FDA to Vow Fast Approval of AIDS Drugs
As far as ADVR is concerned, I believe Allen is correct.
We're still in the "waiting" mode and looking forward to our Gator Day.
South African children are infected with HIV
Andrew Meldrum in Pretoria
The Guardian, May 14, 2004
More than 700,000 South African children aged 14 years and younger are HIV-positive, according to figures reported yesterday.
A survey by the Human Sciences Research Council found that the Aids epidemic was as widespread among the country's young as in the population at large. An estimated 5.7 million of South Africa's 45 million people are infected with the virus, giving it the largest HIV-positive population in the world.
"These are shocking figures that highlight the urgent need to get effective treatment to our young people," said Rukia Cornelius, a spokeswoman for the Treatment Action Campaign (TAC). The survey is expected to add to pressure on the president, Thabo Mbeki, to improve efforts to prevent and treat the disease. Mr Mbeki's government has been widely criticised for reacting too slowly to the Aids crisis.
The survey found that 5.4% of two to 14-year-olds were HIV-positive, compared with 5.3% of the total population. Among two to nine-year-olds the infection rate was 6.7%.
The younger children are believed to have contracted HIV from their mothers, and the older through sexual abuse.
Olive Shisana, the study's chief researcher, told ThisDay newspaper the risk among children had been underestimated. "It appears that children run a much greater risk of contracting the disease than previously thought," she said.
The survey also showed that 3.3% of children between two and 18 had lost one or both parents to Aids. The UN estimates the disease has orphaned 660,000 South African children.
Black youngsters are the hardest hit, with almost half of those infected living in poverty, according to the report.
The infection rates are higher for children in "informal settlements", the term used for squatter camps on the outskirts of major cities.
It said many children were living in high-risk environments where they were threatened with sexual abuse at home, in schools and in their neighbourhoods. TAC, an organisation which lobbies for life-saving treatment for people with HIV, said transmission of the virus from mother to child could be drastically reduced with drug therapy.
"Two years ago we won a court case ordering the government to provide ARVs [anti-retroviral drugs] to pregnant mothers to reduce mother-to-child transmission and yet we still have this terrible rate," Ms Cornelius said.
Mr Mbeki's government began providing the drugs through a few state hospitals early this year. The provision of the treatments remains limited, although authorities say it is growing.
Speeding Up Approval Steps for AIDS Drugs
By LAWRENCE K. ALTMAN
May 17, 2004
WASHINGTON, May 16 — The Bush administration announced a significant shift in its AIDS policy on Sunday, expediting the approval process for generic and combination antiretroviral drugs so they can be purchased at lower prices and provided more efficiently and safely to millions of infected people in Africa and the Caribbean.
The expedited process is also designed to encourage manufacturers to create a single pill, consisting of two or three licensed antiretroviral drugs. The combination of these drugs in single, easy-to-dispense packages could help eliminate the confusing jumble of dosages that can hamper compliance with AIDS treatment, especially among the poor and illiterate.
The quicker process is intended to encourage manufacturers to produce the fixed-dose combinations to ease delivery of drugs in remote areas in severely affected countries and to make their use safer.
At the same time, the Food and Drug Administration will more rapidly review applications from foreign manufacturers to sell as generics in developing countries antiretroviral drugs patented in the United States. Such approved generic drugs will be eligible for purchase under the Bush administration's $15 billion AIDS relief program, largely for countries in Africa and the Caribbean.
Approval for some combinations and generics could take as little as two to six weeks, said Tommy G. Thompson, the secretary of health and human services. Such approvals usually take six months, he said.
Mr. Thompson announced the policy change at a news conference in Geneva, where delegates from the World Health Organization were gathering for the group's annual meeting, which begins Monday.
The Bush administration had been expected to be the target of heavy criticism at the weeklong meeting for its previous reluctance to approve inexpensive combinations of patented antiretroviral AIDS drugs. In the past, the United States insisted on more stringent criteria than the World Health Organization had already required for inexpensive generic copies of these drugs and for approving fixed-dose combinations of them.
Advocacy groups for AIDS patients had accused the Bush administration of bowing to pressure from the American pharmaceutical industry by delaying approval of less costly generic copies to promote the sales of the more expensive, patented original drugs. The policy change announced Sunday could blunt much of that criticism.
At the news conference, Mr. Thompson declined to estimate how long it would take for antiretroviral drugs to reach the people who need them once they had been approved.
It was unclear what specifically had contributed to the administration's change of policy, although the American pharmaceutical industry had clearly been briefed about it in advance. Some big drug companies quickly issued favorable responses.
International health officials also welcomed the announcement.
"It's a pretty radical change in U.S. policy, if applied," Dr. Peter Piot, the director of the United Nations AIDS program, said Sunday in a telephone interview from his office in Geneva.
"It will help AIDS treatment programs everywhere," Dr. Piot said.
Reducing the cost of antiretroviral drugs is only one step in stopping the AIDS epidemic. Other major issues include: distributing the drugs to areas that are accessible only on foot or by bicycle; the lack of testing centers; rudimentary health care systems in much of the developing world and inadequate medical staff.
From a public health perspective, Dr. Piot said, fixed-dose combinations should increase the availability of antiretroviral drugs in remote areas and be safer for patients. Taking one pill, or a small number of pills should increase patient compliance and help prevent the development of resistant strains of H.I.V., the virus that causes AIDS, he said.
Dr. Piot said he expected the new plan to increase competition among drug manufacturers by expanding the market for antiretroviral drugs.
"I'm very, very positive about it," he said.
The White House's global AIDS coordinator, Randal L. Tobias, said in Geneva that he hoped that drug manufacturers would start applying for approval under the new policy as soon as possible. Mr. Tobias is a former chairman and chief executive of the American pharmaceutical company,Eli Lilly.
A number of drug companies said they would work together to market a fixed-dose combination.
Merck, Bristol-Myers Squibb and Gilead Sciences said in a joint statement that they were in discussions to develop a one-pill combination of three antiretroviral drugs and are considering packaging certain products together.
The single pill would include two Gilead drugs — tenofovir disoproxil fumarate, which the company sells under the brand name Viread, and emtricitabine, which it sells under the brand name Emtriva — and a third drug, efavirenz. Bristol-Myers Squibb markets efavirenz under the brand name Sustiva in the United States, Canada and some European countries; Merck sells efavirenz as Stocrin elsewhere.
In March, Gilead filed regulatory applications in the United States and Europe for approval of a single tablet, fixed-dose combination of Viread and Emtriva.
In a separate announcement, two other big pharmaceutical companies, GlaxoSmithKline and Boehringer Ingelheim, said they had entered into discussions to assess the development of packaging antiretroviral drugs together for use in poor countries.
Companies must show that putting three medicines into one pill or package does not make them unsafe or less effective, the government said. Government officials said they would accept existing data from drug companies to support approval of currently licensed antiretroviral drugs instead of requiring data from new trials. Usually it takes three to four years to develop such information, Mr. Thompson and Mr. Tobias said.
In a signal to manufacturers about the government's new plan, the Food and Drug Administration said it would provide technical assistance to foreign companies not familiar with the agency's regulatory process.
Mr. Thompson said foreign manufacturers of generic antiretroviral drugs could receive approval for pills packaged together in two to six weeks and for pills combining three medicines in four to eight weeks.
Lester M. Crawford, the acting commissioner of the F.D.A., said that the agency was determining whether it could waive or reduce the $500,000 or more in fees companies pay when applying for approval of new drugs.
Fiona Fleck contributed reporting from Geneva for this article.
IMO If ADVR can prove that 118 can reverse wasting
with minimal side effects than the big drug companies could
get more interested as they could see 118 as making their
drug more effective in combo with 118. Thus their approval
time can be shortened and ADVR will benefit too.
Advr has taken so long though even for biotech.
I hope they have a plan and a interested partner[s]
when this trial phase is finally over.
you know that in todays post bristol, merk and gilead together are going
to supply an aids drug to be purchased daily so it is less expensive and
that it will help the aids patients...
amazing advr was ahead of its time and now they are in the ass end of a lot of their field... they truly could have been a winner...