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Thai HIV vaccine trial prompts angry exchanges
MEDICINE AND HEALTH POLICY
Australian drugs scheme threatens free-trade talks ustralia’s Pharmaceutical Benefits Scheme (PBS) is causing problems for US–Australia free-trade talks, which are underway in Washington this week. The Australian government uses PBS to bulk-buy medicines and so drive down prescription costs. The scheme covers 159 million prescriptions a year at a cost of AUS$4·6 billion (US$3·5 billion), but it is seen as protectionist by US pharmaceuticals lobbyists. The Pharmaceuticals Research and Manufacturers Association (PhRMA), which represents the major US pharmaceutical and biotech research companies, claims that PBS restricts drug companies’ access to the Australian market. In its submission to US trade representative Robert Zoellick’s annual report on foreign trade barriers, PhRMA singled out PBS as an important issue to be addressed during free-trade talks. “PBS has adopted a series of increasingly draconian regulatory and budgetary cost-control schemes”, the submission stated. Pressure from the US pharmaceuticals and farming industries has already delayed a planned signing of the trade agreement, scheduled for before Christmas. Australian prime minister John Howard, under fire over planned reforms to the country’s Medicare public health system, has pledged to avoid any
A
AP
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
US president George Bush with Australian prime minster John Howard
deal which would increase prescription costs. “There’s no way we’re going to bargain away the enormous advantage that Australian consumers now enjoy as a result of PBS”, he told ABC radio. However, several analysts believe that change is most likely to take place through reforms of Australia’s intellectual property laws to restrict the availability of generics. US negotiators are understood to be particularly keen to limit “springboarding”, through which manufacturers
of generic drugs can use patent-holders’ safety data to obtain regulatory approval. Richard Denniss, of the Australia Institute, claims such patent changes could cost Australian consumers up to AUS$1 billion (US$0·8 billion). “Without generics the PBS isn’t very useful at all”, he said. “If you can manage to keep the generics out of the market, the PBS is basically a wonderful system for comparing one expensive drug with another.” David Fickling
Thai HIV vaccine trial prompts angry exchanges esearchers have clashed over which strategy is best to test an urgently needed HIV vaccine. In a policy paper published in the Jan 16 issue of Science, top AIDS researchers questioned the scientific rationale behind a US government-sponsored phase III trial of an HIV vaccine in Thailand. In Sept 2003, the first participants in the 16 000patient trial began receiving the vaccine, which is comprised of the live canarypox virus vector ALVAC combined with VaxGen’s genetically engineered HIV surface protein gp120. The combination vaccine is intended to improve cellular and humoral immunity to
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prevent and/or control HIV-1. Recent phase III trials testing the components independently resulted in two disappointing failures. One of the Science paper’s 22 authors, Dennis Burton (Scripps Research Institute, La Jolla, California), said that there was little evidence that the vaccine would prove more effective than either component alone. The National Institutes of Health (NIH; Bethesda, Maryland) should have more closely consulted with independent experts, who would probably have recommended modifying the trial, he said. “NIH has been fantastic in supporting basic HIV vaccine research and it’s a shame they
THE LANCET • Vol 363 • January 24, 2004 • www.thelancet.com
don’t draw on the expertise they have created”, said Burton. He warned that the study’s probable failure could destroy public and political confidence in AIDS vaccines. A US phase III trial of a very similar combined vaccine was cancelled in 2002. The decision to initiate the Thai trial “is a debate in which reasonable people will reasonably disagree”, said Peggy Johnston of the NIHbased National Institute of Allergy and Infectious Diseases (NIAID). “The combination [vaccine] induces a broader range of immune responses than VaxGen’s alone did”, she said. Homay Farzadegan (Johns Hopkins University,
Baltimore, Maryland) said that another key issue is the depletion of the pool of willing participants of future HIV/ AIDS vaccine trials. “The lab scientists are looking at [the trial] from strictly a scientific perspective”, said Johnston. “We have to look at from a policy perspective too. The royal Thai government is also involved in this trial, so NIAID is not the only decision-maker in considering possible changes to trial design.” NIAID will submit a formal response for publication in Science in early February, Johnston said. Kathleen Nelson
299
For personal use. Only reproduce with permission from The Lancet publishing Group.
Australian drugs scheme threatens free-trade talks ustralia’s Pharmaceutical Benefits Scheme (PBS) is causing problems for US–Australia free-trade talks, which are underway in Washington this week. The Australian government uses PBS to bulk-buy medicines and so drive down prescription costs. The scheme covers 159 million prescriptions a year at a cost of AUS$4·6 billion (US$3·5 billion), but it is seen as protectionist by US pharmaceuticals lobbyists. The Pharmaceuticals Research and Manufacturers Association (PhRMA), which represents the major US pharmaceutical and biotech research companies, claims that PBS restricts drug companies’ access to the Australian market. In its submission to US trade representative Robert Zoellick’s annual report on foreign trade barriers, PhRMA singled out PBS as an important issue to be addressed during free-trade talks. “PBS has adopted a series of increasingly draconian regulatory and budgetary cost-control schemes”, the submission stated. Pressure from the US pharmaceuticals and farming industries has already delayed a planned signing of the trade agreement, scheduled for before Christmas. Australian prime minister John Howard, under fire over planned reforms to the country’s Medicare public health system, has pledged to avoid any
A
AP
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
US president George Bush with Australian prime minster John Howard
deal which would increase prescription costs. “There’s no way we’re going to bargain away the enormous advantage that Australian consumers now enjoy as a result of PBS”, he told ABC radio. However, several analysts believe that change is most likely to take place through reforms of Australia’s intellectual property laws to restrict the availability of generics. US negotiators are understood to be particularly keen to limit “springboarding”, through which manufacturers
of generic drugs can use patent-holders’ safety data to obtain regulatory approval. Richard Denniss, of the Australia Institute, claims such patent changes could cost Australian consumers up to AUS$1 billion (US$0·8 billion). “Without generics the PBS isn’t very useful at all”, he said. “If you can manage to keep the generics out of the market, the PBS is basically a wonderful system for comparing one expensive drug with another.” David Fickling
Thai HIV vaccine trial prompts angry exchanges esearchers have clashed over which strategy is best to test an urgently needed HIV vaccine. In a policy paper published in the Jan 16 issue of Science, top AIDS researchers questioned the scientific rationale behind a US government-sponsored phase III trial of an HIV vaccine in Thailand. In Sept 2003, the first participants in the 16 000patient trial began receiving the vaccine, which is comprised of the live canarypox virus vector ALVAC combined with VaxGen’s genetically engineered HIV surface protein gp120. The combination vaccine is intended to improve cellular and humoral immunity to
R
prevent and/or control HIV-1. Recent phase III trials testing the components independently resulted in two disappointing failures. One of the Science paper’s 22 authors, Dennis Burton (Scripps Research Institute, La Jolla, California), said that there was little evidence that the vaccine would prove more effective than either component alone. The National Institutes of Health (NIH; Bethesda, Maryland) should have more closely consulted with independent experts, who would probably have recommended modifying the trial, he said. “NIH has been fantastic in supporting basic HIV vaccine research and it’s a shame they
THE LANCET • Vol 363 • January 24, 2004 • www.thelancet.com
don’t draw on the expertise they have created”, said Burton. He warned that the study’s probable failure could destroy public and political confidence in AIDS vaccines. A US phase III trial of a very similar combined vaccine was cancelled in 2002. The decision to initiate the Thai trial “is a debate in which reasonable people will reasonably disagree”, said Peggy Johnston of the NIHbased National Institute of Allergy and Infectious Diseases (NIAID). “The combination [vaccine] induces a broader range of immune responses than VaxGen’s alone did”, she said. Homay Farzadegan (Johns Hopkins University,
Baltimore, Maryland) said that another key issue is the depletion of the pool of willing participants of future HIV/ AIDS vaccine trials. “The lab scientists are looking at [the trial] from strictly a scientific perspective”, said Johnston. “We have to look at from a policy perspective too. The royal Thai government is also involved in this trial, so NIAID is not the only decision-maker in considering possible changes to trial design.” NIAID will submit a formal response for publication in Science in early February, Johnston said. Kathleen Nelson
299
For personal use. Only reproduce with permission from The Lancet publishing Group.