Canada Drops the Ball on its HIV/AIDS Assistance Commitments

Ottawa's Cheshire cat grin to the global AIDS pandemic will vanish in September when the last, small shipment of drugs produced under Canada's Access to Medicines Regime leaves the country for Rwanda.

Virtually no one outside the federal government expects there will be more – a gloomy backdrop to the indictments of the world's wealthiest nations at this week's international AIDS conference in Cape Town, South Africa, for a chain of broken promises on helping poorer countries to obtain life-saving treatment.

In the five years that the Canadian legislation, CAMR – initially dubbed the Jean Chrétien Pledge to Africa Act – has been in place, only one allotment of low-cost medicine has been arranged: for 21,000 Rwandans for one year. The first shipment went last year; the last lot will go at the summer's end.

The consensus among AIDS activists and generic drug manufacturers is that CAMR is so overwhelmingly flawed and cumbersome that no developing country will use it again to apply for assistance, and no generic pharmaceutical company will use it to manufacture anti-retroviral drugs.

“We're still where we were five or six years ago, and the system needs to get fixed,” said Elie Betito, director of public and government affairs for Apotex Inc. in Toronto, which made the Rwandan anti-retroviral product at cost after long and expensive legal negotiations with three pharmaceutical companies holding patents on components of the medication.

“But I don't think this government wants to change [CAMR], because it's not their legislation,” he added. It was introduced by a Liberal government, although passed unanimously by Parliament.

Apotex, one of the world's largest generic drug manufacturers, has said its one and only experience working under CAMR was so bad that it won't seek a new licensing agreement using the legislation, although it's ready to produce a desperately needed pediatric formulation that it says would both meet high Canadian standards and be globally cost competitive.

The CAMR legislation was designed to allow generic pharmaceutical companies to produce and export affordable drugs that are under patent to developing countries facing public health emergencies.

But it requires countries on an approved list to go through a mountain of red tape to apply for assistance and tender for manufacturers, and generic manufacturers to negotiate new licensing agreements with patent holders on each contract and with each country.

Thus, if Apotex was to have won a contract from Rwanda for another year of supplying drugs to the same 21,000 patients, it would have had to go through the same negotiations as before with the patent holders.

“You're looking at 65-page contracts,” Mr. Betito said.

Tony Clement, while national health minister in 2006, told the international AIDS conference, held that year in Toronto, that the legislation was flawed. But since becoming Minister of Industry – with responsibility for the legislation – in 2008, he has not given any intention of amending it.

A government review concluded in 2007 that it would be premature to change the legislation. The patent-holding pharmaceutical manufacturers have said there's nothing wrong with the legislation as it stands, and have lobbied strenuously against changes.

A Senate bill being shepherded by Manitoba Liberal Senator Sharon Carstairs and a House of Commons private member's bill introduced by Manitoba New Democrat Judy Wasylycia-Leis would require only a single licence.

Apotex would prefer the government take over the whole process and simply hand compulsory licences to generic manufacturers.

Laura Esmail, a University of Toronto doctoral candidate in pharmacy whose academic research is on CAMR and affordable AIDS drugs, said the one-licence proposal would allow Canadian companies, such as Apotex, to develop affordable global drugs using economies of scale.

She also said developing countries find themselves pressured by international corporations and other governments not to apply for drugs under legislation such as CAMR, and they need wealthy countries like Canada to make it easier for them to do so.

Michael Valpy
Globe and Mail

AIDS Treatment as a form of Prevention

A lot of people thought Julio Montaner was a little crazy when he first suggested that the best way to eliminate the AIDS epidemic would be a massive scheme to give AIDS medicine to every infected person.

What about the huge financial cost? What about the moral issues, the human-rights issues, the overwhelming number of tests and drugs that would be required? Wouldn't it undermine years of lecturing on monogamy and abstinence? Wouldn't it promote "condom-free sex," as some critics said?

Faced with a host of objections, the Canadian scientist was a lone voice in the wilderness for the past three years, unable to win support from the global AIDS establishment.

But this year, Dr. Montaner's solitary crusade - the controversial notion of "treatment as prevention" - has suddenly become one of the hottest issues in AIDS science. And yesterday, at the International AIDS Society conference in Cape Town, his once-ridiculed idea was endorsed by experts from around the world.

Among the latest support for his proposal is a model by World Health Organization researchers that predicts a 95-per-cent reduction in new HIV cases within 10 years if his idea is adopted.

The proposed new strategy - universal voluntary testing for HIV, combined with immediate anti-retroviral drug treatment for those who have the virus, even in its earliest stages - could save more than seven million lives by 2050, the model says.

The WHO, which had resisted the treatment-as-prevention concept for years, is now organizing a special conference this November to discuss the "feasibility and acceptability" of the concept.

"Treatment as prevention is the topic of the year," Swiss scientist Bernard Hirschel told the AIDS conference yesterday.

"I think Julio deserves a lot of credit for this. Is treatment going to be the answer? We don't know, but we'd better find out."

Dr. Montaner, president of the International AIDS Society and director of the B.C. Centre for Excellence in HIV/AIDS, has been a prominent scientific researcher on AIDS since 1981, before the virus was even identified. A pioneer in the use of anti-retrovirals and other AIDS drugs, he has been campaigning for the treatment-as-prevention strategy since 2006.

Willy Rozenbaum, one of the early discoverers of the AIDS virus and now the president of France's National AIDS Council, was another scientist who lent his support to Dr. Montaner yesterday. Providing proper treatment to those who have the AIDS virus "sharply reduces the chances that they will transmit the virus," he told the conference.

Dr. Rozenbaum acknowledged that researchers must study whether the use of medical treatment as a prevention strategy would encourage "risky" behaviour by those who think that the AIDS virus has been virtually eliminated from their bodies. But medical treatment and condom use can coexist, he said.

In an interview, Dr. Rozenbaum said the notion of treatment as prevention is being resisted by many governments because they are afraid of the cost and reluctant to admit the failure of the traditional prescription of condoms and monogamy. "They've been promoting condoms as the answer for 20 years," he said.

After initial progress in reducing AIDS in the developed world, the condom strategy has failed to make further progress in recent years, he said. "I'm not happy with a plateau. We can't accept just a stabilization of the problem."

As for the short-term financial cost of a massive expansion in AIDS medicine, it would be outweighed by savings within five or 10 years as the transmission rate is swiftly reduced, he said.

The new WHO model of how this strategy could work, presented at the conference by WHO researcher Reuben Granich, says the treatment strategy would drive up costs at first, but "may provide cost savings" in the long run as it increasingly prevents new HIV cases.

Dr. Montaner conceded that some "recalcitrant" people with the AIDS virus will refuse to be tested or treated. His plan would not force them to be tested, but this would not weaken the strategy, he said.

"A person who is appropriately treated becomes dramatically less likely to transmit," he said. "The more you treat, the more you reduce the cases. ... When we first suggested this in 2006, people thought we were a little loony. But it's now fully accepted. We just need to get started."

The notion of treatment as prevention "creates a powerful new rationale" for the expanded use of anti-retrovirals and other AIDS drugs, he said. "We have transformed treatment from being merely a life-saving tool. Now it means we are protecting society, we are protecting our children."

The Harper government in Ottawa is still resisting the proposed new strategy, even as global experts are accepting it, Dr. Montaner said. When he suggested the strategy in a letter to the federal Health Minister, he received only a form letter in response. "It's been increasingly adopted around the world, but where is Canada on this?"

*****

The global AIDS battle

World health leaders are gathering in South Africa to discuss ways to fight the disease

PEOPLE WITH HIV/AIDS AROUND THE WORLD

PERCENTAGE OF WORLD TOTAL/ 2007

Latin America and the Caribbean/ 5.0%

High-income countries/ 5.4%

Eastern Europe and Central Asia/ 3.9%

Asia/ 21.4%

Africa/ 64.4%

The overwhelming majority of people with HIV/AIDS, 95%, live in the developing world.

MONEY AVAILABLE FOR GLOBAL AIDS FIGHT, IN BILLIONS $ US

'05/ $7.9

'06/ $8.8

'07/ $11.3

"08/ $13.8

THE GLOBE AND MAIL / SOURCE: UNAIDS, AVERT.ORG

Engineered antibodies fight AIDS virus

Researchers may have discovered a technique that will eventually lead to a way to vaccinate against the AIDS virus, by creating an artificial antibody carried into the body by a virus.

This synthetic immune system molecule protected monkeys against an animal version of HIV called SIV, the researchers reported in the journal Nature Medicine.

While it will be years before the concept could be tested in humans, it opens up the possibility of protecting people against the fatal and incurable virus.

"Six of nine immunized monkeys were protected against infection by the SIV challenge, and all nine were protected from AIDS," Philip Johnson of Children's Hospital of Philadelphia and colleagues wrote.

Several attempts to create a vaccine against the human immunodeficiency virus that causes AIDS have failed.

AIDS not only attacks the immune cells that usually defend against viruses, but it quickly hides out in an as-yet undiscovered "reservoir" so the immune system must be primed to capture virtually every single virus.

In addition, people do not usually make antibodies against the virus. Antibodies are immune system particles that latch on to invaders so killer cells can destroy them.

Johnson's team engineered an artificial piece of DNA that would make artificial antibodies, called antibody-like proteins or immunoadhesins. They made three different versions.

This stretch of DNA was spliced into a virus, called an adeno-associated virus or AAV, that infects people and monkeys with little effect.

PROTECTED MONKEYS

They injected the monkeys with their lab-engineered AAV, which started cranking out antibodies in the blood of the monkeys. Then they injected the monkeys with SIV.

One injection protected the monkeys -- six never became infected at all -- and the three that did never developed AIDS, the immune system destruction caused by HIV, they reported.

One of the three appeared to work better than the other two but more testing is needed. "To ultimately succeed, more and better molecules that work against HIV, including human monoclonal antibodies, will be needed," they wrote.

"As a concept, I think this is very promising," Dr. Peggy Johnston, head of the HIV Vaccine Research Branch at the National Institute of Allergy and Infectious Diseases, which helped pay for the study, said in a telephone interview.

She said the monkeys had an immune response to the AAV virus and the approach would have to be carefully tested to ensure it was safe. In addition, the monkeys were infected by injection and tests would be needed to show the vaccine protected against HIV acquired sexually.

"We need to make the genes as humanized as possible so that the human body doesn't react to that," she added.

"I don't see this going into humans for years."

Most AIDS experts agree the only hope of controlling the pandemic of HIV is to develop a vaccine. The virus has killed 25 million people since the early 1980s and infects 33 million people now.

Drugs can control infection but often are expensive, have side-effects and often stop working after a time, forcing patients to switch to new drugs.

© Copyright (c) Reuters

HIV Vaccine Ready for Human Tests

An HIV/AIDS vaccine developed in Canada has passed safety tests in animals and the researchers are awaiting approval to begin human trials in the U.S.

"It is a very important milestone for us," said Yong Kang, a professor of microbiology at the University of Western Ontario in London who has been working on the vaccine for 20 years.

Kang said he expects to get the go-ahead soon from the U.S. Food and Drug Administration to begin human toxicology tests and two phases of clinical trials in the United States.

If all three trials are successful, the vaccine should be available within the next decade, Kang told CBC News on the phone while attending a meeting in South Korea.

According to a 2008 United Nations report on the global AIDS epidemic, 33 million people were living with HIV in 2007. Two million people died of causes related to the disease that year.

Dozens of HIV vaccines have already been developed and tested in animal models, but few have been tested in humans, none successfully. A promising trial in 2007 by pharmaceutical giant Merck and Co. was shut down after those receiving the vaccine contracted HIV at a higher rate than those who received the placebo.

Kang has partnered with a Curacom, a South Korean holding company, that has agreed to open an office in London, Ont., to help fund research in Kang's lab and commercialize the vaccine.

A test vaccine is being manufactured in a lab in Maryland near Washington, D.C.

Lab tests showed the vaccine produced no adverse effects or safety risks during immunology tests on animals.

The toxicology tests are expected to include 40 to 50 HIV-positive volunteers in the U.S., and will be designed to test whether the vaccine is toxic in humans.

http://www.cbc.ca/health/story/2009/07/01/health-canadian-aids-hiv-vaccine-kang.html