Responsible use of fetal skin tissue
We respect differing views on medical research practices and on the development of pharmaceutical and cosmetic treatments. However, it is important that any discussion of our products be based on an accurate and well-informed understanding of their origin, production and use.
Recently, an interest group raised questions about the development and manufacture of NEOCUTIS products, which are dispensed by physicians for the treatment of skin conditions and to promote skin restoration after medical procedures. We respect differing views on medical research practices and on the development of pharmaceutical and cosmetic treatments. However, it is important that any discussion of our products be based on an accurate and well-informed understanding of their origin, production and use.
Since the 1930s, the international medical community has used donated fetal tissue to better understand cell biology and as an essential tool in the development of vaccines, which are credited with saving millions of lives worldwide. The 1954 Nobel Prize for medicine was awarded to researchers who utilized fetal kidney cells to develop the polio vaccine. Soon, patients who have suffered a severe burn, leg ulcer or wound—or are recovering from surgery—will heal faster, more safely and with far less scarring thanks to the emergence of new treatments developed from cultured fetal skin cells. Our view—which is shared by most medical professionals and patients—is that the limited, prudent and responsible use of donated fetal skin tissue can continue to ease suffering, speed healing, save lives, and improve the well-being of many patients around the globe.
Of course, the important question is: How does the medical community do this in a way that is respectful of the dignity of human life, and that is conducted in a highly controlled and responsible manner? This is an understandable concern that we take very seriously. The small skin donation that, ultimately, made the development of our treatment possible originated from a single terminated pregnancy that could not survive to term and was deemed medically necessary by the attending physicians. This voluntary donation to medical research was granted by the parents with their written consent, and was performed in adherence with strict Swiss laws that regulate organ donations and similar procedures.
To be clear, our products do not directly use the originally donated tissue in any way. We only use proteins derived from cultured skin cells (grown from a dedicated cell bank). These were not embryonic stem cells. No other donation will ever be necessary. In fact, this cell bank enables the production of some 900 million biological bandages for patients suffering from severe wounds, burns and other serious skin conditions.
We recognize that there are those who oppose any use of fetal skin tissue, regardless of the benefit or how it is obtained. Our belief is the extremely limited use of fetal skin tissue, obtained with the consent of parents, ethics committees and others in a well-monitored and respectful manner can be used for significant medical benefit.
The following was the e-mail sent from Neocutis to COGL:
From: Mark Lemko <Mark.Lemko@neocutis.com>
Date: Tue, Oct 27, 2009 at 4:36 PM
Subject: NEOCUTIS
Dear L. Hall:
Perhaps a simple response is the best.
We believe we are the victims of vicious and damaging misinformation.
We feel that we are in complete compliance with the laws of God and the laws of man.
We were not involved with the acquisition of the original sample of fetal tissue.
However, we know the sample was obtained in a legally, morally, ethically and medically correct manner.
None of our products contain any of the original fetal cells or tissue. None of our products contain aborted babies.
Our lysate is prepared from cultured fibroblasts that have never been part of a fetus.
We are not abortionists nor do we condone voluntary or procured abortion and as such have a clear mind that we have not committed or are complicit in an evil act.
Mark J. Lemko
As far as whether it is ethical or not, here is the guidance from the Congregation for the Doctrine of the Faith (Dignitas Personae):
The use of human “biological material” of illicit origin
34. For scientific research and for the production of vaccines or other products, cell lines are at times used which are the result of an illicit intervention against the life or physical integrity of a human being. The connection to the unjust act may be either mediate or immediate, since it is generally a question of cells which reproduce easily and abundantly. This “material” is sometimes made available commercially or distributed freely to research centers by governmental agencies having this function under the law. All of this gives rise to various ethical problems with regard to cooperation in evil and with regard to scandal. It is fitting therefore to formulate general principles on the basis of which people of good conscience can evaluate and resolve situations in which they may possibly be involved on account of their professional activity.
It needs to be remembered above all that the category of abortion “is to be applied also to the recent forms of intervention on human embryos which, although carried out for purposes legitimate in themselves, inevitably involve the killing of those embryos. This is the case with experimentation on embryos, which is becoming increasingly widespread in the field of biomedical research and is legally permitted in some countries… [T]he use of human embryos or fetuses as an object of experimentation constitutes a crime against their dignity as human beings who have a right to the same respect owed to a child once born, just as to every person”.[54] These forms of experimentation always constitute a grave moral disorder.[55]
35. A different situation is created when researchers use “biological material” of illicit origin which has been produced apart from their research center or which has been obtained commercially. The Instruction Donum vitae formulated the general principle which must be observed in these cases: “The corpses of human embryos and fetuses, whether they have been deliberately aborted or not, must be respected just as the remains of other human beings. In particular, they cannot be subjected to mutilation or to autopsies if their death has not yet been verified and without the consent of the parents or of the mother. Furthermore, the moral requirements must be safeguarded that there be no complicity in deliberate abortion and that the risk of scandal be avoided”.[56]
In this regard, the criterion of independence as it has been formulated by some ethics committees is not sufficient. According to this criterion, the use of “biological material” of illicit origin would be ethically permissible provided there is a clear separation between those who, on the one hand, produce, freeze and cause the death of embryos and, on the other, the researchers involved in scientific experimentation. The criterion of independence is not sufficient to avoid a contradiction in the attitude of the person who says that he does not approve of the injustice perpetrated by others, but at the same time accepts for his own work the “biological material” which the others have obtained by means of that injustice. When the illicit action is endorsed by the laws which regulate healthcare and scientific research, it is necessary to distance oneself from the evil aspects of that system in order not to give the impression of a certain toleration or tacit acceptance of actions which are gravely unjust.[57] Any appearance of acceptance would in fact contribute to the growing indifference to, if not the approval of, such actions in certain medical and political circles.
At times, the objection is raised that the above-mentioned considerations would mean that people of good conscience involved in research would have the duty to oppose actively all the illicit actions that take place in the field of medicine, thus excessively broadening their ethical responsibility. In reality, the duty to avoid cooperation in evil and scandal relates to their ordinary professional activities, which they must pursue in a just manner and by means of which they must give witness to the value of life by their opposition to gravely unjust laws. Therefore, it needs to be stated that there is a duty to refuse to use such “biological material” even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place. This duty springs from the necessity to remove oneself, within the area of one’s own research, from a gravely unjust legal situation and to affirm with clarity the value of human life. Therefore, the above-mentioned criterion of independence is necessary, but may be ethically insufficient.
Of course, within this general picture there exist differing degrees of responsibility. Grave reasons may be morally proportionate to justify the use of such “biological material”. Thus, for example, danger to the health of children could permit parents to use a vaccine which was developed using cell lines of illicit origin, while keeping in mind that everyone has the duty to make known their disagreement and to ask that their healthcare system make other types of vaccines available. Moreover, in organizations where cell lines of illicit origin are being utilized, the responsibility of those who make the decision to use them is not the same as that of those who have no voice in such a decision.
In the context of the urgent need to mobilize consciences in favour of life, people in the field of healthcare need to be reminded that “their responsibility today is greatly increased. Its deepest inspiration and strongest support lie in the intrinsic and undeniable ethical dimension of the health-care profession, something already recognized by the ancient and still relevant Hippocratic Oath, which requires every doctor to commit himself to absolute respect for human life and its sacredness”.[58]
So you can decide for yourself...