[Congressional Record Volume 142, Number 35 (Thursday, March 14, 1996)]
[House]
[Pages H2306-H2307]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       WHY MEDICINE COSTS SO MUCH

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Tennessee [Mr. Duncan] is recognized for 5 minutes.

[[Page H2307]]

  Mr. DUNCAN. Mr. Speaker, one of the worst agencies in the entire 
Federal Government is the Food and Drug Administration. It is arrogant. 
It is abusive. It is bureaucratic. If people in this country wonder why 
medicine costs them so much, they need look no further than the FDA.
  The bureaucratic rules and regulations and red-tape of the Food and 
Drug Administration sometimes cause needed safe drugs to be held off 
the market in this country for years, and sometimes it takes companies 
many, many millions of dollars to get approval and, as I say, only 
after years of paperwork and red-tape.
  There are many safe lifesaving drugs and medical devices kept off the 
market in this country for years while they are being safely used, 
saving lives in countries around the world. I remember a couple of 
years ago reading a front page article in the Wall Street Journal about 
a device, a medical device used to detect breast cancer, that had been 
held off the market for years because this small company in Illinois 
did not bow down to the FDA sufficiently and they had gotten approval 
in every other country in the world in which they had sought approval, 
most of the time within just a few weeks.
  One doctor was quoted saying that this had caused thousands and 
thousands of women to die from breast cancer because of the 
bureaucratic delays and dilatory and unfair tactics of the Food and 
Drug Administration.
  So that is one reason why I read with such great interest a half page 
ad that was run yesterday in the Washington Times by a man named 
Jeffrey N. South of Arnold, MD. He had written a letter, an open letter 
to his Congressman, and he said this. This letter speaks adequately for 
itself, and I would like to read as much of it as time permits.
  It says:
                                                    March 4, 1996.
     Hon. Wayne T. Gilchrest,
     U.S. Congressman,
     Annapolis, MD.
       Dear Congressman Gilchrest: I have been a citizen of 
     Maryland for most of my life and, until now, have never been 
     moved to address any concern to my Congressman. I have 
     witnessed something recently that deserves your attention.
       On Monday, February 26, 1996, I attended a Food and Drug 
     Administration Advisory Panel hearing in Gaithersburg, MD. A 
     company called Biocontrol Technology, Inc. of Pittsburgh was 
     presenting a medical device for the Panel's recommendation to 
     the FDA for approval to market. This medical device reads 
     blood glucose levels non-intrusively via light energy.
       I am not a diabetic but I was exposed to the horrors of 
     what it must be like to be diabetic for the first time in my 
     life. I observed for the entire day a parade of dozens of 
     those diabetics who cared enough to come to the Washington 
     area to testify on behalf of being able to use this new 
     technology towards improving the quality of their lives. 
     Evidently insulin dependent diabetics must perform painful 
     finger prick blood extraction tests numerous times a day in 
     order to determine when they may need insulin. I was amazed 
     to learn that this is such an unpleasant process that over 
     40% (American Diabetes Association Estimates) of diabetics 
     choose to avoid this painful testing procedure at great risk 
     to their lives. I noticed that their fingers looked like raw 
     hamburger from years of sticking their fingers and extracting 
     blood. This medical device would end all of this.
       I was amused by a diabetic woman who passed finger sticks 
     to all the FDA Panel members as she gave her testimony 
     challenging each member to experience the pain of just one 
     prick and to imagine doing it many times a day for their 
     entire life. And to imagine being a very young diabetic child 
     that must do this.
       After ten minutes or so into her testimony she had noticed 
     that not one Panel member had mustered the nerve to perform 
     the stick on their own finger. The entire room of some three 
     hundred plus broke into a laughter of disgust.
       Most of the day was composed of various questions and 
     discussion between the panel members and the scientists and 
     technicians of Biocontrol Technology. I was absolutely 
     shocked and dismayed that the FDA had delegated decision 
     making authority to this body which openly displayed and 
     admitted to very limited, if any, knowledge of the science 
     behind this new technology. Several of the panelists never 
     even received, much less reviewed, any of the vital 
     supporting material that Biocontrol Technology had provided 
     the FDA over two years ago! It wasn't any wonder that, guess 
     what?!--they could not reach a decision to make this 
     technology available to the diabetic public.
       As all of this day unfolded I watched the faces of the 
     public and the technology developers to observe that they too 
     were extremely disillusioned and frustrated as they witnessed 
     this government body embarrass itself with its' incompetence 
     and aloofness. What a pathetic display it was of a 
     bureaucratic process meandering in utter confusion.
       On top of all this, a panel spokesperson disclosed that the 
     FDA can and does exercise wavers for panel members that may 
     have financial or other conflicts with companies whose 
     products are under review. There were several on this panel 
     that did disclose such conflicts and were still permitted to 
     participate. Can you imagine!!!
       I know now why health care costs have soared over the past 
     several decades. Most medical technology developers have to 
     spend millions upon millions of dollars over years waiting 
     for this meandering, incompetent, and perhaps corrupt 
     government process to wave its' magic wand.
       I have enjoyed a healthy and carefree life and can only be 
     thankful that I do not have to depend on such a system. I can 
     only feel extreme sorrow for those who are not healthy and 
     must fight a dreaded disease and wait for the workings of a 
     federal agency the likes of which I witnessed. So very sad 
     for those that forge on knowing that technology exists that 
     could be of great value to them but they must gamble years of 
     their life away waiting for some inept government agency.
       I often hear some say that government is an evil entity and 
     think of those that say it to be extreme. Now I think that 
     they are far more insightful than most of us care to admit.
                                                 Jeffrey N. South.

                              {time}  1545

  Mr. Speaker, in this country today, if some individual came up with a 
cure for cancer, he probably could not get it to market unless he sold 
out to one of the big drug giants. This agency is very harmful to small 
business, and very harmful to the health of the American citizens.

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