[Congressional Record Volume 141, Number 158 (Thursday, October 12, 1995)]
[Extensions of Remarks]
[Page E1932]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  ALZHEIMER'S PATIENTS NEED FDA REFORM

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                        HON. JOHN J. DUNCAN, JR.

                              of tennessee

                    in the house of representatives

                       Thursday, October 12, 1995

  Mr. DUNCAN. Mr. Speaker, I would like to share with my colleagues an 
article written by my constituent, Alzheimer's activist George 
Rehnquist of Knoxville, TN. Mr. Rehnquist is a retired Tennessee Valley 
Authority engineer and founder of the Families for Alzheimer's Rights 
Association.
  One of the most wasteful, bureaucratic agencies in the Federal 
Government today is the FDA. They have delayed approval for medicines 
for sometimes up to years to the detriment of the health of American 
citizens.
  Mr. Rehnquist's personal experience with drug research brings 
awareness to the needless deaths caused by FDA's senseless delay of 
approval on vital medicines. I agree that Congress should no longer 
tolerate this practice.

                  Alzheimer's Patients Need FDA Reform

                        (By George D. Rehnquist)

       If officials of the Food and Drug Administration (FDA) had 
     to take care of an Alzheimer's patient 24 hours a day, 7 days 
     a week, month after month and year after year, the medicine 
     my wife needed would have been approved in record time. As it 
     was, the FDA tied the medicine up in red tape until tens of 
     thousands of Alzheimer's patients who could have been helped 
     by the medicine had died. Congress is considering legislation 
     to reform this agency to make it more responsive to the needs 
     of patients. Hopefully, Congress will stop FDA from playing 
     God with the lives of terminally-ill patients.
       My wife, Lucille, was diagnosed with Alzheimer's disease in 
     1981, but her symptoms began before that, in 1970. She was in 
     her early fifties when she began to get lost on shopping 
     outings. She had to stop playing bridge, because she couldn't 
     remember what cards had been played. She also had to leave 
     her secretarial job at the Tennessee Valley Authority because 
     the work was getting too confusing for her, and she 
     complained that she felt like she was in a continuous daze.
       When we got the Alzheimer's diagnosis--at Duke University 
     Medical Center--I was shattered. There was no medicine, no 
     cure. They told me she might not know me in a year, and that 
     I wouldn't be able to take care of her--I'd have to put her 
     in a nursing home.
       Determined to help my wife, I took early retirement so I 
     could take care of her in our home. I also read everything 
     I could about the disease, and called up people who were 
     doing research. When I read a report that Dr. William K. 
     Summers was having some success with an experimental 
     intravenous drug called THA, or tetrahydroaminoacridine. I 
     contacted him immediately.
       Dr. Summers agreed to treat Lucille, and we flew to 
     California. After four days of treatment, the change was 
     miraculous, Lucille came out of her daze and even baked 
     brownies for Dr. Summers. When she took a orientation test, 
     she got 9 out of 12 answers correct--compared to only one out 
     of 12 before treatment with the drug. She could drive and do 
     housework.
       ``I'm back to my old self again!'' she rejoiced.
       Because Lucille couldn't stay in the hospital to continue 
     intravenous treatment, I tried to get the drug in pill form. 
     That was my first battle with the FDA.
       Dr. Summers had been trying to get permission to treat 
     people with oral THA for several years, but had no success. 
     After two years of pleading with and cajoling the FDA, 
     interventions by my Congressman, and, finally, a letter to 
     President Reagan, the permission came through for Dr. Summers 
     to give Lucille THA in pill form under a ``compassionate IND 
     (investigational new drug)''. Lucille was the first patient 
     to get THA in pill form. She continued to improve and we had 
     five good years together before the disease progressed to the 
     point where she had to enter a nursing home.
       THA is a palliative--not a cure--for Alzheimer's. But for 
     Alzheimer's patients and their families, THA is the only 
     thing that offers any hope at all. THA gave Lucille and me 
     more than five good years together. That should be all the 
     evidence of effectiveness FDA needs. Patients with terminal 
     diseases should be able to make their own decisions about 
     whether or not a drug works.
       Once Lucille entered a nursing home, she had to stop taking 
     the drug. The reason: the nursing home could not give her a 
     drug that hadn't been approved by the FDA. She declined 
     steadily.
       Meanwhile--after an article by Dr. Summers was published in 
     The New England Journal of Medicine--the medical community 
     and the families of Alzheimer's patients clamored for the FDA 
     to approve THA. But the FDA kept throwing blockades. The 
     agency bashed Dr. Summers' research and cited danger of liver 
     damage (which was benign and reversible). The agency also 
     claimed that the medicine wasn't effective, although the 
     families of patients who had been helped by it knew better.
       Finally, after six years of hearings and red tape, the FDA 
     approved the medicine in late 1993. If the agency had acted 
     more quickly, it could have helped many people and saved 
     millions of dollars by enabling families to take care of 
     Alzheimer's patients at home instead of in nursing homes.
       THA, now known by the brand-name Cognex, is now available 
     by prescription and should help many patients have a better 
     quality of life. It is not a cure, but I am concerned that 
     when a cure is finally developed it, too, will get tied up in 
     red tape.
       The way drug development and regulation works now, it takes 
     nearly 15 years between the time a drug is developed and the 
     time it is available at the pharmacy. Sick people--
     particularly people with Alzheimer's disease--can't wait that 
     long. For the sake of people waiting for cures for this and 
     other diseases, Congress must act now to change the way the 
     FDA operates.
       In my struggle with the FDA, I have found rude bureaucrats 
     who were arbitrary and capacious. I believe this come from 
     wielding absolute power for too long. I believe that the 
     power of FDA must be reduced, not expanded as President 
     Clinton now desires.

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