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The license authorizes the health-care giant to enter into a joint venture with Havana's Finlay Institute, which in 1985 developed "what many doctors believe is the world's most advanced meningitis B vaccine" according to a July 23 report in The Wall Street Journal. Since the discovery, Cuba has sold millions of doses of the vaccine to Brazil, Argentina and Colombia, among other countries. The vaccine has been included in Cuba's national immunization program since 1991, and is credited for reducing meningitis B and C rates by 93% since then, to virtually nil. (See article this issue "Cuba's National Immunization Program" by Dr. Miguel Galindo.) The United States itself is faced with annual outbreaks of meningitis B, which strikes primarily children and young people, and can be fatal. Carl Frasch, chief of the Food and Drug Adminstration's Bacterial Polysaccharides Laboratory, wrote last year that 1,000-2,000 cases of meningitis B could be prevented each year in the USA with the Cuban vaccine. "The U.S. would benefit from a collaboration between a large vaccine manufacturer, now licensed in the U.S., with the scientific institutes in Havana, Cuba, to produce an improved group B meningococcal vaccine suitable for use in the U.S.," said Dr. Frasch in a letter to SmithKline. In fact, according to the Centers for Disease Control in Atlanta, community outbreaks of meningococcal disease are increasing in the United States, and 50-55% of the cases are caused by serogroup B, while serogroup C accounts for 20-25%. The Cuban vaccine is effective against both types, but until now the U.S. embargo had precluded use or testing of the Finlay Institute's vaccine, despite offers from the institution.
Although SmithKline Beecham PLC is British, the Belgian testing laboratories to be used for the Cuban vaccine are owned by a U.S. subsidiary, which is subject to U.S. embargo
regulations. According to a SmithKline spokesman, the U.S. Treasury license authorizes SmithKline to initially pay Cuba in food and medicine, but once it begins to sell the vaccine,
the Finlay Institute would be paid in cash royalties. The company's hope, he said, is to introduce the vaccine into the U.S. market after FDA approval.
AIDS and a Cuban Vaccine Update
Table 1: HIV-AIDS in Cuba (from 1986 through April 22, 1999)
Source: Dept. of Epidemiology Santiago de las Vegas Sanatorium Figure 1: HIV+ Detections, AIDS and AIDS Deaths Per Year (Cuba, 1986-98)
Source: Dept. of Epidemiology Santiago de las Vegas Sanatorium
The National AIDS Prevention and Management Commission was founded in 1983 by the Public Health Ministry, which the same year set up an epidemiological surveillance system and prohibited importation of hemoderivatives, which were from that point produced in Cuban laboratories. In 1985, $2 million was invested by the public health system to develop the National AIDS Prevention and Control Program, and in particular to furnish the first 750,000 ELISA-system diagnostic kits and related equipment for the provincial blood banks and 42 diagnostic centers in the country. By late 1986, screenings included all blood donations; persons returned from service in Africa (every six months); and workers in tourism, the merchant marine, fishing and airlines industries (once-a-year). Later, testing would be extended to pregnant women in their first trimester, hospitalized patients, prisoners and patients suffering from sexually-transmitted diseases. In 1987, Cuban laboratories began producing their own diagnostic kits. The Ministry of Public Health's AIDS strategy was based on four main programs:
Perhaps the most controversial of these programs has been the sanatorial care for HIV-positive patients, which originally obligated seropositive Cubans to live the rest of their lives in these institutions. Organized like small communities, the sanatoriums are made up of apartment complexes and small houses, plus infirmary, offices and other patient facilities. In 1993, however, the sanatorium policy underwent changes. Until then, patients were permitted daily visits, but only allowed to return to their families and communities on the weekends. That year, an outpatient program was begun. Under this variation—after an initial six months in the provincial sanatorium for extended diagnosis and treatment recommendations, psychological counseling and education—patients are evaluated by an interdisciplinary team to determine their eligibility for the ambulatory program, based on their "understanding of their condition and commitment to safe sex." If they are approved and choose to do so, they return to their homes and receive regular care from the local family doctor, in addition to periodic visits to specialists. The overwhelming majority of patients have been approved for the outpatient option, but by the end of 1995, only 192 of the 769 HIV patients who had not developed full-blown AIDS had opted for ambulatory care. The explanation is found in the fact that, since the country's economic crisis hit in the early nineties, many patients find they are ensured better living conditions at the sanatorium. Since 1993, HIV-positive persons in Havana and other provinces have been incorporated into other aspects of the National AIDS Program, through the AIDS Prevention Group at the Havana Sanatorium and AIDS prevention work at the National Center for Health Education—whose participation includes educational efforts in the high schools and other institutions, and counseling of newly-diagnosed patients and their families. The Pedro Kourí Institute for Tropical Medicine is the national reference center for clinical management of HIV-AIDS, and provides hospitalization for AIDS cases when necessary and for those whose AIDS-related illness requires more complex services than the ones offered by sanatorium infirmaries. Other Cuban institutions directly involved in the prevention, education, diagnosis, treatment and research concerning AIDS are the National Reference Laboratory for HIV, the National Immunoassay Center, the National Blood Bank System, the Center for Genetic Engineering and Biotechnology (CIGB) and the Finlay Institute. The Cuban Vaccine In 1992, the CIGB, Finlay Institute and Tropical Medicine Institute put together a 12-person special research team. Their goal: develop a Cuban AIDS vaccine. The team is headed today by CIGB's 36-year-old Carlos Duarte, and the majority of its members are younger still. In 1996, the team proposed the first of several 'candidate' vaccines—all genetically engineered, none using the live virus. That same year, 24 scientists (among them, Dr. Duarte and his research team) volunteered for Phase I trials in humans—that is, the stage which tests reactogenicity or adverse effects of the vaccine candidates in human beings. This first vaccine has been reformulated based on the tests, and underwent another round of Phase I tests in early 1999. The Cuban vaccine candidates must still pass Phase II trials to test the immunogenicity of vaccine candidates, and if these are successful, then the vaccine must be tested for effectiveness in Phase III among several thousand volunteers for over two years (field testing). Dr. Duarte comments that the Cuban research is important from an economic as well as a scientific point of view, since one of the objectives of a vaccine developed in Cuba would be to make it "affordable". This is particularly important for the rest of the Third World, and especially for the African countries, where AIDS is taking its heaviest toll per capita.
"Nevertheless," stresses Dr. Duarte, "our research on the AIDS vaccine has been hampered at various points by the US trade embargo against Cuba. Equipment costs three
times as much to purchase and ship from Europe; critical contacts with U.S. scientists are difficult; and in the end, the embargo lengthens our research time."
Abortion in Cuba: A Right and a Responsibility
"The Doctor is In......" "Abortion" is the title of his May 26, 1999 segment. We reproduce it here in English for readers of
MEDICC Review as an example of materials published nationally for public health education in Cuba. The physician interviewed is Dr. Miguel Sosa Marín, OB-GYN and President of the Cuban Society of Family
Development (SOCUDEF), an NGO in the health field. The practice of abortion by choice is legal in Cuba. It is a service provided by Cuban medical institutions, including a sizeable number of hospitals and other facilities authorized to carry out the procedure and staffed with professionals qualified to perform it. According to Dr. Miguel Sosa Marín, these services are offered in response to requests for voluntary abortions (interruptions of pregnancy). Menstrual regulation services are also offered, usually at community polyclinics. Dr. Sosa, Do you think that the legalization of abortion—demanded by women in many countries throughout the world—would make the procedure more accessible, but might also lead to its abuse? Abuse, no, as long as abortion is practiced responsibly. The right to quality abortion services and to choose abortion based on the "right of women and couples to decide on reproduction" is something Cuban women achieved in the early 60s, as part of their struggle for full gender equality. The legalization of abortion in Cuba was also based on the need to reduce highly risky complications from the extensive and indiscriminate practice of illegal abortions, which was accepted and tolerated in the country, and which had resulted in elevated maternal mortality and a high incidence of mutilations. What is the current situation of abortion in Cuba? In Cuba, we record all abortions, including menstrual regulations. Right now, the number of voluntary abortions is about half what it was 12 years ago, and menstrual regulations have also decreased considerably. I should say that the number of abortions in women under 20 has also declined. We estimate that 20 percent of abortions are the result of failed contraceptive methods, and about the same percentage from the failure to use contraception at all. The latter, of course, could be avoided if the couple or the woman decided to consciously practice contraception. What are some of the risks of abortion, even under the best medical conditions? The most common is the persistence of ovular remains, the incomplete abortion, resulting in a high incidence of infection; hemorrhagic complications are also fairly frequent; and traumatic lesions such as perforation of the uterus can also occur. In some cases, the evolution of these complications can put the life of the woman at risk. What is the percentage of women who lose their childbearing capability as a result of abortion? The antecedent of one or more abortions appears in over one half the women whose infertility is due to tubal obstruction, although some studies show an even higher correlation. Are the risks of abortion the same for adolescents as for adult women? Or are there differences? Adolescent and young women are more susceptible to biological or organic complications, since they are still maturing. At the same time, pregnancy itself in teenagers under 18 leads to untimely hormonal and metabolic changes that can negatively impact their growth and development process. Of particular significance are the psychological effects that an unwanted pregnancy can have in very young women, in their partners and families. What is the permissable limit for a woman in terms of the number of interrupted pregnancies? From the medical point of view, the ideal number would be zero—not to subject herself to this risk. Is "menstrual regulation", whether procedural or hormonal, considered a form of abortion? The aspirator method is a technique that results in abortion in over 70 percent of all cases, and that has its own complications. Pharmacological abortions are indeed abortions—registered as such—and not without risk. What is "incomplete abortion"? This is a clinical concept, which is applied to the partial expulsion or extraction of the ovum (including the embryo and related tissues). Persistent pain and abnormal bleeding are the most common symptoms. Finally, Dr. Sosa, what is the time limit for an abortion? How far along in pregnancy? In Cuba, eight weeks into pregnancy for an abortion-by-choice, which is decided by the woman (counted as ten weeks from the first day of her last period). For menstrual regulations, the limit is 45 days from the first day of her last period. MR editor's note: There were 44.7 abortions per 100 pregnancies in Cuba in 1989, down to 36.7 in 1995. MEDICC Review
is planning a full issue on reproductive health, which will carry an update on abortion in Cuba today. |
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he week of July 19, the U.S. Treasury Department granted SmithKline Beecham PLC
a first-of-its-kind license to market the Cuban vaccine against meningitis B, once the product receives FDA approval.
n Cuba, 2,299 HIV-positive cases have been reported since the virus was first detected
on the island in 1986 and through April this year; 856 of these patients have developed full-blown AIDS; and 658 have died (614 from AIDS and 44 from other causes). (See Table 1 and Figure 1
). The average incubation time from HIV infection to AIDS is 11 years, and the average survival time from the onset of AIDS is 18 months.