- Email: [email protected]
China takes action against tuberculosis and HIV co-infection
Editorial
Science Photo Library
New guidelines for genetic tests are welcome but insufficient
For A common framework of principles for direct-to-consumer genetic testing see http://www. hgc.gov.uk/Client/document. asp?DocId=280 §&CAtegoryId=10 For the American Society of Human Genetics statement see http://ashg.org/pdf/dtc_ statement.pdf For the American College of Medical Genetics statement see http://www.acmg.net/AM/ Template.cfm?Section=Policy_ Statements&Template=/CM/ ContentDisplay. cfm&ContentID=2975
A common framework of principles for direct-to-consumer genetic testing, published on Aug 4 by the UK’s Human Genetics Commission (HGC), is a commendably clear and detailed guideline about what constitutes good practice for commercial genetic testing. The guidelines cover the full range of genetic tests currently available—from diagnosis to ancestry tests—and set out minimum standards for consent, data protection, marketing, scientific rigour, and interpretation. Less clear, however, is what practical value the guidelines will have in the context of an international industry that crosses regulatory jurisdictions. The UK Department of Health’s statement to the press that accompanied the publication of the principles was slightly misleading, claiming that they amounted to a “crackdown on genetic testing” and would require companies to abide by the principles espoused by the HGC. But the HGC is not a regulatory body, and there is no framework in place to monitor adherence to the guidelines, let alone enforce compliance. Although the most comprehensive set of guidelines yet published, the HGC framework is similar to several other past statements, notably those from the American
College of Medical Genetics and the American Society of Human Genetics. But with little regulatory oversight of direct-to-consumer genetic testing to back them, these statements often receive little more than lip service from the testing industry. Such a fragmentary regulatory framework has led to a string of high-profile blunders by the testing industry, the most recent of which was in June this year when a US firm sent the wrong results to 96 of its customers, including one woman who was left distraught by the erroneous finding that her son was genetically unrelated. In the 10 years since the publication of the human genome revolutionised genetics, direct-to-consumer genetic testing has proliferated rapidly, and regulators have been unable to keep up with the pace of technological advances. The sheer volume of research into genetics means the industry is certain to continue to grow, so it is essential that regulators not only catch up but get ahead of the game to ensure that consumers are protected by something less ephemeral than guidelines. ■ The Lancet
Ng Han Guan/AP/Press Association Images
China takes action against tuberculosis and HIV co-infection The printed journal includes an image merely for illustration
For more on the national plan see http://news.xinhuanet.com/ english2010/china/201008/03/c_13428432.htm
488
On Aug 3, the Chinese Ministry of Health released a comprehensive national implementation scheme for the prevention and control of tuberculosis and HIV co-infection. Tuberculosis and HIV co-infection has become a huge public health problem in China, which has the world’s second largest tuberculosis burden with more than 1·3 million new cases diagnosed every year. Tuberculosis was the leading cause of death from an infectious disease in China until 2008, when HIV/ AIDS took over. According to the Chinese Ministry of Health and UNAIDS, there were an estimated 560 000– 920 000 people infected with HIV in China by 2009. The new strategy encourages collaboration between those who care for people with tuberculosis and those who specialise in HIV. For example, patients diagnosed with HIV/AIDS should have sputum cytology, chest radiography, and tuberculosis screening questionnaires. Likewise, people newly diagnosed with tuberculosis should be offered HIV-antibody tests. Co-infected patients will receive free treatment and follow-up services.
Better integration of tuberculosis and HIV services is urgently needed in China’s health-care system reform. However, there are problems that the current proposals do not address. There is no strategy for particular atrisk groups, such as migrant workers with limited access to diagnosis and treatment, and people with drug-resistant tuberculosis. There is also a shortage of staff capable of providing prevention services and effective treatment to people co-infected with tuberculosis and HIV. Additionally, patients’ adherence to tuberculosis or HIV treatment is problematic because of extra fees not covered by the programme, and social stigma that can result in concealment of the illness and discontinuation of treatment. The national implementation scheme is an important first step to address the problem of tuberculosis and HIV co-infection in China. To be more effective, it needs to be implemented and monitored actively, and to take the financial and social circumstances of at-risk groups into account. ■ The Lancet
www.thelancet.com Vol 376 August 14, 2010
Science Photo Library
New guidelines for genetic tests are welcome but insufficient
For A common framework of principles for direct-to-consumer genetic testing see http://www. hgc.gov.uk/Client/document. asp?DocId=280 §&CAtegoryId=10 For the American Society of Human Genetics statement see http://ashg.org/pdf/dtc_ statement.pdf For the American College of Medical Genetics statement see http://www.acmg.net/AM/ Template.cfm?Section=Policy_ Statements&Template=/CM/ ContentDisplay. cfm&ContentID=2975
A common framework of principles for direct-to-consumer genetic testing, published on Aug 4 by the UK’s Human Genetics Commission (HGC), is a commendably clear and detailed guideline about what constitutes good practice for commercial genetic testing. The guidelines cover the full range of genetic tests currently available—from diagnosis to ancestry tests—and set out minimum standards for consent, data protection, marketing, scientific rigour, and interpretation. Less clear, however, is what practical value the guidelines will have in the context of an international industry that crosses regulatory jurisdictions. The UK Department of Health’s statement to the press that accompanied the publication of the principles was slightly misleading, claiming that they amounted to a “crackdown on genetic testing” and would require companies to abide by the principles espoused by the HGC. But the HGC is not a regulatory body, and there is no framework in place to monitor adherence to the guidelines, let alone enforce compliance. Although the most comprehensive set of guidelines yet published, the HGC framework is similar to several other past statements, notably those from the American
College of Medical Genetics and the American Society of Human Genetics. But with little regulatory oversight of direct-to-consumer genetic testing to back them, these statements often receive little more than lip service from the testing industry. Such a fragmentary regulatory framework has led to a string of high-profile blunders by the testing industry, the most recent of which was in June this year when a US firm sent the wrong results to 96 of its customers, including one woman who was left distraught by the erroneous finding that her son was genetically unrelated. In the 10 years since the publication of the human genome revolutionised genetics, direct-to-consumer genetic testing has proliferated rapidly, and regulators have been unable to keep up with the pace of technological advances. The sheer volume of research into genetics means the industry is certain to continue to grow, so it is essential that regulators not only catch up but get ahead of the game to ensure that consumers are protected by something less ephemeral than guidelines. ■ The Lancet
Ng Han Guan/AP/Press Association Images
China takes action against tuberculosis and HIV co-infection The printed journal includes an image merely for illustration
For more on the national plan see http://news.xinhuanet.com/ english2010/china/201008/03/c_13428432.htm
488
On Aug 3, the Chinese Ministry of Health released a comprehensive national implementation scheme for the prevention and control of tuberculosis and HIV co-infection. Tuberculosis and HIV co-infection has become a huge public health problem in China, which has the world’s second largest tuberculosis burden with more than 1·3 million new cases diagnosed every year. Tuberculosis was the leading cause of death from an infectious disease in China until 2008, when HIV/ AIDS took over. According to the Chinese Ministry of Health and UNAIDS, there were an estimated 560 000– 920 000 people infected with HIV in China by 2009. The new strategy encourages collaboration between those who care for people with tuberculosis and those who specialise in HIV. For example, patients diagnosed with HIV/AIDS should have sputum cytology, chest radiography, and tuberculosis screening questionnaires. Likewise, people newly diagnosed with tuberculosis should be offered HIV-antibody tests. Co-infected patients will receive free treatment and follow-up services.
Better integration of tuberculosis and HIV services is urgently needed in China’s health-care system reform. However, there are problems that the current proposals do not address. There is no strategy for particular atrisk groups, such as migrant workers with limited access to diagnosis and treatment, and people with drug-resistant tuberculosis. There is also a shortage of staff capable of providing prevention services and effective treatment to people co-infected with tuberculosis and HIV. Additionally, patients’ adherence to tuberculosis or HIV treatment is problematic because of extra fees not covered by the programme, and social stigma that can result in concealment of the illness and discontinuation of treatment. The national implementation scheme is an important first step to address the problem of tuberculosis and HIV co-infection in China. To be more effective, it needs to be implemented and monitored actively, and to take the financial and social circumstances of at-risk groups into account. ■ The Lancet
www.thelancet.com Vol 376 August 14, 2010