Friday, April 14, 2006

Clostridium sordelli - how RU486 allows its growth

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 :

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.
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.
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.

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.









Thursday, April 13, 2006

How the FDA tries to cover up involvement of RU486 in deaths of 6 women in California

According to the latest report on the further deaths of two women from the taking of the drug RU486 the FDA claims that there is no link between the drug and the death of one woman, but that the death of the other woman is under further investigation.

In the second case there is evidence that the bacteria Clostridium sordellii is involved in her death. Now comes the crunch as to how the FDA have investigated these deaths in order to preserve their own decision-making process that has allowed this procedure in the United States of America. They have tested the abortion pills for the bacteria. In this way they can say that there is no link because the tests proved negative. This type of testing, in order to exhonerate RU486 is at best extremely shonky. It would seem that the premise for the investigation is that the bacteria (which normally exists in our bodies) has been introduced by the ingestion of RU486. Such an investigation into those deaths is deficient if there is no study on how the drugs that have been taken interact with the human body.

Owing to the lack of research prior to the introduction of chemical abortion, very little is known about the long term consequences of taking Mifepristone/Misoprostone in order to induce abortion. Since the bacteria Clostridium sordellii already lives within the body, there needs to be an investigation into how this bacteria has managed to migrate from the gut into the lining of the womb so that it causes toxic shock, followed by death for those not treated in time. The FDA study has not even addressed an understanding of how Clostridium sordellii becomes active, instead it has falsely worked on the premise that it was introduced into the body via the off label use of inserting the pill into the vagina.

Is there a cover-up going on in order to protect the intests of Planned Parenthood? After all it is Planned Parenthood clinics that are using Mifepristone/Misoprostone as a means of abortion. Is there an underlying issue of kickbacks involved in the increased recommendation of Mifepristone/Misoprostone? Why else would the FDA be seeking to protect Planned Parenthood in these cases where deaths have occurred? If the FDA can state that there is no link between the taking of Mifepristone/ Misoprostone in the deaths of these 6 California women, then Planned Parenthood is protected from lawsuits by the families of the victims of their irresponsible advocacy of chemical abortion.

The doctors who have investigated these cases have indicated that the bacteria Clostridium sordellii was responsible for the toxic shock that killed these women. It seems that the bacteria travelled to the lining of the womb, where it became active, causing intense pain and other vital symptoms relating to toxic shock syndrome. In the case of Holly Patterson, who was only 18 years of age, she had to travel a bit of a distance to get medical help, and she died because she was not able to get help in time. It would have been doubtful that the bacteria was introduced as a faulty batch of drugs, and that means that there has to be another reason for those deaths, but that does not mean that there is no link between the administration of RU486 and the deaths of these women.

If the available data to date is gathered and analysed by professional people who do not have any self-interest in the matter, one might discover that the warning signs that have been so blithely ignored in the rush to get this drug into the market, have been strong indicators as to why this form of abortion should be abandoned. Mifepristone by itself is virtually useless as an abortion drug. It only becomes more effective when Misoprostone is introduced two days later. However, the combination of these two drugs increases the risk of things going wrong.

Most women are unaware of the normal uses of Misoprostone, that is, the drug is used as an anti-rejection agent for transplant patients. The drug is also used for other therapeutic purposes, and in the case of women, the fact that the drug could have severe consequences for pregnant women is a reason for the issuing of cautions against being pregnant or becoming pregnant during treatment.

If the FDA wants to investigate the link between Misoprostone and the deaths of the six women in California, then they need to study more closely the side effects for women who have been given RU486/PG as a form of abortion. There is an increase in the number of women, who after having this method administered require emergency hospital treatment. Some of the women have required blood transfusions. These side effects must be investigated. As far as the bacteria Clostridium sordellii is concerned, the FDA needs to find the link between that bacteria, the immunosuppression that takes place after the administration of Misoprostone, the severe cramping, diarrhea, and the other severe symptoms that are experienced by these women. The most likely link is that of immunosuppression, which would help in allowing the bacteria to travel to the womb.

It is obvious to me, (and I am not a professional, just an ordinary woman) that the FDA is trying to cover itself because the approval for the use of RU486/PG in the USA was too swift. Will the Australian doctors who have advocated to see this harmful drug introduced into Australia learn anything from these deaths? If they close their eyes and refuse to check into the details, whilst they continue to be proponents of this form of abortion, then they will remain irresponsible in their advocacy, having little or no regard for their female patients.