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AIDS drugs being sold illegally on market stalls in Kenya
MEDICINE AND HEALTH POLICY
US FDA increases scrutiny of tissue banks Currently, screening is not required, but is recommended in informal guidance publications. A second proposal, issued in Jan 2001, would require tissue facilities to follow current “good tissue” practices. Again, this has not yet been issued in a final form. During the past few years, the FDA has weathered severe criticism of its regulation of tissue banks as a result of incidents when tissue grafts spread HIV, hepatitis C, Creutzfeldt-Jakob disease, and various other bacteria and fungi. In 2001, an otherwise healthy 23-year-old man received a knee tissue graft and died from a rare bacterial infection that was later traced to ineffective processing by Cryolife Inc, an Atlanta-based tissue bank. This issue attracted more attention after an investigation, done by the US Centers for Disease Control and Prevention, found 50 or more cases of contaminated grafts, all linked to Cryolife. In 2002, the FDA ordered Cryolife to recall its tissue products.
Only a small proportion of the tissue banks operating in the USA have been subject to registration, inspections, and recalls since 1997—mostly those that process bone, ligaments, skin and tendons.
But the FDA acknowledges that tissue grafts are a rapidly growing business so stricter regulation will definitely be required in future. Alicia Ault
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
Science Photo Library
issue banks in the USA that process bone, ligaments, skin, tendons, and reproductive tissue (including sperm and stem cells), now have to comply with similar laws to those governing blood and organ banks, after the US Food and Drug Administration (FDA) tightened up regulation of these industries on Jan 21. The FDA has already given tissue banks 2 years to prepare for the new regulations, which were initially spelled out in Jan 2001. Every bank must now register with the FDA and provide a list of cells and tissues they produce—a move designed to aid tracking of grafts that may cause severe infections. However, facilities that process heart valves and dura mater grafts are exempt from the new requirements because they are covered by similar laws elsewhere. The FDA is also considering two other proposals that would help protect graft recipients. One idea, proposed in 1999, would set out criteria and requirements for screening tissue donors.
T
A technician placing a piece of skin into a freezer storage unit
AIDS drugs being sold illegally on market stalls in Kenya rugs distributed as part of Kenya’s AIDS medicine programme are being sold on the black market, according to a report. Unscrupulous business people are selling the drugs on the back streets of the capital, Nairobi, at less than US$65 for a monthly cocktail, nearly quarter the normal price. Health minister Charity Ngilu announced last year that selected hospitals would dispense the drugs on strictly prescription-only terms and at subsidised prices. The scheme currently provides antiretroviral drugs to 6000 people infected with HIV. About 10 000 of the 230 000 people who need antiretrovirals is Kenya are currently receiving them; however, by 2005, the government plans to be in a position to provide treatment for three 3 million people. Under the programme, buyers pay about US$20 per month for the drugs—
D
roughly half the current price—while others will receive them for free. The Daily Nation newspaper reported that drugs were being sold in Nairobi’s street markets, including those at Tsavo Road and Ngong Road. In these places, people can purchase a few tablets or substantial quantities of drug without doctors’ prescriptions. Experts interviewed by The Lancet voiced fears of severe side-effects for patients without pescriptions who might react badly to the drugs. They also suggested that taking the drugs without medical guidance would limit their effectiveness. “The safety of patients who use the drugs is not guaranteed. Safety measures are needed to guard against such illicit drug traders”, said Richard Onhiri, a pharmarcist in the city. Onchiri said these drugs were bound to be misused because patients would
either use inadequate amounts or may even take fakes ones. Part of the reason for the illegal trade in drugs is that patients don’t know where to go to get treatment for their disease. Others shy from getting drugs in public because of the stigma attached to the disease. Pharmaceutical companies that manufacture antiretrovirals have bowed to pressure from lobbyists and human rights groups to cut the price of these treatments, helping more patients get access to them. Although it is not easy to trace the source of the drugs on sale in markets, some reports suggest it is common practice for public-health workers to divert drug supplies to private facilities. Treatments may also enter the country through illegal trade routes. Samuel Siringi
THE LANCET • Vol 363 • January 31, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
377
US FDA increases scrutiny of tissue banks Currently, screening is not required, but is recommended in informal guidance publications. A second proposal, issued in Jan 2001, would require tissue facilities to follow current “good tissue” practices. Again, this has not yet been issued in a final form. During the past few years, the FDA has weathered severe criticism of its regulation of tissue banks as a result of incidents when tissue grafts spread HIV, hepatitis C, Creutzfeldt-Jakob disease, and various other bacteria and fungi. In 2001, an otherwise healthy 23-year-old man received a knee tissue graft and died from a rare bacterial infection that was later traced to ineffective processing by Cryolife Inc, an Atlanta-based tissue bank. This issue attracted more attention after an investigation, done by the US Centers for Disease Control and Prevention, found 50 or more cases of contaminated grafts, all linked to Cryolife. In 2002, the FDA ordered Cryolife to recall its tissue products.
Only a small proportion of the tissue banks operating in the USA have been subject to registration, inspections, and recalls since 1997—mostly those that process bone, ligaments, skin and tendons.
But the FDA acknowledges that tissue grafts are a rapidly growing business so stricter regulation will definitely be required in future. Alicia Ault
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
Science Photo Library
issue banks in the USA that process bone, ligaments, skin, tendons, and reproductive tissue (including sperm and stem cells), now have to comply with similar laws to those governing blood and organ banks, after the US Food and Drug Administration (FDA) tightened up regulation of these industries on Jan 21. The FDA has already given tissue banks 2 years to prepare for the new regulations, which were initially spelled out in Jan 2001. Every bank must now register with the FDA and provide a list of cells and tissues they produce—a move designed to aid tracking of grafts that may cause severe infections. However, facilities that process heart valves and dura mater grafts are exempt from the new requirements because they are covered by similar laws elsewhere. The FDA is also considering two other proposals that would help protect graft recipients. One idea, proposed in 1999, would set out criteria and requirements for screening tissue donors.
T
A technician placing a piece of skin into a freezer storage unit
AIDS drugs being sold illegally on market stalls in Kenya rugs distributed as part of Kenya’s AIDS medicine programme are being sold on the black market, according to a report. Unscrupulous business people are selling the drugs on the back streets of the capital, Nairobi, at less than US$65 for a monthly cocktail, nearly quarter the normal price. Health minister Charity Ngilu announced last year that selected hospitals would dispense the drugs on strictly prescription-only terms and at subsidised prices. The scheme currently provides antiretroviral drugs to 6000 people infected with HIV. About 10 000 of the 230 000 people who need antiretrovirals is Kenya are currently receiving them; however, by 2005, the government plans to be in a position to provide treatment for three 3 million people. Under the programme, buyers pay about US$20 per month for the drugs—
D
roughly half the current price—while others will receive them for free. The Daily Nation newspaper reported that drugs were being sold in Nairobi’s street markets, including those at Tsavo Road and Ngong Road. In these places, people can purchase a few tablets or substantial quantities of drug without doctors’ prescriptions. Experts interviewed by The Lancet voiced fears of severe side-effects for patients without pescriptions who might react badly to the drugs. They also suggested that taking the drugs without medical guidance would limit their effectiveness. “The safety of patients who use the drugs is not guaranteed. Safety measures are needed to guard against such illicit drug traders”, said Richard Onhiri, a pharmarcist in the city. Onchiri said these drugs were bound to be misused because patients would
either use inadequate amounts or may even take fakes ones. Part of the reason for the illegal trade in drugs is that patients don’t know where to go to get treatment for their disease. Others shy from getting drugs in public because of the stigma attached to the disease. Pharmaceutical companies that manufacture antiretrovirals have bowed to pressure from lobbyists and human rights groups to cut the price of these treatments, helping more patients get access to them. Although it is not easy to trace the source of the drugs on sale in markets, some reports suggest it is common practice for public-health workers to divert drug supplies to private facilities. Treatments may also enter the country through illegal trade routes. Samuel Siringi
THE LANCET • Vol 363 • January 31, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
377