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.

1 comment:

Anonymous said...

Two New Fatalities from Clostridium sordellii, Neither Linked to Morning-After Pill
http://www.medpagetoday.com/OBGYN/Pregnancy/tb/4456

BOISE, Idaho, Nov. 7 -- Two more fatalities from the rarely encountered pathogen Clostridium sordellii have been reported, neither linked to the so-called morning-after pills, Mifeprex (mifepristone) and Cytotec (misoprostol), according to investigators here
The new cases involved a four-year-old boy after a closed transverse fracture on his arm and a 21-year-old women after a normal birth of a child during which she had a third-degree vaginal laceration, reported Michael Aldape, Ph.D., of the Veteran's Affairs Medical Center here.
These two patients brought to 45 the reported cases of Clostridium sordellii infections in the world's literature from 1927 to 2006, according to a review paper on the pathogen Dr. Aldape and colleagues published in the Dec. 1 issue of Clinical Infectious Diseases.
They found that 69% of patients died, usually within two to six days of developing the infection.
For reasons that the review suggested could not be unraveled with currently available data, five American women who had a medically induced abortion with Mifeprex and Cytotec developed toxic shock and died because of a C. sordellii infection.
Those five cases account for 11% of the 43 found in the literature and two reported by Dr. Aldape and colleagues:
• Eight (or 18%) were associated with normal childbirth and two (or 0.4%) were associated with spontaneous abortion. The fatality rate was 100% in these groups and among those who were infected after a medically induced abortion.
• Ten (or 22%) infections occurred in injection drug users, and half died.
• Nineteen other cases of C. sordellii infection (or 43%) occurred after trauma or surgery, mostly in healthy people, and 53% died.
Last year, in response to reports of deaths associated with the use of Mifeprex and Cytotec, the FDA amended the product labeling to alert physicians.
"While there have been a handful of C. sordellii-related deaths stemming from mifepristone/misoprostol usage in the past few years, I believe the problem is more global," Dr. Aldape said. "There are many examples of non-gynecological infections due to C. sordellii in the literature, of which more than half were fatal."
The problem, the researchers said, is that diagnosis of C. sordellii is "confounded by early, nonspecific signs and symptoms and by the absence of fever." By the time physicians are aware of the possibility, it may be too late -- especially since there is no rapid diagnostic test for the pathogen.
Characteristically, patients with a C. sordellii infection will develop a profound systemic capillary leak, refractory hypotension, and a marked leukemoid reaction, the researchers said, often followed rapidly by fatal tachycardia.
"In fact, the time between onset of symptoms and death is often so short that little time exists to initiate empirical anti-microbial therapy," Dr. Aldape and colleagues said.
There is little or no information on appropriate treatment, they said, adding that there is some evidence that the pathogen, like most of its cousins, is susceptible to β-lactams, clindamycin, tetracycline, and chloramphenicol but is resistant to aminoglycosides and sulfonamides.
In an accompanying editorial, Beverly Winikoff, M.D., of Gynuity Health Projects, a New York-based research organization, said several theories have been put forward to explain why the infection might be associated with medically induced abortion, but none is convincing.
For example, Dr. Winikoff said, one idea was that Mifeprex suppressed the immune system in the five women who died, rendering them unable to battle the infection. But the drug has been used widely in Europe since 1988 -- at a dose triple that used in the U.S. -- and there have been no cases of associated C. sordellii infection reported there.
Also, the women who died after normal childbirth or a spontaneous abortion did not receive the drug, she noted.
Another possible explanation -- since ruled out -- was that the medication had been contaminated with C. sordellii.
"The importance of articles like (the review) is to point out that C. sordellii infections are a broader problem," she said. "It's a big intellectual and strategic error to focus on medical abortions. This is an infectious diseases issue."
But while researchers try to figure out the causes and treatment of C. sordellii infection, Dr. Aldape said, doctors should suspect the pathogen in patients who present within two to seven days after an injury, surgical procedure, drug injection, childbirth, or medically induced abortion and who complain of pain, nausea, vomiting, and diarrhea but have no fever.