Com : France is the biggest consumer of medicine in Europe and every year 500 new drugs are poured into the French market. But before they make their way into our medicine cabinet, they all have been tested by human guinea pigs who loan their body to science.
Today, half of the clinical trials done by Western countries are being conducted in emerging markets.
For the last five years, Argentina with a population of 41 million has become the favorite destination for the big pharmaceutical companies.
In Santiago del Estero, one of the poorest rural provinces of Argentina, the British lab GSK has tested on thousand of babies the Synflorix, a new vaccine against meningitis, otitis and pneumonia. (noise made by babies)
Graveyard (birds singing in the background)
Suzana and her husband go once a month to the graveyard where their son Luis is buried. He was one of the 14 000 children used as guinea pigs by the major British lab.
Oscar « he died on September 28 2007, he was three months old.».
Com : During these clinical trials, 13 other families have lost a child.
Suzanna « I don't like coming here where my son is buried. He would be five now. Why did these people show up here? What for? »
Com : (wait a little as she picks up her daughter let her kiss her): Suzana is 35; she lives in the working-class neighborhood of Banda with her six daughters and her husband.
Live Suzanne « Be good. Go get bread. »
(entrance of the house)
Com : The family lives on Oscar's salary, he works as a courier for 500 dollars per month. They have no other option than to go to the public hospital for free healthcare.
Live Suzanna « Come here sweetie, sit down baby, come and have your maté. "
Com : Even if they didn't get paid for the clinical trial, it was a great opportunity for them to have a free vaccine for their new born. But it turned into a nightmare.
Suzana « He got sick when he was two months old. He was rushed to the hospital, we found out that it was pneumonia and when we were there a lady came up to me and asked me if I wanted him to receive a new pneumococcal vaccine. At first I refused. I told her that I didn't want to. The hospital staff came over my house to insist and try to convince me to give him the shot. They came a few times and offered to have his ID ready quicker if I accepted to have him as guinea pig. They got me his ID and gave him the shot the same day. They came to pick me up in a van, took me to the hospital and drove me back.
The next day I went back to the hospital with my son because he wasn't feeling well. He received a blood transfusion and on Friday he died of cardiac failure. That's it, he died at 5:00 pm.
I had heard that the shot didn't do anything, and that's why I didn't want it. But they were so pushy that I finally gave in and had him vaccinated.
Com : Dozens of families have reported similar irregularities during the protocol. In January 2012, four years after the end of the trials, GSK was finally condemned by the government of Argentina for unethical conduct. Never heard of before in Argentina!
Oscar « This is the article published in "La Nacion" about the lab that got fined. In a few words, we are innocent or ignorant and they take advantage of it. They abuse it. All the babies who died came from poor families. From what I'm told, in our neighborhood of la Banda in Santiago, they didn't vaccinate the babies of the rich families.
Décrypteur
All the major pharmaceutical labs use double standard. That means that in emerging and poor countries they don't apply the same level of precautions and rules than in their own country.
Com : Suzanna signed this contract with GSK without fully understanding what it was about.
Décrypteur
The informed consent means that the patient must be aware of all the risks that the trial may entail, that he must understand what it's about. In this case, they did the vaccine first and then they told the mothers: go home and read it...
It's a 18-20 pages long document. For mothers who didn't' even attend primary school ... and bring it back signed.
Suzana « There were a lot of papers that we were not going to read. They had a doctor, or a social worker who explained us what this document was about».
Com : GSK has conducted its trial in this clinic. These images were taken in 2008 for an investigative TV show for a national channel. Its broadcast was cancelled the day before its broadcast. Enrique Smith, was in charge of the trial and also happens to be the brother of the Minister of health. He denies the existence of any un-ethical conduct. ???? His interview hasn't been released yet.
Enrique Smith
« The people who accepted or not to take part in this trial have read the informed consent, the document which explains everything. The patients received a copy of it so they could read it. If they didn't want to sign it immediately, they could sign it the next day and read it over carefully at home first. And as for all clinical trials, we have some mothers who refused to sign after they read it. Others accepted, because they trusted us, and because they thought it was the right thing to do. And it always happens in front of a neutral witness.
Journalist:
« The doctors or the nurses didn't put any pressure on mothers?
Enrique Smith
« Not at all. We are quite strict here from an ethical point of view, we even have an ethics committee which supervises it all.»
Com : The lab has also recruited children and medical staff from the hospital Eva Peron where the pediatrician Léandro Gamba works. He has been approached by GSK, but he refused to take part in the trial and even fought to have them stopped.
Live Léandro Gamba
«Very well. Now I will show you what you should do with your baby.»
ITV Léandro Gamba
« They were so pushy; they would harass people until they accepted to take part in the trial. They gave them a cell phone number in case they had complications. To people who don't even have a phone ! Just because the protocol mentions that you have to call this cell phone number if the child taking part in the trials suffers any health issue in order for a doctor to come assist you or tell you what to do.»
Com : The doctors who accepted to conduct those trials on behalf of the lab tripled their monthly salary. Apparently, they received 400 dollars for each child that they recruited.
Leandro Gamba :
« What makes me sad is that Argentinian doctors accept to take part in these deals, either to make extra cash, either because they genuinely believe that what they do will help people.
Décrypteur
The investigating doctor who's doing all the trials works at this public hospital. He recruits the patients for the trials at the hospital. He takes advantage of all the infrastructures of the clinic, and on top of it he pockets the money. This is a real shame. When a trial is conducted at the hospital, the money should go to the hospital.
Com : In 2011 approximately 350 clinical trials were conducted throughout the country and the trend is increasing. Lower costs, shorter deadlines to recruit staff, large concentration of patients who have the same characteristics than Europeans. A real bargain for the big players in the pharmaceutical industry.
Seven years ago, the French lab Sanofi Aventis even set up offices in a residential neighborhood of Buenos Aires. They refused to answer our questions.
Com : (office background for the mixer) In order to conduct clinical trials in record time and at lower cost, some western labs outsource outside providers, called CROS.
ITW person in charge of the CRO
CRO, Contract Research Organization, is an agency which develops good clinical practices, conducts a feasibility study, and is in charge of conducting the trial all the way.
ITW Anne Blanchard
Most of our clients are based in Europe: in Germany, in France and Switzerland, and we also work with American companies. They want quick results in terms of approval and recruitment of the patients, because the need quickly some data for the registers, or to show them to pharmacovigilance agencies. But they also want to have their peace of mind and not to have to deal with poorly trained medical staff.
Com : (in the middle of the frame of the adverts with the synthesizer)
These Argentinian or foreign facilitators are paid by the labs and deal with every step of the process. They recruit the doctors and the patients, conduct the clinical tests, and sometimes even provide themselves the results to their clients. The labs are then in charge of handling the report of the trial's report.
Decrypteur :
Here in Argentina, more than half of the clinical trials are done through CROs. So what does that mean? The CRO recruits the patients for its trials in the hospital, it uses all the hospital's infrastructures, and on top of it they pocket the money. If there are any complaints, any problems, the lab does not want to have direct responsibility for legal consequences. That's why they outsource the clinical trials to the CROs. But you know, the CROs, since they are performing as outside providers, are less strict and are in it to make quick money. They always try to hide the responsibility of the lab that's paying for the clinical trial.
Com : The CRO revenues went through the roof, with 65 million euros in 2010, and a yearly increase of 9%. It is very easy for them to recruit patients because the whole country has shifted to a two-tiered healthcare system.
On the one hand, the richest segment of the population can afford these private clinics, super modern, that look like 5-star hotels.
On the other hand, one third of the population, which is about 12 million people, depends on free healthcare at the public hospitals, which are crowded and mostly equipped for emergencies.
So in order to have access to a better treatment many accept to serve as human guinea pigs.
Myriam is suffering from a rare genetic disease that can cause life-threatening edema if a crisis occurs. Four years ago, she took part in a trial on behalf of a German lab.
Myriam « There were 70 of us in the protocol. I decided to take part in it because I thought that it would contribute to advance research and improve my quality of life at the same time. In all honesty, I didn't hesitate to do it. But once I completed the protocol and finished the doses that the lab sent us, I had no choice but to stop taking the medicine.
Com : After having conducted this trial for over a year and achieved good results, the German lab left Argentina, leaving all these guinea pigs without access to the treatment.
Myriam
« I really don't know how all this protocol business works, etc... but in fact the treatment has been really successful and I would like it to be released on the market because we really need it for this particular disease. We know that this medicine is available in all of the Western world, including Germany, but not yet in Argentina. So yes, we are waiting for it. »
Com : With her healthcare plan, Myriam has access to another drug that is less efficient and much more expensive. The other participants who have no healthcare pan have access to none.
(when she leaves)
According to international ethical practices, it is forbidden to test a drug on patients if they don't have access to it afterwards.
Décrypteur
In Argentina, what we are looking for as a trade union federation, it's a law to regulate clinical trials. Such a law does not exist in Argentina. Many bills are being drafted but none of them got passed the initial draft stage and the Argentinian Parliament has neither read nor studied them.
Com : In Argentina, there are some ethical committees designed to provide a legal framework to medical research on humans. But Argentina is a federal state and the healthcare system is not centralized. Juan Carlos Tealdi, doctor and president of the ethics committee of one of the major hospitals in Buenos Aires, struggles every day to synchronize the current practices.
Juan Carlos Téaldi.
« There is no national body to check the ethics of clinical trials and to protect humans. There is no law, no national agency, no controls in the provinces. Each province of the country makes its own choices. If one province doesn't approve a trial, they try their luck in a different one. If an ethical committee refuses to approve the trials, the lab turns to the one next door.
Com : And in the Santiago del Estero province, the families of the victims pay the price of this legal loophole. They are alone, up against GSK, one of the most powerful pharmaceutical companies in the world.
Like Suzanna and Oscar, Alvajo Ovejero has also lost his three months old baby during the trials for Synflorix. For the last five years, he has been fighting to know the truth.
ITW Alvajo Ovejero
These are the signs that we used during the protest rallies. We would march from the steps of the Square of Liberty to the children's hospital. »
(justice)
Com : GSK has finally been condemned to pay the ridiculous amount of 90 000 dollars to the Argentinian government for non respect of the ethical codes, but the families receive no compensation. Worse even, they still haven't received the explanation of the death of these 14 babies.
ITW Alvajo's wife
« In fact, I don't want that my son's death goes unpunished. According to me, there have been many deaths, and much more than what they want to admit. These are poor innocent creatures who didn't ask for anything. I don't want my son's story to be forgotten, the truth is that I really want justice.
Com :
When the scandal broke out, many lawyers got involved in the story, but they gradually shied away under the pressure of the lab and of the authorities, leaving the families without any support.
Over time, a deadly silence has fallen over Santiago del Estero.
Miguel Torres is among the only ones left on the case. In front of the poor families, his answer is still the same.
Alvajo Ovejero
« So what's happened since the doctors have gone to prison? »
ITW Lawyer
« Justice is a bit slow here. Nothing has been solved, your child was sick, he had a respiratory condition and they gave him a shot when they shouldn't have. We still don't know if he received the shot or a placebo. The justice system is trying to find out exactly what happened. »
Com :
GSK rejects any responsibility in the death of the babies. As far as the lab is concerned, they died of their illnesses. Suzanna and her family are convinced that her son's medical condition got worse after the injection of the vaccine.
Oscar
« It's been five years already. In any other case, a justice decision would have been rendered in two years. And when I tell that to the lawyer, he tells me that we still have to wait, that it won't happen in the near future. It's going to be put on hold again.
Suzana
« Nothing is happening for now, nothing's moving. We have no answer.»
Décrypteur
The protocol killed the children. What I mean is that the lack of care when they suffered complications, the illegal recruitment, the threat s made to the poorest kids to deny them access to the welfare plan if they refused to do the trials, the breach of the informed consent, the failure to provide an independent witness. All the rules that were adopted in Helsinki have been abused.
Com :
(sound for a few seconds).
This morning, Suzana and Oscar have an appointment for a routine check with Maria, their little girl who's handicapped.
Suzana
« We are going to the hospital because we have an appointment with a breathing specialist doctor. We have to go there early otherwise so I don't take the risk of losing my job. I have been there twice already, and never managed to see the doctor. »
(background)
Com : The Synflorix scandal has had long-lasting effects among many families and has tarnished the image of the medical profession.
(Sign Hospital de ninos) Despite the doctors' pressure, Suzanna refuses to have her other children get any vaccination.
(arrival hospital) But the Synflorix has been approved in 2012 by the Argentinian government, and is even now required now for all the children.
Live Suzana « This way. Is this the line? »
Léandro Gamba Synthesizer
« The problem is that part of the cell culture of the vaccine has been lost ... and it is extremely dangerous because it leaves entire populations without protection against diseases that can be avoided with a simple vaccine or with a drop inside the mouth. That's the real problem here. »
Suzana
«Come on, eat your yoghurt, watch out you're making a mess »
Maybe the vaccine works today, but I still don't want them to get vaccinated because I've had a bad experience and now I'm scared. Before, I used to trust doctors, it used to be different, and they were different types of doctors. Today they are all corrupted. They are all liars ... They tell you one thing and it isn't true. My son's life is gone, and nobody will bring it back to me.
Com
Synflorix has been authorized in Europe and it sells now in over 90 countries. However, the compliance to international ethics is supposed to be compulsory before releasing a medicine.
Décrypteur
I think it's important that society as a whole realizes that it is a serious problem. It's a problem that affects human rights and if there is a good debate, a good law may be drafted, and if there is a good law, good policies may be implemented. Some politicians may also tackle the issue. And some others will avoid the issue. It's the responsibility of all of us, and we need to keep discussing it in the future. Here and in the rest of the world, not only in Argentina.
Com
During the last five years, clinical trials have dropped by 25% in Europe, and are now being carried out in emerging countries.
In July 2012, the European Commission has made a proposal to make the rules more flexible in order to boost European competitiveness and to regain control over the trials that were being done outside of Europe. These new rules should be enforced in 2016.