MEDICAL: by Charles Francis, AM, QC, RFDNews Weekly
Abortion pill a bonanza for lawyers
, February 18, 2006
In North America, according to Charles Francis AM, RFD, QC, the use of the abortion pill RU-486 has produced many disasters, including the deaths of five women, 64 life-threatening events and 224 severe events.When Roussel Uclaf first announced production of the abortifacient RU-486 (Mifeprex) in France, it was hailed by the media as a "Holy Grail". Despite its many problems, abortion-providers appear still to regard it as a great benefit and argue that politicians have no right to deprive women of it.
Senators Fiona Nash (National Party), Lyn Allison (Australian Democrats), Claire Moore (Labor) and Judith Troeth (Liberal), who have pushed for the availability of RU-486 for Australians, should examine what has happened in the US.
No reputable pharmaceutical company in America wanted to have anything to do with the production or marketing of Mifeprex. It was left to the Population Council Inc (a powerful pro-abortion group) to obtain the rights from Roussel Uclaf to market the drug through a new shell company, Danco Laboratories Inc.Proceedings against Danco
Danco was incorporated in 1995 - not in the US, but in the Cayman Islands. It does not market any other pharmaceuticals. The shareholders were not interested in setting up a company which would produce a range of medications beneficial to mankind. In some of the proceedings against Danco, the inference is they were simply in it for the "quick buck".
After Danco was incorporated, it was revealed that its founder and executive director, Joseph D. Pike, was a disbarred lawyer and convicted forger. This caused disquiet amongst Danco's shareholders and Pike was moved to a less conspicuous position.
When the original application for approval was made to the US Food and Drug Administration (FDA), it was accompanied by two French tests and one US test only, none of which met FDA's standards.
The FDA appears to have been reluctant to approve RU-486; but after intense pressure from the Clinton Administration, the drug was approved in September 2000, subject to a number of restrictions.
However, pro-abortion groups complained the restrictions would limit the accessibility of RU-486. After an intense media campaign and major lobbying by pro-abortion groups attacking the FDA, the FDA eventually crumpled, abandoning most of its safety restrictions, although there had been no scientific breakthrough to suggest these restrictions were unnecessary.
Despite its high-sounding name, Danco was unable to manufacture RU-486 itself, nor could it find anyone in the US prepared to do so.
Eventually Danco settled for a Chinese company located near Shanghai, a company cited by the FDA for producing tainted drugs.
Because Mifiprex on its own is successful in producing an abortion in only 60-80 per cent of cases, the patient is advised to take a second drug, Cytotec (Misoprostol), 48 hours after taking Mifiprex. This created a further problem for Danco, in that the manufacturer, R.G. Searle, has given repeated warnings that Cytotec is a drug unsuitable for abortions. With the addition of Cytotec, the probability of abortion rises to 92-95 per cent. The remainder need surgical abortions.
With all these problems it is hardly surprising the use of RU-486 has produced many disasters. At least five women in North America have died. There have been 64 life-threatening events and 224 severe events. In 237 instances, there has been significant haemorrhaging, with 68 women requiring blood transfusions, 42 per cent of whom lost over half their blood volume.
Inevitably, the deaths of young women led to litigation. A prominent Californian products liability law firm is acting for the relatives of Holly Patterson, Chanelle Bryant and Hua Thuy Tran (referred to as "the decedents").
The complainants' briefs in these cases make poignant, informative and frightening reading. No intelligent person reading these briefs would want RU-486 available in Australia as an abortifacient.
The essence of the main allegations against Danco and the Population Council is that they marketed the drug with full knowledge of "unacceptable risks of serious injury or death". By the time the drug was provided to the decedents, it was already associated with such risks.False representation
It is also alleged Danco concealed these problems, falsely representing the drug was safe, deliberately downplayed the hazards and produced literature on Mifiprex, creating a false impression it was safe. The emergency hospitals where the decedents died were sued on the basis that their diagnoses, advice and treatment fell short of proper standards.
All this has led to a further investigation of RU-486 by the FDA. A Bill, HR 1079 (Holly's Law), has been introduced by 79 sponsors in the US Congress to ban the use of RU-486.
The importation of a drug to kill unborn Australians is a question too important to be left to the Therapeutic Goods Administration (TGA). It is a decision which needs to be made by a minister - or Cabinet - directly responsible to the people.
On current information, any minister would be grossly negligent to allow the importation of RU-486 as an abortifacient.
Prime Minister Howard needs to allow far more time for MPs to learn about this drug. Before voting on RU-486, the Australian Parliament should await the results of the Danco cases, the FDA Inquiry and the US Congressional debate.
- Charles Francis AM, RFD, QC