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Monday
18th October 2004

Global AIDS trial denied patients as US balks at generic drug use    Progress Toward ARV Access in Peru Slower than Expected

Global AIDS trial denied patients as US balks at generic drug use

ERIKA CHECK

Tests of antiretrovirals stalled.

[WASHINGTON] US opposition to generic AIDS drugs is unnecessarily delaying the progress of a major international clinical trial, critics say.

The $120-million trial, which is known as Strategies for Management of Anti-Retroviral Therapy, or SMART, is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID). It aims to enroll 6,000 patients to answer several questions about antiretroviral treatments for HIV, including whether they should be used early and aggressively, or whether treatment should only commence once a patient's immune system begins to fail. But the trial is running behind schedule because NIAID has balked at enrolling patients who take generic versions of the antiretroviral drugs.

According to trial organizers in the United States and elsewhere, patients in Argentina, Brazil and Peru were expected to join the trial earlier this year. But leaders of AIDS trials in South America and Thailand say they were told this summer that their patients would not be able to take part in SMART, because these people are all taking generic versions of brand-name AIDS medicines and those versions have not been approved by the US Food and Drug Administration (FDA). They say the instruction was handed down by the institute, which is part of the US health department's National Institutes of Health (NIH).

Written complaint
"We are told that, in SMART, no drugs not approved by FDA must be used," wrote Bernard Hirschel, leader of an AIDS trial covering Switzerland, Thailand and Australia, in an e-mail sent to colleagues earlier this month. A copy of his e-mail was given to Nature by a third party last week.

The Bush administration said earlier this year that it would not allow recipients of aid under the US President's Emergency Plan for AIDS Relief to buy generic drugs with aid money until they are approved by the FDA. But the NIH is not buying drugs for any patients in the SMART trial. Anthony Fauci, head of NIAID, says it is concerned about generic drugs only because they lack approval.

"NIH funded clinical trials in the developing world must meet the same standards as clinical trials conducted in the developed world, e.g. that the drugs being used are safe and meet accepted standards," Fauci wrote in a 16 September e-mail, in response to Hirschel's concerns.

But activists are sceptical about that statement. "My sense is that what is driving this is a desire to protect the brand-name companies' market share," says Gregg Gonsalves, head of treatment and prevention advocacy at Gay Men's Health Crisis in New York.

Fauci told Nature on 23 September that the NIH had no blanket policy to exclude generic drugs from its international trials. He said the agency would evaluate countries on an individual basis.

"If a country has data that the drugs they're using appear to be comparable to the drugs in other countries, and they want to enroll in this trial, we see no reason why they have to switch to FDA-approved drugs," Fauci said. But he would not say whether any of the countries trying to get into the SMART trial would meet this standard.

Negotiations stalled
Meanwhile, the delays have kept hundreds of patients from joining SMART. Brazil, Argentina and Peru are waiting for NIAID to sign a contract confirming their participation, but that step has repeatedly been delayed, say researchers. The issue has also stalled negotiations with another important potential participant — Thailand.

The delays have implications for AIDS care around the world. SMART was expected to enroll 2,264 patients this year; but has so far enrolled only 792. The South American and Thai arms of the trial would add 733 patients to the total for this year.

"Peru, Brazil and Argentina are in a holding pattern, and Thailand isn't even there because it got held up before it got started," says Fred Gordin, an infectious-diseases specialist at the Veterans Affairs Medical Center in Washington DC and head of the group that has been funded by NIAID to run the SMART trial. "We really need these countries on board," he says.

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Progress Toward ARV Access in Peru Slower than Expected
by Richard Stern* (Lima, Peru)
Crossposted from HealthGAP
*****

Although 700 Peruvians Living with AIDS (PLWA) have begun to receive anti-retroviral therapy this year, the number falls far short of the 5,000 that had been agreed upon by the Health Ministry and the Global Fund.

The original goal for ARV access for 2004 had been decided upon by combining funds from a $23,000,000 Global Fund grant with additional resources provided by the Peruvian Health Ministry. Medications purchased by the Global Fund have arrived in the country but are not yet being disbursed. The 700 people who do receive treatment are seen at five major public hospitals in Lima but three of these five hospitals are now "saturated" and cannot accept additional patients. Peru's Global Fund grant was approved in February of 2003.

Medications to begin treatment for up to 2,000 more PLWA are already in the country, but disbursement has been delayed by cumbersome bureaucratic procedures.

For example, Health Department rules do not permit physicians who are not specialists in infectology to treat PLWA, even if these physicians are already aware of treatment procedures.

In other situations, PLWA in rural areas must wait for CD4 tests to be sent to Lima, a process which takes four to six weeks. Until CD4 test results are received, PLWA must continue to wait for ARVs, even if they are gravely ill. Medications for opportunistic infections are not provided by the Health Ministry.

No one I have spoken to in Lima was aware of the WHO Treatment Guidelines for Resource Poor Countries, which indicate clearly that treatment can begin even without CD4 testing, if the patient is a HIV+ and there is clear development of opportunistic infections.

Both the Health Ministry and the Global Fund are purchasing a combination of generic and originator drugs.
However, the Health Ministry has begun treatment with only one cocktail, Combivir and Nevirapine, and there are no second line drugs available at the moment. Second line drugs will come from the Global Fund stock of medications currently in storage. About 50 PLWA from the "Dos de Mayo" Hospital who could not tolerate the first line cocktail, have been without treatment for periods ranging from several weeks to several months. Some have died.

In the rural city of Chimbote (population 300,000), 500 people are awaiting treatment and anti-retroviral medications have arrived at the Clinic there, but no one is receiving treatment because there is no physician in Chimbote who has been certified by the Health Ministry to prescribe ARVs.

According to AIDS activist Guillermo Murillo, who has just returned from Peru, "it is particularly tragic when medications are in-country, but people are still dying because they cannot access them. Bureaucratic obstacles should be quickly overcome in order to save lives. Why isn't PAHO (the Pan American Health Organization) speaking out on this issue? Why are Peruvian health care authorities unaware of WHO Guidelines for scaling up in resource poor settings? Why are treatment interruptions not being addressed?"

The UNAIDS representative for Peru was transferred out two years ago, and during the past two years Peru has not had a UNAIDS Country Program Advisor. In fact, neither UNAIDS nor PAHO has a single staff member assigned to work full time on issues related to AIDS in Peru, in spite of their well publicized commitments related to the "3 x 5" program in Latin America.

Sources indicated that the Health Ministry will soon begin to distribute ARVs to four Clinics in Lima which are managed by Non-Governmental Organizations, allowing scaling up to progress more rapidly. According to Dr. Virginia Baffigo of CARE, the Principal Recipient for the Global Fund project in Peru, it is hoped an additional 800 people will be placed on treatment by the end of the 2004.

In Peru, there is also a semi-private National Health Insurance program called "ESSALUD" which is providing AIDS treatment to about 1,500 people, but only 20 percent of the country's population is enrolled in this program. Self-employed people, street vendors, domestic employees, and, in general, most of the poorest people in the country are cared for by the Health Ministry and are ineligible for services provided by ESSALUD.

Peru's population is 28,000,000 and the HIV incidence is estimated to be just under 1%.

*Richard Stern
Director
Agua Buena Human Rights Association
San Jose, Costa Rica
506-234-2411
rastern@racsa.co.cr
http://www.aguabuena.org/

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