Covert Trials, Overt violations
The Case Against Quinacrine Method of Sterilization
"Covert clinical trials of Quinacrine chemical sterilization are being conducted in virtually all South Asian countries"
"Quina-what?" says a woman sitting close to me at the workshop of Healthcare professionals and health and women activists in Dhaka, when I ask "who is responsible for giving permission and overseeing the ethical conduct of clinical trials"? Others in the room know what I am talking about. One physician had even tried using it 25 years earlier with disastrous results leading to the death of a woman following instillation of Quinacrine into the uterus. To my question, some laugh and explain that the Bangladesh Medical Research Council (BMRC) is responsible but it depends ... I explain "I want to know if Quinacrine has been approved for testing in Bangladesh".
This 'Quina-what' reaction is not an unusual one. Most people, even in countries where Quinacrine sterilization has been done on thousands and thousands of women do not know that these experiments are literally occurring in the bustees in their backyard. Covert clinical trials of Quinacrine chemical sterilization are being conducted in virtually all South Asian countries, namely, India, Pakistan, Bangladesh and Nepal. Worldwide it is being used in fifteen countries, including, Chile, Vietnam, Indonesia ... the list goes on. Despite the fact that these clinical trials have been reported in certain scientific journals, the women on whom these experimental trials have been conducted do not know that the experiment has not been approved by any national or international agency.
The irony is that the assault on women's bodies is done in the name of providing greater reproductive freedom and wider contraceptive choices. Proponents of Quinacrine sterilization maintain that "500,000 women die each year due to unsafe abortions and their lives could be saved if only they accepted sterilization".
What is Quinacrine Sterilization?Quinacrine is an anti-malarial drug, first synthesized in Germany in the 1920s. During the 2nd World War, it was used widely as a prophylactic in the Asian and Pacific theatre. At the time, toxicity studies were conducted at John Hopkins University. The major toxicity due to chronic use of Quinacrine taken by mouth was yellow skin discoloration. Skin rashes were common and quite severe in a small number, even resulting in fatalities. In at least three people it resulted in skin cancer. Intraperitoneal administration led to severe abdominal pain with fever and sometimes Central Nervous System (CNS) toxicity.
The work with Quinacrine pellets began in earnest in the early 1980s with the pproval by the US Food and Drug Administration (FDA) of a phase I trial. According to Dr. David Sokol, the Director of clinical trials for the Family Health International (FHI), Phase II was not carried out because of concerns about the number of insertions needed and Quinacrine's mutagenicity. What Dr. Sokol neglects to mention in his paper is that FHI did not have permission to conduct a Phase II clinical trial in the USA. Drs. Mumford and Kessel in the meantime were trotting all over the globe with suitcases full of Quinacrine pellets, persuading physicians in Third World countries to continue with the trials in their private clinics. So the covert trials, so-called Phase II clinical trials with Quinacrine, continued in private offices and clinics behind curtains where no scrutiny was possible.
Currently, seven pellets of Quinacrine (252 mg) are inserted trans-cervically, according to the protocol, five days after the menstrual period, after testing whether a woman is pregnant or not. The Quinacrine pellets dissolve within 30 minutes and enter the lumen of the oviducts and cause an inflammatory reaction. It is known to bind to the DNA of cells and is known to be a mutagen. Quinacrine is absorbed rapidly and circulates in the body; it has a long half-life. Inflammatory response due to its corrosive action results in the formation of adhesions and eventually a scar tissue in the junction of the fallopian tube. While the proponents of Quinacrine claim that no adhesions are formed in the uterus this is probably not so because menorrhagia is a frequent complaint. A second insertion is made one month later.
In an interview reported in the January 19, 1997 issue of the Sunday Telegraph, Dr. Mullick (who operates a clinic under the auspices of the Bengal Rural Medical Association and claims to have performed over 10,000 sterilizations himself) retorted sharply to a question by the journalist Rajashri Dasgupta about monitoring of patients for side effects. "What do you mean by monitoring the woman patients?" ... "If they have problems, they will come to me. I have not received a single complaint in the last ten years. Moreover, I don't have the money to do any follow-up". This response is echoed by Dr. Syeda Noorjehan Bhuyian, Principal of the Chittagong Medical College and head of the Obstetrics & Gynaecology department. In an interview granted to me on February 15, 1997 she was more explicit; "We are doing the Quinacrine method secretly. It has not been advertised". She was very open about sharing her data with me. I have recalculated the percentages based on the information provided. According to Dr. Bhuyian, 4% became pregnant. This is high enough but the real figure is 14% which is completely unacceptable for a sterilization method. According to them there were no ectopic pregnancies in the Chittagong studies. Given the low follow-up rate, they cannot know whether ectopic pregnancy had occurred in their subjects. Moreover, in the best obstetric unit, ectopic pregnancy is considered to be a medical emergency. So if any woman has ectopic pregnancy, she is likely to be dead from the internal haemorrhage long before anyone can bring it to the notice of the investigators.
Following publication of the results of a retrospective clinical trial on 31,781 women in Vietnam in the prestigious journal 'Lancet' in 1993 many organizations, like the Association for Voluntary Sterilization Council (AVSC) and the World Health Organization (WHO) convened their technical committees to review the data and decide what should be done about Quinacrine. The main concerns raised were that the proponents of Quinacrine method had failed to provide credible scientific data. The WHO issued a categorical statement that all human trials cease immediately until the basic research is done using modern methods for testing carcinogenic properties of Quinacrine. Therefore, all Quinacrine sterilization are illegal ! !
In none of the Quinacrine trials, was any thought given to the right of women to know that the Quinacrine method was purely experimental. Some lip service has been paid in the publicity material but when you speak to the gynecologists who perform Quinacrine sterilization they do not even understand why you are raising the question of informed consent. Illiterate people, according to them, do not understand these matters! The human rights abuses and violations of the conventions on human experimentation that were established after the Nuremberg trials of the Nazi doctors, continue to be violated. No one has attempted to bring a class action suit against the traveling salesmen who manufacture Quinacrine pellets in their home basement and distribute it to gynecologists in far-flung places.
Perhaps the supposed safety, efficacy, ease of insertion and the low cost of Quinacrine have attracted many gynaecologists like Prof. Syeda Feroza Begum, the well-known gynaecologist in Dhaka. In an interview on February 24, 1997 she stated that she had conducted many sterilization's 20-25 years ago using Quinacrine. However, she is now convinced that Quinacrine is not a good method because the failure rate is too high and side effects are significant. As the chair of the regional medical review committee of the International Planned Parenthood Federation, she has turned down Quinacrine sterilization method four times since 1994. She is willing to speak out against it in Copenhagen at the Federation Internationale de Gynocologue et Obstetricien (FIGO) meeting to be held in July 1997, where Dr. Kessel has organized a session on Quinacrine sterilization.
Missionary Zeal!What is the incentive for Dr. Kessel and Mumford to travel around the world with suitcases full of Quinacrine pellets, urging gynecologists at meetings and conferences to try Quinacrine sterilization. It cannot be explained in terms of monetary rewards for them. This may be a motive for gynecologists like Dr. Mullick and Dr. Bhuyian, but the two Americans speak with missionary zeal about the need to reduce the population of the Third world at any cost. For example, Dr. Mumford, testifying before the Senate hearings on Depo-provera in 1979 argued passionately that the population problem was a national security issue and the responsibility for slowing its growth should be handed over to the US Department of Defense. Both Drs. Mumford and Kessel are funded by Foundations like the Leyland Fikes Foundation that have right-wing connections and are blatantly against immigration from the Third world. If they were just two crazy fanatics, with limited influence, one could dismiss their activities. However, this is not so. They have friends in high places. They are the front men for rich individuals, who do not want to be directly linked to their activities. One hears of these names only in rumors that they are supporting the efforts of Kessel and Mumford.
The International Conference on Population and Health in Cairo in 1994 focused on the reproductive rights and empowerment of women. Yet the international community does not put a stop to the unethical covert trials being conducted by the likes of Kessel and Mumford and all the invisible men and women who continue to finance their work. Until they take actual steps to stop such trials the words "empowerment of women" will remain hollow.
I would be the last person to say that women do not need contraceptives or they should practice natural rhythm methods rather than relying on contraceptives. As a researcher I also think new safe methods can only be developed when carefully thought out, properly controlled studies are undertaken. Poor, illiterate women should not be the ones to pay the price for better methods for the well-educated, well-to-do women of the world. Finally, as long as family planning programs remain divorced from primary quality health care for the whole population such abuses will continue, with or without the blessings of approved clinical trials.
- Shree Mulay, Director, McGill Centre for Research and Teaching on Women