Drug companies using humans as guinea pigs


Khaleej Times
 India’s top court on Monday accused some drug companies of using Indians like “guinea pigs” in illegal clinical trials as it ordered the government to submit a report on the practice.
Rights groups have raised concern that India has become a hotspot for drug trials, with hospital patients sometimes used unwittingly to test new drugs by leading pharmaceutical companies.
Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, the groups say.
“This is most unfortunate that clinical trials take place and people are dying. What action has been taken?” Supreme Court Judges R.M. Lodha and A.S Dave said on Monday in New Delhi.
“There has to be some sense of responsibility. Human beings are treated like guinea pigs.”
The judges also criticised the government for failing to submit a report in time in response to a public interest case filed by a group of doctors and a voluntary organisation, Swasthya Adhikar Manch (Health Rights Group).
The petitioners claim several patients in the central Indian state of Madhya Pradesh seeking medical help were used in drug tests and this was “unethical and illegal”.
The group said they have compiled and submitted a report of more than 200 cases where patients were subjected to clinical trials to check the efficacy of various drugs without seeking their permission.
In May, a government panel found serious problems with the way approvals for foreign drugs are given and clinical trials are being carried out.
Earlier this year, 12 doctors accused of conducting secret drug trials on children and patients with learning disabilities were let off after they paid fines of less than $100 each.
Faced with mounting criticism, the Indian Council of Medical Research in 2011 had sought proposals from doctors and health activists on new draft guidelines for compensation to be paid to people undertaking drug trials.

US nod for once-a-day pill to cut HIV risk

PTI Jul 18, 2012, 05.18AM IST
WASHINGTON: For the first time, a once-a-day pill which reduces the chance of contracting HIV among high risk groups "significantly" has got green signal in the US, where 1.2 million people are infected by the deadly disease. The drug,'Truvada' can now be used by those at high risk of the infection and anyone who may engage in sexual activity with HIV-infected partners, the Food and Drug Administration (FDA) announced.
"In two large clinical trials, daily use of the drug was shown to significantly reduce the risk of HIV infection," it said on Monday. However, some health workers and groups active in the HIV community opposed the approval for the once-a-day pill.
There are concerns that circulation of such a drug could engender a false sense of security and mean people will take more risks. There have also been fears that a drug-resistant strain of HIV could develop. People diagnosed with HIV that without treatment develops into AIDS take antiviral medications to control the infection that attacks their immune system.
In a statement, the FDA stressed that the drug should be used as part of a "comprehensive HIV prevention plan", including condom use and regular HIV testing. Studies show that Truvada reduced the risk of HIV in healthy gay men - and among HIV-negative heterosexual partners of HIV-positive people - by between 44% and 73%.
"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time," Debra Birnkrant, director of the Division of Antiviral Products at FDA, said.
GM bacteria prevents malaria transmission
In a breakthrough, US scientists have genetically modified a bacterium to kill the parasite that causes malaria before it infects humans. Researchers at Johns Hopkins Malaria Research Institute said their breakthrough could help prevent mosquitoes from transmitting malaria to humans. Malaria kills over 800,000 people worldwide every year, most of them are children.
In the new study, published in the journal Proceedings of the National Academy of Sciences, the researchers modified the bacterium, called Pantoea agglomerans, to secrete proteins that are toxic to the malaria parasite, but not harmful to the mosquito or humans. The bacterium is commonly found in the mosquito's midgut. It was found that the modified bacteria were 98 per cent effective in reducing the malaria parasite burden in the insects, the researchers said.

Scientists develop ‘roller’ to keep your back flexible

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Jul 18, 2012 at 8:45 AM
BackacheScientists might have found a revolutionary way to cure back pain. Tiny, artificial rollers, which mimics the flexibility of the spine! Developed by a team at Brigham Young University in the U.S., the “roller” when inserted in the spine replaces damaged discs and provides the same range of movement as the real one.
The replacement disc has a rolling action to allow the spine to move in different directions. It’s intended as an alternative to fusion, where bones either side of the damaged disc area are welded together to reduce pain, the Daily Mail reported. Spinal discs, which contain a gel-like substance, help, cushion the vertebrae during movement. While they are critical for movement, the discs can become the source of back pain when they degenerate. Treatment ranges from painkillers and physiotherapy, to different types of surgery.
One of the most common forms is spinal fusion, in which the vertebrae on either side of the damaged disc are welded together to make one solid bone. However, the operation can limit the flexibility of the spine and restrict movement. To overcome this problem, the Brigham team designed and developed the artificial roller that can move forwards and backwards, as well as side to side.
The device is inserted between the vertebra and disc — tiny spikes in the plates anchor it in place, leaving the roller unimpeded. Early tests on animals and human spines suggest that the device does provide significantly more flexibility than standard disc replacement.
The researchers are now using the device in larger clinical trials. If they are successful, they hope to launch the technology in the next three years. Commenting on the technology, Jane Tadman of Arthritis Research U.K. said: “We welcome news of this new implant. Disc replacement allows a close approximation to the normal spine by allowing it to remain flexible, however new designs need adequate testing.”