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Clinical trial safety
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brainstem and, by reducing the sympathetic outflow from this site, relaxed blood vessels and decreased blood pressure. Such findings provide a better understanding of the mechanisms that underlie such complementary therapies and could pave the way for better treatments for cardiovascular diseases. [Li, P. (2001) Autonom. Neurosci. 89, 38–47] DC
Monthly pill The forgetful among us spend the day in pangs of panic: did we forget the pill this morning? This could soon be a once-a-month panic, with the reinvention of a drug currently used to induce abortion, mifepristone, formerly known as RU486. Unlike the commonly used daily contraceptive pill, mifepristone is not hormone based, thus avoiding the risk of taking hormones every day. The disadvantage – some women might be tempted to use it as an abortion or morning after pill instead. KP
Competition for Viagra® A novel class of anti-impotent drug has recently been licensed by the European Commission. Available as a sublingual tablet, apomorphine (hydrochloride), only the second orally administered treatment (after Viagra) available for impotence, is now marketed in the UK as Uprima® and elsewhere in Europe as Ixense®. Unlike Viagra – which enhances the nitric oxide, cGMP system by selective inhibition of the cGMP-specific type 5 phosphodiesterase in the periphery – apomorphine works centrally by activating dopamine D1 and D2 receptors at sites in the brain and spinal cord that control the erectile response. With claims that apomorphine works faster (<20 min), has fewer side-effects and is cheaper than Viagra, this compound provides an additional therapeutic tool for patients suffering from erectile dysfunction. DC
Cultural clash Research partnerships between universities and industry are on the up all over the http://tips.trends.com
TRENDS in Pharmacological Sciences Vol.22 No.8 August 2001
world. In the USA, formal contracts are being demonstrated to be vital for conflict reduction. Conflicts of interest feature as the most troublesome, leading to drastic consequences such as resignation from projects. A report, Working Together, Creating Knowledge: The University–Industry Research Collaborative Initiative, was released on 6 June as a result of a collaboration between the American Council on Education, an association of 1800 universities and colleges, and the National Alliance of Business, an industry group. The top recommendation was that collaborations should have contracts that cover every aspect from the outset. KP
Clinical trial safety Current concerns about the protection of humans participating in clinical trials has led to the formation of the Association for the Accreditation of Human Research Protection Programs, conveniently shortened to AAHRPP. Founded by the Association of American Medical Colleges (AAMC), Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Associations of State Universities and LandGrant Colleges, National Health Council and Public Responsibility in Medicine and Research, this non-profit organization will accredit institutions. The plan will be to visit sites and construct an educational programme to encourage improvement of human research protection programmes. This should be fully operational by January 2002. KP
401
30 000 laboratory animals and countless laboratory notebooks, computers and freezers were destroyed by the floods, which swept into both Texas and Louisiana. The Baylor College of Medicine was badly affected, although the larger research animals such as cows and pigs were saved. The medical centre comprises 13 hospitals and two medical schools and is a world leader in cancer and heart disease research. The flood could delay drug development for years. KP
Anakinra for arthritis Data presented at the European League Against Rheumatism 2001 Annual European Congress of Rheumatology suggests the rheumatoid arthritis therapy anakinra can arrest joint destruction in patients with established erosions, improving function, productivity and quality of life. Anakinra is a recombinant form of the interleukin 1 receptor antagonist. It competitively binds to interleukin 1 receptors, interfering with the action of the excess interleukin 1 produced by patients. Amgen has filed for regulatory approval of anakinra in the European Union, Canada and the USA. KP
PCBs on a hook
Allison’s trail of destruction
Tropical storm Allison has caused havoc at the world’s largest medical reasearch complex, the Texas Medical Center. Over
A long-term investigation has established a link between polychlorinated biphenyls (PCBs) and the impairment of certain cognitive functions in adults. By studying fishermen who had regularly consumed more than 24 pounds of sport-caught fish a year from Lake Michigan in the USA, the report found that many of these heavy fish-eaters had high blood serum concentrations of PCBs and now experienced problems learning and storing new verbal information. Lead and mercury were also elevated in the fish-eaters, but only the amount of PCBs (which
0165-6147/01/$ – see front matter © 2001 Elsevier Science Ltd. All rights reserved.
brainstem and, by reducing the sympathetic outflow from this site, relaxed blood vessels and decreased blood pressure. Such findings provide a better understanding of the mechanisms that underlie such complementary therapies and could pave the way for better treatments for cardiovascular diseases. [Li, P. (2001) Autonom. Neurosci. 89, 38–47] DC
Monthly pill The forgetful among us spend the day in pangs of panic: did we forget the pill this morning? This could soon be a once-a-month panic, with the reinvention of a drug currently used to induce abortion, mifepristone, formerly known as RU486. Unlike the commonly used daily contraceptive pill, mifepristone is not hormone based, thus avoiding the risk of taking hormones every day. The disadvantage – some women might be tempted to use it as an abortion or morning after pill instead. KP
Competition for Viagra® A novel class of anti-impotent drug has recently been licensed by the European Commission. Available as a sublingual tablet, apomorphine (hydrochloride), only the second orally administered treatment (after Viagra) available for impotence, is now marketed in the UK as Uprima® and elsewhere in Europe as Ixense®. Unlike Viagra – which enhances the nitric oxide, cGMP system by selective inhibition of the cGMP-specific type 5 phosphodiesterase in the periphery – apomorphine works centrally by activating dopamine D1 and D2 receptors at sites in the brain and spinal cord that control the erectile response. With claims that apomorphine works faster (<20 min), has fewer side-effects and is cheaper than Viagra, this compound provides an additional therapeutic tool for patients suffering from erectile dysfunction. DC
Cultural clash Research partnerships between universities and industry are on the up all over the http://tips.trends.com
TRENDS in Pharmacological Sciences Vol.22 No.8 August 2001
world. In the USA, formal contracts are being demonstrated to be vital for conflict reduction. Conflicts of interest feature as the most troublesome, leading to drastic consequences such as resignation from projects. A report, Working Together, Creating Knowledge: The University–Industry Research Collaborative Initiative, was released on 6 June as a result of a collaboration between the American Council on Education, an association of 1800 universities and colleges, and the National Alliance of Business, an industry group. The top recommendation was that collaborations should have contracts that cover every aspect from the outset. KP
Clinical trial safety Current concerns about the protection of humans participating in clinical trials has led to the formation of the Association for the Accreditation of Human Research Protection Programs, conveniently shortened to AAHRPP. Founded by the Association of American Medical Colleges (AAMC), Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Associations of State Universities and LandGrant Colleges, National Health Council and Public Responsibility in Medicine and Research, this non-profit organization will accredit institutions. The plan will be to visit sites and construct an educational programme to encourage improvement of human research protection programmes. This should be fully operational by January 2002. KP
401
30 000 laboratory animals and countless laboratory notebooks, computers and freezers were destroyed by the floods, which swept into both Texas and Louisiana. The Baylor College of Medicine was badly affected, although the larger research animals such as cows and pigs were saved. The medical centre comprises 13 hospitals and two medical schools and is a world leader in cancer and heart disease research. The flood could delay drug development for years. KP
Anakinra for arthritis Data presented at the European League Against Rheumatism 2001 Annual European Congress of Rheumatology suggests the rheumatoid arthritis therapy anakinra can arrest joint destruction in patients with established erosions, improving function, productivity and quality of life. Anakinra is a recombinant form of the interleukin 1 receptor antagonist. It competitively binds to interleukin 1 receptors, interfering with the action of the excess interleukin 1 produced by patients. Amgen has filed for regulatory approval of anakinra in the European Union, Canada and the USA. KP
PCBs on a hook
Allison’s trail of destruction
Tropical storm Allison has caused havoc at the world’s largest medical reasearch complex, the Texas Medical Center. Over
A long-term investigation has established a link between polychlorinated biphenyls (PCBs) and the impairment of certain cognitive functions in adults. By studying fishermen who had regularly consumed more than 24 pounds of sport-caught fish a year from Lake Michigan in the USA, the report found that many of these heavy fish-eaters had high blood serum concentrations of PCBs and now experienced problems learning and storing new verbal information. Lead and mercury were also elevated in the fish-eaters, but only the amount of PCBs (which
0165-6147/01/$ – see front matter © 2001 Elsevier Science Ltd. All rights reserved.