Human papillomavirus infection is the cause of nearly all cases of cervical cancer, and so immunizing young women before they are exposed to the virus could save a great many lives. So, the idea of a large scale clinical trial of an HPV vaccine in India seems like a valid idea, based on the country's supposed huge cervical cancer healthcare burden. Not so--according to a paper published in the Journal of the Royal Society of Medicine, the epidemiology behind the study is flawed and the trial is currently the subject of an investigation by the Indian government.The trial was under the auspices of PATH, an international health charity, and included over 23,000 girls in the Indian states of Gujarat and Andhra Pradesh. The charity had claimed that "in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide." However, according to the study, led by Allyson Pollock of Barts and The London Medical School, the cancer surveillance, registration and monitoring in India in general, particularly in the Gujarat and Andhra Pradesh regions, were incomplete, so that it would be impossible to tell whether the vaccine would be successful in preventing the disease.The figures that do exist for India show that there were only 22 cases of cervical cancer per 100,000 in 2004/2005 in india, falling from 43 cases per 100,000 in 1982/1983--this is around half the rate in countries like Brazil and Zimbabwe."This trial has clearly raised serious concerns for the people and government of India," says Pollock. "We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program."India does have major health burdens, for example in malaria and other infectious diseases, maternal anemia and malnutrition, and so the use of an expensive HPV vaccine, which is one of the more expensive vaccines on the market, for a health issue with a lower impact would seem to be a flawed use of limited financial resources.- read the press release
- see the paperRelated Articles:
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Friday, 22 June 2012
Government Of India-Cervical Cancer-Clinical Trial-Andhra Pradesh-Hpv Vaccine
Friday, 30 March 2012
Intellectual Property-Compulsory License-Indian Government-Natco Pharma-Patent Case
Is intellectual property safe in India? That's the question drugmakers--and now U.S. officials--are asking, as the country's top court considers a landmark patent case, and after the government ordered its first compulsory license on a Big Pharma-patented drug.The issue drives to the heart of pharma's push into emerging markets; after all, if innovative drugs aren't protected, then how can the makers of those drugs profit? But, at the same time, developing countries--and the citizens who can barely pay for food, much less medication--can't afford to pay the prices demanded in mature markets. And what good is a lifesaving drug if only a tiny fraction of patients can use it?Not surprisingly, U.S. Commerce Secretary John Bryson came down on Big Pharma's side, The Economic Times reports. During a visit with Indian Commerce Minister Anand Sharma, Bryson protested the government's order that Bayer ($BAY) allow domestic drugmaker Natco Pharma to knock off its cancer drug Nexavar at a vastly reduced price.Bryson told Sharma that "(a)ny dilution of the international patent regime was a cause for deep concern for the U.S.," a government official told the ET. But Sharma countered, saying the World Health Organization's compulsory licensing provisions were established for cases just like this--life-threatening illness treated by a drug out of reach at brand-name prices.Meanwhile, India's Supreme Court is hearing arguments in Novartis' ($NVS) long-running patent dispute. The fight involves the Swiss drugmaker's groundbreaking cancer treatment Gleevec, which India's patent officials deemed unworthy of market exclusivity. The case not only determines the fate of Gleevec--and the patients who need it--but could affect access to HIV drugs and other treatments now produced and sold at low cost.If Novartis succeeds in striking down the Indian patent provision in question, "it will open a flood of patents," Leena Menghaney, a lawyer with Médecins Sans Frontières, told the Globe and Mail. And that could make many drugs suddenly inaccessible.But Novartis maintains that access to medicines depends on patent protection. The company "is seeking clarity on whether we can rely on patents in India and whether we as a research-based organization can continue to invest in the development of better medicines for India," Novartis' top official in India, Ranjit Shahani, told the newspaper. We'll soon see how the Indian justices feel.- see the ET story
- get more from The Globe and MailRelated Articles:
Indian government forces Bayer to accept generic Nexavar competition
Indian government defends country's generics industry
Natco wants OK to copy patented Pfizer HIV drug read more..