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Pharmaceutical companies pledge vaccines for developing countries
POLICY AND PEOPLE
FDA puts US gene-therapy trial on hold
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US company conducting vascular gene-therapy experiments said on Feb 29 that the US FDA had put one of its trials on hold until the company provided more clinical and pharmacokinetic data. The trial is one of four multicentre trials being done by the company, Vascular Genetics (Durham, NC, USA), to see whether it is possible to stimulate the growth of collateral vessels in patients with severe peripheral and coronary artery disease by treating them with the gene for an angiogenic protein called vascular endothelial growth factor-2 (VEGF-2). US gene-therapy researchers have been under intense scrutiny since a young man died last autumn while participating in a gene-therapy trial at the University of Pennsylvania in Philadelphia. An FDA investigation found what seemed to be serious protocol violations and suspended the university’s programme. Other programmes have been faulted for failing to report adverse reactions to the National Institutes of Health (NIH), including that of Vascular Genetics’ founder Jeffrey Isner of St Elizabeth’s Medical
Center in Boston, Massachusetts, who was criticised for not reporting the deaths of two participants in earlier vascular gene therapy trials to NIH officials (see p 857). But Isner that says such criticism is unwarranted. “Those deaths were reported immediately to the FDA, and in both cases, the FDA agreed the deaths were not related to the therapy”. In addition, data concerning the deaths had been presented at scientific meetings and published in Annals of Thoracic Surgery, he says. The NIH was not notified because, at the time, he and many other researchers in the field did not understand that NIH officials also expected to be informed, he explains. The FDA had no safety concerns about the current trial, Isner says, but given the ongoing controversy about gene therapy, its decision to suspend the trial and request more detailed data was understandable. “We’ll supply whatever is required”, he says. Preliminary results of the completed VEGF-2 trials will be presented later this month at the annual meeting of the American College of Cardiology. Michael McCarthy
Canada’s budget causes mixed emotions he Canadian government has unveiled the 2000–01 federal budget on Feb 28, which triggered dire predictions about the impending death of medicare. Finance minister, Paul Martin, offered the provinces, which administer medicare, an additional $2·5 billion over 4 years for health and postsecondary education, raising the annual total transferred to the provinces to $30·8 billion. But the provinces’ premiers and health-care critics called the rise inadequate and demanded a first ministers meeting to underline the province’s call for an additional $4·2-billion per year. In other measures, Martin set aside $160-million to establish a national genomics initiative, called Genome Canada, under which five genome science centres will be set up in industrial sectors such as agriculture, health, and biopharmaceuticals. The provinces and private sector foundations will be expected to pay in an equivalent amount. Genome Canada’s acting president Martin Godbout said: “Canada will become a player now in the international race of genomics”.
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Wayne Kondro
Pharmaceutical companies pledge vaccines for developing countries fter a meeting with President Clinton on March 2, four vaccine manufacturers pledged more than US$150-million worth of their products to fight infectious diseases in the developing world. The agreement by Merck, American Home Products, SmithKline Beecham, and Aventis Pharma came as President Clinton continued to advance the Millennium Vaccine Initiative (MVI), a programme he announced last month. MVI aims to help lower the toll of infectious diseases, which account for a quarter of all deaths worldwide. In addition to an extra $150 million in next year’s US budget to fight HIV/AIDS and other infectious diseases, Clinton has also proposed a new tax credit to speed development of new vaccines In his State of the Union address in January, he urged the “private sector and our partners around the world to join us in embracing this cause”. Following the White House meeting, Merck announced that it would
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give 5 million doses of its hepatitis B vaccine over the next 5 years; American Home Products stated it would donate 10 million doses of its Haemophilus influenzae type b vaccine. SmithKline Beecham announced it would do paediatric trials of its malaria vaccine in Africa and renewed a pledge made in 1998 to work with WHO to donate five billion doses of albendazole over the next 20 years to eradicate lymphatic filariasis. Aventis Pharma promised 50 million doses of its polio vaccine for “war-torn nations in Africa”.
While emphasising the responsibilities of the public and private sectors, Clinton also he would seek help from other industrialised nations later this year. Clinton also praised the Bill and Melinda Gates Foundation, which has pledged $750 million for the Global Alliance for Vaccines and Immunizations. “Today we’re building a partner– ship to eradicate the leading infectious killers of our time”, added Clinton. Julie Rovner
Global vaccine research progresses The 20th century witnessed a revolution in immunology and saw the introduction of vaccines that led to the reduction or elimination of 21 infectious diseases, states the Jordan Report 2000 by the US National Institute of Allergy and Infectious Diseases (NIAID). The report, which was was released on March 2, updates scientists and policy makers on the current state and future direction of vaccine research. In the case of HIV/AIDS, the report notes that at the end of 1999 there are 34 million people living with the disease. The report reviews some of the recent succeses in overcoming barriers, such as the global variation in HIV strains, and addresses all ongoing research. The report gives an overview of 60 infectious diseases (www.niaid.nih.gov). Haroon Ashraf
THE LANCET • Vol 355 • March 11, 2000
FDA puts US gene-therapy trial on hold
A
US company conducting vascular gene-therapy experiments said on Feb 29 that the US FDA had put one of its trials on hold until the company provided more clinical and pharmacokinetic data. The trial is one of four multicentre trials being done by the company, Vascular Genetics (Durham, NC, USA), to see whether it is possible to stimulate the growth of collateral vessels in patients with severe peripheral and coronary artery disease by treating them with the gene for an angiogenic protein called vascular endothelial growth factor-2 (VEGF-2). US gene-therapy researchers have been under intense scrutiny since a young man died last autumn while participating in a gene-therapy trial at the University of Pennsylvania in Philadelphia. An FDA investigation found what seemed to be serious protocol violations and suspended the university’s programme. Other programmes have been faulted for failing to report adverse reactions to the National Institutes of Health (NIH), including that of Vascular Genetics’ founder Jeffrey Isner of St Elizabeth’s Medical
Center in Boston, Massachusetts, who was criticised for not reporting the deaths of two participants in earlier vascular gene therapy trials to NIH officials (see p 857). But Isner that says such criticism is unwarranted. “Those deaths were reported immediately to the FDA, and in both cases, the FDA agreed the deaths were not related to the therapy”. In addition, data concerning the deaths had been presented at scientific meetings and published in Annals of Thoracic Surgery, he says. The NIH was not notified because, at the time, he and many other researchers in the field did not understand that NIH officials also expected to be informed, he explains. The FDA had no safety concerns about the current trial, Isner says, but given the ongoing controversy about gene therapy, its decision to suspend the trial and request more detailed data was understandable. “We’ll supply whatever is required”, he says. Preliminary results of the completed VEGF-2 trials will be presented later this month at the annual meeting of the American College of Cardiology. Michael McCarthy
Canada’s budget causes mixed emotions he Canadian government has unveiled the 2000–01 federal budget on Feb 28, which triggered dire predictions about the impending death of medicare. Finance minister, Paul Martin, offered the provinces, which administer medicare, an additional $2·5 billion over 4 years for health and postsecondary education, raising the annual total transferred to the provinces to $30·8 billion. But the provinces’ premiers and health-care critics called the rise inadequate and demanded a first ministers meeting to underline the province’s call for an additional $4·2-billion per year. In other measures, Martin set aside $160-million to establish a national genomics initiative, called Genome Canada, under which five genome science centres will be set up in industrial sectors such as agriculture, health, and biopharmaceuticals. The provinces and private sector foundations will be expected to pay in an equivalent amount. Genome Canada’s acting president Martin Godbout said: “Canada will become a player now in the international race of genomics”.
T
Wayne Kondro
Pharmaceutical companies pledge vaccines for developing countries fter a meeting with President Clinton on March 2, four vaccine manufacturers pledged more than US$150-million worth of their products to fight infectious diseases in the developing world. The agreement by Merck, American Home Products, SmithKline Beecham, and Aventis Pharma came as President Clinton continued to advance the Millennium Vaccine Initiative (MVI), a programme he announced last month. MVI aims to help lower the toll of infectious diseases, which account for a quarter of all deaths worldwide. In addition to an extra $150 million in next year’s US budget to fight HIV/AIDS and other infectious diseases, Clinton has also proposed a new tax credit to speed development of new vaccines In his State of the Union address in January, he urged the “private sector and our partners around the world to join us in embracing this cause”. Following the White House meeting, Merck announced that it would
A
908
give 5 million doses of its hepatitis B vaccine over the next 5 years; American Home Products stated it would donate 10 million doses of its Haemophilus influenzae type b vaccine. SmithKline Beecham announced it would do paediatric trials of its malaria vaccine in Africa and renewed a pledge made in 1998 to work with WHO to donate five billion doses of albendazole over the next 20 years to eradicate lymphatic filariasis. Aventis Pharma promised 50 million doses of its polio vaccine for “war-torn nations in Africa”.
While emphasising the responsibilities of the public and private sectors, Clinton also he would seek help from other industrialised nations later this year. Clinton also praised the Bill and Melinda Gates Foundation, which has pledged $750 million for the Global Alliance for Vaccines and Immunizations. “Today we’re building a partner– ship to eradicate the leading infectious killers of our time”, added Clinton. Julie Rovner
Global vaccine research progresses The 20th century witnessed a revolution in immunology and saw the introduction of vaccines that led to the reduction or elimination of 21 infectious diseases, states the Jordan Report 2000 by the US National Institute of Allergy and Infectious Diseases (NIAID). The report, which was was released on March 2, updates scientists and policy makers on the current state and future direction of vaccine research. In the case of HIV/AIDS, the report notes that at the end of 1999 there are 34 million people living with the disease. The report reviews some of the recent succeses in overcoming barriers, such as the global variation in HIV strains, and addresses all ongoing research. The report gives an overview of 60 infectious diseases (www.niaid.nih.gov). Haroon Ashraf
THE LANCET • Vol 355 • March 11, 2000