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by Enrique Anton, MD, PhD

To the Editor:

Pistolesi et al (October 2004)¹ state that “diagnosis and management of malignant pleural mesothelioma (MPM) are major challenges that often frustrate both patient and clinician.” I would like to make the following comments.

Generally, malignant mesothelioma equates with a diffuse malignant mesothelioma, a rare and fatal tumor related frequently to asbestos exposure, which could arise from the surface of all serosas. The most frequent location is the pleura (> 90%), followed by the peritoneum (6 to 10%).² Although the majority of cases are unicavitary, sometimes simultaneous involvement of the pleura and peritoneum can occur.³

Unilateral pleural effusion, an early manifestation of MPM, is the most frequent radiographic finding in MPM,¹ and may be present in up to 95% of patients during clinical evolution.⁴ However, physicians should remember that the absence of pleural effusion is rare but possible,³ and pleural thickening and/or calcification could be the only finding.⁴

Pleural effusion is usually insufficient for diagnosing mesothelioma based on cytologic analysis alone.¹ However, when peritoneal involvement occurs and ascites are present, cytology could be a useful tool, helping in the diagnosis of mesothelioma.³

Currently, the outcome of MPM is unavoidably fatal; although the “median” survival is approximately 9 to 12 months,¹ occasionally an individual patient with mesothelioma could have a very poor outcome.³ Prognostic score systems have been developed in recent years¹ with the aim of being able to help in clinical trials. However, these systems applied to an individual patient could sometimes not be very reliable. If the five prognostic factors of the European Organization for Research and Treatment of Cancer⁵ were applied to the patient referred above,³ the patient would be classified in the good prognostic group (only two poor prognostic factors). In fact, he only lived 1 month after diagnosis.

In our daily clinical practice, physicians have to attend not to a “series” of patients with “mean” features but individual patients sometimes significantly different from classical descriptions. In addition to useful information provided in updates and reviews, we have to take into account other less-frequent features usually absent in these reports but with obvious usefulness for diagnosis and management of our real patients.

The term cloning is used by scientists to describe many different processes that involve making duplicates of biological material. In most cases, isolated genes or cells are duplicated for scientific study, and no new animal results. The experiment that led to the cloning of Dolly the sheep in 1997 was different: It used a cloning technique called somatic cell nuclear transfer and resulted in an animal that was a genetic twin -- although delayed in time -- of an adult sheep. This technique can also be used to produce an embryo from which cells called embryonic stem (ES) cells could be extracted to use in research into potential therapies for a wide variety of diseases.

Thus, in the past five years, much of the scientific and ethical debate about somatic cell nuclear transfer has focused on its two potential applications: 1) for reproductive purposes, i.e., to produce a child, or 2) for producing a source of ES cells for research.

Cloning for Reproductive Purposes

The technique of transferring a nucleus from a somatic cell into an egg that produced Dolly was an extension of experiments that had been ongoing for over 40 years. In the simplest terms, the technique used to produce Dolly the sheep - somatic cell nuclear transplantation cloning - involves removing the nucleus of an egg and replacing it with the diploid nucleus of a somatic cell. Unlike sexual reproduction, during which a new organism is formed when the genetic material of the egg and sperm fuse, in nuclear transplantation cloning there is a single genetic "parent." This technique also differs from previous cloning techniques because it does not involve an existing embryo. Dolly is different because she is not genetically unique; when born she was genetically identical to an existing six-year-old ewe. Although the birth of Dolly was lauded as a success, in fact, the procedure has not been perfected and it is not yet clear whether Dolly will remain healthy or whether she is already experiencing subtle problems that might lead to serious diseases. Thus, the prospect of applying this technique in humans is troubling for scientific and safety reasons in addition to a variety of ethical reasons related to our ideas about the natural ordering of family and successive generations.

Scientific Uncertainties

Several important concerns remain about the science and safety of nuclear transfer cloning using adult cells as the source of nuclei. To date, five mammalian species -- sheep, cattle, pigs, goats, and mice -- have been used extensively in reproductive cloning studies. Data from these experiments illustrate the problems involved. Typically, very few cloning attempts are successful. Many cloned animals die in utero, even at late stages or soon after birth, and those that survive frequently exhibit severe birth defects. In addition, female animals carrying cloned fetuses may face serious risks, including death from cloning-related complications.

An additional concern focuses on whether cellular aging will affect the ability of somatic cell nuclei to program normal development. As somatic cells divide they progressively age, and there is normally a defined number of cell divisions that can occur before senescence. Thus, the health effects for the resulting liveborn, having been created with an "aged" nucleus, are unknown. Recently it was reported that Dolly has arthritis, although it is not yet clear whether the five-and-a-half-year-old sheep is suffering from the condition as a result of the cloning process. And, scientists in Tokyo have shown that cloned mice die significantly earlier than those that are naturally conceived, raising an additional concern that the mutations that accumulate in somatic cells might affect nuclear transfer efficiency and lead to cancer and other diseases in offspring. Researchers working with clones of a Holstein cow say genetic programming errors may explain why so many cloned animals die, either as fetuses or newborns.

Ethical Concerns

The announcement of Dolly sparked widespread speculation about a human child being created using somatic cell nuclear transfer. Much of the perceived fear that greeted this announcement centered on the misperception that a child or many children could be produced who would be identical to an already existing person. This fear is based on the idea of "genetic determinism" -- that genes alone determine all aspects of an individual -- and reflects the belief that a person's genes bear a simple relationship to the physical and psychological traits that compose that individual. Although genes play an essential role in the formation of physical and behavioral characteristics, each individual is, in fact, the result of a complex interaction between his or her genes and the environment within which he or she develops. Nonetheless, many of the concerns about cloning have focused on issues related to "playing God," interfering with the natural order of life, and somehow robbing a future individual of the right to a unique identity.

Policy and Regulation

Several groups have concluded that reproductive cloning of human beings creates ethical and scientific risks that society should not tolerate. In 1997, the National Bioethics Advisory Commission recommended that it was morally unacceptable to attempt to create a child using somatic cell nuclear transfer cloning and suggested that a moratorium be imposed until safety of this technique could be assessed. The commission also cautioned against preempting the use of cloning technology for purposes unrelated to producing a liveborn child.

Similarly, in 2001 the National Academy of Sciences issued a report stating that the United States should ban human reproductive cloning aimed at creating a child because experience with reproductive cloning in animals suggests that the process would be dangerous for the woman, the fetus, and the newborn, and would likely fail. The report recommended that the proposed ban on human cloning should be reviewed within five years, but that it should be reconsidered "only if a new scientific review indicates that the procedures are likely to be safe and effective, and if a broad national dialogue on societal, religious and ethical issues suggests that reconsideration is warranted." The panel concluded that the scientific and medical considerations that justify a ban on human reproductive cloning at this time do not apply to nuclear transplantation to produce stem cells. Several other scientific and medical groups also have stated their opposition to the use of cloning for the purpose of producing a child.