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more scientists and physicians trained in STD and, in fact, gave training the highest priority in its list of recommendations. Advisory Council agreed wholeheartedly with the Study Group's conclusions and priorities and recommended what it felt to be a more realistic funding level--at least $28,140,000 (1980 dollars) invested by 1985.

RECOMBINANT DNA RESEARCH

Question: NIAID has actively conducted and supported a variety of risk assessment experiments. What are the results of your risk assessment studies of the recombinant DNA research techniques?

Answer: Special experiments have been conducted to assess the potential risks associated with recombinant DNA research. These experiments were designed to determine the probability of the occurrence of such events as the escape of an organism containing recombinant DNA into the environment, the likelihood of its survival and the possibility of a change in its natural biology so that it becomes a danger to some higher organism.

The NIH Risk Assessment Plan requires that an annual update be prepared and the first proposed report has been published in the Federal Register, Vol. 45, No. 182, 61874 (attached). A lengthy discussion of all past results and future plans is contained in that document. In summary, no risks of recombinant DNA research have been identified that are not inherent in the microbiological and biochemical methodology used in such research because recombinant DNA technology does not endow the laboratory research system with new hazardous properties not present in the starting materials. Therefore, it is now widely accepted that research performed in accordance with the NIH Guidelines for Recombinant DNA Research poses no threat to the investigator, the community or the environment.

Question:

regard?

Answer:

How do you cooperate with other Institutes in this

Responsibility for coordination and implementation of the risk assessment plan was assigned by the Director, NIH, to the Director, National Institute of Allergy and Infectious Diseases (NIAID). The Office of Recombinant DNA Activities (ORDA), located in NIAID, interacts with designated representatives of other NIH Institutes to coordinate current NIH policies and procedures for the conduct of recombinant DNA research. Cooperation among different Federal agencies is achieved through the Federal Interagency Advisory Committee and through direct contact by ORDA staff with Federal agencies involved in the support of recombinant DNA research.

FOOD ALLERGY

Question: Avoidance is reported to be the preferable approach to managing food allergies, rather than using desensitizing techniques. To what extent can an individual's sensitivity to certain foods change over time?

Answer: Young children, who appear to experience many more allergic or adverse reactions to foods than adults, usually outgrow their reactivity by the time they are five to six years old. Among adults who experience such reactions, persistence of symptoms tends to be the rule. Some individuals face the lifelong hazard of severe,

even life-threatening, reactions.

Question:

How many people are affected by food allergies?

Answer: Without the availability of precise diagnostic tests and procedures, it is impossible to state, at present, how many people are affected by food allergies. However, it is estimated that 1-4 percent of children under age five suffer from food allergy, with lessening incidence noted with advancing age.

IMMUNOLOGIC INFERTILITY

Question: Dr. Gilbert G. Haas, Jr., and his associates at the University of Pennsylvania have developed a test to identify those men and women who are infertile because they produce antibodies to sperm. Have there been further breakthroughs in the area of immunologic infertility since the September 1980 report of an antibody test being developed to aid infertile couples?

Answer: The test developed by Dr. Haas and his associates appears to be more accurate than tests used previously for the detection of anti-sperm antibodies. To our knowledge, no further information has been reported since their publication. We are aware, however, that several groups are now examining the usefulness of Dr. Haas' test in their patient populations.

INTERFERON RESEARCH

Question: What is the status of your research on interferon?

Answer: NIAID supports investigator-initiated research grants for basic research on interferon. Most of these grants deal with mode of action, immune modulatory effects, and properties of the various interferons. Also supported are a wide variety of contract activities ranging from clinical trials of interferon in several types of virus infections, to studies of its effects on the immune system, to projects providing reagents and the support of basic research. The NIAID supported clinical trials that demonstrated the efficacy of interferon against herpes zoster (shingles). Interferon has also been given to patients undergoing trigeminal nerve resection for the painful "tic douloureux syndrome" and it was found to prevent reactivation of latent herpes simplex, a frequent complication. we learn more about treatment of cancer patients, transplant patients, and others who need to be put on immunosuppressive drugs (which reduces their natural resistance), viral infections become an increasingly important problem. Therefore, the role of interferon against viral infections such as chickenpox and cytomegalovirus is currently being investigated. Its role in chronic active hepatitis is also being evaluated.

Question: Have there been any promising results in clinical trials in the past year?

As

Answer: Interferon does indeed seem to have a role in the control of orofacial herpes (Pittsburgh study), zoster or shingles (Stanford) and perhaps in the treatment of chronic active hepatitis B in conjunction with adenine arabinoside (Stanford). A double-blind, placebo-controlled trial is being planned to determine efficacy against chronic hepatitis; a study is currently under way with primary genital herpes. Reports from several countries in the past

year noted encouraging results in the treatment of laryngeal papilloma and other wart-like growths; depending on availability of funds, a study to demonstrate efficacy in this area will be undertaken.

Question: To what extent are you cooperating with the National Cancer Institute in this research?

Answer: In FY 1980 NCI provided $1.145 million to the NIAID to support some contracts of mutual interest (related to interferon) as part of a collaborative effort on this subject between the two Institutes. We have proposed additional projects for a similar collaborative effort in FY 1981 that are under consideration by NCI. In particular, the cooperation between NIAID and the NCI with respect to the purchase of interferons for clinical trials and with respect to the acquisition of interferon standards (standard preparations of interferon to allow for comparison between laboratories) has been excellent. Continued coordination of efforts between the Institutes is anticipated in FY 1982 to avoid a duplication of effort and to insure the careful, coordinated use of resources supporting interferon research in clinical trials.

The NIAID and NCI will continue their collaboration through exchange of information and resources wherever possible. In addition, this Institute is responsible for an informal interagency information exchange committee to assure that all involved organizations have the opportunity to keep abreast of each other's activities and to jointly plan new activities.

Question: How effective is interferon in the treatment of

cancers?

Answer: This is best answered by the National Cancer Institute which is currently investigating this question. From the worldwide publications to date, it appears that interferon will have a positive role in the treatment of cancer, but is by no means a cure for many forms of the disease. It will probably be most effective in conjunction with other treatment modalities in selected cancers.

SEXUALLY TRANSMITTED DISEASES

Question: Gonorrhea has been classified as a national epidemic, with an estimated 2.5 million new cases occurring annually in the U.S. Other sexually transmitted diseases are also appearing more frequently. What progress has been made in treatment of such diseases and prevention of their spread?

Answer: In March 1976, penicillin-resistant strains of gonococci were identified in this country. Fortunately, this new type of gonorrhea has not spread rapidly and it is treatable with other antibiotics such as spectinomycin and tetracycline. However, the appearance of these strains made clear to everyone that drug treatment of gonorrhea is not the ultimate answer to its control. The search for gonococcal vaccine has accelerated and the prospects appear promising. Vaccines are now being tested that inhibit attachment of gonococci to human cells and that stimulate antibodies that kill the bacteria.

Chlamydial infections respond well to antibiotics, but there is a need for simple and inexpensive diagnostic tests. Recent progress

in developing ways to study these infections in animal models will facilitate future research and development of these tests. Other studies have shown the feasibility of treating pregnant women who have chlamydial infections in order to protect their newborn infants. Treatment of the newborn's eyes with erythromycin ointment has prevented chlamydial conjunctivitis. This study lays the groundwork for possible changes in neonatal prophylaxis that will protect infants from both chlamydial and gonococcal infections of the eye.

Several antiviral drugs are being evaluated for their effectiveness against herpes simplex virus, the cause of genital herpes. One of the most promising drugs is acyclovir. The recurrent aspect of herpes infections complicates the search for effective treatments and preventive measures. A scientist recently reported that recurrent lesions are due to a defect in the regulation of virus-specific cell-mediated immunity. The lesions recur in those individuals who suffer from a defect that prevents their immune memory from initiating rapid responses capable of curtailing virus growth and cell-to-cell spread. Perhaps vaccines can be designed to modulate the regulatory aspects of the immune reaction in such a way as to protect from reinfection.

Question: Which of those diseases are presenting the greatest problem at this time?

It

Answer: Genital herpes, caused by the herpes simplex virus (HSV), is one of the most serious sexually transmitted diseases. is estimated that 300,000 to 500,000 new cases occur each year in this country. Since most patients with genital herpes have recurrences, some authorities estimate that between five and ten million episodes of genital herpes occur yearly. This infection also has serious implications for pregnant women and their unborn and newborn babies. The first occurrence of the disease early in pregnancy can result in spontaneous abortion. If the infection occurs later in pregnancy and virus is present in the birth canal during delivery, the baby may develop disseminated HSV infection which is frequently a fatal or crippling disease. It is entirely possible that some mothers of infected babies may show no obvious symptoms of genital herpes; that is, they may have at the time of delivery a subclinical or inapparent infection.

Another major health problem is caused by chlamydial infections. Out of an estimated one million cases of nongonococcal urethritis (NGU) each year in the U.S., 30 to 50 percent are caused by chlamydia. This organism is also an important cause of postgonococcal urethritis, epididymitis, and prostatitis in men. In women, chlamydial infections cause inflammation of the fallopian tubes, the cervix, and the uterus. In newborns, it is the most common cause of conjunctivitis and of pneumonia, affecting more than 100,000 babies each year.

Question:

HERPES SIMPLEX

How serious is the problem of herpes simplex type 2 in the U.S. today?

Answer: Genital herpes, which is caused primarily by herpes simplex virus (HSV) type 1 or type 2, is a very serious problem today. It is estimated that 300,000 to 500,000 new cases occur each year in this country. Since most patients with genital herpes have

recurrences, some authorities estimate that between five and ten million episodes of genital herpes occur yearly. The morbidity of the acute illness, its frequent recurrence rate, its occasional complications such as meningitis, its devastating effect on the newborn, and its epidemiologic association with cervical carcinoma have made this disease a major public health problem.

Question: What are the medical consequences?

Answer:

Painful, prolonged ulcerations associated with fever, burning, and swelling of the genitalia occur during the first episode of infection. The sores may last about three weeks before healing, but then may recur at monthly intervals. Added to this physical burden is the concern that years later the infected mother will carry an increased risk of delivering a premature or stillborn infant or that the virus will be transmitted to the infant during birth, with potential death or neurologic damage to the child. In addition, the risk of the mother developing cervical cancer may be increased. The psychologic-sexual disruption that accompanies this infection often causes strained relationships, severe depression, broken marriages, and lifelong alterations in social and sexual behavior.

Question: What is the association with higher risk of cervical cancer for women with herpes?

Answer: Several studies have shown that antibodies against HSV are more common in patients with cervical cancer than in women without cancer. A recent study has shown that some cervical carcinoma tissue contains HSV genetic material and protein. These studies show only an association and not any cause-and-effect between HSV and cancer. Much research is now under way to try to answer this question definitively.

Question: Without a cure or treatment, how much worse will the situation get in the next few years?

Answer: Several factors are expected to increase the magnitude of the entire STD problem in the next few years. The projected composition of the U.S. population indicates that the number of young adults in the 18- to 29-year age group, which experiences the highest rates of STD's, will continue to increase until the middle of the 1980's. An increasing proportion of teenagers and young adults are having premarital sex with multiple partners, thereby increasing their risk of contracting STD. The chronic, recurrent nature of genital herpes indicates that the prevalence of this disease, in particular, is likely to increase tremendously.

Question: What are the research needs to help people live with the disease and prevent its transmission until a treatment is found?

Answer: Viral latency is still a mystery; still unknown is what happens to the virus between obvious episodes of the disease, and how many people shed the virus without being aware of any sores. Several questions concerning the impact of genital herpes on the newborn also must be answered. Scientists need a better understanding of how and why the infection persists and the factors involved in reactivation. They are testing experimental drugs that are effective in stopping active infections, but the infection does recur. There is a need to identify the role of the immune system in recurrent infections. Investigators are also concerned about drug resistance developing after recurrent infections are treated.

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