News (Updated March 11, 2007)
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Mon Mar 5, 2007 7:04 PM GMT
WASHINGTON (Reuters) - People may be most likely to transmit the AIDS virus when
they are first infected -- before they start showing symptoms and even before
many screening tests detect the virus, Canadian researchers reported on Monday.
This may help explain why the HIV epidemic moves so quickly, they report in the Journal of Infectious Diseases.
Their genetic analysis of HIV-infected patients in Quebec showed that nearly half of all transmissions occurred when patients were in the early stages of the disease.
"The early infection stage can be entirely asymptomatic," said Dr. Mark Wainberg, of the McGill AIDS Center in Montreal, who led the study.
"This is why people who are recently infected may not know it, and will probably often test negative by conventional antibody screening," Wainberg said in a statement.
Early on, the body has not yet mounted an immune defense against the virus. It does not produce many antibodies -- which is what most quick screening tests look for.
"Hence, we must do a much better job of identifying recently infected people if we are to be able to counsel them to modify high-risk sexual behavior and desist from transmitting the virus," Wainberg added.
Wainberg and colleagues from several hospitals and health clinics in Canada studied HIV transmission through phylogenetic analysis, which is a way to draw the family tree of the virus.
Viruses mutate when they live inside a person's body, and the mutations can be steadily clocked to estimate the first date of infection.
The study found that 49 percent of early infections appeared to cluster in a way that would suggest that most new infections were transmitted by people who themselves were in the early stages of infection, before the virus had time to mutate much.
This is in part because people have many copies of the virus in their blood when they first become infected. The more virus there is -- a measure called viral load -- the more people are likely to infect someone else.
The AIDS virus infects 39 million people globally and has killed more than 25 million since it was first identified in the early 1980s. There is no cure, although drug treatment can keep symptoms at a minimum and extend life.
Mon Mar 5, 2007 4:06 PM GMT
By Jeremy Clarke
NAIROBI (Reuters) - AIDS patients line up at dawn outside a small medical center in one of Kenya's teeming slums.
Dr Ivy Mwangi has 1,800 HIV sufferers on her books, but as the winding queue outside steadily grows, her thoughts are on a court case more than 5,000 km (3,000 miles) away in India.
The proceedings pit Swiss pharmaceutical giant Novartis AG against an Indian patent system that it says stifles innovation.
Mwangi fears it could end up costing many, many lives.
"Even with innovation and the development of new drugs, if this case goes through they won't be available to millions who need HIV treatment in the developing world," she said.
At first glance, the link is obscure. Novartis doesn't actually make AIDS medicines. The drug under discussion in a Chennai courtroom, Glivec, is a treatment for rare cancers.
But the trial has become a flashpoint in a long-running battle between "big pharma" and humanitarian campaigners who argue manufacturers are putting patents ahead of patients.
The AIDS virus infects around 40 million people globally, two-thirds of them in sub-Saharan Africa. Most, like Mwangi's patients in Mathare slum, scrape a living in abject poverty.
CHEAP INDIAN SUPPLIES
Health campaigners fear stronger patent laws enacted by India in 2005 -- which Novartis is trying to shore up in the case of Glivec -- will jeopardize India's role as a source of cheap generic medicines for the most needy.
Medical aid agency Medecins Sans Frontieres estimates over half of AIDS drugs used in poor countries come from India. If Novartis wins its case, more medicines will end up being patented, making it very difficult for Indian firms to manufacture cheap copies, it says.
Stung by criticism from campaign groups, Novartis insists tighter intellectual property laws will, in fact, ensure future investment in new medicines by rewarding research.
"I'm convinced -- and I'm a scientist -- that patents save lives, because without patents you cannot discover and develop new drugs and get them to patients," Paul Herrling, Novartis head of corporate research, said in an interview in London.
The company points out that safeguards already exist in international trade agreements. These protect access to essential medicines by allowing for the export of drugs which are produced under compulsory licenses, issued for public health reasons.
Many companies also run access programs, which offer affordable brand-name equivalents to cheap generics.
SOUTH AFRICAN CASE
Still, the row has uncomfortable reverberations for the global drugs industry, which is often accused of not doing enough the improve the health of the world's poorest people.
Five years ago, 39 companies, including Novartis, took the South African government to court in an effort to defeat new legislation in that country designed to bring down drug prices.
That episode ended in a humiliating climbdown and a public relations bloody nose that industry does not want to repeat.
This time, Novartis insists the situation is different.
Herrling said Novartis simply wants patent protection in markets where patients are able to pay -- including India's newly rich middle classes -- and will still make Glivec available for free to the poor in India.
Glivec has already been granted a patent in nearly 40 other countries, including China, he noted.
But Mwangi, speaking to Reuters as security guards ushered children and mothers carrying babies through the gates into her Blue House clinic, fears industry's promised safeguards fall dismally short.
At the moment, all her hundreds of patients infected with the HIV virus are treated with generic medicines made in India.
"The access programs and safeguards in place don't allow anywhere near the number of drugs we need right now," she said.
Seven years ago, Mwangi said, anti-retroviral drugs for AIDS victims cost about $10,000 per person per year. With the availability of generics, that has now fallen to around $70.
"Anything that's going to stop any kind of access is a serious problem," she said. "The only reason we reach tens of thousands in this region with these life-saving drugs is because of the availability of generics coming straight out of India."
As pressure has grown on Novartis, Archbishop Desmond Tutu added his signature last month to a global petition of some 300,000 names calling on the Swiss drugmaker to drop its case.
Others calling on Novartis to change tack include former Swiss president Ruth Dreifuss; Stephen Lewis, former UN special envoy for HIV/AIDS in Africa; and Michel Kazatchkine, new head of Global Fund to fight AIDS, Tuberculosis and Malaria.
Wed Mar 7, 2007 6:46 PM GMT
By Will Dunham
WASHINGTON (Reuters) - Circumcision helps protect men from getting the AIDS virus but may make an already-infected man more likely to infect a woman if he does not let his penis heal completely, researchers said on Tuesday.
Researchers working in Uganda released early findings from a study of 997 HIV-infected men. It indicated that women who had sex with a man who did not wait to heal fully after circumcision seemed to have a higher risk of infection than through sex with an uncircumcised infected man.
Intercourse might cause tiny tears in the surgical wound, which in turn could put HIV-infected blood into the woman's vagina, the researchers speculated.
They found no apparent increased risk for female sex partners of infected men who waited until a doctor certified that the wound had completely healed.
"We thoroughly agree that this should not be used to discredit the incredible value of male circumcision for the prevention of HIV acquisition in men," Dr. Maria Wawer of Johns Hopkins University in Baltimore, who leads the study, told reporters.
Women make up the majority of HIV-infected people in Africa, where HIV largely is spread through heterosexual sex.
The wounds from circumcision take about four weeks to heal. The findings emphasized the importance for men to abstain from sex until fully healed, said Dr. Ron Gray of Johns Hopkins.
The study will be completed in two years. The preliminary findings were issued in Switzerland as U.N. health officials consider circumcision policy recommendations.
Public health leaders think circumcision may be a powerful way to reduce HIV infection in Africa, the continent hardest hit by AIDS. Three previous African studies showed circumcised men are 50 to 60 percent less likely to become infected with the human immunodeficiency virus.
Experts say the lower risk may be because cells on the inside of the foreskin, the part of the penis cut off in circumcision, are particularly susceptible to HIV infection. HIV also may survive better in the warm, damp environment beneath foreskin.
'PARADOXICAL SITUATION'
"The data shows a paradoxical situation," Dr. Kevin De Cock, director of the World Health Organization's Department of HIV/AIDS, said in a conference call with reporters.
De Cock said the new findings were preliminary, incomplete and statistically insignificant because of how few people were involved. He said when the study is completed, it might even show circumcision can protect a man's female sex partner.
The team at Johns Hopkins, the Rakai Health Sciences Program and Makerere University in Uganda said they viewed circumcision as important in AIDS prevention efforts.
The researchers tracked infection rates of 113 previously uninfected female partners of infected men. Of 12 women who had sex with infected men before the circumcision wound was fully healed, three became infected within six months.
Of 55 female partners of infected circumcised men who waited to resume sex until the wound healed, six became infected. That was similar to the infection rate of female partners of uncircumcised infected men -- four of 46.
Of the 39.5 million people worldwide infected with HIV, 24.7 million are in sub-Saharan Africa. About 25 million people have died from AIDS since it was first identified a quarter century ago.
Thu Mar 8, 2007 12:07 PM ET
NEW YORK (Reuters Health) - Cigarette smoking appears to be a risk factor for tuberculosis infection and tuberculosis disease, according to findings from a systematic review of the literature and pooled analysis of studies.
Dr. Kirk R. Smith, of the University of California, Berkeley, and colleagues searched eight databases for relevant articles on the topic and identified 24 that met their inclusion criteria.
Taken together, the data point to a marked increased the relative risk of TB infection and disease among current and former smokers compared with nonsmokers.
There did not appear to be an increased relative risk for death from TB in association with smoking in people with active tuberculosis, the researchers note.
"Tobacco control, which already is known to reduce the burden of a number of important diseases, including heart disease and lung cancer, seems to have an even bigger health benefit than was thought before," Smith said in an interview with Reuters Health.
"From the TB perspective, tobacco control can now be included as part of TB control programs, which have focused on treatment of active cases in most countries," he said.
"It is important to develop additional TB control strategies, however, since TB has been so difficult to manage in many parts of the world, is growing worldwide because of the HIV epidemic, and has evolved in some populations into drug-resistant forms," Smith added.
SOURCE: Archives of Internal Medicine, February 26, 2007.
Monday March 5, 6:25 PM
HONG KONG (Reuters) - Top virologists called on Monday for a greater effort in developing effective vaccines against a potential flu pandemic and warned that all contingency plans would be in vain without them.
While the H5N1 bird flu virus is widely seen as a likely candidate for the next pandemic, the experts cautioned the world against losing sight of other flu viruses.
Flu vaccines thus should be "broad-based" and protect against as many virus strains as possible, they said.
"If you solve the problem of vaccines, our pandemic preparedness planning will be much more realistic," Albert Osterhaus, virology professor at the Erasmus Medical Centre in Rotterdam, told Reuters.
"If we are not prepared in terms of antivirals and vaccines, millions of people are going to die," he said.
Viruses mutate all the time and any vaccine against a pandemic flu virus can only be designed after the disaster has occurred.
But the pharmaceutical industry is already designing "pre-pandemic H5N1 vaccines" in the hope they can offer some form of protection before a pandemic vaccine is ready, a process that can take up to six months.
Osterhaus, who is in Hong Kong for a medical conference, said more work needed to be done to shorten this process.
"We have to find a strategy where we can rapidly have a vaccine in two, three months (of a pandemic)," he said.
"In principle, we have the technology, but we don't have the capacity. To date, the world production of flu vaccine is 400 million doses, but we are over 6 billion people, and probably we have to shoot (inject) twice."
NEW PROJECTS
The threat of a pandemic has spurred new projects to make vaccines cheaper and more effective.
Osterhaus's laboratory is trying to design vaccines that use less antigen and more adjuvants.
Antigens are substances that stimulate the production of antibodies when they are introduced into the body, such as toxins, viruses and bacteria. But there simply would not be enough antigen in the event of any flu pandemic.
"We have to use less of the antigen in the vaccine so we can vaccinate more people. We need more antigen, more than 10 times more, so the key message is we need to go with adjuvants," said Osterhaus.
Adjuvants are additives that enhance the effect of drugs or vaccines.
"We are testing different adjuvant systems, to see which is the best, gives the broadest, longest-lasting protection, and with the least amount of antigen," Osterhaus said.
The search for a viable pandemic vaccine is also brewing in the laboratory of leading HIV/AIDS drug scientist David Ho.
Using DNA technology, Ho has constructed a broad-spectrum vaccine, which he hopes would be effective against various strains of H5N1. Initial tests on mice showed the vaccine was effective against the H5N1 strain in Vietnam.
"These results are still some time away from getting into human testing. This is a very slow process," cautioned Ho, who is in Hong Kong to attend another medical conference organised by Massachusetts General Hospital, University of Hong Kong and the Nature publishing group.
Both Ho and Osterhaus stressed the need to move away from using chicken eggs in the production of flu vaccines.
"In a pandemic, you need much more vaccine. But chickens only lay one egg a day. You can't order them to lay two or three a day," Osterhaus said.
BASEL, Switzerland, March 6 (Reuters) - Novartis AG's chief executive said on Tuesday the Swiss drugmaker did not want "popularity awards" and would continue with legal action over India's patent system.
Daniel Vasella said the company would stand up for what it thinks is right, despite criticism from campaigners and shareholders.
"We don't want popularity awards, we want to serve our patients and remain competitive," Vasella said at Novartis's annual general meeting, where he faced a barrage of questions from investors about the damage the case is doing to the company's image and people's access to cheap drugs.
Novartis is challenging an Indian law that blocks the patenting of minor improvements in known molecules, in a case that closed on Monday. A verdict is expected in about a month and can be appealed by either side to the Indian Supreme Court.
It is also challenging a January decision to reject its patent application in India for cancer drug Glivec, which was turned down because it was a new form of a known substance.
MEDICAL APARTHEID
Novartis says intellectual property laws are key to spurring investment in new medicines and it is important for India, as an emerging economic giant, to embrace the concept. India is a major source of cheap generic medicines.
"When we are convinced that something is right to do then we stand up for it," Vasella said, pointing out that India's rapidly growing middle class could afford to pay for patented drugs.
"There are two markets within one country," he said. "We are only concerned with protection of intellectual property in India."
French humanitarian agency Medecins Sans Frontieres says some 80 percent of the drugs it uses to help poor people come from India and the price of treatment, particularly for HIV, could rocket if Novartis is successful.
"If Novartis were to win this case it would probably strengthen the inequalities up to creating a medical apartheid," said MSF's Switzerland director Christian Captier.
A comprehensive update of the company's portfolio, published in its annual report late on Friday, showed a total of 11 experimental drugs in Phase II clinical trials dropped from development.
Those losses more than offset the entry of seven new commercially significant compounds into intermediate studies.
Andrew Baum, an industry analyst with Morgan Stanley, said on Sunday that the loss of the products -- which were still several years from getting to market -- had eroded potential revenues in 2013 by a net $1.3 billion (671 million pounds).
"Our pre-existing concerns over the strength of GSK's much hyped pipeline have grown following publication of the company's revised pipeline chart," he said in a note to clients.
"The net changes to our modelled pipeline estimates are consistent with at least a 2 (percent) to 3 percent downward risk to our current 2013 revenue estimates."
Notable losses among drugs that have been terminated include odiparcil for thrombosis, solabegron for diabetes and four separate cancer compounds.
Overall, Morgan Stanley said the risk-adjusted revenue estimate for the 11 discontinued products was $2.3 billion in 2013. That was offset by the emergence of seven experimental drugs with aggregate sales potential of $975 million in 2013.
New drugs moving into Phase II include treatments for rheumatoid arthritis, lung disease, diabetes, insomnia and HIV/AIDS.
Glaxo Chief Executive Jean-Pierre Garnier, who is due to retire in May 2008, has often boasted that the British-based company has the best pipeline in the pharmaceuticals industry.
But while investors agree that the line-up of new drug candidates is very large, there has been disappointment in the past six months that Glaxo has not made faster progress in launching products or getting drugs through advanced clinical trials.
Glaxo will face a key test of its new drug capability next week, when the U.S. Food and Drug Administration is due to deliver its verdict on the company's breast cancer pill Tykerb by March 13.
Tykerb, a rival to Roche Holding AG's <ROG.VX> and Genentech Inc 's Herceptin, is one of five new products that Glaxo hopes to launch in 2007.
The big question for investors is how long it will take for the new medicines to generate sales that can move the dial at Glaxo, which had annual revenues last year of 23.2 billion pounds ($45.3 billion).
By Ben Hirschler
LONDON, March 6 (Reuters) - The world risks becoming complacent in the fight against AIDS, the head of a global business organisation set up to fight the disease said on Tuesday.John Tedstrom, executive director of the Global Business Coalition (GBC) on HIV/AIDS, Tuberculosis and Malaria, fears recent progress in rolling out life-saving drugs has deflected attention from the fact infections are still spiralling upwards.
"There is danger in complacency. If we are complacent in what we have done and what we are doing, we risk being complicit in a growing tragedy in terms of lives lost," he said in an interview during a visit to London.
Tedstrom is concerned the global fight against the disease has started to plateau, with last year's international AIDS conference in Toronto marking a shift towards strategic management rather than emergency action.
"We are getting treatment out in Africa more than we did but I think we are watching the wrong metric," he said.
"We are seeing growth year on year (in drug treatment) but we are not watching the fact that the number of people in Africa who become HIV positive every day is still 10 times greater than the number of people who go on ARVs (anti-retrovirals)."
The AIDS virus infects around 40 million people worldwide, most of them in sub-Saharan Africa, according to UNAIDS, the U.N. programme on HIV/AIDS.
Businesses, particularly in Africa, are often on the front line in the battle and have a vested interest in tackling the virus, which typically hits individuals aged 15 to 45 years, who should be at their most economically productive.
Companies are also well placed to help, since prevention and treatment schemes are frequently most practical in the workplace. Mark Moody-Stuart, chairman of both the GBC and miner Anglo American Plc <AAL.L>, said more companies needed to recognise that action on AIDS was in their self-interest in all regions where HIV was spreading fast.
"There is hardly a major company on this planet that doesn't have IT service centres in India or China," he noted.
The GBC in January signed up its first Japanese member, Sumitomo Chemical Co Ltd <4005.T>, but Tedstrom wants a lot more firms in Japan and elsewhere to come on board.
"I'm not satisfied with having 230 member companies," he said. "We have to have many, many, many more companies engaged in taking care of their employees and their families and their communities."