Black Market Dispenses HIV Drugs and Risk

NAIROBI, Kenya — In a hardscrabble street in Nairobi, Kenya, the quickest way for an HIV-positive person to get antiretroviral drugs is to hang around on the sidewalk outside one of the neighborhood pubs and wait for a sidewalk hustler to strike up a conversation. On this particular day, the intermediary leads the way into a dark, shadowy backroom and introduces the prospective buyer to the man with the “sweets,” the code name for black-market ARV medications.

The seller pulls out a small container. “Nevirapine,” he explains, using the generic name for the brand-name antiretroviral drug Viramune. The price: 35 Kenyan shillings, the equivalent of 49 cents in U.S. money, per tablet — a princely sum in a country where more than half of the population has to live on less than $2 a day. He’s got a bottle of Viread, another brand-name ARV, as well. Those go for Ksh 45 per dose — about 63 American cents. Again, it’s not cheap, but for a Kenyan who wants to avoid the hefty medical bills and stigma that might result from going to an HIV/AIDS clinic for treatment, it seems like a bargain.

The specific drugs that are available will vary from visit to visit. Such haphazard self-medication, of course, will increase the risk that a user’s HIV infection will become drug-resistant, but black marketers don’t waste time with such nuances. Neither do they explain precisely where their supply of black-market ARVs comes from. But it’s impossible not to notice that the selection du jour happens to be the same brand-name ARVs dispensed in Kenyan clinics by the President’s Emergency Plan for AIDS Relief (PEPFAR), the Bush administration’s five-year, $15 billion effort to combat HIV/AIDS worldwide.

A source familiar with the ARV black market offers a likely explanation: Impoverished HIV/AIDS patients may be registering for treatment at more than one PEPFAR-supported clinic so they can receive duplicate doses of their medications. They then sell the extras and use the money to buy food.

In addition, those still suffering from the stigma that surrounds the disease are likely to continue feeding this illegal trade as they fear going to centers where they might be seen by people they know, said Timothy Onyango, who was diagnosed with the virus six years ago.

Although great strides have been made to reduce the stigma, several HIV/AIDS activists say that the degree is still high and that it will continue influencing how and where people who are HIV-positive seek HIV/AIDS related services.

65% not getting drugs

Those scenarios provide a glimpse of the complicated world of ARV treatment in Kenya. Of the $142.9 million that PEPFAR provided to fight HIV/AIDS in Kenya in 2005, $58 million — roughly four of every 10 dollars spent by the program — went to underwrite ARV drugs, treatment and laboratory infrastructure for medical testing. ARV treatment has been credited with transforming HIV/AIDS from a fatal condition to a manageable illness. Thanks to the infusion of financing from PEPFAR and other organizations, the number of HIV-positive Kenyans receiving ARV treatment has more than doubled over the past two years, to 70,000.

But with 6.1 percent of the Kenyan population infected, the demand for ARV is still so great that 65 percent of those who need the drugs aren’t getting them. Beyond that, critics say that internal problems have reduced the impact of the PEPFAR-funded effort in Kenya.

The U.S. government’s practice of funding only ARV drugs approved by the U.S. Food and Drug Administration rather than less expensive generic versions available on the international market, they say, has meant that fewer Kenyans are able to receive treatment.

That may change, however, as the country’s PEPFAR program spent 50 percent of its ARV funds on generics in 2006 and plans to use 70 percent of these funds on generics in 2007, according to Warren Buckingham, Kenya’s PEPFAR coordinator.

Critics also say that PEPFAR funding hasn’t sufficiently reduced the cost of medical testing and follow-up monitoring related to ARVs, so that many patients cannot afford the services that they need to remain healthy. Finally, they want PEPFAR to spend more money on nutritional support for impoverished HIV-positive Kenyans, so they aren’t placed in the agonizing dilemma of having to sell their medications to buy food.

While PEPFAR is a good idea, says Dr. Japheth Musiani, a Nairobi-based HIV/AIDS expert, its policy framework is “blind to reality.”

PEPFAR’s success at increasing the number of Kenyans receiving ARV treatment has not been without controversy. The U.S. program’s policy of underwriting only FDA-approved drugs has drawn criticism from Kenyan government officials and HIV/AIDS activists, who argue that the number of people receiving treatment could be doubled or even tripled if cheaper generic versions of ARVs were used.

Use of more affordable generic ARVs is advocated by both the World Health Organization and the Kenyan government. According to the April 2004 edition of the Kenyan National Clinical Manual for ARV Providers, generic versions of various ARVs are acceptable for use in first-line therapy by children and adults.

In response to international criticism, the U.S. government announced in May 2004 that the FDA would set up a “fast-track” approval process for international makers of generic ARVs. But critics have contended that the process remains slow and cumbersome. So far, according to a U.S. Department of Health and Human Services Web site, the FDA had by the end of 2005 approved just 15 generic formulations of ARV drugs, most of them by Indian manufacturers. Since then, according to FDA press releases, several more generic formulations have been approved.

The Kenyan government tried to negotiate with PEPFAR to find a way to use PEPFAR funding to buy generic ARVs, according to a senior official in the Kenyan National AIDS and STDs Control Program (NASCOP), who asked not to be identified. But in the end, Kenyan officials — desperate for funding to fight the nation’s HIV/AIDS epidemic — agreed to accept the U.S. conditions.

“It is like someone, who, knowing very well you are at the point of death, gives you an option to oppose conditions and die or accept and live,” the official said. “You will definitely choose the latter and sort out other issues later. This is the scenario Kenya found itself.”

“The country accepted these kinds of policies,” said Sobbie Mulindi, a psychologist and senior lecturer at the University of Nairobi who sits on several HIV/AIDS committees. “It was anxious to put people on ARVs.”

Dr. Ibrahim Mohammed, the NASCOP director, pronounced the PEPFAR program good. “But we would have been happy if generic drugs were used, as this would have put more people on treatment,” he added.

Dr. Surendra Patel of M.P. Shah Hospital in Nairobi, who has treated HIV/AIDS patients since the first cases were reported in Kenya in 1984, is less diplomatic. “We lost opportunities to save more lives,” he said.

Cost impedes follow-up treatment

PEPFAR’s Buckingham says that in the future, PEPFAR will be spending more of its money on cheaper generic drugs approved by the FDA. But Kenyan HIV/AIDS experts worry that the transition will be too slow. The generic versions of ARVs approved by the FDA so far, they say, are only for first-line, or initial, treatment of the disease.

“The challenge will be how to deal with patients who develop resistance to first-line drugs and have to transit to second-line drugs, whose generics have not been approved by FDA,” said Dr. Omu Anzala, a virologist and project manager at the Kenya AIDS Vaccine Initiative. The issue urgently needs to be tackled, he says, because as more HIV-positive Kenyans get into treatment programs, the chances of lapses in adherence and compliance are likely to increase, providing a fertile ground for drug-resistant strains of HIV to emerge.

HIV-positive Kenyans have another problem that often hinders ARV treatment, according to Ruth Andere, senior nurse at Kenyatta National Hospital’s Comprehensive Care Centre. While PEPFAR-underwritten ARV drugs are provided to them free of charge, many say they are unable to afford the medical consultation fees and routine tests required to put them on treatment. Even those who can afford the initial costs have trouble coming up with the money to pay for the subsequent medical monitoring they need to use ARVs successfully.

At CCC, which runs a major treatment program supported by PEPFAR, the standard consultant fee for an HIV/AIDS patient is Ksh 350 — about $4 in U.S. money, well beyond the means of many Kenyans. Patients must also come up with an additional Ksh 3,700 — roughly $50 — for T-cell counts (which can determine immune system strength and HIV advancement), full hemogram, urea and electroytes, and liver function tests. Once they begin the program, they regularly must come up with the same amount for follow-up monitoring.

Kisabei Phyllis, a CCC counselor who has lived with HIV since 2001, said the cost of the tests is a big burden to her and her husband, who is also HIV-positive. “We have on several occasions been unable to raise the money,” she said. She knows others who scrape to come up with bus fare to the hospital, in hopes that doctors will feel pity for them and do the tests for free or on credit.

PEPFAR’s May 2006 report to the U.S. Congress acknowledges that “although they are often overlooked, the costs of clinical monitoring are an important part” of the plan’s support. In 2005, the program spent nearly $29 million to underwrite services related to ARV — more than the $23 million the U.S. spent on ARV drugs themselves. But for impoverished Kenyans, PEPFAR’s efforts haven’t brought the costs down quite enough.

HIV experts worry that patients who are forced by finances to skip necessary tests have no way of knowing whether their infection is actually responding to the medication. That’s why international organizations, such as Médecins Sans Frontières, which operates a clinic at Mbagathi District Hospital in Nairobi, already are offering free routine tests for patients receiving ARVs.

But for impoverished HIV-positive Kenyans, it isn’t enough simply to receive ARV treatment. To stay healthy, they also must have enough food.

“These drugs are very strong,” said Caroline Sande, a Kenyan who has lived with the virus for nine years. “One cannot take them on an empty stomach.”

CCC and other PEPFAR-funded programs in Kenya are giving nutrition counseling to patients and providing them with nutrient-fortified flour for making porridge. “We tell them how to eat a balanced diet within their means, without having to look for expensive foods,” Andere said.

But for patients who barely can pay for bus fare to the clinic, affording even such austere sustenance is daunting — which is why some resort to the tactic of double-registering for free medication and selling the duplicate doses.

Sarah Mukose, an HIV-positive Nairobi resident, says that others double-register to get extra drug doses for another reason — the fear that funding from PEPFAR and other international donors will someday dry up, leaving them without the medications they need to stay alive.

“There is great apprehension that some of these programs might not be long-lasting and HIV-positive people are using drugs from one center as savings for the future,” said Mukose, who has lived with the virus for 12 years.

Black-marketeering and hoarding of ARV drugs worry physicians. Dr. John Adungosi, director of clinical and community care for the U.S.-based NGO Family Health International (FHI), warns that ARV drugs remain potent for only a finite time.

Those who try to stockpile a supply — or who buy their drugs on the black market to avoid the cost and stigma of going to a clinic — are liable to use expired drugs, he said.

Kenyan HIV/AIDS organizations and clinics have met to discuss what to do about the problem, according to Dr. David Bukusi, the CCC manager. “What came out of the meeting was the need to establish a national database, electronic registration of patients and networking of organizations with treatment programs,” he said.

So far, nothing has come of those discussions. Sam Wambugu, a senior technical officer for monitoring and evaluation at FHI, says that it is now difficult to catch patients who register at more than one PEPFAR-supported ARV clinic. Out of 50 such clinics, Wambugu says that only 30 have computerized patient databases, and none is set up to detect duplicated registrations.

PEPFAR’s Buckingham admits that the program doesn’t have a way to monitor double-dipping. He says that the U.S. program is considering setting up a national patient database and requiring electronic identity cards but that he questions whether the expense would be worthwhile. “The cost of maintaining such a system may be more than the losses when people register at two centers,” he said. He added that as PEPFAR eventually reduces the cost of ARV treatment for patients, the black market in ARV drugs may simply whither away.

But FHI’s Adungosi is not so confident. “If nothing is done now, this problem is not going to go away,” he said. “And as more people are put on treatment, it may move from bad to worse.”

Meanwhile, in the dark corners of shabby pubs in Nairobi, the illicit trade in ARVs continues to flourish. “A person buys what the trader has,” said Peter, one of the local black market dealers. “If this time around is Combivir, you buy. Next time you come and find Viread or Triomune, this is what you take.”