International news
- Barr's cancer drug delayed by FDA
- Call for new human research protections
- Celera Diagnostics and Bristol-Myers Squibb to collaborate in gene search
- deCODE and Merck in obesity alliance
- European Union gives stem cell reprieve
- New Zealand OK's project to put human genes into cattle
- Nobel Prize in medicine for cell death work
- Nuffield Council releases report into the ethics of research into genes and behaviour
- Peanut allergy drug fast-tracked in US
- South Korea bans cloning humans
- UN to ban human cloning under first bioethics treaty
- US: New FDA commissioner announced
- US scientists slam stem cell policy
Barr's cancer drug delayed by FDA
23 September - The US Food and Drug Administration has delayed Barr Laboratories Inc from producing a generic form of the cancer-fighting drug tamoxifen, despite giving approval for a 2002 launch in 1987. The delay comes as AstraZeneca Plc, the drug's manufacturer and patent holder, has achieved a patent extension on the drug for its use to treat cancer in children. Barr currently distributes tamoxifen via an agreement with AstraZeneca. However, its profit margin would significantly increase were it permitted to manufacture its own version of the popular drug. Barr has indicated that it is to appeal the FDA's ruling to try to enforce its earlier decision. The FDA, however, is likely to argue that new rules instigated in 1992 give it the right to delay the generic's launch. If Barr is not successful, its earnings could be up to 25% less than forecast. Tamoxifen, marketed under the name Nolvadex, generated global sales of $1.024bn last year.
[Source: Reuters]
Call for new human research protections
3 October - A US panel of Government advisors has called for increased protections for people who participate in clinical trials. Additionally, the panel has praised the recent establishment of a federal research panel to oversee all clinical research conducted in the US. The panel, a committee of the Institute of Medicine (part of the National Academy of Sciences), began its investigations after the death in 1999 of Jesse Gelsinger in a gene therapy trial. Since then, public confidence in trials has been shaken by further deaths and safety concerns. The panel now believes there needs to be a new system established to restore public faith in clinical trials.
In its report, the panel indicates there is currently very little data as to how many people are harmed in clinical studies. They urge the Government to begin to collect such information. The panel also indicates that Government oversight of federally funded trials is ethically problematic and fraught with conflicts of interest. Additionally, the panel claims:
- a need for privately funded research to be more closely monitored, despite it already being governed by FDA rules and ethics committee review;
- a need for a new federal law to require organisations conducting research to be allowed to do so only under the authority of a Human Research Participant Protection Program, which would guarantee protection to research subjects and ensure researchers and administrators are trained in ethics;
- research review boards should also become more independent, taking at least one quarter of their membership from community members with no stake in the research; and
- people injured in a study should receive compensation for medical expenses, rehabilitation and lost income.
[Source: Reuters Health]
Celera Diagnostics and Bristol-Myers Squibb to collaborate in gene search
8 October - Genes useful in the diagnosis and treatment of cardiovascular disease and diabetes are being sought after in a new collaboration between Celera Diagnostics and Bristol-Myers Squibb. Under the agreement, BMS is to provide clinical samples and data to Celera, which will then undertake studies in the hope of finding new correlations with specific gene sequences. BMS is to receive exclusive rights to develop and market drugs arising from therapeutic targets identified, whilst Celera will retain rights to develop and market diagnostic products. In the project, over 1,000 SNPs will be analysed in more than 3,000 clinically defined samples.
[Source: Pharmalicensing.com]
deCODE and Merck in obesity alliance
30 September - Icelandic genomics company deCODE Genetics and Merck & Co have announced an alliance to develop new treatments for obesity, one of the world's fastest-growing public health challenges. Under the alliance, the two companies will combine their knowledge of the genetics of obesity to validate a series of drug targets for development. Lasting three years, the agreement between the companies will give deCODE substantial research funds, access to technology, license fees and milestone payments as advances are made. The company will also receive royalties on any successfully marketed drugs arising from the alliance.
[Source: Pharmalicensing.com]
European Union gives stem cell reprieve
1 October - European Union ministers are to agree on a funding compromise, to temporarily cease the debate over using embryos in stem cell research. Last month, Italy, Ireland, Germany and Austria withdrew support from stem cell funding, citing ethical worries in using embryos. The debate has had a detrimental effect, with members of the European Parliament threatening to block the EU's entire five-year, €17.5bn research budget. However a compromise is to be reached, which will enable projects to continue but block funds for new stem cell research for at least one year. Stem cell research constitutes only a small proportion of the EU's research budget - with funds in the current budget including €27m for 15 projects.
[Source: (US) ABC News Online]
New Zealand OK's project to put human genes into cattle
1 October - New Zealand regulatory authorities have approved experiments which involve the insertion of human genes into cattle, the country's first experiment in genetic modification outside the laboratory. The research, which will enable the cattle to produce human proteins, is hoped to provide useful treatments for medical conditions such as multiple sclerosis. the approval was granted by a committee of the Environmental Risk Management Authority, which controls all introductions of plants, animals and Genetically Modified Organisms to the country. The approval contains several restrictions, such as electronic tags for the animals and a ban on any of the transgenic animals leaving the secured site. The New Zealand Government plans to remove a ban on the commercial release of GMOs next year.
[Source: Reuters]
Nobel Prize in medicine for cell death work
7 October - Three scientists who have undertaken research on programmed cell death in the nematode worm have been awarded the Nobel Prize in Medicine. Professor Sydney Brenner, Sir John Sulston and Professor Robert Horvitz have received the prize in recognition of their efforts to better understand diseases such as AIDS and cancer. Programmed cell death, or apoptosis, is a necessary process in an organism's growth and development. However when this process goes awry, cells can be lost due to excessive cell death (as is the case with AIDS), or cells can become immune to programmed death (as is the case with cancer).
In their work, Brenner, Sulston and Horvitz examined how genes control programmed cell death in the primitive nematode worm. Brenner was the first to show that different developmental problems with the worm could be linked to mutations in particular genes. Sulston then examined the vital steps for programmed cell death in the worm's development. He then went on to sequence the worm's genetic code, which was completed in 1998. Hulston used the worm in is studies on whether there was a genetic program to control cell death. He was able to identify particular genes which are required for a cell to die.
[Source: Reuters - Anna Peltola]
Nuffield Council releases report into the ethics of research into genes and behaviour
2 October - The United Kingdom's Nuffield Council on Bioethics has published a new report into the ethics of research into genes and behaviour. The report tackles the ethical, legal and social applications of this research, including the selection of embryos for their behavioural traits and the use of behavioural genetics in criminal justice proceedings. Chairman of the working party, Professor Bob Hepple QC, reports that research into genes influencing human behaviour is complex and controversial. Overall, the Council considered that this research can be justified, as it can advance understandings of human behaviour. However, the potential for misuse of the information, such as the "medicalisation" of otherwise normal traits, must be guarded against. Additionally, misuse of this information in the context of employment, insurance or education must be prevented. The report concludes with a call for policy makers to initiate safeguards now, to prevent misuse of the research.
[Source: Nuffield Council Press Release]
Peanut allergy drug fast-tracked in US
24 September - The US Food and Drug Administration has granted fast-track status to an experimental drug to treat peanut allergies. The drug, TNX-901, is manufactured by Tanox Inc. A fast-track designation is usually reserved for products which tackle a significant medical need. Under the designation, Tanox will be able to meet with the FDA to enable the agency to provide input on the drug's development plans. It will also be able to submit its marketing application in sections. The drug is an antibody to IgE, a protein found in the immune system which normally interacts with other cells to produce some of the symptoms resulting from allergen exposure. Recently tested in Phase II trials, it is hoped to be valuable for people with a peanut allergy who accidentally ingest them.
[Source: Reuters Health]
South Korea bans cloning humans
25 September - In light of reports that a Korean woman is carrying the world's first human clone, the Government of South Korea has made it an offence to undertake any form of human cloning. Under the Life, Ethics and Safety Measures Bill, currently being finalised, anyone convicted of cloning a human in South Korea will be imprisoned for 10 years. The Bill also outlaws human cloning for embryonic stem cell research, gene therapy for the genetic treatment of embryos and foetuses and the discriminatory use of a person's genetic information for education, employment or insurance purposes. South Korean scientists have reacted negatively to the ban on embryonic stem cell research, claiming it will thwart the development of an important technology. However, a Government representative maintained that cloning must be banned due to the potential for its misuse. Some exceptions to the ban will be possible, pending permission from a Presidential ethics committee.
[Source: New Scientist Online News - Damian Carrington]
UN to ban human cloning under first bioethics treaty
25 September - In a move unprecedented in the history of the United Nations, a special task force has proposed a ban on cloning to create a human baby. The proposed ban, the fist time the UN has developed a treaty on a bioethics issue, would be binding on all 190 member states of the United Nations. Task force members from France and Germany have urged that the UN general assembly should adopt such a treaty to enforce the ban, potentially with criminal penalties under international law. Proponents of such a ban claim it is necessary to prevent cloning laboratories from shifting from country to country. If the ban is voted for, the UN will then also have to determine whether to ban cloning for the purposes of research.
[Source: USA Today - Richard Willing]
US: New FDA commissioner announced
25 September - Us President George W. Bush has announced his intention to nominate Mark McClellan MD to head the country's Food and Drug Administration. However, the nomination must still be confirmed by the Senate. Dr McLellan is a member of the President's Council of Economic Advisors. He also has a background in economics and research, and is a practising intern and college professor.
[Source: Whitehouse Media Release]
US scientists slam stem cell policy
25 September - Scientists have slammed the US's policy on stem cell research, which limits funding for research to human embryonic stem cell lines in existence as of August 2001. They have told a US Senate subcommittee that the funding limit is slowing medical progress in the country and is forcing researchers to move overseas to countries with more permissive controls. Among the claims made by the scientists are that the rules have delayed patient benefits, that stem cell lines are not being made available to other researchers and that research has been unacceptably slowed across a range of fields. In response Senator Arlen Specter, who chaired the hearing, said he would directly introduce legislation to expand the number of cell lines which qualify for federal funds.
[Source: Reuters Health - Julie Rovner]
