The FDA, through its faulty investigation into the causes of maternal deaths because of medical abortion, has failed to protect women all over the world. Its incompetence relating to the investigation of the deaths of six Californian women is an indicator that it is working not for the protection of individual citizens but for the protection of vested interests. The absurdity has come about because the FDA attempted to discover if the batch of medications were infected, thus coming to the erroneous conclusion that there is in fact no link between Clostridium sordellii and Mifepristone/Misoprostone. Those conclusions are very misleading and there are other doctors outside of the FDA who have been leading the way in investigating these deaths and making a positive link to RU486. This is further evidence of the sloppy way in which there has been a rush to push RU486 as the medical abortion alternative.
Dr. Paul Miech, Associate Professor Emeritus, Department of Molecular Pharmacology, Physiology, and Biotechnology, Brown Medical School, Brown University, 174 Meeting St., Providence, RI 02912-9107, has reported on the pathophysiology of the association between clostridium sordellii and the administration of RU486. The bacteria clostridium sordellii has been found in the endometrium of the 5 of the 6 women who died as a result of the administration of RU486 at Planned Parenthood clinics in California. Professor Miech has noted that :
Dr. Balieu, in a letter to the New England Journal has defended the use of RU486, yet he, and the people who have signed his letter, have glossed over the number of women who have reported adverse events associated with the administration of RU486. Roberta Klein, in her most comprehensive report focused on the initial research into chemical abortion that occurred prior to the discovery of RU486, and what seemed to be clear is that the women who reported adverse events were somehow excluded from the trial data so that the results looked better than they really were. In this particular case, Dr. Balieu has rejected the link between the administration of RU486 and maternal deaths as a result of infection with C. sordellii on the grounds that the numbers are insignificant. What he, and his colleagues have failed to address, in their response, is that the toxic shock that has killed these women has been quite insidious and unless they were able to get immediate medical attention there was very little that could be done to save their lives.
The link between RU486 and toxic shock syndrome is not tenuous because Mifepristone works by suppressing the immune system. A compromised immune system will normally leave a person susceptible to infection, especially from the streptococcus bacteria. In the case of the women who have died as a result of toxic shock due to the invasion of C. sordellii in the endometrium lining, their immune response was severely compromised as a result of the ingestion of Mifepristone.
What the FDA and the CDC need to resolve, therefore, is how the infection occurs in the first place. For example, what is the probability that when the products of the womb were expelled, something was left behind within the womb. If this is the case, then the investigators would need to find out what was left behind, and how quickly this material was infested with C. sordellii. They need to investigate further the way in which the immune response to infection has been compromised within an otherwise healthy individual after the administration of Mifepristone/Misoprostone. They need to investigate the other episodes, especially the episodes of diarrhea to see if there is any link between toxic shock and the administration of RU486. This is not an issue that stems from a faulty batch, rather it is something that gets an impetus due to the delicate balance of the human immune system. To ignore the disruption of this balance is to treat all healthy women who just happen to be pregnant with contempt.
Dr. Paul Miech, Associate Professor Emeritus, Department of Molecular Pharmacology, Physiology, and Biotechnology, Brown Medical School, Brown University, 174 Meeting St., Providence, RI 02912-9107, has reported on the pathophysiology of the association between clostridium sordellii and the administration of RU486. The bacteria clostridium sordellii has been found in the endometrium of the 5 of the 6 women who died as a result of the administration of RU486 at Planned Parenthood clinics in California. Professor Miech has noted that :
DATA SYNTHESIS: The mechanisms of action of mifepristone were incorporated into the pathophysiology of septic shock due to C. sordellii. Mifepristone, by blocking both progesterone and glucocorticoid receptors, interferes with the controlled release and functioning of cortisol and cytokines. Failure of physiologically controlled cortisol and cytokine responses results in an impaired innate immune system that results in disintegration of the body's defense system necessary to prevent the endometrial spread of C. sordellii infection. The abnormal cortisol and cytokine responses due to mifepristone coupled to the release of potent exotoxins and an endotoxin from C. sordellii are the major contributors to the rapid development of lethal septic shock.In more simple language what this report is saying is that the way in which Mifepristone has contributed to the death of these women is through the blocking of the progesterone and glucocoricoid receptors in otherwise healthy women, the controlled release and functioning of cortisol and cytokines has been impaired. This has led to an impaired immune system, and in this case the women did not have the necessary immune defense mechanism to fight off the infection of the endometrial lining thus preventing the spread of the C. sordellii infection.
CONCLUSIONS: Theoretically, it appears that the mechanisms of mifepristone action favor the development of infection that leads to septic shock and intensifies the actions of multiple inflammatory cytokines, resulting in fulminant, lethal septic shock.
Dr. Balieu, in a letter to the New England Journal has defended the use of RU486, yet he, and the people who have signed his letter, have glossed over the number of women who have reported adverse events associated with the administration of RU486. Roberta Klein, in her most comprehensive report focused on the initial research into chemical abortion that occurred prior to the discovery of RU486, and what seemed to be clear is that the women who reported adverse events were somehow excluded from the trial data so that the results looked better than they really were. In this particular case, Dr. Balieu has rejected the link between the administration of RU486 and maternal deaths as a result of infection with C. sordellii on the grounds that the numbers are insignificant. What he, and his colleagues have failed to address, in their response, is that the toxic shock that has killed these women has been quite insidious and unless they were able to get immediate medical attention there was very little that could be done to save their lives.
The link between RU486 and toxic shock syndrome is not tenuous because Mifepristone works by suppressing the immune system. A compromised immune system will normally leave a person susceptible to infection, especially from the streptococcus bacteria. In the case of the women who have died as a result of toxic shock due to the invasion of C. sordellii in the endometrium lining, their immune response was severely compromised as a result of the ingestion of Mifepristone.
What the FDA and the CDC need to resolve, therefore, is how the infection occurs in the first place. For example, what is the probability that when the products of the womb were expelled, something was left behind within the womb. If this is the case, then the investigators would need to find out what was left behind, and how quickly this material was infested with C. sordellii. They need to investigate further the way in which the immune response to infection has been compromised within an otherwise healthy individual after the administration of Mifepristone/Misoprostone. They need to investigate the other episodes, especially the episodes of diarrhea to see if there is any link between toxic shock and the administration of RU486. This is not an issue that stems from a faulty batch, rather it is something that gets an impetus due to the delicate balance of the human immune system. To ignore the disruption of this balance is to treat all healthy women who just happen to be pregnant with contempt.
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