AstraZeneca, Pfizer, Merck et al. turn global poor into non-consenting guinea pigs for drug trials Print E-mail

 London ~ Monday November 14 2011

Without consent: how drugs companies exploit Indian 'guinea pigs'

Illiterate patients say they never agreed to take part in trials run by industry worth £189m

Western pharmaceutical companies have seized on India over the past five years as a testing ground for drugs – making the most of a huge population and loose regulations which help dramatically cut research costs for lucrative products to be sold in the West. The relationship is so exploitative that some believe it represents a new colonialism.

Since restrictions on drug trials were relaxed in 2005, the industry in India has swollen to the point where today more than 150,000 people are involved in at least 1,600 clinical trials, conducted on behalf of British, American and European firms including AstraZeneca, Pfizer, and Merck. There may be more.

While there is no official figure, some estimates suggest the industry may be worth as much as £189m. Regulators have struggled to keep pace with the explosion. Between 2007 and 2010, at least 1,730 people died in India while, or after, participating in such trials. Many of those people, often only eligible for the studies because they were ill, might have died anyway. Yet when there are complications, even those resulting in deaths, there is often a failure properly to investigate.

Campaigners say the industry is wide open to other abuses. While there is no doubt many crucial trials are carried out according to the appropriate guidelines, activists say a lack of oversight has led to numerous situations where poor, sometimes illiterate individuals, recruited from city slums or else tribal communities, are used in the trials without giving proper informed consent – that is, without fully understanding what they are signing up for. Alongside this, a new industry providing participants for these studies has been spawned and is making considerable profits.

Among some of the incidents confirmed by an investigation carried out by The Independent in the states of Madhya Pradesh, Andhra Pradesh, as well as in Delhi and London, were:
* The recruitment of hundreds of tribal girls without parental consent for an immunisation study sponsored by the Bill and Melinda Gates Foundation on the nod of the warden of their government hostel. Several girls subsequently died. The study was halted by the federal authorities.

* The use by drug companies of survivors of the world's worst poisonous gas disaster in Bhopal as "guinea pigs" in at least 11 trials without proper informed consent.

* The completion by doctors at a government hospital in Indore, in central India, of dozens of private trials that a police investigation found "violated the ethical guidelines". The doctors who conducted the trials decided that not one of 81 cases in which a participant suffered an adverse effect was linked to the treatment. New trials were stopped while the state government investigated. A whistle-blower was fired.
India is just one of many developing countries used by leading Western pharmaceutical companies, which spent £40bn in 2010 on research and development. Globally, it is estimated around 120,000 trials are taking place in 178 countries.

Companies can reduce their research costs by an estimated 60 per cent by outsourcing the work. China, Indonesia and Thailand are among the countries which have also seen the incidence of trials soar in recent years. A quarter of all clinical data submitted to European drug regulators to secure market approval for a new drug has been obtained from trials in low- and middle-income countries. Confidential data from drug companies suggests this has recently increased to closer to 50 per cent.

Campaigners say India is a particularly attractive location for researchers not simply because of the lax regulations but because of the size and genetic diversity of the 1.2 billion population and becuase of the variety of conditions to treat. Added to this, almost all doctors speak some English. The infrastructure for such trials, often in the form of government hospitals, is widely available.

The loosening of regulations did away with a measure that had been put in place for the protection of trial subjects. Previously, for a phase three trial of a drug (when it is given to a larger sample of individuals) to be carried out in India, that phase of the trial had already to be have been completed elsewhere. Now they can run concurrently.

A comprehensive picture of the situation regarding drug trials in India following the 2005 amendment to the Drugs and Cosmetics Act is not available because of a lack of transparency and because various agencies are involved in the monitoring of the situation. Instead, much of the information has been gathered by unpaid activists using the country's Right to Information Act.

Much of the data has been collated by Dr Chandra Gulhati, a retired physician who edits the Indian Monthly Index of Medical Specialties, and who pulls together information from across the country on trials going back more than a decade. In his office in Delhi, Dr Gulhati described how lack of oversight and vested interests had created an environment in which many leading institutions had been involved in trials that breached national and international guidelines.

Dr Gulhati said figures released by the authorities suggested around 1,730 people had died following their participation in trials between January 2007 and December 2010. Whether all of these died directly as a result of the trial is unclear; many of those who participated may already have been severely ill and would have died anyway. He claimed there was an absence of clarity because it was left primarily to the doctors overseeing the trial, the ethics committee and the drug companies themselves to determine whether there was a link.

Earlier this year India's Health Minister, Ghulam Nabi Azad, told parliament that a total of 10 foreign drug companies had made payments to the relatives of 22 individuals who had died during or following trials in 2010. The payments came to an average of just 238,000 rupees, or £3,000, for each individual. "Indians are being used by companies to make money selling expensive medicines in the West," claimed Dr Gulhati. "[They are] using illiterate and poor Indians who will never be able to afford these kinds of medicines."

The companies who made the compensation payments were: Pfizer, PPD, Bristol-Myers Squibb, Amgen, Bayer, Eli Lilly, Quintiles, Merck KGaA, Sanofi-Aventis and Wyeth, which is now part of Pfizer. When contacted, most of the companies declined to provide details of the compensation, other than to say the figure had been agreed in conjunction with a supposedly independent ethics committee and the Drug Controller General of India.

A spokeswoman for Eli Lilly also explained that payments totalling £6,340 had been made to the relatives of three individuals who died while participating in a trial of Pemetrexed, an anti-cancer drug. All three were in the advanced stages of cancer. "The causes of death were from known drug-related side effects which were already listed in the package insert," said Dr Anurita Majumdar, a medical adviser to the company. "These events do not lead to death in all patients but can get compounded in certain patients who have poor general condition and nutritional status." Ms Majumdar added: "We were not advised by regulators to stop the trials."

Drug companies insist they always adhere to regulations. In a statement, the Association of the British Pharmaceutical Industry said: "In order for a pharmaceutical company to gain a licence in the UK for a newly developed medicine, the clinical trials, wherever they took place, are subject to a high level of scrutiny by the UK regulatory authorities. It would be of no benefit to companies to conduct clinical trials that were not of the required standard, as any medicine would not gain a licence and not be made available to patients."

While the Indian media has often focused on deaths that have resulted from trials, campaigners say perhaps a bigger issue is the routine exploitation of those who participate in them – individuals who are often poor, ill-educated and unable to read and write.

Many participants said in interviews that they agreed to take part simply because of the recommendation of their doctor, who was very often the person conducting the trials. Since many of those selected to take part are from some of the very poorest communities, individuals have little possibility of redress.

Dr Anand Rai, a former doctor-turned-whistle-blower in the city of Indore, said many of the people recruited for trials at the city's Maharaja Yeshwantrao hospital were from the tribal community.

"There are ethical violations at every level," said Ms N Sarojini, director of the Sama resource group for women, which recently held a forum on clinical trials. "There is a lack of accountability, a lack of monitoring and regulation."

International guidelines have been formulated to protect the rights of trial subjects. They stipulate that the interests of the individual should take precedence over the good of science. Every drug company has policies which conform to these standards. In reality, say activists, these are not adhered to.

The swelling controversy in India has reached the point where the country's parliament was recently told by Brinda Karat, an MP who has called for investigations into abuses: "There is a gross violation of guidelines and laws concerning clinical trials in our country."

Campaigners say the lack of regulation is underscored by the situation regarding ethics committees, from which every institution carrying out a trial must receive approval. Such is the laxity in the guidelines that almost anyone can be part of such a body.

Dr Amar Jesani, editor of the Indian Journal of Medical Ethics, said he was asked to join such a committee at a reputable teaching hospital where there were more than 50 trials registered as ongoing. "There was no organised information about the trials or subjects. When I started going through the protocols so that I could properly assess the study question, the other members said it was the first time they had ever read the protocols," he said.

Indian government officials claim the system includes checks and balances which are being continually improved. In an interview, Dr Vishwa Katoch, director general of the Indian Council of Medical Research, said: "In the last 15 years there has been a remarkable improvement in the functioning of the ethics committees."

Case study: Sarita Kudumula, 13 - Parents only knew Sarita had been in a study after she died
No one told the parents of 13-year-old Sarita Kudumula that the teenager was involved in a medical study. They first they knew of it was after she collapsed and died, some days after receiving the injection. Discovered on the floor of a relative's home, the young girl was rushed first to the local clinic and then to the nearest hospital. By the time they got her there, she was already dead.

The teenager had been part of a study carried out in a remote part of the southern Indian state of Andhra Pradesh (AP) to test the feasibility of vaccinating large numbers of young women against the Human Papiloma Virus (HPV), which is sexually transmitted and is one of the causes of cervical cancer. The trial, administered in conjunction with the state government, was led by a US-based NGO, Path, which received millions of dollars from the Bill and Melinda Gates Foundation. Samples of an anti-cancer vaccine, Gardasil, produced by US company Merck, were provided free of charge. Officials wished to know whether the vaccine could be introduced as part of a national immunisation programme. Up to 74,000 women in India reportedly die from the disease every year.

It seems unlikely that Sarita died as a result of her participation in the study. No one knows exactly what led to her death or those of six others involved in the study in AP and the western state of Gujarat, where another drug, Cervarix, produced by GlaxoSmithKline, was used instead of Gardasil. Both Path and Merck insist that Gardasil is safe. A post-mortem carried out after the girl's death suggested she had committed suicide – a conclusion her parents refuse to accept. A subsequent investigation by the federal government – which suspended the trial after the deaths sparked controversy – concluded it was unlikely the girls had died as a result of having been given the vaccine.

In a sense, though, the cause of Sarita's death is besides the point. What is beyond dispute is that Sarita's father and mother, Nageshwara and Venkatama, and the parents of hundreds of other tribal girls, were not informed their daughters were taking part in a trial – something that is in breach of guidelines laid down by the Medical Research Council of India, which demands that those participating in trials give "informed consent". Sarita's family are adivasis, tribal communities who are among the most vulnerable in India, and Sarita attended a government school and hostel, located a few miles from her home. Only tribal girls attend.

"Nobody came to ask us for permission," said Sarita's father, a farmer, sitting outside his thatched hut in the village of Anjipakka, as he remembered his daughter, who died in January 2010. "She enjoyed the hostel. She was a bright student and took part in all the social activities. She was intelligent. She wanted to become a doctor."

When The Independent visited the pink-painted Government Girls' Ashram and High School in the nearby town of Bhadrachalam, the hostel warden confirmed that health officials had come to the hostel and outlined their plan to vaccinate 300 girls. He said that because it was a government project, he had been told he could authorise the trials without parental permission. "We did not show any forms or ask for the signatures of the girls or the parents," he said. The warden claimed the vaccination programme went off without a hitch.

While the government inquiry did not link the vaccine to the death of the girls or suggest there had been a "major violation of ethical norms", members of the enquiry panel were concerned that tribal girls had participated in the study without consent. "The most significant deficiency in the implementation of the trial was the obtaining of consent," said one finding.

Officials at Path's India office say the study was carried out after the vaccine was already licensed and was not strictly a clinical trial. "Among over 23,000 girls vaccinated [in AP and Gujarat] through the project, seven girls passed away, but the deaths occurred weeks or months following vaccination," said Tarun Vij, Path's country head. Regarding consent, he said: "The state government authorised the wardens to provide this consent for girls who were living at residential schools."

Spokesmen for the Gates foundation, Merck and GlaxoSmithKline all emphasised that the drugs involved in the studies are safe. A GlaxoSmithKline spokesman added that the trials were carried out according to the same standards wherever they were conducted in the world. On the issue of consent, Gates foundation spokesman Chris William said: "The implementing partner on the ground (the state of AP) made the decision to empower headmasters to provide consent for this licensed vaccine in some special circumstances. We haven't seen anything that would suggest that the decision should be second-guessed."

Case study: The Naik family - 'To us a doctor is like a god. We believe them'
Over four years, a close-knit team of senior physicians at the MY hospital in Indore secured and conducted dozens of prestigious trials with drug companies from around the world. They were paid about 50m rupees (£625,000). The doctors insist their work was carried out according to guidelines and an ethics committee oversaw what they did.

But to others, there were causes for concern. Funding for the study was given to the doctors involved and not the hospital. It was not clear that participants fully understood what they were volunteering for. And the only doctors to investigate 81 cases where patients had problems after trials were the same doctors who conducted them.

In the summer of 2010, the state government prevented the hospital from conducting new trials while it held an inquiry. A separate, non-criminal police investigation found doctors had "violated the ethical guidelines on a number of occasions" and that the "fundamental concept of informed consent was also overlooked".

Dr Anand Rai, a physician formerly employed at the hospital who turned whistleblower and was subsequently fired, says that in 81 serious adverse events (SAEs) following 60 trials involving up to 3,000 patients – including one case where a trial subject died – not one was listed as having been the result of a trial and not one person received compensation.

"To us, a doctor is like a god. We believe everything he says," said Ajay Naik, 28, whose baby son, Yatharth, developed white spots on his skin after a trial. "My wife was told a new multi-vaccine had come that costs 8-10,000 rupees and that it was available free of charge." They had no idea they were involved in a trial. "There was a two-page form in English. No one read out the details," he said.

The five doctors named in the complaint to the police adamantly deny wrongdoing and claim they are victims of false allegations levelled by the media and campaigners. Dr Pushpa Verma, one of the physicians involved, said the allegations had been made by "uneducated people" and that the police were unqualified to investigate the matter. She added: "There were no ethical violations."

 London ~ Monday November 14 2011

Leading article: Drugs firms must not prey on poverty

Clinical trials for new pharmaceutical drugs are a sensitive business. Companies are under pressure to come up with new treatments for cancer, Aids, MS – the list is almost endless. But tests can be expensive. If they go wrong, companies are liable for compensation. No surprise, then, that in a globalised economy this business – like many others – is being outsourced to countries such as India where costs are far lower.

In a country of 1.2 billion people, where more than half the population lives in chronic poverty according to a recent UN report, the supply of people willing to take part in tests for very modest fees is inexhaustible. Compensation payouts are a fraction of what they would be in the West. Moreover, legislation on testing in India is lax.

As we report today, more than 1,700 Indians have died from 2007 to the end of last year while taking part in drugs tests sponsored by Western pharmaceutical companies. Many may have died from natural causes, but the fact that we don't know how many highlights a lack of openness and transparency in the way these companies operate. It is not clear that the testing companies have investigated the causes of these deaths while the evidence is strong that many people embarked on trials without having much idea of the risks involved. In some cases it is not clear they even gave consent.

Among the cases we report is one concerning tribal girls who were volunteered for immunisation tests on the say-so of the warden of the hostel in which they lived. Several later died. A further cause of concern is the way the large Western drugs companies farm out tests to other firms. There may be good reasons for this but it is bound to raise suspicions that these companies are trying to evade responsibility for when things go wrong.

Doubtless many people in India are grateful for the fees they have earned from tests. But if the big Western companies don't want to attract opprobrium, they should follow their own rules of conduct more clearly and allow greater outside oversight. They should also be legally present in the countries where tests take place, ensuring greater accountability. Lowering costs in the search for cheaper cures is one thing. Abusing people's poverty is another.

~ Tuesday July 7 2009
Original at:  Tuesday July 7 2009


Drug firms target world's poor as US market contracts

By Avery Johnson

Julio Rodriguez holds his 3-month-old niece in the kitchen of the small house he shares with his wife, mother, sister and niece. (David Rochkind/Rapport for The Wall Street Journal)

JULIO Rodriguez was on a sales call at a clinic in the slum of Petare in Venezuela recently, when he heard four gunshots go off nearby.

It was business as usual for Mr Rodriguez in the area that overlooks the Caracas. As a representative in Venezuela for US pharmaceutical giant Pfizer, his sales route takes him through one of Latin America's most dangerous neighbourhoods. To avoid attracting attention, he wears a polo shirt with a red logo, the colour worn by supporters of President Hugo Chavez.

Mr Rodriguez is part of a strategic shift in the $US770 billion ($965bn) pharmaceutical industry to target the working poor in the developing world.

For the first time in a half-century, sales of prescription drugs are forecast to decline this year in the US, which has historically been the industry's biggest and most profitable market. The administration of US President Barack Obama and Congress's attempt to pass legislation overhauling the healthcare system, including provisions that could lower the cost of medicine, could put the US businesses of drug-makers under further pressure.

As a result, developing countries like Venezuela have begun to look more attractive to the industry. Sales of prescription drugs in emerging markets reached $US152.7bn in 2008, up from $US67.2bn in 2003, according to IMS Health, which tracks the industry. IMS forecasts sales will climb to $US265bn by 2013.

With a handful of other drug-makers, including Britain’s GlaxoSmithKline, Switzerland's Novartis and France's Sanofi-Aventis, Pfizer is making a big push into the developing world. In addition to Venezuela, the company is expanding in China, India, Brazil, Russia and Turkey.

Pfizer brought in $US1.4bn in sales from emerging markets in the first quarter of this year - a fraction of its $US10.8bn in overall sales in the same quarter, but a slice that Pfizer says it is determined to expand.

Until recently, drug companies doing business in emerging economies have catered mostly to the wealthy and middle class. Now, Pfizer is turning to what it calls, in internal marketing discussions, the "bottom of the pyramid". Its program in Venezuela is an exercise in how to reduce prices enough to attract poorer customers while still turning a profit.

"There's an economy in the barrios," says Rafael Mendoza, the man Pfizer has put in charge of the strategy in Venezuela, as he gestures toward the satellite dishes and air conditioners that dot Petare.

Two years ago, Mr Mendoza began laying plans for a program that would involve sending sales representatives into Petare. Caracas's largest shantytown is home to more than 1 million people who live in colourful houses clinging to the side of a mountain overlooking the capital's downtown.

Mr Mendoza decided to hire someone from the slum who would know his way around and possibly be less of a target for theft. One of the office assistants in Pfizer's Caracas office persuaded her cousin, Mr Rodriguez, to apply.

Initially reluctant, Mr Rodriguez, 35, recalls thinking that pharmaceutical sales reps were "snobs" who brushed airily past patients in busy doctors' offices. He was also intimidated by all the science and worried he wouldn't fit in at a big multinational company.

But the opportunity was hard to pass up. One of five children, Mr Rodriguez was raised in Petare by a single mother who needed to stop working because of a shoulder injury. He started peddling women's undergarments in street stalls at age 15.

By 2006, Mr Rodriguez was working as a security guard in the Caracas subway system at night and selling Canon office supplies by day. He enrolled in college, and expects to finish an accounting degree in February.

For the Pfizer job, Mr Rodriguez underwent a three-month training program he found grueling. He had trouble memorising the medical terminology. He recalls being given a binder on the cardiovascular system on a Monday and being tested on it the next Wednesday. One night, he said to his mother in exasperation, "I'm not studying to be a doctor!"

But the work paid off. His job brings in between $US930 and $US1800 a month, depending on commissions, up to 60 per cent more than his previous two jobs combined. Mr Rodriguez drives a new Chevrolet Aveo that he can buy from Pfizer cheaply at the end of its lease.

When Mr Rodriguez started knocking on clinic doors in late 2007, Petare's doctors were surprised to see a drug-company sales rep in a slum. The first question many asked was how he managed to reach their offices without getting his expensive samples ripped off, Mr Rodriguez says. (The answer: He changes his route every day and sometimes carries a rolling bag, and at other times, a shoulder bag.) The second question he usually fielded had to do with the price of Pfizer's drugs.

Pfizer is benefiting from a belief in Venezuela and in much of the developing world that branded medicines are worth paying a premium for because they're safer and more effective than generics. Pfizer's prices in Venezuela tend to be about 30 per cent under US prices, but are still 40-50 per cent more than generics, which are widely available here since patents aren't usually enforced. In some cases, the spread is even wider. In a few Petare pharmacies, for example, Pfizer's cholesterol-lowering drug Lipitor costs between $US100 and $US125 a month for a standard dose, compared with less than $US50 for a generic.

That can add up in a place where the monthly minimum wage is roughly $US450. Some public-health officials question whether Pfizer is promoting what they say is an unfounded perception that generic drugs aren't trustworthy. "The quality of a product has nothing to do with the brand name," says Hans Hogerzeil, the World Health Organisation's director of essential medicines and pharmaceutical policies.

Pfizer says the problem with generics in Venezuela is that laws requiring them to be equivalent to brand-name versions aren't uniformly enforced. Pfizer's Mr Mendoza also cites data from the WHO that up to 30 per cent of drugs sold in the developing world are counterfeit and may not be effective. To help with cost, Pfizer says it offers doctors in Petare discount coupons that knock down the price for its drugs by another 10-20 per cent. Lipitor is part of a separate buy-two-get-one-free promotion. Those deals reduce but don't eliminate the price gap.

"We are Pfizer and we sell BMWs, so we won't put our products at the price of the Chinese car," says Mr Mendoza.

Mr Chavez's socialist regime was elected with a mandate to increase access to healthcare for the poor. But 80 per cent of drugs in Venezuela are still paid for by patients themselves, according to IMS Health, and only a small percentage of well off Venezuelans have private health insurance to cover doctors and drugs.

The Chavez government declined to comment about Pfizer's program in Petare, but Pfizer says the government has expressed interest in learning more about it. Gustavo Villasmil, the Health Minister for Miranda state, where Petare is located and where the opposition took power last year, says he welcomes pharmaceutical sales reps. "Governments, including mine, are not doing well at eliminating barriers to access" to drugs, he says.

Mr Rodriguez's main approach in persuading Petare's doctors to prescribe Pfizer drugs is to emphasise the brand's quality over generics. He tells doctors that Norvasc, Pfizer's hypertension medicine, for example, stays in patients' blood for 56 hours, making it more reliable for older patients who might forget to take their medicines. Generic drugs, says Mr Rodriguez, can't guarantee the same longevity.

He says patients in Petare will follow orders even if it means spending more. "If their doctor, their doctor from birth, the doctor they have had all their life, tells them, 'Look, this is what is going to cure you, this is what will guarantee your health,' that's what the patient buys."

Pfizer also woos doctors by giving them computers and internet access for use at their offices. In the US, the practice of drug-maker "giveaways," even of items as small as pens and coffee cups with logos, has drawn fire for influencing doctors' prescribing, and the industry has voluntarily done away with most freebies.

In Venezuela and much of the developing world, where doctors don't earn as much, the practice is more common, and it sometimes can benefit patients. At one of the clinics Mr Rodriguez visited recently, for example, Carlos Serrano beamed about the computer and free internet access Pfizer has given him. Dr Serrano, who has practised medicine in Petare for 30 years, uses the computer and a Pfizer "telemedicine" web page to help diagnose patients online by communicating in real time with doctors in downtown Caracas.

Pfizer says the computers start out as loans and become permanent gifts once the doctors have shown that they are using them for medical purposes and have signed a waiver stating they understand they're not intended to influence their prescribing.

Dr Serrano says he's increased by 40 per cent the number of Pfizer drugs he prescribes since Mr. Rodriguez started calling on him in late 2007. The aid doesn't sway him, he adds. "There are some illnesses that have to be treated with a good product, no matter what the cost," Dr Serrano says.

In the coming weeks, Pfizer plans to refurbish the crumbling exterior of Dr Serrano's office and paint it with the logo of its program in Petare, called "Healthier Community", which combines "Pfizer blue" and Chavez red.

Mr Rodriguez visits between eight and 10 of Petare's roughly 560 doctors a day. One group he says he's had less success with are Cuban doctors who staff the several dozen government-run clinics - part of an oil-for-medicines swap between oil-rich Venezuela and the Castro regime. The clinics give away free drugs.

He says he courted them for a year by passing them Pfizer-branded prescription pads, free samples and educational materials through the gates outside their buildings. At first sceptical, some doctors finally agreed to talk to him, says Mr Rodriguez. He says he's now able to call on 17 of Petare's roughly 40 Cuban-staffed clinics.

The Venezuelan office that oversees the clinics couldn't be reached for comment. The Venezuelan Embassy in Washington declined to comment.

Maximo Lobato, a 62-year-old resident of Petare who helps support his daughter and grandson on a carpenter's salary of about $US750 a month, says he would rather pay for branded drugs than take free drugs handed out at clinics, or pay for cheaper generics.

Mr Lobato has been diagnosed with high cholesterol and also has had prostate surgery. He has been taking Lipitor and several other medications. Before buying the drugs in June, he said he would allocate money to other pressing bills: $US240 to get his phone turned back on, $US51 for his monthly satellite-TV subscription, and $US23 a week for his grandson's daycare. With what is left over, he said he'd buy a supply of Lipitor and one of the other drugs. Referring to branded drugs, Mr Lobato says, "According to the price, they probably work better."

In part because of this view, drugs like Lipitor continue to sell well in Venezuela. The Venezuelan market has six generic versions of Lipitor. Yet the brand is still the second-biggest seller among all drugs, with $US37.5 million in 2008 sales, up 44 per cent from 2007. In Petare alone, Pfizer has tripled its market share to 18 per cent from 6 per cent in late 2007, when the program launched. Pfizer has hired three reps to work other slums around Caracas and hopes to roll the program out nationwide by the end of the year. It also has plans to expand it to other countries in Latin America.

Not all patients want to splurge for branded drugs. Luis Osuna, 54, needed an antibiotic for his wife's leg infection, and was happy when the pharmacist gave him a generic version of Pfizer's Zithromax that cost $US12. "I don't think there was too much of a difference," he says. "It had the same effect. It worked on her."

Alexis Quijada, who dispenses drugs at the pharmacy where Mr Osuna was shopping, says he routinely recommends generics to patients. He recently suggested a generic alternative to a patient who came in asking for Lipitor because, he says, "Petare is a humble area."

With Juan Carlos Lagorio