Posted 10:18 PM by Dr. Kay

India to conduct clinical trials for HIV vaccine

By Gargi Parsai

New Delhi Oct. 11. India is preparing to go in for Phase-I clinical trials in March next year for a preventive HIV vaccine developed by a scientist of the National Institute of Cholera and Enteric Diseases (NICED), Kolkata, in collaboration with a U.S.-based biotechnology company.

With this, India would join the global effort in finding a vaccine that would prevent healthy, unaffected people from being infected with HIV. Trials are on in parts of the world with no breakthrough yet. India is estimated to have about four million people afflicted with HIV at the end of 2002.

The Phase-I trial, involving administration of the MVA (Modified Vaccinia Ankara) HIV-1 subtype C vaccine for the first time to humans in India would be conducted with 13 healthy volunteers in the age group of 18-50 to determine the efficacy of the vaccine. It would be conducted at the National AIDS Research Institute (NARI) Pune, under a tripartite agreement between the National AIDS Control Organisation (NACO), the Indian Council of Medical Research (ICMR) and the International AIDS Vaccine Initiative (IAVI). Other areas would later be Chennai and the north east.

The Union Government would control the use of the vaccine if and when developed. Three vaccine manufacturers have been shortlisted, though the Phase-I trial vaccine has been manufactured by Therion. About Rs. 17 crores has been invested by ICMR so far. IAVI is looking at an investment of $100 million till the marketing of a vaccine.

The Phase-I would determine the safety, immunogenicity (ability to induce strong immune responses in the person to fight HIV) of the intramuscular vaccine, preliminary dose requirement and schedules for immunisation. This phase is expected to last two years.

Participating in a media workshop here on Friday, the Director-General of ICMR, N.K. Ganguli, and NACO experts expressed the confidence that the ethical and regulatory clearances on safety and toxicology and pre-clinical studies will come before March.

There was no clarity, however, on the norm that a vaccine developed in another country — in this case the U.S. — should first undergo Phase-I clinical trial in the country of origin.

Although the India-specific vaccine has been developed with the involvement of the scientist, Shekhar Chakravorty, of NICED and the U.S. Biotech Company, Therion Biologic Corporation in the U.S., there has been no Phase I clinical trials with this vaccine in that country.

According to Mark Chataway of the IAVI, all HIV laboratory research in vaccine development has to be uniform for global acceptability, though bound by the regulatory requirements of each country.

He hoped the Drugs Controller of India would accept the validity of the ongoing preclinical and toxicology studies on animals (mice) under way at the Therion Corporation.

The current status of the trial in India is that a new vaccine trial centre and immunology dedicated laboratory and staff is being set up at NARI. Efforts are on to enrol volunteers who are likely to be from groups of high-risk sex workers, truck drivers, health care workers and adolescents. The scientists said there would be sufficient safeguards for the volunteers to cover risks.

Posted 1:42 AM by Dr. Kay

SARS case confirmed

By P. S. Suryanarayana

SINGAPORE Sept. 9. In the first case of the Severe Acute Respiratory Syndrome (SARS) in recent months worldwide, a 27-year-old Chinese-Singaporean was today diagnosed to have been infected with the virus after a repeat test was found positive. The World Health Organisation, which was duly notified, said that the current case ``does not fulfil the case definition for SARS as per the new WHO guideline in the post-outbreak period'', the Ministry noted.

Posted 6:11 AM by Dr. Kay

AIDS and the public health challenge

SOUTH AFRICA HAS taken a historic decision to begin treatment in public hospitals of the five million citizens who are infected with HIV. Now that the country with the world's largest HIV population has decided to provide medical care for the affected, can there be hope that India, which has the world's second largest population infected with the virus, will follow in the leader's footsteps? AIDS treatment in the form of active retroviral therapy (ART) offers no cure for the disease. Prevention is the only way to contain the spread of the virus that causes AIDS. India is doing poorly in prevention, with the recent estimates by the National AIDS Control Organisation showing a 15 per cent increase in just one year in the number of new infections. Much more has to be done in the area of prevention. However, society also has a responsibility to care for those infected with HIV. ART provides the infected with an opportunity to lead a normal life, delays the onset of full-blown AIDS, and reduces the transmission of HIV, especially by infected mothers. The only AIDS care now available in India is in private hospitals. The irony is that while Indian pharmaceutical companies caused an upheaval in the global market by offering anti-AIDS generic drugs at just 3.5 per cent of global prices ($350 versus $10,000 for a year), the Government has refused to take advantage of the achievements of Indian industry.

Three kinds of arguments are advanced against the provision of ART through public health programmes. None of them can stand critical scrutiny. One argument is that AIDS care requires adherence to a difficult regimen of intake of toxic drugs and this is not possible in a poor country. The best answer to this objection is provided by the success story of Brazil. In the mid-1990s, this developing country put in place a universal, free AIDS care programme, backed by community programmes that monitored drug consumption. The result has been extremely good standards of adherence, which have led to a stabilisation of the HIV/AIDS population at half a million, a dramatic reduction in AIDS-related deaths, and a control of transmissions. A second argument is that a poor country cannot afford universal care. ART is expensive and the cost of drugs, testing and monitoring can go up to Rs. 35,000 a year for a patient. The answer to this is that at any point only 20 to 30 per cent of the infected need treatment. This means that universal care in India would not cost more than Rs. 4,000 crores a year. This is equivalent to 0.5 per cent of annual GDP and is by no means unaffordable. The third argument against State-provided care is that AIDS is not the only public health priority in India. The number of Indians suffering from and not receiving treatment for tuberculosis, malaria and diabetes is many times the number affected by HIV/AIDS. These populations cannot be ignored.

AIDS cannot be the only illness receiving close attention, but the absence of a cure makes it a unique kind of challenge today. What is required is public health action of a kind that has been lacking: Government provision of medical services that care for Indians suffering from all the major illnesses. The Government of South Africa has decided to provide medical care for its HIV population after maintaining for years that ART would not make a difference. The Government of India has been involved in denial of a different kind; it has simply refused to acknowledge that it is confronted with a major public health crisis. This cannot continue any longer.

Posted 1:55 PM by Dr. Kay

WHO Predicts World Will Be Free of Human SARS Cases in a Few Weeks

BANGKOK (Reuters) Jun 27 - The World Health Organization said Friday the world population should be SARS-free within the next two to three weeks, but warned the disease could emerge from animal reservoirs in China again next winter.

David Heymann, director of the WHO's communicable diseases division, told Reuters he expected Taiwan and Toronto--the only two areas still regarded as zones where the disease could be transmitted--to be given a clean bill of health by the first week of July.

"It appears we've had the peak of the epidemic in all countries," Heymann said in an interview ahead of a meeting of Asia Pacific health ministers in Bangkok Saturday.

"All countries are probably now going to be SARS-free within the next two to three weeks. SARS will be gone, we believe, from human populations."

Severe acute respiratory syndrome (SARS), which is believed to have jumped from animals to humans in southern China late last year, has killed more than 800 people worldwide, infected some 8500, trimmed economic growth forecasts and cost billions of dollars in lost business.

Hong Kong and China, which were the most severely affected, were given the all-clear by WHO this month and Taiwan and Toronto, Canada, are expected to follow soon.

"If these two countries have no reintroduction or no new cases then by the first week of July all countries should be off the list and therefore we can say that transmission has been interrupted in human populations," Heymann said.

He said the WHO was still clarifying with the Taiwanese government when health officials there had isolated their most recent case.

Countries are removed from the WHO's list of areas of SARS transmission when they have gone for 20 consecutive days without reporting a new case, twice the time it takes for the disease to develop in humans.

The WHO says that Taiwan's last SARS patient was isolated on June 15. "This is the period of the greatest danger as was shown in Canada, which exited the list of affected countries and then had another peak. The word now is vigilance," Heymann said.

He however said there was a risk the disease could once again be transmitted to human populations from animals in southern China in November or December of this year and that China's efforts at future prevention would be a major focus of attention at the weekend heath minister's meeting in Bangkok.

"The one thing we don't know is whether it will be cyclical, whether it will occur seasonally," Heymann said.

Posted 9:36 PM by Dr. Kay

'Taiwan free from SARS'

By Our Diplomatic Correspondent

NEW DELHI JULY 9. The seven-year-old Taipei Economic and Cultural Centre (TECC), New Delhi, held its first-ever press conference today to announce that Taiwan was free from the Severe Acute Respiratory Syndrome (SARS). The invitation mentioned that this was the first press conference of its kind that the TECC was organising. K.T. Chen, TECC Representative in New Delhi, who met the press at his office, read out a statement but added that he was not prepared to answer questions.

India and Taiwan have maintained low-key, non-Government contacts and the TECC opened in 1995. A similar Indian entity began functioning in Taipei as well. There are obvious sensitivities involved, with India holding steadfast to its "one China'' policy.

"The Indian side recalled that India was among the first countries to recognise that there is one China and its `one China' policy remains unaltered. The Chinese side expressed its appreciation of the Indian position,'' the recent joint declaration issued by the Chinese and Indian Prime Ministers in Beijing said.

Mr. Chen said the World Health Organisation (WHO) formally removed Taiwan from its list of areas with local transmission of SARS while the travel advisory against the island was lifted on June 17.

Declaring that Taiwan was a "safe and healthy'' place to visit, he said the island stood ready to welcome friends from abroad for business and pleasure. Mr. Chen, however, used his statement to pitch for Taiwan's association with the WHO. "The outbreak and spread of SARS, which had brought illness, death and economic peril to Asia and the rest of the world, has also drawn attention to Taiwan's exclusion from the WHO.'' ``The time has come for the members of WHO to acknowledge that the exclusion of Taiwan's membership or even observer status in the organisation is unjustified, and that this exclusion creates a gap in the global defence against diseases...'' According to Mr. Chen, it was, therefore, "imperative'' that the WHO invites Taiwan to participate, as an observer, in achieving the comprehensive objectives of the organisation.

Twins die on operation table

SINGAPORE July 8. The brave new surgery that an international team of medical professionals carried out in Singapore to separate two adult conjoined twins ended in failure today, as both women died, one after the other, during the marathon operation itself.

The shared wish of the Iranian twins was to become ``separated in all circumstances'' and, in a tragic twist, they died due to heavy loss of blood that followed a clinically "successful'' separation surgery, it was announced here.

The high-risk operation, first of its kind in the world as regards an attempt to separate grown-up twins joined at their heads, began on Sunday morning after a long period of careful assessments of the surgical possibilities and preparations, including counselling of the generally-cheerful twins themselves.

As the surgery proceeded, the doctors reported cautious optimism before they felt inclined to consider suspending the operation in the context of some complications late on Monday.

However, the complex operation was not halted in deference to the stated pre-surgery wishes of the twins to become separated and lead independent lives.

They had reportedly agreed to take the massive risks involved in the unprecedented surgery.

With a suspension of the surgery ruled out, it finally ended by late afternoon today.

Posted 9:29 PM by Dr. Kay

SARS contained, says WHO

Geneva: The World Health Organisation on Saturday said the pneumonia-like illness SARS had been contained worldwide after it declared Taiwan, the last country on its watch list, free of new infections. But it warned the world was not SARS-free and continued vigilance was needed. ``Today the World Health Organisation is removing Taiwan ... from the list of areas with recent local transmission of Severe Acute Respiratory Syndrome (SARS),'' the United Nations agency said in a statement. ``Taiwan is the last area to be removed from the list. It has been 20 days, or two consecutive 10-day incubation periods, since the last case on June 15. ``Based on country surveillance reports, the human chains of SARS virus transmission appear to have been broken everywhere in the world.'' (In the picture, Taiwanese are seen celebrating the WHO's announcement in Taipei on Saturday.)

— AFP

Continue alert against SARS, says WHO

By Our Special Correspondent

NEW DELHI July 5. Even as the SARS scare has become a thing of the past, a meeting of experts convened by the World Health Organisation has emphasised the need to continue the alert against the disease to prevent it from returning.

The three-day consultation, organised by the organistaion's Southeast Asia Regional Office, called for strengthening the mechanism for the surveillance of SARS and other atypical pneumonia and improve upon the facilities for the treatment of such highly infectious diseases.

Besides, the experts underlined the importance of health authorities being `pro-active' in sharing information with the media not only when such an epidemic occurred but also in normal times to ensure a rapid dissemination of correct information for public awareness.

Apart from experts from the 10 countries which were covered by WHO's SEARO, the meeting was attended by specialists from WHO headquarters.

Posted 11:05 AM by Dr. Kay

China SARS case sparks WHO concern

Beijing June 25 . A day after being declared SARS-free, China today reported a new case of Severe Acute Respiratory Syndrome in Guangdong province, sparking concern from the World Health Orgaisation.

One death was also recorded, in Beijing, the Health Ministry said.

``This does not affect our decision and the emergence of another case stays within our guidelines,'' a WHO spokesman, Bob Dietz, said.

``We are concerned, but our concern would be greater if this was a new emerging case and not a case that has developed from an already identified suspected case.

``We know there are people suspected of having SARS, a person not diagnosed as suspected who emerges as a probable case would be a matter of greater concern.

``We do not want to see SARS re-emerge in the general public at large.''

The WHO yesterday lifted its travel advisory against Beijing, the world's most SARS-hit city, and pronounced the country free from the chain of local transmission.

Celebrations

Earlier, with flying confetti and clanging gongs, Beijing celebrated the lifting of the World Health Organization's SARS travel warning over the city, reopened discos and Internet cafes and sought to resuscitate its battered tourism industry.

Banner headlines in Chinese newspapers cheered WHO's yesterday's announcement giving a clean bill of health to the capital of the nation where the outbreak began and lifting the last remaining SARS warning anywhere in the world.

``Our wish is finally fulfilled, we smile again,'' the popular Beijing Youth Daily said above a photograph of city residents posing in front of a banner reading, ``We win!''

``Beijing returns to normal,'' the China Youth Daily said on its front page.

Beijing was simultaneously removed from a WHO list of places with recent local transmissions of the disease — a move recognising the passage of more than 20 days since the last SARS case was isolated.

City travel bureau officials and representatives of tour agencies rallied at the Beijing Exhibition Hall to relaunch the city's tourism industry. Hotels, tour agencies and transportation companies are reported to have suffered 16 billion yuan ($1.9 billions) losses during the outbreak. An estimated 10 million fewer visitors came to the city during the first half of the year due to domestic travel restrictions and foreigners heeding the April 23 WHO advisory, which urged people to delay any non-urgent trips.

``We've taken the opportunity of this suspension to move the Beijing travel industry up a step,'' said Ding Changjiang, director of the Beijing Travel Bureau. — AP/AFP