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Dr. SHULMAN. With the population, we have research that is directed at determining as to whether or not there are bacteria that are responsible for eliciting this response.
Mr. EARLY. Do we have a clinical trial going on in that area? Dr. SHULMAN. No. Mr. EARLY. We have had 40 years where we are not moving-not with this, but on arthritis.
Dr. SHULMAN. We are doing the very best we can.
Mr. EARLY. That isn't it. The people are entitled to more. The committee has to decide whether you put it in this Institute or that Institute. We are not making much progress. Forty years, a hard nut to crack.
Dr. SHULMAN. We are making progress in lupus, making some progress in Lyme disease. We are hoping to make further progress in rheumatoid arthritis.
Mr. EARLY. Are we making progress in Lyme disease?
Mr. EARLY. The parents that call me say, “We can't do anything about our kids who have Lyme disease.” Take Mr. Downey's District in New York.
Dr. SHULMAN. Out on Long Island.
Mr. EARLY. Yes. There is a lot of it out there, and we can't tell those people anything.
Dr. SHULMAN. We need to do more clinical trials in that arena as well.
Mr. EARLY. Do you have any money in here for clinical trials? Do you have a clinical trial that is ready to go on Lyme disease?
Dr. SHULMAN. Yes, sir.
Mr. EARLY. How much money do you need in this budget? I would much rather move money if we aren't moving off block one in 40 years, and put it in Lyme disease.
Dr. SHULMAN. We have proposed two trials in Lyme disease.
Mr. EARLY. What would the start-up cost for the two trials be? Start-up cost?
Dr. SHULMAN. Start-up cost for one of the trials on Lyme disease would be $500,000 the first year, and the other would be $1,000,000.
Mr. EARLY. What would they cost over the duration of the trials? Dr. SHULMAN. $1,100,000 for one and $2,100,000 for the other clinical trial.
Mr. EARLY. Do you think, in your professional judgment, we should be doing those trials?
Dr. SHULMAN. Yes, sir, I do.
SYSTEMIC LUPUS ERYTHEMATOSUS Mr. EARLY. How about lupus? Do we have any clinical trials underway on lupus?
Dr. SHULMAN. Yes, we have a clinical trial going on in lupus in our cooperative systematic studies.
Mr. EARLY. Are there any additional trials that, in your professional judgment, we should start?
Dr. SHULMAN. There are several clinical trials on our list, amd we could do more.
RHEUMATOID ARTHRITIS Mr. EARLY. I have great respect for you, Mr. Shulman, and your Institute, but it is just a question of who gets the money, and it shouldn't be the squeaky wheel. It shouldn't be what is out there because of publicity, but where we make progress.
Dr. SHULMAN. On our list of trials that we could do, we have one on rheumatoid arthritis, as well.
Mr. EARLY. How much will that rheumatoid arthritis trial cost; what is the start-up cost, and how much would it cost over the duration? In those 40 years, we must have done-
Dr. SHULMAN. We have done a lot of clinical trials on rheumatoid arthritis.
Mr. EARLY. We haven't gotten anywhere.
Mr. EARLY. I was taking that from your testimony. You said we haven't moved. It is a tough nut to crack, you kept saying.
Dr. SHULMAN. I was referring only to discovering the basic cause of rheumatoid arthritis.
Mr. EARLY. There are a lot of them-
Dr. SHULMAN. We have made some progress, and I will be glad to report that to you.
Mr. EARLY. Thank you, Mr. Chairman.
Dr. Shulman, the Chairman will have a number of additional questions which he will submit to you for answers in the record, and I suppose other Members will, also.
Mr. PURSELL. I just have one last question. I know it is 5:00.
Who, aside from you, is responsible for the lupus research pro gram?
Dr. SHULMAN. We have several members of my staff who are working on lupus research.
Mr. PURSELL. I know you are a national expert. Aside from that, you are the director. Who is your lieutenant?
Dr. SHULMAN. One is Dr. Michael Ločkshin, who is the Director of the Extramural Program. He is a lupus expert.
Mr. PURSELL. I came out of the military, and we always had somebody responsible. We delegated authority to somebody that was accountable to you or to the commander. Who would be the person?
Dr. SHULMAN. I must tell you, when I was recruited to NIH back some 15 years ago, the person who recruited me was actually in Dr. Raub's position right now said, you would have an opportunity to do something for lupus research. We have been trying.
I would say I still would like to share in that responsibility to do that.
Mr. PURSELL. That is a given, since you are the Director of the Institute.
Dr. SHULMAN. I would say there are other members of my staff, one of them would be Dr. Michael Lockshin.
Mr. PURSELL. Will you provide for the record your team?
Dr. SHULMAN. We have work in skin disease, lupus affects the skin, so Dr. Moshell's program is involved.
Mr. PURSELL. Will you outline that in your response to the committee for us?
Dr. SHULMAN. Pleased to do so. [The information follows:)
LUPUS STAFF The NIAMS staff who are responsible for the lupus program research are: Dr. Lawrence E. Shulman, Director, NIAMS; Dr. Steven J. Hausman, Deputy Director; Dr. Michael D. Lockshin, Director, Extramural Program; Dr. Lawrence M. Petrucelli, Director, Arthritis Program; Dr. Alan N. Moshell, Director, Skin Diseases Program; Dr. Julia B. Freeman, Director, Centers Program and Minority and Women's Affairs; Ms. Reva C. Lawrence, Epidemiology and Data Systems Program Officer; Ms. Connie Raab, Director, Scientific and Health Communications; Dr. John H. Klippel, Clinical Director, Intramural Research Program; and Dr. Alfred D. Steinberg, Chief, Cellular Immunology.
Mr. PURSELL. I know you are internationally known. You can't do it all.
Dr. SHULMAN. Absolutely.
Mr. STOKES. Dr. Shulman, we appreciate your appearance here. We had an excellent hearing, and we look forward to your next appearance.
The committee stands adjourned until 10 a.m. tomorrow morning.
Mr. Natcher: How many new cases of Lyme disease are expected in this country in 1991?
Dr. Shulman: The Centers for Disease Control (CDC) maintains a national surveillance system for reporting cases of Lyme disease. The current provisional data indicate that 7,995 cases have been reported in 1990. After review of some possible cases has been completed, they estimate that the final 1990 figure will approach the 8,552 cases reported in 1989. The CDC believes these figures are well below the actual number of cases of Lyme disease. Underreporting of cases remains high; perhaps as many as 50 percent of cases go unreported. This year the CDC will be making a special effort to enhance detection and reporting of Lyme disease in order to attain a more accurate accounting of cases. They project that, with the enhanced system, 10,000 to 15,000 cases of Lyme disease will be reported in 1991.
Mr. Natcher: Where do you stand in terms of the development of a vaccine to prevent the spread of Lyme disease?
Dr. Shulman: Although it is known that the spirochete Borrelia burgdorferi is the etiologic agent of Lyme disease, the development of an effective vaccine remains a difficult task. The spirochete does not appear to be very antigenic; that is, it presents very few and relatively small amounts of proteins that the human immune system can recognize as foreign and develop effective antibodies with which to combat the spirochete. During infection with B. burgdorferi, antibodies develop relatively late in the infection. It is not clear what role these antibodies play in controlling the infection. The presence of antibodies from an earlier infection does not always prevent what appear to be reinfections from subsequent tick bites. Despite these limitations, researchers at Yale University, the University of Minnesota, the University of Wisconsin, and the Centers for Disease Control are actively pursuing the development of a vaccine, using animal models. Some vaccines have been shown to be effective in preventing Lyme disease in mice and hamsters.
Mr. Natcher: The Committee understands that Lyme disease is also a problem in sections of Eastern Europe. Has there been an attempt to collaborate with other countries in solving this problem?
Dr. Shulman: Lyme disease appears to be endemic throughout most of Eastern and Central Europe, including the Soviet Union. The species of tick responsible for spreading Lyme disease in Europe is related, but slightly different, from the species that is the most common vector in the United States. The spectrum of clinical manifestations of Lyme disease seen in Europe may be different from that seen in the United States, with more neurologic disease and less arthritis in Europe than in the United States.
American scientists have been collaborating with Soviet scientists on studies of Lyme disease through the U.S.-U.S.S.R. Cooperative Program on Arthritis and Musculoskeletal Diseases. survey of patients with Lyme disease from across the U.S.S.R., this collaborative study has found evidence of B. burgdorferi in a wide
swath throughout the southern parts of the U.S.S.R. all the way from Europe to the Pacific Ocean. Last year, Soviet scientists participating in these collaborative studies came to the United States to work with their American colleagues learning laboratory methods that will be useful for their further study of Lyme disease in the U.S.S.R..
In June 1990, the Director of the NIAMS had the opportunity to meet with Lyme disease researchers from all over the World at the Fourth International Conference on Lyme Borreliosis which was held in Stockholm, Sweden. Because of Stockholm's proximity to Eastern Europe and the dramatic political changes that occurred last year, many scientists from Eastern Europe were able to meet with their American and Western European colleagues for the first time. Many potentially useful collaborations are developing as a result.
In September 1990, staff from the NIAMS visited the Czech and Slovak Federal Republic through the sponsorship of the Fogarty International Center's Eastern European Initiative. They visited with scientists at the Institute of Rheumatology, the Institute of Epidemiology and Hygiene, and the Charles University in Prague; and the Institute of Rheumatology in Piestany. At these meetings, collaborative efforts in the study of Lyme disease were discussed including during a substantial meeting with the new Czech Minister of Health, Dr. Martin Bojar, who has conducted many studies of Lyme disease himself.
Mr. Natcher: How much money is budgeted for Lyme disease throughout the NIH in 1991 and how has this grown in recent years?
Dr. Shulman: In FY 1991 the NIAMS plans to spend $3.5 million on Lyme disease, a five-fold increase over the $657,000 spent in FY 1988. In FY 1991 the NIH plans to spend $9.369 million on Lyme disease, a four-fold increase over the $2,258 million spent in FY 1988.
Mr. Natcher: Doctor, as you know, I have been very concerned about the problem of Epidermolysis Bullosa. People who we like come and talk to us about this awful disease every year. They are our friends, Doctor. What can we tell them next month when they come see us? Any progress, Doctor?
Dr. Shulman: I am pleased to report a number of new research findings concerning epidermolysis bullosa (EB) which, we agree, can be such a tragic deforming disease. Both naturally occurring animal models, and genetically engineered animals with defective genes for molecules considered to be important in the adhesion of epidermis to dermis are being utilized. Individual patients with interesting forms of epidermolysis bullosa have been uncovered by the EB Registry. Some of these investigations have uncovered new forms of the disease not previously recognized. This is clearly important in constructing the design and evaluation of clinical trials for the treatment of EB.