the derivation of pluripotent stem cell lines without the creation of human embryos for research purposes and without the destruction or discarding of, or risk of injury to, a human embryo. SEC. 3. HUMAN STEM CELL RESEARCH AND THERAPY. (a) Authorization- Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by inserting after section 409I the following: `SEC. 409J. HUMAN STEM CELL RESEARCH AND THERAPY. `(a) In General- The Secretary shall conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells that may result in improved understanding of or treatments for diseases and other adverse health conditions, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not such pluripotent stem cells have an embryonic source), prioritizing research with the greatest potential for near-term clinical benefit in human patients, provided that such isolation, derivation, production, testing, or use will not involve-- `(1) the creation of a human embryo for research purposes; `(2) the destruction of or discarding of, or risk of injury to, a living human embryo; or `(3) the use of any stem cell, the derivation or provision of which would be inconsistent with the standards established in paragraph (1) or (2). `(b) Guidelines- Not later than 90 days after the date of the enactment of this section, the Secretary, after consultation with the Director of NIH, shall issue final guidelines implementing subsection (a) to ensure that any research (including any clinical trial) supported under subsection (a)-- `(1) is clearly consistent with the standards established in subsection (a) if conducted using human cells, as demonstrated by animal trials or other substantial evidence; `(2) is prioritized in terms of potential for near-term clinical benefit in human patients, as indicated by substantial evidence from basic research or by substantial clinical evidence which may include but is not limited to-- `(A) evidence of improvement in one or more human patients suffering from illness or injury, as documented in reports by professional medical or scientific associations or in peer-reviewed medical or scientific literature; or `(B) approval for use in human trials by the Food and Drug Administration; and `(3) consistent with the standards established in subsection (a), may take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research. `(c) Rule of Construction- Nothing in this section shall be construed as altering the policy in effect on the date of the enactment of this section regarding the eligibility of stem cell lines for funding by the National Institutes of Health. `(d) Definitions- In this section: `(1) HUMAN EMBRYO- The term `human embryo' includes any organism, not protected as a human subject under part 46 of title 45, Code of Federal Regulations, as of the date of the enactment of this section, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. `(2) RISK OF INJURY- The term `risk of injury' means subjecting a human embryo to risk of injury or death greater than that allowed for research on fetuses in utero under section 46.204(b) of title 45, Code of Federal Regulations (or any successor regulation), or section 498(b) of this Act.'. (b) Priority Setting; Reports- Section 492 of the Public Health Service Act (42 U.S.C. 289a) is amended by adding at the end the following: `(d)(1) With respect to human stem cell research, the Secretary, acting through the Director of NIH, shall give priority to conducting or supporting research in accordance with section 409J. `(2) At the end of fiscal year 2008 and each subsequent fiscal year, the Secretary shall submit to the Congress a report outlining the number of research proposals under section 409J that were peer reviewed, a summary and detailed list of all such research proposals that were not funded, and an explanation of why the proposals did not merit funding. The reports under this paragraph shall be in addition to the reporting on stem cell research included in the biennial report required by section 403.'. (c) Biennial Reports- Section 403(a)(5) of the Public Health Service Act (42 U.S.C. 283(a)(5)) is amended-- (1) by redesignating subparagraph (L) as subparagraph (M); and (2) by inserting after subparagraph (K) the following: `(L) Stem cells.'. SEC. 4. STUDY TO EXPAND ACCESS TO THERAPEUTIC STEM CELL PRODUCTS. Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall study and submit recommendations to the Congress on any structural changes to the C.W. Bill Young Cell Transplantation Program established under 379 of the Public Health Service Act (42 U.S.C. 274k) that would help to expand access to new and future stem cell therapeutic products, including stem cells derived from amniotic fluid as well as other sources such as dental pulp, nasal tissue, and fat that may benefit from inclusion in the coordinated distribution of bone marrow and cord blood stem cells.
Don Reed
www.stemcellbattles.com
