Journal of the New Zealand Medical Association, 11-October-2002, Vol 115 No 1163
Their hands on your genes
To date, the debate over the patenting of human DNA has largely consisted of stating and restating entrenched positions: industry, keen to protect investment, is on one side; on the other a mix of NGOs, scientists and other people, who see human DNA as a common heritage that should be protected from commercial exploitation. But there is a tenable middle-ground position, and last week my colleagues and I attempted to outline it in a new report from the Nuffield Council on Bioethics.
Our report does not say that patenting genes is wrong in principle. What it concludes is that far too many gene patents are being granted by a system that is failing to apply the rules strictly enough. Patents involving human DNA should be granted only in rare cases. They should be the exception rather than the norm.
How did we reach these conclusions? The most common objection to this type of patent is that human genes occur naturally: they are there to be discovered and not invented. This is not persuasive. Isolated DNA does not occur naturally, and without isolating and cloning a gene, you cannot decipher its sequence. Moreover, the patent system has long recognised useful applications of discoveries as inventions.
So patent offices are right to conclude that DNA can be considered part of an invention. The key question is where to draw the line.
Sandy Thomas. New Scientist, 3 August 2002
AIDS: the worst is yet to come
Should one be optimistic or pessimistic about the Aids epidemic? Optimists point out that governments and society have never before committed so much to the fight against Aids. Pessimists retort that, although there have already been more than 20 million deaths since 1981, the prospects have never looked grimmer – there are expected to be a further 68 million deaths by 2020 in the 45 worst-affected countries “unless prevention and treatment are massively increased”, according to Unaids, the United Nations programme on HIV-Aids.
There is no doubt that mobilisation against the disease has steadily increased: in January 2000 the UN security council put Aids on its agenda; a year and a half later an extraordinary UN session set up a global fund to fight Aids, tuberculosis and malaria; and last July a big Aids conference was held in Barcelona. But promises of money to the global fund have barely topped one-fifth of the $10bn mark regarded as the minimum annual amount required.
In a report last month Unaids estimated that “the HIV-Aids epidemic is still at an early stage in its development”. The worst is yet to come.
Guardian Weekly, 29 August – 4 September 2002
Are breast cancer screening programmes increasing rates of mastectomy?
In the recent Cochrane review of mammographic screening the authors and editors disagreed with respect to reporting the effect of screening on rates of aggressive treatment for breast cancer. The authors maintained that screening increased the number of mastectomies by around 20%, mainly as a result of overdiagnosis. If this were the case, populations in which screening has been introduced should see a subsequent increase in the number of radical treatments for breast cancer and an increase in the incidence of breast cancer in excess of that expected purely from lead time. We report the changes in rates of radical surgery and incidence of breast cancer since the introduction of the Florence mammographic screening programme.
The rate of breast conserving surgery has increased significantly with the advent of screening, and the rate of radical surgery has declined significantly. Similar reductions in mastectomy rates have been observed elsewhere. This indicates that the introduction of screening brings about a reduction in mastectomy rates, not an increase. Follow up will continue to ascertain whether these findings are maintained.
Top projects suffer as medical funding falters
British biologists funded by the Medical Research Council (MRC) are facing short- falls in cash, after investment in a series of new projects has left the council unable to award grants to many top-ranked projects, Nature has discovered.
The MRC, which distributes British government funds for medical research, generally provides money for all projects given the top alpha-A rating by the council's peer-review board. But at a meeting last month, the council decided not to fund 36 alpha-A projects, and to delay funding for a further three. Forty-five alpha-A projects received funding. “It has been a difficult year for applicants and we are sorry not to have been able to fund more;” says George Radda, the MRC’s chief executive. It is likely that funding will be tight next year, he adds.
An MRC spokesperson says that the shortage is due to the council’s investment in large new projects such as the UK Biobank, a database of the genetic details of half a million British people.
Such projects have the backing of many British researchers, but those who have been denied funding are angry at the way the MRC has managed the situation.
New strains of bacteria and exacerbations of chronic lung disease
This prospective study examined the changes in bacterial isolates from sputum samples obtained monthly from 81 outpatients with chronic obstructive pulmonary disease. There were 374 acute exacerbations of lung disease, which were significantly associated with the acquisition of a new strain of Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae (relative risk for any new strain, 2.15). An exacerbation was diagnosed at 33 percent of the clinic visits that coincided with the appearance of a new bacterial strain in the sputum.
Earlier studies of chronic lung disease showed no association between clinical exacerbations and the presence of bacterial pathogens in the sputum. With the use of modern techniques to identify specific bacterial strains, this carefully performed study does show a relation between clinical deterioration and the presence of a new bacterial strain.
N Engl J Med 2002;347:465
Who should receive HMG CoA reductase inhibitors?
During the last decade, the development of the HMG CoA reductase inhibitors, commonly referred to as ‘statins’, has contributed greatly to cholesterol lowering therapy and cardiovascular risk reduction. These agents are well tolerated and efficacious. Data on nearly 30 000 patients from five long-term randomised, placebo-controlled trials of statins have clearly demonstrated that a broad range of individuals can benefit from such therapy. Results of the recently completed Heart Protection Trial have clearly confirmed the results of the earlier trials and support the use of statin therapy in secondary prevention. The role of statins in acute coronary syndromes is being actively evaluated and appears promising. In primary prevention, the data are not as convincing and generalisations cannot be made as to whether, and in which subgroup, drug therapy to lower low density lipoprotein (LDL) cholesterol should be initiated. There are important cost implications to consider and the use of statin therapy has to be judged on an individual basis, particularly in those with high or very high LDL cholesterol levels and/or with multiple risk factors rendering them at high short- and long-term risk of coronary heart disease. There is evidence of a ‘care gap’ in translating trial data into practice, even in secondary prevention, and this needs closing in order to improve patient outcomes.
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