GlaxoSmithKline has granted a voluntary licence to a company in South Africa to manufacture and distribute low cost generic versions of three of its AIDS drugs. The agreement allows the pharmaceutical company Aspen Pharmacare, the biggest manufacturer of generic drugs in South Africa, to manufacture three AIDS drugs zidovudine (Retrovir), lamivudine (Epivir), and a combination of zidovudine and lamivudine (Combivir).
Under the agreement, GlaxoSmithKline, the patent holder for zidovudine, and Shire Pharmaceuticals Group, the patent holder for lamivudine, have agreed to waive their rights to royalty payments on these products. . Dr Julia Cleves, chief of policy with UNAIDS (the joint United Nations programme on HIV and AIDS), said: "This is an important milestone in efforts to improve the treatment of AIDS in South Africa. We have been asking the big research based pharmaceutical companies to issue voluntary licences for AIDS drugs. Glaxo has pressed ahead and done that for its AIDS drugs."
China admits its AIDS crisis
With unprecedented frankness China''s top health officials have acknowledged that the world''s most populous country faces an HIV and AIDS crisis, and they have vowed to bring new resources to bear in their campaign to limit the spread of the virus. China''s vice minister of health, Yin Dakui, presented alarming data at a Beijing press conference last month indicating that rates of HIV infection are far higher than previously reported, and also that increased percentages of specific groups, such as drug misusers, are now testing positive.
"Like many other countries, we are facing a very serious epidemic of HIV and AIDS," Yin said as he announced that reported infections of HIV in the first six months of 2001 were 67.4% higher than in the same period last year. By the end of 2000, Yin said, China had 6,00,000 people infected with HIV. But he also predicted that China would manage to hold the number below 1.5 million through to 2010.
During his press conference Yin also acknowledged serious lapses in the government''s work on HIV and AIDS, particularly in its efforts at public education and its management of the blood supply. Yin said that between 30,000 and 50,000 people had been infected while selling blood through poorly managed collection operations, where reused and unsterilised equipment is common.
US FDA warns Merck over promotion of rofecoxib
The US Food and Drug Administration has issued a warning letter to the pharmaceutical company Merck for misrepresenting the safety of their blockbuster anti-inflammatory drug, rofecoxib (Vioxx). Rofecoxib, a selective cyclo-oxygenase-2 (COX 2) inhibitor, was approved by the administration in May 1999 for the relief of acute pain, osteoarthritis, and dysmenorrhoea. The drug was heavily promoted by Merck and touted as safer than and superior to non-selective, non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen. In its letter the FDA criticised Merck for playing down the possible risk of stroke associated with rofecoxib and for minimising potential drug interactions of rofecoxib with warfarin.
The risk of stroke was found in an analysis of a large study, dubbed the VIGOR (Vioxx gastrointestinal outcomes research) trial, which compared 50 mg a day of rofecoxib with 500 mg twice a day of naproxen in patients with rheumatoid arthritis. The study found that rofecoxib was significantly less ulcerogenic than naproxen.
However, an analysis of the VIGOR study by cardiologist Eric Topol and colleagues showed that patients taking rofecoxib had a higher relative risk of developing adverse cardiovascular events such as ischaemic strokes, unstable angina, and myocardial infarctions than the patients taking naproxen. Their study suggested that rofecoxib might be prothrombotic and urged further research to see if this was so. The FDA charged that Merck was aware of the cardiovascular risk associated with rofecoxib and minimised it in a press release and in its promotional materials. In a press release Merck responded that the VIGOR study''s data falsely inflated the cardiovascular risk of rofecoxib because it compared the drug with naproxen, which has blood-thinning properties similar to aspirin.
New Generation Drugs for Hepatitis C
It is estimated that more than 200 million people worldwide are infected with the Hepatitis C Virus (HCV). More than 70 percent of those infected with the virus will eventually develop chronic liver disease. The rate of new HCV infection is four times that of HIV. . Many people who may have experimented with intravenous drug use ten or twenty years ago, are now suffering from liver cirrhosis.
Although HCV is not easily transmitted sexually, 20 percent of HCV cases can be attributed to risky sexual behavior involving multiple partners. Others at high risk include health workers and people exposed to needle sticks and blood splashes, and those sharing toothbrushes and razors with another household member, who may be infected. Direct medical costs to treat HCV-related disease could exceed $13 billion for the years 2010 to 2019.
The mainstay treatment for hepatitis C is the antiviral drug, interferon alpha, which is used alone or in combination with ribavirin, a synthetic nucleoside analog. Interferon is effective in approximately 15 percent of patients, whereas the interferon/ribavirin combination works in about 35 percent of patients.
The most recent approval was in August 2001 for Peg-Intron in combination therapy with Rebetol .Other players in the hepatitis C market include Roche with Roferon A (recombinant interferon-alpha 2a), Amgen with Infergen (consensus interferon alpha) and GlaxoSmithKline with Wellferon (recombinant interferon-alpha n1).A number of small molecule compounds, which inhibit viral replication through blocking RNA or DNA, and even a few prophylactic vaccines, are under investigation for hepatitis C.
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com