A preliminary investigation into the UK drug trial which made six healthy young volunteers critically ill has blamed the drug, not the trial design or the manufacturer. The Medicines and Healthcare Products Regulatory Agency (MHRA) says that the trial of the monoclonal antibody TGN1412 was run according to approved protocols, that the correct dose was used, and that no manufacturing problems or contamination were involved.
The MHRA report suggests that it was just a case of extremely bad luck for the participants. However, critics still insist that the drug should have been tested on one volunteer at a time, rather than giving it to the whole group at once. The response of the MHRA is that dosing all patients within two hours seemed to be reasonable at the time. Given that the human dose was a tiny fraction of what had been given to animals, there seemed to be a wide margin of safety.
Many diseases and syndromes are better known by the name of the doctor who first described them. Take Reiter's syndrome, for example, a disorder that causes three seemingly unrelated symptoms: arthritis, redness of the eyes, and urinary tract signs. Nowadays, however, more and more doctors are calling it reactive arthritis. The reason for the shift in terminology is that Hans Reiter (1881- 1969) was tried at Nuremberg and found guilty of conducting typhoid experiments that killed hundred of prisoners in Nazi concentration camps.
This week, another tainted doctor was fingered in The Lancet, Friedrich Wegener (1907-1990), whose name persists in Wegener's granulomatosis, a rare condition characterised by inflamed blood vessels. Although Wegener, unlike Reiter, was never put on trial, he apparently was involved in selecting Jews from the Lodz ghetto for extermination at Auschwitz. He may also have conducted post-mortems on them. Although the evidence is thin, he was definitely a Brownshirt and a convinced Nazi. The Lancet suggests that…
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A dispute between a doctor-researcher, some of his patients, and his former university about ownership of tissue samples has ended in a victory for the university. A US district court judge ruled that tissue samples collected by prostate cancer researcher William Catalona over 20 years belong to Washington University in St Louis, Missouri.
The dispute began in 2002 when WU began to make access to the tissue samples more bureaucratic. Catalona had to apply to use samples he had collected himself. Frustrated with the new arrangements, he jumped ship for Northwestern University in Chicago. Before he left, he wrote to all participants in his studies asking them to "release" their tissue samples to him. Although about 6,000 agreed, WU refused, and Catalona and eight of his patients sued.
Now Judge Stephen Limbaugh has ruled that the tissue samples were a gift" under Missouri law and that patients were not entitled to ask for them to be returned.…
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Not all stem cells work for the Jedi, scientists have learned. Some work for the Dark Side and cause cancer. In a conceptual revolution in cancer biology, it now appears that rogue adult stem cells could be responsible for cancer's habit of recurring and metastasising. If we are able to eradicate the cancer stem cell, we will be able to cure patients," says Dr Jean-Pierre Issa, of the MD Anderson Cancer Center in Houston.
This novel approach began in the 1990s, when scientists found that some leukaemia cells were more dangerous than others. The challenge is to identify and isolate these cancer-causing cells. This would make it possible to create therapies which target stem-cell defining proteins and destroy the cancer at the source.
Time magazine says that the field of cancerous stem cells is burgeoning. Paradoxically this is happening in part because of President George Bush's opposition to the use of embryonic stem cells. Some Federal funding which might have…
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The issue of American health professionals cooperating in legal executions has arisen again, this time in North Carolina. On April 21 61-year-old Willie Brown was executed for a murder he had committed 23 years before. To ensure that Mr Brown would not feel undue pain, thus violating his constitutional right not to suffer cruel and unusual punishment, the prison used a brain wave monitor. This enabled a doctor to determine that he was unconscious when he received an injection of paralytic and heart-stopping drugs. It was the first time that a monitor has been used in an American execution.
The technological fix was proposed by a judge hearing an appeal against the execution. He also required that medical personnel be involved. In North Carolina, a doctor and a registered nurse are supposed to observe the executions.
However, the American Medical Association's code of ethics prohibits doctors from participating in executions. Even monitoring a brain wave machine is banned. The North…
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A British study has found that most children conceived with donated eggs or sperm are not told about their origins, although most IVF children are. Researchers at the University of Cambridge believe that parents who use donor gametes fail to tell their children because of the social stigma surrounding the practice. Their mothers strongly believe that it would be harmful for a child to learn about their donor origins.
On the other hand, the study, which only involved a few dozen children, suggested that there was no difference in parenting skills amongst the three groups of egg donation, donor insemination and IVF. However, mothers of donor insemination children tended to be over-involved and anxious. Their children were also more likely to be bullied.
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The sorry saga of disgraced Korean stem cell researcher Hwang Woo- suk has an American sequel. Questions are still being raised about the work of Hwang's co-author, Gerald Schatten, of the University of Pittsburgh. A special investigation by the Pittsburgh Tribune-Review found that the university had been lax in overseeing Schatten's research and in following government guidelines for human research.
Although the most contentious feature of Hwang's work was cloning human embryos, how he obtained eggs has also been roundly criticised by bioethicists and fellow scientists. It is mainly this issue which has cast a shadow over Schatten's work. A key question in human subject research is whether the participants can be identified. If they can be, the experiment should have full ethical scrutiny by an institutional review board (IRB). Hwang's violation of this principle was egregious: he even drove one of his junior researchers to a clinic where her eggs were removed.
Abortion opponents in the midwest state of Kansas have invoked an obscure law to force an investigation into the death of a mentally- retarded woman after a late-term abortion. A 1970 law allows citizens to initiate a grand jury investigation if they feel that law enforcement officials have failed to act.
In this case, 19-year-old Texas resident Christin Gilbert was brought to a Wichita clinic by her family in January 2005. She was 28 weeks pregnant at the time. The doctor at the clinic, George Tiller, is one of the few American physicians who performs late-term abortions. Three days later she died from an infection. The Kansas Board of Healing Arts has cleared Dr Tiller and his staff. However, activists want to see Dr Tiller charged with involuntary manslaughter and failure to report the abuse of a child. They contend that Ms Gilbert was not able to consent to the abortion.
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Organ sales: The British Transplantation Society claims that there is growing evidence that the organs of thousands of executed prisoners in China are being removed without consent. It has condemned the practice -- whose existence Chinese officials steadfastly deny -- as a breach of human rights.
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Although British authorities say that a drug trial which made six healthy young men violently ill was conducted properly, critics have savaged their informed consent form. The drug, TGN1412, was a monoclonal antibody, a promising type of treatment which has seldom been approved for humans.
Bioethicists claim that the document did not sufficiently inform participants of possible dangers and did not depict the treatment as a novel drug that could harm the body's immune system. The 13-page form also appealed to the subjects' need for money and threatened to withhold their ?2,000 payment if they withdrew early.
The drug company "failed to adequately disclose the degree of uncertainty around a first-in-man trial," said Michael Goodyear, a Canadian cancer physician and research ethicist. "The risks were well known. They're not disclosed in the consent form."
